CompactCath is indicated for use in male, female, and pediatric patients (adolescents and transitional adolescents) with chronic urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

Device Description

The CompactCath Intermittent Urinary Catheter is a sterile, single use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems.

AI/ML Overview

The provided text is a 510(k) summary for the CompactCath Intermittent Urinary Catheter. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria and a study proving a device meets them in the context of an Artificial Intelligence (AI) device.

However, based on the information provided, here's what can be extracted and what cannot be answered concerning acceptance criteria and a study:

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

The document states: "Product testing was completed and met the acceptance criteria. Testing included flow measurements, bond strength, deployment, and insertion force using anatomical models to simulate clinical use for both the CompactCath device and the predicate device. Test results show the products are equivalent."

While acceptance criteria were met, the specific numerical criteria and the reported performance values are not provided in this summary. The word "equivalent" is used to describe the results compared to the predicate device, but no quantitative data for either the criteria or the performance is given.

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

This information is not provided in the document. The testing involved "anatomical models to simulate clinical use," but the number of models/tests, their origin, or whether the study was retrospective or prospective (which isn't directly applicable as it's not a clinical study on human subjects) is not detailed.

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)

This information is not applicable/provided. The testing described involves physical measurements on a medical device (flow, bond strength, deployment, insertion force) using anatomical models. Establishing "ground truth" through expert consensus is typically relevant for diagnostic imaging or AI devices that interpret data, where human experts label or interpret cases. Here, the "ground truth" would be the direct physical measurements themselves (e.g., actual flow rates, actual insertion force).

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

This information is not applicable/provided. Adjudication methods like "2+1" or "3+1" are used in studies where multiple human readers or AI systems interpret data, and discrepancies need to be resolved to establish a consensus ground truth. This is not relevant to the type of physical performance testing described for a urinary catheter.

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

This information is not applicable. The device described is a physical medical device (an intermittent urinary catheter), not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

This information is not applicable. As stated above, this is a physical medical device, not an AI algorithm.

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

For the performance testing, the "ground truth" would be the physical measurements themselves (e.g., direct measurements of flow rates, bond strength, deployment characteristics, and insertion force). These are objective measurements rather than interpretations requiring expert consensus or pathology.

8. The sample size for the training set

This information is not applicable/provided. As this is not an AI device, there is no "training set."

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

This information is not applicable/provided.

Summary

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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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird in flight.

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

April 26, 2016

CompactCath Inc. Naama Stauber Breckler CEO 887 Federation Way Palo Alto, CA 94303

Re: K160858

Trade/Device Name: CompactCath Intermittent Urinary Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: Class II Product Code: EZD Dated: March 25, 2016 Received: March 29, 2016

Dear Naama Stauber Breckler,

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

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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,

Benjamin R. Fisher -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K160858

Device Name

CompactCath Intermittent Urinary Catheter

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."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services (10) ; 443-6746 EF

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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Submitter CompactCath Inc. 887 Federation Way Palo Alto, CA, 94303 Tel: 408-893-9776 Contact Naama Stauber Breckler CEO Trade Name CompactCath Intermittent Urinary Catheter Common Name CompactCath Intermittent Urinary Catheter Classification Class II

EZD

510 (k) Summary

Device Information

Indications for Use

Regulation

Product Code

21 CFR 876.5130

Predicate Devices

K140945 CompactCath Intermittent Urinary Catheter

Device Description

The CompactCath Intermittent Urinary Catheter is a sterile, single use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems.

Comparison with the predicate device

The CompactCath Intermittent Urinary Catheter is equivalent to the features of the predicate product. The indications for use, theory of operation, clinical application, methods of manufacturing, and materials used are substantially equivalent. Both devices are intended for insertion into the urethra. advancing to the bladder and to provide a

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pathway for the drainage of urine in male, female and pediatric patients. Both devices are packaged in a Tyvek pouch, heat-sealed and sterilized. Both devices are intended for single use only.

Performance Testing

Product testing was completed and met the acceptance criteria. Testing included flow measurements, bond strength, deployment, and insertion force using anatomical models to simulate clinical use for both the CompactCath device and the predicate device. Test results show the products are equivalent.

Biocompatibility testing was performed per ISO10993 for the original application. Cytotoxicity was conducted for the special 510(k). All materials were found to be biocompatible and suitable for this use.

Sterilization validation and expiry dating were also completed.

Sterilization

The system is provided sterile and is for single use only.

Packaging

The components are placed in a heat sealed Tyvek pouch.

Materials

All materials used in the manufacture of the CompactCath Intermittent Urinary Catheter are suitable for this use and have been used in previously cleared products. The direct patient contacting material is the same as the predicate devices use silicone as a lubricant for ease of insertion.

Conclusion

The modified CompactCath Intermittent Urinary Catheter is as safe and effective, has the same intended use, technological characteristics and principals of operation as the unmodified predicate device. The minor differences between the modified and the predicate device do not raise any new questions of safety or effectiveness. Therefore, the modified CompactCath Intermittent Urinary Catheter is substantially equivalent.

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.