DOSI-FUSER

K040752 · Leventon, S.A. · MEB · Apr 7, 2004 · General Hospital

Device Facts

• Record ID: K040752
• Device Name: DOSI-FUSER
• Applicant: Leventon, S.A.
• Product Code: MEB · General Hospital
• Decision Date: Apr 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The DOSI-FUSER is designed to provide parenteral drug infusions at a constant flow without impeding patient mobility. It is indicated for patients requiring slow infusion of medication, which may be administered intravenously or via intra-arterial, epidural or subcutaneous routes. The device allows patients to be mobile, thus making it suitable for ambulatory use.

Device Story

DOSI-FUSER is a sterile, disposable, elastomeric infusion pump; provides continuous, portable parenteral drug delivery. Operation relies on mechanical compression of an elastomeric balloon reservoir; fluid flows through an integrated filter (removing air/particles) to a capillary tube that regulates flow rate. Device connects to patient via cannula or needle. Used in ambulatory settings to maintain patient mobility during medication administration. Not intended for blood or blood product delivery. Healthcare providers select the device based on required flow rate; patient carries device during infusion. Benefits include constant flow delivery without tethering patient to stationary equipment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Elastomeric infusion pump; sterile, disposable. Components include elastomeric balloon reservoir, integrated fluid filter, and capillary flow regulator. Operates via passive mechanical pressure (no external energy source).

Indications for Use

Indicated for patients requiring slow, continuous parenteral infusion of medication via intravenous, intra-arterial, epidural, or subcutaneous routes. Suitable for ambulatory use. Not indicated for delivery of blood or blood products.

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 2 ml./h

Submission Summary (Full Text)

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K040752

17

## APR - 7 2004 510 (k) Summary of Safety and Effectiveness for
Flaster - The Flastemarie Infusion Rumm POCLELIOEE Elastomeric Infusion Pump DOSI-FUSER

| 1. Submitter's name: | LEVENTON S.A. |
|----------------------|------------------------------------------------------------------------|
| Address: | Poligono Can Sunyer 11 08740 Sant Andreu de la Barca Barcelona (Spain) |
| Phone number: | [phone] |
| Fax number: | [phone] |
| Contact person: | Mr. Joaquim Soriano (General Manager) |
| Date: | 28.09.01 |

| 2. Trade name: | DOSI-FUSER |
|----------------------|-------------------------------------|
| Common name: | Elastomeric pump |
| Classification name: | Infusion pump (per 21 CFR 880.5725) |

| 3. Legally marketed device: | SINGLEDAY INFUSOR 2 ml./h |
|-----------------------------|---------------------------|
|-----------------------------|---------------------------|

| 4. Description: | DOSI-FUSER is an Elastomeric Infusion Pump. It is a sterile and disposable infusion device, that operates by the action of compression of the elastomeric balloon that contains the liquid to instill. The liquid is supplied at a constant flow rate. |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 5. Intended use: | The DOSI-FUSER is designed to provide parenteral drug infusions at a constant flow without impeding patient mobility. It is indicated for patients requiring slow infusion of medication, which may be administered intravenously or via intra-arterial, epidural or subcutaneous routes. The device allows patients to be mobile, thus making it suitable for ambulatory use. |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

SK

27

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- 2. DOSI-FUSER is a system for continuous and portable infusion of medication with a self-pressured container. It is a sterile and disposable device.
The DOSI-FUSER is designed to provide parenteral drug infusions at a constant flow without impeding patient mobility. It is indicated for patients requiring slow infusion of medication, which may be administered intravenously or via intra-arterial, epidural or subcutaneous routes. The device allows patients to be mobile, thus making it suitable for ambulatory use.

- The fluid contained in the balloon passes to the tube connected to a. the reservoir, goes through the filter (where particles in the fluid are retained and air bubbles are removed) and reaches the capillary. which fixes the flow rate that the patient will receive. The connector at the extreme of the tube must obviously be connected to a cannula. needle, etc. that contacts the blood vessel.
- DOSI-FUSER is applicable to be used with a wide range of drugs, b. not for a specific drug.
- As stated before, DOSI-FUSER is not intended for a specific use. C.
- ರ. This product is not intended in any case for the delivery of blood and blood products.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three wavy lines representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 7 2004

Leventon, S.A. C/O Ms. Stefan Preiss Responsible Third Party Official TUV America, Incorporated 1775 Old Highway 8 New Brighton, Minnesota 55112-1891

Re: K040752

Trade/Device Name: DOSI-FUSER Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: March 9, 2004 Received: March 24, 2004

Dear Ms. Preiss:

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. Preiss

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 (301) 594-56. 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,

M

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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Center For Devices and Radiological

U.S. Food and Drug Administrati

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## Indications for Use

510(k) Number (if known): (xx17752

Device Name: DOSI-FUSER

Indications for Use:

The DOSI-FUSER is designed to provide parenteral drug infusions at a constant flow without impeding patient mobility. It is indicated for patients requiring slow infusion of medication, which may be administered intravenously or via intraarterial, epidural or subcutaneous routes. The device allows patients to be mobile, thus making it suitable for ambulatory use.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aim bms

(Posted November 13, 2003)

(Division Sian-Off) Division of Anesthesiole Infection Control, Dental De

Back to the Indications for Use Page

510(k) Number ..

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