SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY

K982102 · Baxter Healthcare Corp · MEB · Sep 4, 1998 · General Hospital

Device Facts

• Record ID: K982102
• Device Name: SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY
• Applicant: Baxter Healthcare Corp
• Product Code: MEB · General Hospital
• Decision Date: Sep 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The modified devices have the same intended use as the comparison devices. They are indicated for slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications. They are also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. These devices are suitable for use in the hospital and home setting.

Device Story

Elastomeric infusion pump; single-use; disposable. Input: medication reservoir. Operation: elastomeric pressure provides constant flow rate for continuous delivery; Patient Control Module allows patient-triggered bolus doses. Used in hospital or home settings; operated by clinicians or patients. Modification: relocated fill port to housing end; added coiled tubing connecting fill port to volume indicator. Output: controlled medication delivery. Benefits: enables continuous or demand-based drug administration outside clinical settings.

Clinical Evidence

Bench testing only. Standard flow rate testing performed to confirm performance characteristics of the modified device.

Technological Characteristics

Elastomeric infusion pump; single-use; disposable. Modification includes relocated fill port and coiled tubing for volume indicator connection. Mechanical operation via elastomeric pressure. No software or electronic components.

Indications for Use

Indicated for patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural medication administration at a constant flow rate; includes bolus dose administration 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

• Singleday Infusor (K982102)
• Infusor SV (K982102)
• 2 Day Infusor (K982102)
• Multiday Infusor (K982102)
• Seven Day Infusor (K982102)

Submission Summary (Full Text)

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4 1998 SEP

Section 9.0 Page 1

K 982/62

JUN 1 2 1998

### SECTION 9.0

### SMDA INFORMATION

## SUMMARY OF SAFETY AND EFFECTIVENESS

#### " Submitted by:

Vicki L. Drews Baxter Healthcare Corporation I.V. Systems Division Route 120 and Wilson Road Round Lake, IL 60073

Date of Submission: June 12, 1998

# Proposed Device(s):

Singleday Infusor Infusor SV 2 Day Infusor

Multiday Infusor Seven Day Infusor

Comparison Device(s):

Singleday Infusor Infusor SV 2 Day Infusor

Multiday Infusor Seven Day Infusor

#### Intended Use:

The modified devices have the same intended use as the comparison devices. They are indicated for slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications. They are also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. These devices are suitable for use in the hospital and home setting.

#### Technological Characteristics:

A design modification is being made to Baxter's Infusor SV line of Elastomeric Infusion Devices. This modification is being made to facilitate filling and priming the device. The modification involves the relocation of the fill port to the end of the housing and the addition of a piece of coiled tubing to connect the relocated fill port to the volume indicator. Standard flow rate testing was performed to confirm performance characteristics.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 4 1998

Ms. Vicki L. Drews Manager, Regulatory Affairs Baxter Healthcare Corporation I.V. Systems Division Route 120 and Wilson Road Round Lake, Illinois 60073

Re : K982102 Trade Name: Baxter Infusor SV-Elastomeric Infusion Device Unclassified Requlatory Class: Product Code: MEB Dated: June 12, 1998 Received: June 15, 1998

Dear Ms. Drews:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਨਾ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation-(21-CFR-Part 820) and that; -through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. J Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Drews

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general→ information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

S. Autran for

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### SECTION 11.0

## INDICATION 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.

Patricia Ciuente
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital, Intection and General Hospital Devices

510(k) Number K982102

**Prescription Use**
(Per 21 CFR 801.109)

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SEP 0 3 1998