The LoFrice Single Use Urinary Catheter is designed as an intermittent pathway for drainage of the bladder. This device is a single-use disposable unit and is packaged in a thermoformed tray with a heat sealed paper lid. The catheter is available in a variety of lengths and configurations to accommodate individual anatomy of both male and female users. Both Nelaton (straight tip) and Tiemann (curved tip) designs are available.

AI/ML Overview

The provided text is a 510(k) Summary for the LoFric® Single Use Urinary Catheter. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific, quantitative acceptance criteria through a study with a test set, ground truth, or expert review in the way that an AI/ML medical device submission would.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, and expert involvement is not present in the provided 510(k) summary.

Here's why and what information is provided:

510(k) for Catheters vs. AI/ML Devices: The LoFric® catheter is a physical medical device. Its submission focuses on demonstrating that it is "substantially equivalent" to an existing, legally marketed device (the Astra Tech LoFric® Single Use Urinary Catheter - K896750) in terms of intended use, operating principle, design, materials, manufacturing, and sterilization. This is a comparison against a similar existing device, not a performance evaluation against pre-defined statistical acceptance criteria for a new algorithmic output.
Performance Testing: The summary mentions "Performance testing and biocompatibility testing were submitted to address efficacy and safety of the device and to show substantial equivalence to the predicate device." However, it does not provide any details about:
- Specific acceptance criteria for these tests.
- The quantitative results of these tests.
- The sample sizes for these tests.
- How "ground truth" was established (as it's not relevant for a physical device's performance like this).
- Expert involvement or adjudication methods.
- Multi-reader multi-case studies or standalone algorithm performance.

In summary, none of the specific details you requested (points 1-9) are available in this 510(k) summary because it pertains to a physical, non-AI medical device and follows the substantial equivalence pathway, not a performance study pathway that would typically involve such metrics.

Summary

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LoFric® Single Use Urinary Catheter
K113424

510(k) Summary

APR 1 7 2012

Astra Tech AB

LoFric® Single Use Urinary Catheter

April 17, 2012

Head of Regulatory Affairs

ADMINISTRATIVE INFORMATION

Manufacturer Name: Astra Tech AB Aminogatan 1, P.O. Box 14 Mölndal, Sweden SE-431 21 Telephone: +46 31 776 30 00 Fax: +46 31 776 30 10 Official Contact: Christina Lewing

Representative/Consultant:

Floyd G. Larson Kevin A. Thomas, Ph.D. Allison C. Komiyama, Ph.D. PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 Email: flarson@paxmed.com kthomas@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	LoFric® Single Use Urinary Catheter
Classification Name:	Urological catheter and accessories
Classification Regulations:	21 CFR Part 876.5130, Class II
Product Code:	EZD
Classification Panel:	Gastroenterology and Urology Devices Panel
Reviewing Branch:	Urology and Lithotripsy Devices Branch

INTENDED USE

LoFrio® Single Use Urinary Catheter is intended for intermittent urinary catheterization.

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510(k) Summary

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

Astra Tech AB submits information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the LoFric® Single Use Urinary Catheter is substantially equivalent in indications and design principles to the following legally marketed predicate device, which has been determined by FDA to be substantially equivalent to a legally marketed predicate device:

Astra Tech LoFric® Single Use Urinary Catheter - K896750

The subject device and the predicate device both have the same intended use, which is for intermittent urinary catheterization. Both are single-use plastic catheters coated with polyvinyl pyrrolidone. Both are made using the same basic manufacturing technology, and both have the same performance characteristics. Performance testing and biocompatibility testing were submitted to address efficacy and safety of the device and to show substantial equivalence to the predicate device.

Overall, LoFric® Single Use Urinary Catheter has the following similarities to the predicate devices:

has the same intended use, .
. uses the same operating principle,
incorporates the same basic design. .
incorporates the same or very similar materials, and .
. has similar packaging and is sterilized using the same materials and processes

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The text is in all capital letters and is in a sans-serif font.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Astra Tech AB % Mr. Floyd G. Larson President PaxMed International, LLC 11234 El Camino Real, Suite 200 SAN DIEGO CA 92130

APR 17 2012

Re: K113424

Trade/Device Name: LoFric® Single Use Urinary Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: March 30, 2012 Received: April 2, 2012

Dear Mr. Larson:

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

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Page 2-

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher, Ph.D.

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

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510(k) Premarket Notification

LoFric® Single Use Urinary Catheter
K113424

Indications for Use

510(k) Number:

113424

Device Name:

LoFric® Single Use Urinary Catheter

Indications for Use:

LoFrio® Single Use Urinary Catheter is intended for intermittent urinary catheterization.

Prescription Use X ______________________________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D).

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)	Page 1 of __
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(Division Sign-Off)
Division of Reproductive, Gastrointestinal, andUrological Devices
510(k) Number	K113424

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.