Vesair Cystoscopic Sheath

K162356 · Solace Therapeutics · KNY · Mar 2, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K162356
• Device Name: Vesair Cystoscopic Sheath
• Applicant: Solace Therapeutics
• Product Code: KNY · Gastroenterology, Urology
• Decision Date: Mar 2, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Intended Use

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 Story

Vesair Cystoscopic Sheath facilitates atraumatic insertion of catheters/instruments into urethra and bladder; provides visualization of urethra/bladder. Assembly includes visual obturator, sheath, and single-use sterile seal. Used in clinical settings by physicians. Sheath is non-sterile, requiring cleaning and steam sterilization between uses; seal is replaced between uses. Device acts as a physical guide and lubricious barrier to protect urethral tissue during instrumentation.

Clinical Evidence

Bench testing only. Performance data includes design verification, simulated use testing, ship testing, repeat steam sterilization testing, and accelerated aging.

Technological Characteristics

Materials: Stainless steel. Components: Visual obturator, sheath, single-use sterile seal. Dimensions: 166 mm working length, 19.5 Fr ID, 22.5 Fr OD. Sterilization: Steam. Connectivity: None. Software: None.

Indications for Use

Indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between urethral tissue and the catheter or instrument.

Regulatory Classification

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).

Predicate Devices

• Guardian Urethral Sheath (K141252)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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

| <span style="font-size:10px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10px">☐</span> 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: | [phone] |
| Fax: | [phone] |
| 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<br>(21 CFR 876.5130, Product Code KNY) |

# 3. Predicate Devices

Guardian Urethral Sheath (K141252)

# 4. 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.

# 5. Intended Use

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.

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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<br>(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 cystoscope<br>compatibility | 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.