(236 days)
Not Found
No
The description focuses on a mechanical safety feature (sliding sheath) for a syringe and does not mention any computational or data-driven components indicative of AI/ML.
No
The device aids in the prevention of needle stick injuries by shielding the needle, but it does not directly treat or diagnose a medical condition.
No
The description states the device is used to aid in the prevention of needle stick injuries and does not mention any diagnostic capabilities like detecting, monitoring, or predicting diseases.
No
The device description clearly indicates a physical product ("Sliding Sheath Mechanism," "hypodermic syringe," "barrel") designed to prevent needle stick injuries. It is a hardware device with a safety feature.
Based on the provided information, the UNIVEC Sliding Sheath Syringe is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's an "Active Safety Feature for a hypodermic syringe" used to "aid in the prevention of needle stick injuries." This is a safety mechanism for administering substances into the body, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: The description doesn't mention anything about analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The UNIVEC Sliding Sheath Syringe's function is purely mechanical and related to the safe use of a hypodermic syringe for injection.
N/A
Intended Use / Indications for Use
The UNIVEC Sliding Sheath Syringe (K993996) is an Active Safety Feature for a hypodermic syringe. The Sliding Sheath Mechanism is used with a traditional disposable syringe or the Univec Auto-Destruct syringe. The Univec Sliding Sheath Syringe is used to aid in the prevention of needle stick injuries. After an injection, the shield is easily moved from an unextended to an extended position with one hand so that the needle tip is covered by a 360 degree enclosure. The scale is printed on the barrel in a way that allows the Healthcare worker to read through the sheath or from the backside of the sheath.
Product codes
MEG
Device Description
Not Found
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
Healthcare worker
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract shapes resembling birds in flight, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 2000
Mr. S. Levinson UNIVEC 22 Dubon Court Farminqdale, New York 11735
Re : K993996 UNIVEC Sliding Sheath Syringe with/without Trade Name: Auto-Destruct Feature Regulatory Class: II Product Code: MEG June 29, 2000 Dated: Received: July 3, 2000
Dear Mr. Levinson
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 reqistration, listing of devices, good manufacturing practice, labelinq, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
1
Page 2 - Mr. Levinson
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compriation and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene regaracion Cherclose, "MBBB andary" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
UNIVEC SLIDING SHEATH INDICATIONS FOR USE
HYPODERMIC SYRINGE WITH SHARPS PROTECTION
The UNIVEC Sliding Sheath Syringe (K993996) is an Active Safety Feature for a hypodermic syringe. The Sliding Sheath Mechanism is used with a traditional disposable syringe or the Univec Auto-Destruct syringe. The Univec Sliding Sheath Syringe is used to aid in the prevention of needle stick injuries. After an injection, the shield is easily moved from an unextended to an extended position with one hand so that the needle tip is covered by a 360 degree enclosure. The scale is printed on the barrel in a way that allows the Healthcare worker to read through the sheath or from the backside of the sheath.
Aven Neveau for PxC 1/7/00
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices K 993996 510(k) Number_