Vesair Cystoscopes are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the devices include the visualization and manipulation of anatomy as the surgeon deems appropriate. Vesair Cystoscopes are intended to be used in general urological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.

Device Description

The Vesair Cystoscopes described in this submission are rigid reusable endoscopes for visualization of the operating site during cystoscopic minimally invasive procedures in conjunction with a commercially available light guide, light source, video camera, monitor, and printer. Light that is created by an external light source is transmitted from the endoscope's light guide connector through the endoscope itself to the tip via a fiber optic system. Images are transferred the other way back through a rigid lens system.

Technical parameters of the Vesair Cystoscopes that characterize the optical view are the Direction of View (0°, 30°, 70°) and the Field of View (105°). The image can be displayed by a camera/monitor system which can be connected to the endoscope eyepiece. The Vesair Cystoscopes have the same diameter (4mm), and are available in different lengths of the insertion tube (0° - 280mm length, 30° - 185mm or 278mm length, 70° - 185mm or 281mm length). None of the cystoscope models have a working channel. Like other currently marketed rigid cystoscopes, all models have patient-contacting outer surfaces mainly made from metal (304 stainless steel) and incorporate fiber optics for light transmission and rigid lenses for image transmission.

Each cystoscope model is provided non-sterile and requires cleaning and steam sterilization prior to use and between subsequent uses.

AI/ML Overview

The provided text describes the Vesair Cystoscopes, which are rigid reusable endoscopes, and details their comparison to predicate and reference devices for a 510(k) submission. However, it does not describe an AI/ML device or a study that establishes ground truth through expert consensus, pathology, or outcomes data, nor does it include information on a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or training set details.

Therefore, most of the requested information regarding AI device acceptance criteria and study details cannot be extracted from this document.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices based on technological characteristics and performance testing relevant to an endoscope, not an AI/ML system.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the context of an AI/ML device's performance metrics (e.g., sensitivity, specificity, AUC). Instead, it lists performance tests conducted for a medical device (endoscope) and reports that these tests met the required specifications.

Acceptance Criteria (Implied for an Endoscope)	Reported Device Performance
Reprocessing Validation	Met required specifications
Biocompatibility Testing	Met required specifications
Electrical and Thermal Safety Testing	Met required specifications
Shelf-life Study	Met required specifications
Optical Image Quality Testing	Met required specifications
Substantial Equivalence to Predicate Device	Demonstrated

2. Sample size used for the test set and data provenance:

Test set sample size: Not applicable/Not provided. The performance testing described (reprocessing, biocompatibility, safety, shelf-life, optical quality) relates to the physical and functional characteristics of the endoscope, not an AI model evaluated on a data set.
Data Provenance: Not applicable/Not provided. The tests described are bench tests or laboratory analyses on the device itself, not data derived from patients or clinical sources.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

Not applicable/Not provided. Ground truth in the context of expert consensus for AI/ML performance is not relevant to this device's submission which is for an endoscope. The tests performed would have relied on standard testing methodologies and equipment, not clinical experts establishing ground truth for data interpretation.

4. Adjudication method for the test set:

Not applicable/Not provided. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert interpretations to establish ground truth for AI/ML models. This is not relevant to the described device testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

No, a MRMC comparative effectiveness study was not done. This type of study is specific to evaluating diagnostic AI/ML devices in conjunction with human readers, which is not what the Vesair Cystoscopes are.

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

No, a standalone algorithm performance study was not done. The Vesair Cystoscopes are physical medical devices (endoscopes) and do not involve an algorithm.

7. The type of ground truth used:

Not applicable/Not provided. The concept of "ground truth" (expert consensus, pathology, outcomes data) as it applies to AI/ML device validation is not relevant here. The "truth" for the performance tests would be established by reference standards, validated methods, and compliance with specifications.

8. The sample size for the training set:

Not applicable/Not provided. This device is not an AI/ML system and therefore does not have a training set.

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

Not applicable/Not provided. As there is no AI component, there is no training set or associated ground truth establishment.

In summary, the provided text describes a traditional medical device (cystoscope) submission and its performance testing, which does not involve AI or the associated methodologies for validating AI/ML performance.

Summary

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

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 19, 2017

Solace Therapeutics, Inc. Scott Blood Vice President, Quality Assurance and Regulatory Affairs 135 Newbury Street Framingham, MA 01701

Re: K170862

Trade/Device Name: Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope, Vesair 30 degree Cystoscope, Vesair 70 degree Cystoscope Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FAJ Dated: November 3, 2017 Received: November 6, 2017

Dear Scott Blood:

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.

{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 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible, and the overall impression is clean and professional.

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) K170862

Device Name

Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope, Vesair 30 degree Cystoscope, Vesair 70 degree Cystoscope

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)	☐

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/1 description: The image shows the logo for Solace Therapeutics. The logo consists of a purple circle with white lines inside, followed by the word "Solace" in black, with a registered trademark symbol next to it. Below "Solace" is the word "THERAPEUTICS" in purple, with a sans-serif font.

510(k) Summary

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:	Scott Blood, Vice President Quality Assurance & Regulatory Affairs
Date of Preparation:	December 18, 2017

2. Device Information

Trade Name:	Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope, Vesair 30 degree Cystoscope, Vesair 70 degree Cystoscope
Common Name:	Cystoscope
Regulation Number:	21 CFR 876.1500
Regulation Name:	Endoscope and Accessories
Class:	II
Product Code:	FAJ

3. Predicate Device

Schoelly Cystoscopes K150158

4. Device Description

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

Each cystoscope model is provided non-sterile and requires cleaning and steam sterilization prior to use and between subsequent uses.

5. Intended Use

6. Comparison of Technological Characteristics

The Vesair Cystoscopic Sheath is substantially equivalent to the Schoelly Cystoscope per Table 1:

Feature/Specification	Proposed Vesair Cystoscope	Schoelly CystoscopeK150158
Patient-ContactingMaterial	Stainless Steel	Stainless Steel
Sterilization	Steam	Steam
Outer Diameter	4mm	Available in 2.9mm and 4mmsizes
Working length	0° - 280mm30° -185mm or 278mm70° -185mm or 281mm	Available in 280mm, 298mm,300mm, 302mm,303mm
Working Channel	Not available	Not available
Direction of View	Available in 0°,30°,70°	Available in0°,5°,12°,25°,30°,70°
Field of View	1020	70° - 85°
Indications for Use	Vesair Cystoscopes are indicated toprovide the user with the means forendoscopic diagnostic and therapeuticsurgical procedures. Examples for the useof the devices include the visualizationand manipulation of anatomy as thesurgeon deems appropriate. VesairCystoscopes are intended to be used ingeneral urological surgery through aminimally invasive approach by utilizingnatural orifices to access the surgical site.	The Schoelly Cystoscopes/Hysteroscopesand Accessories arc indicated to providethe user with the means for endoscopicdiagnostic and therapeutic surgicalprocedures. Examples for the use of thedevices include the visualization andmanipulation of anatomy as the surgeondeems appropriate. The SchoellyCystoscopes/Hysteroscopes andAccessories are intended to be used ingeneral urological and gynecologicalsurgery through a minimally invasiveapproach by utilizing natural orifices to

Table 1 - Comparison of Proposed Vesair Cystoscope to Predicate Device

{5}------------------------------------------------

Feature/Specification	Proposed Vesair Cystoscope	Schoelly Cystoscope K150158
		access the surgical site.

7. Reference Device

These same models have already been cleared for marketing by FDA (K080560) for use in arthroscopic procedures. The proposed Vesair Cystoscope is the exact same device as the Henke Sass Wolf Arthroscope, except for the working length and Indications for Use.

Feature/Specification	Proposed Vesair Cystoscope	Henke Sass Wolf ArthroscopeK080560
Patient-ContactingMaterial	Stainless Steel	Stainless Steel
Sterilization	Steam	Steam
Outer Diameter	4mm	4mm
Working length	0° - 280mm30° -185mm or 278mm70° -185mm or 281mm	185mm
Working Channel	Not available	Not available
Direction of View	Available in 0°,30°,70°	Available in 0°,30°,70°
Field of View	105°	105°
Indications for Use	Vesair Cystoscopes are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the use of the devices include the visualization and manipulation of anatomy as the surgeon deems appropriate. Vesair Cystoscopes are intended to be used in general urological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.	The HSW Arthroscope and accessories is a tubular endoscopic device with accessory devices which attach to the Arthroscope and is intended to examine and / or perform surgery on the interior of a joint. Arthroscopic minimal invasive procedures are performed in the hip, knee, shoulder, wrist (carpal tunnel syndrome), temporal-mandibular joint, ankle, elbow and feet (plantar fascia release).

Table 2 - Comparison of Proposed Vesair Cystoscope to Reference Device

8. Performance Testing

Performance tests on the bench were performed on the Vesair Cystoscope. The following were performed:

Reprocessing validation study ●
. Biocompatibility Testing
Electrical and Thermal Safety Testing

{6}------------------------------------------------

Shelf-life study
Optical image quality testing

All bench testing has been performed and all components, subassemblies and/or full devices and systems have met the required specifications for the completed tests.

9. Summary

Solace Therapeutics, Inc. has demonstrated that the Vesair Cystoscope is substantially equivalent to its listed predicate devices.

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.