(29 days)
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.
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.
Here's an analysis of the provided text regarding acceptance criteria and device performance:
Based on the provided text, the document describes a 510(k) premarket notification for a medical device, the ON-Q* QuikBloc* Over-the-Needle (OTN) Catheter Set. It asserts substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving quantitative performance against those criteria as would be expected for a novel device or a device demonstrating new clinical claims.
Therefore, much of the requested information for acceptance criteria and a detailed study is not present in this document.
However, I can extract the information that is implicitly or explicitly stated:
1. A table of acceptance criteria and the reported device performance
No explicit quantitative acceptance criteria or detailed performance metrics are provided in this document. The submission is based on substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Biocompatibility (ISO 10993 guidelines) | No adverse reaction to test articles, no adverse effects. Components have existing 510(k) clearance and deemed safe for intended use. |
| Functionality (Operates as intended) | Functions as designed and can be operated by the user as intended through the user interface and instructions provided. |
| Safety & Effectiveness comparable to predicate devices | "The ON-Q* Pain Relief System QuikBloc* Over-the-Needle Catheter Set is as safe and effective and performs as well as the predicate devices." (Conclusion) |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "evaluated for biocompatibility by their corresponding vendors" and "Gamma or EO sterilized samples of the components...were tested". This suggests component-level testing rather than a specific clinical test set for the integrated device.
- Data Provenance: The document states "tested in vitro or in laboratory animals". It doesn't specify country of origin or whether it was retrospective or prospective, but animal and in vitro testing are typically prospective lab studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/specified. This document describes a 510(k) submission based on substantial equivalence and non-clinical testing (biocompatibility, functionality). There is no mention of a human-reader study or ground truth established by experts for performance evaluation.
4. Adjudication method for the test set
Not applicable/specified. There is no mention of human-reader studies or a need for adjudication.
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
Not applicable. This device is a catheter set, 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
Not applicable. This device is a physical medical device, not an algorithm or software.
7. The type of ground truth used
For biocompatibility, the "ground truth" would be established by the standardized methods and endpoints defined in ISO 10993 guidelines (e.g., absence of cytotoxicity, irritation, sensitization). For functionality, the "ground truth" would be the successful operation of the device according to its design specifications and user instructions. There is no mention of pathology, expert consensus, or outcomes data in a clinical sense for performance claims in this document.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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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.
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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
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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)
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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:
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This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Date ofSummaryPrepared: | November 25, 2014 |
|---|---|
| Applicant: | Halyard - Irvine43 Discovery, Suite 100Irvine, CA 92618 |
| OfficialCorrespondent: | Maria E. WagnerSr. Specialist, Regulatory AffairsTel: 949.923-2324Fax: 949.923-2401email: maria.wagner@hyh.com |
| Trade Name: | ON-Q* QuikBloc* Over-the-Needle (OTN) Catheter Set |
| ClassificationName: | Anesthesia Conduction Catheter |
| DeviceClassificationand ProductCode: | Class II per 21 CFR §868.5120Product Code - BSO |
| Existing/PredicateDevices: | Halyard Health currently markets the I-Flow Catheter and consists ofthree design options which can utilize infusion segments rangingfrom epidural to 10 inches K043456).The EchoBright* Echogenic PNB Needle is a peripheral nerve blockinsulated needle with graduated centimeter markings to determinethe depth of the needle advancement into tissue. The needleincorporates a series of patterns designed to optimally scatter thedeflection of ultrasound waves for the needle such that a highpercentage reach the ultrasound probe for improved visualization ofthe needle position in tissue (K111355). |
| Description: | of this special submission is substantially equivalent to the I-FlowCatheter cleared in K043456 and Needle K111355. |
| ON-Q* QuikBloc* Over-the-Needle (OTN) Catheter Sets are availablein four product codes (20 GA x 4" Needle, 16 GA x 3" Catheter (withand 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 modelsinclude an integrated stimulating cable)2) Removable Needle Wing3) Non-DEHP 24 inch Needle Extension Set,4) Non-DEHP 6 inch Catheter Extension Set5) Connector Securement Device6) Occlusive Dressing7) Adhesive Strips8) Catheter ID labelThese devices are sold as disposable, sterile, single use, devices. | |
| Target Market: | Regional analgesia and anesthesia |
| PrimaryApplication: | Peripheral Nerve Block procedures. |
| Intended Use: | ON-Q* Pain Relief System QuikBloc* Over-the-Needle CatheterSet is indicated for delivery of medication for regional anesthesiaand pain management. Route of administration may beintraoperative, percutaneous or perineural. |
| TechnologicalCharacteristics: | 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 maybe intraoperative, percutaneous, or perineural. The onlydifference in the ON-Q* PainRelief System QuikBloc* Over-the-Needle Catheter Set is that it isopen ended to fit a needle through the catheter. |
| PerformanceData: | Components used in the ON-Q* Pain Relief System QuikBloc*Over-the-Needle Catheter Sets have been evaluated forbiocompatibility by their corresponding vendors. Gamma or EOsterilized samples of the components as mentioned below weretested in vitro or in laboratory animals for the listed toxicologicalend-points in accordance with the respective sections in ISO10993 guidelines and Good Laboratory Practices. The resultsfrom these studies revealed no adverse reaction to the testarticles and no adverse effects. In addition, these componentshave 510(k) clearance in the US, which indicate that they havebeen cleared and have been deemed safe for their intended use. |
Device
The ON-Q* QuikBloc* Over-the-Needle (OTN) Catheter Set, subject
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Results of design verification and validation testing demonstrated
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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.
§ 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).