BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P

K032051 · Access Battery, Inc. · MKJ · Jan 9, 2004 · Cardiovascular

Device Facts

• Record ID: K032051
• Device Name: BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P
• Applicant: Access Battery, Inc.
• Product Code: MKJ · Cardiovascular
• Decision Date: Jan 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3

Intended Use

To power the functions of various devices for which the batteries or battery packs are configured. Since rechargeable batteries and battery packs are "device specific" and are designed to operate and fit into the equipment for which they were manufactured, only qualified personnel should evaluate, test, charge, or install these devices, This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. Biomedical equipment service professionals therefore know that the intended use is as a replacement battery.

Device Story

Rechargeable battery packs serve as primary or backup DC power sources for portable and stationary medical equipment. These packs are device-specific, engineered to match the voltage, capacity, and physical form factor of the original equipment manufacturer (OEM) batteries they replace. They function via chemical energy storage (Lead Acid, NiCd, or NiMH). Used in clinical settings, these batteries are installed by biomedical equipment service professionals. By providing reliable power, they ensure the continuous operation of critical medical devices such as defibrillators and cardiac monitors, directly supporting patient safety and device availability during clinical use.

Clinical Evidence

Bench testing only. Testing focused on functional requirements and performance specifications, specifically comparing life cycle (recharge/discharge cycles) and temperature range performance against predicate device benchmarks to ensure the replacement batteries meet or exceed original equipment performance.

Technological Characteristics

Rechargeable battery packs using Lead Acid (SLA), Nickel-Cadmium (NiCd), or Nickel-Metal Hydride (NiMH) cell chemistries. Energy delivery is based on chemical reaction, with voltage and capacity ratings matched to specific host medical devices. Form factor is device-specific to ensure physical fit and electrical compatibility with the host equipment.

Indications for Use

Indicated for use as a replacement power source for specific medical devices, including cardiovascular monitors, defibrillators, and blood pressure monitors. Intended for installation and maintenance by qualified biomedical equipment service professionals.

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

• CAS Medical Systems Series 90000 Blood Pressure Monitors (K982135, K925402)
• Spacelabs Medical Models 90478 and 90479 Telemetry Receivers (K925510)
• Marquette Model 1200 Defibrillator (K882067)
• PPG Biomedical/Litton EK Series EKG Monitors (K890875, K832015)
• Hewlett Packard 4700 Series EKG Pagewriter Electrocardiograph (K802718)
• Datascope/Medical Research Laboratories Passport Monitor & Defibrillator DPD (K952085, K930548)
• Burdick Eclipse 4 Model Electrocardiograph (K946281, K943959)
• Siemens Medical Bedside Monitoring System SC 9000 (K970920, K962291)

Submission Summary (Full Text)

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K0 32051

JAN - 9 2004

# ACCESS Battery, Inc.

Power When It Matters Most! ™

# 510(k) Summary Rechargeable Battery Packs

| Submitter: | Access Battery, Inc.<br>Engineering Department<br>5357 Highway 86,<br>Elizabeth, CO 80107 | | |
|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------|
| Contact Person: | Alexander B. Henderson<br>Technical Manager<br>Access Battery, Inc.<br>Engineering Department<br>5357 Highway 86,<br>Elizabeth, CO 80107<br>Tel: [phone]<br>Fax: [phone] | | |
| Date Prepared: | October 31, 2003 | | |
| Device Name: | Trade/Proprietary Name:<br>Common/Generic Name:<br>Classification Name: | Battery, Rechargeable<br>Battery, Rechargeable<br>Box, Battery, Rechargeable<br>Batteries, Rechargeable | |
| Classification: | Cardiovascular Panel | | Class |
| 21 CFR 870.1025<br>21 CFR 870.1130<br>21 CFR 870.2300<br>21 CFR 870.2340<br>21 CFR 870.5300 | Detector and Alarm, Arrhythmia<br>System, Measurement, Blood Pressure, Non-Invasive<br>Monitor, Cardiac (Including Cardiotachometer & Rate Alarm)<br>Electrocardiograph<br>DC Defibrillator, Low Energy (Including Paddles) | | III<br>II<br>II<br>II<br>III |

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## 510(k) Summary

#### Legally Marketed Predicate Devices:

This submission compares the specifications and functionality of various rechargeable battery packs with those of similar devices that were included as part of the following original predicate equipment and submissions:

- 1. The Access Battery MLA005 I is the same as that used in CAS Medical Systems Series 90000 Blood Pressure Monitors, cleared under 510(k) Notifications K982135 and K925402.
- 2. The Access Battery MLA90479 is the same as that used in Spacelabs Medical Models 90478 and 90479 Telemetry Receivers, cleared under 510(k) Notification K925510.
- 3. The Access Battery MNC 1000EKG is the same as used in the Marquette Model 1200 Defibrillator, cleared under 510(k) Notification K882067.
- 4 The Access Battery MNC1659L is the same as that used in the PPG Biomedical/Litton EK Scries EKG Monitors, cleared under 510(k) Notifications K890875 and K832015.
- 5. The Access Battery MNC4755 is the same as that used in Hewlett Packard's 4700 Series EKG Pagewriter Electrocardiograph, cleared under 510(k) Notification K802718.
- 6. The Access Battery MNC14649P is the same as that used in the Datascope/Medical Research Laboratories Passport Monitor & Defibrillator DPD, cleared under 510(k) Notifications K952085 and K930548.
- 7. The Access Battery MNC862988P is the same as that used in Burdick Eclipse 4 Model Electrocardiograph, cleared under 510(k) Notifications K946281 and K943959,
- The Access Battery MNC431345P is the same as that used in Siemens Medical Bedside 8. Monitoring System SC 9000, cleared under 510(k) Notifications K970920 and K962291.

#### Description:

Rechargeable batteries and battery packs are utilized as a primary direct current (d-c) power source or as a standby or backup d-c power source for portable as well as stationary medical cquipment.

#### Statement of Intended Use:

To power the functions of various devices for which the batteries or battery packs are configured.

### Comparison of Technological Characteristics

The design components and functionality of the various battery packs listed are similar to those of their predicate devices. All these devices provide a means of supplying clectrical power through chemical reaction. The energy provided depends upon the voltage and capacity rating of a particular pack and the amount of current used by the device into which they are installed. The performance and life span of a rechargeable battery depends on operating conditions of temperature, current drain, and the charge/discharge method. These parameters are taken into account in designing such batteries. The goal is to develop battery packs that maintain capacity for as high and as long as possible. Typical cell chemistrics are Lead Acid (SLA), Nickel-Cadmium (NiCd), and Nickel-Metal Hvdride (NiMH).

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#### Testing:

Safety and performance testing of these battery packs have been performed to ensure that these devices meet all functional requirements and performance specifications.

In comparison analysis, the predicate devices set the benchmark. The replacement devices must meet or exceed these benchmark results consistently.

Concerns that are addressed during bench test comparison analysis are

- Life cycle The replacement device must provide as many or more recharge/discharge eveles as the predicate device.
- Temperature The replacement device must function correctly over the same temperature range as the predicate device.

Mechanical & Electrical Component Integrity

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three tail feathers, representing the department's commitment to health, services, and people. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

SEP 3-2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Access Battery, Inc. c/o Mr. Alexander B. Henderson Technical Manager 5357 Highway 86 Elizabeth, CO 80107

Re: K032051

Trade Name: Rechargeable Battery Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: October 31, 2003 Received: November 3, 2003

Dear Mr. Henderson:

This letter corrects our substantially equivalent letter of January 9, 2004. 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 (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 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. Alexander B. Henderson

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 continue 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/dsma/dsmamain.html

Sincerely yours,

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

Enclosure

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Image /page/5/Picture/0 description: The image shows the text "ACCESS Battery, Inc." in a bold, sans-serif font. The text is arranged horizontally, with "ACCESS" appearing first, followed by "Battery," and then "Inc." The letters are black against a white background, creating a high contrast and making the text easily readable.

Power When It Matters Most!

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## INDICATIONS FOR USE STATEMENT

510(K) Number. K03205 |

Device Name: Box, Battery, Rechargeable

Indications for Use:

To power the functions of various devices for which batteries or battery packs are configured.

Since rechargeable batteries and battery packs are "device specific" and are designed to operate and fit into the equipment for which they were manufactured, only qualified personnel should evaluate, test, charge, or install these devices,

This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. Biomedical equipment service professionals therefore know that the intended use is as a replacement battery.

#### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE II NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use

Dna Seevulu

(Division-Sign-Off)
Division of Cardiovascular Devices
510(k) Number K032051

5357 Highway 86 · Eitzabeth. CO 80107- Telephone. [phone] · Fax. [phone] www.accessbattery.com