BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE

K092318 · Baxter Healthcare Corporation · LHI · Oct 30, 2009 · General Hospital

Device Facts

• Record ID: K092318
• Device Name: BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE
• Applicant: Baxter Healthcare Corporation
• Product Code: LHI · General Hospital
• Decision Date: Oct 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The BAXJECT II Hi-Flow Needleless Transfer Device is intended for transferring and mixing of drugs contained in two vials into a syringe.

Device Story

Double-sided needleless transfer device; facilitates transfer and mixing of drugs from two vials into a single syringe. Used in clinical settings; operated by healthcare professionals. Device connects two vials to enable fluid transfer; mechanical operation only. Benefits include needleless drug reconstitution and transfer; reduces risk of needle-stick injuries.

Clinical Evidence

Bench testing only. Functional and biocompatibility testing performed to verify performance and safety. No clinical data provided.

Technological Characteristics

Double-sided needleless transfer device. Materials meet established standards; sterilization process consistent with predicate devices. Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for the transfer and mixing of drugs contained in two vials into a syringe.

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

• BAXJECT II Needleless Transfer Device (K042410)
• Needleless Transfer Device (K001831)

Submission Summary (Full Text)

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

Kof23/8. iofd

Traditional 510(k) Premarket Notification BAXJECT II Hi-Flow Needleless Transfer Device

### Section 5, 510(k) Summary

OCT 3 0 2009 DEVICE DESCRIPTION: The BAXJECT II Hi-Flow Needleless Transfer Device is a double-sided needleless transfer device designed for transferring and mixing of drugs contained in two vials into a syringe. STATEMENT OF The BAXJECT II Hi-Flow Needleless Transfer Device is INTENDED USE: intended for transferring and mixing of drugs contained in two vials into a syringe. The BAXJECT II Hi-Flow Needleless Transfer Device is TECHNOLOGICAL CHARACTERISTICS: substantially equivalent to the predicate devices with regard to technological characteristics, performance, and intended use. ASSESSMENT OF Baxter Healthcare Corporation conducts risk analysis NONCLINICAL according to the requirements of ISO 14971:2007 Medical DATA: Devices-Application of Risk Management to Medical Devices. The device continues to meet the same material testing standards and sterilization process standards as the predicate devices. Device verification testing of performance has been verified through functional and biocompatibility testing. CONCLUSIONS: The BAXJECT II Hi-Flow Needleless Transfer Device is substantially equivalent to the predicate device. Testing against established standards and guidelines for its intended use demonstrate that the proposed device is as safe and effective as the predicate device.

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

K092318p, dotA2

- !,

:

י : : : :

- "">

Traditional 510(k) Premarket Notification BAXJECT II Hi-Flow Needleless Transfer Device Section 5, 510(k) Summary

| 5. 510(k) SUMMARY | |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DATE: | July 20, 2009 |
| OWNER | Baxter Healthcare Corporation<br>One Baxter Parkway<br>Deerfield, IL 60015 |
| CONTACT PERSON: | Valerie Followell<br>Manager, Global Regulatory Affairs<br>1620 Waukegan Road, MPGR-AL<br>McGaw Park, IL 60085<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| DEVICE NAME: | Trade name: BAXJECT II Hi-Flow<br>Common name: Needleless Transfer Device Set, IV Fluid Transfer<br>Classification: Intravascular administration set, Vial adapter<br>Class: Class II<br>Product Code: LHI |

ﻣﻘ

・

PREDICATE DEVICE(S):

Previously cleared 510(k) for Baxter Healthcare Corporation, BAXJECT II Needleless Transfer Device

| Predicate<br>510(k) | Device<br>Name | Indication | Clearance date | Company |
|---------------------|---------------------------------------------|--------------------------------------------------------------------------|----------------|-------------------------------------|
| K042410 | BAXJECT II<br>Needleless Transfer<br>Device | Transfer and mixing of<br>drugs contained in two vials<br>into a syringe | 10/08/2004 | Baxter<br>Healthcare<br>Corporation |
| K001831 | Needleless Transfer<br>Device | Transfer and mixing of<br>drugs contained in two vials<br>into a syringe | 07/11/2000 | MediMop<br>Medical Products |

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Baxter Healthcare Corporation C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

OCT 3 0 2009

Re: K092318

Trade/Device Name: BAXJECT II Hi-Flow Needleless Transfer Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: October 15, 2009 Received: October 16, 2009

Dear Mr. Devine:

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 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.

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

## Page 2- Mr. Devine

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Antrim Co. Antrim

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# INDICATIONS FOR USE STATEMENT

K092318 510(k) Number (if known):

Device Name:

BAXJECT II Hi-Flow Needleless Transfer Device

Indication(s) for Use:

The BAXJECT II Hi-Flow Needleless Transfer Device is intended for transferring and mixing of drugs contained in two vials into a syringe.

Prescription Use: ি

AND/OR

Over-the-Counter Use: I 21 CFR 801 Subpart C

21 CFR 801 Subpart D

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Antti O. Niemi

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

Page __ of

510(k) Number: 15492318