(282 days)
The River-1 is indicated for the evaluation of patients who experience transient symptoms such as dizziness, palpitations, syncope, or chest pain that might suggest arrhythmia. The device is intended to record cardiac activity associated with those infrequent and transient symptoms. Once the data is recorded, the patient transmits this ECG data over the telephone or cellular network to a remote central receiving station to be reviewed by a healthcare professional.
The River-1 is a patient activated electrocardiograph (ECG) symptomatic event recorder and transmitter. The River is a looping type ECG recording device (it records the ECG continuously). When the patient presses the ECG Record Button to record an ECG, the device stores both the recently recorded ECG and the ECG, following activation. The recorded ECG can then be transmitted to a healthcare facility or receiving center via two distinct channels: digitally via cellular network or acoustically via any phone.
The River-1 is a portable programmable device which is worn on the belt of the patient. It features a simple LCD screen, key pad, and is powered by a rechargeable battery. It can accommodate up to three leads for the option of recording 1, 2, or 3 lead ECG data.
This 510(k) submission for the River-1 Electrocardiograph (ECG) Recorder and Transmitter is a premarket notification for a medical device. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing extensive clinical study data with detailed performance metrics against specific acceptance criteria.
Therefore, the provided text does not contain the detailed information required to fill out the requested table regarding acceptance criteria and performance, nor does it describe a study that proves the device meets specific acceptance criteria in the way a clinical trial would.
Here's why and what information can be extracted or inferred:
- Focus on Substantial Equivalence: The core of a 510(k) is to show that a new device is as safe and effective as a predicate device already on the market. This often relies on technological comparisons, not necessarily new, extensive clinical studies with quantitative acceptance criteria for performance.
- Lack of Specific Clinical Study Details: The document mentions "Indications For Use" but does not detail a specific clinical study with a defined test set, ground truth, expert involvement, or statistical analysis of performance against pre-defined acceptance criteria, which would be typical for a PMA or a more rigorous clinical validation study.
- "Study that proves the device meets the acceptance criteria" Missing: There is no description of such a study in the provided text. The FDA's review in this context is about substantial equivalence, not typically about directly "proving" new performance against novel quantitative criteria.
Given these limitations, I will extract what can be inferred from the document and explicitly state what information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Metric | Acceptance Threshold | Reported Device Performance | Comments |
|---|---|---|---|---|
| Not provided in the document. The 510(k) focuses on substantial equivalence to predicate devices, not on explicit, quantitative acceptance criteria for performance in a new clinical study. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document does not describe a clinical test set for performance evaluation in the typical sense.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: No. This device is an ECG recorder and transmitter, not an AI-powered diagnostic imaging tool that would typically involve a multi-reader, multi-case study to assess AI assistance. The "review by a healthcare professional" is mentioned as a human interpretation step after data transmission.
- Effect Size of AI Assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not explicitly described for a specific algorithm. The device "records cardiac activity" and transmits it for review by a healthcare professional. This implies a human-in-the-loop system. The 510(k) for this type of device primarily ensures the accurate recording and transmission of ECG data, not independent algorithmic diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not specified in relation to a performance evaluation study. For substantial equivalence, the "ground truth" implicitly aligns with the established performance of the predicate devices.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is not described as utilizing machine learning or AI that would require a "training set" in the conventional sense for algorithmic development. It's a recording and transmission device.
9. How the ground truth for the training set was established
- How Ground Truth Established: Not applicable.
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510(k) Summary
irsuant to CFR 807.92, the following 510(k) Summary is provided:
- (a) Submitter's George J. Hattub MedicSense, USA Address: 291 Hillside Avenue Somerset, MA 02726
- Manufacturer SHL Telemedicine International, Ltd. . (b) Address: 90 Igal Alon Street SEP 1 8 2007 Tel Aviv Israel, 67891 Mfg. Phone: 972-3-561-2212
- Iki Alroy, CTO/Vice President of R&D Contact Person:
- Date: November 30, 2006
- ું. Device & Classification Name: Electrocardiograph Telephone Transmitter and Receiver (Class 2), Product Code DXH, 21 CFR 878.2920 - Tradename of device: River-1 Electrocardiograph (ECG) Recorder and Transmitter
- King of Hearts® Express+ AF Monitor K020825 Predicate Devices: 3. VST™ Vital Signs Recorder and Transmitter K040942 CardioCall™ Event Recorder K972649
-
- Description: The River-1 is a patient activated electrocardiograph (ECG) symptomatic event recorder and transmitter. The River is a looping type ECG recording device (it records the ECG continuously). When the patient presses the ECG Record Button to record an ECG, the device stores both the recently recorded ECG and the ECG, following activation. The recorded ECG can then be transmitted to a healthcare facility or receiving center via two distinct channels: digitally via cellular network or acoustically via any phone.
The River-1 is a portable programmable device which is worn on the belt of the patient. It features a simple LCD screen, key pad, and is powered by a rechargeable battery. It can accommodate up to three leads for the option of recording 1, 2, or 3 lead ECG data.
-
- Intended Use: The River 1 is indicated for the evaluation of patients who experience transient symptoms such as dizziness, palpitations, syncope, or chest pain that might suggest arrhythmia. The device is intended to record cardiac activity associated with thege infrequent and transient symptoms. Once the data is recorded, the patient transmits this ECG data over the telephone or cellular network to a remote central receiving station to be reviewed by a healthcare professional.
-
- Comparison of Technological With respect to technology, the River-1 System is substantially equivalent to its Characteristics: predicate devices in that it is a patient activated looping device which records and transmits ECG data over the telephone or cellular network. It also has the same basic intended uses as its predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SHL Telemedicine International, Ltd. c/o Mr. George J. Hattub Senior Staff Consultant MedicSense, USA 291 Hillside Avenue Somerset, MA 02726
SEP 1 2 2007
Re: K063609
Trade/Device Name: River-1 Electrocardiograph (ECG) Recorder and Transmitter Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DXH Dated: September 4, 2007 Received: September 7, 2007
Dear Mr. Hattub:
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. George J. Hattub
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 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,
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
KOG 3609 510(k) Number (if known):
Device Name: SHL Telemedicine River-1
Indications For Use: The River-1 is indicated for the evaluation of patients who indications For Ooc. THe River 2 lo mas dizziness, palpitations, syncope, or chest pain expendent of the creation. The device is intended to record cardiac activity that might baggor annyther and transient symptoms. Once the data is recorded, associated with those inn oquent the telephone or cellular network to a remote central receiving station to be reviewed by a healthcare professional.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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 Devices | |
| 510(k) Number | K06360 |
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§ 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).