K100584 · Olympus Medical Systems Corporation · NWB · Jul 2, 2010 · Gastroenterology, Urology
Device Facts
Record ID
K100584
Device Name
EVIS EXERAII 180 SYSTEM
Applicant
Olympus Medical Systems Corporation
Product Code
NWB · Gastroenterology, Urology
Decision Date
Jul 2, 2010
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic, Real-World Evidence, Pediatric
Real-World Evidence
Submission
Device
Sponsor
RWD Sources
RWE Use Summary
Key Tags
K100584 · Jul 2, 2010
EVIS EXERAII 180 SYSTEM
Olympus Medical Systems Corporation
Clinical literature
Clinical literature was provided to support new sales promotional claims for Barrett's esophagus, colorectal polyp detection, and histology prediction.
Barrett's esophagus; colorectal polyp detection; histology prediction; clinical literature
Clinical Evidence
Study Design
Population
Comparator
Key Endpoints
Clinical literature regarding Barrett's esophagus, colorectal polyp detection, and histology prediction
Patients undergoing endoscopic procedures for Barrett's esophagus or colorectal polyp detection
EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180: This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation. EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180: This video system center has been designed to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation. EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180, OLYMPUS GIF TYPE XP180N: These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for transoral or transnasal endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, and duodenum). EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q180, OLYMPUS GIF TYPE H180: These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, and duodenum). EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AL, OLYMPUS CF TYPE Q180AI, OLYMPUS CF TYPE H180AL, OLYMPUS CF TYPE H180AI, OLYMPUS PCF TYPE Q180AL (Pediatric), OLYMPUS PCF TYPE Q180AI (Pediatric), OLYMPUS PCF TYPE H180AL (Pediatric), OLYMPUS PCF TYPE H180AI (Pediatric): These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
Device Story
EVIS EXERA II 180 System comprises xenon light source (CLV-180), video system center (CV-180), and various flexible videoscopes (gastrointestinal/colonovideoscopes). System captures endoscopic images via CCD sensors in scopes; processes signals in CV-180 for display, recording, and transmission. CLV-180 provides white light or Narrow Band Imaging (NBI) via optical filter to enhance visualization of surface/capillary patterns. Used in clinical settings by physicians for diagnosis and treatment. Scope ID function enables automatic compatibility recognition. Output viewed on monitors to guide clinical decision-making, biopsy, or surgery. Benefits include improved visualization of mucosal structures and vasculature.
Clinical Evidence
No clinical trials conducted for this submission. Substantial equivalence based on bench testing and comparison to predicate devices. Clinical literature cited to support promotional claims regarding Barrett's esophagus, colorectal polyp detection, and histology prediction.
Technological Characteristics
System includes xenon short-arc lamp (300W), CCD-based imaging, and NBI optical filtering. CV-180 provides video processing (AGC, white balance, image enhancement). Connectivity via system/foot switch connectors. Class I electrical safety. Compatible with flexible/rigid endoscopes. Sterilization/reprocessing per standard endoscopic protocols.
Indications for Use
Indicated for endoscopic diagnosis, treatment, and video observation of the upper digestive tract (esophagus, stomach, duodenum) and lower digestive tract (anus, rectum, sigmoid colon, colon, ileocecal valve) in patients requiring endoscopic procedures.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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K100584
JUL-- 2 2010
## 510(k) SUMMARY
# EVIS EXERA II 180 SYSTEM
#### February 26, 2010
#### General Information 1
■ Applicant: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan Establishment Registration No.: 8010047
Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance
Center Valley, PA 18034-0610, USA
Email: stacy.kluesner@olympus.com
Olympus America Inc. 3500 Corporate Parkway
Phone: 484-896-5405 FAX: 484-896-7128
PO Box 610
Official Correspondent: .
월 Manufacturer: Light source/Video system center:
Gastrointestinal videoscope/ Colonovideoscope:
Shirakawa Olympus Co., Ltd. 3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura, Nishirakawa-gun, Fukushima, Japan 961-8061
Aizu Olympus Co., Ltd. 500 Aza-Muranishi, Ooaza-lidera, Monden-cho. Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No .: 9610595
Establishment Registration No.: 3002808148
#### 2 Device Identification
■ Device Trade Name:
Common Name: 올리
■ Regulation Number:
■ Regulation Name:
를 Regulatory Class:
- l Classification Panel:
- Product Code:
EVIS EXERA II 180 SYSTEM
Endoscopic Video Imaging System
21 CFR 876.1500
Endoscope and accessories
II
Gastroenterology/Urology
NWB, FDF, FDS
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### 3 Legally Marketed Device to which Substantial Equivalence is Claimed
The following table shows the primary components (part of this submission) of the EVIS EXERA II 180 SYSTEM and each device to which we claim substantial equivalence (predicate device).
| Table 16-1 Primary Components & Predicate Devices of the EVIS EXERA II 180 SYSTEM | | |
|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-----------------------|
| Subject Device<br>(Part of this Submission) | Predicate Device | PD's<br>510(k)<br>No. |
| EVIS EXERA II XENON LIGHT SOURCE<br>OLYMPUS CLV-180<br>(Hereinafter referred to as CLV-180)<br>(K061313, K062049) | EVIS EXERA Xenon Light Source<br>Olympus CLV-160A | K051645 |
| EVIS EXERA II VIDEO SYSTEM<br>CENTER OLYMPUS CV-180<br>(Hereinafter referred to as CV-180)<br>(K061313, K062049) | EVIS EXERA Video System Center<br>Olympus CV-160A | K051645 |
| EVIS EXERA II GASTROINTESTINAL<br>VIDEOSCOPE OLYMPUS GIF TYPE<br>N180<br>(Hereinafter referred to as GIF-N180) | EVIS EXERA Gastrointestinal<br>Videoscope XGIF-N160Y2 | K051645 |
| EVIS EXERA II GASTROINTESTINAL<br>VIDEOSCOPE OLYMPUS GIF TYPE<br>XP180N<br>(Hereinafter referred to as GIF-XP180N) | EVIS EXERA Gastrointestinal<br>Videoscope XGIF-N160Y2 | K051645 |
| EVIS EXERA II GASTROINTESTINAL<br>VIDEOSCOPE OLYMPUS GIF TYPE<br>Q180<br>(Hereinafter referred to as GIF-Q180) | EVIS EXERA Gastrointestinal<br>Videoscope XGIF-Q160Y5 | K051645 |
| EVIS EXERA II GASTROINTESTINAL<br>VIDEOSCOPE OLYMPUS GIF TYPE<br>H180<br>(Hereinafter referred to as GIF-H180) | EVIS EXERA Gastrointestinal<br>Videoscope XGIF-H160Y2 | K051645 |
| EVIS EXERA II COLONOVIDEOSCOPE<br>OLYMPUS CF TYPE Q180AL<br>(Hereinafter referred to as CF-Q180AL) | EVIS EXERA Colonovideoscope<br>XCF-Q160W6L | K051645 |
| EVIS EXERA II COLONOVIDEOSCOPE<br>OLYMPUS CF TYPE Q180AI<br>(Hereinafter referred to as CF-Q180AI) | EVIS EXERA Colonovideoscope<br>XCF-Q160W6L | K051645 |
| EVIS EXERA II COLONOVIDEOSCOPE<br>OLYMPUS CF TYPE H180AL<br>(Hereinafter referred to as CF-H180AL) | EVIS EXERA Colonovideoscope<br>XCF-H160AY2L | K051645 |
| EVIS EXERA II COLONOVIDEOSCOPE<br>OLYMPUS CF TYPE H180AI<br>(Hereinafter referred to as CF-H180AI) | EVIS EXERA Colonovideoscope<br>XCF-H160AY2L | K051645 |
| EVIS EXERA II COLONOVIDEOSCOPE<br>OLYMPUS PCF TYPE Q180AL<br>(Hereinafter referred to as PCF-Q180AL) | EVIS EXERA Colonovideoscope<br>XPCF-Q160AY2L | K051645 |
| EVIS EXERA II COLONOVIDEOSCOPE<br>OLYMPUS PCF TYPE H180AL<br>(Hereinafter referred to as PCF-H180AL) | EVIS EXERA Colonovideoscope<br>XPCF-Q160AY2L | K051645 |
| EVIS EXERA II COLONOVIDEOSCOPE<br>OLYMPUS PCF TYPE H180AI<br>(Hereinafter referred to as PCF-H180AI) | EVIS EXERA Colonovideoscope<br>XPCF-Q160AY2L | K051645 |
1 2 . i
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#### Device Description ব
The EVIS EXERA II 180 SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation of the upper and lower digestive tract.
The primary components of the subject system, which are part of this submission, are:
- EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180
- EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE XP180N .
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q180 .
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180 트
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AL I
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AI .
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AL
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AI
- . EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE Q180AL (PEDIATRIC)
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE Q180AI (PEDIATRIC) 1
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AL (PEDIATRIC) u
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AI (PEDIATRIC)
The EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 is intended for endoscopic diagnosis, treatment and video observation. The CLV-180 is substantially identical to the predicate device, EVIS EXERA Xenon Light Source CLV-160A cleared under K051645 except that the device size has been slightly changed. The CLV-180 has an optional filter which allows the user to enhance endoscopic white light images by selective processing of green and blue light. This feature, referred to as Narrow Band Imaging (NBI), employs an optical filter to filter the white light spectrum, changing it from a broad band to a narrow band. The user can select eihter the standard obsevation mode by pressing the scope switch on the scope or the filter mode switch on the CLV-180. In comparison to conventional white light observation, NBI observation provides the greater contrast of the surface and fine capillary patterns of the mucous membranes.
The EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 is a video processing system intended for use with Olympus endoscopes such as the subject gastrointestinal videoscopes and colonovideoscopes. The CV-180 contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The CV-180 is identical to the predicate device, EVIS EXERA Video System Center CV-160A, cleared under K051645 except that the device size has been slightly changed.
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videoscopes and colonovideoscopes. TThe CV-180 contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The CV-180 is identical to the predicate device, EVIS EXERA Video System Center CV-160A, cleared under K051645 except that the device size has been slightly changed.
The CV-180 incorporates the following features:
1. The CV-180 is compatible with any specified Olympus flexible, both video and fiberoptic, and rigid endoscopes.
2. The CV-180 processes the NBI image, generated by the CLV-180 light source and captured by the endoscope's Charged Coupled Device (CCD), creating an enhanced image of the tissue's vasculature.
Both the CLV-180 and CV-180 can be used with any specified Olympus flexible and rigid endoscope models, including gastroscopes, ultrasound gastroscopes, duodenoscopes, colonoscopes, sigmoidscopes, choledochoscopes, rhino-laryngoscopes, tracheal intubation scopes, transnasal esophago scopes, hysteroscopes, cystoscopes, ureterorenoscopes, laparo-thoracoscopes for conventional white light endoscopy. TThe subject premarket notification is specific for gastrointestinal videoscopes and colonovideoscopes.
Additionally, when they are combined with the subject endoscopes, both an endoscopic image by white light illumination and that by NBI illumination can be obtained. The user can select either the NBI mode or normal light mode by pressing the scope switch on the scope or the filter mode switch on the CLV-180; the NBI filter in the CLV-180 is inserted on the light axis when the NBI mode is selected.
The subject endoscopes are basically identical to each Olympus predicate device shown in Table 16-1 in intended use, and similar in specifications, performance and materials. The CV-180 identifies an NBI-compatible scope when it is connected by using the Scope ID function provided with the scopes ..
#### 5 Indications for Use
. .
#### EVIS EXERA II XENON LIGHT SQURCE OLYMPUS CLV-180
This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
### EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180
This video system center has been designed to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
### EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180, OLYMPUS GIF TYPE XP180N
These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy
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and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, and duodenum).
EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AL, OLYMPUS CF TYPE Q180AI, OLYMPUS CF TYPE H180AL, OLYMPUS CF TYPE H180AI, OLYMPUS PCF TYPE Q180AL (Pediatric), OLYMPUS PCF TYPE Q180Al (Pediatric), OLYMPUS PCF TYPE H180AL (Pediatric), OLYMPUS PCF TYPE H180AI (Pediatric)
These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
#### Comparison of Technological Characteristics હ
Each primary components of the EVIS EXERA II 180 SYSTEM is basically identical to its predicate device in intended use, and similar in specifications. Comparison between the subject and predicate devices is shown in Table 16-2 to 16-11. The clinical literatures provided in this submission support new sales promotional claims for Barrett's esophagus, colorectal polyp detection and histology prediction.
#### Table 16-2 Comparison of Specifications
### Subject Device: EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 ~ Predicate Device: EVIS EXERA Xenon Light Source Olympus CLV-160A (K051645)
| Specifications | Subject Device<br>CLV-180 | Predicate Device<br>CLV-160A |
|--------------------------------|---------------------------------------|----------------------------------------------|
| Power Supply | 100-120V AC ±10%, 50/60 Hz ±<br>1Hz | 100-240V AC±10%, 50/60 Hz ±<br>1Hz |
| Over-current Protection | Identical to the Predicate Device | Fuse type |
| Input Current | Identical to the Predicate<br>Device. | 500VA (at observation) |
| Size | 383(W)×162(H)×536(D)mm | 381(W)×162(H)×536(D)mm |
| Weight | Identical to the Predicate Device | 15.4kg |
| Compatible Endoscopes | Identical to the Predicate Device | Videoscope<br>Fiberscope<br>Rigid scope |
| Examination Lamp | Identical to the Predicate Device | Xenon short-arc lamp<br>(ozone-free)300W |
| Average Lamp Life | Identical to the Predicate Device | Approximately 500 hours of<br>continuous use |
| Emergency Lamp | Identical to the Predicate Device | Halogen lamp 12V 35W |
| Average Emergency<br>Lamp Life | Identical to the Predicate Device | Approximately 500 hours |
| NBI Filter | Identical to the Predicate Device | Provided |
| Brightness Control | Identical to the Predicate Device | Automatic and Manual |
| Automatic Exposure | Identical to the Predicate Device | 17 steps |
| Photography Function | Identical to the Predicate Device | Not provided. |
| Air Feeding | Identical to the Predicate Device | 4 levels available (off, low, mid |
5/12
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| | Emergency Lamp | Identical to the Predicate Device | Halogen lamp 12V 35W |
|--|-------------------------------------------------------------------|-----------------------------------|--------------------------------------------------------|
| | Average Emergency<br>Lamp Life | Identical to the Predicate Device | Approximately 500 hours |
| | NBI Filter | Identical to the Predicate Device | Provided |
| | Brightness Control | Identical to the Predicate Device | Automatic and Manual |
| | Automatic Exposure | Identical to the Predicate Device | 17 steps |
| | Photography Function | Identical to the Predicate Device | Not provided. |
| | Air Feeding | Identical to the Predicate Device | 4 levels available (off, low, mid, high) |
| | Air Feeding Pump | Identical to the Predicate Device | Diaphragm type pump |
| | System Connector | Identical to the Predicate Device | Provided |
| | Foot Switch Connector | Identical to the Predicate Device | Provided |
| | CV Connector | Identical to the Predicate Device | Provided |
| | Cooling Air Direction | Identical to the Predicate Device | Rear |
| | Type of Protection<br>against Electric Shock | Identical to the Predicate Device | Class I |
| | Degree of Protection<br>against Electric Shock of<br>Applied Part | Identical to the Predicate Device | TYPE BF or CF applied part<br>(Depend on applied part) |
| | Applicable Standard | Identical to the Predicate Device | UL60601-1 |
.
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## Table 16-3 Comparison of Specifications (1/2) Subject Device: EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 Predicate Device: EVIS EXERA Video System Center Olympus CV-160A (K051645)
.
| Specifications | | Subject Device<br>CV-180 | Predicate Device<br>CV-160A |
|----------------------------------------------------------------|---------------------------------------|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power Supply | | Identical to the Predicate<br>Device | 100-240V AC±10%, 50/60 Hz ±<br>1Hz |
| Over-current Protection | | Identical to the Predicate<br>Device. | Fuse type |
| Input Current | | Identical to the Predicate<br>Device. | 150VA |
| Size | | 382(W)×91(H)×490 (D) mm | 370(W)×91(H)×462 (D)mm |
| Weight | | 10 kg | 10.6 kg |
| Compatible Endoscopes | | Identical to the Predicate<br>Device. | · Fiber/rigid scope via camera<br>head<br>· Videoscope |
| | Video Signal<br>Output | Identical to the Predicate<br>Device. | RGB:3 Y/C:4 VBS:4<br>HDTV:1 |
| Observation | Auto White<br>Balance | Identical to the Predicate<br>Device. | Automatically adjusted using the<br>white balance switch.<br>At the time of connection with<br>the scope in which Scope ID is<br>provided, compensation is<br>performed automatically. |
| | Standard Color<br>Chart Output | Identical to the Predicate<br>Device. | Color bar image |
| | Color Tone<br>Adjustment | Identical to the Predicate<br>Device. | R: ±8 steps B: ±8 steps<br>CHROMA: ±8steps |
| | Automatic<br>Gain<br>Control (AGC) | Identical to the Predicate<br>Device. | Provided |
| | Image<br>Enhancement | Identical to the Predicate<br>Device. | Edge enhancement: [OFF] [Low]<br>[Med] [High] 4 levels available<br>Structure enhancement:[OFF]<br>[Low] [Med] [High] 4 levels<br>available |
| | Iris Mode<br>Selection | Identical to the Predicate<br>Device. | AUTO/PEAK<br>EXPOSURE Electrical shutter |
| | Optical Zoom | Identical to the Predicate<br>Device. | ×1/×1.2 /×1.5: 3-Mode |
| | NBI<br>Observation | Identical to the Predicate<br>Device. | NBI function |
| | Picture in<br>Picture | Identical to the Predicate<br>Device. | The image of an external device<br>connected to this instrument is<br>displayed on the main monitor<br>together with the endoscopic<br>image. |
| Communication with Scope | | Identical to the Predicate<br>Device. | Provided |
| Foot Switch Connector | | Identical to the Predicate<br>Device. | Provided |
| Specifications | Subject Device<br>CV-180 | Predicate Device<br>CV-160A | |
| Record to Memory Card | Identical to the Predicate<br>Device. | Provided | |
| Type of Protection against<br>Electric Shock | Identical to the Predicate<br>Device. | Class I | |
| Degree of Protection against<br>Electric Shock of Applied Part | Identical to the Predicate<br>Device. | TYPE BF or CF applied part<br>(Depend on applied part) | |
| Applicable Standard | Identical to the Predicate<br>Device. | UL60601-1 | |
.
1000
.
.
.
.
-
{7}------------------------------------------------
### Table 16-3 Comparison of Specifications (Continued, 2/2) Subject Device: EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 Predicate Device: EVIS EXERA Video System Center Olympus CV-160A (K051645)
# Table 16-4 Comparison of Specifications Subject Device: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GIF-N180
# Predicate Device: EVIS EXERA Gastrointestinal Videoscope XGIF-N160Y2 (K051645)
| Specifications | Subject Device<br>GIF-N180 | Predicate Device<br>XGIF-N160Y2 |
|-----------------------------------------|-----------------------------------|---------------------------------|
| Field of View | Identical to the Predicate Device | 120° |
| Depth of Field | Identical to the Predicate Device | 3-100mm |
| Direction of Forward View | Identical to the Predicate Device | 0° |
| Type of CCD | Identical to the Predicate Device | Color |
| Outer Diameter of Distal End | Identical to the Predicate Device | 4.9mm |
| Outer Diameter of Insertion Tube | Identical to the Predicate Device | 4.9mm |
| Bending Section Angulation | Identical to the Predicate Device | UP: 210°<br>DOWN: 120° |
| Working Length | Identical to the Predicate Device | 1100mm |
| Inner Diameter of Instrument<br>Channel | Identical to the Predicate Device | 2.0mm |
.
·
.
{8}------------------------------------------------
# Table 16-5 Comparison of Specifications Subject Device: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GIF-XP180N
| Specifications | Subject Device<br>GIF-XP180N | Predicate Device<br>XGIF-N160Y2 |
|-----------------------------------------|----------------------------------------------------|---------------------------------|
| Field of View | Identical to the Predicate Device | 120° |
| Depth of Field | Identical to the Predicate Device | 3-100mm |
| Direction of Forward View | Identical to the Predicate Device | 0° |
| Type of CCD | Identical to the Predicate Device | Color |
| Outer Diameter of Distal End | 5.5mm | 4.9mm |
| Outer Diameter of Insertion Tube | 5.5mm | 4.9mm |
| Bending Section Angulation | UP: 210°<br>DOWN: 90°<br>RIGHT: 100°<br>LFFT: 100° | UP: 210°<br>DOWN: 120° |
| Working Length | Identical to the Predicate Device | 1100mm |
| Inner Diameter of Instrument<br>Channel | Identical to the Predicate Device | 2.0mm |
#### Predicate Device: EVIS EXERA Gastrointestinal Videoscope XGIF-N160Y2 (K051645)
#### Table 16-6 Comparison of Specifications
### Subject Device: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GIF-Q180 Predicate Device: EVIS EXERA Gastrointestinal Videoscope XGIF-Q160Y5 (K051645)
| Specifications | Subject Device<br>GIF-Q180 | Predicate Device<br>XGIF-Q160Y5 |
|-----------------------------------------|-----------------------------------|----------------------------------------------------|
| Field of View | Identical to the Predicate Device | 140° |
| Depth of Field | Identical to the Predicate Device | 3-100mm |
| Direction of Forward View | Identical to the Predicate Device | 0° |
| Type of CCD | Identical to the Predicate Device | Color |
| Outer Diameter of Distal End | Identical to the Predicate Device | 8.8mm |
| Outer Diameter of Insertion | Identical to the Predicate Device | 8.8mm |
| Bending Section Angulation | Identical to the Predicate Device | UP: 210°<br>DOWN: 90°<br>RIGHT: 100°<br>LEFT: 100° |
| Working Length | Identical to the Predicate Device | 1030mm |
| Inner Diameter of Instrument<br>Channel | Identical to the Predicate Device | 2.8mm |
. .
{9}------------------------------------------------
#### Table 16-7 Comparison of Specifications Subject Device: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GIF-H180 Predicate Device: EVIS EXERA Gastrointestinalvideoscope XGIF-H160Y2 (K051645)
| Specifications | Subject Device | Predicate Device |
|-----------------------------------------|-----------------------------------|----------------------------------------------------|
| | GIF-H180 | XGIF-H160Y2 |
| Field of View | Identical to the Predicate Device | 140° |
| Depth of Field | Identical to the Predicate Device | 2-100mm |
| Type of CCD | Identical to the Predicate Device | Color |
| Outer Diameter of Distal End | Identical to the Predicate Device | 9.8mm |
| Outer Diameter of Insertion Tube | Identical to the Predicate Device | 9.8mm |
| Bending Section Angulation | Identical to the Predicate Device | UP: 210°<br>DOWN: 90°<br>RIGHT: 100°<br>LEFT: 100° |
| Working Length | Identical to the Predicate Device | 1030mm |
| Inner Diameter of Instrument<br>Channel | Identical to the Predicate Device | 2.8mm |
### Table 16-8 Comparison of Specifications Subject Device: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE CF-Q180AL, CF-Q180Al
#### Predicate Device: EVIS EXERA Colonovideoscope XCF-Q160W6L (K051645)
| Specifications | Subject Device<br>CF-Q180AL, CF-Q180AI | Predicate Device<br>XCF-Q160W6L |
|-----------------------------------------|--------------------------------------------------------------------------|-----------------------------------------------------|
| Field of View | Identical to the Predicate Device | 170° |
| Depth of Field | Identical to the Predicate Device | 3-100mm |
| Direction of Forward View | Identical to the Predicate Device | 0° |
| Type of CCD | Identical to the Predicate Device | Color |
| Outer Diameter of Distal End | Identical to the Predicate Device | 13.2mm |
| Outer Diameter of Insertion Tube | Identical to the Predicate Device | 12.8mm |
| Bending Section Angulation | Identical to the Predicate Device | UP: 180°<br>DOWN: 180°<br>RIGHT: 160°<br>LEFT: 160° |
| Working Length | CF-Q180AL: Identical to the<br>Predicate Device<br><br>CF-Q180AI: 1330mm | 1680mm |
| Inner Diameter of Instrument<br>Channel | Identical to the Predicate Device | 3.7mm |
| Flexibility of Insertion Tube | Identical to the Predicate Device | Adjustable by the user. |
.
:
{10}------------------------------------------------
### Table 16-9 Comparison of Specifications Subject Device: EVIS EXERA II COLONOVIDEOSCOPE CF-H180AL, CF-H180AI Predicate Device: EVIS EXERA Colonovideoscope XCF-H160AY2L (K051645)
| Specifications | Subject Device<br>CF-H180AL, CF-H180AI | Predicate Device<br>XCF-H160AY2L |
|-----------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------|
| Field of View | Identical to the Predicate Device | 170° |
| Depth of Field | Identical to the Predicate Device | 2 -100mm |
| Direction of Forward View | Identical to the Predicate Device | 0° |
| Type of CCD | Identical to the Predicate Device | Color |
| Outer Diameter of Distal End | Identical to the Predicate Device | 13.9mm |
| Outer Diameter of Insertion Tube | Identical to the Predicate Device | 12.8mm |
| Bending Section Angulation | Identical to the Predicate Device | UP: 180°<br>DOWN: 180°<br>RIGHT: 160°<br>LEFT: 160° |
| Working Length | CF-H180AL: Identical to the<br>Predicate Device<br>CF-H180AI: 1330mm | 1680mm |
| Inner Diameter of Instrument<br>Channel | Identical to the Predicate Device | 3.7mm |
| Flexibility of Insertion Tube | Identical to the Predicate Device | Adjustable by the user. |
### Table 16-10 Comparison of Specifications Subject Device: EVIS EXERA II COLONOVIDEOSCOPE PCF-Q180AL, PCF-Q180AI Predicate Device: EVIS EXERA Colonovideoscope XPCF-Q160AY2L (K051645)
.
..
:
【
.
| Specifications | Subject Device | Predicate Device |
|-----------------------------------------|--------------------------------------------------|-----------------------------------------------------|
| | PCF-Q180AL, PCF-Q180AI | XPCF-Q160Y2L |
| Field of View | Identical to the Predicate Device | 140° |
| Depth of Field | Identical to the Predicate Device | 3-100mm |
| Direction of Forward View | Identical to the Predicate Device | 0° |
| Type of CCD | Identical to the Predicate Device | Color |
| Outer Diameter of Distal End | Identical to the Predicate Device | 11.3mm |
| Outer Diameter of Insertion Tube | Identical to the Predicate Device | 11.5mm |
| Bending Section Angulation | Identical to the Predicate Device | UP: 180°<br>DOWN: 180°<br>RIGHT: 160°<br>LEFT: 160° |
| Working Length | PCF-Q180AL: Identical to the<br>Predicate Device | 1680mm |
| | PCF-Q180AI: 1330mm | |
| Inner Diameter of Instrument<br>Channel | Identical to the Predicate Device | 3.2mm |
| Flexibility of Insertion Tube | Identical to the Predicate Device | Adjustable by the user. |
{11}------------------------------------------------
### Table 16-11 Comparison of Specifications Subject Device: EVIS EXERA II COLONOVIDEOSCOPE PCF-H180AL, PCF-H180AI Predicate Device: EVIS EXERA Colonovideoscope XPCF-Q160AY2L (K051645)
| Specifications | Subject Device | | Predicate Device |
|-----------------------------------------|------------------------------------------------------------------------|-----------------------------------------------------|------------------|
| | PCF-H180AL, PCF-H180AI | | XPCF-Q160Y2L |
| Field of View | Identical to the Predicate Device | 140° | |
| Depth of Field | 2-100mm | 3-100mm | |
| Direction of Forward View | Identical to the Predicate Device | 0° | |
| Type of CCD | Identical to the Predicate Device | Color | |
| Outer Diameter of Distal End | 11.7mm | 11.3mm | |
| Outer Diameter of Insertion Tube | 11.8mm | 11.5mm | |
| Bending Section Angulation | Identical to the Predicate Device | UP: 180°<br>DOWN: 180°<br>RIGHT: 160°<br>LEFT: 160° | |
| Working Length | PCF-H180AL: Identical to the<br>Predicate Device<br>PCF-H180AI: 1330mm | 1680mm | |
| Inner Diameter of Instrument<br>Channel | Identical to the Predicate Device | 3.2mm | |
| Flexibility of Insertion Tube | Identical to the Predicate Device | Adjustable by the user. | |
## 7 Conclusion
ン
When compared to the predicate device, the EVIS EXERA II 180 SYSTEM does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.
{12}------------------------------------------------
Image /page/12/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Olympus Medical Systems Corporation % Ms. Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance Olympus America, Inc. 3500 Corporate Parkway PO Box 610 CENTER VALLEY PA 18034-0610
JUL.-2 2010
Re: K100584
Trade/Device Name: EVIS EXERA II 180 System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Codes: NWB, FDS, FDF Dated: June 18, 2010 Received: June 22, 2010
Dear Ms. Kluesner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related
{13}------------------------------------------------
Page 2 -
adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{14}------------------------------------------------
# Indications for Use
510(k) Number (if known): Device Name: EVIS EXERA II 180 SYSTEM Indications for Use:
# EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180
This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
# EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180
This video system center has been designed to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number.
Page 1 of
{15}------------------------------------------------
# Indications for Use
510(k) Number (if known):
Device Name: EVIS EXERA II 180 SYSTEM
Indications for Use:
# EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180, OLYMPUS GIF TYPE XP180N
These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for transoral or transnasal endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, and duodenum).
# EVIS EXERA II. GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q180, OLYMPUS GIF TYPE H180
These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, and duodenum).
Prescription Use_ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Dhal Lunn
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices
510(k) Number.
Page 2 of _ 3
{16}------------------------------------------------
# Indications for Use
510(k) Number (if known):
Device Name: EVIS EXERA II 180 SYSTEM
Indications for Use:
EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AL, OLYMPUS CF TYPE Q180AI, OLYMPUS CF TYPE H180AL, QLYMPUS CF TYPE H180AI, OLYMPUS PCF TYPE Q180AL (Pediatric), OLYMPUS PCF TYPE Q180AL (Pediatric), OLYMPUS PCF TYPE H180AL (Pediatric), OLYMPUS PCF TYPE H180Al (Pediatric), These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
Page 3 of _ 3
Division Sign-Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
