(76 days)
Not Found
Not Found
No
The device description and intended use describe a mechanical stopcock for fluid control, with no mention of software, data processing, or AI/ML terms.
No
This device is a control valve used in I.V. therapy and hemodynamic pressure monitoring to manage the flow of fluids and drugs, not to treat a disease or condition itself.
No
Explanation: The device description states it is a control valve for use in I.V. therapy and hemodynamic pressure monitoring, providing functions like simultaneous administration of drugs/fluids, blood sampling, and control of solution flow. These functions are for therapeutic or monitoring purposes, not for diagnosing a condition or disease.
No
The device description clearly outlines physical components such as housing, rotating tap, collar nut, plugs, and a protection cap, 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 clearly states the device is for controlling fluid flow in IV therapy and hemodynamic pressure monitoring. These are procedures performed on the patient, not on a sample taken from the patient for diagnostic purposes.
- Device Description: The description details a mechanical device for controlling fluid flow, not a reagent, instrument, or system used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples or provide diagnostic information.
IVD devices are specifically designed to perform tests on samples like blood, urine, or tissue to diagnose diseases or conditions. This device's function is purely related to the delivery and monitoring of fluids within the patient's circulatory system.
N/A
Intended Use / Indications for Use
The Connecta® Plus 1 and Connecta® Plus 3 2-way and 3-way Stopcocks are intended to be used as control valves in I.V. therapy and hemodynamic pressure monitoring. They are added to IV cannula or extension tubing sets for simultaneous or alternate administration of IV drugs, fluids, and blood, or for blood sampling. They can also be used in areas in which solution flow requires control. Alternatively, they are used for hemodynamic monitoring via an arterial cannula and a central venous catheter.
Product codes
80 FMG
Device Description
The disposable Connecta® Plus 1 and Plus 3 2-way and 3-way Stopcocks consist of:
- · a smoke colored housing with three connectors: two female Luer fittings, and one male Luer fitting;
- · a color coded (white, blue, or red) rotating tap with eight (8) closed and open position indicators (snap on-off);
- · a smoke colored collar nut assembled to the male Luer fitting in the housing. The rotating nut is used to secure the stopcock's connection with the product it is connected with.
- · two white plugs attached to the two female Luer fittings in the housing;
- · a white protection cap attached to the male Luer cone; and
- · optional color-coded (blue or red) pegs used for line identification: blue for venous lines, and red for arterial lines.
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)
Bench tests have been conducted to assess the effects of changes. All results are satisfactory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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
§ 880.5440 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
Medical Devices Division
Image /page/0/Picture/2 description: The image shows the word "OHMEDA" in a bold, sans-serif font. A caduceus symbol is placed vertically between the letters "M" and "E". The letters are black, and the background is white.
THE BOC GROUP
IAN 1 3 1998
Ohmeda Inc The BOC Group Technical Center 100 Mountain Avenue Murray Hill NJ 07974 2005 908 771 6100 Fax 908 771 6488
510(k) Summary Connecta® Plus 1 and Connecta® Plus 3 2-way and 3-way Stopcocks
Attachment 8
Submitted by: Ohmeda Inc., Medical Devices Division 100 Mountain Ave., Murray Hill, NJ 07974
October 27, 1997
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
1. Contact Person:
Ms. Jing Zhang Fax: (908)771-1971 Phone: (908)771-6290
Device Name and Classification: 2.
| Trade Name: | Connecta® Plus 1 and Connecta® Plus 3 2-way
and 3-way Stopcocks |
|-----------------------|--------------------------------------------------------------------|
| Common Name: | Stopcocks |
| Classification Name: | IV Set Stopcock, IV Administration Set |
| Classification Panel: | General Hospital |
| CFR Section: | 21 CFR §880.5440 |
| Device Class: | Class II |
| Device Code: | 80 FMG |
3. Substantial Equivalence:
The Connecta® Plus 1 and Plus 3 2-way and 3-way Stopcocks are substantially equivalent to our own Connecta® TH (through hole) 2-way and 3-way Infusion/Pressure Monitoring Stopcocks.
4. Device Description:
The disposable Connecta® Plus 1 and Plus 3 2-way and 3-way Stopcocks consist of:
- · a smoke colored housing with three connectors: two female Luer fittings, and one male Luer fitting;
- · a color coded (white, blue, or red) rotating tap with eight (8) closed and open position indicators (snap on-off);
1
- · a smoke colored collar nut assembled to the male Luer fitting in the housing. The rotating nut is used to secure the stopcock's connection with the product it is connected with.
- · two white plugs attached to the two female Luer fittings in the housing;
- · a white protection cap attached to the male Luer cone; and
- · optional color-coded (blue or red) pegs used for line identification: blue for venous lines, and red for arterial lines.
5. Intended Use of the Device:
The Connecta® Plus 1 and Connecta® Plus 3 2-way and 3-way Stopcocks are intended to be used as control valves in I.V. therapy and hemodynamic pressure monitoring. They are added to IV cannula or extension tubing sets for simultaneous or alternate administration of IV drugs, fluids, and blood, or for blood sampling. They can also be used in areas in which solution flow requires control. Alternatively, they are used for hemodynamic monitoring via an arterial cannula and a central venous catheter.
Summary of Technological Characteristics of the Device Compared to 6. the Predicate Device:
The new Plus 1 and Plus 3 stopcocks are similar in design and material as the predicate TH stopcocks. They all are used as control valves in I.V. therapy and hemodynamic monitoring. They all are for single patient use, irradiation sterilized, and pyrogen free.
In addition, the new Connecta® Plus 1 and Connecta® Plus 3 2-way and 3-way Stopcocks with the inner conic front in the A-port allows less air bubble entrapment and turbulence, and together with the larger lumen tap, also increases the flow rate, and improves priming condition and dynamic response. The position indicators added make it easier for the user to confirm if the stopcock is completely closed or open. The new grades of polycarbonate and polyethylene materials used improve the stopcocks resistance to cracking. The one-handle "OFF"-directing tap offered on Connecta® Plus 1 stopcock, instead of the three-handles on the existing predicate stopcocks is designed for customer preference only.
-
- Tests and Conclusion:
Bench tests have been conducted to assess the effects of changes. All results are satisfactory.
- Tests and Conclusion:
Denis Hiney
Jing Zhang Manager, Regulatory Affairs Medical Devices Division Ohmeda Inc.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle, there is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 13 1998
Ms. Jing Zhang Manager, Regulatory Affairs Ohmeda, Incorporated Medical Devices Division 100 Mountain Avenue Murray Hill, New Jersey 07974
Re : K974083 Connecta® Plus 1 and Connecta® Plus 3 2-Way Trade Name: and 3-Way Stopcocks Regulatory Class: II Product Code: FMG Dated: October 27, 1997 October 29, 1997 Received:
Dear Ms. Zhang: · ·
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of ... Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
3
Page 2 - Ms. Zhang
this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Timotky\A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
Attachment 1
Indications For Use
510(k) Number (if known): K974083
Device Name: Connecta® Plus 1 and Connecta® Plus 3 2-way and 3-way Stopcocks
Indications for Use:
Connecta® Plus 1 and Connecta® Plus 3 2-way and 3-way Stopcocks are control valves for use in I.V. therapy and hemodynamic pressure monitoring. They are added to IV cannula or extension tubing sets for simultaneous or alternate administration of IV drugs, fluids, and blood, or for blood sampling. They can also be used in areas in which solution flow requires control. Alternatively, they are used for hemodynamic monitoring via an arterial cannula and a central 100 m venous catheter.
| Concurrence of the CDRH, Office of Device Evaluation (ODE) |
|---|
| Patricia Ciconele |
(Division Sign-Om
Division of Dentist, Infection Control,
and General Hospital Devices
510(k) Number 8974083
Prescription Use _ (per 21 CFR 801.109)
OR Over-The-Counter Use _