ADAPTER CABLE

K050884 · Remington Medical, Inc. · DTA · May 19, 2005 · Cardiovascular

Device Facts

• Record ID: K050884
• Device Name: ADAPTER CABLE
• Applicant: Remington Medical, Inc.
• Product Code: DTA · Cardiovascular
• Decision Date: May 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3720
• Device Class: Class 2

Indications for Use

The Model 6149 Pacing Vector Selector Cable Switch is a manually operated unit that connects to the Pacing System Analyzer (PSA) (3105) using a Redel connector. It is used during lead implants for PSA measurements and provides the capability to switch RV and LV tip and ring signals to five possible electrode combinations.

Device Story

The Model 6149 Pacing Vector Selector Cable Switch is a manually operated, non-powered accessory cable designed to interface between a Pacing System Analyzer (PSA) and patient cables. It features a 3-channel molded connector housing with an integrated 2-pole, 5-position switch. This allows clinicians to toggle between five specific pacing vector combinations (LV Tip to RV Coil, LV Ring to RV Coil, LV Ring to LV Tip, LV Tip to LV Ring, and RV Tip to RV Coil) without manually relocating alligator clips on the lead terminal. Used by trained physicians and hospital staff during lead implantation procedures, the device simplifies the measurement process, reducing the need for repeated manual adjustments. It is intended for repeated use and is not part of the sterile field.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Passive, manually operated adapter cable. Features a 3-channel molded connector housing with an integrated 2-pole, 5-position switch. Connects to Pacing System Analyzer via Redel connector. No active circuits, no power source, no sterilization requirements. Designed for repeated use.

Indications for Use

Indicated for use during chronic implantation of a pacing or defibrillation lead system to facilitate PSA measurements.

Regulatory Classification

Identification

A pacemaker electrode function tester is a device which is connected to an implanted pacemaker lead that supplies an accurately calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential.

Predicate Devices

• ERA 300 (K032613)
• ERA 300 (K964190)

Reference Devices

• Guidant Model 3105 Pacing System Analyzer
• Guidant 6697 Patient Cables

Submission Summary (Full Text)

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Korssy

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MAY 1 9 2005

# 510(k) SUMMARY of SAFETY and EFFECTIVENESS

# A. General Information 1. Submitter's Name: Remington Medical Inc. 6830 Meadowridge Court 2. Address: Alpharetta, Georgia 30005 770-888-8520 3. Telephone: Don Rosvold 4. Contact Person: March 31, 2005 5. Date Prepared: 6. Registration Number: 1056553 B. Device Guidant Model 6149 Pacing Vector Selector Patient 1. Name: Adapter Cable 2. Trade Name: Adapter Cable Adapter Cable 3. Common Name: External Pulse Generator, Electrode Function Analyzer, and 4. Classification Name: Generator Function Analyzer DTA, DTC, and DTE 5. Product Code: 6. Class: III 870.3600, 870.3630, and 870.3720 7. Regulation Number: C. Identification of Legally Marketed Devices

l. Name: ERA 300 K032613 and K964190 2. K Number: December 8, 2003 and July 10, 1997 3. Date Cleared:

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Image /page/1/Picture/0 description: The image shows the logo for Remington Medical, Inc. The logo consists of a black geometric shape on the left, with the letters "RMI" in white inside. To the right of the geometric shape is the text "Remington Medical, Inc." in a bold, serif font. The text is arranged in two lines, with "Remington" on the top line and "Medical, Inc." on the bottom line.

## D. Description of the Device

The Model 6149 Pacing Vector Selector Cable Switch was designed to interface between the Guidant Model 3105 or 3106 Pacing System Analyzer and Guidant 6697 Patient Cables. It is manually operated and has no active circuits or power sources.

It is a 3-channel Patient Adapter Cable, easily switchable between PSA vector measurements on implanted leads without relocating alligator clips on the lead terminal.

A 2-pole, 5 position switch is integrated into the 3-channel molded connector housing on the distal end of the cable. The pacing vectors options provided are:

- · Left Ventricle Tip to Right Ventricle Coil
- · Left Ventricle Ring to Right Ventricle Coil
- · Left Ventricle Ring to Left Ventricle Tip
- · Left Ventricle Tip to Left Ventricle Ring
- · Right Ventricle Tip to Right Ventricle Coil

It is indicated for use during chronic implantation of a pacing or defibrillation lead system.

Trained physicians and hospital staff will use the Model 6149 to assist with the implantation of a pacing or defibrillation lead system. No customer interaction will be required.

The Model 6149 is not intended to be part of the sterile field and has no sterilization requirements: It is for repeated use during implant procedures.

### E. Intended Use Statement

The Model 6149 Pacing Vector Selector Cable Switch is a manually operated unit that connects to the Pacing System Analyzer (PSA) (3105) using a Redel connector.

It is used during lead implants for PSA measurements and provides the capability to switch RV and LV tip and ring signals to five possible electrode combinations.

### F. Technological Characteristics Summary

As the Model 6149 is an accessory to ERA 300, the only difference is the Model 6149. The original and subsequent 510(k's) for the ERA 300 did not have and do not have an accessory such as the Model 6149.

In the same view, there are no similarities as the ERA 300 did not have such an accessory.

The addition of the Model 6149 to be used with Guidant's PSA Model 3105 is considered minor and does not raise any safety concerns or effectiveness concerns.

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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

Food and Drug Administr. 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 2005

Remington Medical, Inc. c/o Mr. Don Rosvold President 6830 Meadowridge Court Alpharetta, GA 30005

Re: K050884

R02000 !
Guidant Model 6149 Pacing Vector Selector Patient Adapter Cable Regulation Number: 21 CFR 870.3600 Regulation Name: External Pacemaker Pulse Generator Regulatory Class: III (three) Product Code: DTA Dated: March 31, 2005 Received: April 7, 2005

Dear Mr. Rosvold:

We have reviewed your Section 510(k) premarket notification of intent to market the device in we nave reviewed your becamined the device is substantially equivalent (for the indications felerenced above and nave determined we are and and devices marketed in interstate for use stated in the cherosury to regally to regally the Medical Device Amendments, or to commerce provided to May 26, 1976, the encordance with the provisions of the Federal Food. Drug. devices that have been recalismed in acceraation will of a premarket approval application (PMA). and Cosment Act (Act) that do not require species the general controls provisions of the Act. The Y ou may, therefore, market the device, solo, solo, excepted on the manual registration, listing of the general controls provisions of the rist leveling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classifica (see above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controlions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Our neements concerning your device in the Federal Register.

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#### Page 2 - Mr. Don Rosvold

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), please contact the Office 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/industry/support/index.html.

Sincerely yours,

Bhirminum for

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

Enclosure

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#### Indications for Use

510(k) Number (if known): To be determined

050884

Device Name: Model 6149

Indications for Use:

- The Model 6149 Pacing Vector Selector Cable Switch is a manually operated unit . I he Model 0149 Facting Vector Belocer Creek Brovides the capability to switch
used during lead implants for PSA measurements and provides the capability to switch used during icad implains for x to five possible electrode combinations.
Prescription Use _X__

AND/OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(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)

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