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K Number
K101789
Device Name
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
Manufacturer
STERILMED, INC.
Date Cleared
2010-08-19

(52 days)

Product Code
NLH
Regulation Number
870.1220
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
More Information

K060757, K053582, K042775, K010471, K990958, K982232, K961924, and K946333

Not Found

No
The summary describes a reprocessed electrophysiology catheter and its functional testing, with no mention of AI or ML capabilities.

No.
The device is indicated for diagnostic purposes, specifically for sensing, stimulation, mapping, and evaluation, rather than for treating a condition.

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is for "electrophysiological mapping and evaluation of cardiac structures and arrhythmias," which are diagnostic activities. Additionally, it is referred to as an "electrophysiology diagnostic catheter."

No

The device description clearly outlines a physical catheter with a shaft, handle, electrodes, and cables, indicating it is a hardware device. The submission explicitly states "Only the catheter is the subject of this submission," further confirming it is not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for "intracardiac sensing, cardiac stimulation, and for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias." This involves direct interaction with the patient's body (intracardiac) for diagnostic purposes related to the heart's electrical activity.
  • Device Description: The description details a catheter with electrodes designed to be inserted into the heart. It connects to external equipment for sensing and stimulation.
  • Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes. This device does not process or analyze such specimens.

The device described is a medical device used in vivo (within the body) for diagnostic and potentially therapeutic (stimulation) purposes related to the heart's electrical system.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

NLH

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Intracardiac structures (indicated for electrophysiological mapping and evaluation of cardiac structures)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Functional and Safety Testing:
Representative samples of reprocessed EP diagnostic catheters were tested to demonstrate appropriate functional characteristics. Process validation testing was performed to validate the cleaning and sterilization procedures as well as device packaging. In addition, the manufacturing process includes visual and validated functional testing of all products produced.

Summary of Non-clinical Tests Conducted:
Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP ), biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO 10993-7), packaging validation (ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096), and shelf life validation (ASTM 1980-99). In addition, validation of functional performance (bench testing) was performed and included the following 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K060757, K053582, K042775, K010471, K990958, K982232, K961924, and K946333

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

0

10/789

I. SUMMARY AND CERTIFICATION

AUG 1 9 2010

A.510(k) Summary
Submitter:SterilMed, Inc.
Contact Person:Garrett Ahlborg
11400 73rd Avenue North
Maple Grove, MN 55369
Ph: 763-488-3483
Fax: 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 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. |
| Intended Use: | The reprocessed EP diagnostic catheters are intended for temporary use during electrophysiology studies for
intracardiac sensing, recording, cardiac stimulation, and for the electrophysiological mapping and evaluation
of cardiac structures and arrhythmias. |
| Functional and
Safety Testing: | Representative samples of reprocessed EP diagnostic catheters were tested to demonstrate appropriate
functional characteristics. Process validation testing was performed to validate the cleaning and sterilization
procedures as well as device packaging. In addition, the manufacturing process includes visual and validated
functional testing of all products produced. |
| Summary of Non-
clinical Tests
Conducted: | Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP
), biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO 10993-7), packaging
validation (ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096), and shelf life validation (ASTM
1980-99). In addition, validation of functional performance (bench testing) was performed and included the
following 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. |

1

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

3

Page 3 – Mr. Garret Ahlborg

LIST OF DEVICE MODELS COVERED BY THIS SUBMISSION:

:.

ItemDescriptionTrade NameElectrodesFrenchElectrode SpacingCurve Type
815871120-7-1(2.5)-SM-AF20A-Focus II Steerable Atrial207F1(2.5) mm20 mm diameter
815891114-7-15-SM-AF20A-Focus II Steerable Atrial147F1-5-1 mm20 mm
815911114-7-13-SM-AF15A-Focus II Steerable Atrial147F1-3mm15 mm
815941110-7-3.5-SM-AF15A-Focus II Steerable Atrial107F3.5mm15 mm
815951110-7-5-SM-AFA-Focus II Steerable Atrial107F5 mm20 mm
815961110-7-27-SM-AF20A-Focus II Steerable Atrial107F2-7mm20 mm
815971110-7-2(11)-SM-AF25A-Focus II Steerable Atrial107F2(11) mm25 mm
815981120-7-1(4.5)-SM-AF25A-Focus II Steerable Atrial207F1(4.5) mm25 mm
815991110-7-8-SM-AF25A-Focus II Steerable Atrial107F8mm25 mm
816701112-5-2-(10)-AF20A-Focus II Steerable Atrial125F2(10) mm25 mm
816711114-5-2(9)-AF30A-Focus II Steerable Atrial145F2(9) mm30 mm
816721110-5-27-SM-AF20A-Focus II Steerable Atrial105F2-7 mm20 mm
816731110-5-5-SM-AF20A-Focus II Steerable Atrial105F5mm20 mm
816741110-5-5S-AF20A-Focus II Steerable Atrial105F5mm20 mm
816761110-5-3.5-AF15A-Focus II Steerable Atrial105F3.5mm15 mm
816801110-5-3.5-SM-AF15A-Focus II Steerable Atrial105F3.5mm15 mm
815031104-6-5-L-TE2BE2-BDInquiry Bi-Directional46F5mmLarge 4.1 cm
815041110-6-5-M-TE2BE2-BDInquiry Bi-Directional106F5mmMed 3.2 cm
859311924-SInquiry Diagnostic Connecting Cablesn/an/a1.5m lengthn/a
859531910-SAInquiry Diagnostic Connecting Cablesn/an/a1.5m lengthn/a
859541904-SAInquiry Diagnostic Connecting Cablesn/an/a1.5m lengthn/a
859551914-SAInquiry Diagnostic Connecting Cablesn/an/a1.5m lengthn/a
859301910-SAInquiry Diagnostic Connecting Cablesn/an/a2.5m lengthn/a
800011010-6-25-JInquiry Fixed Curve106F2-5-2 mmJosephson
800021010-6-25-CInquiry Fixed Curve106F2-5-2 mmCoumand
800031010-6-28-SCInquiry Fixed Curve106F2-8-2 mmSpecial
800511010-5-2-JInquiry Fixed Curve105F2MMJosephson
800521010-5-25-JInquiry Fixed Curve105F2-5-2 mmJosephson
800551010-5-25-CInquiry Fixed Curve105F2-5-2 mmCoumand
800631010-5-28-CInquiry Fixed Curve105F2-8-2 mmSpecial Curve
800641010-5-28-SC(60)Inquiry Fixed Curve105F2-8-2 mmSpecial Curve
800651010-5-25-SC(60)Inquiry Fixed Curve105F2-5-2 mmSpecial Curve
801161010-6-2-J-TE4BE4Inquiry Fixed Curve106F2 mmJosephson
801311010-4-5-CInquiry Fixed Curve104F5mmCournand
801321010-4-5(10)5-J1Inquiry Fixed Curve104F2-5-2 mmCournand
801331010-4-2-JInquiry Fixed Curve104F2 mmJosephson
801341010-4-5-JInquiry Fixed Curve104F5 mmJosephson
801351010-4-25-JInquiry Fixed Curve104F2-5-2 mmJosephson
801371010-4-5(50)-J1Inquiry Fixed Curve104F5(50)5 mmJosephson 1
801381010-4-5(10)-J1Inquiry Fixed Curve104F5(50)5 mmJosephson 1
804051004-6-25-JInquiry Fixed Curve46F2-5-2 mmJosephson
804061004-6-5-CInquiry Fixed Curve46F5 mmJosephson
804071004-6-2-7Inquiry Fixed Curve46F2 mmCournand
804081004-6-5-JInquiry Fixed Curve46F2-5-2 mmCournand
804091004-6-5-CInquiry Fixed Curve46F5 mmCournand
804111004-6-25-DInquiry Fixed Curve46F2-5-2 mmDomato
804121004-6-5-DInquiry Fixed Curve46F5 mmDomato
804131004-6-10-JInquiry Fixed Curve46F10mmJosephson
804141004-6-10-CInquiry Fixed Curve46F10mmCournand
804151004-6-10-DInquiry Fixed Curve46F10mmDomato
804511004-5-2-JInquiry Fixed Curve45F2mmJosephson
804521004-5-25-JInquiry Fixed Curve45F2-5-2 mmJosephson
804531004-5-5-JInquiry Fixed Curve45F5mmJosephson
804551004-5-25-CInquiry Fixed Curve45F2-5-2 mmCournand
804561004-5-5-CInquiry Fixed Curve45F5mmCournand
804581004-5-25-CInquiry Fixed Curve45F2-5-2 mmDomato
804591004-5-5-DInquiry Fixed Curve45F5mmDomato
804631004-5-10-CInquiry Fixed Curve45F10mmCournand
804641004-4-2-CInquiry Fixed Curve44F2mmCournand
804651004-4-5-CInquiry Fixed Curve44F5mmCournand
804661004-4-25-CInquiry Fixed Curve44F2-5-2mmCournand
804671004-4-2-JInquiry Fixed Curve44F2mmJosephson
804681004-4-5-JInquiry Fixed Curve44F5mmJosephson
804691004-4-25-JInquiry Fixed Curve44F2-5-2mmJosephson
804841004-5-5-J1Inquiry Fixed Curve45F5mmJosephson I
804851004-4-5-JIInquiry Fixed Curve44F5mmJosephson 1
805011005-6-25-CInquiry Fixed Curve56F2-5-2mmCournand
805081005-6-25-JInquiry Fixed Curve56F2-5-2mmJosephson
805351004-4-25-JIInquiry Fixed Curve44F2-5-2mmJosephson I
805361004-4-5-DInquiry Fixed Curve44F5mmDomato
806021006-6-25-JInquiry Fixed Curve66F2-5-2mmJosephson
806031006-6-5-JInquiry Fixed Curve66F5mmJosephson
806041006-6-2-CInquiry Fixed Curve66F2mmCournand
806061006-6-5-CInquiry Fixed Curve66F5mmCournand
808031008-6-5-JInquiry Fixed Curve85F5mmJosephson
808041008-6-2-CInquiry Fixed Curve86F2mmCournand
808061008-6-5-DInquiry Fixed Curve86F5mmDamato
808101008-6-5-CInquiry Fixed Curve86F5mmCournand
809001014-7-3(70)-TE2BE2Inquiry Fixed Curve147F3-3-3-3-3-3-70Cournand
811101110-6-17-HInquiry H Steerable Atrial106F1 & 7mmH
811201120-7-17-HInquiry H Steerable Atrial207F1 & 7mmH
811211121-7-17-H-SCInquiry H Steerable Atrial217F1-7-1mmH-SC
811241124-7-271-HInquiry H Steerable Atrial247F2-7-1mmH
811251106-6-27-HInquiry H Steerable Atrial66F2-7-2mmH
811261110-6-291-HLInquiry H Steerable Atrial106F2-9-1mmHL
811281121-7-5-H-UPInquiry H Steerable Atrial217F5mmH
811301120-7-19-HLInquiry H Steerable Atrial207F1 & 9mmHL
811311121-7-19-HL-SCInquiry H Steerable Atrial217F1-9-1mmHL-SC
811341124-7-291-HLInquiry H Steerable Atrial247F2-9-1mmHL
811361120-7-5-HL-UPInquiry H Steerable Atrial207F5mmHL
811421106-6-27-HLInquiry H Steerable Atrial66F2-7-2mmHL
811501124-7-271-H-SCEInquiry H Steerable Atrial247F2-7-1mmH-SCE
805671004-4-5-C(HIS)Inquiry HIS Fixed44F5mmCournand
808201008-5-5-(20)5-C(HIS)Inquiry HIS Fixed85F20(5)mmCournand
811011110-6-2-FInquiry Steerable Curves106F2mmMed 3.2 cm
811021110-6-25-MInquiry Steerable Curves106F2-5-2mmMed 3.2 cm
811041110-6-25-LInquiry Steerable Curves106F2-5-2mmLarge 4.1 cm
811051110-6-25-XLInquiry Steerable Curves106F2-5-2mmX-Large 5.0cm
811061110-6-25-FInquiry Steerable Curves106F2-5-2mmFar Reach
811071110-6-5-LInquiry Steerable Curves106F5mmLarge
811081110-6-2-LInquiry Steerable Curves106F2mmLarge
811091110-6-2-L-TE2BE2Inquiry Steerable Curves106F2mmLarge
811711110-5-2-MInquiry Steerable Curves105F2mmMed 3.2 cm
811721110-5-25-MInquiry Steerable Curves105F2-5-2mmMed 3.2 cm
811741110-5-25-LInquiry Steerable Curves105F2-5-2mmLarge 4.1 cm
811761110-5-25-LInquiry Steerable Curves105F2-5-2mmFar Reach
811771110-5-5-LInquiry Steerable Curves105F5mmLarge 4.1 cm
811781110-5-2-LInquiry Steerable Curves105F2mmLarge 4.1 cm
811791110-5-2-EInquiry Steerable Curves105F2mmExtended
Reach
812231110-5-2(20)3-XLInquiry Steerable Curves105F2(50)3mmx-large
814011104-6-5-SInquiry Steerable Curves46F5 mmSmall 2.7 cm
814021104-6-25-MInquiry Steerable Curves46F2-5-2mmMedium 3.2
814031104-6-5-MInquiry Steerable Curves46F5mmMedium 3.2
814041104-6-25-LInquiry Steerable Curves46F2-5-2mmLarge 4.2 cm
814051104-6-5-LInquiry Steerable Curves46F5mmLarge 4.2 cm
814061104-6-25-EInquiry Steerable Curves46F2-5-2mmExtended
Reach
814071104-6-25-FInquiry Steerable Curves46F2-5-2mmFar Reach
Extended
814121104-6-2-EInquiry Steerable Curves46F2mmExtended
Reach
814171104-6-5-XLInquiry Steerable Curves46F5mmX-Large 5.0
814181104-6-25-XLInquiry Steerable Curves46F2-5-2mmX-Large 5.0
814711104-5-5-SInquiry Steerable Curves45F5mmSmall 2.7 cm
814721104-5-25-MInquiry Steerable Curves45F2-5-2mmMed 3.2 cm
814731104-5-5-MInquiry Steerable Curves45F5mmMed 3.2 cm
814741104-5-25-LInquiry Steerable Curves45F2-5-2mmLarge 4.1 cm
814751104-5-5-LInquiry Steerable Curves45F5mmLarge 4.1 cm
814791104-5-25-SInquiry Steerable Curves45F2-5-2mmSmall 2.7 cm
815111105-6-25-MInquiry Steerable Curves66F2-5-2mmMed 3.2 cm
815201110-6-2-XL-TE4BE4Inquiry Steerable Curves106F2mmX-Large 5.0
815241110-6-2-L-TE4BE4Inquiry Steerable Curves106F2mmLarge 4.1 cm
815301110-4-2-MInquiry Steerable Curves104F2mmMed 3.2 cm
815311110-4-25-MInquiry Steerable Curves104F2-5-2mmMed 3.2 cm
815321110-4-025-LInquiry Steerable Curves104F2-5-2mmLarge 4.1 cm
815341110-4-5-LInquiry Steerable Curves104F5mmLarge 4.1 cm
815361110-4-25-M(80)Inquiry Steerable Curves104F2-5-2mmMed 3.2 cm
815371110-4-25-M(SC)(60)Inquiry Steerable Curves104F2-5-2mmMed 3.2 cm
815401104-4-25-MInquiry Steerable Curves44F2-5-2mmMed 3.2 cm
815411104-4-2-MInquiry Steerable Curves44F2mmMed 3.2 cm
815421104-4-5-MInquiry Steerable Curves44F5mmMed 3.2 cm
815431104-4-25-LInquiry Steerable Curves44F2-5-2mmLarge 4.1 cm
815451104-4-5-LInquiry Steerable Curves44F5mmLarge 4.1 cm
816011106-6-5-MInquiry Steerable Curves66F5mmMed 3.2 cm
816021106-6-5-LInquiry Steerable Curves66F5mmLarge 4.1 cm
816031106-6-5-EInquiry Steerable Curves66F5mmExtended
Reach
816041106-6-5-FInquiry Steerable Curves66F5mmFar Reach
816051106-6-5-XLInquiry Steerable Curves66F5mmX-Large 5.0
818011108-6-2-MInquiry Steerable Curves86F2mmMed 3.2 cm
818021108-6-25-MInquiry Steerable Curves86F2-5-2 mmMed 3.2 cm
818071108-6-2-LInquiry Steerable Curves86F2mmLarge 4.1 cm
818091108-6-25-LInquiry Steerable Curves86F2-5-2 mmLarge 4.1 cm
818711108-5-2-MInquiry Steerable Curves85F2mmMed 3.2 cm
818721108-5-25-MInquiry Steerable Curves85F2-5-2 mmMed 3.2 cm
818731108-5-5-MInquiry Steerable Curves85F5mmMed 3.2 cm
818771108-5-2-LInquiry Steerable Curves85F2mmLarge 4.1 cm
818791108-5-25-LInquiry Steerable Curves85F2-5-2 mmLarge 4.1 cm
816831120-7-1(4.5)-SM-OPT25Optima Steerable Lasso205F1(4.5)-
1(4.5)mm25-15mm
816591120-7-1(4.5)-SM-OPT25-EBOptima Steerable Lasso207F1(4.5)-
1(4.5)mm25-15mm
816871110-7-10-SM-OPT25Optima Steerable Lasso107F10mm25-15mm
817171124-7-1(4.5)(20)(3)-SM-
OPT25Optima Steerable Lasso247F4(4.5)25-15mm
812021120-7-2-10-XXLTen-Ten Duodecapolar207F2-10mmXX Large 4.8
812071120-7-5-SLTen-Ten Duodecapolar207F5mmSuper Lrg 5.1
812091120-7-25-SLTen-Ten Duodecapolar207F2-5mmSuper Lrg 5.1
812111120-7-2(20)2(25)2-SLTen-Ten Duodecapolar207F2(20)2(25)2mmSuper Lrg 5.1
819011120-7-13-MTen-Ten Duodecapolar207F1-3mmMed 3.2 cm
819021120-7-13-LTen-Ten Duodecapolar207F1-3mmLarge 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:

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.

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) NumberK101789

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CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.