The secondary indicated use for the SafePro* Plus Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.

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.

AI/ML Overview

Acceptance Criteria and Study for SafePro* Plus Safety Syringe

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated Goal)	Reported Device Performance
Reduce the risk of accidental needlestick injuries (secondary intended use).	No sharps injuries or failures of the safety mechanism occurred in the simulated use study.
Meet customer requirements (functional and performance aspects).	Positive responses from Evaluators regarding functional and performance aspects.
Be safe and effective for its intended use (general purpose aspirating and injecting fluid, and needlestick protection).	Results from bench testing, material safety, and simulated use tests indicated the device is safe and effective.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 500 SafePro* Plus Safety Syringes were evaluated.
Data Provenance: The study was a "simulated use study," implying it was a prospective study conducted specifically for this submission. The text does not specify the country of origin of the participants.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The provided text does not mention experts being used to establish a "ground truth" for the simulated use study. Instead, the study involved "50 participants" who evaluated the syringes and provided "positive responses." It also reported that "no sharps injuries or failures of the safety mechanism occurred." This suggests that the "ground truth" was based on direct observation of safety mechanism functionality and user feedback, rather than expert judgment on complex cases.

4. Adjudication Method for the Test Set

The text does not describe an adjudication method. Since there's no mention of multiple experts establishing ground truth, a formal adjudication process (like 2+1 or 3+1) would not be applicable here. The outcomes (no injuries, no failures, positive responses) appear to be directly observed and collected.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The study described is a simulated use study focusing on the device's functionality and safety, not a comparison of human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

N/A (Not Applicable). The SafePro* Plus Safety Syringe is a physical medical device, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance does not apply.

7. The Type of Ground Truth Used

The ground truth used in this study was based on:

Direct observation of device performance and safety: "No sharps injuries or failures of the safety mechanism occurred."
User feedback/satisfaction: "Positive responses from the Evaluators regarding functional and performance aspects."

This is not a traditional "expert consensus," "pathology," or "outcomes data" in the typical diagnostic sense, but rather a direct assessment of device functionality and user experience.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as the SafePro* Plus Safety Syringe is a physical device, not an AI/ML model. Therefore, there is no training set.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this question is not applicable.

Summary

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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 _____________________________________________________________________________________________________________________________________________________________

vi -

*Trademark

Regulation Number and Section

§ 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).