(86 days)
Not Found
NotFound
No
The description focuses on a mechanical needle retraction mechanism activated by the user, with no mention of AI or ML terms or functionalities.
No.
The device is a syringe designed for medication injection or blood withdrawal, but its primary innovation is a safety feature (needle retraction) to prevent needlesticks, not to provide therapy itself.
No
The device is described as a syringe for injecting medication or withdrawing blood, with a safety feature for needle retraction. It does not perform any diagnostic function.
No
The device description clearly indicates a physical syringe with a mechanical needle retraction mechanism, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for injecting medication into a patient or withdrawing blood from a patient. This is a direct interaction with the patient's body for therapeutic or diagnostic sampling purposes.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside of the body.
- Device Description: The description focuses on the mechanism of needle retraction for safety during injection or blood withdrawal, not on analyzing a sample.
The VanishPoint™ Syringe is a medical device used for administering substances or collecting samples from a patient, which falls under the category of devices used for direct patient care, not for in vitro diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The function of the VanishPoint™ Syringe is to provide a safe and reliable method of injecting medication into a patient or withdrawing blood from a patient. The VanishPoint™ Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe barrel, the syringe user is protected from accidental needlesticks. These accidental needlesticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.
Product codes
MEG
Device Description
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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
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)
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 department's name around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, represented by three curved lines that suggest wings and a body. The text is arranged in a circular fashion around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 1997
Mr. Terance Grisso Director of Requlatory Affairs and Quality 511 Lobo Lane P.O. Box 9 Little Elm, Texas 75068-0009
K970803 Re : Vanish Point™ Syringe Trade Name: Requlatory Class: II Product Code: MEG Dated: February 14, 1997 Received: March 4, 1997
Dear Mr. Grisso:
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 The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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. Grisso
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 ii 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 the promotion and advertising of your device, please contact the Office of Compliance Also, please note the regulation entitled, at (301) 594-4639. "Misbranding by reference to premarket notification" (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,
Lisi Litrust
Timothy A Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications For Use
510(K) Number (if known): K970803
Device Name: .... VanishPoint™ Syringe . . . . . . . . .
Indications for use:
The function of the VanishPoint™ Syringe is to provide a safe and reliable method of injecting medication into a patient or withdrawing blood from a patient. The VanishPoint™ Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe barrel, the syringe user is protected from accidental needlesticks. These accidental needlesticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number
K970803
Prescription Use
Over-The-Counter Use - - -
(Optional Format 1-2-96)