(76 days)
Not Found
No
The description focuses on the mechanical components of a syringe and needle, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
No
The device is a syringe used for injection or withdrawal of fluids, not for treating or rehabilitating a medical condition.
No
The device is described as a syringe and needle for injecting or withdrawing fluids, which are tools used for medical procedures, not for identifying or diagnosing a condition or disease.
No
The device description clearly outlines physical components like a syringe barrel, plunger rod, piston, nozzle cap, and a metal tube needle, indicating it is a hardware device.
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 the withdrawal of fluids from parts of the body below the skin." This describes a procedure performed on the body, not a test performed on samples taken from the body in a laboratory setting.
- Device Description: The description details a syringe and needle, which are tools for administering or withdrawing substances from the body. It doesn't describe a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting specific substances, or providing diagnostic information based on the analysis of these samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device is a tool for administering or withdrawing substances, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The AMSURE® Disposable Syringe with/without Needle is intended for the injection of fluids into, or the withdrawal of fluids from parts of the body below the skin. Needles are intended to mote with mace nozzles of piston syringes or administration sets.
Product codes
FMF, FMI
Device Description
The AMSure® Disposable Syringe is a sterile, single-use hypodermic syringe with or without an attachable hypodermic needle. It consists of a syringe barrel, a plunger rod, a piston, a nozzle cap and/or a single lumen hypodermic needle. The AMSure® Needle is comprised of a metal tube sharpened at one end and joined to a female connector (hub) at the other end.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
parts of the body below the skin
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)
Performance and biocompatibility testing has demonstrated that the AMSure® Disposable Syringe with/without Needle is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
KC6'039
AMSINO
Disposable syringe w/wo Needle 510(k) Submission
20 112
510(K) Summary of Safety and Effectiveness
AMSure® Disposable Syringe with/without Needle
JUN 2 9 2006
| Company: | Amsino International, Inc.
855 Towne Center Drive
Pomona, CA 91767
(909) 626-5888 |
|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ching Ching Seah, Ph.D.
Director of Regulatory Affairs |
| Date Prepared: | January 20, 2006 |
| Classification Name: | Syringe, Piston (880.5860)
Hypodermic Single Lumen Needle (880.5570) |
| Common/Usual Name:
Proprietary Name:
Product Code:
Medical Specialty:
Device Class: | Disposable hypodermic syringe
AMSure® Disposable Syringe with/without Needle
FMF and FMI
General Hospital
Class II |
| Predicate Devices: | Monoject® Piston Syringes (K945715)
Nipro® Disposable Hypodermic Syringes with or without Needle (K051574) |
| Device Description: | The AMSure® Disposable Syringe is a sterile, single-use hypodermic syringe
with or without an attachable hypodermic needle. It consists of a syringe
barrel, a plunger rod, a piston, a nozzle cap and/or a single lumen hypodermic
needle. The AMSure® Needle is comprised of a metal tube sharpened at one
end and joined to a female connector (hub) at the other end. |
| Intended Use: | The AMSure® Disposable Syringe with/without Needle is intended for the
injection of fluids into, or the withdrawal of fluids from parts of the body
below the skin. AMSure® Needles are intended to mate with male nozzles of
piston syringes or administration sets. |
| Comparison to Predicate: | The AMSure® Disposable Syringe with/without Needle is similar to the
predicate devices in operational principle, materials, design, technical
characteristics and intended use. Any existing differences do not
affect safety and effectiveness of the device. |
| Non-Clinical Testing: | Performance and biocompatibility testing has demonstrated that the
AMSure® Disposable Syringe with/without Needle is safe and effective
for its intended use. |
1
Image /page/1/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a bold, sans-serif font. The text is black and the background is white.
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the symbol. The seal is black and white.
JUN 2 9 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Ching Ching Seah Director of Research & Development and Regulatory Affairs Amsino International, Incorporated 855 Towne Center Drive Pomona, California 91767
Re: K061039
Trade/Device Name: AMSURE® Disposable Syringe with/without Needle Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF, FMF, FMI Dated: April 14. 2006 Received: April 14, 2006
Dear Dr. Seah:
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 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 H (PMA), it may be subject to such additional controls. Existing major regulations affècting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 tinfo98. In addition. FDA may publish further announcements concerning your device in the Federal Register.
.. ...
2
Page 2 -Dr. Seah
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 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 vours.
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
3
Indications For Use
510(k) Number (if known): K061039
Device Name: AMSURE® Disposable Syringe with/without Needle
Indications For Use:
The AMSURE® Disposable Syringe with/without Needle is intended for the injection of fluids into, or the withdrawal of fluids from parts of the body below the skin. Needles are intended to mote with mace nozzles of piston syringes or administration sets.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chinta (S)
"estology, General Hospital. Mul Dental Devices
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