The LoFric Primo 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 activated with the water integrated in the package, it becomes slippery and ready to use. The catheter is provided in a variety of lengths and sizes. The catheter and the activation water is separated, sealed in one bag. By holding the product upright and exerting a light pressure on the folded water pocket, the water will run down and wet the catheter. The bag is opened and the catheter is inserted into the patient's urethra.

AI/ML Overview

The provided document is a 510(k) summary for the Astra Tech AB LoFric Primo Single Use Urinary Catheter, dated May 5, 2005. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include detailed information regarding specific acceptance criteria, a comprehensive study proving device performance against those criteria, or the methodology typically associated with AI/ML device studies (such as sample sizes for test/training sets, ground truth establishment, or expert involvement).

Based on the provided text, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance	Study to Prove Acceptance Criteria Met
Material Properties:
Biocompatibility	Met via laboratory testing.	Conducted against design input requirements.
Functionality	Met via laboratory testing.	Conducted against design input requirements.
Sterilization:
Efficacy of new sterilization method	No specific performance metrics provided, but it states "Laboratory data demonstrates this."	Laboratory testing.
Comparison to predicate device:
Substantial equivalence in intended use and design	Achieved.	Comparison of technological characteristics and laboratory data.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document mentions "Laboratory data" and "biocompatibility testing" but does not provide numbers of units tested or details on test methodologies.
Data Provenance: Not specified. It's a medical device submission, so the testing would have been performed in a controlled laboratory setting, likely by the manufacturer or a contracted lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable to this type of device submission. The device is a physical catheter, not an AI/ML diagnostic tool. Ground truth would be based on validated laboratory methods and specifications, not expert consensus on interpretations of data.

4. Adjudication method for the test set

Not applicable. This device does not involve human interpretation or subjective assessment of results in the way an AI/ML diagnostic device would. Performance is measured against predefined physical and chemical specifications.

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

Not applicable. This is not an AI-assisted device, and no human reader studies are mentioned or relevant to this type of product.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth for this device would be established by:
- Validated laboratory methods: For physical properties (e.g., strength, flexibility, lubricity after activation), chemical properties (e.g., integrity of coating), and sterility.
- Biocompatibility standards: Industry and regulatory standards for material safety in contact with human tissue.
- Device specifications: Engineering and design requirements for the catheter's functionality and performance.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document states:

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

And specifically regarding the change in packaging concept and sterilization method:

"The difference between the LoFric Primo Single Use Urinary Catheter and the predicate is the packaging concept, which includes the addition of water. 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 laboratory testing, likely based on established protocols for medical devices of this type, evaluated the device's performance against its design specifications and relevant safety standards. The FDA's 510(k) clearance implies that they found this evidence sufficient to establish substantial equivalence to the predicate device. However, the details of these laboratory tests, specific performance metrics, and sample sizes are not provided in this summary.

Summary

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IC050874

MAY - 5 2005

Astra Tech, Inc

510K Summary

Astra Tech AB Lofric Primo Single Use Urinary Catheter

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

Proprietary Name:	Astra Tech AB LoFric® Primo™ Single Use Urinary Catheter
Common/Usual Name:	Urethral Catheters
Classification Name:	Urethral Catheters and Accessories 72 GBM, Class II - Urology Devices

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

Device Description 4.

The LoFric Primo 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 activated with the water integrated in the package, it becomes slippery and ready to use. The catheter is provided in a variety of lengths and sizes.

The catheter and the activation water is separated, sealed in one bag. By holding the product upright and exerting a light pressure on the folded water pocket, the water will run down and wet the catheter. The bag is opened and the catheter is inserted into the patient's urethra.[1]

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Intended Use 5.

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

Comparison of Technological Characteristics ರಿ

The modified The LoFric Primo 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 LoFric Primo Single Use Urinary Catheter and the predicate is the packaging concept, which includes the addition of water. 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 ¡sjand biocompatibility testing was conducted to determine device functionality and conformance to design input requirements.

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Image /page/2/Picture/2 description: The image shows a circular logo with text around the perimeter and a stylized bird-like symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES". The bird-like symbol consists of three curved lines that resemble wings or feathers.

MAY - 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Scott A. Root President Astra Tech, Inc. 890 Winter Street, Suite 310 WALTHAM MA 02451

Re: K050874

Trade/Device Name: LoFric® Primo™ Single Use Urinary Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: GBM Dated: April 5, 2005 Received: April 7, 2005

Dear Mr. Root:

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 as not one reguirements 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 (Premarket Approval), it may be subject to such 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 statues and regulations administered by other Federal agencies. You must comply with all the r caeral states and registration and 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) (2) 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 his ieter will anow you to oegin maneting your and equivalence of your device to a legally premarket nothication. The PDA midnig of backannal business 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 advice tor your de received by 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 Also, please note the regulation entired, formation on your responsibilities under the Act from the 807.97). I ou may obtain other general infonal and Consumer Assistance at its toll-free number (800) DIVISION of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmamain.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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510(k) Number (if known):

K050874

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

Indications For Use:

The LoFric® Primo™ 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)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__

Nancy C Snowden
(Division Sign-Off)

Division of Reproductive, Abdominal. and Radiological Devi 510(k) Number

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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.