(181 days)
The ClickZip™ Needle Retractable Safety Syringe is to be used for intra-muscular of The ChekZip - Needle Ketractaons into a patient and is intended to prevent needle stick subcutaneous injection of medications into a patient and is intended on the subcutaneous injection of medications into a partificant (1) Needle Retractable injuries. It is currently available in Imal for withdrewing blood In addition when the injuries. It is currently available in this only and simbleding blood. In addition, when the Safely Syringe 13 not intenably the syringe is prevented.
The ClickZip™ Needle Retractable Safety Syringe is sterile, single-use, disposable and nonreusable, needle retractable safety syringe, provided with various size of needle. The products are supplied in many sizes i.e. 1, 3 and 5 ml.
The prompt provided describes a 510(k) premarket notification for a medical device called the "ClickZip™ Needle Retractable Safety Syringe." This document outlines the device's characteristics, intended use, and claims of substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or an analytical study proving the device meets those criteria, as one would typically find for performance testing.
The document primarily focuses on demonstrating substantial equivalence to a predicate device based on:
- Intended Use: Used for intramuscular or subcutaneous injection of medications to prevent needle stick injuries, and not for withdrawing blood.
- Design, Technological, and Operational Characteristics: Sterile, single-use, disposable, non-reusable, and supplied with various needle sizes (1, 3, and 5 ml).
- Compliance with Recognized Standards: The document states that the device "has been shown to meet internationally recognized standards for syringe performance i.e. ISO 7864, ISO 7886-1, ISO 10993 series, ISO 11135. These include physical specification, chemical specification, and biocompatibility and sterilization specification."
There is no detailed information regarding a specific study conducted with acceptance criteria, sample sizes, ground truth establishment, or expert involvement as requested in the prompt. The 510(k) process often relies on demonstrating equivalence through comparison to a legally marketed predicate device that has already established safety and effectiveness, rather than requiring extensive de novo clinical or performance studies for every new submission, especially for devices with well-understood risks like syringes.
Therefore, I cannot populate the table or answer most of the specific questions because the provided text does not contain this level of detail about a performance study with acceptance criteria.
Based on the provided text, here is what can be inferred and what is explicitly missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in detail. The document broadly states compliance with international standards (ISO 7864, ISO 7886-1, ISO 10993 series, ISO 11135) for: | Not specified in detail. The device is stated to meet these standards in general. No specific performance metrics or thresholds are provided in the text. |
| Physical specification | Meets ISO 7864, ISO 7886-1, ISO 10993 series, ISO 11135 |
| Chemical specification | Meets ISO 7864, ISO 7886-1, ISO 10993 series, ISO 11135 |
| Biocompatibility | Meets ISO 7864, ISO 7886-1, ISO 10993 series, ISO 11135 |
| Sterilization specification | Meets ISO 7864, ISO 7886-1, ISO 10993 series, ISO 11135 |
| Prevention of needle stick injuries | Implied by the "Safety Syringe" designation and intended use; assumed to be equivalent to the predicate device. |
| Prevention of reuse | Achieved when the user breaks the plunger; assumed to be equivalent to the predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided in the document. The document mentions compliance with ISO standards, which would imply testing, but does not detail the sample sizes or provenance of any such test data.
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)
- Not applicable / Not provided. The document describes a medical device, not a diagnostic algorithm that relies on expert consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. This is not relevant for the type of device and performance information presented.
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
- No. This is not an AI/diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/diagnostic imaging device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. For a syringe, performance is typically assessed against engineering specifications, material properties, and functional tests outlined in international standards, not against "ground truth" as conceptualized for diagnostic devices.
8. The sample size for the training set
- Not applicable / Not provided. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable / Not provided. This is not an AI/machine learning device.
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Image /page/0/Picture/1 description: The image shows a black medical cross at the top. Below the cross, the text "Medical Device Manufacturer (Thailand) Limited" is present. The text appears to be part of a logo or company identifier.
PREMARKET NOTIFICATION (510 (K)) SUBMISSIONS
Section: II
Page: II- 1
DEC 2 1 2005
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS for ClickZip Needle Retractable Safety Syringe (per 21CFR807.92)
1. SUBMITTER's NAME
Medical Device Manufacturer (Thailand) Ltd. 7/145 Amata City Industrial Estate Pluakdaeng, Rayong 21140 Thailand
| Contact: | Ms. Oytip Kunwunlop, Compliance Director |
|---|---|
| Phone: | 66 1 844 7959 |
| Fax: | 66 38 956 429 |
2. DEVICE NAME
| Trade Name: | ClickZip™ Needle Retractable Safety Syringe |
|---|---|
| Common Name: | Safety Syringe |
| Classification: | II |
| Classification Name: | Piston Syringe with Safety Feature |
| Classification Code: | MEG |
| Nominal Capacity: | 1, 3 and 5 ml. |
3. PREDICATE DEVICE
SECUREGARD® Retractable Safety Syringe with 510(K) number K012121.
4. DEVICE DESCRIPTION
The ClickZip™ Needle Retractable Safety Syringe is sterile, single-use, disposable and nonreusable, needle retractable safety syringe, provided with various size of needle. The products are supplied in many sizes i.e. 1, 3 and 5 ml.
5. INTENDED USE
The ClickZip™ Needle Retractable Safety Syringe is to be used for intra-muscular or The Cheater injection of medications into a patient and is intended to prevent needle stick subculaneous injection of medications into a partent and 5 ml sizes. ClickZip™ Needle Retractable
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- Medical Device Manufacturer
PREMARKET NOTIFICATION
(510 (K)) SUBMISSIONS
Section: II
Page: II-2
Safety Syringe is not intended to be used for withdrawing blood. In addition, when the syringe user breaks the plunger, reuse of the syringe is prevented.
6. SUBSTANTIAL EQUIVALENCE
(Thailand) Limited
Medical Device Manufacturer (Thailand) Ltd. makes a claim of substantial equivalence of the SECUREGARD® Retractable Safety Syringe with 510(K) number K012121 based on similarities in intended use, design, technological and operational characteristics. Both are indicated for injecting fluids into the body and should not be used for blood collection. Both ClickZip™ and SECUREGARDS Retractable Safety Syringe are always supplied with needle attached. 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 has been shown to meet internationally recognized standards for syringe performance i.e. ISO 7864, ISO 7886-1, ISO 10993 series, ISO 11135. These include physical specification, chemical specification, and 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 and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged in a circle around the symbol. The caduceus is a common symbol for healthcare organizations, and the inclusion of the department's name makes it clear that this is the official logo for the U.S. Department of Health and Human Services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 2005
Mr. Oytip Kunwunlop Compliance Director Comphanee Directorer (Thailand) Limited 7/145 Moo 4 Amata City Industrial Estate Rayong, THAILAND 21140
Re: K051694
K051694
Trade/Device Name: ClickZip™Needle Retractable Safety Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: December 2, 2005 Received: December 8, 2005
Dear Mr. Kunwunlop:
We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Section 510(x) premaince is substantially equivalent (for the referenced above and have determined the de realicated by dicate devices marketed in
indications for use stated in the enclosure) to legally marketed predical Device indications for use stated in the cholosaro, to tegain. interstate commerce prior to May 20, 1770, the provins with the provisions of
Amendments, or to devices that have been receive epproval of a premarket Amendments, or to devices that have been recuire approval of a prematice and the Federal Food, Drug, and Cosmetic Act (Free) into sket the device, subject to the general approval application (1117). Tournal), and controls provisions of the Act include controls provisions of the Fet. "The genting 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 If your device is classified (sec above) into entrols. Existing major regulations affecting (PMA), it may of Subject to Sach adamental Prairies of Federal Regulations, Title 21, Parts 800 to 898. In the Corporal your device can be found in the Gode of receive of concerning your device in the Federal Register.
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Page 2 - Mr. Kunwunlop
Please be advised that FDA's issuance of a substantial equivalence determination does not I tease be ac nota has made a determination that your device complies with other requirements moun that I DT has mass statutes and regulations administered by other Federal agencies. or are For of any with all the Act's requirements, including, but not limited to: registration 1 ou intine (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 OF RT rar 007), assility systems (QS) regulation (21 CFR Part 820); and if requirements as sections are quadion 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) I rins letter will and in Jo The FDA finding of substantial equivalence of your device to a promation hoursean on 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), rr you decited 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,
Snette y. Michael Omid
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
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STATEMENT OF INDICATIONS FOR USE
- KOS 1694 510K Number (if known): ____--------------------------------------
Device Name: ClickZip™ Needle Retractable Safety Syringe
Indications for Use:
The ClickZip™ Needle Retractable Safety Syringe is to be used for intra-muscular of The ChekZip - Needle Ketractaons into a patient and is intended to prevent needle stick
subcutaneous injection of medications into a patient and is intended on the subcutaneous injection of medications into a partificant (1) Needle Retractable
injuries. It is currently available in Imal for withdrewing blood In addition when the injuries. It is currently available in this only and simbleding blood. In addition, when the Safely Syringe 13 not intenably the syringe is prevented.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-the-Counter |
|---|---|---|---|
| Use Per 21 CFR 801.109 | (Optional Format 1-2-96) |
§ 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).