(71 days)
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.
Not Found
This document is a 510(k) premarket notification letter from the FDA for a medical device called the "Cord Stick™ Multiple Draw System." This type of letter generally approves a device for marketing by demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and supporting studies as would be found in a clinical trial report or a more extensive submission.
Therefore, the provided text does not contain the information required to answer your specific questions about acceptance criteria and detailed study results.
Here's why and what kind of information is missing:
- Acceptance Criteria and Reported Device Performance: This document states the device is "substantially equivalent" to predicate devices. It doesn't present specific performance metrics (e.g., accuracy, sensitivity, specificity, or quantifiable measures of needle stick injury reduction) or define acceptance criteria for those metrics.
- Sample Size, Ground Truth, Adjudication, MRMC studies, Standalone performance, Training set details: These are all elements of a clinical study or performance evaluation. A 510(k) summary (which is typically a separate document and not fully provided here) might reference such studies, but the letter itself does not detail them. The "Specific Intended Use" enclosure only describes the function of the device.
To answer your questions, you would typically need to consult a more detailed 510(k) summary, clinical study reports, or performance evaluation documents that would have been submitted as part of the 510(k) application. This letter is the FDA's response to such an application, confirming market clearance.
In summary, based only on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and study details.
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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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 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
§ 880.5570 Hypodermic single lumen needle.
(a)
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.(b)
Classification. Class II (performance standards).