(73 days)
Not Found
No
The description focuses on the mechanical aspects and intended use of standard syringes, with no mention of AI or ML.
No
The device is a hypodermic syringe, used for injecting or withdrawing fluids, which is a common medical tool but not typically considered a therapeutic device in itself. Its function is to facilitate a medical procedure, not to directly provide therapy.
No
The device is described as a hypodermic syringe, intended for injecting or withdrawing fluids, which are actions related to treatment or collection rather than diagnosis. There is no mention of diagnostic functions or outputs in the provided text.
No
The device description clearly indicates it is a physical medical device (syringes) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to inject fluids into or withdraw fluids from the body." This describes a direct interaction with the patient's body for therapeutic or diagnostic purposes in vivo (within the living organism).
- IVD Definition: In vitro diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes outside of the body.
- Device Description: The description of syringes with different tips and sizes aligns with devices used for injecting or withdrawing substances directly from the body, not for testing specimens in a lab.
The information provided clearly indicates a device used for direct patient care, not for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The Disposable Hypodermic Syringes with or without Needle are intended for use to inject fluids into or withdraw fluids from the body.
Product codes (comma separated list FDA assigned to the subject device)
FMF, FMF, FMI
Device Description
The subject devices can be classified as piston syringes as described in 21 CFR 880.5860. Among the syringe types described are: luer lock, slip-tip, eccentric, and catheter tip. Syringes will be packaged with and without needles. Various sizes are described including: 1, 3, 5, 10, 20, 30, and 60 milliliters.
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)
Performance tests demonstrated that the devices are substantially equivalent and meet voluntary standards for syringes.
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.
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
Kos-1574
Image /page/0/Picture/1 description: The image shows the logo and contact information for Nipro Medical Corporation. The logo features a stylized graphic element next to the word "NIPRO" in bold, uppercase letters. Below the logo is the company name, followed by the address 3150 N.W. 107 Avenue, Miami, Florida 33172, and the telephone number (305) 599-7174 and fax number (305) 599-8454.
AUG 2 6 2005
SUMMARY OF SAFETY AND EFFECTIVENESS DISPOSABLE HYPODERMIC SYRINGES
807.92 (a)(1)
Contact Person:
Cary Goldsmith Marketing Manager June 6, 2005
Date of Summary Preparation:
807.92 (a)(2)
Trade Name: Common Name: Classification Name:
Disposable Hypodermic Syringes with or without Needle Sterile Disposable Syringe with/without needle Syringe, Piston (880.5860) Hypodermic Single Lumen Needle (880.5570)
807.92 (a)(3)
Legally Marketed Substantially Equivalent Device:
Nipro Branded Disposable Syringes (K944355 and K030683)
807.92 (a)(4)
Description of Device:
The subject devices can be classified as piston syringes as described in 21 CFR 880.5860. Among the syringe types described are: luer lock, slip-tip, eccentric, and catheter tip. Syringes will be packaged with and without needles. Various sizes are described including: 1, 3, 5, 10, 20, 30, and 60 milliliters.
807.92 (a)(5)
Intended Use: The Disposable Hypodermic Syringes with or without Needle are intended for use to inject fluids into or withdraw fluids from the body.
807.92 (a)(6)
Comparison of Technical Characteristics:
The subject and Nipro predicate devices are similar in materials, design and technological characteristics. Performance tests demonstrated that the devices are substantially equivalent and meet voluntary standards for syringes.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three parallel lines that resemble a human figure.
AUG 2 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nipro Medical Corporation C/O Kaelyn B. Hadley, Ph.D. Regulatory Affairs Consultant 1384 Copperfield Court Lexington, Kentucky 40514-1268
Re: K051574
Trade/Device Name: NIPRO Disposable Syringe with or without needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF, FMF, FMI Dated: June 6, 2005 Received: June 14, 2005
Dear Dr. Hadley:
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 III (PMA), it may be subject to such 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.
2
Page 2 - Ms. Hadley
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase be advisou that I Drivision that your device complies with other requirements of the Act that I Dri Hab intato a and regulations administered by other Federal agencies. You must of any I edetar statuates and 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. product ractiation of to begin marketing your device as described in your Section 510(k) rms letter witification. The FDA finding of substantial equivalence of your device to a legally promanted modicate 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 11 you a seen 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 yours,
E. Susan Sumner
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): ____________________________________________________________________________________________________________________________________________________
K05 1574
Device Name: Disposable Hypodermic Syringes with or without Needles
Indications For Use: The Disposable Hypodermic Syringes and Needles are intended for use to inject fluids into or withdraw fluids from the body.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chas. Martin
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
Kysls74 510(k) Number:_