(82 days)
Not Found
No
The document describes a simple mechanical device (stopcocks) and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is described as a stopcock intended for changing the direction of fluid flow in a tubing set, which is a mechanical function rather than a therapeutic one. The description classifies it under 21 CFR 880.5440, which pertains to general hospital and personal use devices, not therapeutic devices.
No
The device, Nipro Disposable Stopcocks, is described as being intended to change the direction of fluid flow through a tubing set, which is a functional purpose in fluid management, not a diagnostic one.
No
The device description clearly states it is a stopcock, which is a physical hardware component used to control fluid flow. 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 change the direction of flow of fluids through a tubing set." This describes a function related to fluid management within a medical tubing system, not the examination of specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The device is described as a "stopcock," which is a mechanical component for controlling fluid flow. This aligns with general medical devices used for fluid delivery or management, not IVDs.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances within specimens
- Providing diagnostic information about a patient's health status
The device's function is purely mechanical and related to the physical manipulation of fluid flow, which falls under the category of general medical devices, not IVDs.
N/A
Intended Use / Indications for Use
The Nipro Disposable Stopcocks are intended to be used to change the direction of flow of fluids through a tubing set.
Product codes
FMG
Device Description
The subject devices can be classified as stopcocks as described in 21 CFR 880.5440. Among the types described here are: click - stop; 3W-R; 3W-L; and, NCN. Both slip tip and luer lock are included.
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 subject devices are safe and suitable for human use. They are substantially equivalent to similar legally marketed devices.
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
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
SEP 2 1 2004
SUMMARY OF SAFETY AND EFFECTIVENESS NIPRO DISPOSABLE STOPCOCKS
| 807.92 (a)(1) | |
|---|---|
| Contact Person: | Cary Goldsmith |
| Marketing Manager | |
| Date of Summary Preparation: | June 30, 2004 |
807.92 (a)(2) Trade Name: Common Name: Classification Name:
Nipro Disposable Stopcocks Stopcocks Stopcocks, I.V.sets (880.5440)
807.92 (a)(3)
Legally Marketed Substantially Equivalent Device: B. Braun Medical Inc.3-way Stopcocks (K911415)
807.92 (a)(4)
Description of Device:
The subject devices can be classified as stopcocks as described in 21 CFR 880.5440. Among the types described here are: click - stop; 3W-R; 3W-L; and, NCN. Both slip tip and luer lock are included.
807.92 (a)(5)
Intended Use: The Nipro Disposable Stopcocks are intended to be used to change the direction of flow of fluids through a tubing set.
807.92 (a)(6)
Comparison of Technical Characteristics:
The Nipro subject devices are similar to the predicate devices in materials, design and technological characteristics. Performance tests demonstrated that the subject devices are safe and suitable for human use. They are substantially equivalent to similar legally marketed devices.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 1 2004
Nipro Medical Corporation C/O Ms. Kaelyn B. Hadley Consultant 1384 Copperfield Court Lexington, Kentucky 40514
Re: K041779
Trade/Device Name: Nipro Disposable Stopcocks, Models 3W-RC, NCN-3, 3W-R. 3W-L Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FMG Dated: June 30, 2004 Received: July 1, 2004
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 Please be advised that I DA 3 issualled on that your device complies with other requirements meall that FDA nas made a deceminations administered by other Federal agencies. of the Act of ally rederal statutes and reguirements, including, but not limited to: registration You must comply with an the Piece Sing (21 CFR Part 801); good manufacturing practice and ifsimg (21 CFR Part 807), labelity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality system of the 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) This letter will anow you te object to and inding of substantial equivalence of your device to a premits the reality marketion. The I Driver 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), If you desire specific at no for pliance 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 may outain other golleral meethia. 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,
Susan Runner
Chiu Lin, Ph.D.
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
K041779 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Nipro Disposable Stopcocks Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Indications For Ose.
The Nipro Disposable Stopcocks are intended for use to change the direction of flow of fluids through a tubing set.
Prescription Use X (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)
Arin Vm
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
K 441799 510(k) Number :_