NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L

K041779 · Nipro Medical Corp. · FMG · Sep 21, 2004 · General Hospital

Device Facts

• Record ID: K041779
• Device Name: NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L
• Applicant: Nipro Medical Corp.
• Product Code: FMG · General Hospital
• Decision Date: Sep 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Nipro Disposable Stopcocks are intended to be used to change the direction of flow of fluids through a tubing set.

Device Story

Nipro Disposable Stopcocks are manual fluid control components used within intravenous tubing sets. The device functions as a mechanical valve to redirect fluid flow. It is operated by clinicians in a clinical setting. The device features both slip tip and luer lock configurations to ensure secure connections within fluid delivery systems. By allowing the redirection of fluids, the device facilitates the management of multiple infusion lines or the administration of medications through a single access point, supporting patient therapy.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mechanical stopcock valve; includes click-stop, 3W-R, 3W-L, and NCN models; features slip tip and luer lock connections; materials, design, and technological characteristics are similar to the predicate device.

Indications for Use

Indicated for use in changing the direction of fluid flow through a tubing set. Intended for prescription use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• B. Braun Medical Inc. 3-way Stopcocks (K911415)

Submission Summary (Full Text)

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K041779

## 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.

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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.

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#### 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 [phone]. 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 [phone] or [phone] 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

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# 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

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(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

K 441799 510(k) Number :_