Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.

Device Description

Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tips of deflectable catheters can be deflected into a curve by manipulating the handpiece; fixed curve catheters have an established distal tip shape.

Alliance Medical Corporation's reprocessing of electrophysiology catheters includes removal of adherent visible soil and decontamination. Each individual electrophysiology catheter is tested for appropriate function of its components prior to packaging and labeling operations.

AI/ML Overview

Alliance Medical Corporation's Reprocessed Electrophysiology Catheters are designed to be substantially equivalent to predicate devices. The submission focuses on demonstrating that the reprocessing method does not alter the device's original performance, safety, or effectiveness.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred)	Reported Device Performance
Functional Performance	The reprocessed device must retain the "appropriate function of its components" and "perform as originally intended" for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping. This implies that electrical and mechanical properties should be maintained.	"Each individual electrophysiology catheter is tested for appropriate function of its components prior to packaging and labeling operations." "Performance testing demonstrates that Reprocessed EP Catheters perform as originally intended." The device's technological characteristics are identical to predicate devices.
Biocompatibility	The reprocessed device must be biocompatible, meaning it does not cause adverse biological reactions in the patient. This would involve ensuring that the reprocessing procedure does not introduce new toxic substances or residues beyond acceptable limits.	"Biocompatibility" testing was conducted.
Reprocessing Validation	The reprocessing procedure (removal of adherent visible soil and decontamination) must be validated to ensure it effectively cleans and decontaminates the devices without compromising their structural integrity or functionality.	"Validation of reprocessing" was conducted. This includes "removal of adherent visible soil and decontamination."
Sterilization Validation	The sterilization method applied after reprocessing must be validated to consistently achieve the required Sterility Assurance Level (SAL) to prevent infection.	"Sterilization Validation" was conducted.
Packaging Validation	The packaging must maintain the sterility and integrity of the reprocessed device until the point of use, and protect it from damage during storage and transport.	"Packaging Validation" was conducted.
Equivalence to Predicate	The reprocessed device must be substantially equivalent to the original predicate devices in terms of design, materials, intended use, clinical applications, patient population, performance specifications, and method of operation. The mechanism of action must remain identical.	"The design, materials, and intended use of Reprocessed Electrophysiology (EP) Catheters are identical to the predicate devices." "The mechanism of action...is identical...in that the same standard mechanical design, materials and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation."

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

The document states: "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed EP Catheter."

Sample Size for Test Set: The exact sample size used for performance testing (functional, biocompatibility, reprocessing, sterilization, packaging) is not specified in the provided text.
Data Provenance: The detailed provenance (e.g., country of origin of data, retrospective or prospective) is not specified. The testing was conducted internally by Alliance Medical Corporation, as implied by statements like "Alliance Medical Corporation's reprocessing... includes... testing..."

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

This type of information is not applicable to this submission. The "ground truth" here is based on objective scientific/engineering standards and measurements (e.g., cleanliness levels, sterility, electrical conductivity, mechanical deflection forces, material integrity after reprocessing, standard biocompatibility assays) rather than expert interpretation of images or clinical outcomes that require human assessment for ground truth determination.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is not applicable to the type of bench and laboratory testing described in this submission. Adjudication processes are typically used in clinical studies involving human interpretation or subjective clinical endpoints, where disagreements between evaluators need to be resolved.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) changes with or without AI assistance, typically in image-based diagnostics. The Reprocessed Electrophysiology Catheter is a medical device, and its evaluation focuses on its physical and functional integrity after reprocessing, not on diagnostic interpretive tasks.

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

Not applicable. This submission does not involve an AI algorithm with standalone performance. The device is a reprocessed physical medical instrument.

7. Type of Ground Truth Used

The ground truth used for this device evaluation is based on objective scientific and engineering metrics and standards. This includes:

Physical/Functional Measurements: To confirm "appropriate function of its components" and "perform as originally intended," likely involving electrical conductivity tests, mechanical integrity tests (e.g., for shaft flexibility, deflection in deflectable catheters, electrode integrity), and dimensional analysis.
Chemical Analysis/Microbiology: For "Biocompatibility," "Validation of reprocessing" (e.g., residual protein, bioburden, endotoxin levels), and "Sterilization Validation" (e.g., sterility testing, often using Biological Indicators).
Packaging Integrity: For "Packaging Validation."
Reference Standards: Comparison against the performance specifications of the original, new predicate devices.

8. Sample Size for the Training Set

Not applicable. This submission does not involve an AI algorithm that requires a training set.

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

Not applicable. As no AI algorithm requiring a training set is involved, this question does not apply.

Summary

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KD52603

NOV 1 6 2005

SECTION B: 510(k) SUMMARY

Submitter:	Alliance Medical Corporation10232 South 51st StreetPhoenix, Arizona 85044
Contact:	Elizabeth RenkenRegulatory Affairs Specialist(480) 763-5300 (o)(480) 763-5310 (f)erenken@alliance-medical.com
Date of preparation:	September 9, 2005
Name of device:	Trade/Proprietary Name: Reprocessed ElectrophysiologyCathetersCommon or Usual Name: Electrophysiology Catheter orElectrode Recording CatheterClassification Name: Electrode Recording Catheter

Predicate device:

K Number	Device Description
K894500	Daig Electrophysiology Catheter
K942379	Daig Diagnostic Electrophysiology Catheter
K012708	Reprocessed Electrophysiology Catheters

Device description: Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tips of deflectable catheters can be deflected into a curve by manipulating the handpiece; fixed curve catheters have an established distal tip shape.

Intended use: Reprocessed Electrophysiology Catheters are intended for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures.
Indications Reprocessed diagnostic EP catheters are indicated for statement: temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.

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Image /page/1/Picture/0 description: The image shows a handwritten number, which appears to be "2052603". The numbers are written in a simple, slightly irregular style. The digits are spaced closely together, and the overall impression is that of a quickly written or informal number.

Technological characteristics:	The design, materials, and intended use of Reprocessed Electrophysiology (EP) Catheters are identical to the predicate devices. The mechanism of action of Reprocessed Electrophysiology (EP) Catheters is identical to the predicate devices in that the same standard mechanical design, materials and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation.
	Alliance Medical Corporation's reprocessing of electrophysiology catheters includes removal of adherent visible soil and decontamination. Each individual electrophysiology catheter is tested for appropriate function of its components prior to packaging and labeling operations.
	Alliance Medical Corporation's reprocessing of EP Catheters includes removal of adherent visible soil and decontamination. Each individual EP Catheter is tested for appropriate function of its components prior to packaging and labeling operations.
Performance data:	Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed EP Catheter.
	BiocompatibilityValidation of reprocessingSterilization ValidationFunction test(s)Packaging Validation
	Performance testing demonstrates that Reprocessed EP Catheters perform as originally intended.
Conclusion:	In accordance with the Federal Food, Drug and Cosmetic Act 21 CFR Part 807 and based on the information provided in this premarket notification, Alliance Medical Corporation concludes that the modified device (the Reprocessed Electrophysiology (EP) Catheter) is safe, effective and substantially equivalent to the predicate devices as described herein.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2005

Alliance Medical Corporation c/o Ms. Elizabeth Renken Regulatory Affairs Specialist 10232 South 51st Street Phoenix, AZ 85044

Re: K052603

Trade Name: Reprocessed Electrophysiology Catheters (See Enclosed List) Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: September 13, 2005 Received: September 21, 2005

Dear Ms. Renken:

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 - Ms. Elizabeth Renken

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 (240) 276-0120. 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/industry/support/index.html.

Sincerely yours,

B.Jiminmarfor

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 – Ms. Elizabeth Renken

List of Models:

St. Jude Live Wire™ SteerableDiagnostic Catheters
401575
401576
401577
401578
401579
401580
401581
401582
401586
401587
401588
401600
401603
401606
401652
401653
401654
401904
401905
401914
401915
401918
401923
401926
401932
401933
401934
401572
401908
401917
401938
401939
401940
401941
401949
401990
401991

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Indications for Use

510(k) Number (if known): K052603

Device Name: Reprocessed Electrophysiology Catheters

Indications For Use: Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

B. Bhumima
Sign-Off

ardlovascular Devices

iance Medical Corporation Reprocessed EP C: Traditional 510/k

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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).