(14 days)
-
- The I-Flow Elastomeric Pump with Bolus 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, subcutaneous, intramuscular and epidural.
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- The I-Flow Elastomeric Pump with Bolus is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/c close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.
This special 510(k) proposes a new optional component for the I-Flow Elastomeric Pump that incorporates a bolus component. The bolus component offers the additional ability to deliver fixed bolus volumes of medication at fixed time intervals instead of just a continuous infusion rate.
The provided text is a 510(k) summary for the I-Flow Elastomeric Pump with Bolus. This document does not contain the detailed acceptance criteria and study information typically found in a clinical trial report or a comprehensive device validation study.
Instead, this 510(k) summary focuses on demonstrating substantial equivalence to an existing legally marketed device (the I-Flow Elastomeric Pump without the bolus component). The key argument is that the new bolus component "utilizes the same technology for dispensing medication as the existing unmodified design," implying that the safety and effectiveness are comparable and, therefore, extensive new performance studies (as outlined in your request) are not required for this type of submission.
Therefore, I cannot provide the information requested in your numbered list directly from the provided text because it's not present. The document explicitly states:
- "Conclusion: The I-Flow Elastomeric Pump with Bolus is substantially equivalent to the existing I-Flow Elastomeric Pump."
- "Technology Comparison: The new Bolus Component utilizes the same technology for dispensing medication as the existing unmodified design."
This type of submission relies on the predicate device's established performance rather than new, extensive studies for the modified device, particularly since the modification is described as an "optional component" that adds a specific function (bolus delivery) but uses the same fundamental technology.
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K0233/8
SPECIAL 510(K) - SUMMARY OF SAFETY AND EFFECTIVENESS
October 3, 2002
OCT 1 8 2002
I-Flow Corporation Submitter: 20202 Windrow Drive Lake Forest, CA 92630
Shane Noehre Contact: Director, Regulatory Affairs I-Flow Corporation
ON-Q. PainBuster, C-bloc, Eclipse, C-Series, Easypump, Homepump Trade Names :
Classification Name: Pump, Infusion, Elastomeric
I-Flow Elastomeric Pump (K020862) Existing Device:
This special 510(k) proposes a new optional component for the I-Flow Device Description: Elastomeric Pump that incorporates a bolus component. The bolus component offers the additional ability to deliver fixed bolus volumes of medication at fixed time intervals instead of just a continuous infusion rate.
Technology Comparison:
The new Bolus Component utilizes the same technology for dispensing medication as the existing unmodified design.
Conclusion: The I-Flow Elastomeric Pump with Bolus is substantially equivalent to the existing I-Flow Elastomeric Pump.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The eagle is positioned to the right of the department's name, which is written in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2002
Mr. Shane Noehre Director, Regulatory Affairs I-Flow Corporation 20202 Windrow Drive Lake Forest, California 92630
Re: K023318
Trade/Device Name: I-Flow Elastomeric Pump with Bolus Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: October 3, 2002 Received: October 4, 2002
Dear Mr. Noehre:
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.
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.
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Page 2 – Mr. Noehre
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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
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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Ver/ 3 - 4/24/96
Applicant:
I-Flow Corporation
510(k) Number (if known):
Device Name:
I-Flow Elastomeric Pump with Bolus
Indications For Use:
-
- The I-Flow Elastomeric Pump with Bolus 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, subcutaneous, intramuscular and epidural.
-
- The I-Flow Elastomeric Pump with Bolus is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/c close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.
Division Sign Off
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control. Dental De 510(k) Number.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 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).