The LoFric® Plus Single Use Urinary Catheter is designed as an intermittent pathway for drainage of the bladder. The device consists of a catheter, coated with a hydrophilic low-friction coating. The surface is hydrophilic and when the catheter is immersed in water or physiological saline solution for 30 seconds, it becomes slippery and ready to use. The catheter is provided in a variety of lengths and sizes.

AI/ML Overview

The provided document is a 510(k) summary for the LoFric® Plus Single Use Urinary Catheter, focusing on its substantial equivalence to a previously marketed device. It does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study that proves the device meets those criteria. The document states that "Laboratory data demonstrates this" but does not provide specifics about the studies performed or their results.

Here's a breakdown of what can be extracted based on the provided text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided 510(k) summary. The document mentions "Laboratory testing and biocompatibility testing was conducted to determine device functionality and conformance to design input requirements." However, it does not specify what those "design input requirements" or their corresponding acceptance criteria were, nor does it report the specific performance metrics achieved.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The document refers to "Laboratory data" but does not detail the sample sizes used for any testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the document describes a medical device (catheter) for drainage, not a diagnostic device that would typically involve expert ground truth for interpretation of results. The "ground truth" would likely be based on physical properties or biological tests.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This is not applicable. An MRMC study is typically used for diagnostic imaging devices where multiple readers interpret images to assess inter-reader variability and the effectiveness of a diagnostic tool, often with and without AI assistance. This document pertains to a physical medical device (catheter).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. Standalone performance refers to the accuracy of an AI algorithm without human involvement, which is not relevant for a physical medical catheter.

7. The Type of Ground Truth Used

The document broadly mentions "Laboratory testing and biocompatibility testing." This implies the "ground truth" would be based on:

Physical Property Measurements: E.g., dimensions, coating slipperiness, strength, flow rates.
Biocompatibility Standards: Meeting established ISO or other regulatory standards for material safety in contact with human tissue.

Specific details about the ground truth (e.g., specific tests, their methodologies, and the standards they adhered to) are not provided.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device; there is no "training set" in the context of an algorithm or AI model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

Summary of Study Information Provided:

Study Name: "Laboratory testing and biocompatibility testing"
Purpose: To "determine device functionality and conformance to design input requirements."
Key Finding: "Laboratory data demonstrates" that the only difference (addition of a 15 cm size length) "do[es] not raise new questions of safety and effectiveness." This implies the new size length performs comparably to existing lengths according to the unspecified acceptance criteria.

Key Missing Information:

The document is a high-level summary for regulatory submission. It does not provide:

Specific quantitative acceptance criteria (e.g., "Coating friction must be X Pascals," or "Tensile strength must be Y Newtons").
Specific performance results against those criteria.
Detailed methodologies of the "laboratory testing and biocompatibility testing."
Sample sizes or statistical analyses from these tests.

Summary

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K01237
Page 1 of 2

AUG 2 3 2001

510K Summary of Safety and Effectiveness

Astra Tech AB Lofric Plus Catheter

1. Sponsor Name Astra Tech, INC. 430 Bedford St. Lexington, MA 02173
1. Device Name

Proprietary Name:	Astra Tech AB LoFric® Plus Single UseUrinary Catheter
Common/Usual Name:	Urethral Catheters
Classification Name:	Urethral Catheters and Accessories72 GBM, Class II - Urology Devices

1. Identification of Legally Marketed Device
  The modified The LoFric® Plus Single Use Urinary Catheter is substantially equivalent in intended use to the LoFric® Single Use Urinary Catheter (K896750).

4. Device Description

The LoFric® Plus Single Use Urinary Catheter is designed as an intermittent pathway for drainage of the bladder. The device consists of a catheter, coated with a hydrophilic low-friction coating.

The surface is hydrophilic and when the catheter is immersed in water or physiological saline solution for 30 seconds, it becomes slippery and ready to use. The catheter is provided in a variety of lengths andsizes.

5. Intended Use

The LoFric® Plus Single Use Urinary Catheter is intended for intermittent catheterization of the urethra.

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K012374
Page 2 of 2

Comparison of Technological Characteristics 6

The modified The LoFric® Plus Single Use Urinary Catheter is substantially equivalent in intended use and design to the currently marketed The LoFric® Plus Single Use Urinary Catheter (K896750).

The only difference between the LoFric® Plus Single Use Urinary Catheter and The only difference both on the addition of a 15 cm size length to the the product line. These differences do not raise new questions of safety and effectiveness. Laboratory data demonstrates this.

6. Performance Testing

Laboratory testing and biocompatibility testing was conducted to determine device functionality and conformance to design input requirements.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. In the center of the seal is a stylized image of an eagle.

Public Health Service

AUG 2 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Astra Tech AB % Mr. Bruce R. Manning New England Biomedical Research, Inc. 96 West Main Street NORTHBOROUGH MA 01532

Re: K012374

Astra Tech AB LoFric® Plus Single Use Urinary Catheter (Urological Catheters and Accessories) Dated: July 25, 2001 Received: July 26, 2001 Regulatory Class: II 21 CFR 876.5130/Procode: 78 GBM

Dear Mr. Manning:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have and assisses We have reviewed your Secuent 116(k) houtsation of mises to the enclosure) to begally marketed predicate contracts on the device is substantaly equiralin (or the marceles). 16, the enactment date of the Medical Device Amendments, or to devices marked in interstate continete provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, that have been reclassified in accordance will the provisions of the Act. The general controls provisions of the Act therefore, market the device, subject on the gallering pro notice, and manufacturing procice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Prematet Approval), it may be subjections If your device is classince (Secadore) into clubs to copied on to topodate over found in the Code of Feaced Regulations, to such additional controls. Existure high regulation assumes compliance with the Current Good Manufacturing
Title 21, Parts 800 to 895. A substantialion assumes of Alabora I I III 21, Patts 800 to 692. A Subsantany Quirtual Collection (QS) for Medical Device: Cencral regulation (2) CFR Pat Practice requirements, is set four in the Quality Of Sock to Aministration (FDA) will verify such assumptions. Failure 820) and that, through periodic QS hispections, the regulatory action. In addition, FDA may publish further announcements to comply with the Unit Tegulation nay result in regalatory this response to your premarket notification sumission in the lucture comerning your device in all I cocral Regised. " Tease notes with a ct for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of the read the substantial equivalence of your device to a legally market 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 and additionally 809.10 for in vite If you done specific arriver to your derite of Campliance at (301) 594-4639. Additionally, for questions on the promotion and diagnosite of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, advising of your derres, promotet notification" (21CFR 807.97). Other general information on your responsibilities under Nisulanding of Icelerice to premation "QS to the 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/dsmadsmamain.html".

Sincerely yours,

Nancy C. Brogdon

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

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Astra Tech AB LoFric® Plus Single Use Urinary Catheter Device Name:

Indications For Use:

The LoFric® Plus Single Use Urinary Catheter is intended for intermittent catheterization of the urethra.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The-Counter Use Prescription Use (Per 21 CFR 801.109) (Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012374

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.