The UNIQSAFE Rotatable, Retractable Safety Syringe (1ml , 3ml , 5ml , 10ml ) 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 injection of medical fluids into the body.

Device Description

The UNIQSAFE Rotatable, Retractable Safety Syringe is sterile, single-use, disposable , Non-reusable, Manual , Retractable, Piston Syringe, provided with needle attached in place., which is used for injection of fluids into the body. The UNIQSAFE Rotatable, Retractable Safety Syringe consist of the following major components. m Plunger , n Piston , h adaptor , i O-Ring , r Barrel, w Hub, i Needle a Cap. It is manufactured in size of 1ml ,3ml ,5ml and 10ml volume.

AI/ML Overview

This document describes the UNIQSAFE Rotatable, Ret retractable Safety Syringe. Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Physical Specifications	Conforms to applicable standards, including ISO 7864 and ISO 7886-1.
Chemical Specifications	Conforms to applicable standards, including ISO 10993 series.
Biological Specifications	Conforms to applicable standards, including ISO 10993 series.
Sterilization Specifications	Conforms to applicable standards, including ISO 11607-1, ISO 11135, and USP Pyrogenic standards.
Reduction of Sharps Injuries	Designed as an anti-stick syringe to reduce the risk of sharps injuries (indicated by intended use).
Prevention of Syringe Reuse	Designed to reduce the potential for syringe reuse (indicated by intended use).
Single Use	Described as single-use.
Disposable	Described as disposable.
Manual Retractability	Described as manual retractable.
Rotatability	Described as rotatable.
Intended Use (Injection of Medical Fluids)	Intended for intramuscular, subcutaneous, and intravenous injection of medical fluids into the body.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "bench testing & simulated use study" but does not specify the sample size for these tests. The data provenance is not explicitly stated as country of origin, nor is it explicitly labeled as retrospective or prospective, beyond indicating they were part of the submission for clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document.

4. Adjudication Method 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, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This document describes a medical device (a safety syringe), not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not done.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This document describes a manual medical device. Therefore, a standalone algorithm performance study is not applicable and was not done.

7. The Type of Ground Truth Used

The document implies that the ground truth for performance was established through adherence to specified standards (ISO, USP) for physical, chemical, biological, and sterilization properties, and through bench testing and simulated use studies to demonstrate equivalence to predicate devices regarding safety and effectiveness. There is no mention of pathology, expert consensus (beyond the assumption that standards are based on expert knowledge), or outcomes data in this context.

8. The Sample Size for the Training Set

This document describes the premarket notification for a physical medical device. The concept of a "training set" is typically relevant for machine learning algorithms. Therefore, a training set is not applicable and was not used in the context of this device's submission.

9. How the Ground Truth for the Training Set Was Established

As a training set is not applicable, the ground truth establishment for it is also not applicable.

Summary

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HAWANISO MINIC

K050116

MAY - 9 2005

This summary of 510(k) safety and effectiveness information is being submitted in accordance with he requirements of SMDA and 21 CFR §807.92

1. Submitter's Name:	UNIQSAFE BIOMEDITECH CO., LTD.
Address:	4F, NO.47 Lane 3, Ji-hu Rd., Neihu District, Taipei 114, Taiwan
Phone:	886-2-6606-0980
Fax:	886-2-6606-0136
Contact:	Mr. Wang Lin / General Manager

1. Device Name :
  UNIQSAFE Rotatable, Retractable Safety Syringe Trade Name: Common Name: Safety Syringe (provided with needle) Classification name Anti-Stick Syringe
1. Classification: Class II Regulatory Number: 880.5860 Product Code: MEG
Predicate Device: 4. . Otter Safety Syringe (K040545) marketed by OTTER (CHINA) TECHNOLOGY CO., LTD.,
- SEZ Safety intramuscular/Subcutaneous syringes (K031163) . marketed by SEZ CORPORATION.
ട്. Device Description: The UNIQSAFE Rotatable, Retractable Safety Syringe is sterile, single-use, disposable , Non-reusable, Manual , Retractable, Piston Syringe, provided with needle attached in place., which is used for injection of fluids into the body. The UNIQSAFE Rotatable, Retractable Safety Syringe consist of the following major components. m Plunger , n Piston , h adaptor , i O-Ring , r Barrel, w Hub, i Needle a Cap. It is manufactured in size of 1ml ,3ml ,5ml and 10ml volume.
ે. Intended Use: UNIQSAFE Rotatable, Retractable Safety Syringe is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe reuse. It is a single use, disposable manual rotatable , retractable safety syringe which is intended for intramuscular, subcutaneous and intravenous injection of medical fluids into the body.

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KOSOIIC 7. Performance In terms of Physical specification, Chemical specification, Biological Summary: specification & Sterilization Specification, the device conforms to applicable standards included ISO 7864, ISO 7886-1, ISO 10993 series, ISO 11607-1, ISO 11135, USP Pyrogenic standards & related standards --- etc.

Conclusions: 8.

The UNIQSAFE Rotatable, Retractable Safety Syringe has the same intended use and similar technological characteristics as the Otter Safety Syring (K040545) marketed by OTTER (CHINA) TECHNOLOGY CO.,LTD. & SEZ Safety intramuscular/Subcutaneous syringes (K031163) marketed by SEZ CORPORATION.. Moreover, bench testing & simulated use study contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the UNIQSAFE Rotatable, Retractable Safety Syringe is substantially equivalent to the predicate devices.

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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 eagle with three lines forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA". The text is arranged in a circular fashion around the eagle.

MAY - 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Uniqsafe Biomeditech Company Limited C/O Ms. Jennifer Reich Harvest Consulting Corporation 3892 South America West Trail Flaggstaff,Arizona 86001

Re: K050116

Trade/Device Name: UNIQSAFE Rotatable, Retractable Safety Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: April 6, 2005 Received: April 7, 2005

Dear Ms. Reich:

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 mendments, 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 approvisions 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 If your device is clabilional controls. Existing major regulations affecting (1 wr t), it may of casyon 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. Reich

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 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 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/industry/support/index.html.

Sincerely yours,

Simpler y. Michie M.D.

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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Indications for Use

K050116 510(k) Number:

UNIQSAFE Rotatable, Retractable Safety Syringe DEVICE NAME: UNIQSAFE BIOMEDITECH CO., LTD.

INDICATIONS FOR USE:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cintan V. mór

න විට කින්දනු General Hospil... on Control, bantal Devices

KYSY 116

Regulation Number and Section

§ 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).