(185 days)
The CardioSen'C device is intended to condition an electrocardiographic signal so that it can be transmitted acoustically via telephone and/or digitally over cellular network to a remote location. The CardioSen'C device is designed to be used by a patient to transmit a 12 lead ECG and rhythm strip in real-time to a physician's office, hospital or other medical receiving center.
The CardioSen'C is a personal, battery powered, hand-held personal ECG transmitter, enabling an individual to immediately transmit a 12-lead ECG and a rhythm strip from a remote location, to a physician's office, hospital or monitoring center. The ECG data can be transmitted in real time via two communication methods. The CardioSen'C produces an ECG frequency modulated acoustical tone that can be coupled with and transmitted by a standard or a cellular telephone. The ECG data can also be transmitted digitally through the cellular network. Either one of these two transmissions methods permits the transfer of a 12-lead ECG and rhythm strip to the medical professional capable of interpreting the data.
The CardioSen'C device is a personal, battery-powered, hand-held personal ECG transmitter. It enables an individual to immediately transmit a 12-lead ECG and a rhythm strip from a remote location to a physician's office, hospital, or monitoring center. The ECG data can be transmitted in real-time via two communication methods: an ECG frequency modulated acoustical tone that can be coupled with and transmitted by a standard or cellular telephone, or digitally through the cellular network.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document states that the CardioSen'C device has been tested against various standards. However, it does not provide a specific table of acceptance criteria with corresponding performance metrics. It indicates adherence to general standards and a conclusion of safety and effectiveness.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| General Electrophysiological/Diagnostic Performance & Safety Standards: - Compliance with ANSI/AAMI EC11-1991 (Diagnostic Electrocardiographic Devices) - Compliance with IEC 60601-2-25 (1993) +A1:1999 requirements for the safety of electrocardiographs - Ability to condition an electrocardiographic signal for transmission - Ability to transmit 12-lead ECG and rhythm strip acoustically via telephone - Ability to transmit 12-lead ECG and rhythm strip digitally over cellular network | The document broadly states that "Further IVD study has shown that the system meets its design specifications and is safe and effective for its intended use." It also concludes that "The results of tests studies and analyses performed with the CardioSen'C device demonstrate that the CardioSen'C device is as safe and effective as its predicate devices without raising any new safety and\or effectiveness concerns." Specifically, the device is reported to be capable of: - "Conditioning an electrocardiographic signal so that it can be transmitted acoustically via telephone and/or digitally over cellular network to a remote location." - "Transmitting a 12-lead ECG and rhythm strip in real-time to a physician's office, hospital or other medical receiving center." |
| Substantial Equivalence: - Same intended use as predicate devices. - Capable of transmitting acoustically via customary telephones (like CardioBeeper® CB 12/12). - Capable of transmitting digitally over cellular network (like River -1). - No new safety and/or effectiveness concerns compared to predicate devices. | The CardioSen'C device is stated to have "the same intended use and is capable of transmitting the electrocardiographic signal acoustically via customary telephones as the CardioBeeper® CB 12/12. Further, the CardioSen'C can transmit digitally over cellular network to a remote location as the River -1 device. The results of tests studies and analyses performed with the CardioSen'C device demonstrate that the CardioSen'C device is as safe and effective as its predicate devices without raising any new safety and\or effectiveness concerns." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text mentions "Further IVD study has shown that the system meets its design specifications." However, no specific sample size for the test set or information regarding data provenance (e.g., country of origin, retrospective or prospective) is provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications. The device transmits ECG data to medical professionals capable of interpreting the data, implying their role in eventual interpretation, but this is distinct from establishing ground truth for a device validation study.
4. Adjudication Method for the Test Set
No information about an adjudication method for the test set is provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of how much human readers improve with AI vs. without AI assistance. The CardioSen'C is an ECG transmission device, not an AI-powered diagnostic tool in the sense of assisting human readers with interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document describes the device as a "transmitter" to be used by a patient to send data to a "medical professional capable of interpreting the data." This indicates that the device is not intended for standalone diagnostic interpretation (i.e., algorithm only without human-in-the-loop performance). Its function is to condition and transmit the signal for human interpretation.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any testing. Given the nature of the device as an ECG transmitter, the ground truth for its performance would primarily relate to the accuracy and fidelity of the transmitted ECG signal compared to the actual electrical activity of the heart. This would likely involve comparisons to a gold-standard ECG recording device, but the document does not elaborate on this.
8. Sample Size for the Training Set
No information about a training set or its sample size is provided. The device's validation focuses on its ability to accurately transmit ECG signals, which typically doesn't involve machine learning training sets in the way an AI diagnostic algorithm would.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, there is no information on how its ground truth was established.
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JUL 11 2008
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510(K) SUMMARY
CardioSen'C
510(k) Number K 080047
| Applicant's Name: | SHL Telemedicine International Ltd.90 Igal Alon St.Tel Aviv 67891ISRAELTel (972)3-561-2212Fax (972)3-624-2414 |
|---|---|
| ------------------- | ----------------------------------------------------------------------------------------------------------------------------------- |
- Contact Person: Yoram Levy, Qsite 31 Haavoda St. Binyamina, Israel 30500 Tel (972)4-638-8837; Fax (972)4-638-0510 Yoram@gsitemed.com
- Trade Name: CardioSen'C
- Classification: Name: Telephone electrocardiograph transmitter and receiver Product Code: DXH Regulation No: 21 CFR 870.2920 Class: II Panel: Cardiovascular
Device Description: The CardioSen'C is a personal, battery powered, hand-held personal ECG transmitter, enabling an individual to immediately transmit a 12-lead ECG and a rhythm strip from a remote location, to a physician's office, hospital or monitoring center.
The ECG data can be transmitted in real time via two communication methods. The CardioSen'C produces an ECG frequency modulated acoustical tone that can be coupled with and transmitted by a standard or a cellular telephone. The ECG data can also be transmitted digitally through the cellular network. Either one of these two transmissions methods permits the transfer of a 12-lead ECG and rhythm strip to the medical professional capable of interpreting the data.
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Intended Use Statement:
The CardioSen'C device is intended to condition an electrocardiographic signal so that it can be transmitted acoustically via telephone and/or digitally over cellular network to a remote location. The CardioSen'C device is designed to be used by a patient to transmit a 12 lead ECG and rhythm strip in real-time to a physician's office, hospital or other medical receiving center.
Predicate Devices:
The CardioSen'C is substantially equivalent to the following predicate devices:
- CardioBeeper ® CB 12/12, 12 Lead Personal ECG Transmitter, . cleared under K002310;
- River 1, ECG Event Recorder and Transmitter, cleared under . K063609.
Performance Data:
The CardioSen'C device has been tested according to various standards and guidance documents, such as ANSI/AAMI EC11-1991 (Diagnostic Electrocardiographic Devices), IEC 60601-2-25 (1993) +A1:1999 requirements for the safety of electrocardiographs, etc. Further IVD study has shown that the system meets its design specifications and is safe and effective for its intended use.
Conclusions:
The CardioSen'C device has the same intended use and is capable of transmitting the electrocardiographic signal acoustically via customary telephones as the CardioBeeper® CB 12/12. Further, the CardioSen'C can transmit digitally over cellular network to a remote location as the River -1 device. The results of tests studies and analyses performed with the CardioSen'C device demonstrate that the CardioSen'C device is as safe and effective as its predicate devices without raising any new safety and\or effectiveness concerns.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 11 2008
SHL TeleMedicine International LTD c/o Qsite Mr. Yoram Levy 31 Haavoda St. Binyamina, 30500 ISRAEL
Re: K080047
CardioSens'C Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DXH Dated: June 22, 2008 Received: June 27, 2008
Dear Mr. Levy:
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 – Mr. Yoram Levy
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); labcling (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,
Qamde
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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
CardioSen'C
Indications for Use:
The CardioSen'C device intended to is condition an electrocardiographic signal so that it can be transmitted acoustically via telephone and/or digitally over cellular network to a remote location. The CardioSen'C device is designed to be used by a patient to transmit a 12 lead ECG and rhythm strip in real-time to a physician's office, hospital or other medical receiving center.
X 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)
(Division Sign-off) Division of Cardiovascular, Respiratory and Neurological Devices 510(k) Number
ces
(Division Sign-Off)
Division of Cardiovascular Devices
Section 1 - Page 2 CardioSen'C - 510k Notifica
§ 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).