(71 days)
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No
The summary describes a data management system and decision support tool, but there is no mention of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML devices.
No.
The device is described as a data management system that records, stores, and displays data from vital signs monitors, serves as a decision support tool, and an electronic medical record. It does not provide any therapy or direct treatment to a patient.
No
The device is described as a data management system, an electronic medical record, and a decision support tool that records, stores, and displays data. It does not state that it diagnoses conditions or diseases.
Yes
The description focuses entirely on the software's function of recording, storing, displaying, and managing data from external monitors and other sources. There is no mention of any hardware component being part of the device itself.
Based on the provided information, the NaviCare® WatchChild™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- NaviCare® WatchChild™ Function: The description clearly states that NaviCare® WatchChild™ is an Obstetrical Data Management System. Its primary functions are to:
- Record, store, and display data from fetal and maternal vital signs monitors.
- Manage patient information.
- Organize clinical data.
- Serve as a decision support tool and electronic medical record.
These functions involve managing and displaying data from other devices and patient information, not performing tests on biological samples.
Therefore, NaviCare® WatchChild™ falls under the category of a data management system and electronic medical record, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
NaviCare® WatchChild™ is indicated for use in a hospital/clinical environment. NaviCare® WatchChild™ is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. NaviCare® WatchChild™ organizes clinical data that would normally be provided on paper records or other clinical systems and devices. This system also serves as a decision support tool and electronic medical record.
Product codes
HGM
Device Description
NaviCare® WatchChild™ is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. NaviCare® WatchChild™ organizes clinical data that would normally be provided on paper records or other clinical systems and devices. This system also serves as a decision support tool and electronic medical record.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
hospital/clinical environment
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission of promoting health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Dawn M. Reilly, RAC Official Correspondent Manager, Regulatory Affairs & Quality Assurance Hill-Rom Manufacturing, Inc. 1225 Crescent Green, Suite 200 CARY NORTH CAROLINA 27518
APR - 9 2008
Re: K080226
Trade Name: NaviCare® WatchChild™ Obstetrical Data Management System Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: March 7, 2008 Received: March 10, 2008
Dear Ms. Reilly:
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 ass suited in also increations 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, the of tee, market the device, subject to the general controls provisions of the Act. The general thorolors, namies are CDTS 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 11 your al), it may be subject to such additional controls. Existing major regulations affecting your Apploval), it the 7 to sally of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/0/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. In the center of the logo are the letters "FDA" in a bold, stylized font. The logo is surrounded by a dotted border.
Protecting and Promoting Public Health
1
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 one of 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" (21 CFR 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-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,
Nancy C Brogdon
Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/2/Picture/0 description: The image shows the logo for Hill-Rom. The logo is white text on a black background. The text is in a sans-serif font and is slightly rounded.
Hill-Rom Manufacturing 1225 Crescent Green, Suite 200 Carv. North Carolina 27518
Attachment A: Indications for Use Statement
510(k) Number: (if known)
Device Name:
NaviCare® WatchChild™
Indications for Use:
NaviCare® WatchChild™ is indicated for use in a hospital/clinical environment. NaviCare® WatchChild™ is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. NaviCare® WatchChild™ organizes clinical data that would normally be provided on paper records or other clinical systems and devices. This system also serves as a decision support tool and electronic medical record.
Prescription Use X (Per 21 CFR 801. 109) AND/OR
Over-The-Counter Use
(Per 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)
Tomitohry
Division Sign-Off) Division of Reproductive. Abdominal. and Radiological Devices 510(k) Number
HILL-ROM CONFIDENTIAL
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