(71 days)
Not Found
Not Found
No
The summary describes a mechanical device for blood collection and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is described as a "Multiple Draw System" for obtaining blood samples and preventing needle stick injury, which are diagnostic and safety functions, not therapeutic.
No
The device is described as a "Multiple Draw System" intended for "obtaining two samples of venous umbilical cord blood." This is a collection system, not a device that analyzes or interprets data to diagnose a condition. Its secondary purpose is injury prevention, not diagnosis.
No
The description clearly states the device is a "Multiple Draw System" intended for obtaining blood samples, implying a physical device with components for drawing blood, not just software.
Based on the provided information, the Cord-Stick™ Multiple Draw System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The primary intended use is to obtain samples of venous umbilical cord blood. It is a tool for sample collection.
- Lack of Diagnostic Function: The description does not mention any analysis, testing, or diagnostic function performed by the device itself on the collected blood samples. IVDs are designed to perform tests on biological samples to provide information for diagnosis, monitoring, or screening.
- Secondary Use: The secondary use is related to safety (prevention of needle stick injury), which is a feature of the device's design, not a diagnostic function.
The Cord-Stick™ Multiple Draw System appears to be a sample collection device, which is a different category of medical device than an IVD. The collected blood samples would likely be sent to a laboratory for in vitro diagnostic testing, but the Cord-Stick™ itself does not perform that testing.
N/A
Intended Use / Indications for 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.
Product codes
FMI, KNA
Device Description
Cord Stick™ Multiple Draw System
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
umbilical cord
Indicated Patient Age Range
newborn infant
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the profiles that resemble a bird in flight.
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.
1
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
2
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