Reprocessed Diagnostic Electrophysiology Catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology 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 hand piece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tip of deflectable catheters can be deflected into a curve by manipulating the hand piece.

AI/ML Overview

This document describes the 510(k) submission for Reprocessed Electrophysiology Catheters by Alliance Medical Corporation. The focus is on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria for novel performance features. Therefore, many of the requested data points related to clinical study design and ground truth are not applicable or not provided in the typical sense for an AI/CAD device.

Given the information provided, here's a breakdown of the acceptance criteria and the "study" that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are primarily related to proving that the reprocessed device performs identically and as originally intended compared to new, predicate devices. The performance data focuses on demonstrating that the reprocessing does not negatively impact the catheter's function and safety.

Acceptance Criteria Category	Specific Criteria / Goal	Reported Device Performance	Comments
Material & Design Equivalence	The design, materials, and intended use of Reprocessed Electrophysiology Catheters are identical to the predicate devices.	Stated that "The design, materials, and intended use of Reprocessed Electrophysiology Catheters are identical to the predicate devices." and "The mechanism of action...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."	This is a foundational criterion for reprocessing; the reprocessed device must function exactly like the original.
Biocompatibility	Reprocessing does not negatively impact the biocompatibility of the device, ensuring it is safe for patient contact.	"Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Electrophysiology (EP) Catheters." Biocompatibility is explicitly listed.	Specific metrics or thresholds for biocompatibility are not provided in this summary.
Reprocessing Validation	The reprocessing methods (cleaning, decontamination, sterilization) are effective and validated to render the device safe and functional.	"Validation of reprocessing" and "Sterilization Validation" are explicitly listed as conducted.	Details of the validation process (e.g., sterilization assurance level, cleanliness levels) are not provided.
Functionality	The reprocessed catheter performs all its intended functions (sensing, recording, stimulation, mapping) as effectively as a new device.	"Function test(s)" is explicitly listed as conducted.	Specific functional parameters (e.g., signal integrity, impedance, deflection capabilities) or their acceptance thresholds are not detailed in this summary.
Packaging Validation	The packaging maintains sterility and protects the device until use.	"Packaging Validation" is explicitly listed as conducted.	No further details provided.

Overall Conclusion regarding "Acceptance Criteria"

The overall acceptance criterion is: "Reprocessed Electrophysiology (EP) Catheters perform as originally intended" and are "safe, effective and substantially equivalent to the predicate devices." The "study" (bench and laboratory testing) aimed to demonstrate this equivalence across the listed categories.

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

Sample Size for Test Set: The document does not specify the sample size for the bench and laboratory testing. It merely states that such testing was conducted.
Data Provenance: Not applicable in the context of patient data provenance, as this is bench/laboratory testing on devices, not a clinical study involving patients.

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

This is not applicable to this type of submission. "Ground truth" in the context of device reprocessing is typically established through established engineering standards, material science, microbiology (for sterility validation), and performance specifications for the original device. There isn't a need for "expert consensus" on diagnostic findings or clinical outcomes in the same way as an AI/CAD device.

4. Adjudication Method for the Test Set

Not applicable as this is bench and laboratory testing against predetermined specifications and scientific principles, not a clinical trial requiring adjudicators for patient outcomes or diagnostic interpretations.

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

No, an MRMC comparative effectiveness study was not done. This is a 510(k) for a reprocessed medical device (a catheter), not an AI/CAD system. Therefore, the concept of "human readers improving with AI" is not relevant to this submission.

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

Not applicable. This device is a reprocessed physical medical instrument, not an algorithm or software. Its performance is inherent to its physical properties and functionality.

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

The "ground truth" for this submission is based on the original performance specifications and safety profiles of the new, predicate electrophysiology catheters, coupled with established engineering, material science, and sterilization validation standards. For example:
- Biocompatibility: Demonstrated against ISO standards for medical devices.
- Sterilization: Validated to achieve a specific Sterility Assurance Level (SAL), often 10^-6, through established microbiological methods.
- Functionality: Measured against the mechanical and electrical specifications of the original device (e.g., impedance range, signal-to-noise ratio, deflection force, physical integrity).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

Not applicable. As there is no training set for an AI/ML model, there is no corresponding ground truth to establish for it.

Summary

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Kosa414

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:	August 26, 2005
Name of device:	Trade/Proprietary Name: Reprocessed ElectrophysiologyCathetersCommon or Usual Name: Electrophysiology Catheter orElectrode Recording CatheterClassification Name: Electrode Recording Catheter
Predicate device:
K924109 K924163 K003452 K954651 K012708 K043393	Steerocath DxPolaris LEPolaris XElectrode Recording CatheterReprocessed Electrophysiology CathetersReprocessed EP Technologies Electrophysiology Catheters
Device description:	Diagnostic Electrophysiology (EP) Catheters are speciallydesigned electrode catheters that transmit electrical impulsesand can be positioned for endocardial recording or stimulation.Diagnostic EP catheters incorporate a hand piece, a flexibleshaft and a distal tip section containing diagnostic electrodes.The distal tip of deflectable catheters can be deflected into acurve by manipulating the hand piece.
Intended use:	Reprocessed Electrophysiology Catheters are intended fortemporary intracardiac sensing, recording, stimulation, andelectrophysiology mapping of cardiac structures.
Indicationsstatement:	Reprocessed Diagnostic Electrophysiology Catheters areindicated for temporary intracardiac sensing, recording,stimulation, and electrophysiology mapping of cardiacstructures.
Technologicalcharacteristics:	The design, materials, and intended use of ReprocessedElectrophysiology Catheters are identical to the predicate

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Image /page/1/Picture/0 description: The image shows a handwritten string of characters. The string appears to be "K052414". The characters are written in a dark ink on a white background. The handwriting is somewhat messy and uneven.

devices. The mechanism of action of Reprocessed Electrophysiology 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 EP Technologies 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.

Performance data: Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Electrophysiology (EP) Catheters.

Biocompatibility
Validation of reprocessing ●
Sterilization Validation .
. Function test(s)
. Packaging Validation

Performance testing demonstrates that Reprocessed Electrophysiology (EP) Catheters perform as originally intended.

Conclusion:

Alliance Medical Corporation concludes that the modified device (the Reprocessed Electrophysiology 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 logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming the wings and a snake-like form at the bottom. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the caduceus.

Public Health Service

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: K052414

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: August 26, 2005 Received: September 2, 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 (OS) 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 vours,

B.Jimmumfor

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:

...

EPT-Dx (5)11011102110313001301Valve Mapper SteeroCath-Dx (7)2200225022702250K22270K22270L2270N4Polaris-Dx (15)557155725574557085571855728557385574S5577557954278તેરણે તે જણાવતા વ્યવસાય ખેતી ખેતી કરવામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામના લોકોનો મુખ્યત્વે આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી,ર્રતત્55765578Polaris LE Mapping (2)ર રેતે 3------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ર રતેરSteeroCath-Dx (2)------------------------------------------------------------------------------------------------------------------------------------------------------------------------------2027BLand the same of the same of the same of the same of the same of the same of the states of the seat the states of the states of the states of the states of the states of the s2028BL------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	EP Technologies, Inc., Mo

______________________________________________________________________________________________________________________________________________________________________________and the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states ofand the state of the state of the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the s

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Indications for Use

510(k) Number (if known): K052414

Device Name: Reprocessed Electrophysiology Catheters

Indications For Use: Reprocessed Diagnostic Electrophysiology Catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.

Prescription Use X (Part 21 CFR 801 Subpart D)

: 10

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)

Blythman
Division Sign-Off

(Division Sign-Off) Division of Cardlovascular Deyloss 510(k) Number 4/5 。

Alliance Medical Corporation Reprocessed Electrophysiology Catheter Traditional 510(k)

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).