BAXJECT II

K042410 · Baxter Healthcare Corp · LHI · Oct 8, 2004 · General Hospital

Device Facts

• Record ID: K042410
• Device Name: BAXJECT II
• Applicant: Baxter Healthcare Corp
• Product Code: LHI · General Hospital
• Decision Date: Oct 8, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

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

Device Story

BAXJECT II is a dual-sided needleless transfer device; facilitates drug reconstitution and transfer between two vials and a syringe. Features siliconized plastic piercing spikes for 20mm vial penetration; includes a deployable tube to minimize foaming during reconstitution; incorporates an air filter to relieve vacuum. A standard luer connector with an embedded product filter allows for final drug transfer. Used in clinical settings by healthcare providers to prepare medications; simplifies the mixing process; reduces potential for foaming; maintains closed system integrity during transfer.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dual-sided needleless transfer device; siliconized plastic piercing spikes; deployable tube for foaming reduction; integrated air filter for vacuum relief; standard luer connector with embedded product filter; designed for 20mm vials.

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

• Needleless Transfer Device (K001831)

Submission Summary (Full Text)

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007 8 - 2004

K042410

'q'

510(k) Premarket Notification
Baxter BAXJECT II
BAXTER HEALTHCARE CORPORATION, Baxter BioScience

Page 27

## 510(k) SUMMARY

| Date Prepared | September 3, 2004 |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | |
| Submitter | Baxter Healthcare<br>Baxter BioScience<br>One Baxter Way<br>Westlake Village, CA 91362 |
| Contact | Ron Lagerquist<br>Senior Manager, Regulatory Affairs |
| Device Name | BAXJECT II Needleless Transfer Device |
| Common/Usual/<br>Classification Name | Set, I.V. Fluid Transfer<br>LHI |
| Device Description | BAXJECT II is a dual sided needleless transfer device designed for transferring and mixing drugs contained in two vials into a syringe. The double-sided device has a vial holder on each end. Siliconized plastic piercing spikes are designed for easy penetration into the rubber stopper of standard 20mm vials. A deployable tube reduces the potential for foaming during reconstitution of powdered materials. The device filters air passing into the system to relieve vacuum. A standard luer connector with embedded product filter allows for the mixed drug to be transferred into a syringe. |
| Intended Use | The BAXJECT II Needleless Transfer Device is intended for transferring and mixing drugs contained in two vials into a syringe. |
| Predicate Device | Needleless Transfer Device<br>MediMop Medical Projects, LTD<br>K001831 |
| Substantial Equivalence | The BAXJECT II is substantially equivalent to the predicate device based on technological characteristics and intended use. The BAXJECT II Needleless Transfer Device conforms with the FDA Guidance Document, "Guidance for Industry and FDA Review Staff: Guidance on Premarket Notifications for Intravascular Administration Sets, October 12, 2000" |

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized eagle with its wings spread.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 8 - 2004

Baxter Healthcare Corporation C/O Mr. Ronald F. Lagerquist Senior Manager, Regulatory Affairs Baxter BioScience One Baxter Way Westlake Village, California 91362

Re: K042410

Trade/Device Name: BAXJECT I I Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: September 28, 2004 Received: September 29, 2004

Dear Mr. Lagerquist:

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 (1 mr), ice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roulish further announcements concerning your device in the Federal Register.

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### Page 2 - Mr. Lagerquist

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that I DTC issuaires on that your device complies with other requirements Incall that I DA nas made a actessand regulations administered by other Federal agencies. of the Act of ally t oderal states are quirements, including, but not limited to: registration 1 ou inust comply with an are rabeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 607), laceling (21 CFR Pat (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality by steam (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 to obja. finding of substantial equivalence of your device to a premarket notification. The PDF 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), rr you desire specific at no for spliance 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 obtain 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,

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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K042410

510(k) Premarket Notification Baxter BAXJECT II BAXTER HEALTHCARE CORPORATION, Baxter BioScience

Page 29

#### Indications for Use

510(k) Number (if known): Ko 42 410

Device Name: BAXJECT II

Indications for Use:

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

Vick Hubbard for Anthony Wilson

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

510(k) Number Ko42 4/0

Prescription Use Over-The-Counter Use ಸ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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