(85 days)
Not Found
No
The 510(k) summary describes a simple infusion catheter and makes no mention of AI or ML technology.
Yes
The device is intended for the infusion of pain medication, which is a therapeutic intervention for pain management.
No
The device is described as an infusion catheter for delivering pain medication, not for diagnosing conditions.
No
The device description clearly states it is a "flexible, tubular infusion catheter" with physical components like holes, a fenestrated segment, and a luerlock connector, indicating it is a hardware device.
Based on the provided information, the McKinley Saturation Catheter™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the continuous and/or intermittent infusion of pain medication to surgical wound sites and/or close proximity to nerves. This is a therapeutic application, delivering a substance to the body for treatment.
- Device Description: The device is described as an infusion catheter used to deliver pain medication. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnostic purposes.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. The McKinley Saturation Catheter™ is used in vivo (inside the body) to deliver medication.
N/A
Intended Use / Indications for Use
The McKinley Saturation Catheter™ is intended for continuous and/or intermittent infusion of pain medication to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative, subcutaneous or percutaneous.
Product codes
BSO, FRN
Device Description
The McKinley Saturation Catheter™ is a single patient use disposable infusion catheter, intended for connection to an infusion device, used to deliver pain medication to a patient for pain management.
The McKinley Saturation Catheter™ is a flexible, tubular infusion catheter with multiple holes located throughout the fenestrated segment along the distal end of the catheter. The catheter will be available in different sizes (varying length of fenestrated segment, number of holes, diameter of catheter body), as appropriate for use in a variety of catheter placements.
The McKinley Saturation Catheter™ connects to an infusion device via a proximal luerlock connector.
The materials contained in the McKinley Saturation Catheter™ are substantially equivalent to those contained in the legally-marketed predicate devices.
The catheter package may include components that are legally marketed (either preamendment or that have been granted permission to market via the premarket notification regulation), such as an introducer needle, syringe, adhesive strips or dressing.
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)
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
Image /page/0/Picture/0 description: The image shows the logo for McKinley Medical. The logo consists of a stylized mountain range above the company name. The mountain range is black, and the company name is in a serif font.
McKinley Medical, LLC 4080 Youngfield Street Wheat Ridge, CO 80033 USA 303.420.9569 303.420.4545 Fax
K 060119
510(k) Summary of Safety and Effectiveness - Traditional 510(k) for the McKinley Saturation Catheter™
APR 1 2 2006
Date Prepared: 6 January 2006 Contact for Questions: John Chappell McKinley Saturation Catheter™ Trade Name: Common Name: Infusion catheter Classification Name: Anesthesia conduction catheter Classification Panel: Anesthesiology Device Classification Class II. 868.5120 Regulation Number: Panel: 73 Product Code: BSO Micor Wundcath Conduction Catheter, K031600 & Predicate Devices Demonstrating Substantial K003966 Equivalence: I-Flow Soaker Catheter, K994374
Statement of Substantial Equivalence:
The McKinley Saturation Catheter™ is substantially equivalent to the Micor Wundcath Conduction Catheter (K031600 & K003966) and the I-Flow Soaker Catheter (K994374).
The McKinley Saturation Catheter 114 is intended for use as follows;
The McKinley Saturation Catheter™ is intended for continuous and/or intermittent infusion of pain medication to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative, subcutaneous or percutaneous.
Summary Description of the McKinley Saturation Catheter™
The McKinley Saturation Catheter™ is a single patient use disposable infusion catheter, intended for connection to an infusion device, used to deliver pain medication to a patient for pain management.
The McKinley Saturation Catheter™ is a flexible, tubular infusion catheter with multiple holes located throughout the fenestrated segment along the distal end of the catheter. The catheter will be available in different sizes (varying length of fenestrated segment, number of holes, diameter of catheter body), as appropriate for use in a variety of catheter placements.
1
The McKinley Saturation Catheter™ connects to an infusion device via a proximal luerlock connector.
The materials contained in the McKinley Saturation Catheter™ are substantially equivalent to those contained in the legally-marketed predicate devices.
The catheter package may include components that are legally marketed (either preamendment or that have been granted permission to market via the premarket notification regulation), such as an introducer needle, syringe, adhesive strips or dressing.
Conclusion:
The McKinley Saturation Catheter™ does not raise any new safety and efficacy concerns when compared to the predicate devices that are already legally marketed. The intended use, function, materials and performance of the McKinley Saturation Catheter 110 are substantially equivalent to the named predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 2006
Mr. John Chappell Regulatory Affairs McKinley Medical, LLC 4080 Youngfield Street Wheat Ridge, Colorado 80033
Re: K060119
Trade/Device Name: McKinley Saturation CatheterTM Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: January 11, 2006 Received: January 17, 2006
Dear Mr. Chappell:
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 cither 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 vour device in the Federa! Register.
3
Page 2 - Mr. Chappell
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 vours.
Serette Y. Michau Davis
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
4
Indications for Use Statement
510(k) Number (if known):
Device Name:
McKinley Saturation Catheter™
Indications for Use:
The McKinley Saturation Catheter™ is intended for continuous and/or intermittent infusion of pain medication to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative, subcutaneous or percutaneous.
Prescription Use I (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Unty O.m.t
ology, General Hospit
logy, General Hospi
... Con... Central Services
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