(22 days)
Not Found
No
The summary describes a mechanical catheter with a design change related to a membrane. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
Yes
The device is described as providing "continuous or intermittent delivery of local anesthetics or narcotics to surgical wound sites and/or close proximity to nerves outside of the epidural space" for pain management, which is a therapeutic function.
No
Explanation: The device, Soaker Catheter, is described as delivering local anesthetics or narcotics, indicating a therapeutic rather than diagnostic function.
No
The device description clearly describes a physical catheter with a closed end tip, multiple holes, and a membrane, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the delivery of local anesthetics or narcotics to surgical wound sites and nerves. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a catheter designed for infusion, which is consistent with drug delivery, not diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver medication directly to a specific site in the body.
N/A
Intended Use / Indications for Use
- With I-Flow Corporation's PainBuster, ON-Q and Nerve Block pain management kits; and
- As a stand alone device to provide continuous or intermittent delivery of local anesthetics 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.
Product codes (comma separated list FDA assigned to the subject device)
MRZ, FRN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical wound sites and/or close proximity to nerves outside of the epidural space
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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)
Soaker Catheter
K022869
SEP 2 0 2002
SPECIAL 510(K) - SUMMARY OF SAFETY AND EFFECTIVENESS
August 23, 2002
| Submitter: | I-Flow Corporation
20202 Windrow Drive
Lake Forest, CA 92630 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Shane Noehre
Director, Regulatory Affairs
I-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 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. |
| Technology
Comparison: | The new Soaker Catheter utilizes the exact same technology for
promoting even distribution along the infusion segment. |
| Conclusion: | The Soaker Catheter is substantially equivalent to the existing Soaker
Catheter. |
1
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.
2
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
3
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