(36 days)
The EnVan Heart Rate Monitor is indicated for use to measure the heart rate of patients who require routine periodic vital signs monitoring. It is intended to provide heart rate information on a wristwatch display for interpretation by a healthcare professional in a hospital, outpatient or ambulatory care setting. It is neither designed nor intended for use in the place of cardiac (electrocardiograph) monitoring.
The EnVan Heart Rate Monitor is not suitable for use within emergency rooms, intensive care or cardiac care units, or operating room or post anesthesia units where cardiac monitors, pacemakers and other types of electrical or electronic medical devices are in use. These devices may interfere with the operation of the EnVan Heart Rate Monitor.
The EnVän Heart Rate Monitor is currently marketed as a consumer product for use as a sports training aid, and intended for use in conjunction with either exercise devices or exercise routines with no medical indications. Clearance of this 510(k) premarket notification will allow the device to be labeled for use to measure heart rate in patients who require routine, periodic vital signs monitoring.
Major Components: Heart rate signals are acquired and transmitted by conductive synthetic rubber pads (IndePad™) then processed and displayed on a digital wristwatch worn by the healthcare professional. The heart rate display on the screen is updated every few seconds, to assure an accurate measurement of heart rate.
The provided text from the 510(k) summary for the EnVän Heart Rate Monitor does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The document primarily focuses on:
- Administrative details: Sponsor, manufacturer, contact information, device trade name, common name, classification, product code, and regulation number.
- Device description: Currently marketed as a consumer product for sports training and proposed for medical indications (routine, periodic vital signs monitoring).
- Intended use/indications for use: To measure heart rate in patients requiring routine periodic vital signs monitoring, displayed on a wristwatch for interpretation by a healthcare professional in specific settings (hospital, outpatient, ambulatory care), explicitly stating it's not for cardiac (ECG) monitoring or use in critical care environments where other medical devices might interfere.
- Major components: Indepad™ conductive synthetic rubber pads and a digital wristwatch display.
- Basis for substantial equivalence: Claims equivalence to predicate devices (Criticare Systems Vital Signs Monitor and Masimo SET® Radical Pulse Oximeter) in indications for use, technological characteristics, performance characteristics, and instructions for use, specifically for heart rate monitoring capabilities.
- FDA correspondence: The FDA's letter of substantial equivalence approval, reiterating the regulatory information and general controls.
Therefore, I cannot extract the requested information regarding acceptance criteria and the study proving adherence to them from this document. The document lists "performance characteristics" as a point of comparison to predicate devices but does not elaborate on what those characteristics are for the EnVän device itself, nor does it present any study data to support them.
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EnVän Health Care
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7.0 PREMARKET NOTIFICATION 510(K) SUMMARY
| Sponsor: | EnVän LLC | APR 0 8 2003 |
|---|---|---|
| P.O. Box 660827 | ||
| Birmingham, Alabama 35266 | ||
| Telephone: (205) 824-2280 | ||
| Fax: (205) 824-2278 | ||
| Contact: Swaid N. Swaid, MD, FACS | ||
| Manufacturer: | EnVän LLC | |
| P.O. Box 660827 | ||
| Birmingham, Alabama 35266 | ||
| Telephone: (205) 824-2280 | ||
| Fax: (205) 824-2278 | ||
| Contact: Swaid N. Swaid, MD, FACS | ||
| Registration: | To be assigned | |
| Contact Person: | Marie Marlow | |
| M Squared Associates, Inc. | ||
| 719 A Street, NE | ||
| Washington DC 20002 | ||
| Telephone: 202-546-1262 | ||
| Fax: 202-546-3848 | ||
| E-mail: mmarlow@msquaredassociates.com | ||
| Trade Name of Device: | EnVän Heart Rate Monitor | |
| Common Name: | Heart Rate Monitor | |
| Classification name: | Cardiac Monitor (including cardiotachometer and rate alarm) | |
| Product Code: | DRT | |
| Regulation Class: | II | |
| Regulation Number: | $870.2300 |
Device Description: The EnVän Heart Rate Monitor is currently marketed as a consumer product for use as a sports training aid, and intended for use in conjunction with either exercise devices or
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exercise routines with no medical indications. Clearance of this 510(k) premarket notification will allow the device to be labeled for use to measure heart rate in patients who require routine, periodic vital signs monitoring.
Indications for Use: The EnVan Heart Rate Monitor is indicated for use to measure the heart rate of patients who require routine periodic vital signs monitoring. It is intended to provide heart rate information on a wristwatch display for interpretation by a healthcare professional in a hospital, outpatient or ambulatory care setting. It is neither designed nor intended for use in the place of cardiac (electrocardiograph) monitoring.
The EnVan Heart Rate Monitor is not suitable for use within emergency rooms, intensive care or cardiac care units, or operating room or post anesthesia units where cardiac monitors, pacemakers and other types of electrical or electronic medical devices are in use. These devices may interfere with the operation of the EnVan Heart Rate Monitor.
Major Components: Heart rate signals are acquired and transmitted by conductive synthetic rubber pads (IndePad™) then processed and displayed on a digital wristwatch worn by the healthcare professional. The heart rate display on the screen is updated every few seconds, to assure an accurate measurement of heart rate.
Basis for Substantial Equivalence
Predicate Devices: Criticare Systems Vital Signs Monitor (K022435) and Masimo SET® Radical Pulse Oximeter (K992340)
- The EnVan Heart Rate Monitor has indications for use equivalent to those for the heart rate . monitoring capabilities of the predicate devices.
- The EnVan Heart Rate Monitor has technological characteristics, performance characteristics, ● and instructions for use equivalent to those for the heart rate monitoring capabilities of the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it.
APR 0 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EnVän, LLC c/o Ms. Marie Marlow President M Squared Associates, Inc. 719 A Street, NE Washington, DC 20002
Re: K030656
Trade Name: EnVän® Heart Rate Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: DRT Dated: February 28, 2003 Received: March 3, 2003
Dear Ms. Marlow:
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 such 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.
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
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Page 2 - Ms. Marie Marlow
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); 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. 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 may be obtained from the Division of Small Manufacturers, International 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,
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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Sponsor:
EnVän
K030656 not yet assigned
510(k) number:
Device Name:
EnVän® Heart Rate Monitor
Indications for Use:
The EnVan Heart Rate Monitor is indicated for use to measure the heart rate of patients who require routine periodic vital signs monitoring. It is intended to provide heart rate information on a wristwatch display for interpretation by a healthcare professional in a hospital, or ambulatory care setting. It is neither designed nor intended for use in the place of cardiac (electrocardiograph) monitoring.
The EnVan Heart Rate Monitor is not suitable for use in emergency rooms, intensive care or cardiac care units, or operating room or post anesthesia units where cardiac monitors, pacemakers and other types of electrical or electronic medical devices are in use. These devices may interfere with the operation of the En Van Heart Rate Monitor.
(Division Sign-O Division of Cardiovas 510(k) Number
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).