(240 days)
Not Found
No
The device description and intended use are for standard disposable syringes, and there is no mention of AI or ML in the provided text.
No
The device is described as a piston syringe used for injecting or withdrawing fluids, which is a diagnostic or procedural tool, not a therapeutic one that treats a disease or condition.
No
Explanation: The "Intended Use" states that the device is for injecting or withdrawing fluids, which are therapeutic or procedural actions, not diagnostic ones. There is no mention of analysis or interpretation of data for medical diagnosis.
No
The device description clearly identifies the device as "piston syringes" and lists various physical sizes in milliliters, indicating a hardware device. There is no mention of software as the primary or sole 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 body for therapeutic or diagnostic purposes on the body, not for testing samples outside the body.
- Device Description: The description aligns with standard syringes used for injections and aspirations, which are not IVD devices.
- Lack of IVD Indicators: There is no mention of:
- Testing biological samples (blood, urine, tissue, etc.)
- Analyzing samples for diagnostic information
- Reagents or assays
- Any of the typical characteristics of an IVD device.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This syringe does not fit that description.
N/A
Intended Use / Indications for Use
The Nipro Disposable Syringes 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
Device Description
The subject devices can be classified as piston syringes as described in 21 CFR 880.5860. Among the syringe types described here are: flat-head; circular irrigation syringes; and, screw nozzle syringes. Various sizes are described including: 1, 2, 2.5, 3, 5, 10, 20, 30, 50, and 100 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.
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
10/31/03
IIPRO MEDICAL CORPORATION 3150 N.W. 107 Avenue Miami, Florida 33172 Tel .: (305) 599-7174 Fax: (305) 599-8454
SUMMARY OF SAFETY AND EFFECTIVENESS NIPRO DISPOSABLE SYRINGES
$807.92 (a)(1)
Contact Person:
Cary Goldsmith Product Manager March 4, 2003
Date of Summary Preparation:
5807.92 (a)(2) Trade Name: Common Name: Classification Name:
Nipro Disposable Syringes Sterile Disposable Syringe with/without needle Piston Syringe, Hypodermic Single Lumen Syringe ($880.5860)
$807.92 (a)(3)
Legally Marketed Substantially Equivalent Device: Nipro Branded Disposable Syringes (K944355)
S807.92 (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 here are: flat-head; circular irrigation syringes; and, screw nozzle syringes. Various sizes are described including: 1, 2, 2.5, 3, 5, 10, 20, 30, 50, and 100 milliliters.
9807.92 (a)(5)
Intended Use: The Nipro Disposable Syringes are intended for use to inject fluids into or withdraw fluids from the body.
9807.92 (a){6)
Comparison of Technical Characteristics:
The Nipro subject and predicate devices are very similar in materials, design and technological characteristics. Performance tests demonstrated that the devices are substantially equivalent.
-13-
1
PublicHealth Service
Image /page/1/Picture/2 description: The image shows a black and white logo. The logo features a stylized bird-like symbol with three curved lines forming its body and wings. The bird is facing right. Encircling the bird is text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES - USA' in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.
OCT 31 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nipro Medical Corporation C/O Ms. Kaelyn B. Hadley Consultant Kaelyn B. Hadley 1384 Copperfield Court Lexington, Kentucky 40514-1268
Re: K030683
Trade/Device Name: Nipro Disposable Syringes Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: September 22,2003 Received: September 23,2003
Dear Ms. 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 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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours.
Chiu Lin, Ph. 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 Statement
510(k) number (if known): K030 c 93
Device name: Nipro Disposable Syringes
Device name: Nipro Disposable Syringes
Indications for use: The Nipro Disposable Syringes are intended for use to inject fluids into or withdraw fluids from the body.
Patricia Cicceretti
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number. K030682
(Do not write below this line- continue on another page if needed.)
OR
Concurrence of CDRH, Office of Device Evaluation(ODE )
3
Prescription Use v (Ber 21 CFR 801.109)
Over-The- Counter-Use -(optional Format 1-2-9 )
Nipro® Disposable Syringes
210(k)
3