(417 days)
Not Found
No
The description focuses on a mechanical safety feature (a sheath covering the needle) and does not mention any computational or learning-based components.
No.
The device's primary function is to administer intramuscular injections and prevent accidental needle sticks, not to treat or cure a disease or condition.
No
The device description and intended use clearly state that the CoverTip™ Safety Syringe is for the administration of intramuscular injections and aids in preventing accidental needle sticks by covering the needle after injection. There is no mention of it being used to diagnose conditions or diseases.
No
The device description clearly indicates it is a physical syringe with a mechanical safety feature (a sheath) that covers the needle. There is no mention of software as a component or the primary function of the 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 the "administration of an intramuscular (IM) injection" and "aids in the prevention of accidental needle sticks." This describes a device used for delivering a substance into the body, not for testing samples in vitro (outside of the body).
- Device Description: The description details a "standard piston syringe" with a "passive sharp safety needle covering feature." This is a physical device for injection, not a reagent, instrument, or system used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnostic testing.
Therefore, the CoverTip™ Safety Syringe is a medical device used for drug delivery and safety, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CoverTip Safety Syringe™ is indicated for use in the administration of an intramuscular (IM) injection. The CoverTip Safety Syringe is a piston syringe intended for use in the administration of an intramuscular (IM) injection. The CoverTip™ Safety Syringe is indicated for use in the administration of an intramuscular (IM) injection. The CoverTip™ Safety Syringe aids in the prevention of accidental needle sticks. The CoverTip™ Safety Syringe has a sheath that covers the sharp needle upon completion of the injection.
Product codes
MEG
Device Description
The CoverTip Safety Syringe is a standard piston syringe which incorporates a passive sharp safety needle covering feature. The syringe automatically deploys a plastic cover (sheath) over the needle as the injection is completed and prior to the needle's removal from the tissue. The sheath protrudes beyond the end of the needle, shielding the user and patient from the sharp after removal. The sheath effectively blunts the end of the needle.
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)
Performance data presented demonstrated that the CoverTip Safety Syringe is substantially equivalent to legally marketed predicate devices. Performance testing conducted demonstrated that the design and manufacture of the CoverTip Safety Syringe meets or exceeds the requirements of relevant international standards. Next, the performance testing demonstrated that the deployed needle sheath of the CoverTip Safety Syringe is substantially equivalent in its needle blunting capability to that found in legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
K 97/077
MAY | 5 |998
510 (k) SUMMARY CoverTip Safety Syringe™ March 21, 1996
This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510(k), premarket notification was in accordance with 21 CFR 807.87 and the SMDA.
1.0 Submitter of 510 (k) and Manufacturer
Name: Medisys Technologies, Incorporated 9624 Brookline Avenue Baton Rouge, LA 70809
| Attention: | Mr. Kerry Frey |
|---|---|
| Telephone: | (504) 926-0422 |
| Facsimile: | (504) 926-1586 |
Consultant:
Joel S. Faden, Ph.D. Joel S. Faden, Ph.D., Inc. Telephone: 301-881-9139 Facsimile: 301-881-9249
Faden is an independent consultant Dr. to Medisys Technologies, Incorporated.
2.0 Name of Device
2.1 Trade/Proprietary Name
CoverTip Safety Syringe
2.2 Common/Usual Name
Piston Syringe
2.3 Classification Name
Piston Syringe (21 C.F.R. 880.5860, class II)
000142
1
3.0 Reason for Submitting the 510 (k)
We are submitting this 510(k) to notify you of our desire to commercially distribute for the first time the CoverTip Safety Syringe.
4.0 Device Description
The CoverTip Safety Syringe is a standard piston syringe which incorporates a passive sharp safety needle covering The syringe automatically deploys a plastic feature. cover (sheath) over the needle as the injection is completed and prior to the needle's removal from the The sheath protrudes beyond the end of tissue. the needle, shielding the user and patient from the sharp after removal. The sheath effectively blunts the end of the needle.
5.0 Indications for Use & Intended Use
5.1 Indications For Use
The CoverTip Safety Syringe™ is indicated for use in the administration of an intramuscular (IM) injection.
5.2 Intended Use
The CoverTip Safety Syringe™ is a piston syringe intended for use in the administration of an intramuscular (IM) injection.
6. Substantial Equivalence
The CoverTip Safety Syringe is substantially equivalent, defined in 21 U.S.C. Section 360c(i), to legally as marketed predicate devices.
The CoverTip Safety Syringe has technological characteristics substantially equivalent to those of legally marketed predicate devices. Provides in Table 1 is a tabulated comparison of the essential technological characteristics of the CoverTip Safety Syringe and several legally marketed predicate devices.
2
| Table 1 | ||||||
|---|---|---|---|---|---|---|
| Technological Characteristics | ||||||
| CoverTip Safety Syringe vs. Predicate Devices |
| Device Name | CoverTip Safety
Syringe | Standard Syringe | Safety-Lok
Syringe | Punctur-Guard |
|-------------------------------|----------------------------------------------|------------------|---------------------------------------------|----------------------------------------------|
| Manufacturer | Medisys Tech. | Becton Dickinson | Becton Dickinson | Bioplexus |
| 510(k) # | current document | pre-enactment | K920321 | K895024 |
| Indicated for IM
injection | yes | yes | yes | no |
| Standard piston
syringe | yes | yes | yes | no - blood
collection needle |
| Safety feature | sheath over needle
extended beyond
tip | none | barrel size tube
extended over
needle | tube inside needle
extended beyond
tip |
| Aim of safety
feature | blunt the needle | not applicable | blunt the needle | blunt the needle |
The CoverTip Safety Syringe was shown to have the same Indication for Use and Intended Use as predicate devices. Further, as indicated in the table the technological characteristics of the CoverTip Safety Syringe and predicate devices are substantially equivalent. Performance data presented demonstrated that the CoverTip Safety Syringe is substantially equivalent to legally marketed predicate devices. Performance testing conducted demonstrated that the design and manufacture of the CoverTip Safety Syringe meets or exceeds the requirements relevant international standards. of Next, the performance testing demonstrated that the deployed needle sheath of the CoverTip Safety Syringe is substantially equivalent in its needle blunting capability to that found in legally marketed predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY | 5 1998
Medisys Technologies, Incorporated ·C/O Joel S. Faden, Ph.D. Consultant Joel S. Faden, Ph.D., Incorporated 11605 Hitching Post Lane Rockville, Maryland 20852
Re : K971077 Trade Name: Covertip Safety Syringe Regulatory Class: II Product Code: MEG Dated: March 20, 1998 March 23, 1998 Received:
Dear Dr. Faden:
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 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). 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 (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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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
4
Page 2 - Dr. Faden
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 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" (21CFR 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/dsma/dsmamain.,html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) - CoverTip Safety Syringe Medisys Technologies, Inc.
Indications For Use
Device Name: CoverTip™ Safety Syringe
Indications For Use:
The CoverTip™ Safety Syringe is indicated for use in the administration of an intramuscular The Cover Tip - Barey Syringe aids in the prevention of accidental needle sticks (Int) inforton. The Ocerapy a sheath that covers the sharp needle upon completion of the injection.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: (Per 21 CFR 801.109)
Over-The-Counter: OR
X
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
Capital Devices
510(k) Number K9716
(k) Number 4971077