(334 days)
Not Found
No
The summary describes a rechargeable battery with increased capacity and "Smart Battery" compatibility, but there is no mention of AI or ML technology.
No
The device is a rechargeable battery for a defibrillator, not the therapeutic device itself. Its purpose is to power another device that performs therapy.
No
The device is a rechargeable battery designed to power a defibrillator, which is a therapeutic device, not a diagnostic one. Its function is to provide power, not to diagnose medical conditions.
No
The device is a physical battery, a hardware component, intended for use in a defibrillator. The description explicitly details its physical characteristics and testing related to hardware performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to power a LifePak-12 defibrillator. Defibrillators are used to deliver an electrical shock to the heart, which is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description clearly states it's a rechargeable battery. Batteries are power sources for medical devices, not devices that perform diagnostic tests on biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The device is a component of a medical device (the defibrillator), but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The HighPak-12 rechargeable lithium battery is intended for use in the LifePak-12 defibrillator.
Product codes
MPD
Device Description
The HighPak -2 is a lithium manganese rechargeable battery. The outer case is molded plastic and is identical in shape and size to the predicate LifePak-12 NiCd battery. The lithium manganese cell technology offers the same voltage but an increased in amp hours resulting in longer life. It is charged in the same manner as the predicate battery and is "Smart Battery" system compatible.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Product testing was conducted to evaluate conformance to product specification. Testing included electromagnetic compatibility (EMC), charging, discharging, proper fit and operation in the LifePak-12 Defibrillator.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K041459, K040775, K010918, K002445, K991910
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 870.5300 DC-defibrillator (including paddles).
(a)
Low-energy DC-defibrillator —(1)Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class II (performance standards).(b)
High-energy DC-defibrillator —(1)Identification. A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
Page 1 of 2
K062331
510(k) Summary
JUL 10 2007
General Information
| Classification | Class II |
|---|---|
| Trade Name | HighPak® -12 Smart Battery |
| Submitter | AD Elektronik GmbH |
| Sudentenstrasse 7-9 | |
| 35883 Wetzlar | |
| Germany | |
| Tel: (49) 06641-9258-0 | |
| Contact | Daniel Kraushaar |
| Operations Manager |
Intended Use
The HighPak-12 rechargeable lithium battery is intended for use in the LifePak-12 defibrillator.
Predicate Devices
| K041459
| Control | LifePak-12 Defibrillator | Medtronic | Inc./Physio- |
|---|---|---|---|
| K040775 | |||
| Control | LifePak-12 Defibrillator | Medtronic | Inc./Physio- |
| K010918 | |||
| Control | LifePak-12 Defibrillator | Medtronic | Inc./Physio- |
| K002445 | |||
| Control | LifePak-12 Defibrillator | Medtronic | Inc./Physio- |
| K991910 | |||
| Control | LifePak-12 Defibrillator | Medtronic | Inc./Physio- |
1
K062331
Device Description
The HighPak -2 is a lithium manganese rechargeable battery. The outer case is molded plastic and is identical in shape and size to the predicate LifePak-12 NiCd battery. The lithium manganese cell technology offers the same voltage but an increased in amp hours resulting in longer life. It is charged in the same manner as the predicate battery and is "Smart Battery" system compatible.
Materials
All materials used in the manufacture of the HighPak -12 Battery are suitable for this use and have been used in numerous previously cleared products.
Testing
Product testing was conducted to evaluate conformance to product specification. Testing included electromagnetic compatibility (EMC), charging, discharging, proper fit and operation in the LifePak-12 Defibrillator.
Summary of Substantial Equivalence
The HighPak-12 Battery is equivalent to the predicate LifePak-12 battery. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized symbol of three human figures connected at the arms, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 0 2007
AD Elektronik GmbH c/o Mr. Gregory J. Mathison President Regulatory Strategies, Inc. 3924 Cascade Beach Road Lutsen, MN 55612
Re: K062331
Trade/Device Name: HighPak-12 Rechargeable Battery Regulation Number: 21 CFR 870.5300 Regulation Name: Auxiliary Power Supply (ac or dc) for Low-Energy dc-Defibrillator Regulatory Class: Class II (two) Product Code: MPD Dated: July 6, 2007 Received: July 9, 2007
Dear Mr. Mathison:
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.
3
Page 2 - Gregory J. Mathison
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 vours.
er R. Vochner
\ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K062331
Indications for Use
510(k) Number (if known):
This application > Ko6233|
Device Name:
Indications for Use:
HighPak® -12 Rechargeable Battery
The HighPak® -12 rechargeable lithium battery is intended for use in the LifePak-12 defibrillator.
X Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-9)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
sumner R. Vechner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_ko6233 |