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

AI/ML Overview

The provided document is a 510(k) Summary for a reprocessed medical device, specifically Electrophysiology Catheters. This type of submission focuses on proving "substantial equivalence" to existing legally marketed devices (predicates) rather than establishing new performance claims or conducting clinical efficacy studies.

Therefore, the acceptance criteria and study information requested, which are typically associated with demonstrating novel performance or clinical superiority of a device, are not directly applicable in the context of this 510(k) submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present specific quantitative acceptance criteria or detailed device performance metrics in the way one would see for a new device's clinical trial or performance study. Instead, the performance demonstration focuses on showing that the reprocessed devices function identically to their predicate devices and meet safety standards after reprocessing.

The "Performance data" section states:

"Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Electrophysiology Catheters."
This included:
- Biocompatibility
- Validation of reprocessing
- Sterilization Validation
- Function test(s)
- Packaging Validation
"Performance testing demonstrates that Reprocessed Electrophysiology Catheters perform as originally intended."

Since there are no specific numeric acceptance criteria or quantitative performance results provided in the summary, a table cannot be populated as requested. The "acceptance criteria" here are implied to be adherence to the original device specifications and established reprocessing standards. The "reported device performance" is a general statement that they "perform as originally intended."

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

The document does not specify the sample size used for the bench and laboratory testing. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective) for these tests. This information is typically found in the detailed test protocols and reports, which are not part of this summary.

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

This is not applicable to the type of testing described (bench and laboratory). Bench testing for medical devices typically relies on engineering specifications and measurement against those specifications, not expert consensus on interpretations of qualitative data.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human readers or experts when establishing ground truth, typically in image interpretation or diagnostic studies. The tests mentioned (biocompatibility, sterilization, function, packaging) are objective, quantitative, or qualitative assessments against predefined standards, not subjective interpretations requiring 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

This is not applicable. The device described is a reprocessed electrophysiology catheter, which is a physical medical device, not an AI or software algorithm. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.

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

This is not applicable as the device is not an algorithm or AI.

7. The Type of Ground Truth Used

For the bench and laboratory testing:

Biocompatibility: Ground truth would be adherence to established biocompatibility standards (e.g., ISO 10993).
Validation of reprocessing: Ground truth would be the successful removal of soil, decontamination, and functionality post-reprocessing, verified by established protocols and measurable criteria.
Sterilization Validation: Ground truth would be a Sterility Assurance Level (SAL) meeting an accepted standard (e.g., 10^-6), confirmed by established sterilization validation methods.
Function test(s): Ground truth would be that the reprocessed catheter performs according to the original manufacturer's specifications for function (e.g., electrical conductivity, deflection, structural integrity).
Packaging Validation: Ground truth would be that the packaging maintains sterility and integrity, confirmed by established packaging validation methods.

8. The Sample Size for the Training Set

This is not applicable. The device is a reprocessed physical medical device, not a machine learning model that requires a training set.

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

This is not applicable, as there is no training set for a physical reprocessed device.

In Summary:

The provided document describes a 510(k) submission for a reprocessed electrophysiology catheter. The "acceptance criteria" and "study" described are fundamental safety and performance validations for a reprocessed medical device, ensuring it remains equivalent to the original, legally marketed device. It does not involve AI, clinical trials, or expert consensus studies for diagnostic interpretation. The focus is on demonstrating that the reprocessing does not compromise the device's original intended use, safety, or effectiveness.

Summary

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JUL - 9 2008

SECTION 5: 510(k) SUMMARY

12/2 Ascent Healthcare Solutions Submitter: 10232 South 51st Street Phoenix, Arizona 85044 Katie Bray Contact: Regulatory Affairs Manager (480) 763-5300 (o) (480) 763-6089 (f) mbarton@ascenths.com Date of preparation: May 9, 2008 Trade/Proprietary Name: Reprocessed Electrophysiology Name of device: Catheters Classification Name: Electrode recording catheter or electrode recording probe Manufacturer 510{k) Title Predicate Device Inquiry™ AFocus ™, Inquiry ™ Irvine Biomedical K042775 AFocusII™, or Inquiry™ Optima™ Steerable Electrophysiology Catheter Irvine Biomedical Inquiry™ AFocus™ Steerable K010471 Electrophysiology Catheter Irvine Biomedical Orthogonal™ Steerable K990958 Electrophysiology Catheter Irvine Biomedical 1BI-1100 Bi-directional Steerable K982232 Electrophysiology Catheter IBI-1100 Steerable Electrophysiology Irvine Biomedical K961924 Catheter Irvine Biomedical IBI-1000™ Electrophysiology K946333 Catheter Diagnostic Electrophysiology (EP) Catheters are specially Device description: 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. Reprocessed Electrophysiology Catheters are intended for Indications for Use: temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures. The design, materials, and intended use of Reprocessed Technological Electrophysiology Catheters are identical to the predicate characteristics: devices. The mechanism of action of Reprocessed Electrophysiology Catheters is identical to the predicate devices

Ascent Healthcare Solutions Reprocessed Electrophysiology Catheters Traditional 510(k)

Page 13

K081329

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K081329

in that the same standard mechanical design, materials, and in that the cultilized. 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 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.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure with three horizontal lines extending from its arm.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 9 2008

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

Re: K081329

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 Codc: NLH Dated: May 9, 2008 Received: May 12, 2008

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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Pagc 2 - Ms. Katie Bray

Please be advised that FDA's issuance of a substantial cquivalence 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,

Bram D. Zuckerman, M

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	Trade Name	Electrodes	FrenchSize	ElectrodeSpacing	Curve Type
80001	1010-6-25-J	Inquiry Fixed Curve	10	6F	2-5-2 mm	Josephson
80002	1010-6-25-C	Inquiry Fixed Curve	10	6F	2-5-2 mm	Cournand
80003	1010-6-28-SC	Inquiry Fixed Curve	10	6F	2-8-2 mm	Special
80051	1010-5-2-J	Inquiry Fixed Curve	10	5F	2 mm	Josephson
80052	1010-5-25-J	Inquiry Fixed Curve	10	5F	2-5-2 mm	Josephson
80055	1010-5-25-C	Inquiry Fixed Curve	10	5F	2-5-2 mm	Cournand
80063	1010-5-28-C	Inquiry Fixed Curve	10	5F	2-8-2 mm	Special Curve
80064	1010-5-28-SC(60)	Inquiry Fixed Curve	10	5F	2-8-2 mm	Special Curve
80065	1010-5-25-SC(60)	Inquiry Fixed Curve	10	5F	2-5-2 mm	Special Curve
80116	1010-6-2-J-TE4BE4	Inquiry Fixed Curve	10	6F	2 mm	Josephson
80131	1010-4-5-C	Inquiry Fixed Curve	10	4F	5 mm	Cournand
80132	1010-4-5(10)5-J1	Inquiry Fixed Curve	10	4F	2-5-2 mm	Cournand
80133	1010-4-2-J	Inquiry Fixed Curve	10	4F	2 mm	Josephson
80134	1010-4-5-J	Inquiry Fixed Curve	10	4F	5 mm	Josephson
80135	1010-4-25-J	Inquiry Fixed Curve	10	4F	2-5-2 mm	Josephson
80137	1010-4-5(50)-J1	Inquiry Fixed Curve	10	4F	5(50)5 mm	Josephson 1
80138	1010-4-5(10)-J1	Inquiry Fixed Curve	10	4F	5(50)5 mm	Josephson 1
80139	1010-6-28-SC(SOFT)	Inquiry Fixed Curve	10	6F	2-8-2 mm	Special
80405	1004-6-25-J	Inquiry Fixed Curve	4	6F	2-5-2 mm	Josephson
80406	1004-6-5-C	Inquiry Fixed Curve	4	6F	5 mm	Josephson
80407	1004-6-2-7	Inquiry Fixed Curve	4	6F	2 mm	Cournand
80408	1004-6-5-J	Inquiry Fixed Curve	4	6F	2-5-2 mm	Cournand
80409	1004-6-5-C	Inquiry Fixed Curve	4	6F	5 mm	Cournand
80411	1004-6-25-D	Inquiry Fixed Curve	4	6F	2-5-2 mm	Domato
80412	1004-6-5-D	Inquiry Fixed Curve	4	6F	5 mm	Domato
80413	1004-6-10-J	Inquiry Fixed Curve	4	6F	10 mm	Josephson
80414	1004-6-10-C	Inquiry Fixed Curve	4	6F	10 mm	Cournand
80415	1004-6-10-D	Inquiry Fixed Curve	4	6F	10 mm	Damato
80440	1004-5-5-C(HIS)(SOFT)	Inquiry HIS FixedCurve	4	5F	5 mm	Cournand
80451	1004-5-2-J	Inquiry Fixed Curve	4	5F	2 mm	Josephson
80452	1004-5-25-J	Inquiry Fixed Curve	4	5F	2-5-2 mm	Josephson
80453	1004-5-5-J	Inquiry Fixed Curve	4	5F	5 mm	Josephson
80455	1004-5-25-C	Inquiry Fixed Curve	4	5F	2-5-2 mm	Cournand
80456	1004-5-5-C	Inquiry Fixed Curve	4	5F	5 mm	Cournand
80458	1004-5-25-C	Inquiry Fixed Curve	4	5F	2-5-2 mm	Damato
ItemNo.	Description	Trade Name	Electrodes	FrenchSize	ElectrodeSpacing	Curve Type
80459	1004-5-5-D	Inquiry Fixed Curve	4	5F	5 mm	Domato
80463	1004-5-10-C	Inquiry Fixed Curve	4	5F	10 mm	Cournand
80464	1004-4-2-C	Inquiry Fixed Curve	4	4F	2 mm	Cournand
80465	1004-4-5-C	Inquiry Fixed Curve	4	4F	5 mm	Cournand
80466	1004-4-25-C	Inquiry Fixed Curve	4	4F	2-5-2 mm	Cournand
80467	1004-4-2-J	Inquiry Fixed Curve	4	4F	2 mm	Josephson
80468	1004-4-5-J	Inquiry Fixed Curve	4	4F	5 mm	Josephson
80469	1004-4-25-J	Inquiry Fixed Curve	4	4F	2-5-2 mm	Josephson
80473	1004-5-5J(SOFT)	Inquiry Fixed Curve	4	5F	5 mm	Josephson
80476	1004-5-5-C (SOFT)	Inquiry Fixed Curve	4	5F	5 mm	Cournand
80479	1004-5-5-D(SOFT)	Inquiry Fixed Curve	4	5F	5 mm	Domato
80484	1004-5-5-J1-TE1BE2	Inquiry Fixed Curve	4	5F	5 mm	Josephson 1
80485	1004-4-5-J1	Inquiry Fixed Curve	4	4F	5 mm	Josephson 1
80501	1005-6-25-C	Inquiry Fixed Curve	5	6F	2-5-2 mm	Cournand
80508	1005-6-25-J	Inquiry Fixed Curve	5	6F	2-5-2 mm	Josephson
80516	1004-6-2-C(SOFT)	Inquiry Fixed Curve	4	6F	2 mm	Cournand
80517	1004-6-25-J(SOFT)	Inquiry Fixed Curve	4	6F	2-5-2 mm	Josephson
80518	1004-6-5-J1(SOFT)	Inquiry Fixed Curve	4	6F	10 mm	Josephson 1
80519	1004-6-10-D(SOFT)	Inquiry Fixed Curve	4	6F	10 mm	Damato
80520	1004-6-10-C(SOFT)	Inquiry Fixed Curve	4	6F	10 mm	Cournand
80533	1010-5-28-SC(SOFT)	Inquiry Fixed Curve	10	5F	2-8-2 mm	Special
80534	1010-5-5(30)5-C(SOFT)	Inquiry Fixed Curve	10	5F	5(30)5	Cournand
80535	1004-4-25-J1	Inquiry Fixed Curve	4	4F	2-5-2 mm	Josephson 1
80536	1004-4-5-D	Inquiry Fixed Curve	4	4F	5 mm	Damato
80537	1004-6-10-J(SOFT)	Inquiry Fixed Curve	4	6F	10 mm	Josephson
80544	1010-5-28-C(SOFT)	Inquiry Fixed Curve	10	5F	2-8-2 mm	Cournand
80567	1004-4-5-C(HIS)	Inquiry HIS FixedCurve	4	4F	5 mm	Cournand
80602	1006-6-25-J	Inquiry Fixed Curve	6	6F	2-5-2 mm	Josephson
80603	1006-6-5-J	Inquiry Fixed Curve	6	6F	5 mm	Josephson
80604	1006-6-2-C	Inquiry Fixed Curve	6	6F	2 mm	Cournand
80606	1006-6-5-C	Inquiry Fixed Curve	6	6F	5 mm	Cournand
80627	1006-5-5-J1 (SOFT)	Inquiry Fixed Curve	6	5F	5 mm	Josephson 1
80803	1008-6-5-J	Inquiry Fixed Curve	8	6F	5 mm	Josephson
80804	1008-6-2-C	Inquiry Fixed Curve	8	6F	2 mm	Cournand
80806	1008-6-5-D	Inquiry Fixed Curve	8	6F	5 mm	Damato
80810	1008-6-5-C	Inquiry Fixed Curve	8	6F	5 mm	Cournand
80820	1008-5-5-(20)5-C(HIS)	Inquiry HIS FixedCurve	8	5F	20(5) mm	Cournand
80900	1014-7-3(70)-TE2BE2	Inquiry Fixed Curve			3-3-3-3-3-3-70-3-3-3-3-3-3mm	Cournand
Item No.	Description	Trade Name	14Electrodes	7FFrench Size	Electrode Spacing	Curve Type
81101	1110-6-2-F	Inquiry Steerable Curves	10	6F	2 mm	Med 3.2 cm
81102	1110-6-25-M	Inquiry Steerable Curves	10	6F	2-5-2 mm	Med 3.2 cm
81104	1110-6-25-L	Inquiry Steerable Curves	10	6F	2-5-2 mm	Large 4.1 cm
81105	1110-6-25-XL	Inquiry Steerable Curves	10	6F	2-5-2 mm	X-Large 5.0 cm
81106	1110-6-25-F	Inquiry Steerable Curves	10	6F	2-5-2 mm	Far Reach
81107	1110-6-5-L	Inquiry Steerable Curves	10	6F	5 mm	Large
81108	1110-6-2-L	Inquiry Steerable Curves	10	6F	2 mm	Large
81109	1110-6-2-L-TE2BE2	Inquiry Steerable Curves	10	6F	2 mm	Large
81110	1110-6-17-H	Inquiry H Steerable Atrial	10	6F	1 & 7 mm	H
81120	1120-7-17-H	Inquiry H Steerable Atrial	20	7F	1 & 7 mm	H
81121	1121-7-17-H-SC	Inquiry H Steerable Atrial	21	7F	1-7-1 mm	H-SC
81124	1124-7-271-H	Inquiry H Steerable Atrial	24	7F	2-7-1 mm	H
81125	1106-6-27-H	Inquiry H Steerable Atrial	6	6F	2-7-2 mm	H
81126	1110-6-291-HL	Inquiry H SteerableAtrial	10	6F	2-9-1 mm	HL
81128	1121-7-5-H-UP	Inquiry H Steerable Atrial	21	7F	5 mm	H
81130	1120-7-19-HL	Inquiry H Steerable Atrial	20	7F	1 & 9 mm	HL
81131	1121-7-19-HL-SC	Inquiry H Steerable Atrial	21	7F	1-9-1 mm	HL-SC
81134	1124-7-291-HL	Inquiry H Steerable Atrial	24	7F	2-9-1 mm	HL
81136	1120-7-5-HL-UP	Inquiry H Steerable Atrial	20	7F	5 mm	HL
81142	1106-6-27-HL	Inquiry H Steerable Atrial	6	6F	2-7-2 mm	HL
81150	1124-7-271-H-SCE	Inquiry H Steerable Atrial	24	7F	2-7-1 mm	H-SCE
81171	1110-5-2-M	Inquiry Steerable Curves	10	5F	2 mm	Med 3.2 cm
81172	1110-5-25-M	Inquiry SteerableCurves	10	5F	2-5-2 mm	Med 3.2 cm
81174	1110-5-25-L	Inquiry Steerable Curves	10	5F	2-5-2 mm	Large 4.1 cm
81176	1110-5-25-L	Inquiry Steerable Curves	10	5F	2-5-2 mm	Far Reach
Item No.	Description	Trade Name	Electrodes	French Size	Electrode Spacing	Curve Type
81177	1110-5-5-L	Inquiry Steerable Curves	10	5F	5 mm	Large 4.1 cm
81178	1110-5-2-L	Inquiry Steerable Curves	10	5F	2 mm	Large 4.1 cm
81179	1110-5-2-E	Inquiry Steerable Curves	10	5F	2 mm	Extended Reach
81202	1120-7-2-10-XXL	Ten-Ten Duodecapolar	20	7F	2-10 mm	XX Large 4.8 cm
81203	1110-5-25-M(80)SOFT	Inquiry Soft Tip Steerable	10	5F	2-5-2 mm	Med 3.2 cm
81207	1120-7-5-SL	Ten-Ten Duodecapolar	20	7F	5 mm	Super Lrg 5.1 cm
81209	1120-7-25-SL	Ten-Ten Duodecapolar	20	7F	2-5 mm	Super Lrg 5.1 cm
81211	1120-7-2(20)2(25)2-SL	Ten-Ten Duodecapolar	20	7F	2(20)2(25)2 mm	Super Lrg 5.1 cm
81223	1110-5-2(20)3-XL	Inquiry Steerable Curves	10	5F	2(50)3	x-large
81401	1104-6-5-S	Inquiry Steerable Curves	4	6F	5 mm	Small 2.7 cm
81402	1104-6-25-M	Inquiry Steerable Curves	4	6F	2-5-2 mm	Medium 3.2 cm
81403	1104-6-5-M	Inquiry Steerable Curves	4	6F	5 mm	Medium 3.2 cm
81404	1104-6-25-L	Inquiry Steerable Curves	4	6F	2-5-2 mm	Large 4.2 cm
81405	1104-6-5-L	Inquiry Steerable Curves	4	6F	5 mm	Large 4.2 cm
81406	1104-6-25-E	Inquiry Steerable Curves	4	6F	2-5-2 mm	Extended Reach
81407	1104-6-25-F	Inquiry Steerable Curves	4	6F	2-5-2 mm	Far Reach
81412	1104-6-2-E	Inquiry Steerable Curves	4	6F	2 mm	Extended Reach
81417	1104-6-5-XL	Inquiry Steerable Curves	4	6F	5 mm	X-Large 5.0 cm
81418	1104-6-25-XL	Inquiry Steerable Curves	4	6F	2-5-2 mm	X-Large 5.0 cm
81471	1104-5-5-S	Inquiry Steerable Curves	4	5F	5 mm	Small 2.7 cm
81472	1104-5-25-M	Inquiry Steerable Curves	4	5F	2-5-2 mm	Med 3.2 cm
81473	1104-5-5-M	Inquiry Steerable Curves	4	5F	5 mm	Med 3.2 cm
81474	1104-5-25-L	Inquiry SteerableCurves	4	5F	2-5-2 mm	Large 4.1 cm
81475	1104-5-5-L	Inquiry SteerableCurves	4	5F	5 mm	Large 4.1 cm
81478	1104-5-2-S	Inquiry SteerableCurves	4	5F	2 mm	Small 2.7 cm
ItemNo.	Description	Trade Name	Electrodes	FrenchSize	ElectrodeSpacing	Curve Type
81479	1104-5-25-S	Inquiry SteerableCurves	4	5F	2-5-2 mm	Small 2.7 cm
81483	1104-5-5-E(HIS)(SOFT)	Inquiry IIIS SteerableCurve	4	5F	5 mm	Extended
81484	1104-5-5-L(EX-HIS)(SOFT)	Inquiry HIS SteerableCurve	4	5F	5 mm	Large
81485	1104-5-5-E(EX-HIS)(SOFT)	Inquiry HIS SteerableCurve	4	5F	5 mm	Extended
81503	1104-6-5-L-TE2BE2-BD	Inquiry Bi-Directional	4	6F	5 mm	Large 4.1 cm
81504	1110-6-5-M-TE2BE2-BD	Inquiry Bi-Directional	10	6F	5 mm	Med 3.2 cm
81511	1105-6-25-M	Inquiry SteerableCurves	6	6F	2-5-2 mm	Med 3.2 cm
81520	1110-6-2-XL-TE4BE4	Inquiry SteerableCurves	10	6F	2 mm	X-Large 5.0cm
81521	1105-5-5(170)-M/L-TE1BE2(SOFT)	Inquiry Soft TipSteerable	5	5F	5(170)	Med/Large
81524	1110-6-2-L-TE4BE4	Inquiry SteerableCurves	10	6F	2 mm	Large 4.1 cm
81530	1110-4-2-M	Inquiry SteerableCurves	10	4F	2 mm	Med 3.2 cm
81531	1110-4-25-M	Inquiry SteerableCurves	10	4F	2-5-2 mm	Med 3.2 cm
81532	1110-4-025-L	Inquiry SteerableCurves	10	4F	2-5-2 mm	Large 4.1 cm
81534	1110-4-5-L	Inquiry SteerableCurves	10	4F	5 mm	Large 4.1 cm
81536	1110-4-25-M(80)	Inquiry SteerableCurves	10	4F	2-5-2 mm	Med 3.2 cm
81537	1110-4-25-M(SC)(60)	Inquiry SteerableCurves	10	4F	2-5-2 mm	Med 3.2 cm
81540	1104-4-25-M	Inquiry SteerableCurves	4	4F	2-5-2 mm	Med 3.2 cm
81541	1104-4-2-M	Inquiry SteerableCurves	4	4F	2 mm	Med 3.2 cm
81542	1104-4-5-M	Inquiry SteerableCurves	4	4F	5 mm	Med 3.2 cm
81543	1104-4-25-L	Inquiry SteerableCurves	4	4F	2-5-2 mm	Large 4.1 cm
81545	1104-4-5-L	Inquiry SteerableCurves	4	4F	5 mm	Large 4.1 cm
81587	1120-7-1(2.5)-SM-AF20	A-Focus II Steerable Atrial	20	7F	1(2.5) mm	20 mm diameter
81589	1114-7-15-SM-AF20	A-Focus II Steerable Atrial	14	7F	1-5-1 mm	20 mm diameter
81591	1114-7-13-SM-AF15	A-Focus II Steerable Atrial	14	7F	1-3 mm	15 mm diameter
Item No.	Description	Trade Name	Electrodes	French Size	Electrode Spacing	Curve Type
81594	1110-7-3.5-SM-AF15	A-Focus II Steerable Atrial	10	7F	3.5 mm	15 mm diameter
81595	1110-7-5-SM-AF	A-Focus II Steerable Atrial	10	7F	5 mm	20 mm diameter
81596	1110-7-27-SM-AF20	A-Focus II Steerable Atrial	10	7F	2-7 mm	20 mm diameter
81597	1110-7-2(11)-SM-AF25	A-Focus II Steerable Atrial	10	7F	2(11) mm	25 mm diameter
81598	1120-7-1(4.5)-SM-AF25	A-Focus II Steerable Atrial	20	7F	1(4.5) mm	25 mm diameter
81599	1110-7-8-SM-AF25	A-Focus II Steerable Atrial	10	7F	8 mm	25 mm diameter
81601	1106-6-5-M	Inquiry Steerable Curves	6	6F	5 mm	Med 3.2 cm
81602	1106-6-5-L	Inquiry Steerable Curves	6	6F	5 mm	Large 4.1 cm
81603	1106-6-5-E	Inquiry Steerable Curves	6	6F	5 mm	Extended Reach
81604	1106-6-5-F	Inquiry Steerable Curves	6	6F	5 mm	Far Reach
81605	1106-6-5-XL	Inquiry Steerable Curves	6	6F	5 mm	X-Large 5.0 cm
81670	1112-5-2-(10)-AF20	A-Focus I Steerable Atrial	12	5F	2(10) mm	25 mm diameter
81671	1114-5-2(9)-AF30	A-Focus I Steerable Atrial	14	5F	2(9) mm	30 mm diameter
81672	1110-5-27-SM-AF20	A-Focus II Steerable Atrial	10	5F	2-7 mm	20 mm diameter
81673	1110-5-5-SM-AF20	A-Focus II Steerable Atrial	10	5F	5 mm	20 mm diameter
81674	1110-5-5-AF20	A-Focus I Steerable Atrial	10	5F	5 mm	20 mm diameter
81676	1110-5-3.5-AF15	A-Focus I Steerable Atrial	10	5F	3.5 mm	15 mm diameter
81680	1110-5-3.5-SM-AF15	A-Focus II Steerable Atrial	10	5F	3.5 mm	15 mm diameter
81683	1120-7-1(4.5)-SM-OPT25	Optima Steerable Lasso	20	5F	1(4.5) mm	25 mm - 15 mm
Item No.	Description	Trade Name	Electrodes	French Size	Electrode Spacing	Curve Type
81687	1110-7-10-SM-OPT25	Optima Steerable Lasso	10	7F	10mm	25 mm - 15 mm
81703	1110-5-28-M/L(SC)(XS)(SOFT)	Inquiry Soft Tip Steerable	10	5F	2-8-2 mm	Med 3.2 cm/Large 4.1 cm
81704	1110-5-5-M/L(SC)(XS)(SOFT)	Inquiry Soft Tip Steerable	10	5F	5 mm	Med 3.2 cm/Large SC 4.1 cm
81705	1110-5-28-M(SC)(XS)(SOFT)	Inquiry Soft Tip Steerable	10	5F	2-8-2 mm	M(SC)(XS)
81706	1110-5-5-M/L(XS)(SOFT)	Inquiry Soft Tip Steerable	10	5F	5 mm	M/L(XS)
81711	1108-5-5(20)5-E(HIS)(SOFT)	Inquiry HIS Steerable Curve	8	5F	5(20)5 mm	Extended
81717	1124-7-1(4.5)(20)(3)-SM-OPT25	Optima Steerable Lasso	24	7F	4(4.5)	25 mm - 15 mm
81721	1110-5-25-M(SC)(SOFT)	Inquiry Soft Tip Steerable	10	5F	2-5-2 mm	Med (SC) 3.2 cm
81730	1110-5-28-M/L(SOFT)	Inquiry Soft Tip Steerable	10	5F	2-8-2 mm	M/L
81732	1110-5-25-M(SOFT)	Inquiry Soft Tip Steerable	10	5F	2-5-2 mm	Med 3.2 cm
81733	1110-5-2-L(SOFT)	Inquiry Soft Tip Steerable	10	5F	2 mm	Large 4.1 cm
81734	1110-5-25-L(SOFT)	Inquiry Soft Tip Steerable	10	5F	2-5-2 mm	Large 4.1 cm
81735	1110-5-5-L(SOFT)	Inquiry Soft Tip Steerable	10	5F	5 mm	Large 4.1 cm
81738	1110-5-1-L(SOFT)	Inquiry Soft Tip Steerable	10	5F	1 mm	Large 4.1 cm
81742	1104-5-25-M(SOFT)	Inquiry Soft Tip Steerable	4	5F	2-5-2 mm	Med 3.2 cm
81743	1104-5-5-M(SOFT)	Inquiry Soft Tip Steerable	4	5F	5 mm	Med 3.2 cm
81745	1104-5-25-L(SOFT)	Inquiry Soft Tip Steerable	4	5F	2-5-2 mm	Large 4.1 cm
81750	1110-5-25-L(60cm)(SOFT)	Inquiry Soft Tip Steerable	10	5F	2-5-2 mm	Large 4.1 cm
81751	1108-5-2-M(SOFT)	Inquiry Soft Tip Steerable	8	5F	2 mm	Med 3.2 cm
81801	1108-6-2-M	Inquiry Steerable Curves	8	6F	2 mm	Med 3.2 cm
81802	1108-6-25-M	Inquiry Steerable Curves	8	6F	2-5-2 mm	Med 3.2 cm
81807	1108-6-2-L	Inquiry Steerable Curves	8	6F	2 mm	Large 4.1 cm
81809	1108-6-25-L	Inquiry Steerable Curves	8	6F	2-5-2 mm	Large 4.1 cm
81823	1108-6-2-M(SOFT)	Inquiry Soft TipSteerable	8	6F	2 mm	Med 3.2 cm
81871	1108-5-2-M	Inquiry SteerableCurves	8	5F	2 mm	Med 3.2 cm
81872	1108-5-25-M	Inquiry SteerableCurves	8	5F	2-5-2 mm	Med 3.2 cm
81873	1108-5-5-M	Inquiry SteerableCurves	8	5F	5 mm	Med 3.2 cm
81877	1108-5-2-L	Inquiry SteerableCurves	8	5F	2 mm	Large 4.1 cm
81879	1108-5-25-L	Inquiry SteerableCurves	8	5F	2-5-2 mm	Large 4.1 cm
ItemNo.	Description	Trade Name	Electrodes	FrenchSize	ElectrodeSpacing	Curve Type
81901	1120-7-13-M	Ten-Ten Duodecapolar	20	7F	1-3 mm	Medium 3.2cm
81902	1120-7-13-L	Ten-Ten Duodecapolar	20	7F	1-3 mm	Large 4.2 cm
81940	1110-6-2-M(SOFT)	Inquiry Soft TipSteerable	10	6F	2 mm	Med 3.2 cm
81943	1110-6-2-L(SOFT)	Inquiry Soft TipSteerable	10	6F	2 mm	Large 4.1 cm
81945	1110-6-25-L(SOFT)	Inquiry Soft TipSteerable	10	6F	2-5-2 mm	Large 4.1 cm
81947	1110-6-5-M/L(SOFT)	Inquiry Soft TipSteerable	10	6F	5 mm	M/L
81951	1104-6-5-M(SOFT)	Inquiry Soft TipSteerable	4	6F	5 mm	Med 3.2 cm
81954	1104-6-5-L(SOFT)	Inquiry Soft TipSteerable	4	6F	5 mm	Large 4.1 cm
85931	1924-S	Inquiry DiagnosticConnecting Cables	n/a	n/a	1.5m length	n/a
85953	1910-SA	Inquiry DiagnosticConnecting Cables	n/a	n/a	1.5m length	n/a
85954	1904-SA	Inquiry DiagnosticConnecting Cables	n/a	n/a	1.5m length	n/a
85955	1914-SA	Inquiry DiagnosticConnecting Cables	n/a	n/a	1.5m length	n/a
85930	1910-S	Inquiry DiagnosticConnecting Cables	n/a	n/a	2.5m length	n/a

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SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: Reprocessed Electrophysiology Catheters

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

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

eamall

Division of Cardiovascular Devices

Kos1329 510(k) Number

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).