CORD STICK MULTIPLE DRAW SYSTEM

K031058 · Cord Stick Corp. · FMI · Jun 13, 2003 · General Hospital

Device Facts

• Record ID: K031058
• Device Name: CORD STICK MULTIPLE DRAW SYSTEM
• Applicant: Cord Stick Corp.
• Product Code: FMI · General Hospital
• Decision Date: Jun 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

Cord-Stick™ Multiple Draw System is intended for obtaining two samples of venous umbilical cord blood after delivery of a newborn infant. Secondary intended use: Cord-Stick™ Multiple Draw System aids in the prevention of needle stick injury.

Device Story

Cord Stick™ Multiple Draw System facilitates collection of two venous umbilical cord blood samples post-delivery. Device design incorporates safety features to mitigate risk of needle stick injuries to healthcare providers. Used in clinical obstetric settings by medical staff during newborn delivery. System enables sequential or simultaneous blood draw from umbilical cord, reducing manual handling and exposure risks associated with traditional needle-based collection methods. Output is two distinct blood samples for clinical analysis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual blood collection system designed for umbilical cord access. Features integrated safety mechanisms to prevent needle stick injuries. Class II (21 CFR 880.5570) and Class I (21 CFR 884.4530) device. Non-electronic, mechanical instrument.

Indications for Use

Indicated for obtaining two venous umbilical cord blood samples from newborn infants post-delivery. Intended to assist in preventing needle stick injuries during the collection process.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 3 2003

Mr. Michael Moen President Cord Stick Corporation 1400 Florida Avenue, Suite 205 Modesto, California 95350

Re: K031058

Trade/Device Name: Cord Stick™ Multiple Draw System Regulation Number: 21 CFR 880.5570, 884.4530 Regulation Name: Hypodermic Single Lumen Needle, Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II, I Product Code: FMI, KNA Dated: March 28, 2003 Received: April 9, 2003

Dear Mr. Moen:

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.

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Page 2 - Mr. Moen

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Susan Runpe

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Specific Intended Use

## 510(k) Number __ K 0 3105 8

## Cord Stick™ Multiple Draw System

## Specific Intended Use

Primary intended use:

Cord-Stick™ Multiple Draw System is intended for obtaining two samples of venous umbilical cord blood after delivery of a newborn infant.

Secondary intended use:

Cord-Stick™ Multiple Draw System aids in the prevention of needle stick injury.

Patara Curecita

neral Hosnital

510(k) Number: K031058