(109 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware modifications and expanded sizes, not advanced image analysis or algorithmic capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The system also provides access for therapeutic interventions using standard endoscopy tools."
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended for diagnostic visualization of the digestive tract."
No
The device description explicitly states that the system consists of hardware components such as camera heads, endoscopes, a video system, a light source, and other ancillary equipment, in addition to the FuseBox™ processor. The submission also details hardware-related testing like safety, EMC compatibility, AER validation, and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "diagnostic visualization of the digestive tract" and "access for therapeutic interventions." This involves directly viewing the inside of the body and performing procedures, not analyzing samples taken from the body.
- Device Description: The description reinforces its use as a tool for viewing and intervention within the digestive tract.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are typically used to detect diseases, conditions, or states of health based on the analysis of these samples.
The Fuse® Colonoscopy System is a medical device used for in vivo (within the living body) diagnostic and therapeutic procedures.
N/A
Intended Use / Indications for Use
The Fuse® Colonoscopy System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. Fuse® Colonoscopes, in conjunction with the FuseBox™ processor, are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients. The Fuse® Colonoscopy System consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment.
Product codes
FDF
Device Description
The Fuse Colonoscopy System is a GI platform indicated for diagnostic visualization and therapeutic intervention of the lower digestive tract in adult patients. The purpose of this submission is to expand the product sizes available for the legally marketed unmodified version Fuse 1C System (K132839) by adding two additional lengths: 133cm and 150cm to the current 168cm Fuse 1C colonoscope.
This 510(k) submission also presents several design changes to the system. The indications for use, fundamental technology and operation principals of the legally marketed device were not changed. The system labeled for healthcare facilities/hospitals enables physicians to view a high- resolution wide field of view of up to 330°
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
healthcare facilities/hospitals enables physicians
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)
The following testing has been performed to demonstrate that the design outputs of the modified version meet the design input requirements. The tests were performed within EndoChoice's laboratory and by accredited third parties.
- In house Benchtop functional, performance, and software testing
- Laboratory Safety / EMC compatibility re-testing. ●
- . Laboratory AER validation
- Laboratory Biocompatibility testing
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)
Fuse™ 1C System (K132839)
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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of three human profiles facing to the right, symbolizing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 30, 2014
EndoChoice, Inc. Tamar Fuerst RA Manager 11810 Wills Road Alpharetta, GA 30009
Re: K141598
Trade/Device Name: Fuse® Colonoscopy System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: September 3, 2014 Received: September 5, 2014
Dear Tamar Fuerst.
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. Iisting 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.
1
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.
Herbert P. Lerner -S
for
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
2
Indications for Use
510(k) Number (if known) K141598
Device Name Fuse® Colonoscopy System
Indications for Use (Describe)
The Fuse® Colonoscopy System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. Fuse® Colonoscopes, in conjunction with the FuseBox™ processor, are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients. The Fuse® Colonoscopy System consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for EndoChoice. The logo consists of a green and blue swirl design on the left, followed by the word "ENDOChoice" in blue and green text. The first part of the word, "ENDO", is in blue, while the second part, "Choice", is in green.
This special 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92
Applicant information:
EndoChoice Inc.
11810 Wills Road Alpharetta, GA 30009 Establishment Registration: 300759133
| Contact Person: | Tamar Fuerst, EndoChoice Innovation Center Ltd. |
|---|---|
| Phone: | (+972) 4-626-7321 |
| Fax: | (+972) 4-626-0205 |
| E-mail: | tamar.fuerst@endochoice.com |
| Date Prepared: | June 2nd, 2014 |
| Device information: | |
| Trade Name: | Fuse® Colonoscopy System |
| Common Name: | Colonoscope and accessories, flexible/rigid |
| Classification Name: | Endoscope and accessories |
| Classification: | Class II per 21 CFR 876.1500 |
| Product Code: | FDF |
| Predicate Device: | Fuse™ 1C System (K132839) |
| Reason for Submission: | Modification of an existing device. |
Intended use and indications for use:
The Fuse® Colonoscopy system is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. Fuse® Colonoscopes, in conjunction with the FuseBox™ processor, are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients. The Fuse® Colonoscopy system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment.
Device Description:
The Fuse Colonoscopy System is a GI platform indicated for diagnostic visualization and therapeutic intervention of the lower digestive tract in adult patients. The purpose of this submission is to expand the product sizes available for the legally marketed unmodified version Fuse 1C System (K132839) by adding two additional lengths: 133cm and 150cm to the current 168cm Fuse 1C colonoscope.
This 510(k) submission also presents several design changes to the system. The indications for use, fundamental technology and operation principals of the legally marketed device were not changed. The system labeled for healthcare facilities/hospitals enables physicians to view a high- resolution wide field of view of up to 330°
4
Characteristics Comparison:
The modified version of the Fuse 1C System incorporates the following additional features compared to the unmodified version of the Fuse 1C System (K132839) which is the predicate:
| Category | FuseTM 1C System
(K132839)
unmodified version | Fuse® 1C System modified
version | Impact of
modification/change on
device performance |
|----------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------|---------------------------------------------------------------------------------------|
| Colonoscope
working length | Standard (168 cm) | Standard (168cm)
and
Shortened (133cm, 150cm) | Both designs utilize
industry-accepted
standard for working
lengths |
| Angulation
Knob Brake | U/D | U/D
R/L | Both designs utilize
industry-accepted
standard for handle brake. |
| Umbilical cord
plug
Umbilical cord
socket | Discrete | Integrated | Both designs utilize
industry-accepted
standard for usability. |
| Post procedure
reprocessing
method | Manual | Manual
and
Automated | Both designs utilize
Industry-accepted
standard for reprocessing
compliance. |
| Insertion tube
coating | TPU | TPU | Both materials are a TPU,
having similar properties. |
| Adhesives | Epoxy resin | Epoxy resin | Both materials are epoxy
resins, having similar
properties. |
| Software | Version 1.0 | Version 1.1.7 | Enhanced features. |
Table 5.1
Performance testing:
The following testing has been performed to demonstrate that the design outputs of the modified version meet the design input requirements. The tests were performed within EndoChoice's laboratory and by accredited third parties.
- In house Benchtop functional, performance, and software testing
- Laboratory Safety / EMC compatibility re-testing. ●
- . Laboratory AER validation
- Laboratory Biocompatibility testing
All test results passed, demonstrating that the device is safe and effective in comparison with the predicate device.
5
The following standards were used / relied upon for testing:
AAMI / ANSI ES 60601-1:2005/(R) 2012 and C1:2009/(R) 2012 AAMI / ANSI ES60601-1:2005/A1:2012 IEC 60601-1-2:2007 IEC 60601-2-18 Edition 3.0 2009-08 IEC 62304:2006 ISO 10993:2009 Part #1 ISO 10993:2009 Part #5 ISO 10993:2010 Part #10 ISO 10993:2012 Part #12 ISO 8600-1 third edition 2013 ISO 8600-3 First edition 1997-07-01 ISO 8600-4 First edition 1997-07-01 ISO 8600-6 First edition 2005-03-15 ASTM E 1837- 96 (reapproved 2007)
Substantial Equivalence:
The data presented above demonstrate that:
- The modified version of the Fuse 1C System and the unmodified version Fuse 1C a. System (K132839), the legally marketed predicate, have the same intended use and indications for use in the lower digestive tract.
- b. The modified version of the Fuse 1C System uses the same technological characteristics as the predicate. It includes additional colonoscope insertion tube sizes.
- The modified version contains similar materials, and similar reprocessing techniques. C.
Conclusion:
Based on the results of verification, validation, and performance testing, the impact of the above differences is insignificant in terms of the device safety and effectiveness for the device's intended use. The modified device performs as well as the predicate in all testing performed. It is the opinion of EndoChoice Inc., that the modified version of the Fuse 1C System is substantially equivalent to the predicate device in terms of safety and effectiveness.