(109 days)
Not Found
No
The summary describes a mechanical safety syringe with a needle retraction mechanism and a plunger break feature to prevent reuse. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on physical, chemical, and biological standards, not algorithmic performance.
No
The device is a syringe for administering medication and preventing needle stick injuries; it is not a therapeutic device itself.
No
Explanation: The device is a safety syringe for administering insulin, designed to prevent needle stick injuries and re-use. Its function is to deliver a substance (insulin) to the body, not to diagnose a condition or disease.
No
The device description clearly indicates it is a physical syringe with a needle, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the subcutaneous injection of insulin into a patient. This is a direct medical intervention on a living organism (in vivo).
- IVD Definition: In Vitro Diagnostics are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
The ClickZip™ syringe is a device used for administering medication directly into the body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml. with U-100 strength insulin is to be used for subcutaneous injection of insulin into a patient and is intended to prevent needle stick injuries.
In addition, when the syringe user breaks the plunger, re-use of the syringe is prevented.
Product codes
MEG
Device Description
The ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml. is sterile, single-use, disposable and non-reusable, needle retractable safety syringe, provided with various size of needle.
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)
ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml. has been shown to meet internationally recognized standards for syringe performance i.e. ISO 7864, ISO 8537, ISO 10993 series, and ISO 11135. These include physical specification, chemical specification, biocompatibility and sterilization specification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows a logo with a cross shape at the top. Below the logo, the text "Medical Device Manufacturer (Thailand) Limited" is present. A horizontal line is located beneath the text.
PREMARKET NOTIFICATION (510 (K)) SUBMISSIONS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS for ClickZip Needle Retractable Safety Syringe Insulin 1 ml. (per 21CFR807.92)
1. SUBMITTER's NAME
JAN - 5 2007
Medical Device Manufacturer (Thailand) Ltd. 7/145 Amata City Industrial Estate Pluakdaeng, Rayong 21140 Thailand
Contact: Ms. Oytip Kunwunlop, Compliance Director 66 1 844 7959 Phone: Fax: 66 38 956 429
2. DEVICE NAME
ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml. Trade Name: Common Namc: Safety Syringe Classification: II Classification Name: Piston Syringe with Safety Feature Classification Code: MEG Nominal Capacity: 1ml. Insulin Unit: U-100
3. PREDICATE DEVICE
- 1cc Insulin SafePro Safety Syringe with 510(K) number K050134 ●
- ClickZip™ Needle Retractable Safety Syringe with 510(K) number K051694 .
4. DEVICE DESCRIPTION
The ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml. is sterile, single-use, disposable and non-reusable, needle retractable safety syringe, provided with various size of needle.
1
Image /page/1/Picture/0 description: The image shows a gray medical cross logo above the text "Medical Device Manufacturer (Thailand) Limited". The cross is made up of small squares. The text is centered below the cross.
PREMARKET NOTIFICATION (510 (K)) SUBMISSIONS
Section: II
Page: III- 2
Kob2780
5. INTENDED USE
The ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml. with U-100 strength insulin is to be used for subcutaneous injection of insulin into a patient and is intended to prevent needle stick injuries.
In addition, when the syringe user breaks the plunger, re-use of the syringe is prevented.
6. COMPARISON of MODIFIED & PREDICATE DEVICE and SUBSTANTIAL EQUIVALENCE
Medical Device Manufacturer (Thailand) Ltd. makes a claim of substantial equivalence of the ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml. to the cited predicates based on similarities in intended use, design, technological and operational characteristics. The syringes are indicated for injecting insulin into the body, while helping to prevent needle stick injuries. ClickZip™ is supplied with needle attached while SafePro is supplied with or without needle packing.
All syringes requires the user to manually activate the safety mechanism. This is done by retracting the needle into the syringe barrel, breaking off the plunger and discarding the pieces.
Medical Device Manufacturer (Thailand) Ltd. believes that the difference between the ClickZip™ Needle Retractable Safety Syringe and the predicate device are minor and they raise no new issues of safety or effectiveness.
7. PERFORMANCE SUMMARY
ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml. has been shown to meet internationally recognized standards for syringe performance i.e. ISO 7864, ISO 8537, ISO 10993 series, and ISO 11135. These include physical specification, chemical specification, biocompatibility and sterilization specification.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circle around the eagle. The logo is black and white and appears to be a seal.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
- 5 2007
Ms. Oytip Kunwunlop Compliance Director Medical Device Manufacturer (Thailand) Limited 7/145 Moo 4 Amata City Industrial Estate Rayong, Thailand 21140
Re: K062780
Trade/Device Name: ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml, Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: November 23, 2006 Received: November 29, 2006
Dear Ms. Kunwunlop:
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.
3
Page 2 -- Ms. Kunwunlop
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 (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/industry/support/index.html.
Sincerely yours.
Susan Quan
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
4
STATEMENT OF INDICATIONS FOR USE
510K Number (if known): 上の62子80
Device Name: ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml.
Indications for Use:
The ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml. with U-100 strength insulin is to be used for subcutaneous injection of insulin into a patient and is intended to prevent needle stick injuries.
In addition, when the syringe user breaks the plunger, re-use of the syringe is prevented.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use | OR | Over-the-Counter | |
|---|---|---|---|
| Use | |||
| Per 21 CFR 801.109 | (Optional Format 1-2-96) |
Orthopedics Urology General Hospital
Dailou Smal Devices
Concurrence of CDRH, Office of Device Evaluation (ODE)