(70 days)
No
The summary describes a manual, mechanical safety syringe and does not mention any computational or data-driven features indicative of AI/ML.
No.
The device is a syringe intended for fluid injection, but its primary function is to safely deliver a substance (which could be therapeutic) into the body, not to provide therapy itself. Its innovation is in reducing sharps injury, not in any therapeutic action.
No
Explanation: The device is described as a "retractable safety piston syringe which is intended for injection of fluids into the body." Its purpose is to administer substances, not to diagnose a condition or disease.
No
The device description clearly indicates it is a physical syringe with a needle, 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 "injection of fluids into the body." This describes a direct interaction with the patient's body for therapeutic or diagnostic purposes (in this case, injection), not for examining specimens in vitro (outside the body).
- Device Description: The description details a syringe and needle, which are instruments used for administering substances into the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening based on specimen analysis.
The device is clearly intended for administering substances into the body, which falls under the category of medical devices used for treatment or direct patient interaction, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The U.S. Technologies, Inc., Retractable Safety Syringe is a sterile, single-use, disposable and non-reusable, manual, retractable safety syringe which is intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
Product codes
MEG
Device Description
The U.S. Technologies, Inc., Retractable Safety Syringe is a sterile, single-use, disposable and non-reusable, manual, retractable 5 mL safety syringe, provided with a detachable 22 gauge, 11/4 inch needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body
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)
Bench testing shows that the operation and performance of the U.S. Technologies, Inc., Retractable Safety Syringe is equivalent to the E.N.S.I. product. Both syringes have two-part plungers. The distal part holds the hypodermic needle and the proximal part has a projection spike that mates with the distal part, thereby locking the needle to the plunger. Both syringes require the user to manually retract the needle/plunger into the syringe barrel, break off the plunger rod, and discard the pieces.
Testing provided in this premarket notification includes biocompatibility, measurement of latex protein, packaging integrity, standards conformity, and testing according to FDA guidance (including a simulated use test).
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
510(k) Summary for the U.S. Technologies, Inc. Retractable Safety Syringe (per 21CFR807.92)
1. SPONSOR
U.S. Technologies, Inc. 1512 West Chester Pike, #122 West Chester, PA 19382
Contact Person: Mr. Abrar Solatch, President Telephone: 610-659-9833
Date Prepared: July 15, 2003
2. DEVICE NAME
U.S. Technologies, Inc., Retractable Safety Syringe Proprietary Name: Common/Usual Name: Hypodermic Syringe (with detachable needle) Classification Name: Piston syringe Hypodermic single lumen needle
3. PREDICATE DEVICE
DEVICE DESCRIPTION 4.
The U.S. Technologies, Inc., Retractable Safety Syringe is a sterile, single-use, disposable and non-reusable, manual, retractable 5 mL safety syringe, provided with a detachable 22 gauge, 11/4 inch needle.
ട. INTENDED USE
The U.S. Technologies, Inc., Retractable Safety Syringe is a sterile, single-use, disposable and non-reusable, manual, retractable safety syringe which is intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
1
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
U.S. Technologies, Inc., makes a claim of substantial equivalence of the U.S. Technologies, Inc., Retractable Safety Syringe to the E.N.S.I. Retractable Safety Syringe (K003348, K000572) based on similarities in intended use, design, technological, and operational characteristics. Both are indicated for injecting fluids into the body, while helping to reduce the risk of sharps injuries. Both syringes are piston syringes that use single lumen hypodermic needles. The U.S. Technologies, Inc., Retractable Safety Syringe is provided with a 22 gauge, 11/4 inch hypodermic needle, while the E.N.S.I. is not provided with needles. Both the U.S. Technologies, Inc., Retractable Safety Syringe and the E.N.S.I. products use a Luer lock connector. Both syringes are provided sterile, single-use, and disposable. Both the U.S. Technologies, Inc., Retractable Safety Syringe and the E.N.S.I. product are supplied with a volume of 5 mL.
Bench testing shows that the operation and performance of the U.S. Technologies, Inc., Retractable Safety Syringe is equivalent to the E.N.S.I. product. Both syringes have two-part plungers. The distal part holds the hypodermic needle and the proximal part has a projection spike that mates with the distal part, thereby locking the needle to the plunger. Both syringes require the user to manually retract the needle/plunger into the syringe barrel, break off the plunger rod, and discard the pieces.
U.S. Technologies, Inc., believes that the differences between the U.S. Technologies, Inc., Retractable Safety Syringe and the predicate device are minor and raise no new issues of safety or effectiveness.
7. PERFORMANCE TESTING
Testing provided in this premarket notification includes biocompatibility, measurement of latex protein, packaging integrity, standards conformity, and testing according to FDA guidance (including a simulated use test).
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
SEP 3 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medical Device Consultants. Incorporated Ms. Rosina Robinson Senior Staff Consultant U.S. Technologies, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K032247
Trade/Device Name: U.S. Technologies, Incorporated Retractable Safety Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: September 12, 2003 Received: September 15, 2003
Dear Ms. Robinson:
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 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 -Ms. Robinson
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. 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 (OS) 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Susan Runner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): ___ Ko32247
Device Name: U.S. Technologies, Inc. Retractable Safety Syringe
Indications For Use:
The U.S. Technologies, Inc., Retractable Safety Syringe is a sterile, single-use, disposable and non-reusable, manual, retractable safety piston syringe which is intended for injection of fluids into the body while reducing the risk of a sharps injury and potential reuse of the syringe.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricio Crescenti
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K032247
Prescription Use 2 (Per 21 CFR 801.109)
OR
Over-The-Counter Ùse
(Optional Format 1-2-96)
U. S. Technologies, Inc., Traditional 510(k) Retractable Safety Syringe
July 21, 2003
Page viii