A properly placed syringe provides access to a vein or tissue for fluid sampling or infusion. The safety syringe is designed for single use and has a needlestick protection feature. The risk of accidental needlesticks is reduced by a needle retraction system which is activated after the infusion procedure is completed.

Device Description

The SafePro* 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

Here's a summary of the acceptance criteria and study details for the SafePro* Safety Syringe, based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Material Safety and Biocompatibility	Meets ISO 10993-1 and US FDA G-95 requirements.
Risk Reduction of Accidental Needlestick Injuries	0 sharps injuries or failure of the safety mechanism observed in the simulated use study.
Functional and Performance Aspects (Customer Requirements)	Positive responses from Evaluators, indicating the device meets customer requirements.

Study Details

Sample Size used for the test set and the data provenance:
- Sample Size: 500 SafePro* Safety Syringes were evaluated by 50 participants. (Note: The document does not specify a separate "test set" from a "training set" in the context of typical AI/machine learning studies. This appears to be a performance validation study for a medical device).
- Data Provenance: Not explicitly stated, however, the study involved "participants" evaluating the syringes, implying prospective human use simulation. No country of origin for the participants is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this device study. This was a simulated use study with direct observation of safety mechanism function and user feedback, not an expert-driven ground truth establishment for a diagnostic output. The "evaluators" (50 participants) provided feedback, but weren't "experts establishing ground truth."
Adjudication method for the test set:
- Not applicable. The study involved direct observation of safety mechanism function and collection of user feedback. There is no mention of a process requiring adjudication among multiple observers for a single outcome.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a physical medical device, not an AI or diagnostic imaging system. No human reader involvement in a diagnostic task is described.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm. The device's safety mechanism operates independently (standalone) after activation, but it's not an "algorithm only" performance evaluation.
The type of ground truth used:
- Direct Observation of Safety Mechanism Function: The absence of sharps injuries and failure of the safety mechanism during simulated use served as direct evidence of the device's protective function.
- User Feedback/Satisfaction Surveys: Positive responses from participants regarding functional and performance aspects.
The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI system that requires a "training set." The development process would have involved internal testing and iterative design, but not a formally defined "training set" in the machine learning sense.
How the ground truth for the training set was established:
- Not applicable, as no "training set" in the machine learning context is described.

Summary

{0}------------------------------------------------

Ko12726

OCT 1 8 2001

510(K) - SafePro* Safety Syringe

SECTION VIII

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS for SafePro* Safety Syringe

1. REGULATORY AUTHORITY

Safe Medical Device Act of 1990, CFR 807.92.

2. CONTACT PERSON

Joseph J. Chang, Ph.D., PE HOU-SE MEDICAL, INC. U.S. Liaison Office P. O. Box 630374 Irving, TX 75063-0374

NAME OF MEDICAL DEVICE 3.

Classification Name: Syringe, Antistick Classification Code: 177 MEG Common/Usual Name: Syringe Proprietary Name: SafePro* Safety Syringe

DEVICE CLASSIFICATION 4.

The General Hospital Panel has classified Antistick Syringes (21CFR880.5600) into Class II, Special Controls under section 513 of the Act.

ડ. STATEMENT OF SUBSTANTIAL EQUIVALENCE

The SafePro* Safety Syringe is substantially equivalent to B-D Luer Lok syringe in terms of normal syringe function for fluid transport, and Retractable Technology, Inc. VanishPoint syringe for needlestick protection feature. See also the attached table.

{1}------------------------------------------------

510(K) - SafePro* Safety Syringe

6. INTENDED USE

The SafePro* Safety Syringe is designed to gain access to a patient's vascular or intramuscular system for short term fluid sampling or infusion. The device is designed for single use and has a needlestick protection feature.

DESCRIPTION OF DEVICE 7.

The SafePro* 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 SafePro* Safety Syringe was tested for material safety and biocompatibility. Test results indicated that the SafePro* Safety Syringe meets ISO 10993-1 and US FDA G-95 requirements.

9. SUMMARY OF SIMULATED USE STUDY

A total of 500 SafePro* Safety Syringes were evaluated by 50 participants. No sharps injuries or failure of the safety mechanism occurred. Successful completion of the study supports the claim that SafePro* Safety Syringe can reduce the risk of accidental needlestick injuries. The positive responses from the Evaluators regarding functional and performance aspects also indicated that the SafePro* Safety Syringe meets customer requirements.

CONCLUSION 10.

The results obtained from bench testing, material safety, and simulated use tests indicate that the SafePro* Safety Syringe is safe and effective for it's intended use.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or abstract shapes. The logo is in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Joseph J. Chang, PHD, P.E. Chief Technology Officer Hou-se Medical, Incorporated

P.O. Box 630374 Irving, Texas 75063-0374

Re: K012726

Trade/Device Name: SafePro™ Safety Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: August 10, 2001 Received: August 15, 2001

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.

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.

OCT 1 8 2001

{3}------------------------------------------------

Page 2 - Dr. Chang

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,

Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE

Applicant

HOU-SE MEDICAL, INC. Address in Taiwan Headquarter Office: 295, 7/F, Sec. 2, Ho-Ping E. Rd., Taipei, Taiwan, R. O. C. Zip Code: 106

Address in U.S. Liaison Office: P.O. Box 630374 Irving, TX 75063-0374

510(K) Number K Ol 2726

This is a new submission and FDA has not assigned a number at this time.

Device Name

SafePro* Safety Syringe

Indication for Use

(Please don 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 (Optional Format 1-2-96)

OR Over-the-Counter __

Sene Naveau for lXC

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number

*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).