(205 days)
Remote Care is a patient management web based application device for use with the Analogic FETALGARD Lite™ to record and graphically display maternal abdominal contractions and the fetal heart rate by means of a display in the format of a graphic or PDF strip file. The data is intended to aid in assessing the well being of the fetus during the final trimester of pregnancy (Non-Stress Test). This device is for trained medical personnel located in hospitals, clinics, doctor's offices and in the patient's home.
Remote Care is intended to be used only with the Analogic Fetalgard Lite to assist in the transmission and graphical display of maternal abdominal contractions and fetal heart rate. Remote Care receives the strip data from the monitoring system via a modem or the CareStation video phone. This strip data is then transmitted to the Remote Care web site for viewing by the health care provider.
Remote Care does not provide real-time capabilities or alerts. The device is intended for use to communicate strip data which can be used to aid in assessing the well being of the fetus in the final trimester of pregnancy. Healthcare professionals must apply clinical judgment and experience to assess the data transmitted. The device is not intended as a replacement for professional medical care. It should not be used for patients requiring emergency intervention.
Remote Care is an internet database application and repository for the storage and archival of patient information with their physiological data that relates to the Remote Care OB customers' prenatal experience. "Remote Care" receives data from the Analogic FETALGARD Lite™ and makes the data available to the medical professional through the World Wide Web.
The "Remote Care" device is an internet database application for storing, archiving, and displaying patient information with physiological data related to prenatal experience, specifically maternal abdominal contractions and fetal heart rate. It receives data from the Analogic FETALGARD Lite™ device and makes it available to medical professionals via the World Wide Web.
Here's an analysis of the provided information regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document (K050234 510(k) Summary) does not explicitly state formal acceptance criteria or quantifiable performance metrics for the "Remote Care" device. Instead, the "Discussion of functional testing" section generally states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional compliance to specifications | Tests have been conducted and successfully completed |
| Performance comparison to the predicate device | Tests have been conducted and successfully completed |
The primary "performance" discussed is the comparison of features between "Remote Care" and its predicate device, Analogic FETALGARD Lite™. This comparison indicates that "Remote Care" offers more advanced features like increased security, a scalable patient database solution, and World Wide Web accessibility.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size used for a test set. There is no mention of patient data (e.g., number of cases, geographical origin) being used for formal testing of the "Remote Care" system's accuracy or efficacy. The "functional testing" appears to refer to internal verification that the system operates as designed and functions similarly to the predicate device in terms of displaying data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish a "ground truth" for a test set. Since the functional testing focuses on the system's ability to receive and display data from the monitoring device, rather than diagnostic accuracy, this type of expert assessment is not described.
4. Adjudication Method:
No adjudication method is mentioned, as there is no description of a clinical study involving interpretation or evaluation of data by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned. The submission focuses on the "Remote Care" system as an accessory for data transmission and display, not as a diagnostic aid that would involve human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The document does not describe a standalone performance study. The device is explicitly stated to "aid in assessing the well being of the fetus" and that "Healthcare professionals must apply clinical judgment and experience to assess the data transmitted." This indicates it's designed as a tool for human professionals, not for independent diagnostic decisions.
7. Type of Ground Truth Used:
No specific "ground truth" (e.g., pathology, outcomes data) is mentioned in relation to the functional testing of the "Remote Care" system. The testing likely focused on the technical fidelity of data transmission and graphical representation in comparison to the predicate device.
8. Sample Size for the Training Set:
The document does not refer to a "training set." The "Remote Care" device is an internet database application and display system, not a device that employs machine learning or AI that would typically require a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set or machine learning components are described in the provided information.
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AUG 2 5 2005
APPENDIX A: SUMMARY AND CERTIFICATION
A. 510(K) SUMMARY
Summary of Safety and Effectiveness
In accordance with 21 CFR 807.92, the following information constitutes the summary for the Remote Care by e.Care Solutions.
| SUBMITTER'S NAME: | e.Care Solutions |
|---|---|
| ADDRESS: | 1345 Wilmington Island RoadSavannah, GA 31410 |
| CONTACT PERSON: | Constance G. Bundy |
| TELEPHONE NUMBER: | 763-574-1976 |
| FAX NUMBER: | 763-571-2437 |
| DATE OF SUBMISSION: | 31 January 2005 |
Identification of device 1.
Proprietary Name: Remote Care Common Name: Perinatal Monitoring System Accessory Classification Status: Class II per regulations 884.2740, Perinatal Monitoring System and Accessories Product Codes: HGM
2. Equivalent devices
e. Care Solutions believes the Remote Care is substantially equivalent to Analogic FETALGARD Lite™ by Analogic Corporation, 510(k) # K002503.
Description of the Device 3.
Remote Care is an internet database application and repository for the storage and archival of patient information with their physiological data that relates to the Remote Care OB customers' prenatal experience. "Remote Care" receives data from the Analogic FETALGARD Lite™ and makes the data available to the medical professional through the World Wide Web.
Intended use 4.
"Remote Care" is a patient management web based application device for use with the Analogic FETALGARD Lite™ to record and graphically display maternal abdominal contractions and the fetal heart rate by means of a display in the format of a graphic or PDF strip file. The data is intended to aid in assessing the well being of the fetus during the final trimester of pregnancy (Non-Stress Test). This device is for trained medical personnel located in hospitals, clinics, doctor's offices and in the patient's home.
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Indications for Use న్.
Remote Care is intended to be used only with the Analogic FETALGARD Lite™ to assist in the transmission and graphical display of maternal abdominal contractions and fetal heart rate. Remote Care receives the strip data from the monitoring system via a modem or the CareStation video phone. This strip data is then transmitted to the Remote Care web site for viewing by the health care provider.
Remote Care does not provide real-time capabilities or alerts. The device is intended for use to communicate strip data which can be used to aid in assessing the well being of the fetus in the final trimester of pregnancy. Healthcare professionals must apply clinical judgment and experience to assess the data transmitted. The device is not intended as a replacement for professional medical care. It should not be used for patients requiring emergency intervention.
Technological characteristics, comparison to predicate device. 6.
"Remote Care" is an accessory to the Analogic FETALGARD Lite™ by Analogic Corporation and is similar in many respects. Remote Care receives data from the Analogic device and graphically displays the data in similar format to the Analogic device. The primary difference is that "Remote Care" has features for increased security and patient database solution, scalable application and database, and World Wide Web accessibility. Remote Care offers an enterprise solution with a security role management process supporting an organization, department and person.
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Comparative Table
| Feature | Remote Caree.Care Solutions | Analogic FETALGARD Lite™Analogic Corporation | |
|---|---|---|---|
| 1. | Fetal Monitor | Analogic FETALGARD Lite™ monitor | Analogic FETALGARD Lite™ monitor |
| 2. | Data Receiver | Analogic FETALGARD Lite™ data receiver | Analogic FETALGARD Lite™ data receiver |
| 3. | FHR/URM Rendering | Analogic FETALGARD Lite™ Viewer - Modified For Multi-user access & the Web | Analogic FETALGARD Lite™ Viewer - Client Machine Only & Single User |
| 4. | Input | Analogic FETALGARD Lite™ data receiver and key board entry from the "Remote Care" web user interface | Analogic FETALGARD Lite™ data receiver and key board entry from Analogic FETALGARD Lite™ Viewer client interface |
| 5. | Output | Screen and Adobe PDF file – see Substantial Equivalence “Remote Care” Output submitted with this document | Screen and Paper – see Substantial Equivalence FETALGARD Lite™ Output submitted with this document |
| 6. | Printing | YES | YES |
| 7. | Patient Database | YES – Extensive – Microsoft SQL Server | YES – Limited – Microsoft Access |
| 8. | Reporting | Yes | NO |
| 9. | Multi-User | YES | YES - Limited |
| 10. | WEB Enabled | YES | NO |
7. Discussion of functional testing.
Tests has been conducted and successfully completed, including functional compliance to specifications and performance comparison to the predicate device.
8. Conclusion
Based on performance testing and a comparison to the predicate device, it is the conclusion of e.Care Solutions that the Remote Care is substantially equivalent to devices already on the marked (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.
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Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three parallel, curved lines resembling a bird in flight. The emblem is black, and the background is white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
e.Care Solutions, Inc. % Ms. Constance G. Bundy Consultant C. G. Bundy Associates, Inc. 6740 Riverview Terrace FRIDLEY MN 55432
Re: K050234
AUG 2 5 2005
Trade/Device Name: Remote Care Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring systems and accessories Regulatory Class: II
Product Code: HGM Dated: July 14, 2005 Received: July 19, 2005
Dear Ms. Bundy:
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 (Premarket Approval), 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.
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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mancing of substantial equivalence of your device to a legally premarket notification. The FDA midnig of Sacomman of - pour device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CIFR Part 801), please If you desire spectic advice for your device on but the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification the Also, please note the regulation chance, "hisornation on your responsibilities under the Act from the 807.97). You may obtain other general monational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K050234
Device Name: Remote Care
Indications for Use:
Remote Care is intended to be used only with the Analogic Fetalgard Lite to assist in Remote Oarc is intendod to be display of maternal abdominal contractions and fetal the transmission and grapment areply trip data from the monitoring system via a modem or the CareStation video phone. This strip data is then transmitted to the model Care web site for viewing by the health care provider.
Remote Care does not provide real-time capabilities or alerts. The device is intended for use to communicate strip data which can be used to aid in assessing the well being for use to oommanibute of pregnancy. Healthcare professionals must apply of the retus in the timester of passess the data transmitted. The device is not intended as a replacement for professional medical care. It should not be used for patients requiring emergency intervention.
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) | |
|---|---|
| Nancy C. Brogdon | |
| (Division Sign-Off) |
(I Division of Reproductive, Abdominal, and Radiological Devices ----------
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).