VENTED VIAL ACCESS DEVICE

K013950 · Churchill Medical Systems, Inc. · FPA · Jan 10, 2002 · General Hospital

Device Facts

• Record ID: K013950
• Device Name: VENTED VIAL ACCESS DEVICE
• Applicant: Churchill Medical Systems, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jan 10, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Indications for Use

Churchill Medical Systems Mini Transfer Device is used for transferring and or dispensing medications, diluents and additives from rubber stoppered multi dose vials.

Device Story

The Churchill Medical Systems Mini Transfer Device is a vented access device designed for medication transfer. It features a universal piercing spike, a female luer lock, and a 0.22-micron hydrophobic filter for air venting. The device is used to access rubber-stoppered multi-dose vials to dispense or transfer medications and diluents. It is intended for use in clinical settings by healthcare professionals. The device facilitates the safe withdrawal of fluids from vials while maintaining pressure equalization through the integrated vent.

Clinical Evidence

Bench testing only. The device was tested for physical, chemical, and biological safety in accordance with ISO 10993-1, USP 24, ISO 11607-1, ISO 11135, and USP pyrogenicity requirements.

Technological Characteristics

Vented vial access device with universal piercing spike and female luer lock. Includes 0.22-micron hydrophobic filter for air venting. Materials and testing conform to ISO 10993-1 (biocompatibility), USP 24, ISO 11607-1 (packaging), and ISO 11135 (sterilization).

Indications for Use

Indicated for transferring and/or dispensing medications, diluents, and additives from rubber-stoppered multi-dose vials.

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

• Baxter Healthcare Chemo-Aide Dispensing Pin (K003730)

Submission Summary (Full Text)

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K013950

#### 510(K) Summary January 07, 2002

## JAN 1 0 2002

#### 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: Churchill Medical Systems, Inc. Address: 87 Venture Drive Dover, NH 03820 Phone: [phone] Fax: [phone] Contact: Keith Paluch (Consultant)

- 2. Device Name: Mini Transfer Device Trade Name: Vented Vial Access Device Classification
- IV Administration Set, Accessory
- Classification: Class II, General Hospital 80 FPA 3.
- Predicate Device: 4. Baxter Healthcare Chemo-Aide Dispensing Pin (K003730)
- న్. Device Description: The Churchill Medical Systems Mini Transfer Device is a standard vented access device. It contains a universal piercing spike with female luer lock and .22 micron hydrophobic filter. The purpose of the filter within the spike body is to provide air-venting.
- Intended Use: Q. This device is used for transferring and or dispensing medications, diluents and additives from rubber stoppered multi dose vials.
- 7. Performance Summary: This device is manufactured and tested in accordance with physical, chemical and biological specification conforming to the applicable requirements set forth in ISO 10993-1, USP 24, ISO 11607-1, ISO 11135, USP Pyrogenicity test requirements as well as documented internal requirements for physical testing.
- 8. Conclusion:

Name:

This device shares similar technical characteristics to dispensing and transfer devices currently available in the marketplace. Specifically, this device performs similarly to the predicate device, referred to as Chemo-Aide Dispensing Pin Accessory (K003730). Testing summary results confirm this device to be safe and effective and substantially equivalent to the predicate device.

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or bird-like figure, composed of three curved lines that suggest wings and a body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JAN 1 0 2002

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

Re: K013950

Trade/Device Name: Vented Vial Access Device Regulation Number: 880.5440 Regulation Name: IV Administration Set, Accessory Regulatory Class: II Product Code: LHI Dated: November 14, 2001 Received: November 30, 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.

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Page 2 – Mr. Paluch

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.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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 Ruma

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

Enclosure

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Indications For Use

510(k) Number (if known): K013950

Device Name: Churchill Medical Systems Mini Transfer Device

Indications For Use:

Churchill Medical Systems Mini Transfer Device is used for transferring and or dispensing medications, diluents and additives from rubber stoppered multi dose vials.

### Concurrence of the CDRH, Office of Device Evaluation (ODE)

**Prescription Use**

Or

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Smant Rame

Pivision Sign-Off) Consion of Dental, Infection Control, - General Hospital Devices Number JARGSO ------------------