LIFE+CEL BATTERY

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and consists of a stylized graphic element. The FDA logo is on the right and includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. November 16, 2021 Amco International Manufacturing & Design, Inc. Alex Henderson Technical Consultant 377 Zane Court Hillside Village Elizabeth, Colorado 80107 Re: K071164 Trade/Device Name: Life+cel Battery Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II Product Code: MHX Dear Alex 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 December 7, 2007. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code MHX. 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. Sincerely, 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}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the symbol. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OEC 7 2007 Amco International Manufacturing & Design, Inc. c/o Mr. Alex Henderson Phoenix Technology 377 Zane Court, Hillside Village Elizabeth, CO 80107 Re: K071164 Trade/Device Name: life+cel™ (or lifecel™) Battery Packs with Model Numbers: 2L226. 5L375. 6L577. 7L991. 9L977. 9L990 and 9L998 Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: MOY, MOX Dated: December 4, 2007 Received: December 5, 2007 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. {2}------------------------------------------------ Page 2 - Mr. Alex 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 (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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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, Blzimima fh Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Page 1 of 1 Image /page/3/Picture/1 description: The image shows the logo for Phoenix Technology. The logo features a phoenix bird with its wings spread, surrounded by a circular halo. The text "PHOENIX TECHNOLOGY" is written in a serif font to the right of the bird. ## INDICATIONS FOR USE STATEMENT 510(K) Number: K071164 Device Name: Box, Battery Indications for Use: To power the functions of various devices for which batteries or battery packs are configured. Since 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 . Only replacement battery 2L226 in this submission (Patient Monitor) is provided Over-the-Counter (OTC). All other replacement batteries, specifically; 5L375, 6L577, 7L991, 9L977, 9L990, and 9L998 in this submission (Defib/AED's) are provided by presc ription only. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Blummo (Division-Sign-Off) Division of Cardiovascular Devices 510(k) Number K071164 377 Zane Court · Elizabeth, Colorado USA 80107 Telephone: 303-646-3715 · Email: alex henderson(@phoenixsolutions.org {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Phoenix Technology. The logo features a stylized phoenix bird with its wings spread, surrounded by a halo. To the right of the bird, the words "PHOENIX TECHNOLOGY" are written in a serif font, with "PHOENIX" in bold and "TECHNOLOGY" in a lighter, less prominent font. OEC - 7 2007 # 510(k) Summary – K071164 -1 of 5- Replacement Battery Packs 2L226, 5L375, 6L577, 7L991, 9L977, 9L990, and 9L998 | Submitter: | Amco International Manufacturing & Design, Inc.<br>Attn: Mr. Adam Milewski<br>69-81 108th Street, Suite 6G<br>Forest Hills, New York 11375 | | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------| | Contact Person: | Alex Henderson<br>Phoenix Technology<br>377 Zane Court,<br>Hillside Village<br>Elizabeth, CO 80107<br>Tel / Fax: 303-646-3715<br>Email: alex_henderson@phoenixsolutions.org | | | Date Prepared: | April 16, 2006 | | | Device Name: | Trade/Proprietary Name: life+celTM or lifecelTM Battery Pack<br>Common/Generic Name: Box Battery OR Pack Battery<br>Classification Name: Box Battery, Rechargeable | | | Classification: | Cardiovascular Panel | Class | | 21CFR 870.1025 | Arrhythmia Detector and Alarm | II | | 21CFR 870.1110 | Blood Pressure Computer | II | | 21CFR 870.1130 | Systems, Measurement, Blood Pressure, Non-Invasive | II | | 21CFR 870.2300 | Monitor, Cardiac (Including Cardio tachometer & Rate Alarm) | II | | 21CFR 870.2340 | Electrocardiograph | II | | No Regulatory Reference | Rechargeable Batteries for Class III Devices | III | 377 Zane Court • Elizabeth, Colorado USA 80107 Telephone: 303-646-3715 ● Email: alex_henderson@phoenixsolutio ns.org {5}------------------------------------------------ # 510(k) Summary -2 of 5 - #### Legally Marketed Predicate Devices: This submission compares the specifications and functionality of various rechargeable battery packs with those of similar devices that were included as part of the following original predicate devices and submissions: - 1. The AMCO 2L226 life+cel™ is equivalent to that manufactured by: - I Alpha Source / Access Battery, cleared under K032051 - Unipower Corp., cleared under K940842 and K935111 - . R & D Battery, cleared under K951281 - I OEM, GE Marquette - Patient Monitor Dash 3000/4000 - Reference: K051367, K020290 (Battery included with device) - 2. The AMCO 5L375 life+cel™ is equivalent to that manufactured by: - प्र Alpha Source / Access Battery, cleared under K920964 - 트 Unipower Corp., cleared under K940842 and K935111 - I R & D Battery, cleared under K951281 - 프 OEM, Physio Control / Medtronic's - Monitor/Defibrillator (FastPak) LP5 - Reference: K890079, K931053 (Battery included with device) - 3. The AMCO 6L577 life+cel™ is equivalent to that manufactured by: - l Alpha Source / Access Battery, cleared under K0920964 - . Unipower Corp., cleared under K940842 and K935111 - 트 R & D Battery, cleared under K951281 - OEM, Physio Control - Monitor/Defibrillator (Non-FastPak) LP5 / LP10 - Reference: K890079, K931053 (Battery included with device) - 4. The AMCO 7L991 life+cel™ is equivalent to that manufactured by: - Alpha Source / Access Battery, cleared under K920964 - . Unipower Corp., cleared under K940842 and K935111 - L OEM, Physio Control / Medtronic's - Monitor/Defibrillator LP12 (NiCad) - Reference: K973486, K010918 (Battery included with device) 377 Zanc Court • Elizabeth, Colorado USA 80107 Telephone: 303-646-3715 ● Email: alex henderson@phoenixsolutions.org {6}------------------------------------------------ # 510(k) Summary -3 of 5 - ## Legally Marketed Predicate Devices (continued): - 5. The AMCO 9L977 life+cel™ is equivalent to that man ufactured by: - Alpha Source / Access Battery, cleared under K920964 . - r Unipower Corp., cleared under K940842 and K935111 - R & D Battery, cleared under K945869 프 - OEM, Health Dyne / Vickers Respironics Smart Monitor 900 Series 트 - Reference: K874695 (Battery included with device) - 6. The AMCO 9L990 life+cel™ is equivalent to that manufactured by: - · Alpha Source / Access Battery, cleared under K032051 - Unipower Corp., cleared under K940842 and K935111 . - OEM, CAS Medical NIBP Monitor 740 . - Reference: K033048 (Battery included with device) - 7. The AMCO 9L998 life+cel™ is equivalent to that manufactured by: - Alpha Source / Access Battery, cleared under K920964 . - . Unipower Corp., cleared under K940842 and K935111 - OEM, Physio Control / Medtronic's Monitor/Defibrillator LP12 (SLA) - Reference: K973486. K010918 (Battery included with device) ## Description: Amco rechargeable and 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 the specific devices for which the batteries or battery packs are intended for back-up power or portable use. ## Comparison of Technological Characteristics The design components and functionality of the various 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 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 Sealed -Lead Acid (SLA), Nickel-Cadmium (NiCad), Nickel-Metal Hydride (NiMH), and Lithium based. > 377 Zane Court · Elizabeth, Colorado USA 80107 Telephone: 303-646-3715 · Email: alex henderson@phoenixsolutio ns.org {7}------------------------------------------------ # 510(k) Summary -4 of 5 - ### 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 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. 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 (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. There are specific DOT, FAA, and EPA requlations and quidelines 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 Zane Court · Elizabeth, Colorado USA 80107 Telephone: 303-646-3715 · Email: alex henderson@phoenixsolutions.org {8}------------------------------------------------ # 510(k) Summary -5 of 5 - ### 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 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. #### I 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 damaqe. 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.