MOBILE BATTERY SERVICE STATION (MBSS)

K030898 · Ad Elektronik GmbH · MKJ · Aug 27, 2003 · Cardiovascular

Device Facts

• Record ID: K030898
• Device Name: MOBILE BATTERY SERVICE STATION (MBSS)
• Applicant: Ad Elektronik GmbH
• Product Code: MKJ · Cardiovascular
• Decision Date: Aug 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3

Indications for Use

The MBSS charging station is used to charge NiCd or SLA batteries of the Lifepak®, Fastpak® and Fastpak 2® series manufactured by Medtronic -Physio Control.

Device Story

Mobile Battery Service Station (MBSS) is a charging unit for NiCd or SLA batteries used in Medtronic-Physio Control defibrillators. Device operates independently of the defibrillator; batteries are removed from the defibrillator and inserted into MBSS charging bays. Available as table-top or wall-mount unit; powered by 120V mains or 12V automotive supply. MBSS performs battery recognition, impedance monitoring, and charging. Used in clinical settings or rescue vehicles by medical personnel. Output consists of charged batteries for use in life-support equipment. Benefits include ensuring availability of functional power sources for defibrillation units.

Clinical Evidence

Bench testing only. Testing evaluated product specifications including battery recognition, charge times, impedance, electrical safety, and electromagnetic interference. All test results met specifications.

Technological Characteristics

Battery charging station for NiCd/SLA batteries. Dimensions: 30cm x 20cm x 10cm. Power: 120V AC or 12V DC. Standards: EN60601-1 (electrical safety), EN60601-1-2 (EMC), UL 60950. Materials are standard and previously cleared. No software or algorithm details provided.

Indications for Use

Indicated for charging NiCd or SLA batteries used in Medtronic-Physio Control Lifepak, Fastpak, and Fastpak 2 series defibrillators. No specific patient population or contraindications described as the device is a battery charger.

Regulatory Classification

Identification

An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.

Predicate Devices

• Lifepak 12 with Battery Charger - Medtronic-Physio Control (K973486)
• Lifepak 12 with Battery Charger - Medtronic-Physio Control (K990338)

Submission Summary (Full Text)

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AUG 2 7 2003

#### 510(k) Summary

K030898

General Information

| Classification | Class III (accessory to Class III defibrillation unit) |
|----------------|-----------------------------------------------------------------------------|
| Trade Name | Mobile Battery Service Station (MBSS) |
| Submitter | AD Elektronk GmbH<br>Sudentenstrasse 7-9<br>35583 Wetzlar<br>Germany |
| U.S. Contact | Richard Tootchen<br>TMS MedTec<br>33 Steeplechase Drive<br>Turnersville, NJ |

[phone] Tel:

#### Intended Use

The MBSS charging station is used to charge NiCd or SLA batteries of the Lifepak®, Fastpak® and Fastpak 2® series manufactured by Medtronic -Physio Control.

#### Predicate Devices

Lifepak 12 with Battery Charger -- Medtronic-Physio Control K973486 Lifepak 12 with Battery Charger - Medtronic-Physio Control K990338

#### Device Description

The MBSS overall dimensions are 30 cm x 20 cm x 10 cm. It is available either as a table top model or wall mount unit. The table top model has a standard power cord which plugs into a 110 volt wall outlet and non-slip rubberized feet. The wall mount model has a bracket for mounting the charger on a vertical surface. For mounting and use in an automobile (ambulance or rescue vehicle), the wall mount bracket is used. Power

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requirements are either standard mains at 120 volts or standard automotive 12 volts.

The charger is only used for charging specific batteries. The batteries are removed from the defibrillator and inserted into the MBSS charging bays. The MBSS is not attached to the defibrillator during operation.

#### Materials

All materials used in the manufacture of the MBSS battery charger are suitable for this use and have been used in numerous previously cleared products.

### Testing

The MBSS is designed to comply with the electrical safety (EN60601-1), electromagnetic compatibility (EN60601-1-2) and UL 60950 standards. The MBSS meets all electrical and EMC requirements.

Testing was conducted to evaluate conformance to the product specification. Testing included:

- Operation of the charger .
- Battery recognition .
- Charge times .
- Appropriate displays .
- Impedance .
- Electrical safety
- Electromagnetic interference ●

In all cases, the product test results met specification

## Summary of Substantial Equivalence

AD Elektronik believes the Mobile Battery Service Station (MBSS) is substantially equivalent to the predicate products. The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate products.

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Image /page/2/Picture/2 description: The image is a black and white circular logo. The logo features a stylized image of an eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle, following its curvature. The logo appears to be a seal or emblem, possibly representing a government agency or organization related to health and human services in the United States.

AUG 2 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AD Elektronic GmbH c/o Mr. Richard Tootchen TMS Medical Technologies 33 Steeplechase Drive Turnersville, NJ 08012

Re: K030898 Mobile Battery Service Station-Model MBSS Regulation Number: 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III Product Code: MKJ Dated: August 4, 2003 Received: August 6, 2003

Dear Mr. Tootchen:

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 - Mr. Richard Tootchen

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 (OS) 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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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,

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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# Indications for Use

510(k) Number (if known):

This application

K030898

Device Name:

Indications for Use:

The MBSS charging station is used to charge NiCd or. SLA batteries of the Lifepak®, Fastpak® and Fastpak 2® series manufactured by Medtronic - Physio Control.

Mobile Battery Service Station (MBSS)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use _
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Over-The-Counter Use _
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