(149 days)
Not Found
No
The summary describes a standard video colonoscopy system with image processing capabilities, but there is no mention of AI or ML algorithms being used for analysis, interpretation, or any other function. The modifications are limited to ancillary components.
Yes
The intended use explicitly states, "The system also provides access for therapeutic interventions using standard endoscopy tools."
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Fuse 1C System is intended for diagnostic visualization of the digestive tract."
No
The device description explicitly lists multiple hardware components including camera heads, endoscopes, a video system, a light source, a main control unit (FuseBox), and ancillary components and accessories. While it mentions image processing, it is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Fuse 1C System is used for diagnostic visualization of the digestive tract and therapeutic interventions using standard endoscopy tools. It directly visualizes the internal anatomy using a camera and light source.
- No Sample Analysis: The device does not analyze samples taken from the body. It is a tool for direct observation and intervention within the body.
Therefore, the Fuse 1C System falls under the category of a medical device used for direct visualization and intervention, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Fuse 1C System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The system is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients.
The Fuse 1C System consists of camera heads, endoscopes, video system, light source and other ancillary equipment.
Product codes
FDF
Device Description
The Fuse™ IC Colonoscopy System is a GI platform for diagnostic visualization and therapeutic intervention of the lower digestive tract. The system enables physicians to view high resolution wide field of view of up to 300°. The Fuse 1C is a modification of the legally marketed (K130718) PeerScope system Model H (the predicate device). The device has been modified to include a water bottle, cap, and tubing that are specified for use only with the Fuse1C.
The Fuse IC Colonoscopy System consists of the following components:
- The Fuse 1C colonoscope is a flexible, adult size video colonoscope labeled for . repeatable clinical usage within health care facilities. The colonoscope design and materials have not been modified, aside from a change in market name.
- The main control unit (FuseBox™) performs image processing and relays video . signals from the video colonoscope to external display monitors. The FuseBox also offers pneumatic controls and interfaces with various external accessories.
- Ancillary components and accessories for use in reprocessing and irrigation. A . change in water bottle/cap/tubing is the difference between the predicate device and · the Fuse 1C device submitted herein for review.
Mentions image processing
The main control unit (FuseBox™) performs image processing and relays video . signals from the video colonoscope to external display monitors.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video
Anatomical Site
Lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve)
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Health care facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing has been performed on the device. Specifically, the following has been completed on the accessory water bottle, cap, and tubing:
- Benchtop functional performance testing
- Laboratory validation testing of the cleaning instructions
- Laboratory validation testing of the high-level disinfection instructions
- Laboratory validation testing of sterilization instructions
- Biocompatibility testing in conformance with ISO 10993-1.
All test results passed, demonstrating that the device is safe and effective in comparison with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
0
EndoChoice, Inc.
FEB - 6 2014
510(k) Summary Fuse 1C Colonoscopy System
1. Company Identification
Manufacturer:
EndoChoice Innovation Center, Ltd. (Formerly PeerMedical, Ltd.) 2 Hatochen St. Business Industrial Park North Caesarea, ISRAEL 38900 Establishment Registration: Active Status, awaiting establishment registration number
Owner/Operator:
EndoChoice, Inc. 11810 Wills Road Suite 100 Alpharetta, GA 30009 Owner/Operator Number: 10028290 Establishment Registration: 300759133
2. Contact Person
Daniel Hoefer Regulatory Affairs Manager EndoChoice, Inc.
3. Device Name
| Trade name: | Fuse IC Colonoscopy System |
|---|---|
| Common/Usual Name: | Colonoscope, Video |
| Classification name: | Endoscope and Accessories |
4. Device Classification
| Common Name: | Colonoscope and accessories, flexible / rigid |
|---|---|
| Classification: | Colonoscope and accessories, 21CFR 876.1500 |
| Product Code: | FDF |
| Committee: | Gastroenterology/Urology |
5. Intended Use
The Fuse 1C System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The system is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients.
The Fuse IC System consists of camera heads, endoscopes, video system, light source and other ancillary equipment
1
K132839 Page 2 of 3
6. Device Description
The Fuse™ IC Colonoscopy System is a GI platform for diagnostic visualization and therapeutic intervention of the lower digestive tract. The system enables physicians to view high resolution wide field of view of up to 300°. The Fuse 1C is a modification of the legally marketed (K130718) PeerScope system Model H (the predicate device). The device has been modified to include a water bottle, cap, and tubing that are specified for use only with the Fuse1C.
The Fuse IC Colonoscopy System consists of the following components:
- The Fuse 1C colonoscope is a flexible, adult size video colonoscope labeled for . repeatable clinical usage within health care facilities. The colonoscope design and materials have not been modified, aside from a change in market name.
- The main control unit (FuseBox™) performs image processing and relays video . signals from the video colonoscope to external display monitors. The FuseBox also offers pneumatic controls and interfaces with various external accessories.
- Ancillary components and accessories for use in reprocessing and irrigation. A . change in water bottle/cap/tubing is the difference between the predicate device and · the Fuse 1C device submitted herein for review.
7. Substantial Equivalence
7.1. Predicate devices
The Fuse IC System is a modification of, and is substantially equivalent to, the PeerScope System Model H (K 130718). The intended use, design, materials and labeling are all substantially equivalent.
7.2. Intended Use
The Fuse IC System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The system is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients.
The Fuse IC System consists of camera heads, endoscopes, video system, light source and other ancillary equipment
The intended use is identical to the predicate device PeerScope System Model H.
7.3. Technical Characteristics
The Fuse IC system is technically identical to the predicate PeerScope System Model H, with the exception of a change in specified accessory.
This is not a change in technology. The change does not impact indications for use. Validation of the modification did not raise new questions of safety and effectiveness.
2
EndoChoice, Inc.
7.4. Performance Characteristics
The system is now specified for use with the SCT-468 Reusable Water Bottle, Cap, and Tubing Set and SCT-469 Reusable Water Bottle, Cap, and Tubing with CO2 Set. These accessorial sub-components are included with the Fuse 1C system.
| Summary of Differences | ||
|---|---|---|
| Category | Predicate Device | |
| (PeerScope system Model | ||
| B K130718) | Subject Device | |
| (Fuse 1C Colonoscope) | ||
| Colonoscope Model | PeerScope CS | Fuse 1C (trade name |
| change) | ||
| Water-feed system | Specified third party water | |
| bottle, cap, and tubing | ||
| pressurized by pump | EndoChoice re-usable | |
| water bottle and water | ||
| bottle cap pressurized by | ||
| pump. Accessory is | ||
| specified for use with Fuse | ||
| endoscope system only. |
The steps for operator use of each of the devices are identical, except that a specified accessory water bottle, cap and tubing set are now identified in instructions. Instructions for use of the accessory are now also included in a separate insert.
8. Non-clinical testing
Non-clinical testing has been performed on the device. Specifically, the following has been completed on the accessory water bottle, cap, and tubing:
- Benchtop functional performance testing ●
- Laboratory validation testing of the cleaning instructions .
- Laboratory validation testing of the high-level disinfection instructions ●
- Laboratory validation testing of sterilization instructions .
- Biocompatibility testing in conformance with ISO 10993-1. .
All test results passed, demonstrating that the device is safe and effective in comparison with the predicate device.
9. Conclusion
The modification of the Fuse 1C is substantially equivalent to the predicate device PeerScope System Model H listed above. It is the same or equivalent in terms of design, intended use, materials, and labeling.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its wings or body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 6, 2014
EndoChoice, Inc. Daniel Hoefer Regulatory Affairs Manager 11810 Wills Road Alpharetta, GA 30009
K132839 Re:
Trade/Device Name: Fuse 1C Colonoscopy System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: December 31, 2013 Received: January 3, 2014
Dear Daniel Hoefer,
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.
4
Page 2 - Daniel Hoefer
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 (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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/6 description: The image shows the name "Benjamin Fisher-S" in a simple, sans-serif font. The text is horizontally oriented and appears to be a logo or heading. The letters are black against a white background, providing a clear contrast.
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
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132839
Device Name
Fuse 1C Colonoscopy System
Indications for Use (Describe)
The Fuse 1C Colonoscopy System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The Fuse 1C Colonoscopy System is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients.
The Fuse 1 C Colonoscopy System consists of camera heads, endoscopes, light source and other ancillary equipment.
Type of Use (Select one or both, as applicable)
X] Prescription Use (Part 21 CFR 801 Subpart D)
. Over-The-Counter Use (21 CFR 801 Subpart C)
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)
Image /page/5/Picture/14 description: The image shows the text "Benjamin R. Fisher" on the first line. The second line shows the date and time as "2014.02.06 11:13:40 05:00". The text appears to be a timestamp or record of some kind, possibly related to the name mentioned on the first line.
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
6
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."