(127 days)
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.
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)
The provided text describes a 510(k) premarket notification for the "Fuse® Gastroscopy System" by EndoChoice Inc. This document focuses on demonstrating substantial equivalence to a predicate device (Fuse PeerScope HG, K131422) after making modifications to the existing device. It does not contain information about a study proving the device meets specific acceptance criteria in the context of diagnostic performance or a comparative effectiveness study with human readers.
The performance testing described here is focused on engineering verification and validation of design changes, ensuring safety and effectiveness after modifications, rather than establishing diagnostic performance acceptance criteria for a new AI or image analysis algorithm.
Therefore, many of the requested sections about acceptance criteria, diagnostic performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, and standalone algorithm performance cannot be extracted from this document.
Here's a breakdown of what can be extracted or inferred based on the provided text, and what cannot:
1. Table of acceptance criteria and the reported device performance:
This information is not explicitly provided in terms of diagnostic performance metrics like sensitivity, specificity, or AUC against specific acceptance criteria. The performance testing section states: "All test results passed, demonstrating that the device is safe and effective in comparison with the predicate device." This refers to internal engineering/safety testing, not diagnostic accuracy.
2. Sample sized used for the test set and the data provenance:
Not applicable. The document discusses performance testing for mechanical, electrical, and reprocessing aspects, not a clinical diagnostic test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth for diagnostic performance is not mentioned as this is not a diagnostic performance study.
4. Adjudication method for the test set:
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was not done. The device is a gastroscopy system (an endoscope), not an AI or image analysis system intended to assist human readers in diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI or algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable, as it's not a diagnostic performance study.
8. The sample size for the training set:
Not applicable, as it's not an AI or algorithm-based device requiring training data.
9. How the ground truth for the training set was established:
Not applicable.
Summary of available information:
The document describes the modifications made to an existing medical device (Fuse® Gastroscopy System) and the engineering-focused performance testing conducted to ensure these modifications did not negatively impact the device's safety and effectiveness.
- Acceptance Criteria & Performance (General): The general acceptance criterion was that "All test results passed," demonstrating the device is "safe and effective in comparison with the predicate device." This relates to bench tests (functional, performance, software), laboratory safety/EMC compatibility, biocompatibility, and reprocessing testing. Specific numerical acceptance criteria for these tests are not provided in this summary.
- Study Type: This was a series of engineering verification and validation tests rather than a clinical diagnostic study. It aimed to demonstrate that design modifications (e.g., new biopsy channel supplier, angulation knob brake, umbilical cord plug, locking lever, 90-degree umbilical cord orientation, updated reprocessing methods) maintained the device's safety and effectiveness compared to the predicate.
- Sample Size/Data Provenance for these engineering tests: Not explicitly stated, though implicitly the tests would have involved a number of manufactured devices or components. Data provenance is "within EndoChoice's laboratory or by accredited third parties."
- Ground Truth for these engineering tests: Established by predefined engineering specifications, regulatory standards (listed in the document), and comparison to the performance of the predicate device. For example, reprocessing testing would have had objective criteria for efficacy.
{0}------------------------------------------------
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
{3}------------------------------------------------
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 GastroscopySystem modified version | Impact ofmodification/change ondevice performance |
|---|---|---|---|
| New supplierfor workingchannel | Teflon PTFE (byAdvanced PowerGroup) | PTFE (by EDC) | No impact on deviceperformance, this materialis similar and used bymedical industry.Biocompatibility andreprocessing testing wererepeated to ensure devicesafety. |
| AngulationKnob Brake | U/D | U/DR/L | Both designs utilizeindustry-acceptedstandard for handle brake. |
| Umbilical cordplug/socket | Discrete | Integrated | Both designs utilizeIndustry-acceptedstandard for usability. |
| Locking lever | NA | Added to FuseBox | This feature was added aspart of user experienceimprovements and has noeffect on device safety orperformance |
| 90 degreeorientation ofumbilical cord | NA | Added to device scope | This feature was addedfor AER compatibility aspart of user experienceimprovements and has noeffect on device safety orperformance |
| Post procedurereprocessingmethod | Manual | Manual and Automated | Both designs utilizeIndustry-acceptedstandard for reprocessingcompliance.Manual methods wereupdated and validated toadapt accepted standardcare 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.
§ 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.