Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. In addition, the LASSO® 2515 Variable Circular Mapping Catheter and the Reflexion Spiral 140 Variable Radius Catheter are designed for electrophysiological mapping of the atria of the heart.

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

The provided text describes the 510(k) summary for Ascent Healthcare Solutions' Reprocessed Electrophysiology Catheters (K090323). This submission focuses on demonstrating substantial equivalence to predicate devices through various performance tests, but it does not include a study design or acceptance criteria related to a diagnostic algorithm or AI performance.

Therefore, I cannot provide information on acceptance criteria for a diagnostic device's performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these items are not discussed in the provided regulatory document.

However, I can extract the information regarding the performance data presented in the 510(k) summary, which focuses on the safety and effectiveness of the reprocessing procedure and the reprocessed physical device, rather than the diagnostic accuracy of an algorithm.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (as pertaining to reprocessed physical device, not AI/diagnostic algorithm performance):

Acceptance Criteria (Bench/Laboratory Test Area)	Reported Device Performance (Conclusion)
Biocompatibility	Demonstrated performance, ensuring safety and effectiveness.
Validation of Reprocessing	Demonstrated performance, ensuring safety and effectiveness.
Sterilization Validation	Demonstrated performance, ensuring safety and effectiveness.
Function Test(s)	Each individual Electrophysiology Catheter is tested for appropriate function of its components prior to packaging and labeling operations. Performance testing demonstrates that Reprocessed Electrophysiology Catheters perform as originally intended.
Packaging Validation	Demonstrated performance, ensuring safety and effectiveness.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the provided text. The document mentions "Bench and laboratory testing," implying physical testing of reprocessed devices, but does not quantify the number of units tested.
Data Provenance: Not specified. The testing was conducted by Ascent Healthcare Solutions. There is no mention of country of origin or whether it was retrospective or prospective, as these terms are typically used for clinical data rather than bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This submission concerns the reprocessing of a physical medical device, not a diagnostic algorithm that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for this submission would be defined by engineering specifications and industry standards for medical device performance and reprocessing.

4. Adjudication method for the test set:

Not Applicable. As explained above, this is not a study assessing diagnostic accuracy 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 type of study is completely unrelated to the content of this 510(k) submission. No AI component is mentioned or evaluated.

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

No. There is no algorithm or AI component in this device.

7. The type of ground truth used:

The "ground truth" for the performance tests (biocompatibility, reprocessing validation, sterilization validation, function tests, packaging validation) would be based on established engineering specifications, industry standards, and regulatory requirements for medical devices and their reprocessing. For example, sterilization validation would have standards for sterility assurance levels, and function tests would have specified electrical and mechanical performance criteria that the reprocessed catheters must meet to perform "as originally intended," mirroring the predicate device.

8. The sample size for the training set:

Not Applicable. There is no training set mentioned or implied as this is not an AI or diagnostic algorithm submission.

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

Not Applicable. There is no training set.

Summary

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K090323

SECTION 5: 510(k) SUMMARY

Submitter:	Ascent Healthcare Solutions10232 South 51st StreetPhoenix, Arizona 85044	APR - 1 2005
Contact:	Katie BrayRegulatory Affairs Manager(480) 763-5386 (o)(480) 763-6089 (f)kbray@ascenths.com
Date of preparation:	February 6, 2009
Name of device:	Trade/Proprietary Name: Reprocessed ElectrophysiologyCathetersClassification Name: Electrode recording catheter or electroderecording probe
Predicate DeviceK072012	510(k) TitleReflexion SpiralTM Variable RadiusCatheter	ManufacturerSt. Jude Medical
K062251	Reflexion SpiralTM Variable RadiusCatheter	St. Jude Medical
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.
Indications for Use:	Reprocessed diagnostic EP catheters are indicated fortemporary intracardiac sensing, recording, stimulation andelectrophysiological mapping of cardiac structures. In addition,the Lasso® 2515 Variable Circular Mapping Catheter and theReflexion SpiralTM Variable Radius Catheter are designed forelectrophysiological mapping of the atria of the heart.
Technologicalcharacteristics:	The design, materials, and intended use of ReprocessedElectrophysiology Catheters are identical to the predicatedevices. The mechanism of action of ReprocessedElectrophysiology Catheters is identical to the predicate devicesin that the same standard mechanical design, materials, andsizes are utilized. There are no changes to the claims, intendeduse, clinical applications, patient population, performancespecifications, or method of operation. In addition, Ascent

and the state of the states of the states

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K090323

Healthcare Solutions' 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.

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.

Conclusion:

Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Electrophysiology Catheters) are safe, effective, and substantially equivalent to the predicate devices as described herein.

Ascent Healthcare Solutions Reprocessed Electrophysiology Catheters Traditional 510(k)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 1 2009

Ascent Healthcare Solutions c/o Ms. Katie Bray Regulatory Affairs Manager, 10232 South 51st Street Phoenix, AZ 85044

Re: K090323

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: February 6, 2009 Received: February 9, 2009

Dear Ms. Bray:

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. Katie Bray

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,

signature

& 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. Katie Bray

List of Models Found SE:

. .

、

ItemNo.	Description	Electrodes	FrenchSize	ElectrodeSpacing	LassoDiameter	InsertionLength	Curve Type
402800	Daig Reflexion™Steerable EPCatheter	10	6Fr	2-5-2 mm	N/A	105 cm	Bi-DirectionalMed Curl
402804	Daig ReflexionSpiral™ VariableRadius EP Catheter	20	7Fr	1-4-1 mm	25-15 mm	99 cm	Bi-Directional90°/180°Asymmetric
402865	Daig ReflexionSpiral™ VariableRadius EP Catheter	10	7Fr	6.30 mm	25-15 mm	99 cm	Bidirectional180°
401661	Daig Reflexion™Diagnostic EPConnecting Cable	N/A	N/A	N/A	N/A	150 cm	N/A

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SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K090323

Device Name: Reprocessed Electrophysiology Catheters

Indications For Use:

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

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)

Atul Bhattar for B Zuckerman

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K090323

Ascent Healthcare Solutions Reprocessed Electrophysiology Catheters 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).