BLOOD HAND PUMP ADMINISTRATION SET

K050115 · Cardinal Health, Alaris Products · BRZ · Apr 1, 2005 · General Hospital

Device Facts

• Record ID: K050115
• Device Name: BLOOD HAND PUMP ADMINISTRATION SET
• Applicant: Cardinal Health, Alaris Products
• Product Code: BRZ · General Hospital
• Decision Date: Apr 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Blood Hand Pump Set will be used for patients that require blood. The set can be used by gravity flow or with hand pump compressions, depending on how quickly blood delivery is needed. It is intended for use by healthcare professionals (including nurses, doctors, emergency technicians, etc.) in clinical environments. The flow rate for hand pump compression administration may be as much as twice that of gravity flow.

Device Story

Single-use, disposable blood administration set; includes blood filter and integrated hand pressure pump. Operates via gravity flow or manual compression of pump bulb by healthcare professional (nurse, doctor, technician) to increase flow rate. Used in clinical settings (ER, ICU, OR, trauma centers, pre-hospital transport) for rapid blood/blood product delivery. Output is controlled flow of blood to patient. Benefits include timely delivery of blood products in urgent clinical scenarios.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing demonstrating that the device meets specified performance requirements and is equivalent to predicate devices.

Technological Characteristics

Single-use, disposable intravascular administration set. Components include blood filter and manual pressure pump bulb. Gravity-fed or manual compression-actuated. No electronic components, software, or external energy source.

Indications for Use

Indicated for patients requiring blood or blood products. Used by healthcare professionals in clinical settings (ER, ICU, OR, trauma centers, pre-hospital transport) for rapid delivery via manual pressure pump or gravity flow.

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

• ALARIS Blood Administration Set (K882302)
• Baxter Fenwal Y-Type Blood/Solution Set (K881321)

Submission Summary (Full Text)

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KD50115

# APR - 1 2005 SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris Products Blood Hand Pump Set

# SUBMITTER INFORMATION

| A. | Company Name: | Cardinal Health, Alaris® Products |
|----|--------------------------------|-----------------------------------------------------------------------------------------|
| B. | Company Address: | 10221 Wateridge Circle<br>San Diego, CA 92121-2733 |
| C. | Company Phone:<br>Company Fax: | [phone]<br>[phone] |
| D. | Contact Person: | Stacy L. Lewis<br>Sr. Regulatory Affairs Specialist<br>Cardinal Health, Alaris Products |
| E. | Date Summary Prepared: | March 16, 2005 |

### DEVICE IDENTIFICATION

| A. | Generic Device Name: | Blood Administration Set |
|----|-------------------------|----------------------------|
| B. | Trade/Proprietary Name: | Blood Hand Pump Set |
| C. | Classification: | Class II |
| D. | Product Code: | BRZ, Blood Transfusion Set |

## DEVICE DESCRIPTION

The Blood Hand Pump Administration Set is a single use, disposable, gravity blood set with a blood filter and hand pressure pump. The addition of the hand pressure pump provides the capability for delivering blood/blood products more rapidly by compressing the pump by hand. Blood sets with hand pressure pumps are typically used by healthcare professionals in clinical settings, including emergency rooms, intensive care units, operating rooms, surgery centers, trauma centers, and pre-hospital transport. Using a hand pump set increases the flow rate and helps ensure timely delivery.

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## SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris Products Blood Hand Pump Set Page 2 of 2

#### SUBSTANTIAL EQUIVALENCE

The Cardinal Health, Alaris Products Blood Hand Pump Administration Set is of comparable type and is substantially equivalent to the following predicate devices:

| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|--------------------------------------------|-------------------------------------|------------|--------------|
| ALARIS Blood<br>Administration Set | Cardinal Health, Alaris<br>Products | K882302 | 7/12/1988 |
| Baxter Fenwal Y-Type<br>Blood/Solution Set | Baxter Corporation | K881321 | 6/16/1998 |

#### INTENDED USE

The Blood Hand Pump Set will be used for patients that require blood. The set can be used by gravity flow or with hand pump compressions, depending on how quickly blood delivery is needed. It is intended for use by healthcare professionals (including nurses, doctors, emergency technicians, etc.) in clinical environments. The flow rate for hand pump compression administration may be as much as twice that of gravity flow.

#### TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the Cardinal Health, Alaris Products Blood Hand Pump Set and the predicate devices has been performed. The results of this comparison demonstrate that the Blood Hand Pump Set is equivalent to the marketed predicate devices in technological characteristics.

#### PERFORMANCE DATA

The performance data indicate that the Cardinal Health, Alaris Products Blood Hand Pump Set meets specified requirements and is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

APR - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Stacy L. Lewis Senior Regulatory Affairs Specialist Cardinal Health, Alaris Products 10221 Wateridge Circle San Diego, California 92121-2772

Re: K050115

Trade/Device Name: Blood Hand Pump Administration Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: BRZ Dated: January 17, 2005 Received: January 18, 2005

Dear Ms. Lewis:

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 will) in the 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.

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Page 2 - Ms. Lewis

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advisor and a determination that your device complies with other requirements mount that I Dr mas and regulations administered by other Federal agencies. or the recor any a vary a vat's requirements, including, but not limited to: registration r od into comply with and 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF Partis of 1, 2017, 1977, 1991, 1991, 1991, 1991, 1997, 1991, 1991, 1991, 11 requirements as bet form in one of 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) This letter wifi une in J . 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), rr you donto 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 maj oveans 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 vours,

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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# INDICATIONS FOR USE

| 510(k) Number: | k050115 | (To Be Assigned By FDA) |
|--------------------|------------------------------------|-------------------------|
| Device Trade Name: | Blood Hand Pump Administration Set | |

Indications For Use:

A single use, disposable, blood administration set with pressure pump and blood filter used to deliver blood/blood products rapidly through use of the pressure pump and/or gravity flow.

Prescription Use _________X

(Per 21 CFR 801.109)

Over-The-Counter Use

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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