PRESSURE ACTIVATED CHECK VALVE

K011888 · Churchill Medical Systems, Inc. · FPA · Sep 10, 2001 · General Hospital

Device Facts

• Record ID: K011888
• Device Name: PRESSURE ACTIVATED CHECK VALVE
• Applicant: Churchill Medical Systems, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Sep 10, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

This device is used to directionally control the flow of fluids. They are added to IV cannula or extension sets for simultaneous or alternate administration of fluids while preventing back flow of medication.

Device Story

Pressure Activated Check Valve; acrylic-polycarbonate alloy body; silicone valve; male/female luer lock connections. Device installed in IV cannula or extension sets; operates by opening at cracking pressures >3.5 PSI +/- 1 PSI; prevents fluid backflow. Used in clinical settings for simultaneous or alternate fluid administration. Benefits patient by ensuring unidirectional flow and preventing medication backflow.

Clinical Evidence

Bench testing only. Device tested for physical, chemical, and biological specifications per ISO 10993, USPXX111, ISO 11607-1, ISO 11135, and USP Pyrogenicity requirements.

Technological Characteristics

Materials: acrylic-polycarbonate alloy body, silicone valve. Connections: male/female luer lock. Cracking pressure: >3.5 PSI +/- 1 PSI. Standards: ISO 10993 (biocompatibility), ISO 11607-1 (packaging), ISO 11135 (sterilization), USPXX111, USP Pyrogenicity.

Indications for Use

Indicated for use as an accessory to IV cannula or extension sets to allow pressurized fluid flow in one direction and prevent back flow of medication.

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

• KVQ Check Valve Accessory (K984441)

Submission Summary (Full Text)

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

K011888

SEP 1 0 2001

## 510(K) Summary

This summary of 510(K) safety and effectiveness information is submitted in accordance with the
requirements of SMDA and 21 CFR 807.92

| 1. | Submitter:<br>Address: | Churchill Medical Systems, Inc.<br>87 Venture Drive<br>Dover, NH 03820 |
|----|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: | 603-743-5988 |
| | Fax: | 603-743-6328 |
| | Contact: | Keith Paluch (Consultant) |
| 2. | Device Name: | Check Valve Accessory |
| | Trade Name:<br>Classification | Pressure Activated Check Valve |
| | Name: | IV Administration Set |
| 3. | Classification: | Class II, General Hospital 80 FPA |
| 4. | Predicate Device: | KVQ Check Valve Accessory (K98441) |
| 5. | Device Description: | The Churchill Medical Systems Pressure Activated Check Valve<br>consists of acrylic-polycarbonate alloy valve body and a silicone valve<br>with male and female luer lock connections. The device opens at<br>cracking pressures of greater than 3.5 PSI +/- 1 PSI and prevents back<br>flow. |
| 6. | Intended Use: | This device is used to directionally control the flow of fluids. They are<br>added to IV cannula or extension sets for simultaneous or alternate<br>administration of fluids while preventing back flow of medication. |
| 7. | Performance Summary: | This device is manufactured and tested in accordance with physical,<br>chemical and biological specification conforming to the applicable<br>requirements set forth in ISO 10993, USPXX111, ISO 11607-1, ISO<br>11135, USP Pyrogenicity test requirements as well as documented<br>internal requirements for physical testing. |
| 8. | Conclusion: | This device shares similar technical characteristics to check valves<br>currently available in the marketplace. Specifically, this device<br>performs similarly to the predicate device, referred to as KVO Check<br>Valve Accessory (K984441). Testing summary results confirm this<br>device to be safe and effective and substantially equivalent to the<br>predicate device. |

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is in all caps and is arranged in a circular fashion to match the shape of the logo.

Public Health Service

SEP 1 0 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Keith Paluch Consultant Churchill Medical Systems, Incorporated 87 Venture Drive Dover, New Hampshire 03820

Re: K011888

> Trade/Device Name: Pressure Activated Check Valve Regulation Number: 21 CFR 880.5440 Regulation Name: Check Valve Accessory Regulatory Class: Class II Product Code: FPA Dated: July 24, 2001 Received: August 2, 2001

Dear Mr. Paluch:

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.

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.

{2}------------------------------------------------

## Page 2 - Mr. Paluch

This letter will allow you to begin marketing your device as described in your Section This letter will anow you to ocgin maileding of substantial equivalence of your device to J ro(k) promation notificate 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 IT you desire specific ad rice for your for in vitro diagnostic devices), please contact the allu additionally 21 CF F R ar 8094-4618. Additionally, for questions on the promotion and Office of Comphance at (301) as contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket Anotification" (21CFR Part 807.97). Other general information on your responsibilities under notheadon' (21 CF I I ar over the Division of Small Manufacturers, International and the Act may be obtained its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely,

Tim Ulatowski

Timothy Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

011888 510(k) number

Page 1 of 1

Device Name: Pressure Activated Check Valve

Indications for Use: Accessory device used to allow pressurized fluid flow in one direction and stop, or check flow in the opposite direction.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) .

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21CFR 801.109) OR

Over-The-Counter Use_

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. K011888