(170 days)
Not Found
Not Found
No
The 510(k) summary describes basic medical devices (needles and syringes) and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices.
No
The provided information describes devices for injecting or withdrawing fluids, such as needles and syringes, which are diagnostic or procedural tools, not therapeutic devices that treat a condition.
No.
The device descriptions indicate that these devices are used to inject or withdraw fluids, which are interventional actions, not diagnostic ones. There is no mention of analysis, measurement, or diagnosis of a condition.
No
The device description is not found, but the intended use clearly describes physical devices (needles and syringes) used for injection and withdrawal of fluids, which are hardware components.
Based on the provided information, none of the devices listed are IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens derived from the human body. This includes things like blood, urine, tissue, etc., to provide information about a physiological state, health, disease, or congenital abnormality.
- The intended uses described for these devices involve injecting or withdrawing fluids directly into or from the body. This is an in-vivo (within the living body) application, not an in-vitro (in glass, or outside the body) application.
The devices described are medical devices used for direct patient care, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Hypodermic single lumen needle: Device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Piston Syringe: Device is used to inject fluids into, or withdraw fluids from the body.
Diabetic Insulin Syringe: Device intended to inject insulin below the surface of the skin.
Product codes
FMF
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)
Not Found
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
FEB 2 5 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shin Chang Medical Company, Ltd. c/o Ms. Jan J. Frank Shin Chang Medical Company, Ltd. VP Customer Relations Delta Hi-Tech, Incorporated 3762 South 150 East Salt Lake City, Utah 84115
Re : K993017 Profi Disposable Syringe, Profi Disposable Trade Name: Needle, DM Ject Regulatory Class: II Product Code: FMF December 9, 1999 Dated: Received: December 10, 1999
Dear Ms. Frank:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP
1
Paqe 2 - Ms. Frank
regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
[signature]
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (If known): K993017
Device Name: Profi Disposable Syringe & Needle, DM Ject Insulin Syringe
Indications For Use:
Hypodermic single lumen needle: Device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Device is used to inject fluids into, or Piston Syringe: withdraw fluids from the body.
Diabetic Insulin Syringe: Device intended to inject insulin below the surface of the skin.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use J (Standard Piston Syringes/Needles) (Per 21 CFR 801.109)
OR
Over-The-Counter Use_I (Insulin Syringes W/Noodle)
(Optional Format 1-2-96)
Daltacio Cuenite
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number