(159 days)
Not Found
No
The device description and performance studies focus solely on the electrical charging function of batteries, with no mention of AI or ML technologies.
No
Explanation: The device is a charging station for batteries used in defibrillators, not a therapeutic device itself. It does not directly provide a medical benefit or treatment.
No
The device is a charging station for batteries, not a diagnostic device that performs medical diagnoses.
No
The device description clearly outlines physical dimensions, power requirements, and a physical mechanism for charging batteries, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is solely to charge batteries for defibrillators. It does not involve testing or analyzing samples from the human body (like blood, urine, tissue, etc.) to provide information about a person's health or condition.
- Device Description: The description details a battery charging station, not a device that interacts with biological samples or performs diagnostic tests.
- Lack of IVD Characteristics: There is no mention of any components or functions related to sample handling, analysis, reagents, or diagnostic output.
- Performance Studies: The performance studies focus on the electrical and operational aspects of the charger, not on diagnostic accuracy or clinical performance related to patient samples.
In summary, the MBSS charging station is an accessory for medical devices (defibrillators), but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MBSS charging station is used to charge NiCd or SLA batteries of the Lifepak®, Fastpak® and Fastpak 2® series manufactured by Medtronic -Physio Control.
Product codes (comma separated list FDA assigned to the subject device)
MKJ
Device Description
The MBSS overall dimensions are 30 cm x 20 cm x 10 cm. It is available either as a table top model or wall mount unit. The table top model has a standard power cord which plugs into a 110 volt wall outlet and non-slip rubberized feet. The wall mount model has a bracket for mounting the charger on a vertical surface. For mounting and use in an automobile (ambulance or rescue vehicle), the wall mount bracket is used. Power requirements are either standard mains at 120 volts or standard automotive 12 volts. The charger is only used for charging specific batteries. The batteries are removed from the defibrillator and inserted into the MBSS charging bays. The MBSS is not attached to the defibrillator during operation.
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)
The MBSS is designed to comply with the electrical safety (EN60601-1), electromagnetic compatibility (EN60601-1-2) and UL 60950 standards. The MBSS meets all electrical and EMC requirements. Testing was conducted to evaluate conformance to the product specification. Testing included: - Operation of the charger. - Battery recognition. - Charge times. - Appropriate displays. - Impedance. - Electrical safety. - Electromagnetic interference. In all cases, the product test results met specification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 870.5310 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
AUG 2 7 2003
510(k) Summary
General Information
| Classification | Class III (accessory to Class III defibrillation unit) |
|---|---|
| Trade Name | Mobile Battery Service Station (MBSS) |
| Submitter | AD Elektronk GmbH |
| Sudentenstrasse 7-9 | |
| 35583 Wetzlar | |
| Germany | |
| U.S. Contact | Richard Tootchen |
| TMS MedTec | |
| 33 Steeplechase Drive | |
| Turnersville, NJ |
(856) 374-8837 Tel:
Intended Use
The MBSS charging station is used to charge NiCd or SLA batteries of the Lifepak®, Fastpak® and Fastpak 2® series manufactured by Medtronic -Physio Control.
Predicate Devices
Lifepak 12 with Battery Charger -- Medtronic-Physio Control K973486 Lifepak 12 with Battery Charger - Medtronic-Physio Control K990338
Device Description
The MBSS overall dimensions are 30 cm x 20 cm x 10 cm. It is available either as a table top model or wall mount unit. The table top model has a standard power cord which plugs into a 110 volt wall outlet and non-slip rubberized feet. The wall mount model has a bracket for mounting the charger on a vertical surface. For mounting and use in an automobile (ambulance or rescue vehicle), the wall mount bracket is used. Power
1
requirements are either standard mains at 120 volts or standard automotive 12 volts.
The charger is only used for charging specific batteries. The batteries are removed from the defibrillator and inserted into the MBSS charging bays. The MBSS is not attached to the defibrillator during operation.
Materials
All materials used in the manufacture of the MBSS battery charger are suitable for this use and have been used in numerous previously cleared products.
Testing
The MBSS is designed to comply with the electrical safety (EN60601-1), electromagnetic compatibility (EN60601-1-2) and UL 60950 standards. The MBSS meets all electrical and EMC requirements.
Testing was conducted to evaluate conformance to the product specification. Testing included:
- Operation of the charger .
- Battery recognition .
- Charge times .
- Appropriate displays .
- Impedance .
- Electrical safety
- Electromagnetic interference ●
In all cases, the product test results met specification
Summary of Substantial Equivalence
AD Elektronik believes the Mobile Battery Service Station (MBSS) is substantially equivalent to the predicate products. The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate products.
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Image /page/2/Picture/2 description: The image is a black and white circular logo. The logo features a stylized image of an eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle, following its curvature. The logo appears to be a seal or emblem, possibly representing a government agency or organization related to health and human services in the United States.
AUG 2 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AD Elektronic GmbH c/o Mr. Richard Tootchen TMS Medical Technologies 33 Steeplechase Drive Turnersville, NJ 08012
Re: K030898 Mobile Battery Service Station-Model MBSS Regulation Number: 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III Product Code: MKJ Dated: August 4, 2003 Received: August 6, 2003
Dear Mr. Tootchen:
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.
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Page 2 - Mr. Richard Tootchen
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 Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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
510(k) Number (if known):
This application
Device Name:
Indications for Use:
The MBSS charging station is used to charge NiCd or. SLA batteries of the Lifepak®, Fastpak® and Fastpak 2® series manufactured by Medtronic - Physio Control.
Mobile Battery Service Station (MBSS)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Di
B. Kb30898 ar Devices
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Prescription Use _
(Per 21 CFR 801.109)
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NU
Over-The-Counter Use _
(Optional Format 1-2-96)