(110 days)
Not Found
Not Found
No
The summary describes a mechanical safety syringe with features to prevent needle sticks and reuse. There is no mention of AI or ML technology.
No
The device is a syringe used for injections, which is a delivery mechanism for therapeutic agents, but it is not itself a therapeutic device. Its primary function is safe drug delivery and injury prevention.
No
Explanation: The device is a syringe intended for administering medication (injection) and preventing needle stick injuries and reuse, not for diagnosing conditions.
No
The device description clearly states it is a "sterile, single-use, disposable hypodermic syringe," which is a physical hardware device. The intended use also describes a physical action ("intramuscular and subcutaneous injection").
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "intramuscular and subcutaneous injection of medication into a patient." This is a therapeutic or drug delivery function, not a diagnostic one.
- Exclusion of Blood Collection: The statement "The syringe should not be used for blood collection" further reinforces that its purpose is not for obtaining samples for in vitro testing.
- Device Description: The description as a "hypodermic syringe" aligns with drug delivery, not in vitro diagnostics.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) outside of the body to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. This syringe's function is to deliver substances into the body.
N/A
Intended Use / Indications for Use
The intended function of the SECUREGARD® Ret retractable Safety Syringe is to provide a safe and reliable method of intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection. The SECUREGARD® Retractable Safety Syringe is also intended to prevent needle stick injuries. In addition, when the syringe user breaks the plunger, reuse of the syringe is prevented.
Product codes (comma separated list FDA assigned to the subject device)
MEG
Device Description
The SECUREGARD® Ret retractable Safety Syringe is a sterile, single-use, disposable hypodermic syringe with sharps injury and reuse prevention features. It is manufactured in sizes of 0.5, 1, 2, 2.5, 3, 5, 10 and 20 mL volume.
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)
No new issues safety and effectiveness as relating to hypodermic syringes. The sharps injury prevention feature was demonstrated to be easily and safely activated by the user, and the needle was effectively shielded by the sharps protection feature.
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.
Not Found
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
§ 880.5860 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
K012/21
OCT 2 4 2001
October 17, 2001
Page 1 of 1
(510k) Summary of Safety and Effectiveness
Pursuant to Section 510(k) of the Federal Food, Drug and Cosmetic Act, Safety and Effectiveness information is enclosed for the following device:
| Device Name: | SECUREGARD® Retractable Safety Syringe |
|---|---|
| Trade Name: | SECUREGARD® Syringe |
| Common Name: | Safety Syringe |
| Classification name: | Piston Syringe / Anti-Stick Syringe |
| Device Class: | Class II |
| Classification Code: | MEG |
| Performance Standard: | None established. |
| Safety and Effectiveness: | No new issues safety and effectiveness as relating to hypodermic |
| syringes. The sharps injury prevention feature was demonstrated | |
| to be easily and safely activated by the user, and the needle was | |
| effectively shielded by the sharps protection feature. | |
| Facility Address: | SafeGard Medical Systems (Hungary) KFT |
| Joszéréncsét tér 15, H-3608 | |
| Farkaslyuk, Hungary |
Establishment Registration Number: 9616482
Indications for Use: The intended function of the SECUREGARD® Retractable Safety Syringe is to provide a safe and reliable method of intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection. The SECUREGARD® Retractable Safety Syringe is also intended to prevent needle stick injuries. In addition, when the syringe user breaks the plunger, reuse of the syringe is prevented.
The SECUREGARD® Retractable Safety Syringe is Substantial Equivalence: substantially equivalent to the SOLOGARD® Locking Plus Syringe. The SECUREGARD is a sterile, single-use, disposable hypodermic syringe with sharps injury and reuse prevention features. It is manufactured in sizes of 0.5, 1, 2, 2.5, 3, 5, 10 and 20 mL volume.
Contact Information:
Pat Grant Jr. Director Regulatory Affairs SafeGard Medical Products, Inc 52 Dragon Court Woburn, MA 01801 Tel. (781) 935 2275 Fax (781) 935 8424
1
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
OCT 2 4 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SafeGard Medical Products, Incorporated C/O Mr. Mike Dayton BioMed Research, Incorporated 14802 Hadleigh Way Tampa, Florida 33624
Re: K012121
Trade/Device Name: SECUREGARD® Retractable Safety Syringes Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: September 21, 2001 Received: October 1, 2001
Dear Mr. Dayton:
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 releved above and had in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Andelheinente, of to do roons one ic Act (Act) that do not require approval of a premarket the rederal I ood, Drag, Drag, therefore, market the device, subject to the general apper of a upprovisions 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 (1 NI ), It ina) of each of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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.
2
Page 2 - Mr. Dayton
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
[signature]
Tim y A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Ko/2121
Indications for Use Statement
510k Number (if known): ______________________________________________________________________________________________________________________________________________________ K012121
Device Name: SECUREGARD® Retractable Safety Syringe
Indications For Use:
The intended function of the SECUREGARD® Retractable Safety Syringe is to provide a safe and reliable method of intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection. The SECUREGARD® Retractable Safety Syringe is also intended to prevent needle stick injuries. In addition, when the syringe user breaks the plunger, reuse of the syringe is prevented.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Patrice Crescent
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices F 1 (k) Number _