(349 days)
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No
The summary describes a simple mechanical syringe with a re-use prevention feature and contains no mention of AI, ML, or any related concepts like image processing or performance metrics associated with AI/ML algorithms.
No
The device is a syringe used for injecting or withdrawing fluids, which is a medical procedure, but it does not inherently treat a disease or condition itself.
No
Explanation: The device is described as a syringe for injecting or withdrawing fluids, which is a therapeutic or procedural tool, not a diagnostic one. It does not mention any function for identifying or analyzing medical conditions.
No
The device description clearly states it is a "disposable syringe," which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "injecting fluid into, or withdrawing fluids from, part of the body below the surface of the skin." This describes a direct interaction with the body for therapeutic or diagnostic purposes in vivo (within a living organism).
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed in vitro (outside of a living organism).
The description of the syringe's function aligns with a standard medical device used for administering substances or collecting samples directly from a patient, not for testing those samples in a laboratory setting.
N/A
Intended Use / Indications for Use
Tlankang disposable syringes with re-use prevention feature with or without needle is a sterile ,single-use , disposable and non reusable safety syringe which is intended to provide a safe and reliable method for injecting fluid into, or withdrawing fluids from, part of the body below the surface of the skin .
Product codes
MEG
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
May 12, 2014
Anhui Tiankang Medical Products Company, Limited C/O James H. Liao 6775 Verde Ridge Road Rancho Palos Verdes, CA 90275
Re: K131531
Trade/Device Name: Tiankang Disposable Syringes With Re-Use Prevention Feature With Or Without Needle
Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: February 11, 2014 Received: February 11, 2014
Dear Mr. Liao:
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 reguirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Mr. Liao ·
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/8 description: The image shows the name "Mary S. Runner" in bold, black font at the top. Below the name, there is a logo that appears to be for the FDA, but the details are not clear. The logo is in a lighter color, making it less prominent than the name above it. The letter "S" is on the left side of the image.
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Company:Anhui Tiankang Medical Products Co.,Ltd Product: Tiankang disposable syringes with re-use prevention feature with or without needle Address:No.20 South Renhe Road , Tianchang City, Anhui Province, China Tel:86-550-7309149 Pax:86-550-7309158 Email: tkquality@126.com
Indications for Use
510(k) Number (if known):
Device Name: Tiankang disposable syringes with re-use prevention feature with or without needle
Indications for Use:
Tlankang disposable syringes with re-use prevention feature with or without needle is a sterile ,single-use , disposable and non reusable safety syringe which is intended to provide a safe and reliable method for injecting fluid into, or withdrawing fluids from, part of the body below the surface of the skin .
Prescription Use _ 7 (Part 21 CFR 801Subpart D) OR Over-The-Counter Use (Part 21 CFR 801Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Devive Evaluation (ODE)
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Digitally signed by Richard C. Chapman Date: 2014.05.12 13:48:30 -04'00'