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 venous catheter.

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.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Connecta® Plus 1 and Connecta® Plus 3 2-way and 3-way Stopcocks). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, much of the requested information (acceptance criteria table, sample sizes for test/training sets, expert qualifications, MRMC study, standalone performance, etc.) is not typically found or required in a 510(k) submission for a Class II device like a stopcock. These submissions primarily rely on bench testing and comparison to an existing device.

Here's an analysis of the available information in relation to your request:

Acceptance Criteria and Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Substantial Equivalence to Predicate Device	"All results are satisfactory." (Bench tests conducted to assess effects of changes, implying it met equivalence requirements.)
Resistance to cracking improved	"The new grades of polycarbonate and polyethylene materials used improve the stopcocks resistance to cracking."
Reduced air bubble entrapment / turbulence	"Connecta® Plus 1 and Connecta® Plus 3... allows less air bubble entrapment and turbulence..."
Increased flow rate	"...together with the larger lumen tap, also increases the flow rate..."
Improved priming condition	"...and improves priming condition..."
Improved dynamic response	"...and dynamic response."
Easier confirmation of closed/open position	"The position indicators added make it easier for the user to confirm if the stopcock is completely closed or open."

The document states that "Bench tests have been conducted to assess the effects of changes. All results are satisfactory." This is a general statement indicating the device met internal performance benchmarks for the specified improvements. However, no specific quantitative acceptance criteria or detailed performance metrics are provided in this summary.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document. The study described is "Bench tests," which typically involve a limited number of device units.
- Data Provenance: The tests were conducted internally by Ohmeda Inc., Medical Devices Division. There is no information on external or country-of-origin data. The tests are prospective in the sense that they evaluate changes to the device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As this involves bench testing of a mechanical device (stopcock), the "ground truth" would be established by objective measurements and engineering standards, not expert consensus on medical images or diagnoses.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of data, typically in diagnostic or clinical studies. Bench tests are assessed based on objective measurements against engineering specifications.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a submission for a mechanical medical device (stopcock), not an AI-powered diagnostic or interpretive system. Therefore, an MRMC study is not relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the bench tests would be defined by engineering specifications, material science properties, and fluid dynamics principles. For example, flow rate would be measured against a standard, cracking resistance against material strength tests, and air bubble entrapment assessed through visual observation or specialized imaging under controlled flow conditions.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
- Not applicable (see above).

In summary: The document describes a 510(k) submission for a mechanical medical device, where equivalence to a predicate device is demonstrated through bench testing and assertions of improved design features. The type of detailed clinical study information (like MRMC, AI performance metrics, expert adjudication, etc.) requested in the prompt is not relevant to this specific device or type of regulatory submission.

Summary

{0}------------------------------------------------

K974083

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-wayand 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.

1. Tests and Conclusion:
  Bench tests have been conducted to assess the effects of changes. All results are satisfactory.

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:

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 _

Regulation Number and Section

§ 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.