(128 days)
Not Found
No
The description focuses on a mechanical retraction mechanism activated by plunger depression, with no mention of AI or ML terms or functionalities.
No
This device is a syringe designed for administering medication and protecting the user from needlesticks, which is a delivery mechanism, not a therapeutic agent itself.
No
This device is described as an injection syringe, designed to administer medication and protect the user from needlesticks. Its function is to inject, not to diagnose a condition.
No
The device description clearly states it is a "standard piston syringe with integral needle" and describes a physical retraction mechanism, indicating it is a hardware device.
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 (subcutaneous and intramuscular use). This is a therapeutic or diagnostic procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device is a syringe with an integral needle designed for administering substances into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
The device is clearly a medical device used for administering injections, with a focus on safety for the user.
N/A
Intended Use / Indications for Use
The function of the NMT Safety Syringe is to provide a safe and reliable method of injecting medication into a patient that also protects the user from potential needlesticks. The NMT Safety Syringe functions as a conventional hypodermic syringe except for its ability to retract the contaminated needle inside the syringe immediately after the completion of the patient injection. Complete delivery of the syringe contents activates the retraction mechanism. For subcutaneous and intramuscular use.
Product codes
MEG
Device Description
The NMT Safety Syringe is a standard piston syringe with integral needle. The syringe incorporates automatic retraction technology that enables contaminated needles to be withdrawn, safely inside the body of the syringe when the syringe plunger is fully depressed. The NMT Safety Syringe is available as a 3cc syringe with 20 to 25g needles.
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
Bench testing has been conducted to examine the key operations associated with the use of both devices. This has included evaluation of the dead space in the device, the graduated capacity, the forces involved with the operation of the retraction mechanism and the pressure rating of the devices under worst case static loading.
Key Metrics
Not Found
Predicate Device(s)
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/3 description: The image shows a black and white close-up of a round object. The object appears to be a fruit or a ball, with a smooth surface and some light reflecting off of it. The background is plain white, which makes the object stand out. The image is simple and focuses on the shape and texture of the object.
510(k) PREMARKET NOTIFICATION NMT Safety Syringe APPENDIX 8: NMT SAFETY SYRINGE RÉLEASEABLE 510(K) SUMI
NMT Safety Syringe Releaseable 510(k) Summary.
This summary regarding 510(k)-safety and effectiveness information is being Hils Sunmary Togal Che requirements of SMDA 1990 and 21 CFR 807.92.
| 1) Date of Summary: | July 10th, 1998. |
|---|---|
| CONTACT NAME: | Richard Young |
| TELEPHONE: | (44) 1506 445000 |
| FACSIMILE: | (44) 1506 430444 |
| SUBMITTERS CONTACT DETAILS: | New Medical Technology Ltd. |
| New Medical House | |
| Oakbank Park | |
| Livingston | |
| Scotland | |
| EH53 OTH | |
| UK |
2)
Device Name: Common Name: Classification name: 3)
NMT Safety Syringe Safety Syringe Piston Syringe
Image /page/0/Picture/12 description: The image shows the word "DRAFT" in bold, outlined letters. The letters are slightly slanted to the right. The font is simple and blocky, with thick lines forming each letter.
Substantailly Equivalent Device: VanishPoint™ Syringe K946219 510(k) Number:
General
The NMT Safety Syringe is a standard piston syringe with integral needle. The syringe incorporates automatic retraction technology that enables contaminated needles to be withdrawn, safely inside the body of the syringe when the syringe plunger is fully depressed.
The NMT Safety Syringe is available as a 3cc syringe with 20 to 25g needles.
5)
The function of the NMT Safety Syringe is to provide a safe and reliable method of injecting medication into a patient that also protects the user from potential needlesticks.
The NMT Safety Syringe functions as a conventional hypodermic syringe except for its ability to retract the contaminated needle inside the syringe immediately after the completion of the patient injection. Complete delivery of the syringe contents activates the retraction mechanism. Because the contaminated needle is automatically withdrawn into the syringe barrel, the syringe user is protected from
1
510(k) PREMARKET NOTIFICATION NMT Safety Syringe APPENDIX 8: NMT SAFETY SYRINGE RELEASEABLE 510(k) SUMMARY
accidental needlesticks. These accidental needlesticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.
The NMT Safety Syringe is substantially equivalent to the previously marketed VanishPoint™ syringe. Technologically, both devices are standard piston syringes which utilize springs to retract the needle when the plunger is fully depressed. Both devices are designed for one-handed operation and have the same intended use. Bench testing has been conducted to examine the key operations associated with the use of both devices. This has included evaluation of the dead space in the device, the graduated capacity, the forces involved with the operation of the retraction mechanism and the pressure rating of the devices under worst case static loading. In all cases the NMT Safety Syringe was either equivalent to, or exceeded the performance of the VanishPoint™ syringe.
Tahn Campbell by M.C. Skovsak
John Campbell, Ph.D., M.B.A Chief Executive Officer
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 1998
New Medical Technology Limited C/O John Campbell, Ph.D., M.B.A. Chief Executive Officer New Medical Technology 1500 West Oak street, Suite 200 P.O. Box 317 Zionsville, Indiana 46077
K982431 Re : NMT Safety Syringe Trade Name: Requlatory Class: II Product Code: MEG Dated: October 5, 1998 Received: October 7, 1998
Dear Dr. Campbell:
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, 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. ਕੇ 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 requlation 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Dr. Campbell
This letter will allow you to beqin 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 the promotion 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 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,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) PREMARKET NOTIFICATION NMT Safety Syringe APPENDIX 10: INDICATIONS FOR USE SHEET
INDICATION FOR USE
510(k) Number (if known): Unknown
NMT Safety Syringe Device Name:
For subcutaneous and intramuscular use. Indications for Use
The function of the NMT Safety Syringe is to provide a safe and reliable method of injecting medication into a patient that also protects the user from potential needlesticks.
The NMT Safety Syringe functions as a conventional hypodermic syringe except for its ability to retract the contaminated needle inside the syringe immediately after the completion of the patient injection. Complete delivery of the syringe contents activates the retraction mechanism.
(PLEASE DO NOT WRITE BELOW THIS LINE - COTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Deyice Evaluation (ODE)
(Division Sign Off) Diveston of Section Control, Infection Control, and General Hospital Devices
510(k) Number 198247
Prescription Use X
Over-the-Counter Use
(Optional Format 1-2-96)
L