(162 days)
Sentinel, a software product, is a computer program intended to organize and manage the databases for compatible Del Mar Reynolds Medical Monitoring products and also to act as a "control panel" for these products. It is indicated when a user wishes to consolidate the databases of his Del Mar Reynolds Medical products.
Sentinel, a software product, is a computer program intended to organize and manage the databases for compatible Reynolds Monitoring program finended to organize and manage the databases tor compatible Reynolds Monitoring products and also to act as a "control panel" for thes that formerly was used with these devices has been transferred to sections of Sentinel. The program itself can be >plied with all products. The individual products are all data-gathering devices used to collect cardiology patient data (ECG or blood pressure). These devices were previously sold with dedicated software programs that allow the devices to be set-up or configured both to program the devices, and to receive downloaded data from the devices and produce reports. In general, the dedicated programs also have a database uniquely for data from that device. As noted before, these dedicated data bases are replaced by the Sentinel database. Sentinel maintains a common cardiology database for the data collected by the compatible devices, and also permits the user to operate the various devices in a manner identical to the way they were operated as individual products. As a common data base, Sentinel stores data collected from each patient in the section of the database, dedicated to that patient. When used as a method for operating the device, the user selects the iron associated with the device. The user then sees the opening screen for the operation of that device, even all socceeding screens, as they were seen when the device was used with its dedicated program. Sentinel has no capacity for analyzing electrocardiograms. When Sentinel is used with the Pathfinder Holter Analysis program, the Pathfinder program is loaded into the same computer, and Pathfinder cannove alled by Sentinel, but there are no other control links Sentinel can be used on a personal computer (PC) that meets specifications established by Del Mar Reynolds Medical. Sentinel will work with products already owned by the user, or with new products (included in the list of compatible products) that the user may purchase later. Sentinel will work on a single computer, but it has been re-configured to be also used in a network
The provided text describes Sentinel, a software product for managing cardiology device databases. It is a Special 510(k) submission, meaning it compares the device to a previously cleared predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not include specific quantitative acceptance criteria or detailed device performance metrics. Instead, it states:
| Criterion | Acceptance | Reported Device Performance |
|---|---|---|
| Safety and Efficacy | Equivalent to predicate device (DelMar Reynolds CardioNavigator Plus, K051960) | "Sentinel has been extensively validated by itself and in conjunction with the associated Del Mar Reynolds Medical devices." |
| Functionality | Organize and manage databases for compatible Reynolds Monitoring products, act as a "control panel," and replace dedicated individual product databases. | "Sentinel maintains a common cardiology database for the data collected by the compatible devices, and also permits the user to operate the various devices in a manner identical to the way they were operated as individual products." |
| Analysis | No capacity for analyzing electrocardiograms. | "Sentinel has no capacity for analyzing electrocardiograms." (When used with Pathfinder, Pathfinder is loaded separately and called by Sentinel, but with no other control links). |
2. Sample Size for Test Set and Data Provenance
The document does not specify a sample size for a test set. It mentions "extensive validation" but provides no details on the number of cases, patients, or the origin (country, retrospective/prospective) of any data used for testing.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention any experts being used to establish ground truth. Given that this is a database management and control panel software, the "ground truth" would likely be related to data integrity, successful data transfer, and correct device operation rather than clinical interpretation requiring expert consensus.
4. Adjudication Method
The document does not specify any adjudication method, as there's no mention of expert review or clinical assessment.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done or reported. The device is a database management system, not an interpretive algorithm that would be used by human readers for diagnosis.
6. Standalone Performance Study
The text states: "Sentinel has been extensively validated by itself and in conjunction with the associated Del Mar Reynolds Medical devices." However, no specific standalone performance study with quantifiable results is described. The validation appears to be functional and integration testing rather than an algorithmic performance study in the typical sense.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. Based on the device's function, the "ground truth" would likely relate to:
- Data Integrity: Verifying that data captured by the monitoring devices is correctly and completely stored, retrieved, and displayed by Sentinel.
- Functional Correctness: Ensuring that Sentinel correctly acts as a "control panel" for compatible devices, allowing users to configure devices and receive downloaded data as intended.
- System Compatibility: Confirming that Sentinel works with various compatible Del Mar Reynolds Medical monitoring products.
8. Sample Size for Training Set
The document does not specify a sample size for a training set. This type of software (database management and control panel) typically undergoes software development and functional testing rather than machine learning training that requires a "training set."
9. How Ground Truth for Training Set Was Established
Since there is no mention of a training set for machine learning, the establishment of ground truth for a training set is not applicable to this document. The "ground truth" in the context of this software would be defined by the functional requirements and specifications of the system and its integration with the compatible monitoring devices.
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Del Mar Reynolds Medical Ltd. Special 510(k) Submission Sentinel 510(k) Summary
(1) Submitter Information
Name: DelMar Reynolds Medical Ltd.
Address:
1-2 Harforde Court John Tate Court Hertford, Herts SG137NW ENGLAND
Telephone Number: 44-1992-507700
Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone 201-727-1703 Fax 201-727-1708
Date Prepared: July 27, 2006
(2) Name of Device
Trade Name: Sentinel Common Name: Central Data Base for Cardiology Devices Classification name: Computers and Software, Medical
(3) Equivalent legally-marketed devices.
- DelMar Reynolds CardioNavigator Plus, K051960
(4) Description
Sentinel, a software product, is a computer program intended to organize and manage the databases for compatible Reynolds Monitoring program finended to organize and manage the databases tor
compatible Reynolds Monitoring products and also to act as a "control panel" for thes
JAN 2 5 2007
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that formerly was used with these devices has been transferred to sections of Sentinel. The program itself can be >plied with all products.
The individual products are all data-gathering devices used to collect cardiology patient data (ECG or blood pressure). These devices were previously sold with dedicated software programs that allow the devices to be set-up or configured both to program the devices, and to receive downloaded data from the devices and produce reports. In general, the dedicated programs also have a database uniquely for data from that device. As noted before, these dedicated data bases are replaced by the Sentinel database.
Sentinel maintains a common cardiology database for the data collected by the compatible devices, and also permits the user to operate the various devices in a manner identical to the way they were operated as individual products. As a common data base, Sentinel stores data collected from each patient in the section of the database, dedicated to that patient. When used as a method for operating the device, the user selects the iron associated with the device. The user then sees the opening screen for the operation of that device, even all socceeding screens, as they were seen when the device was used with its dedicated program.
Sentinel has no capacity for analyzing electrocardiograms. When Sentinel is used with the Pathfinder Holter Analysis program, the Pathfinder program is loaded into the same computer, and Pathfinder cannove alled by Sentinel, but there are no other control links
Sentinel can be used on a personal computer (PC) that meets specifications established by Del Mar Reynolds Medical. Sentinel will work with products already owned by the user, or with new products (included in the list of compatible products) that the user may purchase later.
Sentinel will work on a single computer, but it has been re-configured to be also used in a network
、) Intended Use
Sentinel, a software product, is a computer program intended to organize and manage the databases for compatible Del Mar Reynolds Medical Monitoring products and minutes and manyales for these products. It is indicated when a user wishes to consolidate the databases of his Del Mar Reynolds Medical products.
(6) Performance Data
(a) Non-clinical tests
Sentinel has been extensively validated by itself and in conjunction with the associated Del Mar Reynolds Medical devices.
(b) Clinical tests
Clinical tests are not necessary, since Sentinel uses the same technology as the predicate device.
(c) Conclusions
Sentinel is equivalent in safety and efficacy to the legally-marketed predicate devices.
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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized human figure with three heads in profile, representing the department's focus on health and human well-being. The figure is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 6 2007
Medsys, Inc. c/o Dr. George Myers Official Correspondent 377 Route 17 S Hasbrouck Heights, NJ 07604
Re: K062397
Trade Name: Sentinel Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone electrocardiograph transmitter and receiver Regulatory Class: Class II (two) Product Code: DXH Dated: January 5, 2007 Received: January 8, 2007
Dear Mr. Myers:
This letter corrects our substantially equivalent letter of January 25, 2006.
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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In
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Page 2 - Mr. Myers
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 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 continue 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) 276-4001. 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/dsma/dsmamain.html
Sincerely yours,
B. Armimotor for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
K062397 510(k) Number (if known):
Device Name: Sentinel
Indications for Use:
Sentinel, a software product, is a computer program intended to organize and manage the databases for compatible Del Mar Reynolds Medical Monitoring products and also to act as a "control panel" for these products. It is indicated when a user wishes to consolidate the databases of his Del Mar Reynolds Medical products.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
vision Sign-Off
Page of of a
vision Skan-Off 5 : 0(k) Num
§ 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).