(109 days)
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.
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.
The provided document is a 510(k) summary for the ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml. This document establishes substantial equivalence to predicate devices based on similarities in intended use, design, technological, and operational characteristics, and references adherence to international standards. It does not contain information about a specific diagnostic study with acceptance criteria and device performance metrics, as is typical for AI/ML-based medical devices.
Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable or available in this document.
However, I can provide available information regarding the device's performance summary based on the provided text.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| ISO 7864 (Sterile hypodermic needles for single use) | Device shown to meet this standard. |
| ISO 8537 (Sterile single-use syringes, with or without needle, for insulin) | Device shown to meet this standard. |
| ISO 10993 series (Biological evaluation of medical devices) | Device shown to meet this standard (Biocompatibility specification). |
| ISO 11135 (Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices) | Device shown to meet this standard (Sterilization specification). |
| Physical Specification | Device shown to meet requirements. |
| Chemical Specification | Device shown to meet requirements. |
| Biocompatibility | Device shown to meet requirements (part of ISO 10993 series). |
| Sterilization | Device shown to meet requirements (part of ISO 11135). |
| Intended to prevent needle stick injuries | The device's design is intended for this purpose. |
| Prevents re-use of syringe (plunger breaks) | The device's design is intended for this purpose. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to meeting international standards (ISO standards), which implies performance testing, but does not detail the sample sizes, data provenance, or specific study designs for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The document describes compliance with technical standards, not a diagnostic study involving expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to this device. The ClickZip™ Needle Retractable Safety Syringe is a physical medical device designed for insulin injection and needle stick prevention, not an AI/ML diagnostic tool involving human readers or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable to this device. The ClickZip™ Needle Retractable Safety Syringe is a physical medical device and does not involve an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This is not applicable in the context of a diagnostic ground truth. For this type of device, "ground truth" would refer to the physical and functional characteristics meeting engineering specifications and safety requirements as defined by the ISO standards and the device's intended use (e.g., successful needle retraction, prevention of re-use, sterility, biocompatibility). These are verified through various physical, chemical, and biological tests, not typically through expert consensus on diagnostic images or pathology.
8. The sample size for the training set
This is not applicable to this device. There is no AI/ML algorithm involved.
9. How the ground truth for the training set was established
This is not applicable to this device. There is no AI/ML algorithm involved.
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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.
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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.
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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.
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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
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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)
§ 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).