The Vesair Cystoscopic Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The Vesair Cystoscopic Sheath is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.

Device Description

The Vesair Cystoscopic Sheath is intended for use in visualizing the urethra and bladder as well as the establishment of a protective tract into the bladder to facilitate atraumatic insertion of catheters and instruments through the urethra.

The Vesair Cystoscopic Sheath Assembly includes a Visual Obturator, Sheath and the Vesair Single-Use Sterile Seal. The Sheath is provided non-sterile and requires cleaning and steam sterilization prior to use.

AI/ML Overview

The provided text is a 510(k) premarket notification document for the "Vesair Cystoscopic Sheath." It primarily focuses on demonstrating substantial equivalence to a predicate device ("Guardian Urethral Sheath") rather than providing detailed acceptance criteria and study results for a new, AI-powered medical device.

Therefore, the document does not contain the information requested regarding:

A table of acceptance criteria and reported device performance: The document mentions "in vitro performance tests" but does not provide specific acceptance criteria (e.g., specific thresholds for success in a test) or the quantitative results of these tests.
Sample size used for the test set and data provenance: No information is given about sample sizes for any "test set" in the context of device performance, nor is there any mention of data provenance (e.g., country of origin, retrospective/prospective).
Number of experts and their qualifications for ground truth: This is irrelevant as the device isn't an AI/imaging device requiring expert ground truth for interpretation.
Adjudication method: Not applicable for this type of device and study.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is a medical device, not an AI-assisted diagnostic tool.
Standalone (algorithm only) performance: Not applicable, as there is no algorithm or AI component mentioned.
Type of ground truth used: Not applicable in the context of a new AI/imaging device. The "performance data" mentioned are for mechanical and material properties.
Sample size for the training set: Not applicable, as there's no machine learning or AI training involved.
How ground truth for the training set was established: Not applicable for the same reason.

The document lists "In Vitro Performance Testing" as part of the performance data, including:

Design Verification Testing / Simulated Use Testing
Ship Testing
Repeat Steam Sterilization Testing
Accelerated Aging

However, it does not provide the details of these tests, their acceptance criteria, or the results. It concludes by stating that "Based upon the in vitro performance tests, the Vesair Cystoscopic Sheath has been shown to be substantially equivalent to the currently marketed Guardian Urethral Sheath K141252."

To summarize, the provided text describes a regulatory submission for a medical device (a cystoscopic sheath) and its claim of substantial equivalence to a predicate device, focusing on material, design, and sterilization comparisons. It is not an AI/software device and therefore does not have the types of performance data, ground truth establishment, or study methodologies that would be relevant to the questions posed.

Summary

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

March 2, 2017

Solace Therapeutics, Inc. William Gruber President and CEO 135 Newbury Street Framingham, MA 01701

Re: K162356

Trade/Device Name: Vesair Cystoscopic Sheath Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: KNY Dated: February 7, 2017 Received: February 8, 2017

Dear William Gruber:

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

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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 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.

Charles Viviano -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

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Indications for Use

510(k) Number (if known) K162356

Device Name Vesair Cystoscopic Sheath

Indications for Use (Describe)

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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510(k) Summary

The 510(k) Summary is submitted in accordance with 21 CFR 807.92 and the requirements of the Safe Medical Device ACT (SMDA) of 1990.

1. Sponsor Name

Submitter's Name:	Solace Therapeutics
Address:	135 Newbury St, Framingham, MA 01701
Phone:	(508) 283-1200
Fax:	(508) 283-1199
Contact Person:	William Gruber
Date of Preparation:	August 22, 2016

2. Device Information

Trade Name:	Vesair Cystoscopic Sheath
Common Name:	Urological catheter
Class:	II
Classification Name:	Urological catheter(21 CFR 876.5130, Product Code KNY)

3. Predicate Devices

Guardian Urethral Sheath (K141252)

4. Device Description

5. Intended Use

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6. Comparison of Technological Characteristics

The Vesair Cystoscopic Sheath is substantially equivalent in Guardian Urethral Sheath K141252. Improvements from the Guardian Urethral Sheath include modifications to the length, material, ID/OD, sterilization methodology, Obturator change, and Seal Assembly change.

Feature/Specification	Guardian Urethral Sheath(K141252)	Vesair Cystoscopic Sheath
Working Length	55 mm	166 mm
Material	Polymer	Stainless Steel
Sterilization	Ethylene Oxide	Steam
Inner Diameter	20 Fr	19.5 Fr
Outer Diameter	21 Fr	22.5 Fr
Obturator Change	Blunt nose – no cystoscopecompatibility	Blunt nose with cystoscope compatibility
Seal Assembly	No assembly required	Seal to be replaced between uses by user

Table 1 - Comparison of Proposed Vesair Cystoscopic Sheath to predicate Guardian Urethral Sheath

7. Performance Data

In Vitro Performance Testing

In vitro performance tests were performed on the Vesair Cystoscopic Sheath. The following were performed:

Design Verification Testing / Simulated Use Testing ●
Ship Testing ●
Repeat Steam Sterilization Testing
Accelerated Aging ●

8. Conclusion

Based upon the in vitro performance tests, the Vesair Cystoscopic Sheath has been shown to be substantially equivalent to the currently marketed Guardian Urethral Sheath K141252.

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.