(53 days)
Not Found
No
The summary describes a mechanical safety syringe with no mention of AI or ML capabilities.
No.
The device is used for aspirating and injecting fluids and includes a safety feature for needlestick protection, but its primary function is not therapeutic.
No
The device is described as a safety syringe used for aspirating and injecting fluid, with a built-in safety feature for needlestick protection. There is no mention of it being used to diagnose conditions or process diagnostic information.
No
The device description explicitly states it consists of a "syringe assembly and a needle assembly," which are physical hardware components. The performance study also involves the physical use of the syringe.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general purpose use in aspirating and injecting fluid" and "needlestick protection." This describes a device used directly on or with a patient for therapeutic or protective purposes, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description focuses on the physical components of a syringe and a safety feature, consistent with a device used for administering or withdrawing substances from a living being.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing.
IVD devices are specifically designed to perform tests on samples like blood, urine, or tissue to provide information about a person's health or condition. This syringe does not fit that description.
N/A
Intended Use / Indications for Use
The primary intended use for the Safety Syringe is for general purpose use in aspirating and injecting fluid.
The secondary intended use for the SafePro* Plus Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.
Product codes
MEG
Device Description
The SafePro* Plus Safety Syringe consists of a syringe assembly and a needle assembly. The device has a built-in safety feature to reduce the risk of accidental needlestick injuries.
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
A total of 500 SafePro* Plus Safety Syringes were evaluated by 50 participants. No sharps injuries or failures of the safety mechanism occurred.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Simulated Use Study
Sample Size: 500 SafePro* Plus Safety Syringes were evaluated by 50 participants.
Key Results: No sharps injuries or failures of the safety mechanism occurred. Successful completion of the study supports the claim that SafePro* Plus Safety Syringe may reduce the risk of accidental needlestick injuries. The positive responses from the Evaluators regarding functional and performance aspects also indicated that the SafePro* Plus Safety Syringe meets customer requirements.
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) Application Number: K031830
SECTION VIII
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS for SafePro* Plus Safety Syringe
1. REGULATORY AUTHORITY
Safe Medical Device Act of 1990, CFR 807.92.
2. CONTACT PERSON
Joseph J. Chang, Ph.D., PE FORMOSA MEDICAL DEVICES, INC. U.S. Ljaison Office 11497 Columbia Park Drive West, Suite #9 Jacksonville, FL 32258
3. NAME OF MEDICAL DEVICE
| Classification Name: | Syringe, Antistick |
|---|---|
| Classification Code: | MEG |
| Common/Usual Name: | Syringe |
| Proprietary Name: | SafePro* Plus Safety Syringe |
4. DEVICE CLASSIFICATION
The General Hospital Panel has classified Antistick Syringes (21CFR880.5600) into Class II, Special Controls under section 513 of the Act.
5. STATEMENT OF SUBSTANTIAL EQUIVALENCE
The SafePro* Plus Safety Syringe is substantially equivalent to:
- A) B-D Luer Lok conventional syringe with regard to the conventional syringe/needle and B) VanishPoint™ syringe with regard to retraction of the needle assembly into the barrel
- for needlestick protection feature, and
- C) The previously approved SafePro Safety Syringes (K012726) in design, Instructions for Use, and product claims.
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6. INTENDED USE
The primary intended use for the Safety Syringe is for general purpose use in aspirating and injecting fluid.
The secondary intended use for the SafePro* Plus Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.
7. DESCRIPTION OF DEVICE
The SafePro* Plus Safety Syringe consists of a syringe assembly and a needle assembly. The device has a built-in safety feature to reduce the risk of accidental needlestick injuries.
8. SUMMARY OF MATERIAL TESTING
The materials of construction for the SafePro* Plus Safety Syringe are identical to those for the SafePro* Safety Syringe which were already tested for biocompatibility by an independent. ISO certified, outside testing laboratory. Test results indicated that the entire Safety Syringe meets ISO 10993-1 and US FDA G-95 requirements.
9. SUMMARY OF SIMULATED USE STUDY
A total of 500 SafePro* Plus Safety Syringes were evaluated by 50 participants. No sharps injuries or failures of the safety mechanism occurred. Successful completion of the study supports the claim that SafePro* Plus Safety Syringe may reduce the risk of accidental needlestick injuries. The positive responses from the Evaluators regarding functional and performance aspects also indicated that the SafePro* Plus Safety Syringe meets customer requirements.
10. CONCLUSION
The results obtained from bench testing, material safety, and simulated use tests indicate that the SafePro* Plus Safety Syringe is safe and effective for it's intended use.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle with its wings spread, with three wavy lines below it.
Public Health Service
AUG - 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Formosa Medical Devices, Incorporated C/O Joseph J Chang General Manager and Chief Technology Officer Safepro USA, Incorporated 11497 Columbia Park Drive West Suite #9 Jacksonville, Florida 32258
Re: K031830
Trade/Device Name: SafePro* Plus Safety Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: June 11, 2003 Received: June 13, 2003
Dear Dr. Chang:
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.
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Page 2 -Dr. Chang
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 (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), 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 Runnes
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
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INDICATIONS FOR USE
Device Name
SafePro* Plus Safety Syringe
Indication for Use
The primary indicated use for the SafePro* Plus Safety Syringe is for general purpose use in aspirating and injecting fluid.
The secondary indicated use for the SafePro* Plus Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.
Patricia Cucenite
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K031830
(Please don not write below this line-Continue on another page if needed) Concurrence of CDRH Office of Device Evaluation (ODE)
V Prescription Use Per 21 CFR 801.109 (Optional Format 1-2-96)
OR Over-the-Counter _____________________________________________________________________________________________________________________________________________________________
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*Trademark