DEROYAL SURGICAL, UMBILICUP

K020753 · Deroyal · KSR · Jun 13, 2002 · Hematology

Device Facts

• Record ID: K020753
• Device Name: DEROYAL SURGICAL, UMBILICUP
• Applicant: Deroyal
• Product Code: KSR · Hematology
• Decision Date: Jun 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.9100
• Device Class: Class 2

Indications for Use

a single use only, cord blood sampling, transfer device.

Device Story

Umbilicup is a single-use, drinking-glass-shaped device for umbilical cord blood collection and transfer. Device features two chambers: top chamber with lid for cord blood collection; bottom chamber containing a needle enclosed in rubber for puncturing vacuum tube caps to facilitate blood transfer. Used in clinical settings (labor/delivery) by healthcare providers. Reduces clinician blood exposure during sampling. Dimensions: 4 inches long, 2.5 inches wide. Not for steam sterilization.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-use, drinking-glass-shaped plastic device. Features integrated needle mechanism for vacuum tube interface. Dimensions: 4" L x 2.5" W. Non-autoclavable (do not steam sterilize).

Indications for Use

Indicated for collection and transfer of umbilical cord blood during vaginal or caesarean delivery to aid in blood gas collection and transport.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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