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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the pePER device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K060297) details the pePER's compliance with safety, EMC, and device standards, and its substantial equivalence to a predicate device (HEARTCARD® K010945). It does not present specific quantitative acceptance criteria for performance efficacy in detecting or transmitting cardiac events, nor does it report specific performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" are implied by the device's adherence to relevant standards and its demonstrated equivalence to the predicate device in electrical characteristics and data transmission.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Electrical Safety	Compliance with IEC 60601-1 and related amendments	"The pePER meets the set requirements and is in compliance for this device type." (Implicitly, passes all tests under these standards)
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 and CISPR 11:1997/IEC 55011	"The pePER meets the set requirements and is in compliance for this device type." (Implicitly, passes all tests under these standards)
Diagnostic ECG Device Standards	Compliance with AAMI EC11:1991	"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."
Functional Equivalence (Electrical Characteristics & Data Transmission)	Equivalence to HEARTCARD® (K010945) in main electrical and transmission characteristics.	"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." (A detailed "Characteristics Comparison and Transmission Validation" document is appended, but not provided in the excerpt)
Risk Management	Identification and mitigation of failure modes, with acceptable risk levels.	"A risk analysis is appended... 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." (Implicitly, all identified risks are appropriately managed)

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a separate "test set" in the context of clinical performance evaluation (e.g., a set of patient ECGs used to evaluate the device's diagnostic accuracy). The testing described relates to electrical safety, EMC, and functional characteristics against a predicate device.

Sample Size for Functional Testing: Not explicitly stated as a number of "samples" in the clinical sense. The comparison was based on "data transmissions and the measurements of the main functional characteristics."
Data Provenance: Not applicable in the sense of patient data. The testing was technical in nature, comparing the pePER to the HEARTCARD® device. The manufacturing entity is based in Australia ("Medical Monitors Limited, Eastgardens NSW 2036, Australia").

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided because the submission primarily focuses on technical equivalence and compliance with engineering standards rather than a clinical performance study requiring expert adjudication of ground truth for a test set of patient data.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not conducted or described. The pePER is a "Personal Event Recorder" intended to capture and transmit ECGs for physician review, not an AI-powered diagnostic tool that assists human readers. The submission focuses on the device's technical specifications and equivalence to a predicate device, not on AI-assisted interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The pePER is a hardware device for recording and transmitting ECGs. It does not perform automated diagnostic interpretation or analysis in a "standalone" algorithmic sense that would require such a study. The physician reviews the transmitted ECGs.

7. The Type of Ground Truth Used

The concept of "ground truth" in the diagnostic performance sense (e.g., pathology, outcomes data) is not used or described in this submission. The "truth" or reference for the device's performance is its adherence to industry standards (electrical, EMC, diagnostic ECG device) and its functional equivalence to a legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. The pePER is a physical device, and this submission does not describe an artificial intelligence algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of an AI algorithm or a training set.

Summary

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K060297

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 TowerEastgardens NSW 2036Australia

1. 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.
1. Classification Name: Telephone electrocardiograph transmitter and receiver
1. Common Name: Post-Event ECG Personal Event Recorder
1. 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:

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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:

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.

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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:

AustralianStandard	InternationalStandard	Description
AS 3200.1	IEC 60601-1	Medical electrical equipment - Part 1: Generalrequirements for safety
AS3200.1.1	IEC 60601-1-A1	Amendment 1 to Medical electrical equipment -Part 1: General requirements for safety
AS3200.1.2	IEC 60601-1-2	Electromagnetic compatibility (EMC)
AS 2064.1	CISPR11:1997IEC 55011	Limits and Methods of Measurement of RadioInterference Characteristics of Industrial,Scientific and Medical (ISM) Radio FrequencyEquipment
-
-	AAMIEC11:1991	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.

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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.

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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

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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

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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

Page 1 of 1

Regulation Number and Section

§ 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).