LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER by ASTRA TECH, INC.

The LoFric® Hydro-Kit II 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. The catheter is packed within a bag for urine collection. The urine collection bag is used as a wetting container prior to catheterization. Inside the closed urinary bag, a water sachet is placed. By holding the product upright and exerting a light pressure on the folded water sachet, the water will activate the hydrophilic catheter surface.

AI/ML Overview

The Astra Tech AB LoFric® Hydro-Kit II Single Use Urinary Catheter, as described in the provided 510(k) summary, underwent performance testing to establish its safety and effectiveness. However, the document does not present detailed acceptance criteria in a quantitative table or the specific results against such criteria. Instead, it broadly states that "Laboratory testing and biocompatibility testing was conducted to determine device functionality and conformance to design input requirements."

Here's an analysis based on the information provided and what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a specific table of acceptance criteria or detailed reported device performance metrics/results. The submission focuses on demonstrating substantial equivalence to a predicate device (LoFric® Single Use Urinary Catheter, K896750) rather than presenting a de novo performance study against explicit criteria.

The 510(k) summary states:

"Laboratory testing and biocompatibility testing was conducted to determine device functionality and conformance to design input requirements."
"The difference between the LoFric® Hydro-Kit II Single Use Urinary Catheter and the predicate is the packaging concept and addition of accessories as urine collection bag and water sachet. The method of sterilization is changed. This difference does not raise new questions of safety and effectiveness. Laboratory data demonstrates this."

This indicates that internal performance testing was conducted, likely focusing on aspects such as:

Functionality: Ensuring the hydrophilic coating activates correctly, the catheter remains slippery for the intended duration, and the urine collection bag and water sachet function as designed.
Biocompatibility: To confirm the materials are safe for patient contact.
Sterilization Effectiveness: To validate the new sterilization method.
Physical Integrity: Ensuring the catheter and packaging maintain integrity during handling and use.

Without specific numerical acceptance criteria (e.g., "slipperyness duration ≥ X minutes," "tensile strength ≥ Y N," "sterility assurance level = Z"), a detailed table of objective results cannot be constructed from this document. The "reported device performance" is summarized as the device meeting "design input requirements" and demonstrating that changes "do not raise new questions of safety and effectiveness."

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

The document does not specify the sample size used for the laboratory testing.
The data provenance is internal laboratory data, suggesting it was conducted by the manufacturer, Astra Tech, Inc. The document does not mention the country of origin of the data beyond the manufacturer's location. The testing is implicitly prospective in nature, as it was conducted to validate the new design changes.

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

This type of information is not applicable in this context. The study described is laboratory-based performance testing of a medical device (catheter), not a diagnostic or imaging device where expert interpretation of clinical data would be required to establish ground truth.

4. Adjudication method for the test set

This is not applicable as the study is laboratory performance testing, not a clinical study requiring expert adjudication of patient outcomes or interpretations.

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 is not applicable. The device is a physical medical device (urinary catheter), not an AI-powered diagnostic tool. Therefore, an MRMC study and AI performance metrics are irrelevant to this submission.

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

This is not applicable as the device is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used

For the laboratory performance testing mentioned, the "ground truth" would be established by objective engineering and material science standards and specifications. This could include:

Reference standards: Established methods and instruments for measuring physical properties (e.g., friction, tensile strength, sterility).
Biocompatibility standards: ISO or ASTM standards for material safety.
Design specifications: Internal requirements set by Astra Tech for the performance of the catheter and its components.

It is not based on expert consensus, pathology, or outcomes data in the clinical sense directly, but rather on whether the device performs according to its predetermined engineering and safety parameters.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device. There is no "training set" in the context of machine learning or AI development.

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

This is not applicable as there is no training set for this type of device.

Summary

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K043241
Page 1 of 2

Astra Tech, Inc

DEC 2 3 2004

510K Summary of Safety and Effectiveness

Astra Tech AB Lofric Hydro-Kit II Single Use Urinary Catheter

Sponsor Name 1. Astra Tech, Inc.
Device Name 2.

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

Identification of Legally Marketed Device 3.
The modified The LoFric® Hydro-Kit II Single Use Urinary Catheter is substantially equivalent in intended use to the LoFric® Single Use Urinary Catheter (K896750).

4. Device Description

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.

The catheter is packed within a bag for urine collection. The urine collection bag is used as a wetting container prior to catheterization. Inside the closed urinary bag, a water sachet is placed. By holding the product upright and exerting a light pressure on the folded water sachet, the water will activate the hydrophilic catheter surface.

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K043241
Page 2 of 2

ട. Intended Use
The LoFric® Hydro-Kit II Single Use Urinary Catheter is intended for intermittent catheterization of the urethra.
Comparison of Technological Characteristics රි
The modified The LoFric® Hydro-Kit II Single Use Urinary Catheter is substantially equivalent in intended use and design to the currently marketed The LoFric® Single Use Urinary Catheter (K896750).

The difference between the LoFrio® Hydro-Kit II Single Use Urinary Catheter and the predicate is the packaging concept and addition of accessories as urine collection bag and water sachet. The method of sterilization is changed. This difference does not raise new questions of safety and effectiveness. Laboratory data demonstrates this.

1. 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 2004

Mr. Niklas Lidskog President Astra Tech, Inc. 890 Winter Street, Suite 310 WALTHAM MA 02451

Re: K043241

Ro452 Fi
Trade/Device Name: Astra Tech AB LoFric® Hydro-Kit II Single Use Urinary Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 GBM Dated: November 22, 2004 Received: December 1, 2004

Dear Mr. Lidskog:

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 Section 510(k) I mis letter will and w you'll collection of substantial equivalence of your device to a legally premarked notheadon: "The PDF mastification 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 if you desire specific active as one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Allo, production other general information on your responsibilities under the Act from the 801:27). " Ou may octurers, International and Consumer Assistance at its toll-free number (800) DIVISION of Unian Hallacturess http://www.fda.gov/cdrl/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

Enclosure

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K043241 510(k) Number (if known):

Astra Tech AB LoFric® Hydro-Kit II Single Use Urinary Catheter Device Name:

Indications For Use:

The LoFric® Hydro-Kit II 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)

1 Prescription Use __

Over-The-Counter Use

(Per 21 CFR 801.109)

David A. Hegmann

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

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.