(135 days)
Not Found
No
The 510(k) summary describes a standard sterile syringe and contains no mention of AI, ML, or related concepts like image processing or performance metrics typically associated with AI/ML devices.
No
The device is a sterile syringe for injection or withdrawal of fluids, which is a diagnostic or procedural tool, not a device intended to treat or cure a disease or condition.
No
The device is described as a sterile syringe for injection or withdrawal of fluids, which is a therapeutic or procedural tool, not a diagnostic one.
No
The device is described as a "Sterile Syringe for Single Use," which is a physical medical device used for injection or withdrawal of fluids. There is no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for injection of fluids into or withdraw fluids from the body." This describes a device used directly on or in the body for therapeutic or diagnostic purposes related to the body itself, not for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on sample analysis
- Reagents, calibrators, or controls
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. A sterile syringe is a medical device used for administering or withdrawing substances from the body, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
YI XIN Sterile Syringe for Single Use is a sterile, single-use, disposable and nonreusable syringe intended for injection of fluids into or withdraw fluids from the body.
Product codes
FMF, FMI
Device Description
Not Found
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
Not Found
Key Metrics
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
SEP - 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Yun Yuan Gao Manager Manager
Jiangxi Sanxin (Eversincere) Medical Devices Group Shanjiang Road Nanchang, Jiangxi Province, CHINA 330204
Re: K050999
K0509999
Trade/Device Name: YI XIN Sterile Syringe For Single Use Frade/Device Namber: 21 CFR 880.5860 and 21 CFR 880.5570 Regulation Name: Piston syringe and Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMF and FMI Dated: August 23, 2005 Received: August 30, 2005
Dear Mr. Gao:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained in substantially equivalent (for the indications referenced above and nave decemblicate devices marketed predicate devices marketed in interstate for use stated in the encrosule) to regary manetous provice Americal Device Ameralments, or to commerce prior to May 20, 1970, the chance with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance whiles approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require suppro the general controls provisions of the Act. The You may, therefore, market the device, sabject to the gentration, listing of
general controls provisions of the Act include requirements for annual registranding and general controls provisions of the Act merator requires.
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 If your device is classified (sec above) nike exist one regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA may may be subject to such additional controlis. Little 21, Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Register be found in the Code of Poderal Regarities in the Federal Register.
1
Page 2 - Mr. Gao
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issumor of a backer complies with other requirements of the Act that FDA has made a decisimilation that Jour as 1991 as 1991 agencies. You must or any Federal statutes and regulations administers as your not limited to: registration and listing (21 comply with an the Act 3 requirements, mercessed cannot and includes as set CFR Part 807); nabeling (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if any 1000 1050 forin in the quality systems (QB) regardin (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections our device as described in your Section 5 10(k) I his letter will anow you to begin manomig your antial equivalence of your device to a legally premarket notification. The PDA mixing of cassification 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 If you desire specific advice for Jour as 11 5. Also, please note the regulation entitled, Contact the Office of Comphance at (210) = 0.0 = 0.0 = 0.0 = 0.0 may obtain "Misoranding by relevelee to premainters in the Act from the Division of Small other general information on your responsion.com its toll-free number (800) 638-2041 or Manufacturers, International and Consumit p://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suitte J. Michelin Cms
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
2
K042102 YI XIN Safety syringe
Attachment B5
Indication for Use
510(K) Number (if known):
Device Name: Yi XIN Sterile Syringe for Single Use
Indication For Use:
YI XIN Sterile Syringe for Single Use is a sterile, single-use, disposable and nonreusable syringe intended for injection of fluids into or withdraw fluids from the body.
Prescription Use (Part 21CFR 801 Subpart D) AND/OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (21CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Anthony D. mss
General Hospital, of Anesthesio Infection Control. D
510(k) Number: