The reprocessed electrophysiology diagnostic catheters are indicated for temporary use during electrophysiology studies for intracardiac sensing, cardiac stimulation, and for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias.

Device Description

SterilMed Reprocessed Irvine Biomedical EP diagnostic catheters consist of a shaft with a handle at the proximal end and some models are considered to be steerable. These catheters have a varying outer diameter (French size) and length. These catheters also feature a number of platinum, radiopaque electrodes with a variety of inter-electrode spacing configurations and curve styles at the distal tip. The distal tip may be steerable and cables connect to the handle and interface between the catheter and an external stimulator and /or an electrophysiological recorder. Note: Only the catheter is the subject of this submission, the external stimulator and /or electrophysiological recorder and any other related equipment are not included in the scope of this submission.

AI/ML Overview

This document is a 510(k) premarket notification for SterilMed, Inc.'s Reprocessed Electrophysiology Diagnostic Catheters. The purpose of the submission is to demonstrate substantial equivalence to predicate devices, not necessarily to prove effectiveness against clinical endpoints. Therefore, many of the typical acceptance criteria and study data points that might be found for a novel AI device are not present here.

Here's an breakdown of the available information regarding acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding reported device performance values in the format typically seen for algorithm performance (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the scope of the non-clinical tests performed, aiming to demonstrate that the reprocessed devices perform equivalently to new, un-reprocessed predicate devices.

The "acceptance criteria" can be inferred as successful completion of the specified validation tests, demonstrating that the reprocessed catheters maintain their functional characteristics, sterility, and biocompatibility. The "reported device performance" is the conclusion that the devices met these criteria.

Acceptance Criteria (Inferred from tests)	Reported Device Performance (Summary)
Cleaning Validation	Process validation testing performed to validate cleaning.
Sterilization Validation (ISO 11135, USP <71>)	Sterilization validation performed.
Biocompatibility Testing (ISO 10993-1)	Biocompatibility testing performed.
Ethylene Oxide Residual Testing (ISO 10993-7)	Ethylene oxide residual testing performed.
Packaging Validation (ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096)	Packaging validation performed.
Shelf Life Validation (ASTM 1980-99)	Shelf life validation performed.
Functional Performance (Bench Testing)	Validation of functional performance (bench testing) performed for: electrical leakage, torsional strength, flexation fatigue, fluid integrity, joint bond strength, deflection fatigue, catheter stiffness, and tip buckling.

The conclusion states: "The reprocessed EP diagnostic catheters are substantially equivalent to the Irvine Biomedical, Inc. electrophysiology diagnostic catheters. This conclusion is based upon the devices' similarities in functional design (principle of operation), materials, indications for use and methods of construction." This implies that all non-clinical acceptance criteria were met to support this claim of substantial equivalence.

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

The document mentions "Representative samples of reprocessed EP diagnostic catheters were tested" for functional characteristics. However, specific sample sizes for each test (e.g., number of catheters tested for electrical leakage) are not provided. The provenance of the data is internal to SterilMed, Inc., as these are tests performed on their reprocessed devices. The tests are "non-clinical" and "bench testing," meaning they were conducted in a lab environment on physical devices, not on human patients, so there is no patient data provenance (country of origin, retrospective/prospective).

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)

This is not applicable as the submission pertains to a reprocessed medical device, not an AI/algorithm-based diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for the reprocessed catheters is their adherence to specified engineering and performance standards, which are objectively measurable.

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

Not applicable for a reprocessed medical device. No human adjudication is mentioned or implied for the performance testing of the catheters.

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 submission for a reprocessed physical medical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for this device is based on objective engineering and performance standards for medical devices (e.g., electrical leakage measurements, tensile strength, sterility through biological indicator testing, biocompatibility testing via ISO standards). The reprocessed catheters are compared to these established standards and to the performance of the original, un-reprocessed devices.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. There is no training set for a physical medical device.

Summary

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10/789

I. SUMMARY AND CERTIFICATION

AUG 1 9 2010

A.	510(k) Summary
	Submitter:	SterilMed, Inc.
	Contact Person:	Garrett Ahlborg11400 73rd Avenue NorthMaple Grove, MN 55369Ph: 763-488-3483Fax: 763-488-2051
	Date Prepared:	June 25, 2010
	Trade Name:	Reprocessed Electrophysiology Diagnostic Catheters
	Classification Name:	Electrode Recording Catheter or Electrode Recording Probe
	Classification Number:	Class II, 21 CFR 870.1220
	Product Code:	NLH

Predicate Devices:	The reprocessed EP diagnostic catheters are substantially equivalent to Irvine Biomedical, Inc. catheters(510(k)'s K060757, K053582, K042775, K010471, K990958, K982232, K961924, and K946333).
Device Description:	SterilMed Reprocessed Irvine Biomedical EP diagnostic catheters consist of a shaft with a handle at theproximal end and some models are considered to be steerable. These catheters have a varying outer diameter(French size) and length. These catheters also feature a number of platinum, radiopaque electrodes with avariety of inter-electrode spacing configurations and curve styles at the distal tip. The distal tip may besteerable and cables connect to the handle and interface between the catheter and an external stimulator and/or an electrophysiological recorder.Note: Only the catheter is the subject of this submission, the external stimulator and /or electrophysiologicalrecorder and any other related equipment are not included in the scope of this submission.
Intended Use:	The reprocessed EP diagnostic catheters are intended for temporary use during electrophysiology studies forintracardiac sensing, recording, cardiac stimulation, and for the electrophysiological mapping and evaluationof cardiac structures and arrhythmias.
Functional andSafety Testing:	Representative samples of reprocessed EP diagnostic catheters were tested to demonstrate appropriatefunctional characteristics. Process validation testing was performed to validate the cleaning and sterilizationprocedures as well as device packaging. In addition, the manufacturing process includes visual and validatedfunctional testing of all products produced.
Summary of Non-clinical TestsConducted:	Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP<71>), biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO 10993-7), packagingvalidation (ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096), and shelf life validation (ASTM1980-99). In addition, validation of functional performance (bench testing) was performed and included thefollowing tests: electrical leakage, torsional strength, flexation fatigue, fluid integrity, joint bond strength,deflection fatigue, catheter stiffness, and tip buckling.
Conclusion:	The reprocessed EP diagnostic catheters are substantially equivalent to the Irvine Biomedical, Inc.electrophysiology diagnostic catheters.This conclusion is based upon the devices' similarities in functional design (principle of operation),materials, indications for use and methods of construction.

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Image /page/1/Picture/0 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SterilMed, Inc. c/o Mr. Garret Ahlborg Regulatory Affairs Manager 11400 73td Avenue North Maple Grove, MN 55369

AUG 1 9 2010

Re: K101789

Trade/Device Name: Reprocessed EP Diagnostic Catheter (See Enclosed List) Regulatory Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: II (two) Product Code: 74 NLH Dated: June 25, 2010 Received: June 28, 2010

Dear Mr. Ahlborg:

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.

{2}------------------------------------------------

Page 2 - Mr. Garret Ahlborg

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,

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 – Mr. Garret Ahlborg

LIST OF DEVICE MODELS COVERED BY THIS SUBMISSION:

Item	Description	Trade Name	Electrodes	French	Electrode Spacing	Curve Type
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
81591	1114-7-13-SM-AF15	A-Focus II Steerable Atrial	14	7F	1-3mm	15 mm
81594	1110-7-3.5-SM-AF15	A-Focus II Steerable Atrial	10	7F	3.5mm	15 mm
81595	1110-7-5-SM-AF	A-Focus II Steerable Atrial	10	7F	5 mm	20 mm
81596	1110-7-27-SM-AF20	A-Focus II Steerable Atrial	10	7F	2-7mm	20 mm
81597	1110-7-2(11)-SM-AF25	A-Focus II Steerable Atrial	10	7F	2(11) mm	25 mm
81598	1120-7-1(4.5)-SM-AF25	A-Focus II Steerable Atrial	20	7F	1(4.5) mm	25 mm
81599	1110-7-8-SM-AF25	A-Focus II Steerable Atrial	10	7F	8mm	25 mm
81670	1112-5-2-(10)-AF20	A-Focus II Steerable Atrial	12	5F	2(10) mm	25 mm
81671	1114-5-2(9)-AF30	A-Focus II Steerable Atrial	14	5F	2(9) mm	30 mm
81672	1110-5-27-SM-AF20	A-Focus II Steerable Atrial	10	5F	2-7 mm	20 mm
81673	1110-5-5-SM-AF20	A-Focus II Steerable Atrial	10	5F	5mm	20 mm
81674	1110-5-5S-AF20	A-Focus II Steerable Atrial	10	5F	5mm	20 mm
81676	1110-5-3.5-AF15	A-Focus II Steerable Atrial	10	5F	3.5mm	15 mm
81680	1110-5-3.5-SM-AF15	A-Focus II Steerable Atrial	10	5F	3.5mm	15 mm
81503	1104-6-5-L-TE2BE2-BD	Inquiry Bi-Directional	4	6F	5mm	Large 4.1 cm
81504	1110-6-5-M-TE2BE2-BD	Inquiry Bi-Directional	10	6F	5mm	Med 3.2 cm
85931	1924-S	Inquiry Diagnostic Connecting Cables	n/a	n/a	1.5m length	n/a
85953	1910-SA	Inquiry Diagnostic Connecting Cables	n/a	n/a	1.5m length	n/a
85954	1904-SA	Inquiry Diagnostic Connecting Cables	n/a	n/a	1.5m length	n/a
85955	1914-SA	Inquiry Diagnostic Connecting Cables	n/a	n/a	1.5m length	n/a
85930	1910-SA	Inquiry Diagnostic Connecting Cables	n/a	n/a	2.5m length	n/a
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	Coumand
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	2MM	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	Coumand
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	5mm	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
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	10mm	Josephson
80414	1004-6-10-C	Inquiry Fixed Curve	4	6F	10mm	Cournand
80415	1004-6-10-D	Inquiry Fixed Curve	4	6F	10mm	Domato
80451	1004-5-2-J	Inquiry Fixed Curve	4	5F	2mm	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	5mm	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	5mm	Cournand
80458	1004-5-25-C	Inquiry Fixed Curve	4	5F	2-5-2 mm	Domato
80459	1004-5-5-D	Inquiry Fixed Curve	4	5F	5mm	Domato
80463	1004-5-10-C	Inquiry Fixed Curve	4	5F	10mm	Cournand
80464	1004-4-2-C	Inquiry Fixed Curve	4	4F	2mm	Cournand
80465	1004-4-5-C	Inquiry Fixed Curve	4	4F	5mm	Cournand
80466	1004-4-25-C	Inquiry Fixed Curve	4	4F	2-5-2mm	Cournand
80467	1004-4-2-J	Inquiry Fixed Curve	4	4F	2mm	Josephson
80468	1004-4-5-J	Inquiry Fixed Curve	4	4F	5mm	Josephson
80469	1004-4-25-J	Inquiry Fixed Curve	4	4F	2-5-2mm	Josephson
80484	1004-5-5-J1	Inquiry Fixed Curve	4	5F	5mm	Josephson I
80485	1004-4-5-JI	Inquiry Fixed Curve	4	4F	5mm	Josephson 1
80501	1005-6-25-C	Inquiry Fixed Curve	5	6F	2-5-2mm	Cournand
80508	1005-6-25-J	Inquiry Fixed Curve	5	6F	2-5-2mm	Josephson
80535	1004-4-25-JI	Inquiry Fixed Curve	4	4F	2-5-2mm	Josephson I
80536	1004-4-5-D	Inquiry Fixed Curve	4	4F	5mm	Domato
80602	1006-6-25-J	Inquiry Fixed Curve	6	6F	2-5-2mm	Josephson
80603	1006-6-5-J	Inquiry Fixed Curve	6	6F	5mm	Josephson
80604	1006-6-2-C	Inquiry Fixed Curve	6	6F	2mm	Cournand
80606	1006-6-5-C	Inquiry Fixed Curve	6	6F	5mm	Cournand
80803	1008-6-5-J	Inquiry Fixed Curve	8	5F	5mm	Josephson
80804	1008-6-2-C	Inquiry Fixed Curve	8	6F	2mm	Cournand
80806	1008-6-5-D	Inquiry Fixed Curve	8	6F	5mm	Damato
80810	1008-6-5-C	Inquiry Fixed Curve	8	6F	5mm	Cournand
80900	1014-7-3(70)-TE2BE2	Inquiry Fixed Curve	14	7F	3-3-3-3-3-3-70	Cournand
81110	1110-6-17-H	Inquiry H Steerable Atrial	10	6F	1 & 7mm	H
81120	1120-7-17-H	Inquiry H Steerable Atrial	20	7F	1 & 7mm	H
81121	1121-7-17-H-SC	Inquiry H Steerable Atrial	21	7F	1-7-1mm	H-SC
81124	1124-7-271-H	Inquiry H Steerable Atrial	24	7F	2-7-1mm	H
81125	1106-6-27-H	Inquiry H Steerable Atrial	6	6F	2-7-2mm	H
81126	1110-6-291-HL	Inquiry H Steerable Atrial	10	6F	2-9-1mm	HL
81128	1121-7-5-H-UP	Inquiry H Steerable Atrial	21	7F	5mm	H
81130	1120-7-19-HL	Inquiry H Steerable Atrial	20	7F	1 & 9mm	HL
81131	1121-7-19-HL-SC	Inquiry H Steerable Atrial	21	7F	1-9-1mm	HL-SC
81134	1124-7-291-HL	Inquiry H Steerable Atrial	24	7F	2-9-1mm	HL
81136	1120-7-5-HL-UP	Inquiry H Steerable Atrial	20	7F	5mm	HL
81142	1106-6-27-HL	Inquiry H Steerable Atrial	6	6F	2-7-2mm	HL
81150	1124-7-271-H-SCE	Inquiry H Steerable Atrial	24	7F	2-7-1mm	H-SCE
80567	1004-4-5-C(HIS)	Inquiry HIS Fixed	4	4F	5mm	Cournand
80820	1008-5-5-(20)5-C(HIS)	Inquiry HIS Fixed	8	5F	20(5)mm	Cournand
81101	1110-6-2-F	Inquiry Steerable Curves	10	6F	2mm	Med 3.2 cm
81102	1110-6-25-M	Inquiry Steerable Curves	10	6F	2-5-2mm	Med 3.2 cm
81104	1110-6-25-L	Inquiry Steerable Curves	10	6F	2-5-2mm	Large 4.1 cm
81105	1110-6-25-XL	Inquiry Steerable Curves	10	6F	2-5-2mm	X-Large 5.0cm
81106	1110-6-25-F	Inquiry Steerable Curves	10	6F	2-5-2mm	Far Reach
81107	1110-6-5-L	Inquiry Steerable Curves	10	6F	5mm	Large
81108	1110-6-2-L	Inquiry Steerable Curves	10	6F	2mm	Large
81109	1110-6-2-L-TE2BE2	Inquiry Steerable Curves	10	6F	2mm	Large
81171	1110-5-2-M	Inquiry Steerable Curves	10	5F	2mm	Med 3.2 cm
81172	1110-5-25-M	Inquiry Steerable Curves	10	5F	2-5-2mm	Med 3.2 cm
81174	1110-5-25-L	Inquiry Steerable Curves	10	5F	2-5-2mm	Large 4.1 cm
81176	1110-5-25-L	Inquiry Steerable Curves	10	5F	2-5-2mm	Far Reach
81177	1110-5-5-L	Inquiry Steerable Curves	10	5F	5mm	Large 4.1 cm
81178	1110-5-2-L	Inquiry Steerable Curves	10	5F	2mm	Large 4.1 cm
81179	1110-5-2-E	Inquiry Steerable Curves	10	5F	2mm	ExtendedReach
81223	1110-5-2(20)3-XL	Inquiry Steerable Curves	10	5F	2(50)3mm	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	2-5-2mm	Medium 3.2
81403	1104-6-5-M	Inquiry Steerable Curves	4	6F	5mm	Medium 3.2
81404	1104-6-25-L	Inquiry Steerable Curves	4	6F	2-5-2mm	Large 4.2 cm
81405	1104-6-5-L	Inquiry Steerable Curves	4	6F	5mm	Large 4.2 cm
81406	1104-6-25-E	Inquiry Steerable Curves	4	6F	2-5-2mm	ExtendedReach
81407	1104-6-25-F	Inquiry Steerable Curves	4	6F	2-5-2mm	Far ReachExtended
81412	1104-6-2-E	Inquiry Steerable Curves	4	6F	2mm	ExtendedReach
81417	1104-6-5-XL	Inquiry Steerable Curves	4	6F	5mm	X-Large 5.0
81418	1104-6-25-XL	Inquiry Steerable Curves	4	6F	2-5-2mm	X-Large 5.0
81471	1104-5-5-S	Inquiry Steerable Curves	4	5F	5mm	Small 2.7 cm
81472	1104-5-25-M	Inquiry Steerable Curves	4	5F	2-5-2mm	Med 3.2 cm
81473	1104-5-5-M	Inquiry Steerable Curves	4	5F	5mm	Med 3.2 cm
81474	1104-5-25-L	Inquiry Steerable Curves	4	5F	2-5-2mm	Large 4.1 cm
81475	1104-5-5-L	Inquiry Steerable Curves	4	5F	5mm	Large 4.1 cm
81479	1104-5-25-S	Inquiry Steerable Curves	4	5F	2-5-2mm	Small 2.7 cm
81511	1105-6-25-M	Inquiry Steerable Curves	6	6F	2-5-2mm	Med 3.2 cm
81520	1110-6-2-XL-TE4BE4	Inquiry Steerable Curves	10	6F	2mm	X-Large 5.0
81524	1110-6-2-L-TE4BE4	Inquiry Steerable Curves	10	6F	2mm	Large 4.1 cm
81530	1110-4-2-M	Inquiry Steerable Curves	10	4F	2mm	Med 3.2 cm
81531	1110-4-25-M	Inquiry Steerable Curves	10	4F	2-5-2mm	Med 3.2 cm
81532	1110-4-025-L	Inquiry Steerable Curves	10	4F	2-5-2mm	Large 4.1 cm
81534	1110-4-5-L	Inquiry Steerable Curves	10	4F	5mm	Large 4.1 cm
81536	1110-4-25-M(80)	Inquiry Steerable Curves	10	4F	2-5-2mm	Med 3.2 cm
81537	1110-4-25-M(SC)(60)	Inquiry Steerable Curves	10	4F	2-5-2mm	Med 3.2 cm
81540	1104-4-25-M	Inquiry Steerable Curves	4	4F	2-5-2mm	Med 3.2 cm
81541	1104-4-2-M	Inquiry Steerable Curves	4	4F	2mm	Med 3.2 cm
81542	1104-4-5-M	Inquiry Steerable Curves	4	4F	5mm	Med 3.2 cm
81543	1104-4-25-L	Inquiry Steerable Curves	4	4F	2-5-2mm	Large 4.1 cm
81545	1104-4-5-L	Inquiry Steerable Curves	4	4F	5mm	Large 4.1 cm
81601	1106-6-5-M	Inquiry Steerable Curves	6	6F	5mm	Med 3.2 cm
81602	1106-6-5-L	Inquiry Steerable Curves	6	6F	5mm	Large 4.1 cm
81603	1106-6-5-E	Inquiry Steerable Curves	6	6F	5mm	ExtendedReach
81604	1106-6-5-F	Inquiry Steerable Curves	6	6F	5mm	Far Reach
81605	1106-6-5-XL	Inquiry Steerable Curves	6	6F	5mm	X-Large 5.0
81801	1108-6-2-M	Inquiry Steerable Curves	8	6F	2mm	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	2mm	Large 4.1 cm
81809	1108-6-25-L	Inquiry Steerable Curves	8	6F	2-5-2 mm	Large 4.1 cm
81871	1108-5-2-M	Inquiry Steerable Curves	8	5F	2mm	Med 3.2 cm
81872	1108-5-25-M	Inquiry Steerable Curves	8	5F	2-5-2 mm	Med 3.2 cm
81873	1108-5-5-M	Inquiry Steerable Curves	8	5F	5mm	Med 3.2 cm
81877	1108-5-2-L	Inquiry Steerable Curves	8	5F	2mm	Large 4.1 cm
81879	1108-5-25-L	Inquiry Steerable Curves	8	5F	2-5-2 mm	Large 4.1 cm
81683	1120-7-1(4.5)-SM-OPT25	Optima Steerable Lasso	20	5F	1(4.5)-1(4.5)mm	25-15mm
81659	1120-7-1(4.5)-SM-OPT25-EB	Optima Steerable Lasso	20	7F	1(4.5)-1(4.5)mm	25-15mm
81687	1110-7-10-SM-OPT25	Optima Steerable Lasso	10	7F	10mm	25-15mm
81717	1124-7-1(4.5)(20)(3)-SM-OPT25	Optima Steerable Lasso	24	7F	4(4.5)	25-15mm
81202	1120-7-2-10-XXL	Ten-Ten Duodecapolar	20	7F	2-10mm	XX Large 4.8
81207	1120-7-5-SL	Ten-Ten Duodecapolar	20	7F	5mm	Super Lrg 5.1
81209	1120-7-25-SL	Ten-Ten Duodecapolar	20	7F	2-5mm	Super Lrg 5.1
81211	1120-7-2(20)2(25)2-SL	Ten-Ten Duodecapolar	20	7F	2(20)2(25)2mm	Super Lrg 5.1
81901	1120-7-13-M	Ten-Ten Duodecapolar	20	7F	1-3mm	Med 3.2 cm
81902	1120-7-13-L	Ten-Ten Duodecapolar	20	7F	1-3mm	Large 4.2 cm

and the comments of the country of the country of

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and the control control control control controllers.

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Image /page/7/Picture/0 description: The image shows the logo for STERILMED, INC. The logo is in black and white and features the company name in a bold, sans-serif font. Below the company name, there is smaller text that reads "Medical Device Reprocessing" and "Small Equipment & Instrument Repair."

Indications for Use
510(k) Number (if known):

K101789

Image /page/7/Picture/4 description: The image contains a few black spots scattered across a white background. The spots are irregular in shape and size, with some appearing as small dots and others as larger, more elongated marks. The distribution of the spots is uneven, with some areas having a higher concentration than others.

Device Name: Reprocessed Electrophysiology Diagnostic Catheters

Indications for Use:

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

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number	K101789

Page 1 of 1

CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.

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).