HEARTSTART MRX, MODEL M3535A

K040404 · Philips Medical Systems, Inc. · MKJ · May 4, 2004 · Cardiovascular

Device Facts

• Record ID: K040404
• Device Name: HEARTSTART MRX, MODEL M3535A
• Applicant: Philips Medical Systems, Inc.
• Product Code: MKJ · Cardiovascular
• Decision Date: May 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3

Indications for Use

The Cadex Battery Charger for Philips HeartStart Batteries is used to recharge and analyze rechargeable batteries that are used with Philips HeartStart manual defibrillator/monitors.

Device Story

Device consists of a multi-bay battery charger and specific mechanical adapters for Philips HeartStart defibrillator batteries. Charger accepts rechargeable batteries as input; performs charging and capacity analysis. Adapters contain embedded software to execute battery-specific charging algorithms. Used in clinical settings to maintain readiness of defibrillator power sources. Output provides charged batteries and capacity status to healthcare providers, ensuring device availability for emergency cardiac resuscitation. Benefits include reliable battery performance and extended service life for life-saving equipment.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Multi-bay (2- or 4-bay) battery charger with mechanical adapters. Employs battery-specific charging algorithms. Software-controlled charging and capacity analysis. Standalone device.

Indications for Use

Indicated for recharging and analyzing rechargeable batteries used in Philips HeartStart manual defibrillator/monitors. Prescription use only.

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

• ZOLL Medical Corp., PowerBase™
• Medtronic Physio-Control Battery Support System 2

Submission Summary (Full Text)

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K040404

#### 510(k) Summary 15.

## Date Summary Prepared

February 6, 2004

#### Submitter's Name and Address

Philips Medical Systems Cardiac and Monitoring Systems Cardiac Resuscitation 3000 Minuteman Road Andover, MA 01810-1099

### Contact Person

Peter Ohanian Philips Medical Systems Cardiac and Monitoring Systems Cardiac Resuscitation Telephone: [phone] Facsimile: [phone]

### Device Name

| Proprietary Name: | Cadex Battery Charger for Philips HeartStart Batteries |
|-----------------------|--------------------------------------------------------|
| Common Name: | Battery Charger for Defibrillator Batteries |
| Classification Names: | Arrhythmia Detection & Alarms (Automatic External) |
| Defibrillator | |

#### Predicate Devices

The legally marketed devices to which Philips Medical Systems claims equivalence for the Cadex Battery Charger for Philips HeartStart Batteries are as follows:

- ZOLL Medical Corp., PowerBase™ .
- Medtronic Physio-Control Battery Support System 2 .

The design of the Cadex Battery Charger for Philips HeartStart Batteries is substantially equivalent in safety and performance to the devices listed above.

#### Device Description

The Cadex Battery Charger for Philips HeartStart Batteries is used to charge and analyze rechargeable batteries used in Philips HeartStart defibrillators. The Battery Charger consists of a commercially available battery charger and an adapter specifically designed to interface with the Philips HeartStart batteries. The battery charger is available in 2- and 4-bay models, which allow for the simultaneous charging of up to 4 batteries. The adapters allow for the mechanical interface between the battery and the battery charger. The adapters also contain the software that allows the battery charger to charge the battery using the appropriate algorithm for the type of battery being charged. The battery charger also analyzes a battery to determine its capacity.

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## Intended Use

The Cadex Battery Charger for Philips HeartStart Batteries is used to recharge and analyze rechargeable batteries that are used with Philips HeartStart manual defibrillator/monitors.

# Comparison of Technology Characteristics

The Cadex Battery Charger for Philips HeartStart Batteries employs the same fundamental scientific technologies as the commercially available predicate devices used for comparison.

# Tests Used in Determination of Substantial Equivalence

The tests used in the determination of substantial equivalence included only bench testing. Bench testing includes hardware and software testing demonstrating that the performance of the device meets its specification

# Conclusion from Testing

Based on the results of the testing described above, it is concluded that the Cadex Battery Charger for Philips HeartStart Batteries does not raise any different questions regarding the safety or effectiveness as compared with the predicate devices. It is considered to be substantially equivalent to the predicate devices.

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Image /page/2/Picture/11 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that features a stylized image of a bird or eagle with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 4 2004

Philips Medical Systems c/o Mr. Peter Ohanian Director, Quality and Regulatory Affairs Cardiac and Monitoring Systems Cardiac Resuscitation 3000 Minuteman Road, MS 0222 Andover, MA 01810

Re: K040404

Trade Name: Cadex Battery Charger for Philips HeartStart Batteries Regulation Number: 21 CFR 870.1025 Regulation Name: Arrythmia Detector and Alarm Regulatory Class: III (three) Product Code: MKJ Dated: March 11, 2004 Received: March 12, 2004

#### Dear Mr. Ohanian:

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 for tose batter in the energency)76, 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 he found in the Codc 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. Peter Ohanian

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of actived that i be review that your device complies with other requirements of the Act 4 or any Federal statutes and regulations administered by other Federal agencies. You must r or 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 SI I art 8077, laceming (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. product raincilled on the begin marketing your device as described in your Section 510(k) I mo letter notification. The FDA finding of substantial equivalence of your device to a legally premated noticated 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 n you a 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 other general micronational 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,

Bran 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 2.

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

Ko40404

Device Name: Cadex Battery Charger for Philips HeartStart Batteries

Indications for Use: The Cadex Battery Charger for Philips HeartStart Batteries is used to recharge and analyze rechargeable batteries that are used with Philips HeartStart manual defibrillator/monitors.

Over-The-Counter Use: No Prescription Use: Yes AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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