(102 days)
Not Found
No
The device is a replacement battery pack and the description and testing focus solely on battery performance and safety, with no mention of AI or ML.
No.
The device is a replacement battery pack for a medical device (AED), not a therapeutic device itself. Its function is to provide power, not to directly treat or diagnose.
No
The device is described as a replacement battery pack for an AED, indicating it provides power to another medical device rather than performing diagnostic functions itself.
No
The device description clearly states it is a "Non-rechargeable battery pack" and details physical testing protocols (incoming inspection, Cadex testing, voltage testing, defibrillator testing, safety and performance testing including temperature and mechanical integrity). This indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "replacement disposable battery pack, for use in the Philips Medical Systems FR2 Series AED". This describes a power source for a medical device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on the battery's chemistry and function as a power source.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
- Testing: The testing described focuses on battery performance (voltage, capacity, shock delivery) and safety, which are relevant to a power source for a medical device, not an IVD.
Therefore, the 6L785 Sealed Manganese Dioxide (MnO2) life+cel battery pack is a medical device accessory (a power source for an AED), but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To power the functions of various devices for which the batteries or battery packs are intended.
The 6L785 Sealed Manganese Dioxide (MnO2) life+cel (or lifecel) is a replacement disposable battery pack, for use in the Philips Medical Systems FR2 Series AED, specifically OEM Part Number M3863A. This battery pack has a shelf life of 5 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.
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 battery packs are performed to ensure that these devices meet all functional requirements and performance specifications.
In comparison analysis, OEM Battery Packs set the benchmark. Replacement devices must meet or exceed these benchmark results consistently.
Concerns that are addressed during bench test comparison analysis are:
Life cycle: The replacement battery must provide as many or more charge and discharge cycles as the original. This is an ongoing process and is not part of the standard QC final inspection protocol. Shelf life, on the other hand, is based on the original cell manufacturer's specification sheets and Certificates of Conformance.
Temperature: The replacement battery must function correctly over the same temperature range as compared to the original. Testing is done at 0, 25, and 50℃ (32, 77, and 122°F respectively).
Mechanical & Electrical Component Integrity: Normal testing would involve drop tests from a predetermined height, usually 2-3 feet, onto a hard, uniform surface. Battery packs are inspected for case cracks, cell separation, and electrical/electronic component damage. Root cause analysis is performed should any damage occur. If there is no visible damage, the battery is tested for form, fit, and function. Active Safety devices are inspected and tested before use and after installation.
Additional testing protocols:
Incoming inspection: All cells are inspected for correct specification, visible damage, and randomly voltage tested prior to acceptance. The lot numbers are recorded for tracking purposes should any fail during final assembly and inspection activities. Cases are also inspected for form, fit, function, and cosmetics.
CADEX TESTING: Voltage and capacity of rechargeable battery cells and core packs are tested using a Cadex Electronics Battery Analyzer Model C7400ER (Extended Range) in the "Auto Mode" prior to installation into cases or shrink wrap. This exercises the batteries in order to identify performance characteristics by running them through three (3) full charge/discharge cycles. Tests typically take 12 hours for each battery pack. Non-Rechargeable packs are tested to depletion on a random lot sample basis. All battery chemistries can be tested using custom test parameters, depending on Quality Control and customer requirements. This allows for various C-Rates, delta V (ΔV), and volts-per-cell to be entered into the test protocol through the Cadex Battery Shop Software utility. Target capacity is the percentage of the battery capacity compared to nominal capacity and serves as a threshold. This threshold, or target capacity, can be set to any desired range (90 - 95% is typical). Target capacity is a pass/fail mark and our batteries must meet or exceed a required threshold of 90%, or higher, prior to final Quality Control inspection. Any samples that do not meet the criteria are rejected, and subsequently, the entire lot is tested in this manner. Battery packs are not shipped fully charged (except non-rechargeable Lithium types). There are specific DOT, FAA, and EPA regulations and guidelines that address these concerns.
VOLTAGE TESTING - Completed Packs: All Battery Packs are tested 100% for correct voltage / polarity prior to shipment. Those devices that fail are rejected and quarantined.
DEFIBRILLATOR TESTING: Independent testing (Beta Tests), as well as random tests on finished packs, are performed using NETECH Model Delta 2000 Defibrillator Analyzers to insure that they meet the expected number of shocks as specified by the OEM's.
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.
0
APR 11 2008
Image /page/0/Picture/2 description: The image shows the logo for Phoenix Technology. On the left side of the logo is a black and white image of a phoenix. To the right of the phoenix image is the text "PHOENIX TECHNOLOGY".
510(k) Summary -1 of 4-
:
Replacement Battery Pack 6L785
| Submitter: | Amco International Manufacturing & Design, Inc.
Attn: Mr. Adam Milewski
69-81 108th Street, Suite 6G
Forest Hills, New York 11375 | | |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|--|
| Contact Person: | Alexander B. Henderson
Phoenix Technology
377 Zane Court,
Elizabeth, CO 80107
Tel: 303-646-3715
Email: alex_henderson@phoenixsolutions.org | | |
| Date Prepared: | December 20, 2007 | | |
| Device Name: | Trade/Proprietary Name:
Common/Generic Name:
Classification Name: | life+cel™ or lifecel™ Battery Pack
Box Battery
Box, Battery, Non-Rechargeable | |
| Classification: | Cardiovascular Panel | Class | |
| 21CFR 870.5300 | DC-Defibrillator | III | |
377 Zane Court • Elizabeth, Colorado USA 80107 Telephone / Fax: 303-646-3715 ● Email: alex_henderson@phocnixsolutions.org
1
510(k) Summary - 6L785 -2 of 4-
Legally Marketed Predicate Devices:
This submission compares the specifications and functionality of various battery packs with those of similar devices that were included as part of the following original predicate equipment and submissions:
The AMCO 6L785 life+cel™ is the same as that used in the Philips Medical HeartStart FR2 AED cleared under 510(k) notification K013425. The OEM battery was bundled in the submission.
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.
Statement of Intended Use:
To power the functions of various devices for which the batteries or battery packs are intended.
Comparison of Technological Characteristics
The design components and functionality of the 6L785 battery pack are identical to those of their predicate devices. All 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 charge/discharge method (if applicable). 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 chemistries are Lithium Dioxide, Sealed-Lead Acid (SLA), Nickel-Cadmium (NiCd), and Nickel-Metal Hydride (NiMH).
The Amco 6L785 battery chemistry is Manganese Dioxide (MnO2) based and is non rechargeable. Cell specifications are included with this submission. Cadex Testing is performed to battery pack depletion, in terms of total available capacity in amp -hours.
377 Zane Court · Elizabeth, Colorado USA 80107 Telephone / Fax: 303-646-3715 ● Email: alex_henderson@phoenixsolutions.org
2
510(k) Summary - 6L785 -3 of 4-
BATTERY PACK TESTING - GENERAL PROTOCOL
INCOMING INSPECTION
All cells are inspected for correct specification, visible damage, and randomly voltage tested prior to acceptance. The lot numbers are recorded for tracking purposes should any fail during final assembly and inspection activities. Cases are also inspected for form, fit, function, and cosmetics.
CADEX TESTING
Voltage and capacity of rechargeable battery cells and core packs are tested using a Cadex Electronics Battery Analyzer Model C7400ER (Extended Range) in the "Auto Mode" prior to installation into cases or shrink wrap. This exercises the batteries in order to identify performance characteristics by running them through three (3) full charge/discharge cycles. Tests typically take 12 hours for each battery pack. Non -Rechargeable packs are tested to depletion on a random lot sample basis.
All battery chemistries can be tested using custom test parameters, depending on Quality Control and customer requirements. This allows for various C -Rates, delta V (ΔV), and voltsper-cell to be entered into the test protocol through the Cadex Battery Shop Software utility (Reference Cadex Test Report Examples - Exhibit A).
Target capacity is the percentage of the battery capacity compared to nominal capacity and serves as a threshold. This threshold, or target capacity, can be set to any desired range (90 - 95% is typical).
Target capacity is a pass/fail mark and our batteries must meet or exceed a required threshold of 90%, or higher, prior to final Quality Control inspection. Any samples that do not meet the criteria are rejected, and subsequently, the entire lot is tested in this ma nner.
Battery packs are not shipped fully charged (except non -rechargeable Lithium types). There are specific DOT, FAA, and EPA regulations and guidelines that address these concerns.
VOLTAGE TESTING - Completed Packs
All Battery Packs are tested 100% for correct voltage / polarity prior to shipment. Those devices that fail are rejected and quarantined.
DEFIBRILLATOR TESTING
Independent testing (Beta Tests), as well as random tests on finished packs, are performed using NETECH Model Delta 2000 Defibrillator Analyzers to insure that they meet the expected number of shocks as specified by the OEM's.
377 Zanc Court · Elizabeth, Colorado USA 80107 Telephone / Fax: 303-646-3715 • Email: alex_henderson@phoenixsolutions.org
3
510(k) Summary - 6L785 -4 of 4 -
BATTERY PACK TESTING (continued)
SAFETY and PERFORMANCE
Safety and performance testing of battery packs are perfor med to ensure that these devices meet all functional requirements and performance specifications.
In comparison analysis, OEM Battery Packs set the benchmark. Replacement devices must meet or exceed these benchmark results consistently.
Concerns that are addressed during bench test comparison analysis are:
. Life cycle
The replacement battery must provide as many or more charge and discharge cycles as the original. This is an ongoing process and is not part of the standard QC final inspection protocol. Shelf life, on the other hand, is based on the original cell manufacturer's specification sheets and Certificates of Conformance.
■ Temperature
The replacement battery must function correctly over the same temperature range as compared to the original. Testing is done at 0, 25, and 50℃ (32, 77, and 122°F respectively).
Mechanical & Electrical Component Integrity ■
Normal testing would involve drop tests from a predetermined height, usually 2 -3 feet, onto a hard, uniform surface. Battery packs are inspected for case cracks, cell separation, and electrical/electronic component damage. Root cause analysis is performed should any damage occur.
-
If there is no visible damage, the battery is tested for form, fit, and function.
-
Active Safety devices are inspected and tested before use and after installation.
377 Zane Court · Elizabeth, Colorado USA 80107 Telephone / Fax: 303-646-3715 ● Email: alex_henderson@phoenixsolutions.org
4
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 1 2008
Amco International Manufacturing & Design, Inc. c/o Mr. Alexander B. Henderson Phocnix Technology 377 Zane Court Elizabeth, Colorado 80107
Re: K073716
Trade/Device Name: life+cel or lifecel Battery Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (Three) Product Code: MKJ Dated: March 13, 2008 Received: March 18, 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 for the enated in 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 he 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.
5
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 (OS) 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 Compliance 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 Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding 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-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
B. Summer for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Page 1 -
Indications for Use
510(k) Number (if known): K073716
Device Name: 6L785 life+cel or lifecel Battery Pack
Indications for Use:
The 6L785 Sealed Manganese Dioxide (MnO2) life+cel (or lifecel) is a replacement disposable battery pack, for use in the Philips Medical Systems FR2 Series AED, specifically OEM Part Number M3863A. This battery pack has a shelf life of 5 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)
B. Bimmons
Aces Division of Cardiova 510(k) Number
Page 1 of 1