(14 days)
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.
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.
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 fluid contained in the balloon passes to the tube connected to 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.
The provided text is a 510(k) summary for the DOSI-FUSER, an elastomeric infusion pump. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes for test/training sets, expert qualifications, or adjudication methods.
Therefore, I cannot populate the requested table and answer the detailed questions based on the provided input.
The document primarily focuses on establishing substantial equivalence to a legally marketed predicate device (SINGLEDAY INFUSOR 2 ml./h) for market clearance, rather than presenting a performance study with detailed acceptance criteria and supporting data.
Here's what can be gathered from the provided text, and what cannot:
- 1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The document is a 510(k) summary for regulatory clearance, not a detailed performance study report.
- 2. Sample sized used for the test set and the data provenance: This information is not present.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This information is not present.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not present.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This information is not present. The device is an elastomeric infusion pump, not an AI-assisted diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present. The device is an elastomeric infusion pump, not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not present.
- 8. The sample size for the training set: This information is not present.
- 9. How the ground truth for the training set was established: This information is not present.
In summary, the provided document is a regulatory submission for device clearance and does not contain the detailed performance study data requested.
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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: | +34 93 653 20 11 |
| Fax number: | +34 93 653 25 56 |
| 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
{1}------------------------------------------------
-
- 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.
- 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 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.
{3}------------------------------------------------
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 (800) 638-2041 or (301) 443-6597 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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Center for Devices and Radiological Health / CDRH
§ 880.5725 Infusion pump.
(a)
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.(b)
Classification. Class II (performance standards).