PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES

K061977 · Pinmed, Inc. · DXH · Jul 21, 2006 · Cardiovascular

Device Facts

• Record ID: K061977
• Device Name: PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES
• Applicant: Pinmed, Inc.
• Product Code: DXH · Cardiovascular
• Decision Date: Jul 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

1-12 lead electrocardiograph capable of recording and transmitting standard ECGs for . the purpose of cardiac monitoring and diagnosis; the system incorporates recording/ transmitting circuitry, a package of firmware and software, and is intended for use by a medical professional . The ECG can be recorded and transmitted to a local or remote receiving station for consultation with a medical professional . The ECG can be recorded and transmitted to a local or remote hand-held device or a . Personal Computer or a printer for viewing and processing . Allows patients at remote locations to display and transmit their ECG data to medical professionals via a communication device to a remote server . Intended for self-testing by patients and by healtheare professionals at home and in medical settings

Device Story

Pelex-04 is a wireless 1-12 lead ECG system; captures cardiac electrical signals; transmits data via communication devices to local/remote receiving stations, PCs, or printers. System includes recording/transmitting hardware, firmware, and software (Personal Heart Expert, Pelex Server&Database, Pelex Explorer). Used by medical professionals in clinics or patients at home for self-testing. Healthcare providers view transmitted ECGs on PCs or handheld devices to facilitate remote consultation and cardiac diagnosis. Enables remote monitoring and timely clinical decision-making by providing accessible ECG data to professionals.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Wireless 1-12 lead ECG system. Components: recording/transmitting circuitry, firmware, and software (Personal Heart Expert, Pelex Server&Database, Pelex Explorer). Connectivity: supports transmission to local/remote stations, PCs, handheld devices, and printers. Class II device (21 CFR 870.2920).

Indications for Use

Indicated for cardiac monitoring and diagnosis via 1-12 lead ECG recording and transmission. Intended for use by medical professionals and patients for self-testing in home and medical settings.

Regulatory Classification

Identification

A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines curving upwards. The seal is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 1 2006

Pinmed. Inc. c/o Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Service NA, Inc. 2307 East Aurora Rd., Unit B7 Twinsburg, OH 44087

Re: K061977

Trade Name: Pelex-04 Wireless Electrocardiograph with Software Accessories Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DXH Dated: July 12, 2006 Received: July 13, 2006

Dear Mr. Devine:

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.

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Page 2 - Mr. Neil E. Devine, Jr.

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): 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 [phone]. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrth/industry/support/index.html.

Sincerely yours,

B. Zimmerman for

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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## Indications for Use

## 510(k) Number (if known):

Device Name: Pelex-04 wireless electrocardiograph with software accessories (Personal Heart Expert software, Pelex Server&Database software, and Pelex Explorer software)

Indications for Use:

- 1-12 lead electrocardiograph capable of recording and transmitting standard ECGs for . the purpose of cardiac monitoring and diagnosis; the system incorporates recording/ transmitting circuitry, a package of firmware and software, and is intended for use by a medical professional
- . The ECG can be recorded and transmitted to a local or remote receiving station for consultation with a medical professional
- The ECG can be recorded and transmitted to a local or remote hand-held device or a . Personal Computer or a printer for viewing and processing
- . Allows patients at remote locations to display and transmit their ECG data to medical professionals via a communication device to a remote server
- . Intended for self-testing by patients and by healtheare professionals at home and in medical settings

Preseription U se (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Bhimmana
Asst. Exe. Engr.

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