(36 days)
Not Found
No
The device description and intended use focus on a mechanical pump for fluid delivery, with no mention of AI/ML capabilities or data processing.
Yes
The device is intended for the infusion of medications for pain management and regional anesthesia, and claims to significantly decrease narcotic use and pain, which are therapeutic actions.
No
Explanation: The I-Flow Elastomeric Pump is intended for the infusion of medications and local anesthetics, not for diagnosing conditions. Its purpose is therapeutic (delivery of substances) rather than diagnostic (identification of diseases or conditions).
No
The device description clearly states it is an "Elastomeric Pump" which is a physical hardware device, not software.
Based on the provided information, the I-Flow Elastomeric Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- I-Flow Elastomeric Pump Function: The I-Flow Elastomeric Pump is described as a device for infusing medications directly into the body through various routes (intravenous, subcutaneous, etc.) or to surgical wound sites and nerves. It is a drug delivery system.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its function is to deliver substances into the body, not to analyze substances from the body.
Therefore, the I-Flow Elastomeric Pump falls under the category of a therapeutic or drug delivery device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The I-Flow Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural.
The 1-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia. Administration may be intraoperative, perineural or percutaneous.
The I-Flow Elastomeric Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.
Product codes
MEB
Device Description
The I-Flow Elastomeric Pump consists of an elastomeric pressure source with an integrated administration line. The current device has an optional Y-adapter that splits the administration line into two delivery sites. This special 510(k) proposes a multi-Y adapter that can provide 3 or more integrated administration lines for multi-site delivery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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
SPECIAL 510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS
August 3, 2005
Submitter:
I-Flow Corporation 20202 Windrow Drive Lake Forest, CA 92630
Contact:
Shane Noehre Director, Regulatory Affairs I-Flow Corporation
Trade Name: I-Flow Elastomeric Pump
Infusion Pump and Administration Set Common Name:
Classification Name: Pump, Infusion
Existing Device: I-Flow Elastomeric Pump (K040337)
Device Description: The I-Flow Elastomeric Pump consists of an elastomeric pressure source with an integrated administration line. The current device has an optional Y-adapter that splits the administration line into two delivery sites. This special 510(k) proposes a multi-Y adapter that can provide 3 or more integrated administration lines for multi-site delivery.
| Technology
Comparison: | The multi-Y adapter utilizes the same technology for
splitting the administration line as the existing
unmodified design. |
| --------------------------- | --------------------------------------------------------------------------------------------------------------------------------- |
|---|
Conclusion: The new I-Flow Elastomeric Pump with a multi-Y adaptor model is simply an extension of the existing I-Flow Elastomeric Pump product line.
I-Flow Corporation believes that the new I-Flow Elastomeric Pump with a mulit-Y adaptor model is substantially equivalent to the existing (unmodified) I-Flow Elastomeric Pump and no new issues of safety or effectiveness arise from this design change.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three wings and two legs, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circle around the eagle.
SEP - 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Shane Noehre Director, Regulatory Affairs I-Flow Corporation 20202 Windrow Drive Lake Forest, California 92630
Re: K052117
Trade/Device Name: I-Flow Elastomeric Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: August 3, 2005 Received: August 11, 2005
Dear Mr. Noehre:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave roviewed your become mined 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to devroos that have o Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvin uppheansed (the Act. The general controls provisions of the Act include controls providents of the ristration, 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 (1 Mr), it may of subject to Bach adam Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements concerning your device in the Federal Register.
2
Page 2 - Mr. Noehre
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours.
Clus
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
3
Indications for Use
510(k) Number (if known): K(152117
Device Name:
I-Flow Elastomeric Pump
Indications For Use:
-
- The I-Flow Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural.
-
- The 1-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of r no i row Esucturesthetics or narcotics) to surgical wound sites and/or close modiation (so nerves for preoperative, perioperative and postoperative regional anesthesia proxinity to norvos for processf administration may be intraoperative, perineural or percutaneous.
-
- The I-Flow Elastomeric Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.
Prescription Use _ × (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula M. Minsky, MD for A. Wilson, GA DB 9/8/05
Division of Anesthesiology, General Hospit Infection Control, Dental Device
510(k) Number: Ka52117