ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set

K143164 · Kimberly-Clark Corporation · BSO · Dec 2, 2014 · Anesthesiology

Device Facts

• Record ID: K143164
• Device Name: ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set
• Applicant: Kimberly-Clark Corporation
• Product Code: BSO · Anesthesiology
• Decision Date: Dec 2, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5120
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

ON-Q* QuikBloc* OTN Catheter Set facilitates regional anesthesia and pain management; used for intraoperative, percutaneous, or perineural medication delivery. Kit includes catheter (some with integrated stimulating cable), removable needle wing, extension sets, connector securement device, occlusive dressing, adhesive strips, and ID label. Device is disposable, sterile, and single-use. Clinician inserts catheter over-the-needle to target site; open-ended design allows needle passage. Provides continuous or bolus medication delivery for analgesia. Benefits include improved needle visualization (when using echogenic/stimulating options) and secure catheter placement for pain relief.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility evaluated per ISO 10993 guidelines; components tested in vitro or in laboratory animals with no adverse reactions reported. Design verification and validation testing confirmed device functions as designed.

Technological Characteristics

Catheter set for regional anesthesia. Components include catheters, needles (some stimulating), extension sets, and securement accessories. Open-ended catheter design. Sterilization via Gamma or EO. Biocompatibility per ISO 10993. Non-DEHP materials used in extension sets.

Indications for Use

Indicated for delivery of medication for regional anesthesia and pain management via intraoperative, percutaneous, or perineural routes. Contraindicated for the epidural space.

Regulatory Classification

Identification

An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.

Predicate Devices

• I-Flow Catheter (K043456)
• EchoBright* Echogenic PNB Needle (K111355)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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 of<br>Summary<br>Prepared: | November 25, 2014 |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Halyard - Irvine<br>43 Discovery, Suite 100<br>Irvine, CA 92618 |
| Official<br>Correspondent: | Maria E. Wagner<br>Sr. Specialist, Regulatory Affairs<br>Tel: [phone]<br>Fax: [phone]<br>email: [e-mail] |
| Trade Name: | ON-Q* QuikBloc* Over-the-Needle (OTN) Catheter Set |
| Classification<br>Name: | Anesthesia Conduction Catheter |
| Device<br>Classification<br>and Product<br>Code: | Class II per 21 CFR §868.5120<br>Product Code - BSO |
| Existing/Predicate<br>Devices: | Halyard Health currently markets the I-Flow Catheter and consists of<br>three design options which can utilize infusion segments ranging<br>from epidural to 10 inches K043456).<br><br>The EchoBright* Echogenic PNB Needle is a peripheral nerve block<br>insulated needle with graduated centimeter markings to determine<br>the depth of the needle advancement into tissue. The needle<br>incorporates a series of patterns designed to optimally scatter the<br>deflection of ultrasound waves for the needle such that a high<br>percentage reach the ultrasound probe for improved visualization of<br>the needle position in tissue (K111355). |
| Description: | of this special submission is substantially equivalent to the I-Flow<br>Catheter cleared in K043456 and Needle K111355. |
| | ON-Q* QuikBloc* Over-the-Needle (OTN) Catheter Sets are available<br>in four product codes (20 GA x 4" Needle, 16 GA x 3" Catheter (with<br>and without Stimulating needle); 20 GA x 6" Needle, 16 GA x 5"<br>Catheter (with and without stimulating needle)). The kits include:<br>1) ON-Q* QuikBloc* Over-the-Needle Catheter Set (some models<br>include an integrated stimulating cable)<br>2) Removable Needle Wing<br>3) Non-DEHP 24 inch Needle Extension Set,<br>4) Non-DEHP 6 inch Catheter Extension Set<br>5) Connector Securement Device<br>6) Occlusive Dressing<br>7) Adhesive Strips<br>8) Catheter ID label<br>These devices are sold as disposable, sterile, single use, devices. |
| Target Market: | Regional analgesia and anesthesia |
| Primary<br>Application: | Peripheral Nerve Block procedures. |
| Intended Use: | ON-Q* Pain Relief System QuikBloc* Over-the-Needle Catheter<br>Set is indicated for delivery of medication for regional anesthesia<br>and pain management. Route of administration may be<br>intraoperative, percutaneous or perineural. |
| Technological<br>Characteristics: | Both the modified ON-Q* Pain Relief System QuikBloc* Over-the-<br>Needle Catheter Set and the predicate I-Flow Catheter (K043456)<br>have the same basic fundamental technological characteristics.<br>Both catheters deliver medication. Routes of administration may<br>be intraoperative, percutaneous, or perineural. The only<br>difference in the ON-Q* Pain<br>Relief System QuikBloc* Over-the-Needle Catheter Set is that it is<br>open ended to fit a needle through the catheter. |
| Performance<br>Data: | Components used in the ON-Q* Pain Relief System QuikBloc*<br>Over-the-Needle Catheter Sets have been evaluated for<br>biocompatibility by their corresponding vendors. Gamma or EO<br>sterilized samples of the components as mentioned below were<br>tested in vitro or in laboratory animals for the listed toxicological<br>end-points in accordance with the respective sections in ISO<br>10993 guidelines and Good Laboratory Practices. The results<br>from these studies revealed no adverse reaction to the test<br>articles and no adverse effects. In addition, these components<br>have 510(k) clearance in the US, which indicate that they have<br>been cleared and have been deemed safe for their intended use. |

## Device

The ON-Q* QuikBloc* Over-the-Needle (OTN) Catheter Set, subject

- 8.

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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.