K Number

Device Name

COMPACTCATH INTERMITTENT URINARY CATHETER

Manufacturer

COMPACTCATH INC

Date Cleared

2014-08-22

(130 days)

Product Code

EZD

Regulation Number

876.5130

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K100878

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical medical device (urinary catheter) and its performance characteristics, with no mention of AI, ML, image processing, or data sets typically associated with AI/ML development.

Therapeutic

Yes
The device is used to drain urine from the bladder, which alleviates symptoms and manages a medical condition (chronic urine retention and voiding dysfunction), thus providing therapeutic benefit.

Diagnostic

The device description clearly states its purpose is for "draining urine from the bladder," which is a therapeutic rather than a diagnostic function. The "Intended Use / Indications for Use" section also describes its use for patients with "chronic urine retention and patients with post void residual volume (PVR) due to neurogenic and non- neurogenic voiding dysfunction," indicating a management or treatment role, not a diagnostic one.

SaMD (Software as a Medical Device)

The device description clearly states it is a "sterile, single use urine drainage catheter," which is a physical hardware device. The performance studies also describe physical testing like flow measurements and bond strength.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information about a person's health.
This device is a catheter that is inserted into the body (specifically the urethra and bladder) to drain urine. It is a therapeutic device used for a physical intervention, not a diagnostic test performed on a sample.

The description clearly states its function is to drain urine from the bladder, which is a direct physical action within the body, not an analysis of a sample outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

EZD

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

urethra to reach the bladder

Indicated Patient Age Range

male, female, and pediatric patients (adolescent and transitional adolescent)

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Insertion force: Female 0.08 lbf, Male 1.08 lbf (CompactCath); Female 0.06 lbf, Male 1.38 lbf (Coloplast)
Flow test: 504 ml/min (CompactCath); 520 ml/min (Coloplast)
Hub pull: 17.97 (lbf, {N}) (CompactCath); 14.96 (lbf, {N}) (Coloplast)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K100878

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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.

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

Indications For Use

Indication

Indications of Use Red-line version:

Indication

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)

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 St
San 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.

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

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 Intermittent
Urinary Catheter 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 neuorgenic and non-
neurogenic voiding dysfunction.
The catheter is inserted into the
urethra to reach the bladder
allowing urine to drain.	The Self Cath Catheter is intended
for use in male, female, and
pediatric patients (neonates,
infants, children, adolescents, and
transitional adolescents) requiring
bladder drainage as determined by
their physician. This device is
indicated for those individuals
unable to promote a natural urine
flow or for those individuals who
have a significant volume of
residual urine following a natural
bladder-voiding episode.	Equivalent - both devices are indicated
for bladder drainage in males, females
and adolescents, and transitional
adolescents patients. Intermittent
catheterization is indicated for patients
who have residual urine remaining in
their bladder.
Technology & Design /
Description	Tubular catheter which is inserted
into the urethra and advanced into
the bladder to facilitate urine
drainage	Tubular catheter which is inserted
into the urethra and advanced into
the bladder to facilitate urine
drainage	Equivalent - both devices are tubular
catheters that allow urine drainage when
inserted into the urethra to the bladder
Materials	Catheter - PVC	Catheter - PVC	Equivalent - same base materials - exact
vendor and classification of predicate

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

				material unknown.
Physical
Dimensions	Length	16" (for adults), 10" (for pediatric)	16" (for adults), 10" (for pediatric)	Same
	Diameter	8-12FR	8-18FR	Same
	Number of
eyelets	2	2	Same
Clinical Procedure		Inserted into the urethra and
advanced into the bladder to
facilitate urine drainage	Inserted into the urethra and
advanced into the bladder to
facilitate urine drainage	Equivalent - same clinical application -
device is introduced into the urethra and
advanced to the bladder to facilitate
urine drainage
Theory of Operation		Provides a pathway for urine
drainage	Provides a pathway for urine
drainage	Same
Lubricated		Yes - silicone	Yes - silicone	Equivalent - both catheters are pre-
lubricated for ease of use and patient
comfort
Method of Sterilization		Radiation	ETO	Equivalent - both devices are provided
sterile. CompactCath is sterilized with
Radiation in a validated cycle. Predicate
device is sterilized using ETO gas.
SAL		10-6	Unknown	Equivalent - assumed to be 10-6 as this is
a 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 lbf
Male 1.08 lbf	Female 0.06 lbf
Male 1.38 lbf
		Flow test	504 ml/min	520 ml/min
		Hub pull	17.97 (lbf, {N})	14.96 (lbf, {N})