The system consists of a Rinspiration™ Catheter and a KPS Rinspirator™ and its accessories. The KPS Rinspiration™ Catheter is a multi-lumen catheter that has perforations located near the distal end of the catheter to dispense an infusible fluid. The Rinspiration™ Catheter will be placed in the peripheral vasculature of a patient over a guide wire. The Rinspiration™ Catheter is available in over the wire and rail configurations. The catheter includes a radiopaque marker band at the distal tip and two radiopaque marker bands designating the infusion portion of the catheter. The catheter has a hub on the proximal end that allows access to the infusion and aspiration lumens. The KPS Rinspirator™ and its accessories is a sterile, single-use mechanical device. This hand-activated device allows for simultaneous irrigation and aspiration of the treatment site. The device activates two syringes for infusion and aspiration. This action is known as "Rinspiration™."

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the KPS Rinspiration™ System:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Safety and Effectiveness for Intended Use (implied, not explicitly stated as a quantitative criterion)	"Results of bench testing demonstrate that the KPS Rinspiration™ System is safe and effective for its intended use." (Functional Test Results). The device is found "substantially equivalent" to predicate devices.
Biocompatibility (implied, not explicitly stated as a quantitative criterion)	"The materials used in the KPS Rinspiration™ System have been shown to be biocompatible when tested in accordance with ISO 10993-1 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing requirements."

Critique: The provided document does not explicitly state quantitative acceptance criteria for the device's performance. Instead, it makes general statements about safety, effectiveness, and biocompatibility, and concludes substantial equivalence based on these.

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

Sample Size: Not specified. The document mentions "bench testing," but doesn't provide details on the number of units tested or the specific conditions.
Data Provenance: Not specified. It's implied to be internal testing by the applicant ("Results of bench testing demonstrate..."), but no country of origin or whether it's retrospective/prospective is mentioned.

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

Number of Experts: Not applicable. This study appears to be a bench test of a physical device, not related to interpretation of images or clinical data by experts.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. This study appears to be a bench test, not requiring adjudication of expert opinions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission describes bench testing, not a study involving human readers or clinical cases.
Effect Size of AI assistance: Not applicable, as no AI component or human-in-the-loop study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Standalone Study: Yes, in a sense, the "Functional Test Results" which state "Results of bench testing demonstrate that the KPS Rinspiration™ System is safe and effective for its intended use" represent the standalone performance of the device itself. However, this is for a physical medical device, not a software algorithm.

7. Type of Ground Truth Used:

Ground Truth Type: For the functional test results, the ground truth is likely based on engineering specifications and performance metrics defined by the manufacturer and accepted industry standards for infusion/aspiration systems in the peripheral vasculature. For biocompatibility, the ground truth is established by the ISO 10993-1 standard and its specific testing requirements.

8. Sample Size for the Training Set:

Sample Size: Not applicable. The device is a physical catheter system, not an AI model that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

Ground Truth Establishment: Not applicable, as there is no training set for an AI model.

Summary of deficiencies in the provided information relative to AI/software device submission expectations:

The provided document is a 510(k) summary for a physical medical device (catheter system) from 2003. It predates the widespread regulatory focus on AI/ML-driven medical devices and therefore does not contain the type of information typically required for an AI/ML device submission, particularly concerning:

Quantitative performance metrics (e.g., sensitivity, specificity, AUC)
Detailed test set characteristics (sample size, data provenance, expert labels)
Specific ground truth establishment methods for algorithms
Any mention of training sets, validation sets, or AI model development
Studies involving human readers or comparative effectiveness with or without AI assistance

The "acceptance criteria" discussed are primarily about general safety, effectiveness, and biocompatibility, demonstrating substantial equivalence to predicate devices through bench testing, rather than the rigorous statistical evaluation of algorithm performance against a defined ground truth that would be expected for an AI-powered device today.

Summary

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9.0 APPENDIX A: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Date Prepared: May 9, 2003

510(k) number:

Applicant Information:

Kerberos Proximal Solutions, Inc. 1400 Terra Bella Ave Suite K Mountain View, CA 94043

Contact Person:	Tom Mason
Phone Number:	(650) 254-1005
FAX Number:	(650) 254-1034

Device Information:

Classification: Class II Trade Name: KPS Rinspiration™ System Classification Name: Catheters, Intravascular, Diagnostic (21 CFR 870.1200)

Predicate Device:

The subject device is substantially equivalent in intended use and/or method of operation to a combination of the Merit Medical Fountain Infusion System (K974067/K981417), the Mallinckrodt Guiding Catheter (K873004) and the OriGen Dual Lumen Catheter (K003288).

Intended Use:

The KPS Rinspiration™ System is intended to infuse and aspirate in the peripheral vasculature.

Device Description:

Functional Test Results:

Results of bench testing demonstrate that the KPS Rinspiration™ System is safe and effective for its intended use.

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Biocompatibility:

The materials used in the KPS Rinspiration™ System have been shown to be biocompatible when tested in accordance with ISO 10993-1 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing requirements.

Summary:

Based on the intended use, product performance and biocompatibility information provided in this notification, the subject device has been shown to be substantially equivalent to currently marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird or eagle.

Public Health Service

SEP 2 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kerberos Proximal Solutions c/o Mr. Tom Mason 1400 Terra Bella, Suite K Mountain View, CA 94043

Re: K031485 KPS Rinspiration™ System Regulation Number: 21 CFR 870.1200 Regulation Name: Catheter, Intravascular, Diagnostic Regulatory Class: Class II (two) Product Code: DQO Dated: July 22, 2003 Received: July 23, 2003

Dear Mr. Mason:

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 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.

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Page 2 - Mr. Tom Mason

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Delattre, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

1 031485 510(k) Number:

Device Name:

KPS Rinspiration™ System

Indications for Use:

The KPS Rinspiration™ System is intended to infuse and aspirate in the peripheral vasculature.

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

Concurrence of CDRH, Office of Device Evaluation ODE
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K031485

Prescription Use
(Per 21 CFR 801.199)
OR
Over the Counter Use
(Optional Format 1-2-96)

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).