(29 days)
- The I-Flow Variable Rate 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, intraarterial, subcutaneous, intramuscular and epidural.
- The I-Flow Variable Rate Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative and postoperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.
The I-Flow Variable Rate Elastomeric Pump consists of an elastomeric pressure source with an integrated administration line. This special 510(k) proposes a labeling change to the existing device submitted under K020660 for the variable flow rate component.
The provided document K023883 is a 510(k) summary for a special 510(k) submission. This type of submission is typically used for modifications to a legally marketed device that do not raise new questions of safety and effectiveness.
In this specific case, the submission is for a labeling change to the existing I-Flow Variable Rate Elastomeric Pump (K020660) concerning its variable flow rate component. The document explicitly states: "The Variable Flow Rate Component is identical in design to the one recently cleared under K020660."
Therefore, this submission relies on the substantial equivalence to its predicate device (K020660 and K020251 for the variable flow rate component) rather than presenting new performance data from a dedicated study. As a result, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets them, as it is not a de novo submission or a new device evaluation requiring such extensive testing protocols.
Here's a breakdown of why this information is absent in this particular document:
- No new performance claims: The special 510(k) is for a labeling change and explicitly states the component is identical to a previously cleared one. This means no new performance is being claimed that would require new acceptance criteria or a new study.
- Reliance on predicate device: The basis for clearance is "substantial equivalence" to the existing I-Flow Elastomeric Pump and the variable flow rate component cleared under K020251. The performance characteristics were established and accepted during the clearance of those predicate devices.
Therefore, I cannot populate the table or answer the specific questions because the provided document does not contain a study demonstrating new device performance against new acceptance criteria.
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SPECIAL 510(K) - SUMMARY OF SAFETY AND EFFECTIVENESS
December 18, 2002
DEC 2 0 2002
DEC 2
| Submitter: | I-Flow Corporation20202 Windrow DriveLake Forest, CA 92630 |
|---|---|
| Contact: | Shane NoehreDirector, Regulatory AffairsI-Flow Corporation |
| Trade Name: | I-Flow Variable Rate Elastomeric Pump |
| Common Name: | Infusion Pump and Administration Set |
| Classification Name: | Pump, Infusion |
| Existing Device: | I-Flow Elastomeric Pump (K020660) |
| Device Description: | The I-Flow Variable Rate Elastomeric Pump consists of an elastomericpressure source with an integrated administration line. This special510(k) proposes a labeling change to the existing device submittedunder K020660 for the variable flow rate component. |
| Technology Comparison: | The Variable Flow Rate Component is identical in design to the onerecently cleared under K020660. |
Conclusion: The I-Flow Variable Rate Elastomeric Pump was cleared under K020660 on March 20, 2002. It was found to be substantially equivalent to the existing I-Flow Elastomeric Pump anc the variable flow rate component cleared under K020251.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
DEC 2 0 2002
200 Corporate Boulevari Rockville MD 20850
·Mr. Shane Noehre Director, Regulatory Affairs I-Flow Corporation 20202 Windrow Drive Lake Forest, California 92630
Re: K023883
Trade/Device Name: I-Flow Variable Rate Elastomeric Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: November 19, 2002 Received: November 21, 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 111 (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.
Image /page/1/Picture/10 description: The image shows a partial view of the Department of Health & Human Services seal. The seal features the department's name in a circular arrangement around a central emblem. The emblem appears to depict a stylized human figure or symbol, though the full details are not visible in this partial view.
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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 (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
Timothy A. Ulatowski
Timothy A. Jlatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/3/Picture/0 description: The image shows the logo for I-Flow Corporation. The logo consists of the text "I-FLOW" inside of a rounded rectangle. There is a small droplet above the "I" in the logo. Below the logo is the text "I-Flow Corporation".
20202 Windrow Drive or 949-206-2700
| Ver/ 3 - 4/24/96 | |
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| -- | ------------------ |
Applicant:
I-Flow Corporation
510(k) Number (if known):
Device Name:
I-Flow Variable Rate Elastomeric Pump
Indications For Use:
-
- The I-Flow Variable Rate 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, intraarterial, subcutaneous, intramuscular and epidural.
-
- The I-Flow Variable Rate Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative and postoperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.
(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)
Patricio Cucureste
(Optional Format 1-2-96)
(Division Sign-Off) (Division Sign-O'l')
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: __
§ 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).