(177 days)
No
The description focuses on basic ECG recording and transmission technology, with no mention of AI/ML for analysis or interpretation.
No
The device is described as an ECG event recorder and transmitter used for diagnosis, not for treating any condition.
Yes
The device is described as an "ECG event recorder and transmitter" that captures electrocardiograms for patients experiencing symptoms suggesting "cardiac arrhythmia, conduction abnormalities or other rhythm disturbances." This indicates its use in identifying or diagnosing medical conditions.
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 functionality, 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.
- Device Function: The pePER is an ECG event recorder. It records electrical activity of the heart directly from the patient's body and transmits this data. It does not analyze samples taken from the body.
- Intended Use: The intended use describes the device being used by patients to record their own cardiac events, not to analyze biological samples.
Therefore, the pePER falls under the category of a medical device that monitors physiological signals, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The pePER 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
DXH
Device Description
The pePER 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 pePER stores the ECG after the `record' button is depressed. The recording period is preset up to 40 seconds with 2 recordings stored. The stored ECGs are transmitted by acoustic output by coupling the telephone mouthpiece over the pePER.
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, HEARTCARD® (K010945), were compared to the pePER ('pePER -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 the pePER Transtelephonic ECG Recorder, when compared to the HEARTCARD® (K010945), indicate that the pePER is substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
FDA Request for Advillanal Information » July levice Narde, perfilifo 54000 Number 16060287 viedical Monitors L'd
AUG 0 2 2006
Traditional 510(k) Summary
The following information is being submitted in conformance with 21 CFR 807.87(h):
| 1. | Submitter's Name: | Medical Monitors Limited |
|---|---|---|
| Submitter's Address: | Suite 407, Westfield Office Tower | |
| Eastgardens NSW 2036 | ||
| Australia |
-
- Richard Hyman Contact Person: Telephone: +61 2 9344 8100 +61 2 9344 8200 Fax: rhyman@medmon.com.au Email:
- Date Prepared: 31st January 2006 3.
-
- Classification Name: Telephone electrocardiograph transmitter and receiver
-
- Common Name: Post-Event ECG Personal Event Recorder
-
- Proprietary Name: pePER
| 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 pePER 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 pePER stores the ECG after the `record' button is depressed. The recording period is preset up to 40 seconds with 2 recordings stored. The stored ECGs are transmitted by acoustic output by coupling the telephone mouthpiece over the pePER.
1
FDA Request for Additional Information - July 2006 Deside Norman bestifik - 510gt) Number K060297 网站群体育官网官网下载 be
12. Intended Use:
The pePER 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.
13. Establishment Registration Number: 9618016
| 14. | Substantial Equivalence: | Legally marketed predicate device | |
|---|---|---|---|
| 510(k) NUMBER | PRODUCT | MANUFACTURER | |
| K010945 | HEARTCARD® | INSTROMEDIX, INC |
15. Comparison of Electrical Characteristics and Data Transmission
The main electrical and transmission characteristics of the predicate device, HEARTCARD® (K010945), were compared to the pePER ('pePER -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 the pePER Transtelephonic ECG Recorder, when compared to the HEARTCARD® (K010945), indicate that the pePER is substantially equivalent.
2
5DA Request for Adailional Information - July 2006 ිlevice Name: paPER 510(k) Number K060297 Medical Monitors Lici
16. Summary of Safety:
The pePER 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 pePER in accordance with the requirements the above listed standards. In addition, testing was performed, where applicable, in accordance with AAMI EC11:1991.
The pePER meets the set requirements and is in compliance for this device type.
17. Risk Analysis:
.
A risk analysis is appended (Risk Analysis - pePER Transtelephonic ECG Recorder). The analysis identifies possible failure modes. For failure modes considered to be of medium or high probability of occurrence. system design 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 and Contraindications for Use:
The pePER has no known contraindications, however, it should be used in accordance with the instructions as indicated in the pePER User Manual or as directed by a physician.
3
FDA Request for Additional Information -- July 2006 ිෂණය Name: paPER Viedical Monitors Lid
19. Regulatory Approvals:
The pePER has the following requlatory approvals:
Australian Communications Authority C-Tick - N3769
20. Labeling:
The pePER labels appended are in conformance with 21 CFR 801 (Labeling)
- Key sheet label (i)
- Serial number label (ii)
Additional Support Documents: 21.
Included here to support our claims for the safety and efficacy of the pePER are the following additional documents:
- Predicate Device Specification Comparison Chart (i)
- Truthful and Accurate Statement (ii)
- 510(K) Statement ( iii )
- (iv) Indications for Use Statement
- Image of the pePER (v)
- pePER Front Panel Keysheet (vi)
- (vii) pePER Back Panel Serial Number Label and Setup Label
- pePER Characteristics Comparison & Transmission Validation (viiii)
- pePER Risk Analysis (ix)
- pePER User Manual (x)
- pePER Patient Guide (xi)
22. Conclusion - Safety and Effectiveness:
The pePER utilises similar technology currently found in legally marketed predicate devices. Based on testing and comparison with the predicate device, the pePER indicated no adverse indications or results.
It is our determination that the pePER is safe, effective and performs within its design specifications and is substantially equivalent to the predicate device.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter of the circle. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 2 2006
Medical Monitors Limited c/o Mr. Richard Hyman Suite 407, Westfield Office Tower Eastgardens NSW 2036 Australia
IRe: K060297
Trade/Device Name: pePER Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DXH Dated: July 25, 2006 Received: July 27, 2006
Dear Mr. Hyman:
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 Codc 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 vour 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
5
Page 2 - Mr. Richard Hyman
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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
B/leumicma for
Brett D. Zuckerman, M.D.
Bran D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K060297
Device Name: pePER
Indications for Use:
The pePER is indicated for use by patents 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.
| Prescription Use | X |
|---|---|
| (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhamuna
ision Sign-( Division of Caralovascular Devices 510(k) Number
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