(103 days)
No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML applications.
No.
The Nipro Disposable Syringe is described as a mechanical device for injecting or withdrawing fluids, not for treating a disease or condition. It is a delivery/collection tool, not a therapeutic agent itself.
No
Explanation: The device is described as a syringe intended for injecting or withdrawing fluids, which is a therapeutic or procedural function, not a diagnostic one. There is no mention of it being used to identify or monitor medical conditions.
No
The device description clearly states it is a physical syringe with mechanical function, consisting of a barrel, plunger rod, gasket, and nozzle tip cap. It is a hardware device.
Based on the provided information, the Nipro Disposable Syringe is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject fluids into or withdraw fluids out of the body." This describes a direct interaction with the patient's body for therapeutic or diagnostic purposes (like drawing blood for testing, but the syringe itself isn't performing the test).
- Device Description: The description focuses on the mechanical function of the syringe for fluid transfer.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs are typically used for tests on blood, urine, tissue, etc.
Therefore, the Nipro Disposable Syringe is a medical device, but it falls under a different classification than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Nipro Disposable Syringe is intended to inject fluids into or withdraw fluids out of the body.
Product codes
FMF
Device Description
The NIPRO Disposable syringe is a piston syringe consisting of graduated barrel, plunger rod, gasket and nozzle tip cap. Its function is mechanical and it is intended to inject fluids into or withdraw fluids out of the body. The syringe is sterile, single to only, non-toxic, non-pyrogenic and sterilized by Gamma radiation.
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)
Comparison of technological characteristics: Nipro Medical Corporation considers the modified NIPRO® Disposable Syringe Gamma to be substantially equivalent to the current NIPRO® Disposable Syringe (K944355) with regard to intended use, materials of construction, labeling, and overall performance characteristics.
Non-clinical tests submitted: Biocompatibility data, performance testing and comparison testing with the predicate are included in this submission and demonstrate substantial equivalence, Conclusions drawn from non-clinical and clinical tests: The results of the performance testing and the comparison of technological characteristics demonstrate that the NIPRO® Disposable Syringe Gamblegical characteristics device and is a from and ff device and is safe and effective when used as intended.
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
K091279 p. lot 2
Image /page/0/Picture/1 description: The image shows the logo for Nipro. The logo consists of a stylized, abstract symbol on the left and the word "NIPRO" in bold, sans-serif font on the right. The symbol is composed of two interlocked, curved shapes, creating a sense of movement and connection. The overall design is clean and modern, with a focus on simplicity and visual impact.
Florida 33172 05) 599-7174 (305) 599-8454
AUG 1 2 2009
510(k) Summary NIPRO® Disposable Syringe
807.92(a) (1)
Applicant: Establishment Reg.:
Nipro Medical Corporation 1056186
Contact Person:
Jessica Oswald Regulatory Affairs Specialist
Date of summary preparation: April 30, 2009
807.92(a) (2)
NIPRO® Disposable Syringe Trade Name: Common Name: disposable syringe Classification Number: 880.5860 Classification Name: Piston syringe Panel: 80 Product Code: FMF
807.92(a) (3)
Legally marketed substantial equivalent device: NIPRO Disposable Syringe (K944355)
807.92(a) (4)
Description of device:
The NIPRO Disposable syringe is a piston syringe consisting of graduated barrel, plunger rod, gasket and nozzle tip cap. Its function is mechanical and it is intended to inject fluids into or withdraw fluids out of the body. The syringe is sterile, single to only, non-toxic, non-pyrogenic and sterilized by Gamma radiation.
807.92(a) (5)
Indications for Use:
The Nipro Disposable Syringe is intended to inject fluids into or withdraw fluids out of the body.
NIPRO® Disposable Syringe (Gamma) 5 510(k) Summary
1
K091277 p.20f2
807.92(a) (6)
Comparison of technological characteristics:
Nipro Medical Corporation considers the modified NIPRO® Disposable Syringe Gamma to be substantially equivalent to the current NIPRO® Disposable Syringe (K944355) with regard to intended use, materials of construction, labeling, and overall performance characteristics.
807.92(b) (1)
Non-clinical tests submitted:
Biocompatibility data, performance testing and comparison testing with the predicate are included in this submission and demonstrate substantial equivalence,
807.92(b) (3)
Conclusions drawn from non-clinical and clinical tests:
The results of the performance testing and the comparison of technological characteristics demonstrate that the NIPRO® Disposable Syringe Gamblegical characteristics
device and is a from and ff device and is safe and effective when used as intended.
NIPRO® Disposable Syringe (Gamma) 5 510(k) Summary
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the logo.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Jessical Oswald Regulatory Affairs Specialist Nipro Medial Corporation 3150 North West 107th Avenue Miami. Florida 33172
AUG 1 2 2009
Re: K091279
Trade/Device Name: NIPRO® Disposable Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: July 13, 2009 Received: July 15, 2009
Dear Ms. Oswald:
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 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.
3
Page 2- Ms. Oswald
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/
CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
Anthony V. Mastrofini
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number:
.
Device Name: NIPRO® Disposable Syringe
Indications for Use:
The Nipro Disposable Syringe is intended to inject fluids into or withdraw fluids out of the body.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K0912-
NIPRO® Disposable Syringe (Gamma)