(191 days)
Not Found
No
The summary describes a replacement battery for medical devices and does not mention any AI or ML capabilities.
No
The device is a replacement battery or battery pack, which is a component that powers therapeutic devices, but it is not a therapeutic device itself.
No
Explanation: The device is described as a replacement battery/battery pack used to power medical equipment, not to diagnose medical conditions. Its function is to provide power, not to perform diagnostic procedures.
No
The device description clearly states it is a rechargeable battery or battery pack, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to "power the functions of various devices for which batteries or battery packs are configured." This describes a power source for medical equipment, not a device used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description states the batteries are used 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 equipment." This reinforces its role as a power supply.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information
- Mentioning any specific disease or condition being diagnosed or monitored through the device's function.
The device is clearly described as a power source for other medical devices, which are themselves regulated, but the battery itself does not perform an in vitro diagnostic function.
N/A
Intended Use / Indications for Use
To power the functions of various devices for which the batteries or battery packs are configured.
Product codes
MKJ
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 cycles as the predicate device.
- Temperature The replacement device must function correctly over the same temperature range as the predicate device.
Mechanical & Electrical Component Integrity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K982135, K925402, K925510, K882067, K890875, K832015, K802718, K952085, K930548, K946281, K943959, K970920, K962291
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5310 Automated external defibrillator system.
(a)
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.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
K0 32051
JAN - 9 2004
ACCESS Battery, Inc.
Power When It Matters Most! ™
510(k) Summary Rechargeable Battery Packs
| Submitter: | Access Battery, Inc.
Engineering Department
5357 Highway 86,
Elizabeth, CO 80107 | | |
|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------|
| Contact Person: | Alexander B. Henderson
Technical Manager
Access Battery, Inc.
Engineering Department
5357 Highway 86,
Elizabeth, CO 80107
Tel: 1-800-373-3301
Fax: 1-800-373-0669 | | |
| Date Prepared: | October 31, 2003 | | |
| Device Name: | Trade/Proprietary Name:
Common/Generic Name:
Classification Name: | Battery, Rechargeable
Battery, Rechargeable
Box, Battery, Rechargeable
Batteries, Rechargeable | |
| Classification: | Cardiovascular Panel | | Class |
| 21 CFR 870.1025
21 CFR 870.1130
21 CFR 870.2300
21 CFR 870.2340
21 CFR 870.5300 | Detector and Alarm, Arrhythmia
System, Measurement, Blood Pressure, Non-Invasive
Monitor, Cardiac (Including Cardiotachometer & Rate Alarm)
Electrocardiograph
DC Defibrillator, Low Energy (Including Paddles) | | III
II
II
II
III |
1
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:
-
- 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.
-
- 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.
-
- 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.
- 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).
2
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
3
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.
4
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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
5
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!
Page 1 of 1
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. (303) 646-9400 · Fax. (303) 646-9888 www.accessbattery.com