(116 days)
Defibrillation is a means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. The AED mode is for use on patients in cardiopulmonary arrest. Pacing is used to treat symptomatic bradycardia and asystole. ECG monitoring is used for identifying and diagnosing cardiac rhythms and dysrhythmias and calculating heart rate. Pulse oximetery is used to check the saturation of in the arterial blood of patients who are at risk of developing hypoxemia.
The LIFEPAK 12 defibrillator/monitor series is a complete acute cardiac response system - battery or auxiliary powered defibrillator (manual and AED), monitor, pacemaker, 3 lead ECG, interpretive 12 lead ECG and pulse oximeter. Data can be transmitted by landline or cell phone to computer, fax, printer, or ECG storage system
The provided 510(k) summary for the Physio-Control LIFEPAK® 12 defibrillator/monitor/pacemaker system does not contain a detailed study with specific acceptance criteria and performance results in the format requested.
Instead, the document states that "Information is provided in the 510(k) regarding compliance to applicable sections of the following voluntary industry standards and FDA guidance documents:" followed by a list of standards for diagnostic electrocardiographic devices, cardiac monitors, cardiac defibrillator devices, and automatic external defibrillators. It concludes by saying, "This information demonstrates that the LIFEPAK 12 is substantially equivalent to the predicate devices with respect to safety, effectiveness, and performance."
Therefore, based on the provided text, I cannot complete the table and answer all points as specific study details are not given. The submission relies on compliance with existing industry standards rather than a new standalone clinical study with explicit acceptance criteria and corresponding performance metrics for the device itself.
Here's a breakdown of what can and cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document refers to compliance with industry standards, but does not list specific numerical acceptance criteria or performance metrics for the LIFEPAK 12 itself beyond stating substantial equivalence to predicate devices.
2. Sample size used for the test set and the data provenance
Not available in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not available in the provided text.
4. Adjudication method for the test set
Not available in the provided text.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device described is a defibrillator/monitor/pacemaker system, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not explicitly stated in the context of a "study" with performance metrics. The device's automated functions (like AED mode) would inherently operate in a "standalone" fashion, but performance data is not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not available in the provided text.
8. The sample size for the training set
Not available in the provided text.
9. How the ground truth for the training set was established
Not available in the provided text.
{0}------------------------------------------------
K973486
Jan 9, 1998
510(k) Summary
Submitter's Name and Address: Physio-Control Corporation 11811 Willows Road Northeast P.O. Box 97006 Redmond, WA 98073
Sherri L. Pocock Contact Person: (206) 867-4332
September 12, 1997 Date Summary Prepared:
Device:
Physio-Control Corporation LIFEPAK® 12 defibrillator / monitor / pacemaker system
Classification:
Low-Energy DC - Defibrillators (including Paddles): Class II (21 CFR 870.5300)
Cardiac Monitors (including cardiotachometers and Rate Alarms): Class II (21 CFR 870.2300)
External Transcutaneous Cardiac Pacemakers (noninvasive): Class III (870.5550)
Oximeter: Class II (21 CFR 870.2700)
Automated External Defibrillator: Class III
Interpretive 12 lead ECG: Class III
Substantial Equivalence:
The intended use and function of the LIFEPAK 12 system are substantially equivalent to those of the
Physio-Control LIFEPAK 11 defibrillator / pacemaker, 510(k) no. K951593.
Physio-Control LIFEPAK 11 monitor, 510(k) no. K912189
WAB
3-1
{1}------------------------------------------------
Hewlett Packard CodeMaster 100 defibrillator/monitor, 510(k) no. K950483
Marquette Electronics Responder 1500 Defibrillator/Monitor, 510(k) no. K903644
Marquette Electronics Eagle 4000 monitor with 12SL, 510(k) no. K964750
Description:
The LIFEPAK 12 defibrillator/monitor series is a complete acute cardiac response system - battery or auxiliary powered defibrillator (manual and AED), monitor, pacemaker, 3 lead ECG, interpretive 12 lead ECG and pulse oximeter. Data can be transmitted by landline or cell phone to computer, fax, printer, or ECG storage system
The users will be Advanced Life Support and Basic Life Support providers in a variety of hospital and prehospital settings. Emergency Medical Services users will include Paramedics and Emergency Medical Technicians trained and authorized to respond to medical emergencies. This device will be used in the prehospital setting and in the hospital, in critical areas (emergency departments, critical care, operating rooms etc.) and on general duty floors (e.g. medical/surgical.) It will also be used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.)
Indications for Use:
Defibrillation is a means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. The AED mode is for use on patients in cardiopulmonary arrest. Pacing is used to treat symptomatic bradycardia and asystole. ECG monitoring is used for identifying and diagnosing cardiac rhythms and dysrhythmias and calculating heart rate. Pulse oximetery is used to check the saturation of in the arterial blood of patients who are at risk of developing hypoxemia.
DADAM
3-2
{2}------------------------------------------------
Technological characteristics of new and predicate devices:
The features and functions of the LIFEPAK 12 system are very similar to those of currently marketed Physio-Control devices. The LIFEPAK 12 is smaller than our currently marketed multiparameter devices and the design has been optimized for both prehospital, hospital, and transport use.
Summary of Performance Information:
Information is provided in the 510(k) regarding compliance to applicable sections of the following voluntary industry standards and FDA guidance documents:
- ANSI / AAMI EC11 1991, Diagnostic Electrocardiographic Devices . Standard
- ANSI/AAMI EC13 1992, Cardiac Monitors Standard ●
- ANSI / AAMI DF2 1989, Cardiac Defibrillator Devices Standard ●
- ANSI / AAMI DF39 1993, Automatic External Defibrillator . Standard
This information demonstrates that the LIFEPAK 12 is substantially equivalent to the predicate devices with respect to safety, effectiveness, and performance.
3-31225
{3}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 9 1998
Mr. Michael D. Willingham Vice President Quality and Regulatory Affairs Physio-Control Corporation 11811 Willows Road Northeast Post Office Box 97006 98073-9706 Redmond, WA
Re: K973486 LIFEPAK® 12 Defibrillator/Monitor System Regulatory Class: III (three) Product Code: 74 MKJ Dated: December 17, 1997 Received: December 18, 1997
Dear Mr. Willingham:
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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
{4}------------------------------------------------
Page 2 - Mr. Michael D. Willingham
On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows The specific requirements of the the patients who receive them. regulation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.
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 regulation (21 CFR part 801 and additionally 809.10 for in vitro diagnostic devices), 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" (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.gov/cdrh/dsmamain.html".
Please be advised that, in the future, FDA may require postmarket surveillance of this device under the authorities granted under section 522 of the Federal Food, Drug and Cosmetic Act. This issue is currently undergoing consideration by FDA and you will be notified of our decision in writing.
Sincerely yours,
Thoma f. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
{5}------------------------------------------------
LIFEPAK 12 defibrillator/monitor series - Indications for use
Automated External Defibrillator feature
The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm.
Defibrillator Therapy
Defibrillation therapy is used as a means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating supraventricular tachycardia, atrial fibrillation, atrial flutter, and, in relatively stable patients, ventricular tachycardia.
Noninvasive Pacemaker
Noninvasive pacing is used as a means of treating symptomatic bradycardia and asystole.
Electrocardiograph
3-Lead (3 wire) and 6-Lead (4 wire) ECG Monitoring:
The 3 and 4 wire ECG allows for identification or interpetation of cardiac rhythms or dysrhythmias and calculation of heart rate.
12-lead electrocardiogram (ECG)
The 12-lead electrocardiogram (ECG) is used to identify, diagnose, and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute myocardial infarction.
Pulse Oximetery
A pulse oximeter is a noninvasive device that checks the saturation of oxygen in arterial blood (SpO2). It is used for monitoring patients who are at risk of developing hypoxemia.
3
4
§ 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.