The Reprocessed CS Bi-Directional Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

Device Description

The reprocessed Biosense Webster® Coronary Sinus (CS) EZ STEER™ Diagnostic Electrophysiology (EP) Catheter (hereinafter CS Bi-Directional Diagnostic EP Catheter) is a steerable, multi-electrode catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart. The device is a 7FR catheter with a usable length of 115 cm. The catheter has a high-torque shaft with a braided bi-directional deflectable tip section containing platinum electrodes that can be used for recording and stimulation. Two asymmetric curve types, DF and FJ, are available providing two 180° opposed, single plane curves. The rocker lever located on the handpiece is used to deflect the tip section. A Friction Control Knob is located on the opposite side of the rocker lever and can be rotated clockwise to lock both the tip curve and rocker lever in place. The high torque shaft allows the plane of the curved tip to rotate, enabling accurate positioning of the catheter tip at the preferred site.

AI/ML Overview

The provided document (K100254) describes the performance data for a reprocessed medical device, the "Reprocessed CS Bi-Directional Diagnostic Electrophysiology Catheter." However, it does not contain the specific information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/algorithm-driven device.

This submission is for a medical device reprocessed by Ascent Healthcare Solutions that is "substantially equivalent" to a predicate device. The performance data presented is focused on demonstrating that the reprocessed device performs as originally intended, which is typical for a 510(k) submission for reprocessed devices rather than a novel AI/algorithm.

Therefore, most of the specific questions regarding AI performance criteria, sample sizes for AI test sets, expert ground truth, MRMC studies, or training sets cannot be answered from the provided text.

Here's a breakdown of what can be extracted and what is missing:

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

Acceptance Criteria: The document implies that the acceptance criteria are that the reprocessed device performs "as originally intended" and is "safe, effective, and substantially equivalent to the predicate devices." No specific quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, specificity) are provided for the reprocessed catheter itself in terms of electrophysiological performance.
Reported Device Performance:
- Bench and laboratory testing was conducted.
- Tests included: Biocompatibility, Validation of reprocessing, Sterilization Validation, Function test(s), Packaging Validation.
- Conclusion: "Performance testing demonstrates that reprocessed electrophysiology catheters perform as originally intended."
Table (Based on the document):

Test Category	Acceptance Criteria (Implied)	Reported Performance (Implied)
Overall Performance	Safe, effective, and substantially equivalent to predicate devices.	Performs as originally intended.
Biocompatibility	Biocompatible (no adverse biological reactions).	Testing conducted, assumed to meet requirements.
Reprocessing Validation	Reprocessing effectively cleans and prepares the device for reuse.	Testing conducted, assumed to meet requirements.
Sterilization Validation	Sterilization renders the device sterile.	Testing conducted, assumed to meet requirements.
Function Test(s)	Device components function appropriately (e.g., steerability, recording).	Each individual catheter tested for appropriate function.
Packaging Validation	Packaging maintains sterility and device integrity until use.	Testing conducted, assumed to meet requirements.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated. The document mentions "Each individual CS Bi-Directional Diagnostic EP Catheter is tested for appropriate function," which suggests a 100% inspection or a statistically determined sample from reprocessed lots, but the exact numbers are not given.
Data Provenance: Not specified. The testing was conducted by Ascent Healthcare Solutions.

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)

Not Applicable. This is a reprocessed physical device, not an AI/algorithm that requires expert-established ground truth for its performance evaluation in the way an AI diagnostic tool would. The "ground truth" for the device's function is its intended mechanical and electrical performance.

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

Not Applicable. As above, this is for a physical device performance, not an AI output requiring expert adjudication.

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. This is not relevant for the type of device and study described. There is no AI component or human reader interaction with an AI.

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

No. There is no algorithm or AI component mentioned.

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

The "ground truth" for this device's performance would be engineering specifications, established functionality of the original predicate device, and compliance with reprocessing standards. It's not a medical diagnostic ground truth like pathology or expert consensus on an image.

8. The sample size for the training set

Not Applicable. There is no AI or algorithm that would require a training set.

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

Not Applicable. There is no AI or algorithm that would require a training set.

Summary

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K100254/

SECTION 5: 510(k) SUMMARY

Submitter:	Ascent Healthcare Solutions10232 South 51st StreetPhoenix, Arizona 85044
Contact:	Amanda BabcockSenior Regulatory Affairs Specialist(480) 763-5300 (o)(863) 904-2312 (f)ababcock@ascenths.com
Date of preparation:	January 27, 2010
Name of device:	Trade/Proprietary Name: Reprocessed CS Bi-DirectionalDiagnostic Electrophysiology CatheterClassification Name: Electrode recording catheter or electroderecording probe
Predicate DeviceK050877	510(k) TitleCoronary Sinus Deflectable MappingCatheter	ManufacturerBiosense Webster, Inc.
Device description:	The reprocessed Biosense Webster® Coronary Sinus (CS) EZSTEER™ Diagnostic Electrophysiology (EP) Catheter(hereinafter CS Bi-Directional Diagnostic EP Catheter) is asteerable, multi-electrode catheter with a deflectable tipdesigned to facilitate electrophysiological mapping of the heart.The device is a 7FR catheter with a usable length of 115 cm.The catheter has a high-torque shaft with a braided bi-directional deflectable tip section containing platinum electrodesthat can be used for recording and stimulation. Two asymmetriccurve types, DF and FJ, are available providing two 180°opposed, single plane curves.The rocker lever located on the handpiece is used to deflect thetip section. A Friction Control Knob is located on the oppositeside of the rocker lever and can be rotated clockwise to lockboth the tip curve and rocker lever in place. The high torqueshaft allows the plane of the curved tip to rotate, enablingaccurate positioning of the catheter tip at the preferred site.
Indications for Use:	The Reprocessed CS Bi-Directional Diagnostic EP Catheter isindicated for electrophysiological mapping of cardiac structures;i.e., stimulation and recording only. The catheter is designed foruse in the coronary sinus.
Technologicalcharacteristics:	The design, materials, and intended use of Reprocessed CS Bi-Directional Diagnostic EP Catheters are identical to the

Ascent Healthcare Solutions Reprocessed Coronary Sinus Bi-Directional Diagnostic Electrophysiology Catheter
Traditional 510(k)

. "

・、

Page 13

、

. .

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predicate devices. The mechanism of action of Reprocessed CS Bi-Directional Diagnostic 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. In addition, Ascent Healthcare Solutions' reprocessing of CS Bi-Directional Diagnostic EP Catheters includes removal of adherent visible soil and decontamination. Each individual CS Bi-Directional Diagnostic 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 reprocessed electrophysiology catheters. This included the following tests:

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

Performance testing demonstrates that reprocessed electrophysiology catheters perform as originally intended.

Ascent Healthcare Solutions concludes that the modified devices (Reprocessed CS Bi-Directional Diagnostic EP Catheter) are safe, effective, and substantially equivalent to the predicate devices as described herein.

Conclusion:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with a distinctive design of intertwined snakes and a staff.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ascent Healthcare Solutions c/o Ms. Amanda Babcock Senior Regulatory Affairs Specialist, 10232 South 51st Street Phoenix, AZ 85044

MAY 2 8 2010

Re: K100254

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 (two) Product Code: NLH Dated: May 19, 2010 Received: May 21, 2010

Dear: Ms. Babcock;

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. Amanda Babcock

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
W. Wood.

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. Amanda Babcock

. . . . .

List of Models Found SE:

Item No.	Description	FrenchSize	InsertionLength	Curve Type
BD710FJ282RTS	Biosense WebsterCS Bi-DirectionalDiagnostic EPCatheter	7Fr	115 cm	B-directional;J curve with a10.2 cmdeflectablespan length
BD710DF282RTS	Biosense WebsterCS Bi-DirectionalDiagnostic EPCatheter	7Fr	115 cm	Bi-directional;D curve with6.4 cmdeflectablespan length

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SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: Reprocessed Coronary Sinus Bi-Directional Diagnostic Electrophysiology Catheter

Indications For Use:

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)

W.M.D.

ision Sign-Off) sion of Cardiovascular Devices

510(k) Numbe

Page 12

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).