LoFric® Sense™ is a single-use catheter designed as an intermittent pathway for drainage of the bladder. The catheters are available in one length with a Nelaton (straight) tip and a variety of diameters to accommodate individual anatomy. Each catheter is packaged with a water packet that is to be broken immediately before use in order to soak the tubing.

AI/ML Overview

Here's an analysis of the provided information, focusing on acceptance criteria and the supporting study details:

Device: LoFric® Sense™ (Urological catheter and accessories)
Submission Number: K123751
Date: February 28, 2013

1- A table of acceptance criteria and the reported device performance

Based on the provided document, the acceptance criteria are not explicitly stated as numerical targets. Instead, the study's primary goal was to demonstrate substantial equivalence to a predicate device. This means the acceptance criteria are implicitly met if the device shows comparable performance characteristics to the predicate device.

Acceptance Criteria (Implicit for Substantial Equivalence):

Safety: The device should not raise new issues of safety compared to the predicate.
Efficacy/Performance: The device should have similar performance characteristics to the predicate.
Biocompatibility: The device should be biocompatible.
Dimensional Integrity: The device must meet specified dimensional requirements.

Reported Device Performance:
The document states that the LoFric® Sense™:

"has the same intended use" as the predicate.
"uses the same operating principle" as the predicate.
"incorporates the same basic design" as the predicate.
"incorporates the same or very similar materials" as the predicate.
"has similar packaging and is sterilized using the same materials and processes" as the predicate.
"Performance testing and biocompatibility testing were submitted to address efficacy and safety of the device and to show substantial equivalence to the predicate device."
"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."
"Any differences in the technological characteristics between the subject and predicate device do not raise new issues of safety or efficacy."

Acceptance Criteria Category	Specific Criteria (Implicit for Substantial Equivalence)	Reported Device Performance
Safety	No new safety issues compared to predicate.	"Any differences in the technological characteristics between the subject and predicate device do not raise new issues of safety or efficacy." "Biocompatibility testing was submitted to address safety."
Efficacy/Performance	Similar performance characteristics to the predicate.	"has the same intended use," "uses the same operating principle," "incorporates the same basic design," "incorporates the same or very similar materials," "has similar packaging and is sterilized using the same materials and processes." "Modified performance testing according to ASTM F623" was performed.
Biocompatibility	Biocompatible (verified by testing).	"Biocompatibility testing was submitted to address efficacy and safety."
Dimensional Integrity	Meets specified dimensional requirements.	"Dimensional analysis" was performed.
Manufacturing/Sterilization	Same/similar manufacturing technology; similar packaging/sterilization to predicate.	"made using the same basic manufacturing technology," "has similar packaging and is sterilized using the same materials and processes."

2- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of human subject testing or a clinical trial. The evaluation primarily relies on non-clinical testing data.

Sample Size: Not explicitly stated for specific non-clinical tests (e.g., how many catheters were dimensionally analyzed or used for performance testing).
Data Provenance: The manufacturer, Wellspect HealthCare, is based in Mölndal, Sweden. It is highly probable the non-clinical testing was conducted in Sweden or by contracted labs. The document does not specify if any data originates from other countries.
Retrospective/Prospective: Non-clinical testing (dimensional analysis, biocompatibility, performance testing) is inherently prospective as it's conducted specifically for the submission.

3- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the study described is a non-clinical, substantial equivalence comparison to a predicate device, not a diagnostic accuracy study relying on expert-established ground truth.

4- Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the study described is a non-clinical, substantial equivalence comparison to a predicate device. There is no mention of a "test set" requiring adjudication by human readers/experts.

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 information is not applicable. The submission is for a urological catheter (medical device), not an Artificial Intelligence (AI) enabled diagnostic or assistive tool.

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

This information is not applicable. The submission is for a physical medical device, not an algorithm or AI system.

7- The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the non-clinical testing, the "ground truth" for demonstrating substantial equivalence is based on:

Industry Standards and Regulations: Adherence to standards like ASTM F623 for performance testing.
Reference Materials/Specifications: For dimensional analysis, the ground truth would be the defined design specifications of the device.
Established Methods: For biocompatibility, validated biological test methods determine the ground truth regarding material safety.
Predicate Device Data: The performance and characteristics of the legally marketed predicate device (Astra Tech, LoFric® Primo™ - K122078) serve as a crucial comparative "ground truth."

8- The sample size for the training set

This information is not applicable. The submission is for a physical medical device, not an AI or machine learning model that requires a training set.

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

This information is not applicable. There is no training set involved in this medical device submission.

Summary

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K123751
Page 1 of 2

LoFric® Sense™

FEB 2 8 2013

510(k) Summary

Wellspect HealthCare

LoFric® Sense™

December 27, 2012

ADMINISTRATIVE INFORMATION

Manufacturer Name	Wellspect HealthCareAminogatan 1, P. O. Box 14Mölndal, Sweden SE-431 21
	Telephone:	+46 31 376 40 00
	Fax:	+46 31 376 30 10
Official Contact	Herman Fahlström
	Head of Quality Systems and Regulatory Affairs
Representative/Consultant	Allison C. Komiyama, Ph.D.
	Floyd G. Larson
	PaxMed International, LLC
	12264 El Camino Real, Suite 400
	San Diego, CA 92130
	Telephone:	+1 (858) 792-1235
	Fax:	+1 (858) 792-1236
	Email:	akomiyama@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	LoFric® Sense™
Classification Name	Urological catheter and accessories
Classification Regulations	21 CFR Part 876.5130, Class II
Product Code	EZD
Classification PanelReviewing Branch	Gastroenterology and Urology Devices PanelUrology and Lithotripsy Devices Branch

510(k) Summary

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510(k) Summary

K123751
Page 2 of 2

INTENDED USE

Intermittent urinary catheterization.

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

Wellspect HealthCare submits information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, LoFric® Sense " is substantially equivalent in indications and design principles to the following legally marketed predicate device:

Astra Tech, LoFric® Primo™ - K122078

The subject device and the predicate device have the same intended use 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 device. Any differences in the technological characteristics between the subject and predicate device 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 demonstrate substantial equivalence to the predicate device listed above.

Overall, LoFric® Sense" has the following similarities to the predicate device:

. 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

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

February 28, 2013

Wellspect HealthCare % Allison C. Komiyama, Ph.D. Senior Regulatory Specialist PaxMed International, LLC 12264 El Camino Real, Suite 400 SAN DIEGO CA 92130

Re: K123751

Trade/Device Name: LoFric® Sense™ Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: December 5, 2012 Received: December 6, 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. Ilsting 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.

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

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/3/Picture/6 description: The image shows the name "Benjamin B. Fisher -S" in a stylized font. The first name, Benjamin, is written in a simple, bold font. The middle initial and last name are written in a more complex, geometric font that appears to be made up of lines and shapes. The "-S" at the end is written in the same simple, bold font as the first name.

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

K123751 510(k) Number:

LoFric® Sense™ Device Name:

Indications for Use:

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

Benjamin 2013.02.28

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Jrological Devices 510(k) Number _ KIZ375

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.