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

Reprocessed Electrophysiology (EP) Catheter Cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Alliance Medical Corporation's Reprocessed Electrophysiology (EP) Catheters. It describes the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it broadly claims that the reprocessed devices "perform as originally intended" and are "safe, effective and substantially equivalent to the predicate devices."

Acceptance Criteria Category	Reported Device Performance (Summary)
Biocompatibility	Demonstrated through testing
Validation of Reprocessing	Demonstrated through testing
Sterilization Validation	Demonstrated through testing
Function Test(s)	Tested prior to packaging and labeling; deemed to perform "as originally intended"
Overall Safety & Effectiveness	Safe, effective, and substantially equivalent to predicate devices

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

The document does not specify the sample size for the test set used in the performance studies (biocompatibility, reprocessing validation, sterilization validation, function tests).

The data provenance is implied to be prospective bench and laboratory testing conducted by Alliance Medical Corporation. There is no mention of country of origin for the data in this summary.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set. The nature of the tests (biocompatibility, sterilization, function) suggests objective laboratory measurements rather than expert human interpretation in a clinical setting.

4. Adjudication Method for the Test Set

Not applicable. The tests mentioned (biocompatibility, reprocessing, sterilization, function) are objective laboratory or bench tests, not requiring an adjudication method among experts.

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 a 510(k) submission for a reprocessed medical device (catheter), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.

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

Not applicable. This is a medical device, not an algorithm. The testing focuses on the physical and functional properties of the reprocessed catheter.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests would be based on:

Established standards and protocols: for biocompatibility and sterilization.
Predetermined functional specifications: for the function tests, likely defined by the original manufacturer's specifications for new devices.
Validated reprocessing procedures: for reprocessing validation.

8. The Sample Size for the Training Set

Not applicable. This is a medical device approval, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for a machine learning model.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal, there is a stylized representation of three human profiles facing to the right, with three parallel lines above them.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 2004 NOV

Alliance Medical Corporation c/o Ms. Moira Barton Regulatory Affairs Manager 10232 South 51st Street Phoenix, AZ 85044

Re: K030109 - Supplemental Validation Submission Trade Name: See Enclosed List Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter and Patient Transducer and Electrode Cable (including connector) Regulatory Class: Class II (two) Product Code: NLH & DSA Dated: January 9, 2003 Received: January 13, 2003

Dear Ms. Barton:

The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on August 8, 2003. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices in the Federal Register.

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Page 2 - K030109

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 applicable 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.

The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.

If you desire specific advice for your devices 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/dsma/dsmamain.html.

Sincerely yours,

B. Zimmer, M.D.

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

Enclosures

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Page 3 – K030109

1000 - 1000

Enclosure – List of Devices

K030109
Models [OEM, (n)](n = 38)
Cordis Webster (38)
1086-182-RT
1086-223-RT
1086-259-S
1086-463-S
1086-508-S
1086-515-RT
1086-577-S
F5-QA-005-PS
F5-QA-252-PS
F5-QD-005-PS
F5-QF-005-PS
F5-QF-005-TS
F5-QF-010-PS
F5-QL-005-PS
F6-20T-282-FS
F65-QA-005-PS
F6-DF-252-FS
F6-HA-002-FS
F6-HA-002-RT
F6-HF-002-TS
F6-HF-005-FS
F6-HF-010-TS
F6-OA-002-TS
F6-OF-002-FS
F6-QA-002-PS
F6-QA-005-PS
F6-QA-005-RT
F6-QA-010-PS
F6-QA-252-PS
F6-QD-002-PS
F6-QD-005-PS
F6-QD-010-PS
F6-QF-002-PS
F6-QF-005-PS
F6-QF-010-PS
F6-QF-010-TS

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1000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Image /page/3/Picture/1 description: The image shows a label with the text "K030109" at the top, followed by "Models [OEM (n))". Below this, the text "(#=38)" is visible. The label also contains two lines of text: "F6-QF-252-PS" and "F6-QL-005-PS". The text appears to be machine-printed on a label, which is likely affixed to a product or component.

Carlos Concession

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Indications for Use Statement II.

510(k) Number (if known):

Device Name: Alliance Medical Corporation Reprocessed Electrophysiology (EP) Catheters

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

Indications for Use: Reprocessed Electrophysiology (EP) Catheter Cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K030109

Prescription Use	X	or	Over-the-Counter Use ______
(per 21 CFR 801.109)

Alliance Medical Corporation Reprocessed Electrophysiology Catheters Traditional 510(k)

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AUG - 8 2003

Image /page/5/Picture/1 description: The image shows the text "KO30109" in a stylized, handwritten font. Below the text, there are three curved lines that resemble brush strokes, adding a decorative element to the image. The text and lines are black against a white background.

A L L I A N C E
MEDICAL CORPORATION

PART B: 510(k) SUMMARY

	10232 South 51st StreetPhoenix, Arizona 85044
Submitter:	Alliance Medical Corporation10232 South 51st StreetPhoenix, Arizona 85044	TEL 480.763.5300FAX 480.763.5310Toll Free 888.888.3433www.alliance-medical.com
Contact:	Moira BartonSenior Regulatory Affairs Specialist(480) 763-5300 (o)(480) 763-5310 (f)
Date of preparation:	6/13/2002
Name of device:	Trade/Proprietary Name: Reprocessed ElectrophysiologyCatheterCommon or Usual Name: Electrophysiology Catheter orElectrode Recording CatheterClassification Name: Electrode Recording Catheter
Predicate device(s):	K992965 Cordis Webster Fixed Curve Catheters, Models D-11
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 handpiece, a flexibleshaft and a distal tip section containing diagnostic electrodes.The distal tips of deflectable catheters can be deflected into acurve by manipulating the handpiece; fixed curve catheters havean established distal tip shape.
Intended use:	Reprocessed Electrophysiology Catheters are intended fortemporary intracardiac sensing, recording, stimulation, andelectrophysiological mapping of cardiac structures.
Indications statement:	Reprocessed diagnostic EP catheters are indicated fortemporary intracardiac sensing, recording, stimulation andelectrophysiological mapping of cardiac structures.
	Reprocessed electrophysiology catheter cables are indicated foruse with the appropriate electrode catheter duringelectrophysiology studies.
Technological characteristics:	The design, materials, and intended use of ReprocessedElectrophysiology (EP) Catheters are identical to the predicatedevices. The mechanism of action of Reprocessed

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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.

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

Biocompatibilitv ●
Validation of reprocessing .
Sterilization Validation ●
Function test(s) .

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

Conclusion: 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.

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).