CompactCath Intermittent Urinary Catheter is indicated for use in male, female, and pediatric patients (adolescent and transitional adolescent) 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 document describes the CompactCath Intermittent Urinary Catheter and its substantial equivalence to a predicate device, K100878 Self Cath Catheter Coloplast A/S. The information about the acceptance criteria and the study that proves the device meets them is limited, as the document focuses on demonstrating substantial equivalence rather than presenting a detailed clinical study report with, for example, a standalone algorithm performance, or an MRMC study.

However, based on the Testing section and the Performance specifications & testing summary (avg.) table, we can extract the following information:

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

Acceptance Criteria Category	Specific Test Parameter	Acceptance Criteria (from predicate)	Reported Device Performance (CompactCath)
Performance Specifications	Insertion Force (Female)	0.06 lbf	0.08 lbf
	Insertion Force (Male)	1.38 lbf	1.08 lbf
	Flow Test	520 ml/min	504 ml/min
	Hub Pull	14.96 (lbf, {N})	17.97 (lbf, {N})
Biocompatibility	Per ISO10993	"All materials suitable for this use"	"All materials were found to be biocompatible and suitable for this use."
Sterilization	Validation	"Validated cycle" (for radiation)	"Sterilization validation... were also completed."
	Shelf Life	2 Years	6 months
	Sterility Assurance Level (SAL)	10^-6	10^-6 (Assumed for predicate, explicitly stated for CompactCath)
Material Equivalence	Direct Patient Contacting Material	Silicone	Silicone
	Catheter Material	PVC	PVC
Physical Dimensions	Length (adults)	16"	16"
	Length (pediatric)	10"	10"
	Diameter	8-18FR	8-12FR
	Number of Eyelets	2	2

Note on Acceptance Criteria: The document states "Product testing was completed and met the acceptance criteria." The table above extrapolates the "acceptance criteria" from the reported performance of the predicate device (Coloplast) as the basis for comparison to demonstrate substantial equivalence. The CompactCath performance is then compared directly against these values. For some criteria, the CompactCath matches or is within an acceptable range, while for others (like shelf life), the difference is acknowledged and deemed equivalent in the context of substantial equivalence, not necessarily identical.

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

Sample Size for Test Set: The document does not explicitly state the sample sizes used for the various tests (flow measurements, bond strength, deployment, insertion force, biocompatibility, sterilization validation, expiry dating). It only mentions that testing was completed.
Data Provenance: Not specified. The studies appear to be in-house laboratory testing of the devices, not human clinical trials or data from specific countries of origin. They are therefore prospective in nature, as they involve testing the manufactured devices.

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)

Not applicable. The tests performed are engineering and laboratory tests (e.g., flow rate, force measurement, biocompatibility, sterilization validation), not subjective assessments requiring expert consensus on a "ground truth" in the way a medical image or diagnostic test would.

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

Not applicable, for the same reasons as point 3.

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 type of study (MRMC for AI assistance) is not relevant to this medical device, which is a physical intermittent urinary catheter, not an AI-powered diagnostic or therapeutic system.

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

Not applicable, as it's a physical medical device, not an algorithm.

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

The "ground truth" for the performance tests appears to be the measured performance data of the legally marketed predicate device (Coloplast Self Cath Catheter). For other tests like biocompatibility, the ground truth is adherence to recognized standards (ISO10993). For sterilization, the ground truth is validated sterilization cycles achieving a specific SAL (10^-6).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable, as explained in point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of three faces in profile, stacked on top of each other. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the image.

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

August 21, 2014

CompactCath % Gregory Mathison President Regulatory Strategies, Inc. 3924 Cascade Beach Road Lutsen, MN 55612

Re: K140945

Trade/Device Name: CompactCath Intermittent Urinary Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD Dated: June 30, 2014 Received: August 14, 2014

Dear Gregory Mathison,

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.

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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 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 vours.

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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Indications For Use

Indication

Indications of Use Red-line version:

Indication

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K140945

Device Name

CompactCath Intermittent Urinary Catheter

Indications for Use (Describe)

CompactCath Intermittent Urinary Catheted for use in male, female, and pediatric patients (adolescent and transitonal adolescent) with chronic urine retention and patients with post void residual volume (PVR) due to newogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

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

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Modified 510(K) Summary

510(k) Summary

Date of Submission:	March 31, 2014
Classification	Class II
Trade Name	CompactCath Intermittent Urinary Catheter
Submitter	CompactCath Inc.2945A Bush StSan Francisco, CA, 94115
	Contact:Gregory Mathison

Regulatory Affairs

Indications for Use

The CompactCath Intermittent Urinary Catheter is indicated for use in male, female, and pediatric patients (adolescent and transitional adolescent) 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.

Predicate Devices

K100878 Self Cath Catheter Coloplast A/S

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.

Sterilization

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

Packaging

The components are placed in a heat sealed Tyvek pouch.

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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 device. Both devices use silicone as a lubricant for ease of insertion.

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. All materials were found to be biocompatible and suitable for this use.

Sterilization validation and expiry dating were also completed.

Summary of Substantial Equivalence

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 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.

Feature/ Information	CompactCath	Coloplast	Substantial Equivalence
Manufacturer	CompactCath Inc.	Coloplast A/S
510(k) Number	K140945	K100878
FDA Classification	Class II	Class II	Same
Regulation number	876.5130	876.5130	Same
Product Code	EZD	EZD	Same
Indications for Use	The CompactCath IntermittentUrinary Catheter is indicated foruse in male, female and pediatricpatients (adolescents andtransitional adolescents) withchronic urine retention and patientswith post void residual volume(PVR) due to neuorgenic and non-neurogenic voiding dysfunction.The catheter is inserted into theurethra to reach the bladderallowing urine to drain.	The Self Cath Catheter is intendedfor use in male, female, andpediatric patients (neonates,infants, children, adolescents, andtransitional adolescents) requiringbladder drainage as determined bytheir physician. This device isindicated for those individualsunable to promote a natural urineflow or for those individuals whohave a significant volume ofresidual urine following a naturalbladder-voiding episode.	Equivalent - both devices are indicatedfor bladder drainage in males, femalesand adolescents, and transitionaladolescents patients. Intermittentcatheterization is indicated for patientswho have residual urine remaining intheir bladder.
Technology & Design /Description	Tubular catheter which is insertedinto the urethra and advanced intothe bladder to facilitate urinedrainage	Tubular catheter which is insertedinto the urethra and advanced intothe bladder to facilitate urinedrainage	Equivalent - both devices are tubularcatheters that allow urine drainage wheninserted into the urethra to the bladder
Materials	Catheter - PVC	Catheter - PVC	Equivalent - same base materials - exactvendor and classification of predicate

Refer to the table below for comparison data and substantial equivalence rationale

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				material unknown.
PhysicalDimensions	Length	16" (for adults), 10" (for pediatric)	16" (for adults), 10" (for pediatric)	Same
	Diameter	8-12FR	8-18FR	Same
	Number ofeyelets	2	2	Same
Clinical Procedure		Inserted into the urethra andadvanced into the bladder tofacilitate urine drainage	Inserted into the urethra andadvanced into the bladder tofacilitate urine drainage	Equivalent - same clinical application -device is introduced into the urethra andadvanced to the bladder to facilitateurine drainage
Theory of Operation		Provides a pathway for urinedrainage	Provides a pathway for urinedrainage	Same
Lubricated		Yes - silicone	Yes - silicone	Equivalent - both catheters are pre-lubricated for ease of use and patientcomfort
Method of Sterilization		Radiation	ETO	Equivalent - both devices are providedsterile. CompactCath is sterilized withRadiation in a validated cycle. Predicatedevice is sterilized using ETO gas.
SAL		10-6	Unknown	Equivalent - assumed to be 10-6 as this isa FDA cleared product
Single Use		Yes	Yes	Same
Shelf Life		6 months	2 Years	Equivalent
Packaging		Tyvek pouch	Tyvek pouch	Equivalent
Performance specifications &testing summary (avg.)		Insertion force	Female 0.08 lbfMale 1.08 lbf	Female 0.06 lbfMale 1.38 lbf
		Flow test	504 ml/min	520 ml/min
		Hub pull	17.97 (lbf, {N})	14.96 (lbf, {N})

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.