The TMD™ 1ml Safety Syringe (FA11 Series 1ml) is designed as an anti-stick svringe to reduce the risk of sharps injuries and the potential for syringe reuse. It is a single use, disposable and manual retractable safety syringe that is intended for injection of fluids into the body after the aspiration of fluid.

The TMD™ 1ml Insulin Safety Syringe (FA51 Series U-100 Insulin) is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe reuse and is a single use, disposable and manual retractable safety syringe which is intended for use for subcutaneous injection of Insulin

The TMD 1ml Tuberculin Safety Syringe (FA71 Series Tuberculin) is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe reuse and is a single use, disposable and manual retractable safety syringe which is intended to use for the three types of injection(subcutaneous, intra-dermal and intra-muscular) of Tuberculin.

Device Description

The TMD 1ml Safety Syringe (FA11 Series 1ml/FA51 Series U-100 Insulin / FA71 Series Tuberculin) is a single use, sterile, disposable syringes that is designed to reduce the risk of sharps injuries. The insulin syringe has scale lines in insulin units. The Tuberculin syringe has scale lines of Tuberculin.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device (TMD™ 1ml Safety Syringe). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics typically seen in clinical trials for new technologies.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies, and detailed ground truth establishment is not available in this type of regulatory submission.

The document states:

"Performance data has been generated in compliance with the design control requirement and appropriate standards. The result demonstrated equivalent to the predicate devices." (Section 7)
"Additional performance data was conducted to demonstrate the compliance with ISO8537 (Insulin Syringes) specification." (Section 7)
The comparison table (Section 9) focuses on technological characteristics rather than specific performance outcomes against predefined acceptance criteria for clinical efficacy.

Here's a breakdown of what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document as specific quantifiable acceptance criteria and corresponding device performance metrics (e.g., success rate of the safety mechanism in preventing needlestick injuries in a controlled user study) are not detailed. The document generally states that performance data was generated and demonstrated equivalence to predicate devices and compliance with ISO8537.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document mentions "Performance data has been generated" but does not detail the number of units tested or the methodology.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. The manufacturer is based in Taiwan, and the submission is to the US FDA, but the origin or nature of the performance data is not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not specified. This type of information is typically relevant for diagnostic devices where subjective interpretation (e.g., by radiologists) is being evaluated against a ground truth. For a safety syringe, performance data would likely involve engineering tests, biomechanical tests, and possibly simulated use tests, not expert consensus on "ground truth" labels.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/Not specified. Similar to point 3, adjudication methods are used for resolving disagreements in expert interpretations for diagnostic accuracy, which is not the primary focus for a safety syringe's performance data.

5. 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. MRMC studies and "human improvement with AI" are relevant for AI-powered diagnostic or assistive technologies. This device is a manual safety syringe, not an AI system.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This question is for AI algorithms. The device is a physical safety syringe.

7. The type of ground truth used

Not applicable/Not specified in detail. For a safety syringe, "ground truth" would relate to objective measurements of mechanical function, sterility, biocompatibility, and possibly the actual successful activation of the safety mechanism in simulated use. The document broadly refers to "compliance with the design control requirement and appropriate standards" and ISO8537.

8. The sample size for the training set

Not applicable/Not specified. Training sets are relevant for machine learning algorithms. This is a physical device without an AI component.

9. How the ground truth for the training set was established

Not applicable.

Summary

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K031062

Appendix G

MAY 2,2003

510(k) Summary

Taiject Medical Device, Co., Ltd.

Special 510(k)

March 28, 2003

TMD™ 1ml Safety Syringe (FA11 Series 1ml/FA51 Series U-100 Insulin/FA71 Series Tuberculin) Page 21

168

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510(k) Summary of Safety and Effectiveness for the TMD™ 1ml Safety Syringe (FA11 Series 1ml/FA51 Series U-100 Insulin / FA71 Series Tuberculin) (per 21CFR807.92)

1. SPONSOR

Taiject Medical Device Co., Ltd. 10F, No300, Section 2 Chung Feng Road Chu Tung Town, Hsin Chu Taiwan 310 Republic of China Tel: 886 3 595 9986 Fax: 886 3 595 9950 Contact person: Mr. David Huang Date Prepared: March 28, 2003

2. DEVICE NAME

Proprietary Name:	TMD™ 1ml Safety Syringe (FA11 Series 1ml/FA51Series U-100 Insulin / FA71 Series Tuberculin)
Common/Usual Name:	Safety Syringe
Classification Name:	Piston syringe (FMF)Anti-Stick Syringe (MEG)

3. Predicate Device (Legally Marketed Device):

Legally Marketed Device: TMD™ Safety Syringe (FA12 Series 3 ml/FA13 Series 5 ml) with 510K number K022278.

DEVICE DESCRIPTION 4.

Taiject Medical Device, Co., Ltd. Special 510(k) March 28, 2003 TMDTM 1ml Safety Syringe

(FA11 Series 1ml/FA51 Series U-100 Insulin / FA71 Series Tuberculin) Page 22

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INTENDED USE 5.

--- The TMD™ 1ml Safety Syringe (FA11 Series 1ml) is designed as an anti-stick svringe to reduce the risk of sharps injuries and the potential for syringe reuse. It is a single use, disposable and manual retractable safety syringe that is intended for injection of fluids into the body after the aspiration of fluid.

--- The TMD™ 1ml Insulin Safety Syringe (FA51 Series U-100 Insulin) is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe reuse and is a single use, disposable and manual retractable safety syringe which is intended for use for subcutaneous injection of Insulin

-- The TMD 1ml Tuberculin Safety Syringe (FA71 Series Tuberculin) is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe reuse and is a single use, disposable and manual retractable safety syringe which is intended to use for the three types of injection(subcutaneous, intra-dermal and intra-muscular) of Tuberculin.

TECHNOLOGICAL CHARACTERISTICS 6.

The technological characteristics are the same as the legally market device. TMD™ Safety Syringe (FA12 Series 3 ml/FA13 Series 5 ml) with 510K number K022278 and TMD The Safety Syringe (FA14 Series 10 ml/FA15 Series 20 ml) with 510K number K023458.

7. PERFORMANCE DATA

Performance data has been generated in compliance with the design control requirement and appropriate standards. The result demonstrated equivalent to the predicate devices.

Additional performance data was conducted to demonstrate the compliance with ISO8537 (Insulin Syringes) specification.

Additional Biocompatibility and Sterility evaluation: 8.

Additional biocompatibility tests were performed. None of the tests indicates any Taiject Medical Device, Co., Ltd. March 28, 2003 Special 510(k)

TMD™ Iml Safety Syringe

(FA11 Series 1ml/FA51 Series U-100 Insulin / FA71 Series Tuberculin) Page 23

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issues of the biocompatibility.

Additional sterility validation was performed in the process control to demonstrate the Sterility Assurance Level (SAL) of 100.

COMPARISON INFORMATION 9.

Comparison of the TMD™ 1ml Safety Syringe (FA11 Series 1ml/FA51 Series U-100 Insulin / FA71 Series Tuberculin) with Legally Marketed Device TMD TM Safety Syringe (FA12 Series 3ml/FA13 Series 5ml)

	Submission Device	Legally Market Device
	TMDTM 1ml Safety Syringe(FA11 Series 1ml/FA51Series U-100 Insulin / FA71Series Tuberculin)	TMDTM Safety Syringe(FA12 Series 3ml/FA13 Series5ml)
Indicationsfor Use	As a single use, hypodermicsyringe. Safety featureprotects after administration.	As a single use, hypodermicsyringe. Safety feature protectsafter administration.
Volume (ml)	1ml	3ml/5ml
NeedlesGauge	25~31Garge5/8" or Shorter	18-25Garge11/2" or Shorter
NeedleConnection	Fixed needle	LuerLockLuerSlip
SafetyFeatures	Active safety feature,manually activated by users	Active safety feature,manually activated by users
SyringeType	Plunger, Antistick withfixed needles	Plunger, Antistick withhypodermic needles
Material	Piston-Butyl RubberBarrel, plunger, Needleholder - PolypropyleneLubricant	Piston-Butyl RubberBarrel, plunger, Needle holder- PolypropyleneLubricant

Taiject Medical Device, Co., Ltd. Special 510(k) TMD™ 1ml Safety Syringe

March 28, 2003

171

(FA11 Series 1ml/FA51 Series U-100 Insulin / FA71 Series Tuberculin) Page 24

snipping cartons. I was a

In summary, TMD™ 1ml Safety Syringe (FA11 Series 1ml/FA51 Series U-100 Inculin / EAZ1 Sames Tubernylin) is a smaller version of the legally marketed

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

MAY - 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tailect Medical Device Company Limited C/O Dr. Jim-Son Chou Achevé Technology, Incorporated P.O. Box 8853 Newport Beach, California 92658

Re: K031062

Trade/Device Name: TMD™ 1ml Safety Syringe (FA11 Series 1ml/FA51 Series U-100 Insulin/ FA71 Series Tuberculin) Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: March 28, 2003 Received: April 15, 2003

Dear Dr. Chou:

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. Chou

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 vour 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,

Super Runne

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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K03/062

510(k) Number (if known):

Device Name: TMD™ 1ml Safety Syringe (FA11 Series 1ml/FA51 Series U-100 Insulin / FA71 Series Tuberculin)

Indications For Use:

--- The TMD™ Iml Safety Syringe (FA11 Series Iml) is intended for ir jection of fluids into the body after the aspiration of fluid.

-- The TMD™ 1ml Insulin Safety Syring: (FA51 Series U-100 I 1sulin) is intended for use for subcutancous injection of Insulin.

--- The TMD™ Iml Tuberculin Safety Syringe (FA71 Series Tuberculin) is intended for intra-dermal injection of Tubercuiin.

All the three syringes above incomorate a safety feature that is designed to aid the reduction of needlestick injuries and the potential of syringe reuse.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE (IN ANOTHER PAGE IF NICES! ARY M

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
other than
within

Over-The-Counter Use

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510(k) Number: N031062

Special S10(k) Taiject Medical Device, Co., Ltd. March 28, 2003 TMDTM Iml Safety Syringe (FA11 Series 1ml/FA51 Scries U-100 Insulin / FA71 Series Tuberculin) Page ii

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).