The Inquiry™ AFocusII™ Diagnostic Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The Inquiry™ AFocusII™ Diagnostic Catheters are to be used to map the atrial regions of the heart.

Device Description

The Inquiry™ AFocusII™ Diagnostic Catheter is a flexible, radiopaque catheter with a variable number of electrodes with the first electrode located at the distal tip and the other band electrodes following at predetermined distances. A connecting cable is used to connect the catheter to electrogram devices. The catheter has a distal double loop in a plane perpendicular to the catheter body. The circumferential shape or loop allows the electrophysiologist to record the potentials of cardiac structures without changing the position of the catheter. The catheter shaft is steerable by manipulating the handle. The placement of the electrodes around the entire circumference of the distal loop also assists the electrophysiologist during fluoroscopy with visualization. The distal loop shape is easily straightened with the thumb and forefinger to facilitate insertion into sheaths and introducers. Once the catheter is extended beyond the sheath, the catheter resumes its pre-formed shape. The device is supplied sterile and is intended for single use only.

AI/ML Overview

The provided text describes a medical device, the Inquiry™ AFocusII™ Diagnostic Catheter, and its clearance process, but it does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria, as one would expect for an AI/ML device.

This document is a 510(k) summary for a traditional medical device (catheter), not an AI/ML diagnostic tool. Therefore, many of the requested elements (like sample size for test set, number of experts, MRMC studies, standalone performance, ground truth for training data) are not applicable or
not present in this type of submission.

The "Brief summary of nonclinical tests and results" section in the document states:
"The bench testing for the Inquiry™ AFocusII™ Diagnostic Catheter was based on the The belieft tosument "Electrode Recording Catheter Preliminary Guidance, Draft Version'', March 1995. Test results indicate reliable performance when the device is used version , March 1999 Instructions for Use. The catheter does not raise new issues of safety, effectiveness, or performance of the product."

This indicates that:

Acceptance Criteria: Were likely derived from the "Electrode Recording Catheter Preliminary Guidance, Draft Version'', March 1995. These guidance documents typically specify performance metrics for parameters like electrical characteristics, mechanical integrity, biocompatibility, and sterilization for catheters. Specific numerical acceptance criteria are not provided in this summary.
Study: Bench testing was performed. The nature of this testing would involve physical and electrical measurements of the catheter's components and overall function.
Reported Device Performance: "Test results indicate reliable performance when the device is used version , March 1999 Instructions for Use." No specific numerical results are provided in this summary.

Therefore, many parts of your request cannot be answered directly from the provided text because it pertains to a different type of medical device submission (a physical catheter, not an AI/ML software).

Here's how to address your questions based on the available information:

A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred)	Reported Device Performance
Compliance with "Electrode Recording Catheter Preliminary Guidance, Draft Version'', March 1995 (covering electrical characteristics, mechanical, etc.)	Reliable performance according to Instructions for Use.
Not raising new issues of safety, effectiveness, or performance compared to predicates.	Confirmed to not raise new issues of safety or performance.

*Note: Specific numerical criteria and results are not provided in this summary.*

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* This information is not provided in the document. For bench testing of a physical device like a catheter, the "test set" would typically refer to the number of catheters subjected to various engineering tests (e.g., durability, electrical impedance, steerability). Data provenance (country of origin, retrospective/prospective) is not applicable in the typical sense for this type of bench testing.

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 as this is not an AI/ML diagnostic device requiring expert interpretation for ground truth. The "ground truth" for a catheter would be its measured physical and electrical properties compared against engineering specifications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable for bench testing of a medical catheter.
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 study was not done. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device would be its engineering specifications and performance benchmarks as established by the "Electrode Recording Catheter Preliminary Guidance." It is not based on clinical "ground truth" like pathology or expert consensus related to diagnostic accuracy.
The sample size for the training set
- This is not applicable as this is not an AI/ML device that requires a training set.
How the ground truth for the training set was established
- This is not applicable as this is not an AI/ML device that requires a training set or ground truth establishment in that context.

Summary

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K101623
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Section 14 Summary Of Safety And Effectiveness

AUG 1 3 2010

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA and 21 CFR 807.92.

Submitter's name, address, telephone number, contact person, and date summary 1. prepared:

a.	Submitter:	Irvine Biomedical, Inc.a St. Jude Medical Company2375 Morse AvenueIrvine, CA 92614Tel. (949) 769-5000
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b. Contact Person: Quynh Phuong Le Regulatory Affairs Specialist II Tel. (949) 769-5058
Date Summary Prepared: June 8, 2010 C.

2. Name of device, including trade name and classification name:

Trade/Proprietary Name: InquiryTM AFocusIITM Diagnostic Catheter a.
Catheter, Electrode Recording b. Classification names:
1. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:

Company:	Irvine Biomedical, Inca St. Jude Medical Company
Device:	Inquiry™ AFocusII™ Steerable Electrophysiology Cathete
510(k):	K042775
Date Cleared:	November 4, 2004

Company: St. Jude Medical Reflexion HDTM High-Density Mapping Catheter Device: 510(k): K080179 Date Cleared: January 7, 2009

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K101623
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A description of the device that is the subject of the 510(k), including explanation of 4. how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):

The catheter has a distal double loop in a plane perpendicular to the catheter body. The circumferential shape or loop allows the electrophysiologist to record the potentials of cardiac structures without changing the position of the catheter. The catheter shaft is steerable by manipulating the handle. The placement of the electrodes around the entire circumference of the distal loop also assists the electrophysiologist during fluoroscopy with visualization. The distal loop shape is easily straightened with the thumb and forefinger to facilitate insertion into sheaths and introducers. Once the catheter is extended beyond the sheath, the catheter resumes its pre-formed shape. The device is supplied sterile and is intended for single use only.

Statement of intended use: 5.

The Inquiry™ AFocusII™ Diagnostic Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The Inquiry™ AFocusII™ Diagnostic catheters are to be used to map the atrial regions of the heart.

Statement of how the technological characteristics of the device compare to those of 6. the predicate or legally marketed device.

The Inquiry™ AFocusII™ Diagnostic Catheter and its predicate devices are intended for electrogram recording and stimulation during electrophysiological studies. The encertifications do not affect the intended use or scientific technology of the device, as embodied in the catheter.

Brief summary of nonclinical tests and results: 7.

The bench testing for the Inquiry™ AFocusII™ Diagnostic Catheter was based on the The belieft tosument "Electrode Recording Catheter Preliminary Guidance, Draft Version'', March 1995. Test results indicate reliable performance when the device is used version , March 1999 Instructions for Use. The catheter does not raise new issues of safety, effectiveness, or performance of the product.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

100 13 WW

St. Jude Medical c/o Ms. Quynh Phuong Le Regulatory Affairs Specialist II Atrial Fibrillation Division 2375 Morse Avenue Irvine, CA 92614-6233

Re: K0101623

Trade/Device Name: Inquiry AFocusII Diagnostic Catheter Regulatory Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: II (two) Product Code: DRF Dated: June 08, 2010 Received: June 09, 2010

Dear Ms. Le:

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 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. Quynh Phuong Le

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
W.W.S.

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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Section 13

Indications for Use

510(k) Number (if known): K101623

AUG 13 2010

Device Name: InquiryTM AFocusII™ Diagnostic Catheter

Indications for Use:

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.M.S.

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number

Page . of

13-1

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).