(293 days)
The Heartstream XLT Defibrillator/Monitor is to be used for the termination of ventricular tachycardia and ventricular fibrillation.
This device is for use by emergency personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, defibrillation, or other physician-authorized emergency medical response. It must be used by or on the order of a physician.
The SMART Biphasic waveform utilized in the Heartstream XLT Defibrillator/Monitor has undergone clinical testing in adults. These trials support the waveform's effectiveness for defibrillation of ventricular tachyarrhythmias at 150J.
In the manual mode operation, the Heartstream XLT Defibrillator/Monitor incorporates some user selectable lower energy levels that were not used in the clinical trials.
AED Therapy:
To be used in the presence of a suspected cardiac arrest on patients that are unresponsive, not breathing and pulseless.
Pacing:
Noninvasive pacing is one method of treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early.
SpO2 Monitoring:
SpO2 monitoring is indicated for use when it is beneficial to assess a patient's oxygen saturation level.
The Heartstream XLT Defibrillator/Monitor has two modes of operation: AED and manual. Non-invasive external pacing, as well as SpO2 and 3/5-wire ECG monitoring are also available.
The Heartstream XLT defibrillator uses the Heartstream SMART biphasic waveform for defibrillation, the same waveform utilized in the Heartstream ForeRunner AED.
ECG data and events can be stored on a Data Card by the Heartstream XLT for Jater downloading and reporting with the Heartstream CodeRunner data management system.
The provided text describes a 510(k) summary for the Heartstream XLT Defibrillator/Monitor and its comparison to predicate devices, but it does not contain the specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested.
The document primarily focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and repetition of previous testing. It mentions a "Conclusion from Testing" that the device "does not raise any different questions regarding the safety or effectiveness as compared with the predicate devices," but this is a high-level summary, not a report of specific acceptance criteria and performance data.
Here's an breakdown of what can and cannot be extracted from the provided text according to your request:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided text. The document states: "For each function on the Heartstream XLT that is leveraged from previous HP products, such as the CodeMaster 100 or the Heartstream ForeRunner, the testing done for the previous product was repeated in order to demonstrate equivalence, although in some cases, more stringent procedures and/or acceptance criteria were required for the XLT." However, neither these "more stringent procedures and/or acceptance criteria" nor the specific performance results are described.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not explicitly stated for the non-clinical tests.
For the clinical testing of the SMART Biphasic waveform, it states: "The SMART Biphasic waveform utilized in the Heartstream XLT Defibrillator/Monitor has undergone clinical testing in adults." However, it does not provide the sample size, country of origin, or whether it was retrospective or prospective.
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)
This information is not present in the provided text. The document mentions tests but not the use of experts to establish a ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided text.
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
This information is not present in the provided text. The device is a defibrillator/monitor, not an AI-assisted diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document mentions "algorithm and software testing" for nonclinical tests, but it does not provide details about standalone performance metrics or if it was conducted without human intervention in the context of defibrillation effectiveness.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not explicitly stated. For the "clinical testing in adults" of the SMART Biphasic waveform, it implicitly suggests that the ground truth would be successful termination of ventricular tachyarrhythmias (outcomes data), but this is not definitively stated. For the other non-clinical tests, the ground truth would likely be established in accordance with engineering standards and predicate device performance.
8. The sample size for the training set
This information is not present in the provided text. Since the document primarily describes reuse of existing algorithms and technologies from predicate devices rather than a newly trained AI model, the concept of a "training set" in the context of machine learning might not be directly applicable to the described evaluation.
9. How the ground truth for the training set was established
This information is not present in the provided text.
Summary of available information:
The document describes the Heartstream XLT Defibrillator/Monitor and asserts its substantial equivalence to predicate devices (HP CodeMaster 100, HP Heartstream ForeRunner AED, HP CodeMaster XL, HP Viridia Telemetry System).
- Nonclinical Tests: Bench testing (hardware, algorithm, software) and animal testing were performed. The animal testing evaluated the safety and effectiveness of the Heartstream SMART biphasic waveform up to 200J.
- Clinical Testing (for waveform): The SMART Biphasic waveform underwent clinical testing in adults, supporting its effectiveness for defibrillation of ventricular tachyarrhythmias at 150J. No further details on this study (sample size, methodology, acceptance criteria, specific results) are provided.
- Equivalence Approach: The core approach was to repeat tests performed on predicate devices, sometimes with more stringent procedures/acceptance criteria, to demonstrate that the Heartstream XLT does not raise new safety or effectiveness concerns.
To fulfill your request completely, significantly more detailed study reports would be required than what is provided in this 510(k) summary.
{0}------------------------------------------------
MAY 1 8 2000
510(k) Summary for Heartstream XLT Defibrillator/Monitor
Date Summary Prepared
May 17, 2000
Submitter's Name and Address
Agilent Technologies, Inc. Healthcare Solutions Group 3000 Minuteman Road Andover, MA 01810-1099
Contact Person
Teresa Skarr Agilent Technologies, Inc. Heartstream Operation Telephone: (206) 664-5290 Facsimile: (206) 664-5001
Device Name
| Proprietary Name: | Heartstream XLT Defibrillator/Monitor |
|---|---|
| Common Name: | Defibrillator/Monitor |
| Classification Names: | Low-Energy Defibrillator, Electrocardiograph, ExternalTranscutaneous Pacemaker (noninvasive), and Oximeter |
Predicate Devices
The legally marketed devices to which Hewlett-Packard claims equivalence for the Heartstream XLT Defibrillator/Monitor are as follows:
- The HP CodeMaster 100 Defibrillator/Monitor, .
- The HP Heartstream ForeRunner AED for the defibrillation waveform and voice . prompts.
- The HP CodeMaster XL for the battery, and .
- The HP Viridia Telemetry System for $pO2 functionality. ●
The design of the Heartstream XLT Defibrillator/Monitor is substantially equivalent in safety and performance to the devices listed above.
{1}------------------------------------------------
Device Description
The Heartstream XLT Defibrillator/Monitor has two modes of operation: AED and manual. Non-invasive external pacing, as well as SpO2 and 3/5-wire ECG monitoring are also available.
The Heartstream XLT defibrillator uses the Heartstream SMART biphasic waveform for defibrillation, the same waveform utilized in the Heartstream ForeRunner AED.
ECG data and events can be stored on a Data Card by the Heartstream XLT for Jater downloading and reporting with the Heartstream CodeRunner data management system.
Intended Use
The Heartstream XLT Defibrillator/Monitor is for use by emergency personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, defibrillation, or other physician-authorized emergency medical response.
Comparison of Technology Characteristics
The Heartstream XLT Defibrillator/Monitor employs the same technologies as the predicate devices used for comparison. The XLT acquires and analyzes ECG signals like the predicates, utilizes the same shock advisory criteria utilized in the CodeMaster 100, and advises the user to deliver a shock when required utilizing voice prompts as in the Heartstream ForeRunner AED. The Heartstream SMART Biphasic waveform is utilized for defibrillation shocks, as in the Heartstream ForeRunner AED. Heart rate alarms, noninvasive pacing and pulse oximetry functions are provided, as in the HP CodeMaster. The XLT's SpOz technology is identical to the HP Viridia Telemetry System. The battery type and chemistry are the same as the HP CodeMaster XL batterv.
Nonclinical Tests Used in Determination of Substantial Equivalence
The objective of the testing performed on the Heartstream XLT Defibrillator/Monitor was to determine whether any of the device's new or revised functions raise any questions regarding the safety or effectiveness of the device. The philosophy of this approach is that if the Heartstream XLT passes equivalent tests done with the previous devices, then it can be concluded that there are no questions with respect to safety or effectiveness of the new Heartstream XLT.
For each function on the Heartstream XLT that is leveraged from previous HP products, such as the CodeMaster 100 or the Heartstream ForeRunner, the testing done for the previous product was repeated in order to demonstrate equivalence, although in some cases, more stringent procedures and/or acceptance criteria were required for the XLT. In other cases, the features of the predicate devices are identical to those on the Heartstream XLT and did not require repetition.
The nonclinical tests used in determination of substantial equivalence include both bench and animal testing. Bench testing includes hardware, algorithm and software
{2}------------------------------------------------
testing. Animal testing was also performed in order to evaluate the safety and effectiveness of the Heartstream SMART biphasic waveform up to 200J.
Conclusion from Testing
Based on the results of the testing described above, it is concluded that the Heartstream XLT does not raise any different questions regarding the safety or effectiveness as compared with the predicate devices.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the seal of 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 a stylized image of an eagle with three wing-like shapes.
MAY 1 8 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Teresa Skarr Regulatory and Medical Affairs Manager Agilent Technologies Heartstream Operation 2401 Fourth Ave., Suite 500 98121-1436 Seattle, WA
K992543 Re: K992343
Heartstream XLT Defibrillator/Monitor Model M3500B Regulatory Class: III Product Code: 74 MKJ, DRO, LDD, MWI April 5, 2000 Dated: Received: April 6, 2000
Dear Ms. Skarr:
We have reviewed your Section 510(k) notification of intent to market we nave reviewed your boosing the have determined the device is the device ferenced above and no indications for use stated in the substantially equivalence (see ) (see a seement devices marketed in enclosure) to regarly marketed productions been reclassified interstate commerce prior to hap cost that have been reclassified Medical Device Amendales, of the Federal Food, Drug, and in accordance with the provisions of the market the device, subject to Cosmeric Act (Act). Tour may) canf the Act. The general controls the general Controls provisions of the enter for annual registration, provisions of the not of manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special II your device is crassifica (boo aboroval), it may be subject to such Controls) of Class III (Fremains of regulations affecting your device additionar concrerer. Encof Federal Regulations, Title 21, Parts 800 und in the code of realermination assumes compliance to 895. co over in Jubbeancearly officturing Practice requirements, as set with the Current Cood namem Regulation (QS) for Medical Devices: forch in the gaarry by CFR Part 820) and that, through periodic QS General Tegulation (2) orit rare due), and Drug Administration (FDA) will verify such inspections, Ene rood and Brig with the GMP regulation may result in In addition, FDA may publish further announcements regulatory action. regulatory accron. In the Federal Register. Please note: this concerning your device in the ification submission does not affect any response to your premained inder sections 531 through 542 of the Act obligation you might have andoi Product Radiation Control provisions, or other Federal laws or regulations.
{4}------------------------------------------------
Page 2 - Ms. Teresa Skarr
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 equilts 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 Additionally, for questions on the promotion and (301) 594-4648. (100) 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). firebranding by formation 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/dsma/dsmamain.html".
Sincerely yours,
Brim E. Atwerm
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): K992543
Device Name: Heartstream XLT Defibrillator/Monitor
Indications For Use: The Heartstream XLT Defibrillator/Monitor is to be used for the termination of ventricular tachycardia and ventricular fibrillation.
This device is for use by emergency personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, defibrillation, or other physician-authorized emergency medical response. It must be used by or on the order of a physician.
The SMART Biphasic waveform utilized in the Heartstream XLT Defibrillator/Monitor has undergone clinical testing in adults. These trials support the waveform's effectiveness for defibrillation of ventricular tachyarrhythmias at 150J.
In the manual mode operation, the Heartstream XLT Defibrillator/Monitor incorporates some user selectable lower energy levels that were not used in the clinical trials.
AED Therapy:
To be used in the presence of a suspected cardiac arrest on patients that are unresponsive, not breathing and pulseless.
The AED mode is not intended for use on children less than 8 years of age. For children older than 8 years, the American Heart Association recommends that standard operating procedures for AEDs be followed. American Heart Association. Textbook of Advanced Cardiac Life Support. Dallas, Tex: AHA; 1997.
Pacing:
Noninvasive pacing is one method of treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early.
SpO2 Monitoring:
SpO2 monitoring is indicated for use when it is beneficial to assess a patient's oxygen saturation level.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE) Concurrence of CDRH, Office of Device Evaluation (ODE)
or
Brim E. Haro
5/18/02
Prescription Use √
(Per 21 CFR 801.109)
Over-The-Counter Use _
§ 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.