The ZP9141 is a disposable non-rechargeable battery pack for use in the Cardiac Science PowerHeart® Non-G3 Model 9100 and 9200, or Survivalink Non-G3 9100 and 9200 AED's and is designed to replace the Cardiac Science Model / Part Number 9141-001 battery pack. This battery pack has a shelf life of 5 years from the date of manufacture.

The ZP9146Y (or W) is a disposable non-rechargeable battery pack for use in the Cardiac Science PowerHeart® Non-G3 Model 9300E AED's and is designed to replace the Cardiac Science Model / Part Number 9146-001 battery pack. This battery pack has a shelf life of 5 years from the date of manufacture.

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.

The Zeller Power Products ZP9141 / ZP9146 battery packs utilize Saft LO26SHX, 3.0 Vdc / 7.5 Ah (amp-hour) primary lithium sulfur dioxide (Li-SO2) D- size spiral cells wired in series (4 cells) which produces a total maximum output of 12Vdc @ 7.5Ah. Two (2) additional cells in the ZP9146 provide 6Vdc for auxiliary functions.

Diodes are included to prevent recharging by blocking current into the cells while allowing current out of the cells. Thermal fuses (thermistors) are utilized to cut-off current flow should the battery packs overheat. Ceramic slow-blow fuses protect the pack from short circuits.

A proprietary IC is utilized as an Identification (ID Sensor) chip which signals the appropriate Cardiac Science AED that the battery pack is the correct model.

The only difference between the ZP9146Y and ZP9146W is the case color and label in order to accommodate end user preference.

AI/ML Overview

The document pertains to the 510(k) premarket notification for Zeller Power Products' ZP9141, ZP9146Y, and ZP9146W Non-Rechargeable Battery Packs. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices, specifically Cardiac Science battery packs 9141-001 and 9146-001.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a formal table with pass/fail thresholds. Instead, it describes performance characteristics that the replacement batteries must meet or exceed compared to the predicate devices.

Performance Characteristic	Predicate Device (Cardiac Science 9141-001/9146-001)	Reported Device Performance (ZP9141/ZP9146)
Electrical Characteristics
Nominal Amp-hour rating	7.5 Amp @ Ambient Room temp. of 25 Deg. C	Meets or exceeds specifications
Minimum voltage maintained during discharge	11.50 Volts (at required current)	Meets or exceeds specifications
Capacity Testing
Target capacity compared to nominal	A threshold setting of 80% (provides balance between adequate energy reserves and long service life)	Must pass this 80% threshold prior to final Quality Control inspection
Safety Testing
Recharging prevention	Internal diodes (block current into cells)	Diodes included to prevent recharging
Overheat protection	Thermistors (cut-off current flow)	Thermal fuses (thermistors) utilized
Short circuit protection	Fuses	Ceramic slow-blow fuses protect from short circuits
Physical/Mechanical Characteristics
Cell case material	Rigid ABS plastic	Equivalent (Rigid ABS plastic)
Connector location, internal PC board, contacts	Identical	Identical
Shelf Life	5 years from date of manufacture (for predicate)	5 years from date of manufacture (for replacement)
Voltage Pre-Shipment	-	100% of Battery Packs tested for voltage prior to shipment

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state a specific sample size used for the "test set" in terms of number of units. It mentions "All Battery Packs are tested 100% for voltage prior to shipment" and that "Those devices that fail are rejected and quarantined." This implies a 100% inspection for voltage for production units rather than a specific test set for regulatory submission.

The general performance testing involving capacity and electrical characteristics seems to be done on representative units, but the quantity is not specified. The data provenance is internal to Zeller Power Products / Battery Beast, LLC, as indicated by "internal testing" and "feedback from end users" in the conclusions. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective, though it would likely be prospective testing conducted for the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable to this device. The device is a non-rechargeable battery pack for AEDs, not a diagnostic or AI-driven medical imaging device. There is no concept of "ground truth" established by experts in the context of electrical and physical performance of a battery. The performance is objectively measured by instruments.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable for the reasons stated above. There is no subjective assessment requiring adjudication for this type of device.

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

This section is not applicable as the device is a battery pack, not an AI or diagnostic tool requiring human interpretation or a comparative effectiveness study involving human readers.

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

This section is not applicable for the same reasons as above. The device is a battery, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This section is not applicable as there is no "ground truth" in the clinical or diagnostic sense for a battery pack. The "truth" for its performance is based on direct electrical and physical measurements against engineering specifications and industry standards.

8. The sample size for the training set

This section is not applicable. As a physical medical device (battery pack), there is no concept of a "training set" like there would be for an AI algorithm. The performance is assessed through direct testing and comparison with the predicate device's known characteristics.

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

This section is not applicable for the same reasons as above. There is no training set or clinical ground truth involved.

Summary of the Study Proving Acceptance:

The study proving the device meets the described performance characteristics is primarily a bench testing program and comparison to predicate device specifications.

Bench Testing: The document states, "The predicate and replacement battery packs are tested using a Cadex Electronics Battery Analyzer Model C7000 in the 'Auto Mode'. This exercises both devices in order to identify performance characteristics." This includes measuring nominal Amp-hour rating, minimum voltage maintained during discharge, and demonstrating "Target capacity...of 80%."
Safety Features: Internal components like diodes, thermistors (thermal fuses), and ceramic slow-blow fuses are included and are stated to be "Identical" or "Equivalent" to the predicate.
Physical/Mechanical Equivalence: The cell case material, connector location, internal PC board, and contacts are declared "Equivalent" or "Identical" to the predicate.
Shelf Life: The replacement battery packs are designed to have a 5-year shelf life, based on data sheets from the cell manufacturer, similar to the predicate.
100% Voltage Testing: All battery packs are "tested 100% for voltage prior to shipment" as a final quality control step.
Additional Testing: "Additional battery pack testing included drop, temperature vs. energy, and life cycle as outlined under the Performance Testing - Bench section."

The conclusion states that Zeller Power Products "has demonstrated through its continued evaluation and testing...that these devices are substantially equivalent to the current Cardiac Science AED non-rechargeable battery packs, as outlined in this submission and indicated by internal testing, comparison analysis, and feedback from end users."

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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three human profiles facing to the right.

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

November 25, 2014

Zeller Power Products Mr. Doug Austin, Owner Battery Beast, LLC Medical Division 3975 West Post Road Las Vegas, Nevada 89118

Re: K141231

Trade/Device Name: ZP9141, ZP9146Y, ZP9146W Non-Rechargeable Battery Pack Regulatory Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (Three) Product Code: MKJ Dated: October 6, 2014 Received: October 16, 2014

Dear Mr. Austin:

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 – Mr. Doug Austin

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/CDRH0ffices/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

For Bram D. Zuckerman, M.D. 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 (if known): K141231

Device Name: ZP9141, ZP9146Y, ZP9146W Non-Rechargeable Battery Pack

Indications for Use:

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)

Indications for Use Statement

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K141231

510(k) Summary
(Per 21 CFR 807.92)

Submitter:	Zeller Power ProductsBattery Beast, LLC Medical Division3975 West Post RoadLas Vegas, Nevada USA 89118
Contact Information	Douglas Austin / OwnerTel: 702-609-9213Fax: 208-752-1291Email: doug@batterybeast.com
Date Prepared	January 22, 2014
Device Information
Trade/Proprietary Name:Common/Generic Name:Classification Name:Regulatory Class:Product Code:	ZP9141, ZP9146Y, ZP9146W Non-Rechargeable Battery PackBox, BatteryBox, Battery, Non-RechargeableIIIMKJ
Classification	Cardiovascular Panel
	Class

21 CFR 870.5310 Automated External Defibrillator III (3)

Identification of Predicate Devices

Cardiac Science battery packs 9141-001 and 9146-001
Approved under K031987 and K040438 for their associated Cardiac Science PowerHeart® or Survivalink AED devices.

Legally Marketed Predicate Devices

The ZP9141 is the same as the Cardiac Science replacement battery Model 9141-001 for use in the Cardiac Science PowerHeart® AED Non-G3 Model 9100 and 9200, or Survivalink Non-G3 9100 and 9200 AED cleared under 510(k) notification K031987 and K040438.

The ZP9146Y (or W) is the same as the Cardiac Science replacement battery Model 9146-001 for use in the Cardiac Science PowerHeart® AED Non-G3 Model 9300A and 9300E cleared under 510(k) notification K031987 and K040438.

The Cardiac Science batteries were bundled in the original submission(s) as accessories.

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Device Description - Overview

A proprietary IC is utilized as an Identification (ID Sensor) chip which signals the appropriate Cardiac Science AED that the battery pack is the correct model.

The only difference between the ZP9146Y and ZP9146W is the case color and label in order to accommodate end user preference.

Indications for Use

The ZP9141 is a disposable non-rechargeable battery pack for use in the Cardiac Science PowerHeart® Non-G3 Model 9100 and 9200, or Survivalink Non-G3 9100 and 9200 AED's and are designed to replace the Cardiac Science Model / Part Number 9141-001 battery pack. This battery pack has a shelf life of 5 years from the date of manufacture.

The ZP9146Y (or W) is a disposable non-rechargeable battery pack for use in the Cardiac Science PowerHeart® Non-G3 Model 9300A and 9300E AED's and are designed to replace the Cardiac Science Model / Part Number 9146-001 battery pack. This battery pack has a shelf life of 5 vears from the date of manufacture.

Substantial Equivalence

The design components and functionality of the ZP9146Y (or W) replacement battery packs are substantially equivalent to other legally marketed predicate devices. Cell chemistry and type are identical; sealed (vented) Lithium Sulfur Dioxide (LiSO2) as well as all safety components and hardware.

Reference:

Specifications and Comparison Data, 510(k) Summary Pages 3 thru 6.
Substantial Equivalence Comparison Chart, Executive Summary.

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Specifications and Comparison Data

Zeller Power Products ZP9141 Battery Pack, 12.0 Volt / 7.5 Amp-Hours

Image /page/5/Picture/3 description: The image shows a blue rectangular battery pack. The battery pack has a series of gold-colored electrical contacts on one end. The battery pack appears to be made of plastic and has a smooth, glossy finish. The battery pack is likely used to power a portable electronic device.

Device Name / Intended Use

Name:	Replacement Battery Pack for Cardiac Science PowerHeart® Non-G3Model 9100 and 9200 or Survivalink Non-G3 9100 and 9200 AED's.
Manufacturer/OEM:	Cardiac Science, Inc. (Survivalink is a subsidiary of Cardiac Science)
Classification:	Class III Device, 21 CFR 870.5310 – Automatic External Defibrillator
General:	Extended Life Lithium Battery (5-year), PowerHeart® AED orSurvivaLink® AED.

Predicate or After-Market Device(s)

K031987 (approved 07/30/2003)
K040438 (approved 07/01/2004)
Battery pack bundled / included with AED device submissions.

Predicate Device Comparison Data of Technological Characteristics

Basic Technology / Chemistry

Predicate:	Replacement:
- Cells used: Four (4) Saft LO26SHX3.0 V / 7.5 Ah D Cells, Non-Rechargeable	Identical
- Chemistry: Sealed Lithium Sulfur Dioxide (LiSO2)- Internal diodes, thermistors, fuse	IdenticalIdentical
Physical / Mechanical Characteristics
Predicate:	Replacement:
Predicate:	Replacement
- Cell case material: Rigid ABS plastic.	Equivalent
- Connector location, Internal PC board, contacts	Identical

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Zeller Power Products Replacement Battery Packs ZP9141 and ZP9146 Traditional 510(k) Notification

Electrical Characteristics

Predicate:

Nominal Amp-hour rating at 7.5 Amp @ Ambient Room temp. of 25 Deg. C
Minimum voltage maintained during Discharge at required current: 11.50 Volts

Replacement:

Meets or exceeds specifications

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Specifications and Comparison Data

Zeller Power Products ZP9146 Battery Pack, 12.0 Volt / 7.5 Amp-Hours

Image /page/7/Picture/3 description: The image shows a yellow battery pack. The battery pack is rectangular and has a series of metal contacts at one end. The battery pack is likely used to power a portable electronic device. The battery pack is made of plastic and has a smooth surface.

Device Name/Intended Use

Name:	Replacement Battery Pack for the PowerHeart® Non-G3 Model 9300A or9300 E Automatic AED's.
Manufacturer/OEM:	Cardiac Science, Inc.
Classification:	Class III Device, 21 CFR 870.5310 – Automatic External Defibrillator

Predicate or After-Market Device(s)

Predicate Device:	Cardiac Science P/N: 9146-001
	- K031987 (approved 07/30/2003)
	- K040438 (approved 07/01/2004)
	- Battery pack bundled / included with AED device submissions

Predicate Device Comparison Data of Technological Characteristics

Basic Technology/Chemistry

Predicate:	Replacement:
- Cells used: Six (6) Saft LO26SHX3.0 V / 7.5 Ah D Cells, Non-Rechargeable	Identical
- Chemistry: Sealed Lithium Sulfur Dioxide (LiSO2)	Identical
- Internal diodes, thermistors, fuse	Identical
Physical/Mechanical Characteristics
Predicate:	Replacement:
- Cell case material: Rigid ABS plastic	Equivalent
- Connector location, Internal PC board, contacts	Identical

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Zeller Power Products Replacement Battery Packs ZP9141 and ZP9146 Traditional 510(k) Notification

Electrical Characteristics

Predicate:	Replacement:
Nominal Amp-hour rating at 7.5 Amp@ Ambient Room temp. of 25 Deg. C	Meets or exceeds specifications
Minimum voltage maintained duringDischarge at required current: 11.50 Volts	Meets or exceeds specifications

Summary of Performance and Safety Testing

Voltage and capacity:

The predicate and replacement battery packs are tested using a Cadex Electronics Battery Analyzer Model C7000 in the "Auto Mode". This exercises both devices in order to identify performance characteristics.

Target capacity is the percentage of the battery capacity compared to nominal capacity and serves as a threshold. A threshold setting of 80% maintains batteries by providing a balance between adequate energy reserves and long service life.

Target capacity is a pass/fail mark and our replacement device must pass this threshold prior to final Quality Control inspection.

All Battery Packs are tested 100% for voltage prior to shipment. Those devices that fail are rejected and quarantined.

Proper use, discharging, and maintenance procedures for maximum performance of the predicate battery pack are generally provided by the manufacture of the equipment into which it is installed. This would apply equally to our replacement since both are electrically identical and similar in construction. The OEM Operator, User, Maintenance Manual must be referenced.

Shelf life is based on data sheets supplied by the battery manufacturer for the specific cell(s) utilized in the replacement. Since the cells are the same or equivalent to the predicate, shelf life should be also.

Replacement batteries are expected to perform as well as the predicate under the same environmental conditions since the cells are the same or equivalent.

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Zeller Power Products Replacement Battery Packs ZP9141 and ZP9146 Traditional 510(k) Notification

These devices are intended for use by qualified medical personnel and are typically installed by Biomedical Technicians or Maintenance Engineers in a hospital or medical clinic or service setting. Other than misuse by the end user, the only potential problem would be a bad cell lot from the cell manufacturer.

Additional battery pack testing included drop, temperature vs. energy, and life cycle as outlined under the Performance Testing - Bench section.

Conclusions

Zeller Power Products / Battery Beast, LLC has demonstrated through its continued evaluation and testing of the ZP9141 and ZP9146 replacement battery packs, and that these devices are substantially equivalent to the current Cardiac Science AED non-rechargeable battery packs, as outlined in this submission and indicated by internal testing, comparison analysis, and feedback from end users. Differences are generally cosmetic in nature and do not affect form, fit, or function.

The proposed ZP9141 and ZP9146 non-rechargeable battery packs are substantially equivalent with respect to indications for use, technological characteristics, and materials to those currently distributed commercially. This notification contains all information required by 21 CFR 807.87

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.