The Reprocessed Electrophysiology Diagnostic Catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias; and for electrophysiologic mapping of cardiac structures during these evaluations.

Device Description

The device consists of a reprocessed catheter that has a high-torque shaft with a handle at the proximal end, and may or may not be steerable. These catheters have an outer diameter of 4F to 8F, a length ranging from 60 to 160 cm, with 2-20 platinum, radiopaque electrodes along the tip shaft and a variety of inter-electrode spacings and curve styles at the tip. The tip generally is deflectable. Specific cables, as recommended by the original manufacturer, connect to the handle and interface between the catheter and an external stimulator and/or an electrophysiologic recorder. It should be noted that this submission pertains to the catheter only. It does not include any other components in a system such as, connector cables, external stimulators, or electrophysiologic recorders.

AI/ML Overview

This is not an AI/ML device, and therefore the criteria listed in parts 1-9 do not apply. This is a reprocessed medical device (electrophysiology diagnostic catheters) that functions identically to original manufacturer devices. The 510(k) summary focuses on demonstrating that the reprocessed device is substantially equivalent to predicate devices in terms of functional design, materials, indications for use, and construction.

Here's an analysis of the provided text, addressing the requested information where applicable for a non-AI/ML device:

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

For this reprocessed device, the "acceptance criteria" are essentially demonstrating substantial equivalence to the original, predicate devices. The performance is measured against these established characteristics rather than novel AI/ML metrics.

Acceptance Criteria (Demonstrated Equivalence)	Reported Device Performance
Functional Design: Electrical, mechanical, and physical characteristics must be identical to original.	The reprocessed catheter has a high-torque shaft with a handle, 4F to 8F outer diameter, 60 to 160 cm length, 2-20 platinum, radiopaque electrodes. Tip is deflectable.
Materials: Must be the same as or equivalent to original manufacturer's materials.	"essentially identical to the predicate devices in terms of functional design, materials, indications for use, and construction." (Conclusion statement)
Indications for Use: Must be identical to the predicate device's intended use.	Intended for temporary use during electrophysiology studies for intracardiac sensing, recording, stimulation, temporary pacing for cardiac arrhythmias, and electrophysiology mapping. (Identical to predicate device indications)
Construction: Manufacturing and reprocessing methods must yield a device structurally equivalent.	The manufacturing process includes visual and functional testing of all products produced. This implies quality control for construction integrity.
Cleaning & Sterilization: Effective removal of contaminants and sterilization without compromising device integrity.	Process validation testing done to validate the cleaning and sterilization procedures as well as the device's packaging.
Biocompatibility: Reprocessed materials must not introduce new biological risks.	Not explicitly detailed but implied by the "materials" equivalence and the safety testing for medical devices.

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 an AI/ML model. Instead, it refers to "Representative samples of reprocessed electrophysiology diagnostic catheters" used for design testing. The sample size is not quantified.

Sample Size: Not specified beyond "Representative samples."
Data Provenance: Not explicitly stated, however, the testing would be conducted internally by SterilMed, Inc. (Minneapolis, MN, USA) on their reprocessed devices. This would be prospective for the reprocessed devices.

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 is not applicable to this type of device. "Ground truth" in the context of this device would refer to the established performance characteristics and safety profiles of the original predicate devices, as well as the successful validation of reprocessing steps (cleaning, sterilization). These are typically established through engineering standards, clinical trials of the original devices, and scientific validation methods, not expert consensus on interpretations like in AI/ML.

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

Not applicable. Adjudication is a term relevant to resolving discrepancies in expert interpretations, typically in AI/ML or clinical trial settings where subjective assessment is involved. The testing described for this device (functional and safety) involves objective measurements and validation protocols.

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

Not applicable. This is not an AI-assisted diagnostic device, and therefore MRMC studies are irrelevant.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this reprocessed device is established by:

Predicate Device Specifications: The known functional, material, and performance specifications of the original, legally marketed electrophysiology diagnostic catheters.
Engineering Standards & Bench Testing: Objective measurements and tests (e.g., electrical conductivity, mechanical integrity, sterility assays) to ensure the reprocessed device meets these predefined specifications.
Process Validation: Scientific evidence that the cleaning, sterilization, and packaging processes consistently achieve their intended outcomes without degrading the device.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" for this device.

Summary

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K012523

SECTION 2. SUMMARY AND CERTIFICATION

510(K) SUMMARY A.

Submitter:	SterilMed, Inc.
Contact Person:	Patrick Fleischhacker11400 73rd Avenue NorthMinneapolis MN, 55369Ph: 888-856-4870Fax: 763-488-3350
Date Prepared:	August 3, 2001
Trade Name:	SterilMed Reprocessed Electrophysiology DiagnosticCatheters
Classification Name:and Number:	Class II, 21 CFR 870.1220
Product Code:	DRF
Predicate Device(s):	The SterilMed reprocessed electrophysiology diagnosticcatheter is substantially equivalent to: the A20 (K953768),manufactured by Biosense Webster (formerly known asCordis Webster), the Bard Dynamic Tip Catheter(K912213), and the Bard Intracardiac Electrode Cathetermanufactured by C.R. Bard Inc., the Stablemapr EPDiagnostic Catheter (K981642), manufactured byMedtronic Inc., and the original manufacturers' devices.
Device Description:	The device consists of a reprocessed catheter that has ahigh-torque shaft with a handle at the proximal end, andmay or may not be steerable. These catheters have an outerdiameter of 4F to 8F, a length ranging from 60 to 160 cm,with 2-20 platinum, radiopaque electrodes along the tipshaft and a variety of inter-electrode spacings and curvestyles at the tip. The tip generally is deflectable. Specificcables, as recommended by the original manufacturer,connect to the handle and interface between the catheterand an external stimulator and/or an electrophysiologicrecorder. It should be noted that this submission pertains tothe catheter only. It does not include any other componentsin a system such as, connector cables, external stimulators,or electrophysiologic recorders.
Intended Use:	These cardiac diagnostic catheters are intended fortemporary use during electrophysiology studies forintracardiac sensing, recording, and stimulation. They alsoprovide temporary pacing for the evaluation of cardiacarrhythmias, and are used for electrophysiology mapping ofcardiac structures during these evaluations.
Functional andSafety Testing:	Representative samples of reprocessed electrophysiologydiagnostic catheters underwent design testing todemonstrate appropriate functional characteristics. Processvalidation testing was done to validate the cleaning andsterilization procedures as well as the device's packaging.In addition, the manufacturing process includes visual andfunctional testing of all products produced.
Conclusion:	The electrophysiology diagnostic catheters reprocessed bySterilMed are substantially equivalent to the A20(K953768), manufactured by Biosense Webster (formerlyknown as Cordis Webster), the Bard Dynamic Tip Catheter(K912213), and the Bard Intracardiac Electrode Cathetermanufactured by C.R. Bard Inc., the Stablemapr EPDiagnostic Catheter (K981642), manufactured byMedtronic Inc., and the reprocessed devices' counterpartsfrom the original manufacturers. This conclusion is basedupon the fact that these devices' are essentially identical tothe predicate devices in terms of functional design.materials, indications for use, and construction.

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2005

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Image /page/2/Picture/0 description: The image is a black and white circular logo. The logo features the symbol of the Department of Health and Human Services (HHS) in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2002

SterilMed. Inc. c/o Mr. Patrick Fleischhacker Vice President of Regulatory and Quality 11400 730 Avenue North Minneapolis, MN 55369

Rc: K012523

Trade Name: Reprocessed Electrophysiology Diagnostic Catheters Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: May 20, 2002 Received: May 21, 2002

Dear Mr. Fleischhacker:

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. Iisting 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. Patrick Fleischhacker

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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

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 Page

Device Name: Reprocessed Electrophysiology Diagnostic Catheters

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off)
Division of Cardiovascular
and Respiratory Devices
8/14/02
510(k) Number K012523

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 870.1220 Electrode recording catheter or electrode recording probe.

(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).