(59 days)
Not Found
Not Found
No
The provided 510(k) summary explicitly states "Not Found" for all sections that would typically describe AI/ML components, training data, or performance metrics associated with such technologies.
No
The provided text lacks specific information about the device's function or intended use to determine if it is therapeutic. The "Intended Use" section only vaguely refers to "indications for use stated in the enclosure," which is not provided.
No
The provided information only includes "Intended Use / Indications for Use for the indications for use stated in the enclosure" and states "Device Description Not Found". Without a description or specific indications for use, it's impossible to determine if it's a diagnostic device.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only.
Based on the provided information, it is not possible to determine if this device is an IVD.
Here's why:
- The only information available is the "Intended Use / Indications for Use" which simply states "for the indications for use stated in the enclosure". This is a circular reference and doesn't provide any details about what the device actually does or what it is used for.
- All other relevant sections that would typically describe an IVD are marked as "Not Found". These sections include Device Description, Input Imaging Modality, Anatomical Site, etc., which are crucial for identifying if a device is used to examine specimens from the human body (the core definition of an IVD).
To determine if this is an IVD, you would need to see the actual "indications for use stated in the enclosure" and potentially the "Device Description".
N/A
Intended Use / Indications for Use
Not Found
Product codes
MEG, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are black and have a flowing, wave-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the profiles in a circular fashion.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 0 2002
Taiject Medical Device Company Limited C/O Mr. Jim-Son Chou Acheve Technology, Incorporated P.O. Box 8853 Newport Beach, California 92658
Re: K022278
Trade/Device Name: TMD™ Safety Syringe (FA12 Series 3ML/FA13 Series 5ML) Regulation Number: 880.5860 and 880.5570 Regulation Name: Anti-Stick Syringe/Single Lumen Hypodermic Needle Regulatory Class: II Product Code: MEG and FMI Dated: July 12, 2002 Received: July 15, 2002
Dear Mr. Chou:
This letter corrects our substantially equivalent letter of September 12, 2002 regarding the address.
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). You may, therefore, market the device, subject to the general controls provisions 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 (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.
1
Page 2 - Mr. Chou
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 (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.
This letter will allow you to continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Clus Ls/or
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure