REPEATER PUMP II TUBE SETS

K062909 · Baxa Corp. · FPA · Mar 9, 2007 · General Hospital

Device Facts

• Record ID: K062909
• Device Name: REPEATER PUMP II TUBE SETS
• Applicant: Baxa Corp.
• Product Code: FPA · General Hospital
• Decision Date: Mar 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Repeater Pump II tube set tube sets are fluid transfer tube sets used in conjunction with the Repeater Pump II pharmacy pump in hospital and compounding pharmacies to provide a pathway through which fluid is transferred from one source container into another suitable container.

Device Story

Repeater Pump II tube sets provide fluid pathway, pump cavity, and valving for Repeater Pump II system; used in hospital/compounding pharmacies by trained personnel. Device utilizes plastic piston and pump core to mechanically pump pharmaceutical liquids from source containers to destination containers (IV bags, syringes, elastomeric infusers). Piston stroke delivers 0.2mL to 10mL; system eliminates need for frequent calibration/flow factor adjustments common in peristaltic pumps. Tube sets available in eight configurations; designed for 200L pumping life with automatic end-of-life alerts. Healthcare providers use system to facilitate repeatable drug dosage distribution and reconstitution. Benefits include improved accuracy and efficiency in pharmacy fluid transfer workflows.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993-1), sterilization validation (ANSI/AAMI/ISO 11137), endotoxin testing, human factors/system validation, microbial ingress validation, and packaging validation. Performance metrics include dispensing accuracy of +/- 0.02mL for 0.2-2mL range and +/- 1% for >2mL.

Technological Characteristics

Piston pump mechanism; non-DEHP PVC tubing; various configurations with vented spikes and male luer lock connectors (ISO 594-1/2). Sterilized via Gamma radiation. Designed for 200L fluid throughput. Standalone tube set component for use with Repeater Pump II platform.

Indications for Use

Indicated for use by trained pharmacy personnel (pharmacists and pharmacy technicians) in hospital and compounding pharmacies for fluid transfer between containers. Not for direct patient contact.

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

• Repeater™ Pump Tube Sets (K872743)

Submission Summary (Full Text)

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

Kola2909
1 of 4

## SECTION 5: 510(k) SUMMARY

| Submitted by: | Baxa Corporation | MAR 09 2007 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person:<br>Phone:<br>Fax: | Kimberly Zizik, Regulatory Assurance Supervisor<br>[phone]<br>[phone] | |
| Date Prepared: | | |
| Manufacturing Facility: | Baxa Corporation<br>14445 Grasslands Drive<br>Englewood, CO 80112 | |
| Submitted Device: | Trade Name: Repeater Pump II Tube Sets<br>(Baxa Tubing Sets for Pump) | |
| | Common Name: Set, IV Fluid Transfer | |
| Device Classification: | 21 CFR § 880.5440 Intravascular administration set,<br>Product Code LHI | |
| | (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<br>regulator, a drip chamber, an infusion line filter, an I.V. set<br>stopcock, fluid delivery tubing, connectors between parts of the<br>set, a side tube with a cap to serve as an injection site, and a<br>hollow spike to penetrate and connect the tubing to an I.V. bag<br>or other infusion fluid container. | |
| | (b) Classification. Class II | |
| Predicate Device: | Trade Name: Repeater™ Pump Tube Sets<br>(Baxa Tubing Sets for Pump) | |
| | Common Name: Set, IV Fluid Transfer | |
| Predicate Device<br>Classification: | 21 CFR § 880.5440 Intravascular administration set<br>Product Code LHI | |
| | (b) Classification. Class II | |
| | Manufacturer: Baxa Corporation<br>510(k) Number: K872743 | |
| Product Description: | The Repeater Pump II tube set provides the fluid pathway, pump<br>cavity, valving, and tube set for the Repeater Pump II system.<br>The tube set and pump platform work together to provide sterile<br>transfer and reconstitution of pharmaceutical liquids. The tube<br>set utilizes a plastic piston to mechanically pump required<br>amounts of fluid from 0.2mL to 10mL with each piston stroke. A<br>plastic pump core works in conjunction with the piston to provide<br>appropriate fluid pathways for the draw and discharge strokes. | |

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

There are two tube set connections for inlet and outlet fluid pathways. The Repeater Pump II tube set will be available in eight (8) unique configurations to accommodate various source and final container connections.

The Repeater Pump II tube set:

- . Provides an integrated pump body/cavity, piston, pump core, and tube set that are used with standard pharmaceutical fluid and drug administration containers
- . Utilizes standard connections in different configurations to meet different pumping requirements
- Eliminates the need for frequent calibration and flow . factor adjustments normally required with peristaltic pumping
- Designed for pumping life of 200L. Pump . automatically alerts users when end of tube set life is met

The Repeater Pump II tube set is for use with Repeater Pump II Intended Use: device. This device provides piston pump driven fluid transfer that facilitates repeatable drug dosage distribution and reconstitution in hospital pharmacies. The Repeater Pump II tube set provides the fluid pathway and pumping mechanism for the pump system. The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Some sets are sold sterile and others are not based on the requirements for the end use of the set.

## Statement of substantial equivalence:

A summary of the essential features between the Repeater Pump Tube sets (Predicate Device) and the Baxa Corporation Repeater Pump II Tube sets (New Device) is contained in below:

| Feature | Repeater Pump II Tube Set<br>(Piston Pump New Device) | Repeater Pump Fluid Transfer Tube Set<br>(Peristaltic Pump Predicate Device) |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for<br>Use | The Repeater Pump II tube sets are fluid<br>transfer tube sets used in conjunction with the<br>Repeater Pump II pharmacy pump in hospital<br>pharmacies to provide a pathway through<br>which fluid is transferred from one source<br>container into another suitable container. | The Repeater Pump tube set is part of the<br>Repeater Pump™ device. This device<br>provides peristaltic pump driven fluid<br>transfer that facilitates repeatable drug<br>dosage distribution and reconstitution in<br>hospital pharmacies. The Repeater Pump<br>tube set provides the fluid pathway and<br>pumping mechanism for the pump system.<br>The device is for use with IV bags,<br>syringes, elastomeric infusers, and other<br>drug administration containers. Some sets<br>are sold sterile and others are not based on<br>the end use of the set. |
| Intended<br>Use | This product would be used for fluid transfer in<br>hospital pharmacies | This product would be used for fluid transfer<br>in hospital pharmacies |
| Capacity | 10mL per stroke with min/max delivery of<br>2mL/10mL per stroke and a maximum flow | Inner diameter of pump tube set allows over<br>14 mL per second to be pumped at the |
| | rate of over 21mL per second. | highest speed. |
| Tubing | Various Durometer Non-DEHP PVC tubing | Various durometer PVC and silicone tubing |
| Connections | Model #3601 | Model #11 |
| | Vented Spike/Male Luer Lock Connectors<br>Fluid Transfer with Vented Spike | Vented Spike/Male Luer Lock Connectors<br>Fluid Transfer with Vented Spike |
| | Model #3603<br>Male Luer Lock/Male Luer Lock Connectors<br>Fluid Transfer with Luer Lock Connectors | Model #21<br>Male Luer Lock/Male Luer Lock Connectors<br>Fluid Transfer with Luer Lock Connectors |
| | Model #3605<br>Male Luer Lock/Male Luer Lock Connectors<br>Low Prime Volume Fluid Transfer | Model #331<br>Male Luer Lock/Male Luer Lock Connectors<br>Low Prime Volume Fluid Transfer |
| | Model #3612<br>Vented Spikes (2)/Male Luer Lock<br>Bifurcated Tube Set | Model #62<br>Vented Spikes (2)/Male Luer Lock<br>Bifurcated Tube Set |
| | Model #3614<br>Vented Spike (3)/Male Luer Lock<br>Trifurcated Tube Set | Model #63<br>Vented Spike (3)/Male Luer Lock<br>Trifurcated Tube Set |
| | Model #3623<br>SS Weight Inlet/Male Luer Lock<br>Oral Liquid Transfer | Model #13<br>SS Weight Inlet/Male Luer Lock<br>Oral Liquid Transfer |
| | Model #3620<br>Male Luer Lock Connector<br>Top Fill Bag<br>Gel Bag | Model #26<br>Male Luer Lock Connector<br>Top Fill Bag<br>Gel Bag |
| | Model #3625<br>Male Luer Lock Connector<br>Top Fill Bag<br>Gel Bag | Model #46<br>Male Luer Lock Connector<br>Top Fill Bag<br>Gel Bag |
| Target<br>Population | Customers for the tube sets are Baxa<br>pharmacy pump users, including hospital and<br>home care pharmacists and pharmacy<br>technicians. These tube sets are used by<br>trained personnel, and do not have direct<br>contact with a patient. | Customers for the tube sets are Baxa<br>pharmacy pump users, including hospital<br>and home care pharmacists and pharmacy<br>technicians. These tube sets are used by<br>trained personnel, and do not have direct<br>contact with a patient. |
| Anatomical<br>sites | N/A | N/A |
| Where Used | This product would be used by Pharmacists<br>and Pharmacy technicians both inside and<br>outside of flow hoods | This product would be used by Pharmacists<br>and Pharmacy technicians both inside and<br>outside of flow hoods |
| Performance | • Using a rigid pumping cavity and piston<br>pump methodology, solutions of different<br>viscosities and flow rates can be pumped<br>without any recalibration due to tube set<br>characteristic changes. | • Using different durometer PVC tubing,<br>solutions of different viscosities can be<br>pumped while minimizing dripping from<br>the end of the tube set. Using different<br>silicone tubing diameters, differing<br>volumes can be pumped with repeatable<br>accuracy. |
| | • Sterilized by Gamma Radiation<br>• Minimum dispensing volume of 0.2mL. | • Sterilized by ETO (ethylene oxide) gas.<br>• Minimum dispensing volume of 0.2 mL. |
| | +/- 0.02ml for .2ml to 2ml pumping<br>+/- 1% for >2ml pumping | • Volume accuracy:<br>+/- 10% @ 0.2 mL<br>+/- 5% @ 0.5 mL<br>+/- 3% @ 1.0 mL |
| | • High flow tube set allows over 21ml per<br>second to be pumped at highest speed<br>• The pump tube set will perform to<br>specification for up to 200 liters of fluid.<br>Pump automatically alerts users when end<br>of tube set life is met | • Inner diameter of pump tube set allows<br>over 14 mL per second to be pumped,<br>highest speed.<br>• The pump tube set will perform to<br>specification for up to 150 Liters of fluid. |
| Materials | See Section 11, "Device Description" for<br>material information | Fluid contact materials:<br>Sunlite Plastics Vysun 102-85-22 Medical<br>Grade PVC resin<br>Medical Grade silicone tubing |
| Biocompatibi<br>lity | Materials will be tested per ISO 10993-1<br>(2003): Biological Evaluation of Medical<br>Devices Part 1: Evaluation and Testing | Materials have been tested per ISO 10993-<br>1 (2003): Biological Evaluation of Medical<br>Devices Part 1: Evaluation and Testing |
| Compatibility<br>with the<br>environment<br>and other | #3601, #3603, #3605, #3620, #3623<br>connections are compatible with standard luer-<br>lock connections per ISO 594-1 and -2. | #11 connections are compatible with<br>standard luer-lock connections per ISO<br>594-1 and -2. |
| devices | #3612, #3614 use a 5mm large bore<br>connector and are compatible only with other<br>5mm connectors | |
| Sterility | Sterilized using Gamma radiation | Sterilized using Ethylene Oxide (ETO) |

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

K063909
3 of 4

. . .

יי

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

K062909
4.84

From the above table it can be seen that the two types of devices share basic features for fluid transfer applications.

Testing:

Testing will include:

Biocompatibility testing - ISO 10993-1

Sterilization validation -- ANSI/AAMI/ISO11137

Endotoxin Test - Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products and Medical Devices. U.S. Dept. of Health and Human Services and Drug Administration, December 1987.

Human Factors/System Validation Disposable Design Verification Microbial Ingress Validation System Design Verification

Packaging validation

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

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES (USA)" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kimberly Zizik Regulatory Assurance Supervisor Baxa Corporation 14445 Grasslands Drive Englewood, Colorado 80112

MAR 0 9 2007

Re: K062909

Trade/Device Name: Repeater Pump IITM Tube Sets Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: February 16, 2007 Received: February 20, 2007

Dear Ms. Zizik:

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.

{5}------------------------------------------------

## Page 2 -Ms. Zizik

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 (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), please contact the Office of Compliance 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 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,

Sutte G. Michan M.D.

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

{6}------------------------------------------------

## Indications For Use

510(k) Number: K062909

Device Name: Repeater Pump II™ Tube Sets

Indications for Use: The Repeater Pump II tube set tube sets are fluid transfer tube sets used in conjunction with the Repeater Pump II pharmacy pump in hospital and compounding pharmacies to provide a pathway through which fluid is transferred from one source container into another suitable container.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anin Im

Lab/2020

Page 1 of 1