(29 days)
Not Found
No
The summary describes a mechanical catheter set for delivering medication and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
Yes
The device is indicated for "delivery of medication for regional anesthesia and pain management," which is a therapeutic purpose.
No
Explanation: The device is described as an "Over-the-Needle Catheter Set ... indicated for delivery of medication for regional anesthesia and pain management." It is used for administering treatment, not for diagnosing a condition.
No
The device description explicitly lists multiple hardware components, including needles, catheters, extension sets, and dressings.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of medication for regional anesthesia and pain management. This involves administering substances into the body for therapeutic purposes.
- Device Description: The device is a catheter set designed for inserting into the body to deliver medication.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests on bodily samples.
The device is clearly intended for direct patient treatment through medication delivery, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The ON-Q* QuikBloc* Over-the Needle Catheter Set is indicated for delivery of medication for regional anesthesia and pain management. Route of administration may be intraoperative, percutaneous, or perineural. The ON-Q* QuikBloc* Over-the-Needle Catheter Set is contraindicated for the epidural space.
Product codes (comma separated list FDA assigned to the subject device)
BSO
Device Description
ON-Q* QuikBloc* Over-the-Needle (OTN) Catheter Sets are available in four product codes (20 GA x 4" Needle, 16 GA x 3" Catheter (with and without Stimulating needle); 20 GA x 6" Needle, 16 GA x 5" Catheter (with and without stimulating needle)). The kits include: 1) ON-Q* QuikBloc* Over-the-Needle Catheter Set (some models include an integrated stimulating cable) 2) Removable Needle Wing 3) Non-DEHP 24 inch Needle Extension Set, 4) Non-DEHP 6 inch Catheter Extension Set 5) Connector Securement Device 6) Occlusive Dressing 7) Adhesive Strips 8) Catheter ID label These devices are sold as disposable, sterile, single use, devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Components used in the ON-Q* Pain Relief System QuikBloc* Over-the-Needle Catheter Sets have been evaluated for biocompatibility by their corresponding vendors. Gamma or EO sterilized samples of the components as mentioned below were tested in vitro or in laboratory animals for the listed toxicological end-points in accordance with the respective sections in ISO 10993 guidelines and Good Laboratory Practices. The results from these studies revealed no adverse reaction to the test articles and no adverse effects. In addition, these components have 510(k) clearance in the US, which indicate that they have been cleared and have been deemed safe for their intended use.
Results of design verification and validation testing demonstrated that the ON-Q* QuikBloc* Over-the-Needle Catheter Set functions as designed and can be operated by the user as intended through the user interface and instructions provided.
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
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 2,2014
Kimberly-Clark Corporation Ms. Maria E. Wagner Senior Regulatory Affairs Specialist 43 Discovery, Suite 100 Irvine, CA 92618
Re: K143164
Trade/Device Name: On-O QuikBloc Over-the-Needle (OTN) Catheter Set Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: October 21, 2014 Received: November 3, 2014
Dear Ms. Wagner:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
Page 2 - Ms. Wagner
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
of Surveillance and Biometrics/Division of Postmarket Surveillance.
Sincerely yours,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below
510(k) Number (if known) K143164
Device Name: ON-Q* QuikBloc* Over-the-Needle Catheter Set
Indications for Use (Describe)
The ON-Q* QuikBloc* Over-the Needle Catheter Set is indicated for delivery of medication for regional anesthesia and pain management. Route of administration may be intraoperative, percutaneous, or perineural. The ON-Q* QuikBloc* Over-the-Needle Catheter Set is contraindicated for the epidural space.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Date of
Summary
| Prepared: | November 25, 2014 |
|---|---|
| Applicant: | Halyard - Irvine |
| 43 Discovery, Suite 100 | |
| Irvine, CA 92618 | |
| Official | |
| Correspondent: | Maria E. Wagner |
| Sr. Specialist, Regulatory Affairs | |
| Tel: 949.923-2324 | |
| Fax: 949.923-2401 | |
| email: maria.wagner@hyh.com | |
| Trade Name: | ON-Q* QuikBloc* Over-the-Needle (OTN) Catheter Set |
| Classification | |
| Name: | Anesthesia Conduction Catheter |
| Device | |
| Classification | |
| and Product | |
| Code: | Class II per 21 CFR §868.5120 |
| Product Code - BSO | |
| Existing/Predicate | |
| Devices: | Halyard Health currently markets the I-Flow Catheter and consists of |
| three design options which can utilize infusion segments ranging | |
| from epidural to 10 inches K043456). |
The EchoBright* Echogenic PNB Needle is a peripheral nerve block
insulated needle with graduated centimeter markings to determine
the depth of the needle advancement into tissue. The needle
incorporates a series of patterns designed to optimally scatter the
deflection of ultrasound waves for the needle such that a high
percentage reach the ultrasound probe for improved visualization of
the needle position in tissue (K111355). |
| Description: | of this special submission is substantially equivalent to the I-Flow
Catheter cleared in K043456 and Needle K111355. |
| | ON-Q* QuikBloc* Over-the-Needle (OTN) Catheter Sets are available
in four product codes (20 GA x 4" Needle, 16 GA x 3" Catheter (with
and without Stimulating needle); 20 GA x 6" Needle, 16 GA x 5"
Catheter (with and without stimulating needle)). The kits include:
- ON-Q* QuikBloc* Over-the-Needle Catheter Set (some models
include an integrated stimulating cable) - Removable Needle Wing
- Non-DEHP 24 inch Needle Extension Set,
- Non-DEHP 6 inch Catheter Extension Set
- Connector Securement Device
- Occlusive Dressing
- Adhesive Strips
- Catheter ID label
These devices are sold as disposable, sterile, single use, devices. |
| Target Market: | Regional analgesia and anesthesia |
| Primary
Application: | Peripheral Nerve Block procedures. |
| Intended Use: | ON-Q* Pain Relief System QuikBloc* Over-the-Needle Catheter
Set is indicated for delivery of medication for regional anesthesia
and pain management. Route of administration may be
intraoperative, percutaneous or perineural. |
| Technological
Characteristics: | Both the modified ON-Q* Pain Relief System QuikBloc* Over-the-
Needle Catheter Set and the predicate I-Flow Catheter (K043456)
have the same basic fundamental technological characteristics.
Both catheters deliver medication. Routes of administration may
be intraoperative, percutaneous, or perineural. The only
difference in the ON-Q* Pain
Relief System QuikBloc* Over-the-Needle Catheter Set is that it is
open ended to fit a needle through the catheter. |
| Performance
Data: | Components used in the ON-Q* Pain Relief System QuikBloc*
Over-the-Needle Catheter Sets have been evaluated for
biocompatibility by their corresponding vendors. Gamma or EO
sterilized samples of the components as mentioned below were
tested in vitro or in laboratory animals for the listed toxicological
end-points in accordance with the respective sections in ISO
10993 guidelines and Good Laboratory Practices. The results
from these studies revealed no adverse reaction to the test
articles and no adverse effects. In addition, these components
have 510(k) clearance in the US, which indicate that they have
been cleared and have been deemed safe for their intended use. |
Device
The ON-Q* QuikBloc* Over-the-Needle (OTN) Catheter Set, subject
4
Results of design verification and validation testing demonstrated
5
that the ON-Q* QuikBloc* Over-the-Needle Catheter Set functions as designed and can be operated by the user as intended through the user interface and instructions provided.
The ON-Q* Pain Relief System QuikBloc* Over-the-Needle Conclusion: Catheter Set is as safe and effective and performs as well as the predicate devices.