(87 days)
No
The description focuses on standard battery charging and monitoring circuitry, with no mention of AI or ML technologies.
No
This device is a battery charger for medical devices, not a medical device itself that provides therapeutic intervention to a patient.
No
This device is a charger for defibrillator batteries, designed to test, recalibrate, and charge them. It is not used to diagnose a medical condition in a patient.
No
The device description explicitly states it is a "single-bay unit" and a "product line extension" of a "four bay charger system," indicating it is a physical hardware device for charging and testing batteries.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "test, recalibrate, and charge a single ZOLL rechargeable defibrillator battery." This is a function related to maintaining and preparing a medical device (a defibrillator battery), not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on the electrical and communication aspects of charging and testing batteries. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The document does not contain any of the typical indicators of an IVD, such as:
- Mention of biological specimens (blood, urine, tissue, etc.)
- Diagnostic purposes
- Measurement of analytes
- Use in a laboratory setting for patient testing
The device is clearly a charger and maintenance tool for a medical device battery.
N/A
Intended Use / Indications for Use
The ZOLL SurePower Single Bay Charger is a single-bay unit that can test, recalibrate, and charge a single ZOLL rechargeable defibrillator battery.
The charging bay in the SurePower Single Bay Charger is designed to accommodate the following ZOLL rechargeable lithium ion batteries:
· SurePower Battery Pack
· SurePower II Battery Pack
Product codes
MKJ
Device Description
The ZOLL SurePower Charger System was cleared by the agency under 510(k) application K060559. This device is a four bay charger system that contains circuitry to monitor the battery's current, temperature, and voltage to ensure safe and effective battery charging and testing. The charging bays in the SurePower Charger Station are designed to accommodate the following ZOLL rechargable lithium ion battery:
· SurePower Battery Pack
-
· SurePower II Battery Pack
and the following ZOLL rechargable lead acid batteries: -
· Battery Pack PD4410
-
· Smart Ready Battery
-
· Smart Battery
-
· XL Smart Ready Battery
-
· XL Smart Battery
The batteries communicate with the ZOLL SurePower Charger Station over a serial communication interface utilizing the SMBus communications protocol.
The SurePower Single Bay Charger is a product line extension of the SurePower (four bay) Charger Station currently in production. The following is a comparison summary of the proposed ZOLL SurePower Single Bay Battery Charger when compared to the ZOLL SurePower Charger:
- The SurePower Single Bay Charger is a one bay version of the existing SurePower . Charger.
- The SurePower Single Bay Charger charges ZOLL Lithium Ion battery packs only . which includes the SurePower and SurePower II battery packs
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)
Extensive performance testing ensures that the ZOLL SurePower Single Bay Charger performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications. Safety testing assures that the device complies with applicable sections of recognized industry and safety standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary:
Submitter's Name and Address:
ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 (978) 421-9655
Contact Person:
Tanmay B. Shukla (978) 421-9171
Date Summary Prepared:
September, 2012
Device:
ZOLL SurePower Single Bay Charger
Classification:
Automatic External Defibrillators: Class III (21 CFR 870,5310)
Description:
The ZOLL SurePower Charger System was cleared by the agency under 510(k) application K060559. This device is a four bay charger system that contains circuitry to monitor the battery's current, temperature, and voltage to ensure safe and effective battery charging and testing. The charging bays in the SurePower Charger Station are designed to accommodate the following ZOLL rechargable lithium ion battery:
· SurePower Battery Pack
-
· SurePower II Battery Pack
and the following ZOLL rechargable lead acid batteries: -
· Battery Pack PD4410
-
· Smart Ready Battery
-
· Smart Battery
-
· XL Smart Ready Battery
-
· XL Smart Battery
DEC 1 3 2012
1
The batteries communicate with the ZOLL SurePower Charger Station over a serial communication interface utilizing the SMBus communications protocol.
The SurePower Single Bay Charger is a product line extension of the SurePower (four bay) Charger Station currently in production. The following is a comparison summary of the proposed ZOLL SurePower Single Bay Battery Charger when compared to the ZOLL SurePower Charger:
- The SurePower Single Bay Charger is a one bay version of the existing SurePower . Charger.
- The SurePower Single Bay Charger charges ZOLL Lithium Ion battery packs only . which includes the SurePower and SurePower II battery packs
Intended Use:
The ZOLL SurePower Single Bay Charger is a single-bay unit that can test, recalibrate, and charge a single ZOLL rechargeable defibrillator battery.
The charging bay in the SurePower Single Bay Charger is designed to accommodate the following ZOLL rechargeable lithium ion batteries:
- · SurePower Battery Pack
- · SurePower II Battery Pack
Substantial Equivalence:
The features and functions of the ZOLL SurePower Single Bay Charger are substantially equivalent to the currently marketed ZOLL SurePower Charger (K060559, cleared for use on 8/17/2006).
Comparison of Technological Characteristics
The technological characteristics of the ZOLL SurePower Single Bay Charger are substantially equivalent to the currently marketed ZOLL SurePower Charger (K060559, cleared for use on 8/17/2006).
Performance Testing:
Extensive performance testing ensures that the ZOLL SurePower Single Bay Charger performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications. Safety testing assures that the device complies with applicable sections of recognized industry and safety standards.
Conclusion
Performance and safety testing of the ZOLL SurePower Single Bay Charger demonstrates that its features and functions are substantially equivalent to those of the indicated commercially distributed predicate device with regard to performance, safety and effectiveness.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
DEC 1 3 2012
Zoll Medical Corporation c/o Mr. Tanmay B Shukla 269 Mill Road Chelmsford, MA 01824
Re: K122839
Trade Device Name: Zoll SurePower Single Bay Charger Regulation Number: 21 CFR 870.5310 Regulation Name: Automated external defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: November 13, 2012 Received: November 18, 2012
Dear Mr. Shukla:
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.
3
Page 2 – Tanmay B. Shukla
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
? Bram D. Z
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4 - Indications for Use
510(k) Number (if known): K122839
ZOLL SurePower Single Bay Charger Device Name:
The ZOLL SurePower Single Bay Charger is a single-bay unit that can test, recalibrate, and charge a single ZOLL rechargeable defibrillator battery.
The charging bay in the SurePower Single Bay Charger is designed to accommodate the following ZOLL rechargeable lithium ion batteries:
· SurePower Battery Pack
· SurePower II Battery Pack
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR ·
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Owen P. Faris -S
2012.12.13
16:21:15 -05'00'
16:21:15 -05'00'