(22 days)
- With I-Flow Corporation's PainBuster, ON-Q and Nerve Block pain management kits; and 1.
- As a stand alone device to provide continuous or intermittent delivery of local anesthetics 2. or narcotics to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative, percutaneous or perineural.
The Soaker Catheter has a closed end tip with multiple holes arranged radially along the lateral surface along the infusion segment at the distal end of the device. A membrane in the inner diameter of the catheter promotes even distribution along the infusion segment. This special 510(k) proposes a slight design change that has the membrane along the outside diameter of the catheter instead of the inside diameter.
The provided text is a Special 510(k) for a "Soaker Catheter" from I-Flow Corporation (K022869). This document describes a design change to an existing device, specifically moving a membrane from the inside to the outside diameter of the catheter.
Based on the nature of this submission (a Special 510(k) for a minor design change to an already cleared device), the typical detailed clinical studies and performance evaluations against specific acceptance criteria, as might be seen for a novel device or a device making substantial performance claims, are not present in this document.
Instead, the submission relies on demonstrating substantial equivalence to the predicate device (the earlier Soaker Catheter, K991543 and K994374). The justification for this substantial equivalence is that the "new Soaker Catheter utilizes the exact same technology for promoting even distribution along the infusion segment." This implies that the performance characteristics, and thus the "acceptance criteria," are inherently met by virtue of the device being functionally identical to the previously cleared version.
Therefore, many of the requested elements for a detailed study proving device meets acceptance criteria are not applicable (N/A) in this specific 510(k) summary.
Here's the breakdown of the information as requested, with explanations for why certain elements are N/A:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Maintain "even distribution along the infusion segment" (same as predicate device) | Utilizes "exact same technology for promoting even distribution along the infusion segment," therefore performance is considered equivalent to predicate |
| Biocompatibility (same materials as predicate) | Assumed to be the same and met as the predicate device (no mention of material change) |
| Sterility (same as predicate) | Assumed to be the same and met as the predicate device |
| Functional integrity (no adverse effects from design change) | Design change (membrane position) does not alter fundamental functional mechanism |
Explanation: This 510(k) is for a minor design modification where the manufacturer asserts that the fundamental technology and performance are unchanged. Therefore, explicit, quantitative acceptance criteria and a study dedicated to proving these new criteria are not typically provided in such a submission. The "acceptance" is that the device performs equivalently to its predicate, which has already been deemed safe and effective.
2. Sample size used for the test set and the data provenance
N/A. No specific test set or clinical data is presented for this Special 510(k) based on the provided text. The submission focuses on the engineering change and its lack of impact on existing performance characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. No ground truth establishment by experts is described in this document.
4. Adjudication method for the test set
N/A. No test set or adjudication method is described in this document.
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
N/A. This is a medical device (catheter), not an AI-powered diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A. This is a medical device (catheter), not an algorithm. Standalone performance studies in this context are not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
N/A. No ground truth is specified or needed for this type of device modification under a Special 510(k) that claims substantial equivalence based on an identical functional principle.
8. The sample size for the training set
N/A. As this is a physical medical device and not a machine learning model, the concept of a "training set" is not applicable.
9. How the ground truth for the training set was established
N/A. Not applicable, as there is no training set for a physical medical device.
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Special 510(k)
Soaker Catheter
K022869
SEP 2 0 2002
SPECIAL 510(K) - SUMMARY OF SAFETY AND EFFECTIVENESS
August 23, 2002
| Submitter: | I-Flow Corporation20202 Windrow DriveLake Forest, CA 92630 |
|---|---|
| Contact: | Shane NoehreDirector, Regulatory AffairsI-Flow Corporation |
| Trade Name: | Soaker Catheter |
| Common Name: | Anesthetic Catheter |
| Classification Name: | Anesthesia Conduction Catheter |
| Existing Device: | Soaker Catheter (K991543 and K994374) |
| Device Description: | The Soaker Catheter has a closed end tip with multiple holes arrangedradially along the lateral surface along the infusion segment at thedistal end of the device. A membrane in the inner diameter of thecatheter promotes even distribution along the infusion segment. Thisspecial 510(k) proposes a slight design change that has the membranealong the outside diameter of the catheter instead of the insidediameter. |
| TechnologyComparison: | The new Soaker Catheter utilizes the exact same technology forpromoting even distribution along the infusion segment. |
| Conclusion: | The Soaker Catheter is substantially equivalent to the existing SoakerCatheter. |
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. The central image is a stylized depiction of an eagle with three heads, suggesting a focus on people and services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 0 2002
Ms. Shane Noehre Director, Regulatory Affairs I-Flow Corporation 20202 Windrow Drive Lake Forest, California 92630
Re: K022869 Trade/Device Name: Soaker Catheter Regulation Number: 880.5725 Regulation Name: Accessories, Infusion Pump Regulatory Class: II Product Code: MRZ and FRN Dated: August 23, 2002 Received: August 29, 2002
Dear Ms. 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 - Ms. 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
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
I-Flow Corporation Applicant:
510(k) Number (if known): _ KO22869
Device Name: Soaker Catheter
Indications For Use:
- With I-Flow Corporation's PainBuster, ON-Q and Nerve Block pain management kits; and 1.
- As a stand alone device to provide continuous or intermittent delivery of local anesthetics 2. or narcotics to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative, percutaneous or perineural.
(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)
Patticia Cucurullo
510(k) Number: K022867
§ 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).