(118 days)
Cerner FetaLink is a software application intended for use in both hospital and clinic settings by obstetrical healthcare professionals providing care to pregnant women in the antepartum and/or intrapartum phases of pregnancy. Cerner FetaLink can be used at the bedside, the central nursing station, or at remote locations to help the clinician monitor the labor of patients by displaying data sent from fetal monitoring devices, providing a graphical display of the relationship between uterine contractions and fetal heart rate, and alerting the clinician to out-of-reference-range data trends.
Cerner FetaLink is a software application intended for use in both hospital and clinic settings by obstetrical healthcare professionals providing care to pregnant women in the antepartum and/or intrapartum phases of pregnancy. Cerner FetaLink can be used at the bedside, the central nursing station, or at remote locations to help the clinician monitor the labor of patients by displaying data sent from fetal monitoring devices, providing a graphical display of the relationship between uterine contractions and fetal heart rate, and alerting the clinician to out-of-reference-range data trends.
The provided document is a 510(k) clearance letter from the FDA for the Cerner FetaLink™ device. It primarily focuses on the regulatory approval of the device based on substantial equivalence to predicate devices and outlines the device's indications for use.
Crucially, this document does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.
The FDA clearance letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a legally marketed device or has different technological characteristics but does not raise different questions of safety and effectiveness. This determination is primarily based on a comparison to predicate devices, not typically on a new, comprehensive clinical study with specific performance metrics and acceptance criteria that would be detailed in the submission.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present in the FDA clearance letter.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not present.
- 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: Not present. The Cerner FetaLink™ is described as a software application that displays data and alerts clinicians, implying it's a monitoring and information-display system, not necessarily an AI-powered diagnostic tool that would typically undergo MRMC studies for improved human reader performance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. Given its description as displaying data and alerting clinicians, it's inherently a human-in-the-loop system.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
To obtain this information, you would need to consult the original 510(k) submission document (if publicly available in a more detailed form than the clearance letter), or technical documentation provided by Cerner Corporation for FetaLink™.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
. .
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
AUG 2 5 2009
Shelley S. Looby, MT (ASCP) BB Director, Regulatory Affairs/Quality Assurance Cerner® Corporation 2800 Rockcreek Parkway KANSAS CITY MO 64117
Re: K091251
Trade/Device Name: Cerner FetaLink™ Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: July 27, 2009 Received: July 29, 2009
Dear Ms. Looby:
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 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); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Sammy M. Mourel
Janine M. Morris Acting 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 (if known): K091251
Device Name: Cerner FetaLinkTM
Indications for Use:
Cerner FetaLink is a software application intended for use in both hospital and clinic settings by obstetrical healthcare professionals providing care to pregnant women in the antepartum and/or intrapartum phases of pregnancy. Cerner FetaLink can be used at the bedside, the central nursing station, or at remote locations to help the clinician monitor the labor of patients by displaying data sent from fetal monitoring devices, providing a graphical display of the relationship between uterine contractions and fetal heart rate, and alerting the clinician to out-of-reference-range data trends.
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)
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Lozza K. Nhay
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Device
510(k) Number
§ 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).