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, or install these devices.

This battery is shipped only to customers who request a replacement battery for a PhysioControl LP500 AED (OEM P/N: 3005380-026, 11141-00013) or to replace a competitor's replacement battery for the same AED.

Biomedical equipment service professionals therefore know that the intended use is as a replacement battery.

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.

AI/ML Overview

This document is a 510(k) summary for a replacement battery pack, not a comparative effectiveness study or a standalone AI algorithm performance study. Therefore, it does not contain the detailed information requested regarding acceptance criteria, study design for proving equivalence, and information about AI model testing.

Here's a breakdown of what can be gleaned from the provided text, and what cannot:

What can be extracted (though not in the format requested as it's not a performance study):

Device: R & D Battery Pack P/N 6019
Intended Use: To power functions of various devices, specifically as a replacement battery for a PhysioControl LP500 AED.
Predicate Device: AMCO Battery Pack P/N 5L500, also used in the PhysioControl LP500 AED.
Basis of Equivalence: The document states "The design components and functionality of the R & D Batteries Inc. P/N 6019 battery pack is identical to the predicate device. Cell chemistry and type are identical. Sealed (Vented) Lithium / Sulphur Dioxide (Li/SO2)."

Information that is NOT available in this document:

Since this is a 510(k) premarket notification for a battery pack, not a medical device driven by an algorithm or intended for diagnostic/therapeutic functions requiring complex performance metrics, the following information is not applicable or not provided:

A table of acceptance criteria and the reported device performance: While there would be internal specifications and performance targets for the battery, this document does not present them as "acceptance criteria" for a primary efficacy or diagnostic study. The equivalence is based on being "identical" to a predicate, not necessarily meeting a specific set of clinical performance cutoffs.
Sample size used for the test set and the data provenance: Not applicable. Equivalence is primarily demonstrated through design and material identity, along with bench testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There's no ground truth in the context of expert consensus for a battery's performance in this type of submission.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted diagnostic or therapeutic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a battery, not an algorithm.
The type of ground truth used: Not applicable in the context of clinical outcomes or expert consensus. For a battery, "ground truth" relates to its physical and electrical properties meeting specifications.
The sample size for the training set: Not applicable. This is not an AI device.
How the ground truth for the training set was established: Not applicable.

What performance/safety testing was done (as per the document):

Type of Study: Bench tests
Equipment used: Medtronic's/PhysioControl LP500 AED and a NETECH Model Delta 2200 Defibrillator Analyzer.
Tests conducted:
- Life Cycle
- Temperature
- Mechanical & Electrical Component Integrity
Reference: The document refers to "013 Performance Testing for procedures and results," which is an internal document not provided here.

In summary, this document is a regulatory submission demonstrating substantial equivalence of a replacement battery pack to an existing one, based on identical design, materials, and bench testing, rather than a clinical study evaluating diagnostic or therapeutic efficacy of a complex medical device or AI system.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is a stylized representation of human profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 8, 2014

R & D Batteries. Inc. c/o Ms. Karen Manley, Owner/Consultant ZMT, LLC 2063 Woodbourne Terrace Castle Rock, CO 80104

Re: K141795

Trade/Device Names: R & D Battery Pack P/N 6019 Regulatory Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: Oct. 6, 2014 Received: Oct. 23, 2014

Dear Ms. Manley:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Ms. Karen Manley

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Melissa A. Torres -S

Bram D. Zuckerman, M.D. For Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(K) Number: K141795

Device Name: Box, Battery, Non-Rechargeable R & D Batteries, Inc. P/N 6019

Indications for Use:

To power the functions of various devices for which batteries or battery packs are configured. 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, or install these devices.

Biomedical equipment service professionals therefore know that the intended use is as a replacement battery.

Prescription Use _ √ (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)

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K141795

510(k) Summary

K141795

	(Per 21 CFR 807.92)
Submitter/Owner:	R & D Batteries, Inc.3300 Corporate Center Drive,Burnsville, MN 55306 USA
Official Correspondent:	ZMT, LLCKaren ManleyPhone: 303-808-4863Email: karen@karenmanley.com
Date Prepared:	June 25, 2014
Device Name:	Battery Pack, Disposable
Trade/Proprietary Name:Common/Generic Name:Classification Name:	R & D Battery Pack P/N 6019Box, BatteryBox, Battery, Non-RechargeableRegulatory Class III, Product Code MKJ
Predicate Devices:	AMCO Battery Pack P/N 5L500
Classification:	Cardiovascular Panel	Class
21 CFR 870.5310	Automated External Defibrillator	III

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510(k) Summary R & D Batteries Replacement Battery Pack P/N 6019

Legally Marketed Predicate Devices:

The R & D Batteries Inc. P/N 6019 is the same as the AMCO replacement battery P/N 5L500 used in the PhysioControl LP500 AED.

Device Description:

Statement of Intended Use:

To power the functions of various devices for which batteries or battery packs are configured.

This battery is shipped only to customers who request a replacement battery for a Physio Control LP500 AED (OEM P/N: 3005380-026, 11141-00013) or to replace a competitor's replacement battery for the same AED.

Biomedical equipment service professionals therefore know that the intended use is as a replacement battery.

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K141795

510(k) Summary R&D Batteries Replacement Battery Pack P/N 6019

Substantial Equivalence:

The design components and functionality of the R & D Batteries Inc. P/N 6019 battery pack is identical to the predicate device. Cell chemistry and type are identical. Sealed (Vented) Lithium / Sulphur Dioxide (Li/SO2)

Reference: Substantial Equivalence Comparison Chart (Section 010_)

Summary of Performance and Safety Testing:

Bench tests are performed on the R & D Batteries, Inc. P/N 6019 using the applicable Medtronic's/PhysioControl LP500 AED and a NETECH Model Delta 2200 Defibrillator Analyzer including:

Life Cycle
Temperature ●
Mechanical & Electrical Component Integrity

Reference: 013 Performance Testing for procedures and results.

Conclusions:

R&D Batteries Inc. has demonstrated through its continued evaluation and testing of the R&D Batteries Inc. P/N 6019 replacement battery pack, that this device is equivalent to the AMCO replacement battery P/N 5L500 used in the PhysioControl LP500 AED, as outlined in this submission.

The R&D Batteries Inc. P/N 6019 replacement battery pack is 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

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.