(278 days)
Not Found
No
The description focuses on mechanical safety features and does not mention any computational or learning capabilities.
No
The device is a safety needle system used for venipuncture procedures to protect against needlestick injuries, not to treat a disease or condition.
No
The device is described as a safety needle system used for routine venipuncture procedures and blood collection, which are parts of diagnostic processes, but the device itself does not perform diagnosis or analyze samples. Its primary function is for safe blood collection.
No
The device description clearly states it is a "single use, sterile holder designed with an integrated, multiple sample needle and safety shield," indicating it is a physical hardware device, not software.
Based on the provided information, the VACUETTE® Premium Safety Needle System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for routine venipuncture procedures, which is the process of collecting blood from a vein. This is a procedure performed on the patient, not a test performed on a sample in vitro (outside the body).
- Device Description: The description focuses on the physical components and their function in the blood collection process, specifically for safety during venipuncture.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze a sample, detect substances in a sample, or provide diagnostic information based on a sample.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The VACUETTE® Premium Safety Needle System is a tool for collecting the sample, not for testing it.
N/A
Intended Use / Indications for Use
The VACUETTE® Premium Safety Needle System is used in routine venipuncture procedures. The holder is designed with an integrated, multiple sample needle and safety shield. Upon insertion of the first blood collection tube, the safety shield is automatically released. The safety shield covers the needle immediately following blood collection from the patient.
Product codes (comma separated list FDA assigned to the subject device)
FMI, MEG
Device Description
The VACUETTE® PREMIUM Safety Needle System is a single use, sterile holder designed with an integrated, multiple sample needle and safety shield to provide protection against needlestick injury during venipuncture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately trained healthcare professionals
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.
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
SECTION V
JUN 1 8 2008
510(k) SUMMARY
Contact:
510(k) Owner's Name - MedPro Safety Products, Inc. Address - 817 Winchester Road, Suite 200, Lexington, KY 40505 Phone - (859) 225-5375 Facsimile - (859) 225-5347 Contact Person - Mr. Walter Weller Date of Summary - September 12, 2007
Name of Device:
Trade or Proprietary Name - VACUETTE® PREMIUM Safety Needle System Common Name - Safety device for blood collection Classification Name - Hypodermic single lumen needle with antistick syringe (21 CFR 880.5570, Product Code FMI and 21 CFR 880.5860, Product Code MEG)
| Predicate Device: | The Guarded Needle 2000 |
|---|---|
| 510(k) Number: | K003406 |
| Date of Concurrence: | January 21, 2001 |
BD Vacutainer Passive Shielding Blood Collection Needle Predicate Device: 510(k) Number: K003461 Date of Concurrence: February 1, 2001
Substantial Equivalence Declaration:
The term "Substantial Equivalence" as used in this 510(k) Premarket Notification is limited to the definition of Substantial Equivalence found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR §807, Subpart E, under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of, substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.
Device Description:
Product Description
The VACUETTE® PREMIUM Safety Needle System is a single use, sterile holder designed with an integrated, multiple sample needle and safety shield to provide protection against needlestick injury during venipuncture.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 8 2008
Medpro Safety Products, Incorporated C/O Mr. Greg E. Mitchell Frost Brown Todd, LLC 250 West Main Street, Suite 2700 Lexington, Kentucky 40507-1749
Re: K072602
Trade/Device Name: VACUETTE® PREMIUM Safety Needle System Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI, MEG Dated: June 11, 2008 Received: June 12, 2008
Dear Mr. Mitchell:
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.
2
Page 2 - Mr. Mitchell
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours.
Suite y. Michael md.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(k) Number (if known): New submission
Device Name: VACUETTE® PREMIUM Safety Needle System
Indications for Use:
The VACUETTE® Premium Safety Needle System is used in routine venipuncture procedures. The holder is designed with an integrated, multiple sample needle and safety shield. Upon insertion of the first blood collection tube, the safety shield is automatically released. The safety shield covers the needle immediately following blood collection from the patient. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Anthony Dean
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _