K Number
K031062
Device Name
TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN)
Date Cleared
2003-05-02

(29 days)

Product Code
Regulation Number
880.5860
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
More Information

No
The device description and intended use clearly describe a manual, mechanical safety syringe with no mention of software, algorithms, or data processing that would indicate AI/ML.

No
The device is described as an anti-stick safety syringe intended for the injection of fluids or insulin into the body, not for providing therapy or treatment itself. Its primary function is to facilitate the delivery of substances, not to treat a condition.

No

The device is described as an anti-stick safety syringe intended for the injection of fluids into the body, specifically for insulin and tuberculin. There is no mention of it being used to diagnose conditions or process diagnostic information.

No

The device description clearly indicates it is a physical syringe with mechanical features for safety and retraction, not a software program.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for the "injection of fluids into the body after the aspiration of fluid" and "subcutaneous injection of Insulin" or "three types of injection(subcutaneous, intra-dermal and intra-muscular) of Tuberculin". This describes a device used for administering substances into the body, not for testing samples from the body to diagnose conditions.
  • Device Description: The description focuses on the physical characteristics of a syringe designed for injection, including safety features and different scales for specific substances (insulin, tuberculin). There is no mention of components or functions related to analyzing biological samples.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Testing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring specific analytes
    • Providing information for diagnosis, monitoring, or screening

The device is a syringe, which is a medical device used for administering substances, not for in vitro diagnostic testing.

N/A

Intended Use / Indications for Use

--- The TMD™ 1ml Safety Syringe (FA11 Series 1ml) 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.

Product codes (comma separated list FDA assigned to the subject device)

MEG

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.

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K022278

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K023458

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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

1

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/FA51
Series 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.

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.

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

2

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

3

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 DeviceLegally Market Device
TMDTM 1ml Safety Syringe
(FA11 Series 1ml/FA51
Series U-100 Insulin / FA71
Series Tuberculin)TMDTM Safety Syringe
(FA12 Series 3ml/FA13 Series
5ml)
Indications
for UseAs a single use, hypodermic
syringe. Safety feature
protects after administration.As a single use, hypodermic
syringe. Safety feature protects
after administration.
Volume (ml)1ml3ml/5ml
Needles
Gauge25~31Garge
5/8" or Shorter18-25Garge
11/2" or Shorter
Needle
ConnectionFixed needleLuerLock
LuerSlip
Safety
FeaturesActive safety feature,
manually activated by usersActive safety feature,
manually activated by users
Syringe
TypePlunger, Antistick with
fixed needlesPlunger, Antistick with
hypodermic needles
MaterialPiston-Butyl Rubber
Barrel, plunger, Needle
holder - Polypropylene
LubricantPiston-Butyl Rubber
Barrel, plunger, Needle holder
  • Polypropylene
    Lubricant |

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

4

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.

5

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

6

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

OR

Over-The-Counter Use

Patrica Crescenti

ivision Sign-Off) Sion Sign-O'!!
ion of Anesthesiology, General Hospital, tion Control, Dental Devic

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

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