(14 days)
Not Found
No
The document describes a mechanical safety syringe and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a syringe intended for injecting fluids or insulin, which is a delivery mechanism, not a therapeutic agent itself.
No
The device is a syringe, intended for the injection of fluids, and is not described as being used to diagnose conditions or diseases.
No
The device description clearly indicates it is a physical syringe with a safety feature, not a software application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the syringes are for "injection of fluids into the body," "subcutaneous injection of Insulin," and "intra-dermal of Tuberculin." These are all procedures performed on the body, not on samples taken from the body for diagnostic purposes.
- Device Description: The description focuses on the physical characteristics of the syringe and its safety features, not on any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, providing diagnostic information, or any other typical characteristics of an IVD device.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device is for administering substances into the body.
N/A
Intended Use / Indications for Use
- The TMD™ 0.5ml Safety Syringe (FA18 Series 0.5ml) is intended for injection of fluids into the body after the aspiration of fluid.
- The TMD™ 0.5ml Insulin Safety Syringe (FA58 Series U-100 Insulin) is intended for use for subcutaneous injection of Insulin.
- The TMD™ 0.5ml Tuberculin Safety Syringe (FA78 Series Tuberculin) is intended intra-dermal of Tuberculin.
All the three syringes above incorporate a safety feature that is designed to aid the reduction of needle stick injuries and the potential of syringe reuse.
Product codes (comma separated list FDA assigned to the subject device)
MEG, FMF
Device Description
The TMD 0.5ml Safety Syringe (FA18 Series 0.5ml/FA58 Series U-100 Insulin / FA78 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.
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.
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2004
Taiject Medical Device, Company Limited C/O Dr. Jim-Son Chou Vice President Achevé Technology, Incorporated P.O. Box 8853 Newport Beach, California 92658
Re: K042426
Trade/Device Name: TMD 0.5mL Safety Syringe (FA18 Series 0.5mL/FA58 Series U-100 Insulin/FA78 Series Tuberculin) Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: September 3, 2004 Received: September 8, 2004
Dear Dr. Chou:
This letter corrects our substantially equivalent letter of September 22, 2004 regarding the trade name.
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 (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 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.
1
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 (OS) 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 continue 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 (240) 276-0115. 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,
Carls
Chiu Lin, Ph.D. 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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K042426
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SEP 2 2 2004
510(k) Summary of Safety and Effectiveness for the TMDTM 0.5ml Safety Syringe (FA18 Series 0.5ml/FA58 Series U-100 Insulin / FA78 Series Tuberculin) (per 21CFR807.92)
1. SPONSOR
Taiject Medical Device Co., Ltd. 1F, No. 22, KeDung 3 rd Road , Science-Based Industrial Park Chu Nan, MiaoLi, Taiwan 350 Republic of China Tel: 886 37 585599 Fax: 886 37 585589 Contact person: Mr. David Huang Date Prepared: September 3rd, 2004
2. DEVICE NAME
| Proprietary Name: | TMD TM 0.5ml Safety Syringe (FA18 Series 0.5ml/FA58
Series U-100 Insulin / FA78 Series Tuberculin) |
|----------------------|---------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Safety Syringe |
| Classification Name: | Piston syringe (FMF)
Anti-Stick Syringe (MEG) |
Predicate Device (Legally Marketed Device): 3.
Legally Marketed Device:
FA11 Series Iml/FA51 Series U-100 Insulin/FA71 Series Tuberculin) with 510K number K031062 and FA12 Series 3 ml/FA13 Series 5 ml with 510K number K022278
DEVICE DESCRIPTION 4.
The TMD 1 0.5ml Safety Syringe (FA18 Series 0.5ml/FA58 Series U-100 Insulin / FA78 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
Taiject Medical Device, Co., Ltd. Special 510(k) September 3, 2004 TMDTM 0.5ml Safety Syringe (FA18 Series 0.5ml/FA58 Series U-100 Insulin / FA78 Series Tuberculin) Page 18
3
K042426
2 of 3
units. The Tuberculin syringe has scale lines of Tuberculin.
INTENDED USE ડ.
--- The TMD™ 0.5ml Safety Syringe (FA18 Series 0.5ml) is intended for injection of fluids into the body after the aspiration of fluid.
--- The TMD™ 0.5ml Insulin Safety Syringe (FA58 Series U-100 Insulin) is intended for use for subcutaneous injection of Insulin.
--- The TMD™ 0.5ml Tuberculin Safety Syringe (FA78 Series Tuberculin) is intended intra-dermal of Tuberculin.
All the three syringes above incorporate a safety feature that is designed to aid the reduction of needle stick injuries and the potential of syringe reuse.
TECHNOLOGICAL CHARACTERISTICS 6.
The technological characteristics are the same as the legally market device, FA11 Series 1ml/FA51 Series U-100 Insulin/FA71 Series Tuberculin) with 510K number K031062 and FA12 Series 3 ml/FA13 Series 5 ml with 510K number K022278
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.
COMPARISON INFORMATION 8.
Comparison of the TMD™ 0.5ml Safety Syringe (FA18 Series 0.5ml/FA58 Series U-100 Insulin / FA78 Series Tuberculin) with Legally Marketed Device TMD™ Safety Syringe (FA12 Series 3ml/FA13 Series 5ml)
| Submission Device | Legally Market Device | |
|---|---|---|
| -- | ------------------- | ----------------------- |
September 3, 2004 Taiject Medical Device, Co., Ltd. Special 510(k) TMDTM 0.5ml Safety Syringe (FA18 Series 0.5ml/FA58 Series U-100 Insulin / FA78 Series Tuberculin) Page 19
4
| | TMD™ 0.5ml Safety
Syringe (FA18 Series
0.5ml/FA58 Series U-100
Insulin / FA78 Series
Tuberculin) | TMD™ Safety Syringe
(FA11 Series 1ml/FA51 Series
U100 insulin/FA71 Series
Tuberculin ) |
|------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Indications
for Use | As a single use, hypodermic
syringe. Safety feature
protects after administration. | As a single use, hypodermic
syringe. Safety feature
protects after administration. |
| Volume (ml) | 0.5ml | 1ml |
| Needles | 2531Garge | 2531Garge |
| Gauge | 5/8" or Shorter | 5/8" or Shorter |
| Needle
Connection | Fixed needle | Fixed needle |
| Safety
Features | Active safety feature,
manually activated by users | Active safety feature, manually
activated by users |
| Syringe
Type | Plunger, Antistick with fixed
needles | Plunger, Antistick with
hypodermic needles |
| Material | Piston-Butyl Rubber
Barrel, plunger, Needle
holder - Polypropylene
Lubricant | Piston-Butyl Rubber
Barrel, plunger, Needle holder
- Polypropylene
Lubricant |
| Color | Parts- Clear
Printing-Black
Orange - Insulin
Gray - Tuberculin
Transparent - Safety syringe | Parts- Clear
Printing-Black
Orange - Insulin
Gray - Tuberculin
Transparent - Safety syringe |
In summary, TMD™ 0.5ml Safety Syringe (FA18 Series 0.5ml/FA58 Series U-100 Insulin / FA78 Series Tuberculin) is a smaller version of the legally marketed TMD™ Safety Syringe (FA11 Series 1ml/FA51 Series U-100 Insulin/FA71 Series Tuberclin) and FA12 Series 3 ml/FA13 Series 5 ml with 510K number K022278.
Taiject Medical Device, Co., Ltd. Special 510(k) September 3, 2004 TMD™ 0.5ml Safety Syringe (FA18 Series 0.5ml/FA58 Series U-100 Insulin / FA78 Series Tuberculin) Page 20
5
K042426
1 of 2.
Indications for Use
K042426 510(k) Number (if known):
Device Name:TMDTM 0.5ml Safety Syringe (FA58 Series U-100 Insulin)
Indications For Use:
--- The TMD™ 0.5ml Insulin Safety Syringe (FA58 Series U-100 Insulin) is intended for use for subcutaneous injection of Insulin.
This syringe above incorporates a safety feature that is designed to aid the reduction of needle stick injuries and the potential of syringe reuse.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne
ivision Sian-Off on of Anesthesiology, General Hospital. Infection Control, Dental Devices
Page i of ii
510(k) Number: K092896
Special 510(K) Tailect Medical Device, Co., Ltd. TMDTM 0.5ml Safety Syringe
September 3rd, 2004
6
K042426
2 of.2
Indications for Use
K042426 510(k) Number (if known):
Device Name: TMD™ 0.5ml Safety Syringe (FA18 Series 0.5ml/ FA78 Series Tuberculin)
Indications For Use:
--- The TMD™ 0.5ml Safety Syringe (FA18 Series 0.5ml) is intended for injection of fluids into the body after the aspiration of fluid.
--- The TMD™ 0.5ml Tuberculin Safety Syringe (FA78 Series Tuberculin) is intended intra-dermal of Tuberculin.
All these two syringes above incorporate a safety feature that is designed to aid the reduction of needle stick injuries and the potential of syringe reuse.
AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runge
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Division of Anosthoental Devices
Page ii of iii
Koy2a4b
iect Medical Device, Co., Ltd. TMDTM 0.5ml Safety Syringe
Special 510(K)
September 3rd, 2004