K131855 · Pentax Medical Company · FDF · Apr 9, 2014 · Gastroenterology, Urology
Device Facts
Record ID
K131855
Device Name
PENTAX VIDEO COLONOSCOPES (EC FAMILY)
Applicant
Pentax Medical Company
Product Code
FDF · Gastroenterology, Urology
Decision Date
Apr 9, 2014
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
This instrument is intended to be used with a PENTAX Video Processor (including light source), documentation equipment, Monitor, Endotherapy Device 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
PENTAX Video Colonoscopes (EC Family) are flexible endoscopes designed for lower gastrointestinal tract visualization and surgery. The device consists of an insertion portion (with distal end, bending section, objective lens, light guide, instrument channel, and air/water/water-jet nozzles) and a control body (with angulation knobs, suction/irrigation valves, and remote buttons). The device connects to a PENTAX Video Processor and light source. A CCD at the distal end captures reflected light from the body cavity, converting it into image data transmitted to the processor for display on a monitor. Clinicians operate the device to navigate the colon, perform suction/irrigation, and insert endotherapy devices (e.g., biopsy forceps) through the instrument channel. The device facilitates real-time visualization to assist in clinical decision-making during diagnostic or therapeutic procedures, potentially benefiting patients by enabling minimally invasive examination and intervention.
Clinical Evidence
Bench testing only. Performance evaluated via design verification and validation in accordance with 21 CFR 820.30, including electrical safety (IEC 60601-1 series), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993-1, 5, 10), and reprocessing validation (AAMI TIR12, TIR30, TIR79).
Technological Characteristics
Flexible video colonoscope; insertion portion with CCD sensor, light guide, and instrument channels. Materials evaluated per ISO 10993. Connectivity via PVE connector to PENTAX Video Processor. Standards: IEC 60601-1, IEC 60601-2-18, ISO 8600-1/3/4, ISO 10993, ISO 14971, IEC 62304. Reprocessing: Manual cleaning and high-level disinfection.
Indications for Use
Indicated for endoscopic visualization and surgery within the lower digestive tract, including the anus, rectum, sigmoid colon, colon, and ileocecal valve, in patients requiring diagnostic or therapeutic colonoscopy.
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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# 510(k) Summary
The following summary is provided in accordance with 21 CFR 807.92:
APR 0 9 2014
K131855 Page 1 of 5
Date: 19 Jun 2013
| Submitter: | PENTAX Medical Company,<br>HOYA Corporation PENTAX Division<br>3 Paragon Drive<br>Montvale, New Jersey 07645-1782 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Krishna Govindarajan<br>Regulatory Manager<br>PENTAX Medical Company,<br>3 Paragon Drive<br>Montvale, New Jersey 07645-1782<br>Phone: 800-431-5880 x 2125, 201-251-2300 x 2125<br>Fax: 201-799-4117<br>Email: Krishna.govindarajan@pentaxmedical.com |
| Trade/Device Name: | PENTAX Video Colonoscopes (EC Family) |
| Model Numbers: | EC-3890TLK, EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi,<br>EC-3490LK, EC-3890LK, EC-3890LZi, EC34-i10L, EC38-i10L |
| Common/Usual Name: | Colonoscope and Accessories, Flexible/Rigid |
| Regulation Number: | 21 CFR Part 876.1500 |
| Regulation Name: | Endoscope and accessories |
| Regulatory Class: | Class II |
| Product Code: | FDF |
| Predicate Device: | OLYMPUS Colonovideoscope CF TYPE Q160AL<br>(K001241; dated May 9 2000)<br>OLYMPUS Colonovideoscope CF TYPE Q180AL<br>(K100584; dated Jul 2 2010) |
| Regulation Number: | 21 CFR Part 876.1500 |
| Regulation Name: | Endoscope and accessories |
| Regulatory Class: | Class II |
| Product Code: | FDF |
PENTAX Video Colonoscopes (EC Family) 510(k) Summary
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# Device Description:
Image /page/1/Picture/1 description: The image shows the words "PENTAX MEDICAL" in bold, black letters. Below that, the text "K131855 Page 2 of 5" is printed in a smaller font size. The text appears to be part of a document or report, possibly indicating a page number and a reference number.
The PENTAX Video Colonoscopes (EC Family), Model Numbers: EC-3890TLK, EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC-3890LZi, EC34-i10L, EC38i10L are used with a Video Processor.
The EC-3890TLK is composed of the following main parts: an Insertion Portion, Control Body and PVE Connector.
The Insertion Portion is inserted into the body cavity of patient. The Insertion includes the Distal End and Bending Section. The Objective Lens, Light Guide, Instrument Channel, Air/Water Nozzle, and Water Jet Nozzle are located on the Distal End of the Insertion Portion. The Control Body is held by the user's hand. The Control Body includes the Angulation Control Knob, Angulation Lock Knob/Lever, Air/Water, Suction Cylinder, Remote Button, Suction Selector Cylinder, and Instrument Channel Inlet. The AirMater Feeding Valve is attached to the Air/Water Cylinder, and the Suction Control Valve is attached to the Suction Cylinder. The Suction Channel Selector is attached to the Suction Selector Cylinder. The Inlet Seal is attached to the Instrument Channel Inlet. The PVE Connector is connected to the Video Processor via an Electrical Contacts.
The Bending Section is bent by the Angulation Control Knob to operate the endoscope anqulation. The Angulation Lock Knob/Lever is used to adjust the rotation torque of the Angulation Control Knob. The Air/Water Feeding System is used to deliver the air and water to the Objective Lens from the AirMater Nozzle. When the hole at the top of Air/Water Feeding Valve is covered, the air is delivered. When the Air/Water Feeding Valve is pushed, the water is delivered. The Suction Control System is used to suction the fluid and air in body cavity from the Instrument Channel. When the Suction Control Valve is pushed, the fluid and air are suctioned. The EC-3890TLK has two channels; the primary channel and secondary one. Suction Channel Selector is used to switch between the primary and secondary channels as necessary. The Remote Button is used to operate the function of video processor and external device from the control body, as necessary.
Endotherapy Device such as Biopsy Forceps is inserted from the Instrument Channel Inlet into the body cavity through the instrument channel.
The Water Jet System is used to stream forward the sterile water from Water Jet Nozzle.
The Light Guide of the Distal End is used to illuminate the body cavity by light which is carried through the Light Carrying Bundle. The Light Carrying Bundle guides the light from Light Guide Plug which is connected to the Light Source inside the Video Processor.
The CCD built into the Distal End receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the image inside the body cavity is " displayed on the Monitor. The CCD built into the Distal End receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the image inside the body cavity is displayed on the Monitor.
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Image /page/2/Picture/0 description: The image shows the words "PENTAX MEDICAL" in bold, with a line separating the two words. Below the words, there is the text "K131855 Page 3 of 5". The text appears to be part of a document or report.
# Intended Use:
This instrument is intended to be used with a PENTAX Video Processor (including light source), documentation equipment, Monitor, Endotherapy Device 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.
# Summary of Technology Characteristics
PENTAX Video Colonoscopes (EC Family), Model Numbers: EC-3890TLK, EC-2990Li, EC-3490Li. EC-3890Li. EC-3490TLi, EC-3490LK, EC-3890LK, EC-3890LZi, EC34-i10L, EC38-i10L has the same fundamental technology and operating principles in comparison to those of the predicate devices, including same intended use, design technological characteristics, such as Insertion Portion, Control Body and fiberoptics illumination. The minor differences in the Depth of Field, Distal end width, Insertion Tube width, instrument channel width, and Total Length between two devices do not impact the intended use, and do not raise different questions of safety and effectiveness and that the device is as safe and effective as a legally marketed device.
# Safety and Performance Data (Non-clinical tests)
Design Verification and Validation testing has been performed in accordance with Design control per 21 CFR Part 820.30. The performance of the PENTAX Video Colonoscopes (EC Family) were evaluated using the appropriate methodology as specified in the following FDA recognized consensus standards in conjunction with our in-house test protocols and use of external testing laboratories:
- Medical electrical equipment Part 1: 1. IEC 60601-1:1988+A1:1991+A2:1995 General requirements for basic safety and essential performance
- Medical electrical equipment- Part 1-1: General requirements IEC 60601-1-1:2000 2. for safety- Collateral standard: Safety requirements for medical electrical systems
- IEC 60601-1-2:2001+A1:2004 Medical electrical equipment- Part 1-2: General 3. requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and 4. testing within a risk management process
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro ട. cvtotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10:Tests for ട. irritation and skin sensitization
- IEC 60601-2-18:1996+A1:2000 Medical electrical equipment- Part 2-18: Particular 7. requirements for the basic safety and essential performance of endoscopic equipment
- ISO 8600-1:2005 Optics and photonics Medical endoscopes and endotherapy 8. devices - Part 1: General requirements
- ISO 8600-3:1997+A1:2003 Optics and optical instruments -Medical endoscopes and ത endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics
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Image /page/3/Picture/0 description: The image shows the words "PENTAX MEDICAL" in bold, black letters. Below the word "MEDICAL" is the alphanumeric code "K131855" and the text "Page 4 of 5". The text is arranged in a way that suggests it is part of a document or report.
- 10. ISO 8600-4:1997 Optics and optical instruments -Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
- 11. AAMITIR12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers
- 12. AAMITIR30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
- ANSI/AAMI TIR79:2010 Comprehensive quide to steam sterilization and sterility 13. assurance in health care facilities
- IS013485:2003 Medical devices Quality management systems Requirements for 14. requiatory purposes
- ISO 14971:2007 (corrected version): Medical devices -Application of risk 15. management to medical devices
- Medical electrical equipment- Part 1-4: General 16. IEC 60601-1-4:2000 Ed. 1.1 requirements for safety- Collateral Standard: Programmable electricalmedical systems
- IEC 60601-1-6:2010 Medical electrical equipment Part 1-6: General requirements 17. for basic safety and essential performance - Collateral standard: Usability
- IEC 62366:2007 Medical devices -Application of usability engineering to medical 18. devices
- IEC 62304:2006 Medical device software- Software life cycle processes 19.
- IEC 604171SO 7000-DB-12M:2004 Graphical symbols for use on equipment- 12-20. month subscription to online database comprising all graphical symbols published in IEC 60417 and ISO 7000
- Medical devices Symbols to be used with medical device labels, 21. ISO 15223-1:2012 labeling and information to be supplied - Part 1: General requirements
- 22. IEC 60878:2003 Graphical symbols for electrical equipment in medical practice
PENTAX Video Colonoscopes (EC Family), Model Numbers: EC-3890TLK, EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC-3890LZi, EC34-i10L, Master Device (EC-3890TLK) test results satisfy the acceptance criteria specified by the above applicable standards.
# Biocompatibility Test
Biocompatibility of direct and indirect contact materials were confirmed by testing the Cytotoxicity, Sensitization and Intracutaneous Reactivity for the surface device, mucosal membrane contact less than 24 hours duration device category in accordance with the ISO 10993-1, 5, and 10 Biological evaluation of medical devices standard and the FDA's guidance the Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'.
# Reprocessing Validation
Simulated use conditioned test samples were used in the Cleaning validation and High Level Disinfection validation studies for validating the effectiveness of the reusable Colonoscope Reprocessing procedures/methodology in accordance with the FDA's Draft Guidance for Industry and FDA Staff Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling distributed in May 2, 2011, AAMI TIR 12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A
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quide for device manufacturers. AAMI TIR 30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices, and AAMI TIR79:2010 Comprehensive guide to steam sterilization and sterility assurance in health care facilities. All the study results satisfy the acceptance criteria specified by the above applicable standards.
In addition, the Reprocessing Instructions (Manual) were validated based on the FDA's Draft Guidance for Industry and FDA Staff Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling distributed in May 2, 2011. The validation confirmed that the PENTAX Video Colonoscopes (EC Family), Model Numbers: EC-3890TLK, EC-2990Li, EC-3490Li. EC-3890Li. EC-3490TLi. EC-3490LK, EC-3890LK, EC-3890LZi, EC34-110L, Reprocessing Instructions are complete, understandable, and can reasonably be executed by the user.
## EMC and Electrical Safety
The acceptable level of Electromagnetic compatibility (EMC) and Electrical Safety (ES) for the PENTAX Video Colonoscopes (EC Family), Model Numbers: EC-3890TLK, EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LZi, EC-3890LZi, EC34-i10L were confirmed by testing in accordance with the IEC 60601-1-2; IEC 60601-1-2; IEC 60601-1-4; IEC 60601-1-6; Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, Safety requirements for medical electrical systems, Electromagnetic compatibility - Requirements and tests; and IEC 60601-2-18:1996+A1:2000 Medical electrical equipment- Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment.
# Substantial Equivalence discussion:
The PENTAX Video Colonoscopes (EC Family), Model Numbers: EC-3890TLK, EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC-3890LZi, EC34-i10L has the same intended use, fundamental technology and operating principles including design technological characteristics, such as Insertion Portion, Control Body and fiberoptics illumination in comparison to those of the predicate device. The minor dimensional differences in the Depth of Field, Distal end width, Insertion Tube width, instrument channel width, and Total Length between two devices do not impact the intended use, and do not raise different questions of safety and effectiveness and that the device is as safe and effective as a legally marketed device.
### Conclusion:
The PENTAX Medical Company believes that the PENTAX Video Colonoscopes (EC Family), Model Numbers: EC-3890TLK, EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC-3890LZi, EC34-i10L, as indicated in this 510(k) premarket notification submission is to be as safe, as effective and substantially equivalent in performance to the above identified cleared predicate device/system.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 9, 2014
PENTAX Medical Krishna Govindarajan Regulatory Affairs, Americas 3 Paragon Drive Montvale, NJ 07645
Re: K131855
Trade/Device Name: PENTAX Video Colonoscopes (EC Family) Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: March 28, 2014 Received: March 31, 2014
Dear Krishna Govindarajan,
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 cnactment 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 (sec 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.
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Page 2 - Krishna Govindarajan
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 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.
Sincerely yours.
Image /page/6/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a bold, sans-serif font. The text is horizontally oriented and appears to be a name or title. The letters are clearly legible, with varying degrees of boldness.
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
#### 510(k) Number (if known) K131855
#### Device Name
PENTAX Video Colonoscopes (EC Family)
#### Indications for Use (Describe)
This instrument is intended to be used with a PENTAX Video Processor (including light source), documentation equipment, Monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.
Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
:
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: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
... ... Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
# Benjamin R. Fisher 2014.04.08 22:15
::
FORM FDA 3881 (1/14)
::
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Exact vs. fuzzy search: what's the difference?
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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.
