The SterilMed Reprocessed Imaging Catheter is intended for intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart. This device is intended for use in the right-heart only.

Device Description

The SterilMed Reprocessed Imaging Catheter is intended to be used with a compatible ultrasound imaging system. It is steerable, has a useable length of 90 cm and a diameter of 10 French. The distal end of the catheter contains an ultrasonic phased array imaging transducer. The transducer offers imaging modes at frequencies between 4.0 and 10.0 MHz.

AI/ML Overview

The SterilMed Reprocessed IVUS Imaging Catheter (K043453) is a reprocessed medical device, and its acceptance criteria primarily hinge on demonstrating "substantial equivalence" to a predicate device. This is achieved through functional and safety testing to ensure the reprocessed device performs identically to the original.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Functional Characteristics	The reprocessed catheter must demonstrate appropriate functional characteristics, identical to the predicate device, including steerability, usable length, diameter, and ultrasonic imaging parameters (frequency range).	"Representative samples of reprocessed imaging catheters underwent design testing to demonstrate appropriate functional characteristics." The conclusion states the device "is identical to the predicate device in terms of its design, materials, indications for use, and construction." Specific quantitative results for each functional parameter are not provided in this summary but are implied to have met the predicate's specifications.
Cleaning and Sterilization	The cleaning and sterilization procedures must be validated to ensure the device is safe for patient use and meets established sterility assurance levels (SALs).	"Process validation testing was done to validate the cleaning and sterilization procedures..." Specific validation results (e.g., bioburden reduction, SAL) are not provided but are implied to have met regulatory standards.
Device Packaging	The packaging must maintain sterility and protect the device during transport and storage.	"...as well as the device's packaging." Specific packaging validation results (e.g., seal integrity, shelf-life) are not provided but are implied to have met regulatory standards.
Manufacturing Process	The manufacturing process must include visual and functional testing of all products to ensure consistency and quality.	"...the manufacturing process includes visual and functional testing of all products produced." This indicates internal quality control measures are in place.
Special 510(k) Report	Any additional testing required for the Special 510(k) pathway (due to reprocessing) must be successfully performed and submitted.	"Finally, testing to support the required Special 510(k) Report was successfully performed and provided to the Agency." The specific tests are not detailed but would typically involve material integrity, biocompatibility, and electrical safety after reprocessing.
Substantial Equivalence	The reprocessed device must be substantially equivalent to the predicate device "in terms of its design, materials, indications for use, and construction." This is the overarching criterion for 510(k) clearance for reprocessed devices.	The conclusion explicitly states: "The imaging catheters reprocessed by SterilMed are substantially equivalent to the AcuNav™ Diagnostic Ultrasound Catheter Manufactured by Acuson Corp. (K992631). This conclusion is based upon the fact that this device is identical to the predicate device in terms of its design, materials, indications for use, and construction."

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

The summary does not specify the exact sample size used for the test set. It mentions "Representative samples of reprocessed imaging catheters." This typically means a statistically significant number of devices were tested, but the precise count is not disclosed.

The data provenance is retrospective in the sense that the reprocessed device is being compared to an already marketed predicate device. The performance data generated for the reprocessed device itself would be prospective for that specific batch of reprocessed devices. The country of origin of the data is implicitly the United States, as the submission is to the FDA.

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

This information is not provided in the summary. For reprocessed devices, ground truth isn't typically established by expert consensus on specific cases but rather by comparison to the known performance specifications of the original predicate device and adherence to reprocessing standards. The "experts" involved would likely be engineers, microbiologists, and regulatory specialists involved in the design, testing, and approval process.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of reprocessing, "adjudication" in the sense of clinician agreement on imaging findings is not typically relevant. Instead, the testing involves objective measurements against predefined 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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a reprocessed hardware component (an imaging catheter), not an AI-powered diagnostic algorithm. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

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

A standalone performance study was not done. This device is a hardware component and does not operate as a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this reprocessed device is the performance specifications and safety profile of the original, new predicate device (AcuNav™ Diagnostic Ultrasound Catheter Manufactured by Acuson Corp., K992631). The reprocessed device must meet or exceed these established parameters. This is achieved through:

Engineering measurements (e.g., dimensional checks, electrical tests, imaging performance).
Microbiological testing (e.g., sterility, endotoxin levels).
Biocompatibility testing (if materials are altered or new residues are introduced).

8. The Sample Size for the Training Set

This information is not applicable as this is a reprocessed hardware device, not a machine learning algorithm that requires a training set.

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

This information is not applicable for the reason stated above.

Summary

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K043453
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MAR 1 - 2065

SUMMARY AND CERTIFICATION SECTION 2.

2.A. 510(K) SUMMARY

Submitter:	SterilMed, Inc.
Contact Person:	Dr. Bruce R. LesterSterilMed, Inc.11400 73rd Avenue NorthMinneapolis, MN 55369Ph: 763-488-3409Fax: 763-488-3350
Date Prepared:	December 13, 2004
Trade Name:	SterilMed Reprocessed IVUS Imaging Catheter
Classification Name:and Number:	Angiography CatheterClass II, 21 CFR 870.1200
Product Code:	NLI
Predicate Device(s):	The SterilMed Reprocessed Imaging Catheter issubstantially equivalent to the AcuNav™ DiagnosticUltrasound Catheter Manufactured by Acuson Corp.(K992631).
Device Description:	The SterilMed Reprocessed Imaging Catheter is intended tobe used with a compatible ultrasound imaging system. It issteerable, has a useable length of 90 cm and a diameter of10 French. The distal end of the catheter contains anultrasonic phased array imaging transducer. The transduceroffers imaging modes at frequencies between 4.0 and 10.0MHz.
Intended Use:	The SterilMed Reprocessed Imaging Catheter is intendedfor intravascular or intracardiac ultrasound imaging inorder to provide visualization of vascular anatomy, cardiacand great vessel anatomy and physiology, or other devicesin the heart. This device is intended for use in the rightheart only.
Functional andSafety Testing:	Representative samples of reprocessed imaging cathetersunderwent design testing to demonstrate appropriate

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functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced. Finally, testing to support the required Special 510(k) Report was successfully performed and provided to the Agency.

The imaging catheters reprocessed by SterilMed are Conclusion: substantially equivalent to the AcuNav™ Diagnostic Ultrasound Catheter Manufactured by Acuson Corp. (K992631). This conclusion is based upon the fact that this device is identical to the predicate device in terms of its design, materials, indications for usc, and construction.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight.

MAR 1 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SterilMed, Inc. c/o Bruce Lester, Ph.D. Vice President Research and Development 11400 73rd Avenue North Minneapolis, MN 55369

Re: K043453

1949139
Trade Name: Sterilmed Reprocessed IVUS Imaging Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: NLI Dated: December 13, 2004 Received: December 15, 2004

Dear Dr. Lester:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have teviewed your bocurer. 310(s) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars actment date of the Medical Device Amendments, or to conninered provision to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that to not requent of the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of general controls profitive proctice, 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 If your device is crassimod (soc ac refrols. Existing major regulations affecting your device can may be subject to saen adonations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Coursements concerning your device in the Federal Register.

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Page 2 -- Bruce Lester, Ph.D.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issualites of a cases of the other requirements of the Act that I DA has made a dolorimiation administered by other Federal agencies. You must or any rederal statutes and regulations and limited to: registration and listing (21 Comply with an the Act 3 requirements, morealing, and manufacturing practice requirements as set CFK Part 807), adomig (21 CFRT art 820), good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro risions (oveting your device as described in your Section 5 lo(k) This letter will anow you to begin maxicoling of substantial equivalence of your device to a legally premarket notheation. The PDA muding of backandar 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 If you titsire specific at 700-10-10-10-10-20 Also, please note the regulation entitled, Collider the Orifice of Councilication" (21CFR Part 807.97). You may obtain of Small other general information on your response 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 vours,

Bhiminor for

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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Page 3 -- Bruce Lester, Ph.D.

Enclosure - List of Devices Substantially Equivalent

Orig Models found to be SE
Acuson (1)
55790

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Indications for Use

510(k) Number (if known):

K043457

Device Name:

Reprocessed Imaging Catheters

Indications For Use:

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blamminion

ision Sign-Off Division of Cardiovas 510(k) Number

Page I of 1

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).