(158 days)
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No
The document describes a replacement battery for an AED and focuses on its electrical and mechanical performance, with no mention of AI or ML.
No
This device is a battery pack, which is a power source for medical equipment, not a therapeutic device itself.
No
The device is described as a non-rechargeable battery pack intended to power medical equipment, specifically an AED. Its function is to supply electrical power, not to diagnose medical conditions.
No
The device description clearly states it is a non-rechargeable battery pack, which is a hardware component providing electrical power through chemical reaction.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "To power the functions of various devices for which batteries or battery packs are configured." Specifically, it's a replacement battery for a PhysioControl LP500 AED. This is a power source for a medical device, not a device used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on the battery's function as a power source through chemical reaction, its electrical properties, and performance characteristics under various conditions. This aligns with the description of a power supply, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information. The device's function is purely to provide electrical power.
Therefore, based on the provided text, this battery is a medical device accessory (a power source for a medical device), but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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. 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.
Product codes
MKJ
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
qualified personnel, Biomedical equipment service professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
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Predicate Device(s)
AMCO Battery Pack P/N 5L500
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/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.
1
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.
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.
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)
3
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, LLC | |
| Karen Manley | ||
| Phone: 303-808-4863 | ||
| Email: 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 6019 | |
| Box, Battery | ||
| Box, Battery, Non-Rechargeable | ||
| Regulatory 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 |
4
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:
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.
Statement of Intended 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.
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.
5
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