SubQKath Catheter and Needle Set

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September 9, 2020 HK Surgical Gary Mocnik Official Correspondent 1271 Puerto del Sol San Clemente, California 92673 Re: K193664 Trade/Device Name: SubQKath Catheter and Needle Set Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: Class II Product Code: BSO Dated: August 6, 2020 Received: August 10, 2020 ## Dear Gary Mocnik: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Food and Drug Administration | Expiration Date: 06/30/2020 | | Indications for Use | | | | See PRA Statement below. | | 510(k) Number (if known) | | | Device Name | SubQKath Catheter and Needle Kit | | Indications for Use (Describe) | The SubQKath Catheter and Needle Kit is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for subcutaneous infiltration local anesthesia, peripheral plexus anesthesia and pain management during pre-operative, perioperative and post-operative periods associated with surgical procedures. | | Type of Use (Select one or both, as applicable) | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 {3}------------------------------------------------ ## 1. 510(k) Summary # K193664 #### I. SUBMITTER HK Surgical 1271 Puerto del Sol San Clemente, CA 92673 Contact person: Gary Mocnik Phone: (949) 433.0413 Date prepared: December 24, 2019 #### II. DEVICE Trade name: SubQKath Catheter and Needle Set Common name: Subcutaneous Catheter Classification name: Anesthesia Conduction Catheter Classification Regulation : 868.5120 Class: II Product Code: BSO ### III. PREDICATE DEVICE PAINfusor Catheter (K111031)- primary predicate This predicate has not been subject to a design-related recall PAJUNK Wound Infiltration Catheter Kit (K080675)- reference predicate This predicate has not been subject to a design-related recall #### IV. DEVICE DESCRIPTION The HK SubOKath Subcutaneous Catheter is a device intended to provide a means of delivery of local analgesics into the human body via a fenestrated catheter. The device is a single lumen catheter available in a single gauge (16g) size. The distal end of the device allows for flow of analgesia into the surgical wound. The device is supplied sterile and is intended for single use. #### V. INDICATIONS FOR USE The SubQKath Catheter and Needle Kit is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for subcutaneous infiltration local anesthesia, peripheral plexus anesthesia and pain management during pre-operative, perioperative and post-operative {4}------------------------------------------------ periods associated with surgical procedures. The SubQKath Catheter and Needle Kit is intended for use in adult patients. ### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The technological characteristics of the SubQKath Catheter and Needle Kit are highly analogous to the predicate devices. The similarities and differences are illustrated in the table below: | | SubQKath<br>Catheter and<br>Needle Kit | PAINfusor<br>Catheter<br>(K111031)<br>Primary<br>Predicate | PAJUNK Wound<br>Infiltration<br>Catheter Kit<br>(K080675)-<br>Reference<br>Predicate | |---------------------------------|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------------| | Principle of<br>Operation | Insertion of<br>catheter at or near<br>the surgical site<br>and infusion of<br>analgesia/<br>anesthetics | SAME | SAME | | Patient population | Adults | SAME | SAME | | Catheter placement<br>technique | Over-the-needle | SAME | SAME | | Materials | Medical grade<br>polymers, metals | SAME | SAME | | Catheter Diameter<br>(OD) | 16G | 19G | 19G | | Catheter Length | 5.67" (14.40 cm) | 37.5cm<br>42.5cm<br>50cm<br>57.5cm<br>65cm | 420mm<br>500mm<br>600mm<br>700mm<br>900mm | | Tip type | Fenestrated | SAME | SAME | | Fenestration length | (length of<br>fenestration, 4.3-<br>4.5 inches<br>number of holes,<br>11<br>diameter of holes<br>0.040") | Fenestration<br>length:<br>2.5cm<br>7.5cm<br>15cm<br>22.5cm<br>30cm | Fenestration<br>length:<br>25mm-300mm | | Placement duration | Up to 72 hours | SAME | SAME | | Needle<br>Configuration | Straight<br>length<br>gauge: | Straight | Straight | | Luer engagement | Yes | SAME | SAME | {5}------------------------------------------------ | | SubQKath<br>Catheter and<br>Needle Kit | PAINfusor<br>Catheter<br>(K111031)<br>Primary<br>Predicate | PAJUNK Wound<br>Infiltration<br>Catheter Kit<br>(K080675)-<br>Reference<br>Predicate | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Flow Rate | Flow rate is<br>dependent on the<br>infiltration pump<br>used and the<br>associated flow<br>rates. The<br>differences in<br>fenestration<br>pattern did not<br>affect flow<br>characteristics, as<br>demonstrated by<br>flow performance<br>testing. | Flow rate is<br>dependent on the<br>infiltration pump<br>used and the<br>associated flow<br>rates. Fenestration<br>features do not<br>affect flow<br>characteristics as<br>demonstrated by<br>flow performance<br>testing | Flow rate is<br>dependent on the<br>infiltration pump<br>used and the<br>associated flow<br>rates.<br>Fenestration<br>features do not<br>affect flow<br>characteristics as<br>demonstrated by<br>flow performance<br>testing | | Components of<br>Device Kit | • Catheter<br>• Needle<br>introducer | • Catheter<br>• Needle<br>introducer<br>• Dressing | • Infiltration<br>Catheter<br>• Puncture<br>cannula (needle)<br>• Filter<br>• Syringe<br>• Pump | | How provided | Sterile, single use | Sterile, single use | Sterile, single use | #### VII. PERFORMANCE DATA The following performance data were evaluated in support of the substantial equivalence. - Physical Properties Verification - I Bond and Material Strength Verification - Needle quality - Sharpness after one-year aging ● - Stiffness after one-year aging (ISO 9626) . - l Kink resistance - Flow rate characterization ' - l Liquid leakage - . Functional Verification - Biocompatibility The indwelling Sub Q Kath catheter portion of the HK Surgical SubQKATH device is considered to fall under the guidelines for an externally communicating device with direct tissue/bone contact for a prolonged patient contact duration (> 24 hours to 30 days per the ISO guideline and typically a maximum exposure of 48 hours in the actual {6}------------------------------------------------ clinical application) as defined by the International Organization for Standardization (ISO) 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and U.S. Food and Drug Administration (FDA) Guidance Document for the Use of ISO 10993-1 (issued 06/16/2016) guidelines. The aspects of biocompatibility for consideration as suggested by the ISO 10993-1 and FDA guidelines were follows in Table 2. ### Biocompatibility tests conducted - Cytotoxicity . Sensitization ● . . Intracutaneous Systemic Irritation Toxicity . Genotoxicity - Implantation ● In summary, the HK Surgical Sub Q Kath device was evaluated with a test battery addressing the suggested aspects of biocompatibility as suggested in the ISO 10993-1:2018 guidelines. - Sterilization Validation l A protocol was successfully executed to establish the procedures for validation of an ethylene oxide sterilization process to a 10-6 sterility assurance level (SAL). Performance qualifications was executed using the overkill approach as referenced in the international standard. ANSI/AAMI/ISO 11135. - . Sterile Barrier Performance Testing was successfully executed to demonstrate compliance with applicable elements of ISO 11607. The subject device met the acceptance criteria of the above tests, and did not raise new questions of safety and effectiveness. #### CONCLUSIONS VIII. The non-clinical testing performed for the SubQKath Catheter and Needle Kit demonstrated that the performance of the device is equivalent to the legally marketed predicate devices. In summary, the SubQKath Catheter and Needle Kit has the same intended use as the proposed predicate and difference in technological features do not raise different questions of safety and effectiveness.