(77 days)
The Cadex Battery Charger for Philips HeartStart Batteries is used to recharge and analyze rechargeable batteries that are used with Philips HeartStart manual defibrillator/monitors.
The Cadex Battery Charger for Philips HeartStart Batteries is used to charge and analyze rechargeable batteries used in Philips HeartStart defibrillators. The Battery Charger consists of a commercially available battery charger and an adapter specifically designed to interface with the Philips HeartStart batteries. The battery charger is available in 2- and 4-bay models, which allow for the simultaneous charging of up to 4 batteries. The adapters allow for the mechanical interface between the battery and the battery charger. The adapters also contain the software that allows the battery charger to charge the battery using the appropriate algorithm for the type of battery being charged. The battery charger also analyzes a battery to determine its capacity.
The provided text describes the Cadex Battery Charger for Philips HeartStart Batteries and its 510(k) summary, but it does not contain information about specific acceptance criteria or a study proving that the device meets those criteria with numerical performance data.
The document states:
- "Tests Used in Determination of Substantial Equivalence: The tests used in the determination of substantial equivalence included only bench testing. Bench testing includes hardware and software testing demonstrating that the performance of the device meets its specification."
This indicates that internal specifications were used, but the document does not detail those specifications as explicit acceptance criteria or provide the results of the bench testing in terms of reported device performance.
Therefore, I cannot populate the table or answer most of the questions as the specific details of the acceptance criteria, reported performance, and study methodology are not present in the provided text.
Here's a breakdown of what can be inferred from the provided text, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (e.g., Charging time, Recharging capacity, Battery analysis accuracy) | Reported Device Performance |
|---|---|
| Not specified in the provided text. | Not specified in the provided text. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified. The document only mentions "bench testing."
- Data Provenance: Not specified.
- Retrospective/Prospective: Not specified.
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)
- Not applicable. Bench testing of a battery charger typically relies on engineering specifications and measurement equipment for "ground truth," not human experts in the way clinical studies do.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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
- No. This is a battery charger, not an AI diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not precisely. The "algorithm" here refers to the battery charging and analysis software. The document states "software testing demonstrating that the performance of the device meets its specification," implying standalone testing of the charging functions. However, it's not an "AI algorithm" in the typical sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For bench testing of a battery charger, the "ground truth" would typically be established by:
- Engineering specifications/Design requirements for charging parameters (voltage, current, time).
- Reference measurement equipment (e.g., calibrated multimeters, power analyzers) for verifying output and charging characteristics.
- Known battery specifications for capacity and performance.
8. The sample size for the training set
- Not applicable. This is not a machine learning/AI device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not a machine learning/AI device requiring a training set.
Conclusion:
The provided 510(k) summary for the Cadex Battery Charger for Philips HeartStart Batteries indicates that "bench testing" was performed to ensure the device "meets its specification." However, it does not provide the specific acceptance criteria (specifications), the quantitative results of these tests, or detailed methodology regarding sample sizes or the establishment of "ground truth" beyond general engineering principles. No clinical studies, expert reviews, or AI-specific evaluations were part of this submission, which is appropriate for a device of this nature.
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510(k) Summary 15.
Date Summary Prepared
February 6, 2004
Submitter's Name and Address
Philips Medical Systems Cardiac and Monitoring Systems Cardiac Resuscitation 3000 Minuteman Road Andover, MA 01810-1099
Contact Person
Peter Ohanian Philips Medical Systems Cardiac and Monitoring Systems Cardiac Resuscitation Telephone: (978) 659-3397 Facsimile: (978) 659-4878
Device Name
| Proprietary Name: | Cadex Battery Charger for Philips HeartStart Batteries |
|---|---|
| Common Name: | Battery Charger for Defibrillator Batteries |
| Classification Names: | Arrhythmia Detection & Alarms (Automatic External) |
| Defibrillator |
Predicate Devices
The legally marketed devices to which Philips Medical Systems claims equivalence for the Cadex Battery Charger for Philips HeartStart Batteries are as follows:
- ZOLL Medical Corp., PowerBase™ .
- Medtronic Physio-Control Battery Support System 2 .
The design of the Cadex Battery Charger for Philips HeartStart Batteries is substantially equivalent in safety and performance to the devices listed above.
Device Description
The Cadex Battery Charger for Philips HeartStart Batteries is used to charge and analyze rechargeable batteries used in Philips HeartStart defibrillators. The Battery Charger consists of a commercially available battery charger and an adapter specifically designed to interface with the Philips HeartStart batteries. The battery charger is available in 2- and 4-bay models, which allow for the simultaneous charging of up to 4 batteries. The adapters allow for the mechanical interface between the battery and the battery charger. The adapters also contain the software that allows the battery charger to charge the battery using the appropriate algorithm for the type of battery being charged. The battery charger also analyzes a battery to determine its capacity.
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Intended Use
The Cadex Battery Charger for Philips HeartStart Batteries is used to recharge and analyze rechargeable batteries that are used with Philips HeartStart manual defibrillator/monitors.
Comparison of Technology Characteristics
The Cadex Battery Charger for Philips HeartStart Batteries employs the same fundamental scientific technologies as the commercially available predicate devices used for comparison.
Tests Used in Determination of Substantial Equivalence
The tests used in the determination of substantial equivalence included only bench testing. Bench testing includes hardware and software testing demonstrating that the performance of the device meets its specification
Conclusion from Testing
Based on the results of the testing described above, it is concluded that the Cadex Battery Charger for Philips HeartStart Batteries does not raise any different questions regarding the safety or effectiveness as compared with the predicate devices. It is considered to be substantially equivalent to the predicate devices.
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Image /page/2/Picture/11 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that features a stylized image of a bird or eagle with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 4 2004
Philips Medical Systems c/o Mr. Peter Ohanian Director, Quality and Regulatory Affairs Cardiac and Monitoring Systems Cardiac Resuscitation 3000 Minuteman Road, MS 0222 Andover, MA 01810
Re: K040404
Trade Name: Cadex Battery Charger for Philips HeartStart Batteries Regulation Number: 21 CFR 870.1025 Regulation Name: Arrythmia Detector and Alarm Regulatory Class: III (three) Product Code: MKJ Dated: March 11, 2004 Received: March 12, 2004
Dear Mr. Ohanian:
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 for tose batter in the energency)76, 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 he found in the Codc 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. Peter Ohanian
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of actived that i be review that your device complies with other requirements of the Act 4 or any Federal statutes and regulations administered by other Federal agencies. You must r or 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 SI I art 8077, laceming (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. product raincilled on the begin marketing your device as described in your Section 510(k) I mo letter notification. The FDA finding of substantial equivalence of your device to a legally premated noticated 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 n you a the Office of Compliance at (301) 594-4648. 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 from the Division of Small other general micronational 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,
Bran 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 2.
510(k) Number (if known): To be assigned
Ko40404
Device Name: Cadex Battery Charger for Philips HeartStart Batteries
Indications for Use: The Cadex Battery Charger for Philips HeartStart Batteries is used to recharge and analyze rechargeable batteries that are used with Philips HeartStart manual defibrillator/monitors.
Over-The-Counter Use: No Prescription Use: Yes AND/OR (Part 21 CFR 801 Subpart D) (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)
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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.