The InCare Intermittent Catheter is indicated for use by male, female and pediatric patients for the purpose of bladder drainage. The Catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.

Device Description

The InCare Intermittent Catheters are intended to be used as a means of managing urinary incontinence by draining urine from the bladder. The InCare Intermittent Catheters are sterile, non-latex, PVC catheters. A unique manufacturing process ensures that the eyes of the intermittent catheters are polished and smooth to help eliminate trauma to the urethra, reducing the possibility of hematuria. The catheter packaging has been designed to facilitate easy opening for those users with limited dexterity. The InCare Intermittent catheters are available in various sizes to accommodate a wide range of male, female, and pediatric end users.

AI/ML Overview

The provided text is a 510(k) Summary for the InCare Intermittent Catheter. This document does not describe a study to prove the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices. Substantial equivalence relies on comparing the new device's design, materials, and intended use to existing, legally marketed devices, rather than conducting new performance studies against specific acceptance criteria.

Therefore, the requested information elements related to a study (like acceptance criteria table, sample sizes, expert ground truth, adjudication, MRMC, standalone performance, and ground truth for training data) are not available in this document.

Here's what can be extracted based on the nature of the document:

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

This information is not provided. The document focuses on demonstrating substantial equivalence rather than performance against pre-defined acceptance criteria from a specific study.

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

This information is not applicable. No specific test set or study data is mentioned for performance evaluation.

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. No test set or ground truth establishment by experts is described for performance evaluation.

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

This information is not applicable. No test set or adjudication method is described.

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 MRMC study was done, as this is not an AI-assisted device.

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

Not applicable, as this is not an algorithm or AI device.

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

Not applicable. The "ground truth" in a 510(k) for substantial equivalence relies on comparing features to existing predicate devices, not on a ground truth for performance.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm device that requires a training set.

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

Not applicable. This is not an AI/algorithm device that requires a training set or ground truth for it.

Based on the provided text, the key information is related to the substantial equivalence determination:

Acceptance Criteria for Substantial Equivalence: The criteria implicitly accepted by the FDA for substantial equivalence in this context are:
- Identical Intended Use: The new device must have the same intended use as the predicate device(s).
- Same Technological Characteristics: If the technological characteristics are the same, the device is substantially equivalent.
- Different Technological Characteristics but as Safe and Effective: If the technological characteristics are different, the device must not raise different questions of safety and effectiveness, and information must be provided that demonstrates the device is as safe and effective as the legally marketed device.
Reported Device Performance (in terms of Substantial Equivalence):
- Intended Use: The InCare Intermittent Catheter is "indicated for use by male, female and pediatric patients for the purpose of bladder drainage" which is stated as substantially equivalent to the predicate devices.
- Technological Characteristics: The device is described as "substantially equivalent to the predicate devices in design, materials used, and intended use." Specifically, it is made of "PVC material that is substantially equivalent to the predicate devices."
- Biocompatibility: A biocompatibility assessment was conducted based on established guidelines (USP, G95-1, ISO 10993-1). The materials are "considered biocompatible and appropriate for their intended use." This addresses a key aspect of safety.

In summary, this 510(k) document is a declaration of substantial equivalence, not a report of a performance study against specific acceptance criteria.

Summary

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Hollister Incorporated 2000 Hollister Drive Libertyville, Illinois 60048-3781

JAN 0 7 2002

InCare Intermittent Catheter

Telephone: 847,680,1000 Facsimile: 847.918.3860

. 013345
Page 1 of 2

Hollister

510(k) Summary

1. Sponsor's name, Address and Contact Person

Sponsor Hollister Incorporated 2000 Hollister Drive Libertyville IL. 60048 Contact Person Joseph S. Tokarz Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 (847) 680-2849 Ph: (847) 918-3860 Fax:

Date Summary Prepared - October 5, 2001

2. Name of Device:

InCare Intermittent Catheter

3. Name of Predicate Device(s)

Conveen Intermittent Catheters Mentor Self Cath Rusch FloCath (K000070)

4. Description of Device

The catheter packaging has been designed to facilitate easy opening for those users with limited dexterity.

The InCare Intermittent catheters are available in various sizes to accommodate a wide range of male, female, and pediatric end users.

5. Statement of Intended Use

The InCare Intermittent Catheter is indicated for use by male, female and pediatric patients for the purpose of bladder drainage. The catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.

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K013345
Page 2 of 2

InCare Intermittent Catheter

Image /page/1/Picture/2 description: The image shows the word "Hollister" in a bold, sans-serif font. To the left of the word is a geometric design that resembles a stylized snowflake or asterisk. The design is also in bold and black, matching the text.

6. Statement of Technological Characteristics of the Device

The InCare Intermittent catheter is substantially equivalent to the predicate devices in design, materials used, and intended use. The InCare Intermittent Catheters are made of a PVC material that is substantially equivalent to the predicate devices.

Biocompatibility assessment of the InCare Intermittent Catheter has been conducted based on the principles and guidelines established by various governmental regulatory agencies and standard setting organizations. Among these are the following: United States Pharmacopoeia, General program memorandum #G95-1, United States Food and Drug Administration Office of Device Evaluation and The International Standards Organization ISO 10993-1 Biological Dovice Linatation of Medical Devices. Based upon the results of this assessment, the materials used to Evariate in of incere Intermittent Catheters are considered biocompatible and appropriate for their intended use.

7. Conclusion

Based on information presented above and in the body of this premarket notification the InCare Intermittent Catheter is substantially equivalent to devices currently in distribution.

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Food and Drug Administration 9200 Corporate Boulevard Rockville . MD 20850

JAN 0 7 2002

Mr. Joseph S. Tokarz Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive LIBERTYVILLE IL 60048-3781 Re: K013345

Trade/Device Name: InCare Intermittent Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 KOD Dated: October 5, 2001

Received: October 9, 2001

Dear Mr. Tokarz:

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.

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); 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.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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InCare Intermittent Catheter

Page 1 of 1

b. Statement of Intended Use

510(k) Number (if Known): Device Name:

K 013345
InCare Intermittent Catheter

Indications For Use:

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

Prescription Use	OR
(Per 21 CFR 801.109)

Nancy C broaden

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K013345

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-the-Counter-Use

(Optional Format 1-2-96)

PAGE S

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.