K Number
K012523
Device Name
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
Manufacturer
Date Cleared
2002-08-14

(373 days)

Product Code
Regulation Number
870.1220
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Reprocessed Electrophysiology Diagnostic Catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias; and for electrophysiologic mapping of cardiac structures during these evaluations.
Device Description
The device consists of a reprocessed catheter that has a high-torque shaft with a handle at the proximal end, and may or may not be steerable. These catheters have an outer diameter of 4F to 8F, a length ranging from 60 to 160 cm, with 2-20 platinum, radiopaque electrodes along the tip shaft and a variety of inter-electrode spacings and curve styles at the tip. The tip generally is deflectable. Specific cables, as recommended by the original manufacturer, connect to the handle and interface between the catheter and an external stimulator and/or an electrophysiologic recorder. It should be noted that this submission pertains to the catheter only. It does not include any other components in a system such as, connector cables, external stimulators, or electrophysiologic recorders.
More Information

No
The description focuses on the physical characteristics and intended use of a reprocessed catheter, with no mention of AI or ML capabilities.

No
The device is used for diagnostic purposes (sensing, recording, stimulation, and mapping during electrophysiology studies) rather than for treating a condition.

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is for "intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias; and for electrophysiologic mapping of cardiac structures during these evaluations," which are diagnostic activities. The product name also contains "Diagnostic Catheters".

No

The device description clearly states it is a reprocessed catheter with physical components like a shaft, handle, electrodes, and cables, indicating it is a hardware device.

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, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias; and for electrophysiologic mapping of cardiac structures". This describes a device used within the body for diagnostic and therapeutic purposes, not a device used to test samples outside the body (which is the definition of an IVD).
  • Device Description: The description details a catheter with electrodes designed to be inserted into the heart. This aligns with the intended use and further confirms it's an invasive medical device, not an IVD.
  • Lack of IVD Characteristics: There is no mention of testing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.

Therefore, this device falls under the category of an invasive medical device used for electrophysiology procedures, not an IVD.

N/A

Intended Use / Indications for Use

These cardiac diagnostic catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and stimulation. They also provide temporary pacing for the evaluation of cardiac arrhythmias, and are used for electrophysiology mapping of cardiac structures during these evaluations.

The Reprocessed Electrophysiology Diagnostic Catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias; and for electrophysiologic mapping of cardiac structures during these evaluations.

Product codes

DRF

Device Description

The device consists of a reprocessed catheter that has a high-torque shaft with a handle at the proximal end, and may or may not be steerable. These catheters have an outer diameter of 4F to 8F, a length ranging from 60 to 160 cm, with 2-20 platinum, radiopaque electrodes along the tip shaft and a variety of inter-electrode spacings and curve styles at the tip. The tip generally is deflectable. Specific cables, as recommended by the original manufacturer, connect to the handle and interface between the catheter and an external stimulator and/or an electrophysiologic recorder. It should be noted that this submission pertains to the catheter only. It does not include any other components in a system such as, connector cables, external stimulators, or electrophysiologic recorders.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Intracardiac 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)

Representative samples of reprocessed electrophysiology diagnostic catheters underwent design testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.

The electrophysiology diagnostic catheters reprocessed by SterilMed are substantially equivalent to the A20 (K953768), manufactured by Biosense Webster (formerly known as Cordis Webster), the Bard Dynamic Tip Catheter (K912213), and the Bard Intracardiac Electrode Catheter manufactured by C.R. Bard Inc., the Stablemapr EP Diagnostic Catheter (K981642), manufactured by Medtronic Inc., and the reprocessed devices' counterparts from the original manufacturers. This conclusion is based upon the fact that these devices' are essentially identical to the predicate devices in terms of functional design, materials, indications for use, and construction.

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

Not Found

Predicate Device(s)

K953768, K912213, K981642

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

K012523

SECTION 2. SUMMARY AND CERTIFICATION

510(K) SUMMARY A.

Submitter:SterilMed, Inc.
Contact Person:Patrick Fleischhacker
11400 73rd Avenue North
Minneapolis MN, 55369
Ph: 888-856-4870
Fax: 763-488-3350
Date Prepared:August 3, 2001
Trade Name:SterilMed Reprocessed Electrophysiology Diagnostic
Catheters
Classification Name:
and Number:Class II, 21 CFR 870.1220
Product Code:DRF
Predicate Device(s):The SterilMed reprocessed electrophysiology diagnostic
catheter is substantially equivalent to: the A20 (K953768),
manufactured by Biosense Webster (formerly known as
Cordis Webster), the Bard Dynamic Tip Catheter
(K912213), and the Bard Intracardiac Electrode Catheter
manufactured by C.R. Bard Inc., the Stablemapr EP
Diagnostic Catheter (K981642), manufactured by
Medtronic Inc., and the original manufacturers' devices.
Device Description:The device consists of a reprocessed catheter that has a
high-torque shaft with a handle at the proximal end, and
may or may not be steerable. These catheters have an outer
diameter of 4F to 8F, a length ranging from 60 to 160 cm,
with 2-20 platinum, radiopaque electrodes along the tip
shaft and a variety of inter-electrode spacings and curve
styles at the tip. The tip generally is deflectable. Specific
cables, as recommended by the original manufacturer,
connect to the handle and interface between the catheter
and an external stimulator and/or an electrophysiologic
recorder. It should be noted that this submission pertains to
the catheter only. It does not include any other components
in a system such as, connector cables, external stimulators,
or electrophysiologic recorders.
Intended Use:These cardiac diagnostic catheters are intended for
temporary use during electrophysiology studies for
intracardiac sensing, recording, and stimulation. They also
provide temporary pacing for the evaluation of cardiac
arrhythmias, and are used for electrophysiology mapping of
cardiac structures during these evaluations.
Functional and
Safety Testing:Representative samples of reprocessed electrophysiology
diagnostic catheters underwent design testing to
demonstrate appropriate functional characteristics. Process
validation testing was done to validate the cleaning and
sterilization procedures as well as the device's packaging.
In addition, the manufacturing process includes visual and
functional testing of all products produced.
Conclusion:The electrophysiology diagnostic catheters reprocessed by
SterilMed are substantially equivalent to the A20
(K953768), manufactured by Biosense Webster (formerly
known as Cordis Webster), the Bard Dynamic Tip Catheter
(K912213), and the Bard Intracardiac Electrode Catheter
manufactured by C.R. Bard Inc., the Stablemapr EP
Diagnostic Catheter (K981642), manufactured by
Medtronic Inc., and the reprocessed devices' counterparts
from the original manufacturers. This conclusion is based
upon the fact that these devices' are essentially identical to
the predicate devices in terms of functional design.
materials, indications for use, and construction.

Image /page/0/Picture/5 description: The image shows the text "Page 4" and the number "2004". The text "Page 4" is located on the left side of the image, and the number "2004" is located on the right side of the image. The number "2004" is written in a handwritten style.

1

:

2005

2

Image /page/2/Picture/0 description: The image is a black and white circular logo. The logo features the symbol of the Department of Health and Human Services (HHS) in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2002

SterilMed. Inc. c/o Mr. Patrick Fleischhacker Vice President of Regulatory and Quality 11400 730 Avenue North Minneapolis, MN 55369

Rc: K012523

Trade Name: Reprocessed Electrophysiology Diagnostic Catheters Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: May 20, 2002 Received: May 21, 2002

Dear Mr. Fleischhacker:

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. Iisting 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.

3

Page 2 – Mr. Patrick Fleischhacker

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

2

Enclosure

4

Indications for Use Page

Device Name: Reprocessed Electrophysiology Diagnostic Catheters

Indications for Use:

The Reprocessed Electrophysiology Diagnostic Catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias; and for electrophysiologic mapping of cardiac structures during these evaluations.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off)
Division of Cardiovascular
and Respiratory Devices
8/14/02
510(k) Number K012523

Prescription Use
(Per 21 CFR 801.109)