CLEARSTAR ENTERAL NUTRITION PUMP

K981541 · Frantz Medical Development, Ltd. · LZH · Aug 13, 1998 · General Hospital

Device Facts

• Record ID: K981541
• Device Name: CLEARSTAR ENTERAL NUTRITION PUMP
• Applicant: Frantz Medical Development, Ltd.
• Product Code: LZH · General Hospital
• Decision Date: Aug 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The ClearStar pump can be used for adult and pediatric patients provided the patients can tolerate a feeding range within the pump operational specifications. Those specifications are: - * The flow rate range is 1-300 ml/hr in I mL/hr increments - * The flow rate accuracy is ± 10% or ± 0.5 mL/hr, whichever is greater - * The occlusion pressure limit is 26-30 psi. If these specifications are not appropriate for a given patient, the ClearStar pump should not be used.

Device Story

ClearStar Enteral Nutrition Pump delivers nutritional formula to patients via nasogastric, jejunostomy, or gastrostomy tubes. Device operates at flow rates of 1-300 ml/hr. Features automatic clog clearing function applying 26-30 psi pressure; limits clearing attempts to 20 minutes or 10 cycles per 4-hour period to prevent occlusion alarms. Designed to maintain pressure below 40 psi to prevent feeding set disconnection. Used in clinical or home settings; operated by healthcare providers or trained users. Provides controlled delivery of nutrition; alerts users to occlusions to ensure patient safety and prevent underfeeding. Benefits include reliable enteral feeding and automated management of tube clogs.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Enteral feeding pump; flow rate 1-300 ml/hr; occlusion pressure 26-30 psi; automatic clog clearing mechanism; AC power with charger; compatible with specific ClearStar Pump Sets; mechanical pressure regulation to prevent exceeding 40 psi.

Indications for Use

Indicated for adult and pediatric patients requiring enteral nutrition who can tolerate flow rates of 1-300 ml/hr and occlusion pressures of 26-30 psi. Contraindicated for patients requiring specifications outside these ranges or those sensitive to potential bolus-feeding/over-delivery.

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

• Companion enteral feeding pump
• Quantum enteral feeding pump

Submission Summary (Full Text)

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AUG 1 3 1998

K98/1541

106

## SUMMARY OF SAFETY and EFFECTIVENESS FOR THE CLEAR STAR PUMP

The ClearStar pump raises no new questions of safety or effectiveness above those currently associated with enteral feeding pumps. The operator's manual for the ClearStar pump provides warnings regarding volume sensitive patients similar to those found in the operating manuals of the Companion and Quantum enteral feeding pumps.

The pump's automatic clog clearing function has been designed to ensure that the nominal pressure exerted on a clog is in the 26 to 30 psi range. Additionally, to ensure that the patient is not underfed, the pump, if unsuccessful in clearing a clog before ten (10) minutes have elapsed, will alarm occlusion. Finally, the pump can only be in the clog clearing mode a maximum of twenty (20) minutes or ten times in any consecutive four (4) hour period. If twenty (20) minutes or ten times are exceeded, the pump will alarm occlusion.

Product literature for enteral feeding tubes (nasogastric and gastrostomy) cautions not to use a pump or syringe that causes pressures to build beyond 40 psi This warning is pressures above 40 psi can cause med-port plugs to separation of the feeding set from the feeding tube. Pressure build-up with the ClearStar pump during occlusion is maintained safely below the maximum pressure specification of the feeding tubes.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 3 1998

Mr. J. Paul Hanson Vice President Metabolic & Diagnostic Division Frantz Medical 7740 Metric Drive Mentor, Ohio 44060

Re : K981541 ClearStar Enteral Nutrition Pump Trade Name: Requlatory Class: II Product Code: LZA Dated: June 4, 1998 Received: June 5, 1998

Dear Mr. Hanson:

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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 Regulations, Title 21, Parts 800 to 895. A --------substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 through 542 of

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Page 2 - Mr. Hanson

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" (21 CFR 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/dsmamain.html".

Sincerely yours,

S. Butman for

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

Enclosure

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510(k) Number (if known): _(1981541

Device Name: ClearStar Enteral Nutrition Pump

Indications For Use:

The ClearStar pump can be used for adult and pediatric patients provided the patients can tolerate a feeding range within the pump operational specifications. Those specifications are:

- * The flow rate range is 1-300 ml/hr in I mL/hr increments
- * The flow rate accuracy is ± 10% or ± 0.5 mL/hr, whichever is greater
- * The occlusion pressure limit is 26-30 psi.

If these specifications are not appropriate for a given patient, the ClearStar pump should not be used.

Precautions

All enteral pumps have the potential to bolus-feed or over deliver, which is an important consideration in feeding volume-sensitive patients. In these patients, a volume of product no more than four times the hourly feeding rate should be hung.

Confirm proper placement and function.

Confirm proper placement and function of patient's enteral feeding tube (nasogastric, jejunostomy, gastrostomy, etc.), and verify the following before initiating feeding:

- 1. A ClearStar Pump Set is being used.
- 2. Cassette is properly seated in pump.
- 3. When on AC power, pump is fully seated in charger.
- 4. Flow rate is set at the prescribed ml/hr.
- 5. Pump dial is turned to RUN.

Note: The Power Supply Cord is the DISCONNECT DEVICE

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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| Prescription Use | <div style="text-align:center;">X</div> |
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| (Per 21 CFR 801.109) | |

| | <div><i>(Division Sign-Off)</i></div> |
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Division of Dental, Infection Control,
and General Hospital Devices

| 510(k) Number | K981541 |
|---------------|---------|
|---------------|---------|

| Over-The-Counter Use | |
|--------------------------|--|
| (Optional Format 1-2-96) | |