The LoFric® Primo™ and LoFric® Hydro-Kit™ are single-use catheters designed as intermittent pathways for drainage of the bladder. The catheters are 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. Each catheter is packaged along with a water packet that is to be broken immediately before use in order to soak the tubing.

AI/ML Overview

The LoFric® Primo™ and LoFric® Hydro-Kit™ are urological catheters that were cleared based on substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and performance metrics. Therefore, the information typically found in an AI/CAD device submission regarding detailed acceptance criteria and a study proving those criteria are met is not present. This submission relies on performance testing and biocompatibility testing as compared to existing, legally marketed predicate devices.

Here's an analysis based on the provided text, addressing the points where information is available or can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Inferred from Equivalence Claims)	Reported Device Performance (Summary)
Intended Use: Intermittent urinary catheterization	Met: Same intended use as predicate devices.
Operating Principle: Same as predicate devices	Met: Uses the same operating principle as predicate devices.
Basic Design: Same as predicate devices	Met: Incorporates the same basic design as predicate devices.
Materials: Same as predicate devices	Met: Incorporates the same materials as predicate devices.
Manufacturing Technology: Same as predicate devices	Met: Made using the same basic manufacturing technology.
Performance Characteristics: Similar to predicate devices	Met: Has similar performance characteristics. Performance testing according to ASTM F623 was conducted.
Biocompatibility: Demonstrated as safe	Met: Biocompatibility testing was submitted and addressed.
Sterilization: Same materials and processes	Met: Sterilized using the same materials and processes.
Packaging: Similar to predicate devices	Met: Has similar packaging.

Explanation: The "acceptance criteria" for this submission are fundamentally defined by the characteristics of the predicate devices. The new devices are deemed "substantially equivalent" if they meet these characteristics and do not raise new issues of safety or efficacy.

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

This information is not provided in the submission. The submission describes non-clinical testing data including "dimensional analysis, biocompatibility testing and modified performance testing according to ASTM F623." However, specific sample sizes for these tests, or information on test sets derived from patient data (retrospective or prospective), are not included. Given that it's a medical device (catheter) rather than a diagnostic AI/CAD system, "data provenance" in the sense of patient data doesn't directly apply in this type of submission for substantial equivalence.

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

This information is not applicable/not provided. This is a submission for a physical medical device (catheter), not an AI/CAD system requiring expert-established ground truth on clinical images or data. The "ground truth" for demonstrating equivalence largely comes from engineering specifications, material science, and performance standards (like ASTM F623) in comparison to predicate devices, not expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. As explained above, this is not an AI/CAD system requiring adjudication of interpretations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

This information is not applicable/not provided. MRMC studies are typically performed for diagnostic AI/CAD systems to evaluate the impact on human reader performance. This submission is for a physical medical device.

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

This information is not applicable/not provided. This is not an algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" for this substantial equivalence submission is essentially derived from:

Predicate Device Characteristics: The established safety and effectiveness profiles of the legally marketed predicate devices.
Engineering Specifications and Standards: Compliance with relevant engineering and material standards, such as ASTM F623 for performance testing.
Biocompatibility Standards: Successful completion of biocompatibility testing to ensure safety in contact with biological tissues.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This is not an AI/ML device that requires a "training set" in the computational sense. The "learning" for the manufacturer comes from established manufacturing processes and prior device iterations (e.g., K113424, K043241, K050874, which are predicate devices).

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

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

Summary

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510(k) Summary

K122078

LoFric® Primo™ and LoFric® Hydro-Kit™

510(k) Summary

OCT 31 2012

Astra Tech

LoFric® Primo™ and LoFric® Hydro-Kit™

July 13, 2012

ADMINISTRATIVE INFORMATION

Manufacturer Name

Astra Tech Aminogatan 1. P. O. Box 14 Mölndal, Sweden SE-431 21 +46 31 776 30 00 Telephone: Fax: +46 31 776 30 10

Official Contact

Representative/Consultant

Christina Lewing Head of Regulatory Affairs

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

DEVICE NAME AND CLASSIFICATION

LoFric® Primo™ and LoFric® Hydro-Kit™ Trade/Proprietary Name Classification Name Urological catheter and accessories 21 CFR Part 876.5130, Class II Classification Regulations EZD Product Code Classification Panel Gastroenterology and Urology Devices Panel Reviewing Branch Urology and Lithotripsy Devices Branch

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KJ22078

LoFric® Primo™ and LoFric® Hydro-Kit™

INTENDED USE

LoFric® Primo™ and LoFric® Hydro-Kit™ are intended for intermittent urinary catheterization.

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

Astra Tech submits information in this Premarket Notification to demonstrate that, for the purposes of FDA 's regulation of medical devices, the LoFric® Primo™ and LoFric® Hydro-Kit™ are substantially equivalent in indications and design principles to the following legally marketed predicate devices:

Astra Tech AB, LoFric® Single Use Urinary Catheter - K113424 Astra Tech, Inc., Astra Tech AB LoFric® Hydro-Kit II Single Use Urinary Catheter - K043241 Astra Tech, Inc., Astra Tech AB LoFric® Primo™ Single Use Urinary Catheter - K050874

The subject devices and the predicate device have the same intended use, which is for intermittent urinary catheterization. All are single-use plastic catheters coated with polyvinyl pyrrolidone. They are made using the same basic manufacturing technology, and all have similar 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 devices. Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy.

Non-clinical testing data that was submitted, referenced, or relied upon to demonstrate substantial equivalence included: dimensional analysis, biocompatibility testing and modified performance testing according to ASTM F623.

The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.

Overall, LoFric® Primo™ and LoFric® Hydro-Kit™ has the following similarities to the predicate devices:

has the same intended use, .

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510(k) Summary

LoFric® Primo™ and LoFric® Hydro-Kit™

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

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three curved lines representing its wings or feathers.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

OCT 31 2012

Astra Tech, Inc. % Allison C. Komiyama, Ph.D. Regulatory Specialist PaxMed International, LLC 11234 El Camino Real, Suite 200 SAN DIEGO CA 92130

Re: K122078.

Trade/Device Name: LoFric® Primo™ and Lofric® Hydro-Kit™ Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: September 28, 2012 Received: October 1, 2012

Dear Dr. Komiyama:

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.

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Page 2 - Allison C. Komiyama, Ph.D.

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 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.

C. Hales Lewens no

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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Indications for Use

K122078 510(k) Number:

LoFric® Primo™ and LoFric® Hydro-Kit™ Device Name:

Indications for Use:

LoFric® Primo™ and LoFric® Hydro-Kit™ are 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 1

Hela Lemer

Gastro-Renal,

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.