The Boa Endoscopic Valve™ is used with endoscopes and endoscopic devices with a maximum outer diameter up to 0.167 in. Endoscopic devices are inserted through the Boa Endoscopic Valve™ and through the endoscope. The Boa Endoscopic Valve™ forms a seal around endoscopic devices, supports the endoscopic device, and maintains the position relative to the endoscope biopsy channel port. It is compatible with biopsy port valves and is positioned against the biopsy valve of the endoscope. The Boa Endoscopic Valve™ is non-sterile and is designed for single patient use.

AI/ML Overview

The provided document is a 510(k) summary for the Boa Endoscopic Valve™. It states that the device is substantially equivalent to a predicate device (EndoChoice Seal Biopsy Valve, K111821).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text, using the structure you requested:

The document does not specify "acceptance criteria" in terms of performance metrics like sensitivity, specificity, accuracy, or specific thresholds for leakage rates or device passage force. Instead, the "acceptance criteria" in this context appear to be met by demonstrating substantial equivalence to a predicate device through various non-clinical tests.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Pass: Biocompatibility testing was performed in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1.
Physical Performance	Pass: Design verification and validation testing performed.
Simulated Use Performance	Pass: Design verification and validation testing performed.
Reliability	Pass: Design verification and validation testing performed.
Safety	Pass: Design verification and validation testing performed.
Clinical Attributes	Equivalent to predicate.
Technological Characteristics	Equivalent to predicate (attached to proximal biopsy channel port, aids in insertion/use/removal of accessories, minimizes leakage, used in hospitals/sub-acute care/surgery centers/doctor's office, single-patient disposable). The only stated difference is the rotation mechanism vs. pull-up mechanism.
Expected Performance	Comparable to legally marketed predicate (K111821).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for any of the bench or biocompatibility tests. It also does not mention data provenance (country of origin) or whether the tests were retrospective or prospective, as these are non-clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a mechanical endoscopic valve, and the evaluation involved non-clinical performance and biocompatibility testing, not expert interpretation of medical images or data requiring ground truth established by medical experts in that context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As noted above, this was a non-clinical evaluation that did not involve human adjudication for ground truth.

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

Not applicable. This is a medical device (endoscopic valve), not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a medical device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this type of device would be established by engineering specifications, material standards, and performance test methods. For example:

Biocompatibility: Adherence to ISO 10993 standards and FDA guidance.
Physical/Simulated Use/Reliability/Safety: Meeting pre-defined engineering specifications and performance benchmarks (e.g., specific force to pass a device, seal integrity tests, durability tests) that are typically established by the manufacturer and validated by test results.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no training set.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for a machine learning model, this question is not relevant.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 13, 2015

C2 Therapeutics, Inc. Theresa Brandner-Allen VP of Regulatory Affairs and Quality Assurance 303 Convention Way, Suite 1 Redwood City, CA 94063

Re: K152140 Trade/Device Name: Boa Endoscopic Valve Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX Dated: September 24, 2015 Received: September 25, 2015

Dear Theresa Brandner-Allen,

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.

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) K152140

Device Name

Boa Endoscopic Valve™M

Indications for Use (Describe)

The Boa Endoscopic Valve™ is intended to provide access for endoscopic device passage and exchange throughout the endoscopic procedure.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CER 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}------------------------------------------------

510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

SUBMITTER I.

Submitter Name: C2 Therapeutics, Inc.

Address: 303 Convention Way, Suite 1 Redwood City, CA 94063 Phone Number: 650-521-5921 Fax Number: 650-556-1145
Contact Person: Theresa Brandner-Allen VP of Regulatory Affairs and Quality Assurance

July 30, 2015 Date Prepared:

II. DEVICE

Name of Device: Boa Endoscopic Valve™ Common Name: Endoscopic valve Classification Name: Endoscope and accessories, 21 CFR§876.1500 Regulatory Class: Class II Product Code: OCX

III. PREDICATE DEVICE

EndoChoice Seal Biopsy Valve, K111821 This predicate device has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The Boa Endoscopic Valve™ is intended to provide access for endoscopic device passage and exchange throughout the endoscopic procedure.

{4}------------------------------------------------

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Boa Endoscopic Valve™ has similar technological characteristics to the legally marketed predicate. The subject device and predicate device are based on the following same technological elements:

· Attached to the proximal biopsy channel port of an endoscopic device to provide endoscopic device passage and exchange
Aids in the insertion, use, and removal of the endoscopic accessories during . endoscopic procedures
. Minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure
Used in hospitals, sub-acute care institutions, surgery centers, or doctor's office . where endoscopic procedures may be performed
. Used in a single patient (disposable) undergoing endoscopic procedures

The following technological differences exist between the modified device and predicate device:

The top of the modified device is rotated during use, and the top of the predicate . device is pulled up during use

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

Biocompatibility testing was performed in accordance with the FDA Blue Book Memorandum #G95-1 Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing and ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process.

Bench Testing

Design verification and validation testing were performed on the Boa Endoscopic Valve™ to evaluate physical, simulated use, reliability, and safety specifications.

VIII. CONCLUSION

The Boa Endoscopic Valve™ has the same clinical attributes, technological characteristics, and expected performance as the legally marketed predicate, EndoChoice Seal Biopsy Valve (K111821). The design verification and validation test results demonstrate that the Boa Endoscopic Valve™ should perform as intended in the specified use conditions and should perform comparably to the legally marketed predicate that is currently marketed for the same intended use.

Regulation Number and Section

§ 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.