(98 days)
Used as a supplement to Holter Monitoring to document infrequent/transient symptoms such as lightheadedness, chest discomfort, palpitations, pre-syncope and syncope events.
Heartrak Smart AT/ Heartrak Smart ² is a patient-activated transtelephonic ECG loop memory monitor which records cardiac patients' symptoms. The patient calls the receiving center, hospital or physician's office from the patient's home. Heartrak Smart AT/Heartrak Smart² converts signals into audio tones which are transmitted over telephone lines. Heartrak Smart AT/Heartrak Smart" is a hand held, portable, externally applied device which is intended for transtelephonic use. Heartrak Smart AT/Heartrak Smart² does not deliver any energy, administer any drugs, or control a patient's life. Heartrak Smart AT/Heartrak Smart² is not a diagnostic tool and performs no diagnostic functions.
The provided text is a 510(k) summary for the Heartrak Smart AT/Heartrak Smart2 device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics.
Therefore, the requested information regarding an acceptance criteria table, detailed study design, sample sizes, expert qualifications, and specific performance results like sensitivity, specificity, or MRMC outcomes is not present in the provided document.
Instead, the document highlights:
- Predicate Device: Heartrak XL (K960499)
- Basis for Substantial Equivalence: Identical intended use, materials, packaging, labeling, method of operation, and manufacturing methods as the predicate device. It also states that the safety and effectiveness are substantially equivalent, and the technological characteristics are equivalent to the predicate and other event recorders.
- Intended Use: As a supplement to Holter Monitoring to document infrequent/transient symptoms such as lightheadedness, chest discomfort, palpitations, pre-syncope, and syncope events.
- Device Function: Patient-activated transtelephonic ECG loop memory monitor which converts signals into audio tones for transmission over telephone lines. It explicitly states it is not a diagnostic tool and performs no diagnostic functions.
In summary, this 510(k) relies on demonstrating similarity to an already approved device rather than providing a new clinical study with the detailed performance metrics requested. Consequently, sections like "Acceptance Criteria," "Reported Device Performance," "Sample Size for Test Set," "Number of Experts," "Adjudication Method," "MRMC Study," "Standalone Performance," "Type of Ground Truth," and "Training Set Information" cannot be filled from the given text.
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FEB = 5 2004 510K SUMMARY
K033451
1 of 2
Applicant's Name, Address, Telephone and Fax Numbers:
Universal Medical, Inc., 101 Ludlow Drive, Ewing, New Jersey 08638; phone-(609-671-1790); fax-(609-671-1765).
Contact Person:
Douglas M. Lurio, Esquire and Margaret Sherry Lurio, Esquire, Lucio & Associates, P.C., Suite 2340, One Commerce Square, 2005 Market Street, Philadelphia, PA 19103, phone-(215)665-9300; Esquire fax-(215)665-8582; email-Douglas M. Lurio, Esquire (doug@luriolaw.com); Margaret Sherry Lurio, (mslu@luriolaw.com).
Classification Name:
Telephone Electrocardiograph Transmitters and Receivers, 21 CFR 870.2920.
Common/Usual Name:
Hand held, portable, externally applied transtelephonic event recorders, which are intended for transtelephonic use.
Proprietary Name:
Heartrak Smart AT/Heartrak Smart2.
Device Description and Intended Use:
Heartrak Smart AT/ Heartrak Smart ² will be manufactured by Universal Medical, Inc. at its offices at 101 Ludlow Drive, 08638. Heartrak Smart AT/Heartrak Smart² is a Ewing, NJ patient-activated transtelephonic ECG loop memory monitor which records cardiac patients' symptoms. The patient calls the receiving center, hospital or physician's office from the patient's home. Heartrak Smart AT/Heartrak Smart² converts signals into audio tones which are transmitted over telephone lines. Heartrak Smart AT/Heartrak Smart" is a hand held, portable, externally applied device which is intended for transtelephonic use. Heartrak Smart AT/Heartrak Smart² does not deliver any energy, administer any drugs, or control a patient's life. Heartrak Smart AT/Heartrak Smart² is not a diagnostic tool and performs no diagnostic functions. There are no patient age limitations for Heartrak Smart AT/Heartrak Smart".
Establishment Registration Number:
No. 2248680
Classification:
In the Federal Reqistration notice of February 5, 1980, relative to Cardiovascular Devices, the FDA identified Telephone Electrocardiograph Transmitters and Receivers as a Class II
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device.
Promotional Material:
Promotional literature and advertisements for the device have not yet been prepared.
Predicate Device:
Heartrak XL (K960499)
Substantial Equivalences:
The Heartrak Smart At/Heartrak Smart² is substantially equivalent to the predicate device. The intended use, materials, packaging, labeling, method of operation and manufacturing methods have been proven to be identical. The safety and effectiveness of these devices is substantially equivalent to the predicate device. There are no known contradictions for use of this type of device. All of the features in one or both of these devices present a non-significant risk to the user.
Address for Manufacturing Site:
Smart AT/Heartrak Smart² will be manufactured by Heartrak Universal Medical, Inc. at its offices at 101 Ludlow Drive, Ewing, New Jersey 08638.
Materials :
The materials used in the manufacture of the Heartrak Smart AT/Heartrak Smart² are identical to the materials used in the predicate device.
Technological Characteristics:
The device is technologically equivalent to the predicate device and other event recorders.
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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 consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The bird is positioned above a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 5 2004
Universal Medical, Inc. c/o Ms. Margaret Sherry Lurio Lurio and Associates, P.C. 2005 Market Street, Suite 2340 Philadelphia, PA 19103-7015
Re: K033451
Trade Name: Heartrak Smart AT/Heartrak Smart 2 Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DXH Dated: January 14, 2003 Received: January 15, 2004
Dear Ms. Lurio:
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 - Ms. Margaret Sherry Lurio
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r vase or as never 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 or any 1 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 Of R Fart 6077, accems (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) I mis lotter will and my Jowne FDA finding of substantial equivalence of your device to a legally premailer noticate 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 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,
Dmnar R. Vochner
(1) 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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Page 1_ of 1
510(k) Number (if known): K033451
Device Name: Heartrak Smart AT/ Heartrak Smart2
Indications for Use:
Used as a supplement to Holter Monitoring to document infrequent/transient symptoms such as lightheadedness, chest discomfort, palpitations, pre-syncope and syncope events.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED:
Concurrence of CDRH, Office of Device Evaluation (ODE)
or
Prescription Use
Over-the Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Daniele R. Vechner
(Division of
Division
510(k) Number: K033451
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
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.(b)
Classification. Class II (performance standards).