(98 days)
a single use only, cord blood sampling, transfer device.
The Umbilicup is suitable for vaginal delivery and caesarean delivery.
The Umbilicup reduces blood exposure and aids in blood gas collection and transport.
A blood collection/transfer device with a drinking glass shaped body, divided in half. The top half is used to collect umbilical cord blood for analysis and has a lid. The bottom half has a needle enclosed in rubber used to puncture the rubber caps of vacuum tubes and transfer the collected blood from the top chamber. It is 4 inches in length and 2.5 inches in width.
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "DeRoyal Surgical, Umbilicup." This document primarily addresses the substantial equivalence of the device to a predicate device and regulatory compliance.
It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics such as sensitivity, specificity, accuracy, or any clinical study results.
The document states the "Indications for Use Statement" and a brief description of the device: "a single use only, cord blood sampling, transfer device... reduces blood exposure and aids in blood gas collection and transport." However, it does not provide any data or study details to support these claims beyond the device's design and intended function.
Therefore, I cannot extract the requested information (acceptance criteria table, sample size, ground truth details, MRMC study, etc.) from the provided text.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines beneath them. The image is in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 3 2002
Ms. Audrey Daniels Regulatory Affairs DeRoyal 200 DeBusk Lane Powel, TN 37849
Re: K020753 Trade/Device Name: DeRoyal Surgical, Umbilicup Regulation Number: 21 CFR 864.9100 Regulation Name: Empty container for the collection and processing of blood and blood components Regulatory Class: Class II Product Code: KSR Dated: May 31, 2002 Received: June 6, 2002
Dear Ms. Daniels:
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.
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 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 and v additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International 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/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k): K 020753
Device Name: DeRoyal, Surgical, Umbilicup
Intended Use: a single use only, cord blood sampling, transfer device.
A blood collection/transfer device with a drinking glass shaped body, divided in half. The top half is used to collect umbilical cord blood for analysis and has a lid. The bottom half has a needle enclosed in rubber used to puncture the rubber caps of vacuum tubes and transfer the collected blood from the top chamber. It is 4 inches in length and 2.5 inches in width.
The Umbilicup is suitable for vaginal delivery and caesarean delivery.
The Umbilicup reduces blood exposure and aids in blood gas collection and transport.
Do not steam sterilize.
Josephine Bautista
510(k) Number
§ 864.9100 Empty container for the collection and processing of blood and blood components.
(a)
Identification. An empty container for the collection and processing of blood and blood components is a device intended for medical purposes that is an empty plastic bag or plastic or glass bottle used to collect, store, or transfer blood and blood components for further processing.(b)
Classification. Class II (performance standards).