(127 days)
Not Found
No
The document explicitly states that the fundamental technology and operation principles of the legally marketed device were not changed, and there are no mentions of AI, ML, or related terms.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "The system also provides access for therapeutic interventions using standard endoscopy tools."
Yes
The "Intended Use / Indications for Use" states that "The Fuse Gastroscopy System is intended for diagnostic visualization of the digestive tract." This explicitly indicates its diagnostic purpose.
No
The device description explicitly lists hardware components such as "camera heads, endoscopes, video system, light source and other ancillary equipment." It also mentions testing related to hardware like "Laboratory Safety / EMC compatibility" and "Laboratory Biocompatibility testing."
Based on the provided information, the Fuse Gastroscopy System 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 visualizing the internal anatomy of the patient.
- Device Description: The description reinforces its use as a "GI platform indicated for diagnostic visualization and therapeutic intervention."
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. The Fuse Gastroscopy System operates inside the body to directly visualize and interact with the digestive tract.
Therefore, the Fuse Gastroscopy System falls under the category of a medical device used for direct visualization and intervention within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Fuse Gastroscopy System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The Fuse Gastroscopy System is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). The Fuse Gastroscopy System consists of camera heads, endoscopes, video system, light source and other ancillary equipment.
Product codes (comma separated list FDA assigned to the subject device)
FDS
Device Description
The Fuse Gastroscopy System is a GI platform indicated for diagnostic visualization and therapeutic intervention of the upper digestive tract. The purpose of this submission is to propose new biopsy channel supplier and also to present several design changes that enhance device usability and robustness. 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 245° (measured diagonally), or 210° (measured horizontally)
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
upper digestive tract (including the esophagus, stomach, and duodenum)
Indicated Patient Age Range
Not Found
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 or by accredited third parties.
- In house Bench tests functional, performance, and software testing ●
- Laboratory Safety / EMC compatibility ●
- Laboratory Biocompatibility testing ●
- Laboratory Reprocessing 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.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Fuse PeerScope HG (K131422)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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 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" written around it. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 10, 2015
EndoChoice Inc. Daniel Hoefer Regulatory Affairs Manager 11810 Wills Rd. Alpharetta. GA 30009
Re: K152182 Trade/Device Name: Fuse® Gastroscopy System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDS Dated: November 11, 2015 Received: November 13, 2015
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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
for
Sincerely yours,
Herbert P. Lerner -S
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) K152182
Device Name Fuse® Gastroscopy System
Indications for Use (Describe)
The Fuse Gastroscopy System is intended for diagnostic visualization of the digestive tract.
The system also provides access for therapeutic interventions using standard endoscopy tools. The Fuse Gastroscopy System is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). The Fuse Gastroscopy System consists of camera heads, endoscopes, video system, light source and other ancillary equipment.
| 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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Image /page/3/Picture/0 description: The image shows the logo for EndoChoice. The logo consists of a circular design on the left, made up of three curved lines in shades of green and blue. To the right of the circular design is the word "ENDOChoice" in a sans-serif font. The "ENDO" portion of the word is in blue, while the "Choice" portion is in green, matching the colors of the circular design.
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: 3007591333
| Contact Person: | Daniel Hoefer, EndoChoice Inc. USA |
|---|---|
| Phone: | 678-708-4743 |
| Fax: | 678-878-3373 |
| E-mail: | daniel.hoefer@endochoice.com |
| Date Prepared: | August 4, 2015 |
| Device information: | |
| Trade Name: | Fuse® Gastroscopy System |
| Common Name: | Colonoscope and accessories, flexible/rigid |
| Classification: | Class II per 21 CFR 876.1500 |
| Product Code: | FDS |
| Predicate Device: | Fuse PeerScope HG (K131422) |
| Reason for Submission: | Modification of an existing device |
Intended use and indications for use:
The Fuse Gastroscopy System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The Fuse Gastroscopy System is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). The Fuse Gastroscopy System consists of camera heads, endoscopes, video system, light source and other ancillary equipment.
Device Description:
The Fuse Gastroscopy System is a GI platform indicated for diagnostic visualization and therapeutic intervention of the upper digestive tract. The purpose of this submission is to propose new biopsy channel supplier and also to present several design changes that enhance device usability and robustness. 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 245° (measured diagonally), or 210° (measured horizontally)
Characteristics Comparison:
The modified version of the Fuse Gastroscopy System incorporates the following additional features compared to the unmodified version of the PeerScope HG (Branded Fuse Gastroscopy System) (K131422) which is the predicate:
Rev 01
4
| Category | PeerScope HG
(K131422)
unmodified version | Fuse Gastroscopy
System modified version | Impact of
modification/change on
device performance |
|-----------------------------------------------|-------------------------------------------------|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| New supplier
for working
channel | Teflon PTFE (by
Advanced Power
Group) | PTFE (by EDC) | No impact on device
performance, this material
is similar and used by
medical industry.
Biocompatibility and
reprocessing testing were
repeated to ensure device
safety. |
| Angulation
Knob Brake | U/D | U/D
R/L | Both designs utilize
industry-accepted
standard for handle brake. |
| Umbilical cord
plug/socket | Discrete | Integrated | Both designs utilize
Industry-accepted
standard for usability. |
| Locking lever | NA | Added to FuseBox | This feature was added as
part of user experience
improvements and has no
effect on device safety or
performance |
| 90 degree
orientation of
umbilical cord | NA | Added to device scope | This feature was added
for AER compatibility as
part of user experience
improvements and has no
effect on device safety or
performance |
| Post procedure
reprocessing
method | Manual | Manual and Automated | Both designs utilize
Industry-accepted
standard for reprocessing
compliance.
Manual methods were
updated and validated to
adapt accepted standard
care methods |
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 or by accredited third parties.
- In house Bench tests functional, performance, and software testing ●
- Laboratory Safety / EMC compatibility ●
- Laboratory Biocompatibility testing ●
- Laboratory Reprocessing testing ●
5
All test results passed, demonstrating that the device is safe and effective in comparison with the predicate device.
The following standards were used / relied upon for testing:
AAMI / ANSIES 60601-1:2005/(R) 2012 and C1:2009/(R) 2012 AAMI / ANSI ES60601-1:2005/A1:2012 IEC 60601-1-2: 2007-03 IEC 60601-2-18 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 8600-1:2013 ISO 8600-3:1997 ISO 8600-4:2014 ISO 8600-6:2005 ASTM E 1837- 96 (reapproved 2007)
Substantial Equivalence:
The data presented above demonstrate that:
- a. The modified version of the Fuse Gastroscopy System and the unmodified version PeerScope HG (K131422), the legally marketed predicate, have the same intended use and indications for use in the upper digestive tract.
- b. The modified version of the Fuse Gastroscopy System uses the same technological characteristics as the predicate.
- C. The modified version contains similar materials, and similar reprocessing techniques, except for working channel. This was tested for reprocessing and biocompatibility.
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 Gastroscopy System is substantially equivalent to the predicate device in terms of safety and effectiveness.