GUARDIAN URETHRAL SHEATH by SOLACE THERAPEUTICS

The Guardian Urethral Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The Guardian Urethral 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 Solace Guardian Urethral Sheath is an everting sleeve sheath with a backflow valve for the establishment of a protective tract to the bladder to facilitate atraumatic insertion of catheters and instruments through the urethra. The sheath consists of a thin-walled rigid plastic tube, an obturator, and an everting sleeve that deploys from the obturator during insertion to reduce friction. Improvements from the Generation I sheath include a silicone disc to improve patient comfort at the external contact point, a single handed fluid management system, and independent fill and waste lines.

The Urethral Sheath is supplied sterile and is single use. The working channel is sized to accommodate instruments up to 19 French. The sheath outside size is 24 French with a working length of 4.7 cm.

The Sheath helps the patient by protecting the urethra and reducing abrasion or tenderness resulting from instruments passing through the urethra.

AI/ML Overview

This 510(k) summary describes a medical device, the Guardian Urethral Sheath, and its testing for substantial equivalence to a predicate device. However, it does not involve an AI/ML device, and therefore, many of the requested criteria related to AI/ML performance studies, such as sample sizes for test and training sets, ground truth establishment, expert adjudication, and MRMC studies, are not applicable.

Here's an analysis of the provided text based on your prompt, highlighting the available information and noting where AI/ML-specific criteria are not met:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from text)	Reported Device Performance
Biocompatibility in accordance with ISO 10993:2009:- Cytotoxicity- Sensitization- Irritation or Intracutaneous reactivity	Biocompatibility tests were conducted on the Guardian Urethral Sheath according to the requirements of ISO 10993:2009. The following were completed: Cytotoxicity, Sensitization, Irritation or Intracutaneous reactivity. (Implies satisfactory completion as it supports the conclusion of substantial equivalence).
In Vitro Performance Testing:- Simulated Use Testing- Design Verification Testing- Process Validation Testing	In vitro performance tests were performed on the Guardian Urethral Sheath. The following were performed: Simulated Use Testing, Design Verification Testing, Process Validation Testing. (Implies satisfactory completion as it supports the conclusion of substantial equivalence).
Substantial Equivalence: Material, design, and function to the Generation 1 Guardian Urethral Sheath K052298.	"The Generation 2 Guardian Urethral Sheath is substantially equivalent in material, design and function to the Generation 1 Guardian Urethral Sheath K052298 (formerly CYSTOGLIDE INTRODUCER SHEATH).""Based upon these biocompatibility and in vitro performance tests, the Guardian Urethral Sheath has been shown to be substantially equivalent to the currently marketed Guardian Urethral Sheath K052298."

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

Not Applicable (N/A) for AI/ML context. The testing described is for a conventional hardware medical device (a urethral sheath), not an AI/ML diagnostic or predictive algorithm. Therefore, there isn't a "test set" in the sense of a dataset for algorithm evaluation.
The performance data provided are for physical and biological characteristics (biocompatibility, in vitro performance). The text does not specify sample sizes for these tests (e.g., number of devices tested for simulated use, number of animal subjects for biocompatibility, etc.).
Data Provenance: Not specified for the general performance testing. Biocompatibility tests are standardized. "Simulated Use Testing" implies a lab setting.

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

N/A for AI/ML context. Ground truth in the context of expert consensus for image or data interpretation is not relevant for this device. The "ground truth" for this device would be established by physical and chemical testing standards and clinical performance expectations. The text does not specify experts involved in establishing these test criteria or evaluating the results, beyond the implied expertise in conducting ISO standard tests.

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

N/A for AI/ML context. Adjudication methods like 2+1 are used for resolving disagreements among human readers or labelers in AI/ML performance evaluation. This concept does not apply to the physical and biological testing of a conventional medical device.

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. This is not an AI/ML device, so an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed or described.

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

N/A. This is not an AI/ML algorithm.

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

For Biocompatibility: The ground truth is established by adherence to the ISO 10993:2009 standards for material safety (cytotoxicity, sensitization, irritation).
For In Vitro Performance: The ground truth is established by Design Verification Testing, Simulated Use Testing, and Process Validation Testing, which would compare the device's performance against pre-defined engineering specifications and functional requirements. These are objective measures based on engineering and manufacturing standards.

8. The sample size for the training set

N/A for AI/ML context. This is not an AI/ML device, so there is no "training set."

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

N/A for AI/ML context. As there is no training set for an AI/ML model, this question is not applicable.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of biocompatibility tests and in vitro performance tests.

Biocompatibility Testing: Conducted according to ISO 10993:2009 standards, which include tests for Cytotoxicity, Sensitization, and Irritation or Intracutaneous reactivity. The positive outcome of these tests implies that the device materials are safe for their intended use.
In Vitro Performance Testing: This encompassed Simulated Use Testing, Design Verification Testing, and Process Validation Testing. These tests would evaluate the device's functional integrity, design specifications, and manufacturing consistency under controlled, laboratory conditions. For instance, simulated use testing would assess how the sheath performs during insertion and withdrawal of instruments, and how well the backflow valve functions, within a simulated anatomical environment. Design verification would confirm that the device meets its specified dimensions, material properties, and operational characteristics. Process validation would ensure that the manufacturing process consistently produces devices that meet these specifications.

The conclusion drawn from these tests is that the Guardian Urethral Sheath (Generation 2) has been shown to be substantially equivalent to its predicate device (Guardian Urethral Sheath K052298) in terms of material, design, and function. The FDA's 510(k) clearance further confirms this determination of substantial equivalence, based on the provided data.

Summary

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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.

l. Sponsor Name Submitter's Name: Solace Therapeutics Address: 135 Newbury St, Framingham, MA 01701 Phone: (508) 283-1200 Contact Person: William Gruber Date of Preparation: May 30, 2013
1. Device Information Trade Name: Guardian Urethral Sheath Common Name: Urological catheter Class: Il Classification Name: Urological catheter (21 CFR 876.5130, Product Code KNY)

AUG 20 2013

1. Predicate Devices Guardian Urethral Sheath K052298 (formerly CYSTOGLIDE INTRODUCER SHEATH)
1. Device Description

The Sheath helps the patient by protecting the urethra and reducing abrasion or tenderness resulting from instruments passing through the urethra.

1. Intended Use
  The Guardian Urethral Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The Guardian Urethral 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.
1. Comparison of Technological Characteristics

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The Generation 2 Guardian Urethral Sheath is substantially equivalent in material, design and function to the Generation 1 Guardian Urethral Sheath K052298 (formerly CYSTOGLIDE INTRODUCER SHEATH)

Improvements from the Generation 1 sheath include a silicone disc to improve patient comfort at the external contact point, a single handed fluid management system, and independent fill and waste lines.

1. Performance Data
  Biocompatibility Testing

Biocompatibility tests were conducted on the Guardian Urethral Sheath according to the requirements of ISO 10993:2009. The following were completed:

Cytotoxicity .
. Sensitization
. Irritation or Intracutaneous reactivity

In Vitro Performance Testing

In vitro performance tests were performed on the Guardian Urethral Sheath. The following were performed:

Simulated Use Testing .
Design Verification Testing .
Process Validation Testing .

Conclusion

Based upon these biocompatibility and in vitro performance tests, the Guardian Urethral Sheath has been shown to be substantially equivalent to the currently marketed Guardian Urethral Sheath K052298.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G6(19 Silver Spring, MD 20993-0002

August 20, 2013

Solace Therapeutics % William Gruber President 135 Newbury Street Framingham, MA 01701

Re: K131803

Trade/Device Name: Guardian Urethral Sheath Regulation Number: 21 CFR$ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KNY Dated: July 23, 2013 Received: July 24, 2013

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 (sec 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.

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Page 2 - William Gruber

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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

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K131803 510(k) Number (if known):

Guardian Urethral Sheath Device Name:

Indications For Use:

Prescription Use X (Per 21 CFR 801.109 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﺴﺴ

Herbert P. Lerner -S

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(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K131803 510(k) Number _

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.