(153 days)
No
The device description and performance studies focus on basic ECG recording and transmission technology, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is an ECG event recorder and transmitter, primarily used for diagnosis and monitoring of cardiac rhythm disturbances, not for treatment.
Yes
The device is described as an "ECG event recorder and transmitter" that captures and stores electrocardiograms for patients experiencing symptoms suggesting cardiac arrhythmia or other rhythm disturbances. This process of recording and transmitting physiological data to identify and characterize medical conditions falls under diagnostic activities.
No
The device description explicitly states it is a "battery operated transtelephonic ECG event recorder and transmitter," indicating it is a hardware device with software components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- Device Function: The PER is described as a "transtelephonic ECG event recorder and transmitter." It records electrocardiograms (ECGs), which are measurements of the electrical activity of the heart. This is a measurement taken from the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is to record transient symptoms that may suggest cardiac arrhythmia, conduction abnormalities, or other rhythm disturbances. This is a diagnostic tool used to capture physiological data directly from the patient.
Therefore, the PER falls under the category of a medical device used for physiological monitoring and recording, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PER is indicated for use by patients as directed by a physician, who experience transient symptoms that may suggest cardiac arrhythmia, conduction abnormalities or other rhythm disturbances that may result in shortness of breath, pre-syncope or palpitations.
Product codes (comma separated list FDA assigned to the subject device)
DXH
Device Description
The PER is a battery operated transtelephonic ECG event recorder and transmitter that is capable of storing multiple electrocardiograms and the transmission of these recordings by telephone to a receiving system. The PER stores the ECG before and after the `record' button is depressed. The recording period is preset up to 80 seconds with 2 recordings stored. The stored ECGs are transmitted by acoustic output by coupling the telephone mouthpiece over the PER
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The main electrical and transmission characteristics of the predicate device, KING OF HEARTS® EXPRESS (K920984), were compared to the PER Recorder ("PER- Characteristics Comparison and Transmission Validation' is appended). A specification comparison chart is also appended indicating the device similarities and equivalence.
The results of data transmissions and the measurements of the main functional characteristics of PER Transtelephonic ECG Recorder, when compared to the KING OF HEARTS® EXPRESS (K920984), indicate that the PER is substantially equivalent and gave better performance results for a number of key characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Traditional 510(k) Summary
The following information is being submitted in conformance with 21 CFR 807.87(h):
| 1. ' | Submitter's Name:
Submitter's Address: | Medical Monitors Limited
Suite 407, Westfield Office Tower
Eastgardens NSW 2036
Australia |
|------|-------------------------------------------------|----------------------------------------------------------------------------------------------------|
| 2. | Contact Person:
Telephone:
Fax:
Email: | Harry L. Platt
+61 2 9344 8100
461 2 9344 8200
hplatt@medmon.com.au |
| 3. | Date Prepared: | 6th January 2003 |
| 4. | Classification Name: | Telephone electrocardiograph transmitter and
receiver |
| 5. | Common Name: | Transtelephonic ECG Event Recorder |
| 6. | Proprietary Name:
Model Number: | PER
Memo |
| 7. | Product Code: | DXH |
| 8. | C.F.R. Section: | 870.2920 |
| 9. | Classification: | Class II - Performance Standards |
| 10. | Classification Panel: | Cardiovascular |
11. Device Description:
The PER is a battery operated transtelephonic ECG event recorder and transmitter that is capable of storing multiple electrocardiograms and the transmission of these recordings by telephone to a receiving system. The PER stores the ECG before and after the `record' button is depressed. The recording period is preset up to 80 seconds with 2 recordings stored. The stored ECGs are transmitted by acoustic output by coupling the telephone mouthpiece over the PER
12. Intended Use:
The PER is indicated for use by patients as directed by a physician, who experience transient symptoms that may suggest cardiac arrhythmia, conduction abnormalities or other rhythm disturbances that may result in shortness of breath, pre-syncope or palpitations.
1
Medical Monitors Limited
Establishment Registration Number: 9618016 13.
| 14. | Substantial Equivalence: | Legally marketed predicate device | ||
|---|---|---|---|---|
| 510(k) NUMBER | PRODUCT | MANUFACTURER | ||
| K920984 | KING OF HEARTS® EXPRESS | INSTROMEDIX, INC |
Comparison of Electrical Characteristics and Data Transmission 15.
The main electrical and transmission characteristics of the predicate device, KING OF HEARTS® EXPRESS (K920984), were compared to the PER Recorder ("PER- Characteristics Comparison and Transmission Validation' is appended). A specification comparison chart is also appended indicating the device similarities and equivalence.
The results of data transmissions and the measurements of the main functional characteristics of PER Transtelephonic ECG Recorder, when compared to the KING OF HEARTS® EXPRESS (K920984), indicate that the PER is substantially equivalent and gave better performance results for a number of key characteristics.
16. Summary of Safety:
The PER has been tested in accordance with the requirements of the following safety, EMC and device standards:
| Australian
Standard | International
Standard | Description |
|------------------------|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| AS 3200.1 | IEC 60601-1 | Medical electrical equipment - Part 1: General
requirements for safety |
| AS 3200.1.1 | IEC 60601-1-A1 | Amendment 1 to Medical electrical equipment - Part 1:
General requirements for safety |
| AS 3200.1.2 | IEC 60601-1-2 | Electromagnetic compatibility (EMC) |
| AS 2064.1 | CISPR 11:1997
IEC 55011 | Limits and Methods of Measurement of Radio Interference
Characteristics of Industrial, Scientific and Medical (ISM)
Radio Frequency Equipment |
| - | AAMI
EC11:1991 | Diagnostic electrocardiographic devices |
Electrical safety and EMC testing was performed on the PER in accordance with the requirements the above listed standards. In addition, testing was performed, where applicable, in accordance with AAMI EC11:1991.
The PER meets the set requirements and is in compliance for this device type.
17. Risk Analysis:
A risk analysis is appended (Risk Analysis – PER Transtelephonic ECG Recorder). The analysis identifies possible failure modes. For failure modes considered to be of medium or high probability of occurrence, system design
2
features and procedures used to mitigate the associated hazard are listed. For failure modes considered being of low probability, reasons for low probability estimates are given.
18. Precautions:
The PER has no known contraindications, however, it should be used in accordance with the instructions as indicated in the PER User Manual or as directed by a physician.
19. Regulatory Approvals:
The PER has the following requlatory approvals:
Australian Therapeutic Goods Listing - AUST L60797 Australian Communications Authority C-Tick - N3769
20. Labeling:
The PER labels appended are in conformance with 21 CFR 801 (Labeling)
- Key sheet label (i)
- Serial number label ( ii )
21. Additional Support Documents:
Included here to support our claims for the safety and efficacy of the PER are the following additional documents:
- (i) Predicate Device Specification Comparison Chart
- Truthful and Accurate Statement ( ii )
- 510(K) Statement (iii)
- (iv) Indications for Use Statement
- Image of the PER (v)
- (vi) PER Front Panel Keysheet
- PER Back Panel Serial Number Label and Setup Label (vii)
- Australian Therapeutic Goods Administration Listing (viii)
- PER Characteristics Comparison & Transmission Validation (ix)
- (x) PER Risk Analysis
- PER User Manual (xi)
- PER Patient Guide (xii)
22. Conclusion - Safety and Effectiveness:
The PER utilises similar technology currently found in legally marketed predicate devices. Based on testing and comparison with the predicate device, the PER indicated no adverse indications or results.
It is our determination that the PER is safe, effective and performs within its design specifications and is substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2003
Medical Monitors Limited c/o Mr. Harry L. Platt Executive Director Suite 407, Westfield Office Tower Eastgardens NSW 2036 Australia
Re: K030218
Trade Name: PER Regulation Number: 21 CFR 870.2920 Regulation Name: Regulatory Class: Class II (two) Product Code: DXH Dated: April 29, 2003 Received: May 2, 2003
Dear Mr. Platt:
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.
4
Page 2 -- Mr. Harry L. Platt
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 (OS) 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 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
5
Indications for Use Statement
Ver/ 3 - 4/24/96
Applicant: Medical Monitors Limited
510(k) Number (if known):
Device Name: PER Memo
Indications For Use:
The PER is indicated for use by patients as directed by a physician, who experience transient symptoms that may suggest cardiac arrhythmia, conduction abnormalities or other rhythm disturbances that may result in shortness of breath, pre-syncope or palpitations.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109)
N. De Ge T.A
510(k) Num
Prescription Use Only
(Optional Format 1-2-96)