(25 days)
Not Found
Not Found
No
The device description explicitly states "There are no new materials or technology associated with the modification" and the modification is purely mechanical (adding a "Y" fitting). There is no mention of AI, ML, or any related concepts in the summary.
Yes
The device is used for the continuous infusion of medications for pain management, which is a therapeutic function.
No
The device is described as an "Infusor" for the "slow, continuous infusion of medications" for pain management, which indicates it is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is a modification of an elastomeric infusion device, which is a hardware-based medical device. The modification involves adding physical components (a "Y" fitting and additional tubing).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "slow, continuous infusion of medications directly into an intraoperative site or subcutaneously for postoperative pain management." This describes a device used for delivering substances into the body for therapeutic purposes.
- Device Description: The description details an elastomeric pump used for infusion, a type of device used for drug delivery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of the Dual Port Infusor does not involve any testing of samples or diagnostic procedures.
Therefore, the Dual Port Infusor is a therapeutic device for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Dual Port Infusor is indicated for the slow, continuous infusion of medications directly into an intraoperative site or subcutaneously for postoperative pain management.
The Dual Port Infusor line of elastomeric pumps is indicated for the slow, continuous infusion of medications directly into an intraoperative site or subcutaneously for postoperative pain management.
Product codes
MEB
Device Description
The dual port line of Infusors are a modification of Baxter's currently marketed Infusor line of elastomeric infusion devices. The modification consists of adding a "Y" fitting and an additional section of administration set tubing resulting in a bifurcated tubing. There are no new materials or technology associated with the modification. In all other respects, the dual port Infusors are identical to Baxter's current Infusor SV and LV elastomeric pumps. Furthermore, the range of flow rates through each single port as well as through both ports combined, is within the current range of flow rates available in the single port Infusor devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoperative site or subcutaneously
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
K02/274
MAY 1 7 2002
ATTACHMENT 6
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:
April 19, 2002
Proposed Device(s):
Baxter Dual Port Infusor
Baxter Pain Mate™ Pain Management System (Convenience Kits containing the Baxter Dual Port Infusor)
Comparison Device(s):
Infusor SV and LV Elastomeric Infusion Device
Description of Device(s):
The dual port line of Infusors are a modification of Baxter's currently marketed Infusor line of elastomeric infusion devices. The modification consists of adding a "Y" fitting and an additional section of administration set tubing resulting in a bifurcated tubing. This allows solution flow through two ports. There are no new materials or technology associated with the modification. In all other respects, the dual port Infusors are identical to Baxter's current Infusor SV and LV elastomeric pumps. Furthermore, the range of flow rates through each single port as well as through both ports combined, is within the current range of flow rates available in the single port Infusor devices.
Indications for Use:
The Dual Port Infusor is indicated for the slow, continuous infusion of medications directly into an intraoperative site or subcutaneously for postoperative pain management.
Technological Characteristics:
The technological characteristics of the Dual Port Infusor are identical to those of the Infusor SV and Infusor LV devices. The Dual Port Infusor incorporates a bifurcated tubing to allow for solution flow through two ports.
1
510(k) Premarket Notification Dual Port Infusor
A contraindication has been added to the labeling of the Pain-Mate Pain Management Systems with dual port Infusors. The Dual Port Infusor devices are contraindicated for intravenous, intra-arterial, and epidural use.
6 May 14, 2002
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with stylized wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 7 2002
Ms. Vicki L. Drews Manager, Regulatory Affairs Baxter Healthcare Corporation I. V. Systems Division Route 120 and Wilson Road Round Lake, Illinois 60073-0490
Re: K021274
Trade/Device Name: Baxter Dual Port Infusor Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: Unclassified Product Code: MEB Dated: April 19, 2002 Received: April 22, 2002
Dear Ms. Drews:
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. Drews
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Susan Runnor
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Premarket Notification Dual Port Infusor
ATTACHMENT 8
INDICATIONS FOR USE
The Dual Port Infusor line of elastomeric pumps is indicated for the slow, continuous infusion of medications directly into an intraoperative site or subcutaneously for postoperative pain management.
Patricia Cucenite
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number __ 4 02/2
BAXTER CONFIDENTIAL
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7 May 14, 2002