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.

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.

AI/ML Overview

The provided documents are a 510(k) premarket notification and subsequent administrative change letter for the Amco International Manufacturing & Design, Inc. Life+cel Or Lifecel Battery Pack, Model 51500. This device is a replacement battery pack for the Medtronic LifePak 500 AED.

The information provided primarily focuses on the substantial equivalence argument, comparing the replacement battery pack to its predicate device (the battery pack used in the Medtronic LifePak 500 AED cleared under 510(k) notification K052057). It outlines the general testing protocols used for quality control and provides some information regarding safety and performance testing for the replacement battery pack itself, aiming to meet or exceed OEM battery pack benchmarks.

However, the document does not contain a detailed "study that proves the device meets the acceptance criteria" in the format of a clinical trial or a formal comparative effectiveness study as would be seen for a new diagnostic or therapeutic device. Instead, it describes internal testing procedures to ensure the replacement battery pack functions comparably to the original.

Based on the available information, here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and the Reported Device Performance

The document describes general testing protocols and targets, rather than specific, quantified acceptance criteria with corresponding performance metrics for clinical outcomes. The "acceptance criteria" appear to be internal quality control thresholds.

Acceptance Criteria (Internal QC/Benchmark)	Reported Device Performance (Internal QC/Benchmark)
Incoming Inspection:
- Correct cell specification	- Cells inspected for correctness
- No visible damage	- Cells inspected for visible damage
- Random voltage test acceptance	- Random voltage tested prior to acceptance
Cadex Testing (Non-rechargeable):
- Target capacity ≥ 90% of nominal capacity	- Batteries meet or exceed 90% threshold
Voltage Testing (Completed Packs):
- 100% correct voltage/polarity	- Packs tested 100% for correct voltage/polarity
Defibrillator Testing (Random):
- Meet expected number of shocks (OEM spec)	- Tests performed to ensure meeting OEM shock specs
Life Cycle (Ongoing process):
- As many or more charge/discharge cycles than original	- Stated goal; "ongoing process," not part of standard QC final inspection. Shelf life based on original cell manufacturer's specs.
Temperature Functionality:
- Correct function at 0, 25, 40°C	- Testing done at 0, 25, and 40°C
Mechanical Integrity (Drop Tests):
- No case cracks, cell separation, electrical/electronic component damage after drop from 2-3 feet	- Battery packs inspected for damage; root cause analysis if damage occurs.
Form, Fit, Function (After Drop Test if no visible damage):	- Battery tested for form, fit, and function
Active Safety Devices:
- Inspected and tested before use and after installation	- Inspected and tested

Note: The performance described is primarily based on internal quality control and bench testing, aiming to match or exceed the predicate device's characteristics. There are no clinical performance metrics reported.

2. Sample Size Used for the Test Set and the Data Provenance

Test Set Description: The "test set" in this context refers to batches of manufactured battery packs undergoing internal quality control and bench testing, not a clinical trial test set.
Sample Size:
- Cadex Testing: "Non-Rechargeable packs are tested to depletion on a random lot sample basis." If samples do not meet criteria, "the entire lot is tested in this manner."
- Defibrillator Testing: "Independent testing (Beta Tests), as well as random tests on finished packs, are performed."
- Voltage Testing: "All Battery Packs are tested 100% for correct voltage / polarity prior to shipment."
- Incoming Inspection: "All cells are inspected," "randomly voltage tested."
Data Provenance: The data provenance is internal to Amco International Manufacturing & Design, Inc. and its contracted testing facilities (like Phoenix Technology for the 510(k) summary). There is no mention of country of origin of the data or whether it's retrospective or prospective in a clinical sense. It's prospective in a manufacturing quality control sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This section is not applicable in the traditional sense for this type of device and submission. The "ground truth" for the performance characteristics of a replacement battery pack is its ability to power the intended medical device (Medtronic LifePak 500 AED) according to original equipment manufacturer (OEM) specifications, which are established engineering and performance criteria. No human experts are described as establishing "ground truth" in the way radiologists establish cancer diagnoses. The "experts" would be the engineers and technicians performing the quality control and bench testing, comparing to established OEM and internal specifications.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is typically used in clinical studies, particularly for subjective assessments where multiple readers provide independent interpretations.
For this device, the "adjudication" is essentially based on:

Pre-defined engineering specifications and thresholds (e.g., ≥90% capacity, correct voltage, meeting OEM shock count).
Pass/fail criteria based on objective measurements from instruments like the Cadex Electronics Battery Analyzer and NETECH Model Delta 2000 Defibrillator Analyzers.
Visual inspections for damage after mechanical stress tests.
There is no mention of a formal adjudication process involving multiple human reviewers for subjective assessments.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids that assist human readers (e.g., radiologists interpreting images). The submitted device is a replacement battery pack, which is a hardware component, not an AI diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No, a standalone performance study in the context of an algorithm or AI system was not done. The device is a battery pack, a physical component, not an algorithm. Its performance is inherent in its electrical and mechanical properties, not in an "algorithm only" mode.

7. The type of ground truth used

The "ground truth" for the battery pack's performance is tied to engineering specifications, OEM performance benchmarks, and industry standards for battery characteristics (voltage, capacity, life cycle, temperature range, mechanical integrity). This is primarily objective, measurable physical and electrical properties.

8. The sample size for the training set

This device does not involve a "training set" in the context of machine learning or AI. As a manufactured hardware component, it does not learn or get trained from data. The manufacturing process involves quality control, testing, and adherence to design specifications.

9. How the ground truth for the training set was established

Since there is no training set for this hardware device, this question is not applicable. The "ground truth" for manufacturing a battery pack is defined by its design specifications and the performance requirements of the device it powers (Medtronic LifePak 500 AED).

Summary

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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

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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.

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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

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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.

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-

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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 Milewski69-81 108th Street, Suite 6GForest Hills, New York 11375
Contact Person:	Alexander B. HendersonPhoenix Technology377 Zane Court,Elizabeth, CO 80107Tel: 303-646-3715Email: alex_henderson@phoenixsolutions.org
Date Prepared:	September 10, 2007
Device Name:	Trade/Proprietary Name:Common/Generic Name:Classification Name:	life+cel™ or lifecel™ Battery PackBox BatteryBox, Battery, Non-Rechargeable
Classification:	Cardiovascular PanelClass
21CFR 870.102521CFR 870.111021CFR 870.113021CFR 870.230021CFR 870.2340	Arrhythmia Detector and AlarmBlood Pressure ComputerSystems, Measurement, Blood Pressure, Non-InvasiveMonitor, Cardiac (Including Cardio tachometer & Rate Alarm)ElectrocardiographNo 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

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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:

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

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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.

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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.

Regulation Number and Section

§ 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.