RAPID-FILL TUBESET, MODEL 90005

K022523 · Baxa Corp. · LHI · Aug 12, 2002 · General Hospital

Device Facts

• Record ID: K022523
• Device Name: RAPID-FILL TUBESET, MODEL 90005
• Applicant: Baxa Corp.
• Product Code: LHI · General Hospital
• Decision Date: Aug 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Rapid-Fill Tubeset, is a fluid transfer device used in the pharmacy to provide the fluid path for transferring large source container ingredients into a smaller containers.

Device Story

Rapid-Fill Tubeset functions as a fluid transfer path within a pharmacy environment; used in conjunction with the Rapid-Fill pharmacy pump. Device facilitates the transfer of ingredients from a large source container into multiple smaller containers. Input consists of fluid from a source container; output is the dispensed fluid in smaller containers. Operated by pharmacy personnel to automate or assist in the filling of syringes or other small vessels. Benefits include standardized fluid transfer and efficiency in pharmacy compounding workflows. Device components include vented/non-vented spikes and tubing.

Clinical Evidence

Bench testing only. Testing includes biocompatibility (ISO 10993-1), packaging validation, and sterilization validation.

Technological Characteristics

Fluid transfer device consisting of tubing and spikes. Materials: Non-DEHP Polyvinyl Chloride (PVC). Sterilization: Radiation. Connectivity: None (mechanical fluid path).

Indications for Use

Indicated for use in a pharmacy setting as a fluid path for transferring ingredients from large source containers into smaller containers.

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

• Exacta-Mix™ 2400 Compounding System Administration Set (K002705)

Submission Summary (Full Text)

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AUG 1 2 2002

# 510(k) Summary

| Submitted by: | Baxa Corporation<br>13760 E. Arapahoe Road<br>Englewood, CO 80112 | |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Contact Person: | Karl Steineck | |
| Phone: | 303-617-2181 | |
| Fax: | 303-690-4804 | |
| Date Prepared: | July 26, 2001 | |
| Manufacturing Facility: | Baxa Corporation<br>13760 E. Arapahoe Road<br>Englewood, CO 80112 | |
| Submitted Device: | Trade Name: | Rapid-Fill™ Tubeset(s) |
| | Common Name: | Administration Set |
| Device Classification: | Class II<br>21 CFR § 880.5440 Intarvascular administration set | |
| | (a) Identification. An intravascular administration set is a device<br>used to administer fluids from a container to a patient's vascular<br>system through a needle or catheter inserted into a vein. The<br>device may include the needle or catheter, tubing, a flow regulator,<br>a drip chamber, an infusion line filter, an I.V. set stopcock, fluid<br>delivery tubing, connectors between parts of the set, a side tube<br>with a cap to serve as an injection site, and a hollow spike to<br>penetrate and connect the tubing to an I.V. bag or other infusion<br>fluid container.<br>(b) Classification. Class II (performance standards) | |
| Predicate Device: | Exacta-Mix™ 2400 Compounding System Administration Set<br>510(k): K002705, Cleared March 28, 2001<br>Baxa Corporation<br>Englewood, CO | |
| Product Description: | The Rapid-Fill Tubeset, is a tubeset used in conjunction with the<br>Rapid-Fill pharmacy pump to fill multiple syringes. | |
| Intended Use: | The Rapid-Fill Tubeset, is a fluid transfer device used in the<br>pharmacy to provide the fluid path for transferring large source<br>container ingredients into a smaller containers. | |

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#### Statement of substantial equivalence-

The Rapid-Fill Tubeset is very similar to the Exacta-Mix 2400 Compounding System Administration set in the following areas; intended use, operation, and function. The Rapid-Fill Tubeset and the predicate device are both used to transfer large source into smaller containers.

A summary of the essential features between the Exacta-Mix 2400 Compounding System Administration set (predicate device) and the Rapid-Fill Tubeset is contained in Table 1

#### Table 1

### Comparison between the Exacta-Mix™ 2400 Compounding System Administration Set and the new device, Rapid-Fill tubeset.

| Feature | Exacta-Mix Administration<br>Set<br>(Predicate Device) | Rapid-Fill™ Tubeset |
|--------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Intended use | used to transfer multiple large<br>container ingredients into one<br>final solution | Used to transfer one large<br>container ingredient to<br>multiple small containers. |
| Inlet Spike | Vented and non-Vented source<br>container spike | Vented and non-Vented<br>source container spike |
| Tubing | Non- DEHP Polyvinyl<br>Chloride (PVC) | Non- DEHP Polyvinyl<br>Chloride (PVC) |
| Sterile Fluid Path | Radiation Sterilized | Radiation Sterilized |

From Table 1 it can be seen that the two types of devices share the same basic features for fluid transfer.

#### Testing:

Testing will include: Biocompatibility testing - ISO 10993-1 Packaging validation Sterilization validation

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#### 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 features a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the top and left side of the profile graphic.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2002

Mr. Karl Steinbeck Baxa Corporation 13760 East Arapahoe Road Englewood. California 80112

Re: K022523

Trade/Device Name: Rapid-Fill Tubeset, Model 90005 Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: July 19, 2002 Received: July 30, 2002

Dear Mr. Steinbeck:

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 vour 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

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Page 2 - Mr. Steinbeck

requirements as set forth in the quality systems (OS) 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.qov/cdrh/dsma/dsmamain.html

Sincerely vours.

Timothy A. Ulatowski

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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# SECTION I: PRE-MARKET SUBMISSION (CONTINUED)

Indications for Use Statement (New and Predicate Device)

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# New Device

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| Applicant: | Baxa Corporation |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | |
| New Device Name: | Rapid-Fill™ Tubeset |
| Indications For Use: | The Rapid-Fill Tubeset, manufactured by Baxa Corporation, is a fluid transfer device used in the pharmacy to provide the fluid path for transferring large source container ingredients into a smaller containers. |

Patricia Curenite
(Division Sign. O.R.)

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

510(k) Number: K022523

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