(140 days)
The heartEVENT^T 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.
The heartEVENT* is a battery operated transtelephonic ECG event recorder and transmitter that is capable of storing multiple electrocardiograms. The transmission of these recordings is by telephone to a receiving system.
The heartEVENTAT has two operating modes – manual and automatic trigger.
In the manual mode, the heartEVENT^T stores the ECG before and after the 'record' button is depressed. The recording period is preset up to 80 seconds with 2 manually activated recordings stored.
The heartEVENTAT also has an automatic triggering function where recording is automatically activated when the user experiences a cardiac symptom. Cardiac symptoms captured by the auto-trigger function include bradycardia, pause and atrial fibrillation.
The heartEVENT^T is configured with 'pre' and 'post' event memories with a total ECG recording time for up to 320 sec.
The stored ECGs are transmitted by acoustic output by coupling the telephone mouthpiece over the heartEVENTAT by manually depressing the 'send' button.
This 510(k) submission (K072385) for the heartEVENTAT ECG Recorder with Auto-Trigger does not contain the detailed information necessary to answer all parts of your request about acceptance criteria and study proving device meets them.
The document is a summary for a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (KING OF HEARTS EXPRESS + AF MONITOR, K020825). While it states that the heartEVENTAT shares similar technology and "indicated no adverse indications or results" based on testing, it does not provide the specifics of those tests, acceptance criteria, or performance metrics in the way you've outlined.
Here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (Explicitly Stated in Document) |
|---|---|
| N/A - Not explicitly stated | "heartEVENTAT indicated no adverse indications or results" |
| "Same or better specifications and characteristics" than the predicate device | "heartEVENTAT has the same or better specifications and characteristics and is substantially equivalent to the KING OF HEARTS EXPRESS + AF MONITOR (K020825)." |
| Device is "safe and effective" | "It is our determination that the heartEVENTAT is safe and effective, performing within its design specifications..." |
Missing Information: The document does not provide specific, quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy, detection rates for specific cardiac events) or corresponding numerical performance results for the device. The claims are qualitative and based on comparison to the predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing Information: The document makes no mention of a specific clinical "test set" with a defined sample size. It refers to "testing" in a general sense, but no details of the number of patients, recordings, or the nature of the data (e.g., retrospective vs. prospective, country of origin) are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Missing Information: Since no explicit clinical test set or study is detailed, there is no information on experts used to establish ground truth or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing Information: No adjudication method is mentioned as there is no detailed information on a test set or ground truth establishment process.
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
Missing Information: This device is a direct-to-patient ECG event recorder with an auto-trigger function, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not applicable and not mentioned in the document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Information Provided: The device has an "automatic triggering function where recording is automatically activated when the user experiences a cardiac symptom." This implies a standalone algorithm for detecting specific cardiac events (bradycardia, pause, and atrial fibrillation) to initiate recording.
Missing Information: While the device has an auto-trigger algorithm, the document does not present a standalone performance study with specific metrics (e.g., sensitivity, specificity for AF detection) for this algorithm. It only states that the device is "safe and effective, performing within its design specifications."
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Missing Information: The document does not specify the type of ground truth used, as no detailed study or validation is described. For devices like this, ground truth would typically be established by physician review of ECG recordings.
8. The sample size for the training set
Missing Information: No information is provided about a "training set" or any machine learning model training process. This implies that the auto-trigger functions were likely implemented using more traditional signal processing and rule-based algorithms rather than modern large-scale machine learning, or details are simply not included in this summary.
9. How the ground truth for the training set was established
Missing Information: As no training set is mentioned, there is no information on how its ground truth was established.
In summary: This 510(k) submission is a high-level summary primarily focused on demonstrating substantial equivalence to a predicate device. It does not contain the granular detail about acceptance criteria, specific study designs (like randomized controlled trials or large-scale validation studies), sample sizes, expert qualifications, or detailed performance metrics that your request seeks. This level of detail is typically found in full study reports or more comprehensive technical documentation, which are not usually included in a public 510(k) summary.
{0}------------------------------------------------
DIAGNOSTIC DEVICES
ACN 119 788 582
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is: K072385
Submitter Information (21 CFR 807.92(a)(l))
| Submitter's Name: | Diagnostic Devices Pty Ltd | |
|---|---|---|
| Submitter's Address: | Suite 405, Westfield Office TowerEastgardens NSW 2036Australia | JAN 11 2008 |
| Contact Person: | Harry Platt | |
| Telephone: | +61 2 8347 2244 Australia203 654 7093 USA | |
| Fax: | +61 2 8347 2299 Australia | |
| Date Prepared: | 21st August 2007 |
Name of Device and Classification (21 CFR 807.92(a)(2))
| Classification Name: | Telephone electrocardiograph transmitter and receiver |
|---|---|
| Common Name: | heartEVENT-AT ECG Recorder with Auto-Trigger |
| Proprietary Name: | heartEVENTAT |
| Product Code: | DXH |
| C.F.R. Section: | 870.2920 |
| Classification: | Class II - Performance Standards |
- Classification Panel: Cardiovascular
Diagnostic Devices Pty. Ltd. Suite 405 Office Tower Westfield Eastgardens Eastgardens N.S.W. 2036 Australia Tel +61 2 8347 2244 Fax +61 2 8347 2299
Page 1 of 3
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for Diagnostic Devices. The logo consists of the letters DD in a stylized font, with the word "DIAGNOSTIC DEVICES" written in all caps to the right of the letters. Below the company name is the text "ACN 119 781 532".
Identification of Legally Marketed Predicate Device (21 CFR 807.92 (a)(3))
- Predicate Name: KING OF HEARTS EXPRESS + AF MONITOR
- Predicate Manufacturer: CARD GUARD SCIENTIFIC SURVIVAL LTD.
- Predicate 510(k) Number: K020825
This legally marketed predicate device was used to determine substantial equivalence in accordance with 21 CFR 807.92(a)(3).
The KING OF HEARTS EXPRESS + AF MONITOR (K020825) is a transtelephonic cardiac event recorder. When an ECG is recorded on the King of Hearts Express AF, the stored ECG it can be transmitted via telephone. Along with being able to record patient-activated events, the recorder also has the ability to detect asymptomatic events with auto-triggers capable of automatically capturing atrial fibrillation, tachycardia and bradycardia.
Device Description (21 CFR 807.92 (a)(4))
Device Description Summary:
The heartEVENT* is a battery operated transtelephonic ECG event recorder and transmitter that is capable of storing multiple electrocardiograms. The transmission of these recordings is by telephone to a receiving system.
The heartEVENTAT has two operating modes – manual and automatic trigger.
In the manual mode, the heartEVENT^T stores the ECG before and after the 'record' button is depressed. The recording period is preset up to 80 seconds with 2 manually activated recordings stored.
The heartEVENTAT also has an automatic triggering function where recording is automatically activated when the user experiences a cardiac symptom. Cardiac symptoms captured by the auto-trigger function include bradycardia, pause and atrial fibrillation.
The heartEVENT^T is configured with 'pre' and 'post' event memories with a total ECG recording time for up to 320 sec.
The stored ECGs are transmitted by acoustic output by coupling the telephone mouthpiece over the heartEVENTAT by manually depressing the 'send' button.
Page 2 of 3
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for Diagnostic Devices. The logo consists of a stylized "DD" symbol on the left, followed by the words "DIAGNOSTIC DEVICES" in a sans-serif font. Below the words "DIAGNOSTIC DEVICES" is the text "ACN 119 788 582". There is also some text in the upper right corner that is difficult to read.
Intended Use (21 CFR 807.92 (a)(5))
Intended Use:
The heartEVENT^T 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.
Precautions and Contraindications for Use:
The HeartEVENT^] should be used in accordance with the instructions as indicated in the heartEVENTAT User Manual or as directed by a physician.
The HeartEVENT^T is contraindicated for use in combination with external cardiac defibrillators or any other high frequency surgical equipment. The patient leads must be disconnected prior to performing any procedure utilizing this equipment.
Similarities to the Predicate (21 CFR 807.92 (a)(6))
Substantial Equivalence:
The KING OF HEARTS EXPRESS + AF MONITOR (K020825) legally marketed predicate device was used to determine substantial equivalence in accordance with 21 CFR 807.92(a)(3).
The specifications and characteristics of the predicate device, KING OF HEARTS EXPRESS + AF MONITOR (K020825), were compared to the heartEVENTAT
The results of this comparison indicate that the heartEVENTAT has the same or better specifications and characteristics and is substantially equivalent to the KING OF HEARTS EXPRESS + AF MONITOR (K020825).
Safety and Effectiveness:
The heartEVENTAT utilises similar technology currently found in the legally marketed predicate device. Based on testing and comparison with the predicate device, the heartEVENTAT indicated no adverse indications or results.
It is our determination that the heartEVENTAT is safe and effective, performing within its design specifications and is substantially equivalent to the predicate device.
Page 3 of 3
{3}------------------------------------------------
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
JAN 1 1 2008
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
Diagnostic Devices, PTY, Ltd., c/o Mr. Harry Platt Project Manager Suite 405, Office Tower Westfield Eastgardens Eastgardens, NSW 2306 AUSTRALIA
Re: K072385
Trade/Device Name: HeartEVENTAT ECG Event Recorder with Auto-Trigger Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DXH Dated: January 2, 2008 Received: January 7, 2008
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 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 (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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Bhimmeron fr
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
4. INDICATIONS FOR USE STATEMENT
INDICATIONS FOR USE STATEMENT
Applicant: Diagnostic Devices Pty Ltd
K072385 510(k) Number (if known):
Device Name: heartEVENTAT
Indications for Use:
The heartEVENT^T 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, presyncope or palpitations.
Contraindications for Use:
The HeartEVENT^ is contraindicated for use in combination with external cardiac defibrillators or any other high frequency surgical equipment. The patient leads must be disconnected prior to performing any procedure utilizing this equipment.
Prescription Use > (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)
Blommers
§ 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).