(65 days)
Replacement battery for Physio-Control 803704-01 Life-Pak 9 Low-Energy Cardiac Monitor/Defibrillator, 510(k) Number 935674. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
Replacement battery for Physio-Control 803704-01 Life-Pak 9 Low-Energy Cardiac Monitor/Defibrillator.
The provided documents are a 510(k) clearance letter from the FDA for a replacement battery (LP9) and its "Indications for Use" statement. This type of document does not contain the detailed information necessary to describe acceptance criteria and a study that proves a device meets those criteria, especially for AI/ML devices.
The 510(k) clearance process for this device (a replacement battery) primarily relies on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves:
- Performance testing: Ensuring the battery meets the electrical and safety specifications equivalent to the original battery and the predicate.
- Material compatibility: Ensuring materials are appropriate for the intended use.
- Labeling review: Verifying that the labeling accurately reflects the device's intended use and contraindications.
Here's why the requested information cannot be fully provided from these documents:
- No AI/ML Component: The device is a replacement battery, which does not involve AI or machine learning. Therefore, concepts like "training set," "test set," "ground truth," "MRMC study," "human readers with/without AI assistance" are not applicable.
- Focus on Substantial Equivalence: The letter explicitly states that the device is "substantially equivalent" to predicate devices. This means its performance is compared to an existing device, rather than establishing novel acceptance criteria based on a new technology's performance.
- Lack of Detailed Study Report: The 510(k) clearance letter is an outcome document, not the detailed study report itself. It confirms the clearance but does not provide the specifics of the testing performed, sample sizes, or expert qualifications that would be found in the actual submission.
However, based on the general principles of medical device regulation and what can be inferred for a replacement battery, here's a conceptual outline of what one might expect for such a device, and why it's not present here:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Conceptual for a Battery) | Reported Device Performance (Inferred) |
|---|---|
| Electrical Performance: | |
| - Output Voltage (e.g., 12V ± X%) | - Met specified voltage range |
| - Capacity (e.g., Y mAh) | - Met/exceeded original capacity |
| - Charge/Discharge Cycles (e.g., Z cycles) | - Met/exceeded original cycle life |
| - Internal Resistance | - Within acceptable limits |
| Safety: | |
| - Overcharge Protection | - Compliant with safety standards |
| - Over-discharge Protection | - Compliant with safety standards |
| - Short Circuit Protection | - Compliant with safety standards |
| - Thermal Stability | - Passed temperature tests |
| - Chemical Leakage | - No leakage observed |
| Physical/Mechanical: | |
| - Dimensions/Fit | - Matched original battery form factor |
| - Durability (e.g., drop test) | - Passed relevant tests |
Due to the nature of the provided documents (a 510(k) clearance letter), specific numerical acceptance criteria and reported performance values are not detailed. These would be found in the detailed test reports submitted to the FDA.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified in the provided document. For a battery, this would likely involve a statistically significant number of units (e.g., dozens to hundreds) to demonstrate consistent performance and safety.
- Data Provenance: Not specified. Typically, testing would be conducted in a controlled laboratory environment by the manufacturer or a certified testing house.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: For a battery, "ground truth" isn't established by experts in the same way it is for diagnostic AI/ML. The "ground truth" is typically defined by objective electrical and safety standards (e.g., IEC, UL standards) and the specifications of the original device. Engineers and technicians perform the tests and verify adherence to these objective criteria.
4. Adjudication method for the test set
- Not Applicable: Adjudication is relevant for situations involving subjective interpretation (e.g., image reading). For objective performance tests of a battery, results are directly measured and compared against predefined specifications.
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
- Not Applicable: This type of study is specifically for AI/ML diagnostic tools that impact human interpretation. A replacement battery has no such AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: The device is a physical battery, not an algorithm.
7. The type of ground truth used
- Objective Standards and Electrical Specifications: For a battery, the "ground truth" would be the documented electrical specifications (voltage, capacity, impedance, etc.) of the original battery and the Life-Pak 9 device, as well as adherence to relevant national and international safety standards (e.g., for lithium-ion batteries if applicable, even though specific chemistry isn't mentioned here).
8. The sample size for the training set
- Not Applicable: There is no "training set" as the device is not an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not Applicable: There is no "training set."
In summary, the provided FDA clearance letter for a replacement battery is not the type of document that would contain the detailed technical evaluation information asked for, particularly for AI/ML-related questions. The clearance is based on the battery's substantial equivalence in performance and safety to existing predicate devices, verified through standard engineering and safety testing.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1998
Mr. Ken Heimendinger Alexander Manufacturing Company 1511 South Garfield Place Mason City, IA 50401
Re: K982896 Replacement Battery Part Number LP9 Requlatory Class: II (two) Product Code: 74 LDD Dated: Auqust 13, 1998 Received: August 17, 1998
Dear Mr. Heimendinger:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 reqistration, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Ken Heimendinger
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas 6. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number:
Device Name: LP9
Indications for Use:
Replacement battery for Physio-Control 803704-01 Life-Pak 9 Low-Energy Cardiac Monitor/Defibrillator, 510(k) Number 935674.
This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark Kramer
(Divisio Division of cular, Re and Neurological Devices 510(k) Numbe
Prescription Use
OR
COUNTER USE OVER-THE (optional Form 1-2-96
§ 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.