K102616 · Smart Medical Systems , Ltd. · FDF · Dec 30, 2010 · Gastroenterology, Urology
Device Facts
Record ID
K102616
Device Name
NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE
Applicant
Smart Medical Systems , Ltd.
Product Code
FDF · Gastroenterology, Urology
Decision Date
Dec 30, 2010
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
The NaviAid™ BGC device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope during endoscopy of the small and large intestine (standard endoscope-i.e., an endoscope that has an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization).
Device Story
NaviAid™ BGC is a disposable accessory for standard endoscopes used in small and large intestine procedures. System consists of a single-use balloon catheter and a reusable Air Supply Unit (ASU). The balloon catheter is inserted through the endoscope's instrument channel; the ASU, controlled by a footpedal, inflates/deflates the balloon with ambient air. The balloon acts as a distal anchor; the inflation tube functions as a guidewire, allowing the endoscope to be advanced toward the anchor. Operated by clinicians in a clinical setting, the device facilitates endoscope advancement without limiting the use of standard therapy tools (e.g., biopsy forceps, snares), which can be swapped by removing the balloon catheter. The device improves procedural navigation and positioning, potentially enhancing diagnostic or therapeutic access to the intestine.
Clinical Evidence
No clinical data. Bench testing only, including handle/channel compatibility, air leakage, bending radius, flexibility, assembly degradation, inflation/deflation cycles, in-vitro validation, packaging validation, and component bond strength.
Technological Characteristics
Disposable balloon catheter and reusable Air Supply Unit (ASU). Balloon inflated with ambient air via footpedal-controlled pump. Compatible with standard endoscopes (instrument channel ≥3.7mm). Materials comply with ISO 10993 biocompatibility standards. Electrical/mechanical safety per IEC 60601-1; EMC per IEC 60601-1-2. Software validation per IEC 60601-1-4.
Indications for Use
Indicated for use as an accessory to standard endoscopes (instrument channel ≥3.7mm) to facilitate positioning during endoscopy of the small and large intestine.
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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# SECTION 5 - 510(K) SUMMARY OF SAFETY & EFFECTIVENESS
## NaviAid™ BGC device
DEC 3 0 2010
510(k) Number K_10 a 6 / 6 / 6 / 26
.
Jeg 1 of 7
## Applicant's Name:
| Company name: | Smart Medical Systems Ltd. |
|---------------|---------------------------------------|
| Address: | 10 Hayetsira Str.Ra'anana 43663ISRAEL |
| Tel.: | +972-9-7444478 |
| Fax: | +972-9-7444543 |
| e-mail: | ayoselzon@smartmedsys.com |
## Contact Person:
| Official Correspondent: | Adva Yoselzon |
|-------------------------|----------------------------|
| Company name: | Smart Medical Systems Ltd. |
| Address: | 10 Hayetsira Str. |
| | Ra'anana 43663 |
| | ISRAEL |
| Tel.: | +972-9-7444478 |
| Fax: | +972-9-7444543 |
| e-mail: | ayoselzon@smartmedsys.com |
## Name of the device:
NaviAid™ BGC device
## Trade or proprietary name, if applicable:
NaviAid™ BGC device
## Common or usual name:
Balloon Guided Colonoscopy Device
# Establishment Registration No.:
3005261802
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K102616
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### Classification Name:
Endoscope and accessories
## Classification:
FDA has classified Endoscope and accessories devices as a Class II medical device, with product code KOG and 21 CFR classification code 876.1500. Review by the Gastroenterology/Urology Devices Panel.
### Predicate Device:
The NaviAid™ BGC device is substantially equivalent to the NaviAid™ ICVI device (manufactured by Smart Medical Systems Ltd. and the subject of 510(k) document no. K101191) and the Double Balloon Colonoscope (manufactured by Fujinon and the subject of 510(k) document no. K090116). A comparison table and detailed discussion are presented in Section 12 of this application.
### Device Description:
The NaviAid™ BGC Disposable is an on-demand disposable that is inserted through the instrument channel of the endoscope in order to ensure positioning of a standard endoscope during endoscopy of the large or small intestine (standard endoscope - i.e., an endoscope that has an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization). The NaviAid™ BGC system comprises a disposable balloon system and an Air Supply Unit for inflating and deflating the balloon system. The role of the BGC disposable is to facilitate advancement of a standard endoscope into the large and/or small intestine. The NaviAid™ BGC Disposable includes the BGC Balloon and the BGC inflation tube. The balloon is inflated by ambient air. The Air Supply Unit ("ASU") operates and controls the inflation and deflation of the balloon through a footpedal. The balloon is connected to a dedicated inflation tube that runs inside the instrument channel of the endoscope, and is connected at its proximal (user) end to the ASU. The BGC balloon can be advanced ahead of the endoscope tip or pulled back by pushing/pulling action on the BGC inflation tube at its proximal side, outside the patient's body. When the BGC balloon is advanced and then inflated, it functions as a distal anchor, to which the endoscope tip is advanced, and the BGC inflation tube serves
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as a "guide wire" that leads the endoscope as it is pushed towards the anchoring BGC balloon.
The balloon and tube negligibly compromise the endoscope's flexibility, or its field of view. Additionally, the BGC disposable negligibly compromise the maneuverability of the endoscope's tip and does not limit the usage of any standard endoscopy tools, such as biopsy forceps, snare, needle etc. The BGC disposable can be pulled back at any time during the procedure in order to allow use of therapy tools.
The NaviAid™ BGC disposable is intended for single use, while the ASU is re-usable.
## Intended Use / Indication for Use:
The NaviAid™ BGC device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope during endoscopy of the small and large intestine (standard endoscope-i.e., an endoscope that has an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization).
## Comparison of Technological Characteristics with the predicate device:
a. Comparison between the NaviAid™ BGC device and the NaviAid™ ICVI device
The NaviAid™ BGC device is similar to the NaviAid™ ICVI device regarding the intended use, technological characteristics, principle of operation, specifications, materials and safety requirements of the device.
Both the NaviAid™ BGC device and the NaviAid™ ICVI device are intended to ensure positioning of standard endoscopes in the intestine, while maintaining all the advantages of an endoscopic procedure, such as back-and-forth navigation, stopping propagation if needed, real-time operation, video imaging, instrument channel including biopsy and treatment. During both the NaviAid™ BGC procedure and the NaviAid™ ICVI procedure the disposables can be removed from the instrument channel of the endoscope and a therapy tool may inserted instead. The NaviAid™ BGC device is intended for the large and small intestine while the NaviAid™ ICVI device is intended for the small intestine.
The NaviAid™ BGC includes a single balloon; similarly to the NaviAid™ ICVI balloon. The balloon traverses ahead of the endoscope through the endoscope's instrument
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channel, thus it can be applied on demand and there is no need for a pre-procedure preparation of the device. The utilization of the BGC balloon and the ICVI balloon is the same and their characteristics are similar. They are both designed to anchor the intestine at similar pressure and be maneuvered manually in a similar form.
Both the NaviAid™ BGC and the NaviAid™ ICVI utilizes specialized single balloon system used with standard endoscopy system (standard endoscope i.e. an endoscope that is used for the intestinal visualization and has an instrument channel that is at least 3.7mm diameter).
Both the ICVI balloon BGC Balloon can be advanced ahead of the endoscope tip or pulled back by pushing/pulling action on the inflation tube at its proximal side, outside the patient's body. When the balloon is advanced and then inflated, it functions as a distal anchor, towards which the endoscope tip is advanced, and the inflation tube serves as a "guide wire" that leads the endoscope as it is pushed towards the anchoring balloon.
Both the BGC Disposable and the ICVI Disposable are supplied non-sterile, for single use only and is supplied in a Tyvek pouch.
All patient contact materials comply with biocompatibility testing.
.
The NaviAid™ ASU is identical in both the BGC device and the NaviAid™ ICVI device and complies with the electrical and mechanical safety testing requirements and the electromagnetic compatibility testing requirements for electronic medical devices.
# b. Comparison between the NaviAid™ BGC device and the Double Balloon Colonoscope
The NaviAid™ BGC device is similar to the Double Balloon Colonoscope regarding the intended use, technological characteristics, principle of operation and safety requirements.
Both the NaviAid™ BGC device and the Double Balloon Colonoscope are intended to facilitate positioning of an endoscope in the intestine while maintaining all the advantages of an endoscopic procedure, such as back-and-forth navigation, stopping propagation if needed, real-time operation, video imaging, instrument channel including biopsy and treatment. During the NaviAid™ BGC procedure the NaviAid™ BGC
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disposable can be removed from the instrument channel of the endoscope and a therapy tool may inserted instead. The Double Balloon Colonoscope's instrument channel may be used for the insertion of a therapy tool during the procedure.
Both devices include similar components for achieving positioning of the endoscope in the intestine, including an Air Supply Unit / Air Pump and a balloon system for advancing the endoscope. In both devices the balloon system utilizes an endoscope and is controlled by the balloon pump. The pump controls inflation and deflation of the balloon system.
The Fujinon Double Balloon Colonoscope System features two balloons, one attached to the distal end of the endoscope and the other attached to a tube sliding over the Colonoscope (an over-tube). The balloon and over-tube are mounted on the endoscope prior to the Double Balloon Colonoscopy procedure. When inflated with air, the balloons anchor onto the intestine and facilitate the advancement of the endoscope deeper into the intestine. The NaviAid ™ BGC device features a single balloon system. The balloon traverses ahead of the endoscope through the endoscope's instrument channel, thus it can be applied on demand and there is no need for a pre-procedure mounting and preparation of the device. Similarly to the Double Balloon Colonoscope, when inflated with air, the NaviAid™ BGC balloon anchors onto the intestine and facilitates advancement of the endoscope deeper into the intestine.
The NaviAid™ BGC utilizes specialized single balloon used with standard endoscopy system (standard endoscope-i.e. an endoscope that is used for intestinal visualization and has an instrument channel that is at least 3.7mm diameter). The balloon can be moved back and forth ahead of the endoscope tip by pushing/pulling action on the inflation tube at its proximal side, outside the patient's body. When the balloon is advanced and then inflated, it functions as a distal anchor, towards which the endoscope tip is advanced, and the inflation tube serves as a "guide wire" that leads the endoscope as it is pushed towards the anchoring balloon.
The air supply unit and control pump are much the same with similar dimensions, weight, electrical input and indicators.
The BGC Disposable is supplied non-sterile, for single use only and is supplied in a Tyvek pouch. The Fujinon Double Balloon Colonoscope System disposable components are supplied sterile.
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K102616
pg 6 of 7
All patient contact materials comply with biocompatibility testing
Both the NaviAid™ BGC device and the Fujinon Double Balloon Colonoscope System comply with the electrical and mechanical safety testing requirements and the electromagnetic compatibility testing requirements for electronic medical devices.
### Non-Clinical Performance Data
The performance tests include testing of the NaviAid™ BGC Device. The following performance tests were conducted on the NaviAid™ BGC device:
- 1. BGC Handle and Instrument Channel Compatibility (Doc. No. TP310001)
- 2. BGC Air Leakage (Doc. No. TP310003)
- 3. BGC Bending Radius (Doc. No. TP310005)
- 4. Endoscope Flexibility (Doc. No. TP310006)
- 5. BGC Assembly Degradation Test (Doc. No. TP310007)
- 6. BGC Inflation/Deflation Test (Doc. No. TP310009)
- 7. BGC In-Vitro Validation Test (Doc. No. TP310014)
- 8. Packaging Validation (ISO 111607/Doc. No. TP310015)
- 9. BGC Balloon (Doc. No. TP310019)
- 10. Component Bond Strength (Doc. No. TP320034)
- 11. BGC Balloon Cover (Doc. No. TP310077)
## Clinical Performance Data
Not Applicable
### Conclusions Drawn from Non-Clinical and Clinical Tests:
The non-clinical tests demonstrated that the NaviAid™ BGC device meets its design and performance specifications. Furthermore, the tests showed that the NaviAid™ BGC device is easy to use and does not cause damage to the intestine or to the endoscope. The NaviAid™ BGC device may be safely and effectively used in procedures in order to ensure positioning of a standard endoscope into the small and large intestine.
## Clinical Performance Data
Not Applicable
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K 10 26 16
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### Substantial Equivalence:
In summary, the NaviAid™ BGC Device is a similar to both the NaviAid™ ICVI device and the Double Balloon Colonoscope in intended use, basic technology, principle of operation and safety requirements. The minor differences in specifications do not raise new questions of safety and effectiveness. Consequently, the NaviAid™ BGC device is substantially equivalent to the NaviAid™ ICVI Device and to Double Balloon Colonoscope and no new questions of safety and effectiveness are raised.
### Performance Standards:
The NaviAid™ BGC device complies with the voluntary recognized standards:
- 1. Electrical & Mechanical Safety Testing (IEC 60601-1)
- 2. Electromagnetic Compatibility Testing (IEC 60601-1-2)
- 3. Software Validation (IEC 60601-1-4 & FDA Guidelines)
- 4. Biocompatibility Testing (ISO 10993)
Note: Though the Air Supply Unit (ASU) is identical for both the NaviAid™ BGC and the NaviAid™ ICVI, and performance tests relating to standards 1-2 listed above are described is K101191 of the NaviAid™ ICVI , for the reviewer's convenience the performance tests relating to standards 1-2 listed above are described in detail again in section 17 of this 510(k).
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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird-like figure. The logo is presented in black and white.
Food and Drug Administration l 0903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Adva Yoselzon Director of Regulatory and Clinical Affairs SMART® Medical Systems Ltd. 10 Hayetsira St. Ra'anana 43663 ISRAEL
DEC 30 2010
Re: K102616 Trade/Device Name: NaviAid™ BGC Device Regulation Number: 21 CFR 8876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: December 2, 2010 Received: December 8, 2010
Dear Ms. Yoselzon:
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
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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/CDRHQffices/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.
Sincerely yours,
Huker Lemur MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
### Enclosure
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### INDICATIONS FOR USE STATEMENT SECTION 4
510(k) Number (if known):
Device Name:
NaviAid™ BGC Device
### Indications for use:
The NaviAid™ BGC device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope during endoscopy of the small and large intestine (standard endoscope-i.e., an endoscope that has an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization).
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Use (Per 21 C.F.R. 801 Subpart D) OR
Over-The-Counter
(Optional Format Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
__ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ _______________________________________________________________
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shafigh Khor
ﺰﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K102616
4-1
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.
