(111 days)
Not Found
No
The description focuses on the mechanical design and safety features of a syringe, with no mention of AI or ML.
No
The device is described as a safety syringe for the injection of medical fluids, designed to reduce sharps injuries and prevent reuse, rather than directly treating a disease or condition.
No
The device is described as a safety syringe for the injection of medical fluids, not for diagnosing conditions.
No
The device description clearly outlines physical components like a plunger, piston, barrel, hub, needle, and cap, indicating it is a hardware device.
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 device is for "injection of medical fluids into the body." This is an in vivo (within the living body) application, not an in vitro (outside the living body) diagnostic test.
- Device Description: The description details a syringe with components like a plunger, barrel, and needle, all designed for injecting substances into a patient. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside the body to diagnose a condition. There's no mention of reagents, assays, or any other components typically associated with IVD devices.
Therefore, the UNIQSAFE Rotatable, Retractable Safety Syringe is a medical device intended for therapeutic or procedural use, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 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.
Product codes (comma separated list FDA assigned to the subject device)
MEG
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.
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)
In terms of Physical specification, Chemical specification, Biological 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.
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
HAWANISO MINIC
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 |
-
- Device Name :
UNIQSAFE Rotatable, Retractable Safety Syringe Trade Name: Common Name: Safety Syringe (provided with needle) Classification name Anti-Stick Syringe
- Device Name :
-
- 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.
1
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.
2
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.
3
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
4
Indications for Use
K050116 510(k) Number:
UNIQSAFE Rotatable, Retractable Safety Syringe DEVICE NAME: UNIQSAFE BIOMEDITECH CO., LTD.
INDICATIONS FOR USE:
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.
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