INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES

K062457 · Baxter Healthcare Corporation · MEB · Sep 21, 2006 · General Hospital

Device Facts

• Record ID: K062457
• Device Name: INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES
• Applicant: Baxter Healthcare Corporation
• Product Code: MEB · General Hospital
• Decision Date: Sep 21, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Baxter's Infusor SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated for patients requiring slow, continuous intravenous, intraarterial, subcutaneous or epidural administration of medications at a constant flow rate. The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. It is suitable for use in the hospital or home setting.

Device Story

Single-use, disposable elastomeric infusion pump; delivers medication at constant preset flow rates (0.5mL/hr to 5mL/hr). Input: medication reservoir. Transformation: elastomeric pressure drives fluid through a plastic tubing flow restrictor. Output: continuous infusion or patient-controlled bolus (via Patient Control Module). Used in hospital or home settings; operated by patients or healthcare providers. Modification replaces previous glass restrictor/housing with plastic tubing restrictor, coupler, and Luer lock connector. Benefits: provides consistent, portable medication delivery for various administration routes.

Clinical Evidence

Bench testing only. No clinical data presented. Verification testing included mechanical, biocompatibility, and flow rate testing to confirm performance equivalence following design modifications.

Technological Characteristics

Single-use, disposable elastomeric infusion pump. Flow control via plastic tubing restrictor (replacing glass). Includes coupler and Luer lock connector. Mechanical operation; no external energy source. Biocompatibility testing performed.

Indications for Use

Indicated for patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural medication administration at a constant flow rate; includes optional patient-controlled bolus dosing via Patient Control Module; suitable for hospital or home use.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• Single day Infusor (K802820, K905778, K982102)
• Half Day Infusor (K853881, K905778, K982102)
• 2 Day Infusor (K802820, K842479, K870242, K905778, K982102)
• Multiday Infusor (K842905, K905778, K982102)
• Seven Day Infusor (K842479, K842905, K870242, K905778, K982102)

Submission Summary (Full Text)

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K062457

# 5. 510(K) SUMMARY

SEP 2 1 2006

### DATE PREPARED:

August 8, 2006

#### OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

# CONTACT PERSON:

Nanette Hedden Regulatory Affairs Manager 1620 Waukegan Rd. McGaw Park, IL 60085 Telephone: [phone] Fax: [phone]

### DEVICE NAME:

Trade name: Infusor SV Elastomeric Infusion Device

- Singleday Infusor
- · Half Day Infusor
- · 2 Day Infusor
- Multiday Infusor
- · Seven Day Infusor

### COMMON NAME:

Infusion Pump

# CLASSIFICATION NAME:

Infusion Pump (21 CFR 880.5725, Product Code MEB, MEA,

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# PREDICATE DEVICE(S):

| Device | Previous 510(k) | Clearance date |
|--------------------|-----------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Single day Infusor | K802820<br>K905778<br>K982102 | November 7, 1980<br>July 12, 1991<br>September 4, 1998 |
| Half Day Infusor | K853881<br>K905778<br>K982102 | December 2, 1985<br>July 12, 1991<br>September 4, 1998 |
| 2 Day Infusor | K802820<br>K842479<br>K870242<br>K905778<br>K982102 | November 7, 1980<br>November 2, 1984<br>March 13, 1987<br>July 12, 1991<br>September 4, 1998 |
| Multiday Infusor | K842905<br>K905778<br>K982102 | November 1, 1985<br>July 12, 1991<br>September 4, 1998 |
| Seven Day Infusor | K842479<br>K842905<br>K870242<br>K905778<br>K982102 | November 2, 1984,<br>November 1, 1985<br>March 13, 1987<br>July 12, 1991<br>September 4, 1998 |

#### Table 5-1. Previous 510(k)s

## DESCRIPTION OF THE DEVICE AND MODIFICATION:

Baxter's Infusor SV devices are single-use, disposable elastomeric infusion pumps designed to deliver solution at a constant preset flow rate ranging from 0.5mL/hr to 5mL/hr, depending on device configuration. The modifications made to the Infusor SV devices include replacing the glass restrictor tube and housing used in previous versions of the device with a plastic tubing flow restrictor, a coupler to connect the tubing flow restrictor to the tube set and a Luer lock connector.

## STATEMENT OF INTENDED USE:

Baxter's Infusor SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated for patients requiring slow, continuous intravenous, intraarterial, subcutaneous or epidural administration of medications at a constant flow rate

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The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. It is suitable for use in the hospital or home setting.

# TECHNOLOGICAL CHARACTERISTICS:

The plastic tubing flow restrictor, Luer lock connector and coupler are replacing the current glass flow restrictor and Luer housing. These components provide the equivalent performance; however the materials differ in that the glass is replaced by plastic tubing and the coupler and Luer together replace the function of the current Luer housing by connecting the restrictor to the device tubing set and providing a Luer lock for connection to the patient's catheter.

# DISCUSSION OF NONCLINICAL TESTS:

Baxter Healthcare conducts risk analyses using procedures based on ISO 14971 (2000) "Medical Devices - Application of Risk Management to Medical Devices." The risk analysis method used to assess the impact of the modification was Failure Modes and Effects Analysis (FMEA). Design verification tests based on the result of risk analysis and design input were performed to verify the modifications. Testing of the device and components included mechanical, biocompatibility, and flow rate testing. All test results meet the acceptance criteria, and prove that the modifications are appropriate.

# CONCLUSION:

The Infusor SV Elastomeric Infusion Device with the modifications is as safe and effective as the predicate device and the performance is substantially equivalent to the predicate device.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 2 1 2006

Ms. Nanette Hedden Regulatory Affairs Manager Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, Illinois 60085

Re: K062457

Trade/Device Name: Infusor Small Volume (SV) Elastomeric Infusion Device Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: August 22, 2006 Received: August 23, 2006

Dear Ms. Hedden:

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.

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Page 2 -- Ms. Hedden

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 (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.

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,

Chiu Lin, Ph.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

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#### INDICATIONS FOR USE

510(k) Number (if known):

K062457

Device Name: Infusor Small Volume (SV) Elastomeric Infusion Devices

Indications For Use: Baxter's Infusor SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated for patients requiring slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications at a constant flow rate. The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. It is suitable for use in the hospital or home setting.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

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on Sign-Off)

ion of Anesthesiology, General Hospital,

tion Control, Dental Devices