BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME)

K041738 · Baxter Healthcare Corporation · FRN · Jul 9, 2004 · General Hospital

Device Facts

• Record ID: K041738
• Device Name: BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME)
• Applicant: Baxter Healthcare Corporation
• Product Code: FRN · General Hospital
• Decision Date: Jul 9, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Infusor LV and Infusor SV Devices includes the slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications. It may also include the slow, continuous infusion of medications directly into an intraoperative site or subcutaneously for postoperative pain management.

Device Story

The Infusor LV and SV are elastomeric infusion devices designed for the slow, continuous delivery of medications. These devices function as passive, non-electronic pumps that utilize elastomeric pressure to drive fluid flow. They are intended for use in clinical settings for intravenous, intra-arterial, subcutaneous, or epidural administration, as well as for postoperative pain management. The device is operated by healthcare professionals. The system provides a controlled, continuous infusion rate, which assists clinicians in managing medication delivery for patients requiring prolonged therapy. The device is a modification of the existing Baxter Infusor line.

Clinical Evidence

Bench testing only. Performance was verified through standard flow rate and pressure testing during manufacturing.

Technological Characteristics

Elastomeric infusion pump; passive, non-electronic energy source; modified design for flow rate control; 100% manufacturing testing for flow rates and pressure.

Indications for Use

Indicated for slow, continuous delivery of medications via intravenous, intra-arterial, subcutaneous, or epidural routes, including intraoperative site infusion or subcutaneous administration for postoperative pain management.

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

• Infusor SV (K002380)
• Infusor LV (K002380)

Submission Summary (Full Text)

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K041738

# JUL - 9 2004

### Attachment 6

### 510 (k) Summary

# Submitted by:

Karen Spranger Baxter Healthcare Corporation I.V. Systems Division Route 120 and Wilson Road Round Lake, IL 60073

## Date of Submission:

June 11, 2004

# Proposed Device(s): Infusor SV

Infusor LV

# Comparison Device(s):

Infusor SV Infusor LV

### Intended Use:

The intended use of the proposed devices has not changed as compared to the marketed devices. The intended use of the Infusor LV and Infusor SV Devices includes the slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications. It may also include the slow, continuous infusion of medications directly into an intraoperative site or subcutaneously for postoperative pain management. This is consistent with the intended use for the Infusor SV and Infusor LV devices as cleared under premarket notification K002380.

### Technological Characteristics:

A modified design is being added to Baxter's Infusor line of Elastomeric Infusion Devices. Standard flow rate testing was performed to confirm performance characteristics. Routine testing in manufacturing includes 100% testing for flow rates and pressure.

BAXTER CONFIDENTIAL

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 9 2004

Ms. Karen Spranger Regulatory Affairs Associate III Baxter Healthcare Corporation Route 120 & Wilson Road Round Lake, Illinois 60073-0490

Re: K041738

Trade/Device Name: Infusor LV and Infusor SV Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN, MEB Dated: June 25, 2004 Received: June 28, 2004

Dear Ms. Spranger:

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 Eederal Register.

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Page 2 - Ms. Spranger

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. or the For or any 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 and insting (21 CFR 2 th in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as 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) rms leter witification. The FDA finding of substantial equivalence of your device to a premainter nour one 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), rl 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 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/dsma/dsmamain.html

Sincerely yours.

Carl Shin, 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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510(k) Premarket Notification Infusor LV and Infusor SV

# Attachment 3 Indications for Use

510(k) Number (if known):_K662380

Device Name:___ Infusor LV and Infusor SV

Indications For Use:

The modified Infusion Pumps can be utilized for slow, continuous delivery though clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications. In addition, the intended use of the devices includes continuous infusion of medications directly into an intraoperative site or subcutaneously for post operative pain management.

Arene Naceure for ADw

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

510(k) Number: K041738

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)

S:1510K\INFUSOR\Attachment 3.DOC Last Saved On 6/25/2004 8:20 AM BAXTER CONFIDENTIAL

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