(72 days)
Not Found
No
The device description and intended use clearly define the device as a disposable replacement battery pack, which is a purely electrical/chemical component and does not involve AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No.
Explanation: The device is a replacement battery pack for an AED, acting as a power source, not directly providing therapeutic intervention itself.
No
The device is described as a non-rechargeable battery pack that provides electrical power to medical equipment, specifically AEDs, rather than performing any diagnostic functions.
No
The device description clearly states it is a non-rechargeable battery pack, which is a hardware component providing electrical power through chemical reaction.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these are replacement battery packs for Automated External Defibrillators (AEDs). AEDs are medical devices used to treat sudden cardiac arrest by delivering an electrical shock. This is a therapeutic and life-support function, not an in vitro diagnostic function.
- Device Description: The description details the battery's function as a power source for medical equipment through chemical reaction. This aligns with the function of a battery, not a diagnostic test performed outside the body.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or assays
The device is a power source for a medical device, not a diagnostic tool itself.
N/A
Intended Use / Indications for Use
The 5L318 Lithium/Manganese Dioxide (Li/MnO2) AMCO battery is a disposable replacement battery pack for use in the Philips Medical / HeartStream ForeRunner AED; specifically Philips Medical battery part number BT1. This battery has a shelf life of 4 years from the date of manufacture.
The AM5070 Lithium/Manganese Dioxide (Li/MnO2) AMCO battery is a disposable replacement battery pack for use in the Philips Medical / HeartStream FRx and HeartStart Home AED; specifically Philips Medical battery part number AM5070A. This battery has a shelf life of 4 years from the date of manufacture.
Product codes
MKJ
Device Description
Non-rechargeable 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 equipment. These devices provide a means of supplying electrical 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 these batteries depends on operating conditions of temperature, current drain, and the 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 under a specified range of environmental conditions.
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
Only qualified personnel, such as Biomedical Engineers, Medical Clinics, EMT's, etc., should evaluate, test, or install these battery packs.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K955628, K020715, K040904, K050004
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
Image /page/0/Picture/1 description: This image shows a black and white picture of the Earth. The continents of North and South America are visible. The image is a simple representation of the planet, with the landmasses appearing dark and the oceans appearing light.
BraunSolutions®
AUG 0 7 2009
K
510(k) Summary (Per 21 CFR 807.92)
Submitter/Owner:
Amco International Manufacturing & Design, Inc. Attn: Mr. Adam Milewski Medical Battery Division 10 Conselyea Street, Brooklyn, NY 11211 USA
Official Correspondent:
Alexander B. Henderson BraunSolutions 377 Zane Court, Elizabeth, CO 80107 USA Tel: 303-646-3715 Email: alex henderson@msn.com
Date Prepared:
May 18, 2009
Device Name:
Trade/Proprietary Name: Common/Generic Name: Classification Name:
Predicate Devices:
Battery Pack, Disposable
AMCO™ Battery Pack Box, Battery Box, Battery, Non-Rechargeable Regulatory Class III, Product Code MKJ
Philips Medical Replacement Battery ForeRunner BT1 Defibrillator - Approved under K955628 Philips Medical Replacement Battery HeartStart FRx On-Site / Home AED - Approved under K020715, K040904, K050004
| Classification: | Cardiovascular Panel | Class |
|---|---|---|
| 21 CFR 870.5300 | DC-Defibrillator | III |
| 21 CFR 870.5310 | Automated External Defibrillator | III |
Page 1 of 3
377 Zane Court · Elizabeth, Colorado USA 80107 Telephone / Fax: 303-646-3715 · Email: alex henderson@msn.com
1
510(k) Summary AMCO Replacement Battery Packs 5L318 and AM5070
Legally Marketed Predicate Devices:
The Amco 5L318 is the same as the Philips Medical / Agilent replacement battery BT1 used in the ForeRunner and HeartStart FR AED's.
The Amco AM5070 is the same as the Philips Medical replacement battery M5070A used in the HeartStream / HeartStart FRx On-Site and Home (OTC) AED's.
These HeartStream / Philips Medical / Agilent battery packs were most likely bundled in the original submission(s) as accessories.
Device Description:
Non-rechargeable 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 equipment. These devices provide a means of supplying electrical 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 these batteries depends on operating conditions of temperature, current drain, and the 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 under a specified range of environmental conditions.
Statement of Intended Use:
To power the specific HeartStream / Philips Medical / Agilent AED's for which these replacement battery packs are intended. Only qualified personnel, such as Biomedical Engineers, Medical Clinics, EMT's, etc., should evaluate, test, or install these battery packs.
Substantial Equivalence:
The design components and functionality of the AMCO™ 5L318 and AM5070 battery packs are identical to those of their predicate devices. Cell chemistry and type are identical, Sealed (Vented) Lithium / Manganese Dioxide (Li/MnO2).
Reference: Substantial Equivalence Comparison Charts - Section B, Page 1.
Page 2 of 3
2
510(k) Summary AMCO Replacement Battery Packs 5L318 and AM5070
Conclusions:
Amco International Manufacturing and Design, Inc. has demonstrated through its continued evaluation and testing of the AMCO™ 5L318 and AM5070 replacement battery packs, that these devices are equivalent to the HeartStream / Philips Medical / Agilent battery packs, as outlined in this submission.
The AMCO™ 5L318 and AM5070 replacement battery packs are identical with respect to indications for use, technological characteristics, materials, form. fit, and function to those currently distributed commercially. This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission
377 Zane Court · Elizabeth, Colorado USA 80107 Telephone / Fax: 303-646-3715 · Email: alex henderson@msn.com
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 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 abstract image of an eagle with three tail feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
Amco International Manufacturing & Design, Inc. c/o Mr. Alexander B. Henderson Braun Solutions 377 Zane Court Elizabeth, Colorado 80107
AUG 0 7 2009
Re: K091548
Trade/Device Name: Model 5L318 battery and Model AM5070 battery Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Dated: May 26, 2009 Received: May 27, 2009
Dear Mr. Henderson:
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 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 mav 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): K091548
Device Name: AMCO Replacement Battery Packs 5L318 and AM5070
Indications for Use:
The 5L318 Lithium/Manganese Dioxide (Li/MnO2) AMCO battery is a disposable replacement battery pack for use in the Philips Medical / HeartStream ForeRunner AED; specifically Philips Medical battery part number BT1. This battery has a shelf life of 4 years from the date of manufacture.
The AM5070 Lithium/Manganese Dioxide (Li/MnO2) AMCO battery is a disposable replacement battery pack for use in the Philips Medical / HeartStream FRx and HeartStart Home AED; specifically Philips Medical battery part number AM5070A. This battery has a shelf life of 4 years from the date of manufacture.
Prescription Use 2 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ompel
Division Sian-Off Division of Cardiovascular Devices
Ko91548 510(k) Number
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