(138 days)
The SAVI Wireless PM500, is a pager-sized, handheld or patient worn device designed specifically to record and transmit ambulatory ECG signals. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature.
The SAVI Wireless Model PM500, is a small, auto triggered, hand-held device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia. Shortness of breath and palpitations are examples of these symptoms. This device may be worn for a period of days or weeks - whatever time is necessary to capture and record the ECG.
The device consists of the SAVI Wireless event monitor, patient cable, and off the shelf cellular telephone. The device can be used with accessories, including a belt clip, lanyard, and PC interface cable.
The provided text describes a 510(k) premarket notification for the SAVI Wireless Model PM500, a cardiac event/loop recorder. It primarily focuses on demonstrating substantial equivalence to a predicate device (CardioPAL SAVI Model PM410) rather than presenting a study with specific acceptance criteria and performance data for the subject device itself.
Based on the document:
-
Table of acceptance criteria and the reported device performance:
The document does not explicitly define acceptance criteria as a separate, quantitative set of metrics that the SAVI Wireless Model PM500 device needed to meet. Instead, the "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to the predicate device. The performance is reported qualitatively by comparing features and stating that "there are no differences in their technological characteristics, thereby not raising any new issues of safety or effectiveness."Feature Predicate Device (CardioPAL SAVI PM410) Subject Device (SAVI Wireless PM500) ECG Storage 20 Minutes 20 Minutes On Board Analysis Yes Yes ECG Input 1-Ch 2-Wires, 1-Ch 3-Wires, 2-Ch 3-Wires, 2-Ch 5-Wires 1-Ch 2-Wires, 1-Ch 3-Wires, 2-Ch 3-Wires, 2-Ch 5-Wires User Interface Audio Beeper, 2x16 LCD, 3 Buttons Audio Beeper, 2 Buttons, Cellular Telephone PC Interface Trans-telephonic, USB Cellular Network, Bluetooth, USB Case Plastic Plastic EC38 Type Type 3 Type 3 Battery 1 AA 1 AA, 1 Rechargeable Reported Device Performance: The document asserts that the subject device has "identical indications for use" and that "bench testing... demonstrates that there are no differences in their technological characteristics." The "study" proving this involved non-clinical tests.
-
Sample size used for the test set and the data provenance:
The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This indicates that no clinical test set with human patients or their data was used for this specific 510(k) submission. The testing performed was "derived from the risk assessment which evaluated the effects of the feature changes" and included IEC 60601-1, IEC 60601-1-2 (electrical safety and electromagnetic compatibility), and environmental and software validation testing. These are bench tests, not clinical performance tests on a sample set of patient data. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set with associated ground truth was used. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set was used. -
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 device is an ECG recorder, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document describes "On Board Analysis: Yes" for both the predicate and subject devices, suggesting some level of automated analysis. However, it does not provide details or results of any standalone performance study of this "on board analysis" algorithm, nor does it define its specific function beyond general "on board analysis" in the context of an event/loop recorder which relies on subsequent physician review. The 510(k) submission focused on hardware safety and equivalence, not algorithm performance. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable, as no clinical performance study requiring ground truth was conducted. The ground truth for the non-clinical tests would be defined by the specifications and standards (e.g., successful completion of IEC 60601-1 tests). -
The sample size for the training set:
Not applicable, as no clinical data training set is mentioned or implied for a machine learning algorithm. The "on-board analysis" capability is not further detailed as an AI/ML component in this document. -
How the ground truth for the training set was established:
Not applicable, as no training set is mentioned.
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pg 6f3
OCT 2 6 2009
EXHIBIT #1
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: KC910960
Submitter's Identification: 1.
Medicomp, Inc. 7845 Ellis Road Melbourne, Florida 32904
Date Summary Prepared: May 8, 2009
Contact: Mr. Michael Thomas
2. Name of the Device:
SAVI Wireless Model PM500
3. Predicate Device Information:
K#043454, CardioPAL SAVI (Model PM410) Event/Loop Recorder, Medicomp, Inc.
4. Device Description:
The SAVI Wireless Model PM500, is a small, auto triggered, hand-held device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia. Shortness of breath and palpitations are examples of these symptoms. This device may be worn for a period of days or weeks - whatever time is necessary to capture and record the ECG.
The device consists of the SAVI Wireless event monitor, patient cable, and off the shelf cellular telephone. The device can be used with accessories, including a belt clip, lanyard, and PC interface cable.
5. Intended Use:
The SAVI Wireless Model PM500, is a pager-sized, hand-held or patient worn device designed specifically to record and transmit ambulatory ECG signals. The device can be worn for days or weeks, as it is intended for use by patients
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K0916896
pg 2 of 3
who are experiencing symptoms that are transient and infrequent in nature. Since the SAVI Wireless is patient-activated, the device is not intended for patients who are unable to activate the Record switch when they are experiencing a symptom.
દ. Comparison to Predicate Device:
The following comparison chart outlines similarities and differences between the subject device and the predicate device:
| Features | Predicate DeviceCardioPAL SAVI (PM410) | Subject DeviceSAVI Wireless (PM500) |
|---|---|---|
| ECG Storage | 20 Minutes | 20 Minutes |
| On Board Analysis | Yes | Yes |
| ECG Input | 1 Channel 2 Wires1 Channel 3 Wires2 Channel 3 Wires2 Channel 5 Wires | 1 Channel 2 Wires1 Channel 3 Wires2 Channel 3 Wires2 Channel 5 Wires |
| User Interface | Audio Beeper2 Line x 16 Character LCD3 Buttons | Audio Beeper2 ButtonsCellular Telephone |
| PC Interface | Trans-telephonicUSB | Cellular NetworkBluetoothUSB |
| Case | Plastic | Plastic |
| EC38 Type | Type 3 | Type 3 |
| Battery | 1 AA | 1 AA1 Rechargeable |
6. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence:
All testing performed on the SAVI Wireless was derived from the risk assessment which evaluated the effects of the feature changes. Testing included IEC 60601-1, IEC 60601-1-2, and environmental and software validation testing.
Discussion of Clinical Tests Performed: 8.
Not Applicable
9. Conclusions:
The subject device, SAVI Wireless Model PM500, has identical indications for use as the predicate device, CardioPAL SAVI Model PM410. The bench testing
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K091696
pg 3 of 3
contained in our submission demonstrates that there are no differences in their technological characteristics, thereby not raising any new issues of safety or effectiveness. Thus, the SAVI Wireless Model PM500, is substantially equivalent to the predicate device, the CardioPAL SAVI Model PM410.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
OCT 2 6 2009
Medicomp, Inc. c/o Ms. Susan D. Goldstein-Falk mdi Consultants Inc 55 Northern Blvd., Suite 200 Great Neck, NY 11021
Re: K091696
Trade/Device Name: SAVI Wireless Model PM500 Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DRG Dated: September 30, 2009 Received: October 1, 2009
Dear Ms. Goldstein-Falk:
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.
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.
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Page 2 - Ms. Susan D. Goldstein-Falk
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
W.M.P.
St Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Exhibit B
Page 1 of
510(k) Number (if known): K091696
Device Name: SAVI Wireless Model PM500
Indications For Use:
The SAVI Wireless PM500, is a pager-sized, handheld or patient worn device designed specifically to record and transmit ambulatory ECG signals. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature.
Prescription Use × (Per 21 CFR 801 Subpart D)
OR
Over-The Counter Use (21 CFT 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W.W. West
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K091696
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).