DETECT SURGICAL PACING AND MAPPING TOOL

K040812 · Medtronic Vascular · LDF · Sep 2, 2004 · Cardiovascular

Device Facts

• Record ID: K040812
• Device Name: DETECT SURGICAL PACING AND MAPPING TOOL
• Applicant: Medtronic Vascular
• Product Code: LDF · Cardiovascular
• Decision Date: Sep 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DETECT™ Surgical Pacing and Mapping Tool is a handheld, single use device designed to provide temporary cardiac pacing or monitoring.

Device Story

The Detect™ Mapping and Pacing Tool is a handheld, single-use surgical instrument used for temporary cardiac pacing or monitoring. The device consists of a handle, a malleable stainless steel shaft with a fluoropolymer sheath, and a textured ball-tip electrode. It includes a grounding needle electrode. The device connects to external diagnostic equipment, such as the Medtronic External Temporary Pacemaker (Model 5388) or Programmer/Analyzer (Model 2090/2290), via a cable. It is operated by clinicians in a surgical or clinical setting. By providing an electrical interface with the heart, the device allows the physician to deliver pacing stimuli or monitor cardiac electrical activity, facilitating intraoperative or temporary post-operative cardiac management.

Clinical Evidence

Bench testing only. The device was evaluated for safety and effectiveness in accordance with the 'Electrode Recording Catheter Preliminary guidance' (1995) and international standards IEC 60601-1 and IEC 60601-2-7.

Technological Characteristics

Handheld electrode probe; materials include stainless steel shaft and fluoropolymer sheath; textured ball-tip electrode; includes grounding needle electrode. Sterile, nonpyrogenic, single-use. Connectivity via cable to external pacing/diagnostic units. Complies with IEC 60601-1 and IEC 60601-2-7.

Indications for Use

Indicated for temporary cardiac pacing or monitoring in patients requiring such intervention.

Regulatory Classification

Identification

Temporary pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. Permanent pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.

Predicate Devices

• Streamline™ 6494 Unipolar Temporary Myocardial Pacing Wire (K012459)

Submission Summary (Full Text)

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# 510 (K) SUMMARY of Safety and Effectiveness

(In accordance with SMDA of 1990 and pursuant with 21 CFR 807.92)

#### l. Applicant Information:

## SEP - 2 2004

| Date Prepared: | July 29, 2004 |
|-----------------------------------|---------------------------------------------------------|
| Submitter: | Medtronic, Inc. |
| Address: | 710 Medtronic Parkway, NE<br>Minneapolis, MN 55432-5604 |
| Establishment<br>Registration No. | 2135394 |
| Contact Person: | David D. Cox<br>Principle Regulatory Affairs Specialist |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |

#### = Device Information:

| Trade Name: | Detect™ Mapping and Pacing Tool |
|--------------|---------------------------------|
| Common Name: | Detect™ Electrode Probe |

| Classification Name: | Electrode, Pacemaker, Temporary |
|----------------------|---------------------------------|
| Classification: | Class II, 21 CFR 870.3680 |
| Product Code: | LDF |

Streamline™ 6494 Unipolar Temporary Myocardial Pacing Wire Predicate Device: 510(k) No. K012459, Reg. No. 870.3680; Product Code: LDF

> The Model 6494 Unipolar Temporary Device Intended Use: Myocardial Pacing Wire is intended for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY .

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### Detect™ Mapping and Pacing Tool, model 10650 Pre-market notification-510(K)

The Medtronic® Detect™ Temporary Pacing and Mapping Device Description: Electrode Probe consists of a handle, a malleable stainless steel shaft with a flouropolymer sheath ending in a textured ball tip electrode, and a cable for connection to diagnostic device. Sterile, Nonpyrogenic, Disposable, Single use only.

> The Grounding Electrode consists of a needle and a cable for connection to a diagnostic device. Sterile, Nonpyrogenic, Disposable, Single use only.

> The Detect™ Electrode Probe is compatible with the Medtronic External Temporary Pacemaker (Model 5388), and the Medtronic Programmer/ Analyzer (Model 2090/2290).

- The DETECTIM Surgical Pacing and Mapping Tool is a Intended Use: handheld, single use device designed to provide temporary cardiac pacing or monitoring.
### III. SUBSTANTIAL EQUIVALENCE TESTING SUMMARY

The DETECT™ Mapping and Pacing Tool and the Grounding Needle Electrode have been tested and are considered safe and effective per the "Electrode Recording Catheter Preliminary guidance", Mark Massi, Pacing and Electrophysiology Device Branch, Division of Cardiovascular, Respiratory and Neurological Devices, Office of Device Evaluation FDA, CDRH, 1995.

The DETECT™ Mapping and Pacing Tool and the Grounding Needle Electrode have been tested and are considered safe and effective per "Standard for Medical Equipment; Part 1: General requirements, IEC 60601-1; IEC 60601-27

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Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three abstract shapes resembling birds in flight, arranged in a stacked formation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 2 2004

Medtronic, Inc c/o David D. Cox, Ph.D. Principle Regulatory Affairs Specialist Cardiac Surgery Technologies 710 Medtronic Parkway, NE Minneapolis, MN 55432-5604

Re: K040812

Trade Name: Detect™ Mapping and Pacing Tool Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular Permanent or Temporary Pacemaker Electrode Regulatory Class: II (two) Product Code: LDF Dated: July 30, 2004 Received: August 02, 2004

Dear Dr. Cox:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - David D. Cox, Ph.D.

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 Of R Fart 877) adoming (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 If you dosine of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Neil R., Oph.

Bram D. Zuckerman, M.D.

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

Enclosure

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# Indications for Use

510(k) Number (if known): K040812

Detect™ Surgical Pacing and Mapping Tool, Model 10650 Device Name:

Indications for Use:

The DETECT™ Surgical Pacing and Mapping Tool is a handheld, single use device designed to provide temporary cardiac pacing or monitoring.

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)

Neil R.P. Ogle

(Division Sign-Off)
Division of Cardiovascular Devices

for bDz

510(k) Number_

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