(57 days)
Not Found
No
The device description and intended use clearly describe a disposable battery pack, with no mention of AI or ML capabilities.
No.
The device is a replacement battery pack for an AED, not a therapeutic device itself.
No
This device is a battery pack that provides power to medical equipment, specifically AEDs. It does not perform any diagnostic functions itself.
No
The device description explicitly states it is a "Non-rechargeable battery pack" which is a hardware component, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that the device is a "disposable replacement battery pack" for an AED (Automated External Defibrillator). Its function is to provide electrical power to the AED.
- Intended Use: The intended use is to power a medical device (AED), not to perform a diagnostic test on a biological sample.
- Lack of IVD characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes.
Therefore, the device is a medical device component (a battery pack for an AED), but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The 2L561 Lithium Sulfur Dioxide (LiSO2) AMCO battery is a disposable replacement battery pack for use in the Cardiac Science PowerHeart® AED; specifically Cardiac Science Model / Part Number 9141-001. This battery has a shelf life of 4 years from the date of manufacture.
The 7L877 Lithium Sulfur Dioxide (LiSO2) AMCO battery is a disposable replacement battery pack for use in the Cardiac Science PowerHeart® AED G3; specifically Cardiac Science Model / Part Number 9146-001. This battery has a shelf life of 4 years from the date of manufacture.
Product codes (comma separated list FDA assigned to the subject device)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/1 description: The image shows the logo for BraunSolutions. The logo consists of a black globe on the left and the text "BraunSolutions" on the right. The word "Solutions" has a registered trademark symbol next to it.
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| NOV 2 5 2008 | |||
|---|---|---|---|
| uring & Design, Inc. |
K
| 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: | September 22, 2008 |
| Device Name: | |
| Trade/Proprietary Name: | AMCO™ Battery Pack |
| Common/Generic Name: | Box, Battery |
| Classification Name: | Box, Battery, Non-Rechargeable
Regulatory Class III, Product Code MKJ |
| Predicate Devices: | Cardiac Science Replacement Battery 9141-001
- Approved under K031987 and K040438
Cardiac Science Replacement Battery 9146-001 - Approved under K031987 and K040438 |
| Classification: | Class |
| 21 CFR 870.5300 | Cardiovascular Panel
DC-Defibrillator III |
| 21 CER 870 5310 | Automated External Defibrillator III |
510(k) Summary (Per 21 CFR 807.92)
Page 1 of 3
1
510(k) Summary AMCO Replacement Battery Packs 2L561 and 7L877
Legally Marketed Predicate Devices:
The Amco 2L561 is the same as the Cardiac Science replacement battery Model and / or Part Number 9141-001 used in the Cardiac Science PowerHeart® AED cleared under 510(k) notification K031987 and K040438.
The Amco 7L877 is the same as the Cardiac Science replacement battery Model and / or Part Number 9146-001 used in the Cardiac Science PowerHeart® AED G3 cleared under 510(k) notification K031987 and K040438.
The Cardiac Science 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 Cardiac Science AED's for which these 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™ 2L561 and 7L877 Battery Packs are identical to those of their predicate devices. Cell chemistry and type are identical, Sealed (Vented) Lithium Sulfur Dioxide (LiSO2). The only difference between the devices is that the 7L877 (9146-001) is designed specifically for the PowerHeart® G3 AED. Therefore, the molded plastic case has a stub (key) in order that it cannot be installed in the PowerHeart® AED requiring the 2L561 (9141-001). Both Amco Battery Pack models can be used in the Cardiac Science PowerHeart® G3 AED.
Reference: Substantial Equivalence Comparison Charts - Section B, Page 1.
2
510(k) Summary AMCO Replacement Battery Packs 2L561 and 7L877
Conclusions:
Amco International Manufacturing and Design, Inc. has demonstrated through its continued evaluation and testing of the AMCO™ 2L561 and 7L877 Replacement Battery Packs, that these devices are equivalent to the current PowerHeart® Series AED Replacement Battery Packs, as outlined in this submission. The proposed AMCO™ 2L561 and 7L877 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
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Amco International Manufacturing & Design, Inc. c/o Mr. Alexander B. Henderson Braun Solutions 377 Zane Court Elizabeth, Colorado 80107
NOV 2 5 2008
Re: K082861
Trade/Device Name: AMCO Replacement Battery Packs 2L561 and 7L877 Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: September 22, 2008 Received: September 29, 2008
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 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.
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
4
Page 2 - Mr. Alexander B. Henderson
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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliare at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Q.Mee
Bram D. Zuckorpan, 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): K 08286 أ
Device Name: AMCO Replacement Battery Packs 2L561 and 7L877
Indications for Use:
The 2L561 Lithium Sulfur Dioxide (LiSO2) AMCO battery is a disposable replacement battery pack for use in the Cardiac Science PowerHeart® AED; specifically Cardiac Science Model / Part Number 9141-001. This battery has a shelf life of 4 years from the date of manufacture.
The 7L877 Lithium Sulfur Dioxide (LiSO2) AMCO battery is a disposable replacement battery pack for use in the Cardiac Science PowerHeart® AED G3; specifically Cardiac Science Model / Part Number 9146-001. This battery has a shelf life of 4 years from the date of manufacture.
Prescription Use V (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)
|--|--|
(Division Sign-Off) Division of Cardiovascular Devices
108286 510(k) Number_
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