(132 days)
Not Found
No
The document describes a replacement battery pack and its testing procedures, with no mention of AI or ML technologies.
No
Explanation: This device is a replacement battery pack for a therapeutic device (AED), but it is not a therapeutic device itself. Its function is to power the therapeutic device, not to provide therapy directly.
No.
This device is a replacement battery pack for a diagnostic device (AED), but it does not perform any diagnostic functions itself. It only provides power to the AED.
No
The device is a replacement battery pack, which is a hardware component, not software. The description focuses on physical and electrical properties and testing of the battery.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "replacement battery pack for the Medtronic LifePak 500 AED." This is a power source for a medical device, 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 reinforces that it's 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 describes its function 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 specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing diagnostic information
- Using reagents or assays
The testing described focuses on the battery's performance as a power source (voltage, capacity, temperature range, mechanical integrity, number of shocks it can support), which is consistent with a power supply for a medical device, not an IVD.
N/A
Intended Use / Indications for Use
The 5L500 Lithium life+cel or lifecel is a replacement battery pack for the Medtronic LifePak 500 AED.
Since non-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, EMT's, etc. therefore know that the intended use is as a replacement battery.
The replacement battery pack in this submission, Amco Part Number 5L500, is to be provided by prescription only.
Product codes (comma separated list FDA assigned to the subject device)
MKJ, MOY
Device Description
The AMCO 5L500 life+cel™ Non-rechargeable battery pack is 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
qualified personnel, Biomedical equipment service professionals, EMT's
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 non-rechargeable battery cells and core packs are tested using a Cadex Electronics Battery Analyzer Model C7400ER (Extended Range) in the "Auto Mode" This exercises the batteries in order to identify performance characteristics by running them through a full discharge cycle. 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 (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 (9 0 - 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.
SAFETY and PERFORMANCE
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 40°C (32, 77, and 104°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.
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
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 16, 2021
Amco International Manufacturing & Design, Inc. Alexander Henderson Technical Consultant 377 Zane Ct. Elizabeth, Colorado 80107
Re: K072596
Trade/Device Name: Life+cel Or Lifecel Battery Pack, Model 51500 Regulation Number: 21 CFR 870.5310 Regulation Name: Automated external defibrillator system Regulatory Class: Class III Product Code: MKJ
Dear Alexander Henderson:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 24, 2008. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code MKJ.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jennifer Shih, Office of Cardiovascular Devices, 301-796-5813, Jennifer.Shih@fda.hhs.gov.
Sincerelv.
Jennifer W. Shih -S
Jennifer Shih Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
OF HEALTH & HUMAN SERVICES - USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2008
Amco International Manufacturing & Design, Inc. c/o Mr. Alexander Henderson Phoenix Technology 377 Zane Court Elizabeth, CO 80107
Re: K072596
Trade Name: 5L500 life+cel™ or lifecel™ Battery Pack Regulation Number/Name: unclassified Regulatory Class: III (three) Product Code: MOY Dated: January 8, 2008 Received: January 11, 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, EDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Alexander 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 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-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. Kommerla
Bram B. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the logo for Phoenix Technology. The logo features a phoenix bird rising from flames, with its wings spread wide. The text "PHOENIX TECHNOLOGY" is written in a serif font to the right of the bird. The logo is black and white.
INDICATIONS FOR USE STATEMENT
510(K) Number: K072596
Device Name: 5L500 life+cel or lifecel Battery Pack
Indications for Use:
The 5L500 Lithium life+cel or lifecel is a replacement battery pack for the Medtronic LifePak 500 AED.
Since non-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, EMT's, etc. therefore know that the intended use is as a replacement battery.
The replacement battery pack in this submission, Amco Part Number 5L500, is to be provided by prescription only.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhummer
510(k) Number
377 Zane Court • Elizabeth, Colorado USA 80107 Telephone: 303-646-3715 • Email: alex_henderson@phoenixsolutions.org
-iv-
4
Image /page/4/Picture/1 description: The image shows the logo for Phoenix Technology. The logo features a stylized phoenix bird rising from flames on the left side. To the right of the bird is the text "PHOENIX TECHNOLOGY" in a serif font, with "PHOENIX" in a larger size than "TECHNOLOGY".
510(k) Summary – K072596 -1 of 4-
Replacement Battery Pack 5L500
| 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: | September 10, 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 870.1025
21CFR 870.1110
21CFR 870.1130
21CFR 870.2300
21CFR 870.2340 | Arrhythmia Detector and Alarm
Blood Pressure Computer
Systems, Measurement, Blood Pressure, Non-Invasive
Monitor, Cardiac (Including Cardio tachometer & Rate Alarm)
Electrocardiograph
No Regulatory Reference Rechargeable Batteries for Class III Devices | |
377 Zane Court · Elizabeth, Colorado USA 80107 Telephone / Fax: 303-646-3715 • Email: alex_henderson@phoenixsolutions.org
5
510(k) Summary - 5L500 -2 of 4-
Legally Marketed Predicate Devices:
This submission compares the specifications and functionality of AMCO Lithium 5L500 life+cel or lifecel battery packs with those of similar devices that were included as part of the following original predicate equipment and submissions:
The AMCO 5L500 life+cel™ is the same as that used in the Medtronic Emergency Response System LifePak 500 AED cleared under 510(k) notif ication K052057.
Description:
The AMCO 5L500 life+cel™ Non-rechargeable battery pack is 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 AMCO Lithium 5L500 life+cel or lifecel battery packs listed are similar 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 c urrent 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 accoun t 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 Sulfur Dioxide, Sealed -Lead Acid (SLA), Nickel-Cadmium (NiCd), and Nickel-Metal Hydride (NiMH).
377 Zane Court • Elizabeth, Colorado USA 80107 Telephone / Fax: 303-646-3715 · Email: alex_henderson@phoenixsolutions.org
6
510(k) Summary - 5L500 -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 non-rechargeable battery cells and core packs are tested using a Cadex Electronics Battery Analyzer Model C7400ER (Extended Range) in the "Auto Mode" This exercises the batteries in order to identify performance characteristics by running them through a full discharge cvcle. Tests typically take 12 hours for each bat tery 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 Sho p 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 (9 0 - 95% is typical).
Target capacity is a passfail 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.
7
510(k) Summary - 5L500 -4 of 4-
BATTERY PACK TESTING (continued)
SAFETY and PERFORMANCE
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 st andard 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 temper ature range as compared to the original. Testing is done at 0, 25, and 40°C (32, 77, and 104°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 fo rm, fit, and function.
- Active Safety devices are inspected and tested before use and after installation.