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.

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.

AI/ML Overview

This document describes the 510(k) premarket notification for the SubQKath Catheter and Needle Set (K193664). The acceptance criteria and study proving the device meets these criteria are primarily based on non-clinical performance data demonstrating substantial equivalence to predicate devices, rather than a clinical study involving human patients or complex AI algorithm performance.

Therefore, many of the typical questions for AI/ML-based medical devices (like sample size for test/training sets, expert consensus, MRMC studies, or standalone algorithm performance) are not applicable to this submission. This device is a physical medical device, and its safety and effectiveness are established through engineering testing and comparison to existing devices.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list acceptance criteria in a quantitative table format for each test, but it states that "The subject device met the acceptance criteria of the above tests, and did not raise new questions of safety and effectiveness." The study design is focused on demonstrating physical and material properties, rather than diagnostic accuracy metrics.

Acceptance Criteria (Implied)	Reported Device Performance
Pass Physical Properties Verification	Met acceptance criteria (details not specified)
Pass Bond and Material Strength Verification	Met acceptance criteria (details not specified)
Pass Needle Quality (Sharpness after 1-year aging)	Met acceptance criteria (details not specified)
Pass Needle Quality (Stiffness after 1-year aging per ISO 9626)	Met acceptance criteria (details not specified)
Pass Kink resistance	Met acceptance criteria (details not specified)
Pass Flow rate characterization	Passed; "differences in fenestration pattern did not affect flow characteristics, as demonstrated by flow performance testing."
Pass Liquid leakage	Met acceptance criteria (details not specified)
Pass Functional Verification	Met acceptance criteria (details not specified)
Pass Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous, Systemic Irritation, Toxicity, Genotoxicity, Implantation)	Evaluated with a test battery addressing suggested aspects of biocompatibility per ISO 10993-1:2018; met acceptance criteria.
Pass Sterilization Validation (Ethylene Oxide to 10-6 SAL)	Successfully executed using overkill approach as referenced in ANSI/AAMI/ISO 11135.
Pass Sterile Barrier Performance	Successfully executed to demonstrate compliance with applicable elements of ISO 11607.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in terms of a "test set" as this is a physical device and testing involves material and functional evaluations, not typically patient data sets. The sample sizes for the various engineering and biocompatibility tests would be dependent on the specific test protocols (e.g., number of catheters tested for flow rate, number of samples for material strength). These details are not provided in this summary.
Data Provenance: Not applicable in the context of clinical data. The data provenance refers to the results of laboratory-based physical, chemical, and biological performance testing of the device itself. This would be generated from the manufacturer's testing facilities or contract labs.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable. Ground truth for a physical device is established through validated testing methodologies and adherence to standards (e.g., ISO, ANSI/AAMI). There's no "ground truth" derived from expert consensus on medical images or clinical outcomes in this type of submission.
Qualifications of Experts: Not applicable in the context of clinical readers. The "experts" would be engineers, material scientists, and toxicologists conducting the specified tests and interpreting the results according to relevant standards.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This is not a study requiring reader adjudication of medical data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No. This is not an AI/ML diagnostic device, nor is it a device that would typically undergo a human-reader comparative effectiveness study. It's a physical catheter.
Effect Size of Human Readers' Improvement: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this device is based on engineering specifications, material science standards (e.g., ISO 9626, ISO 11607, ISO 10993-1), and functional performance requirements of similar, legally marketed predicate devices. For biocompatibility, it's the biological response measured against established safety thresholds.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device does not involve AI/ML and therefore does not have a "training set."

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set Establishment: Not applicable.

Summary

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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. 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.

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

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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

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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)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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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

V. INDICATIONS FOR USE

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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:

	SubQKathCatheter andNeedle Kit	PAINfusorCatheter(K111031)PrimaryPredicate	PAJUNK WoundInfiltrationCatheter Kit(K080675)-ReferencePredicate
Principle ofOperation	Insertion ofcatheter at or nearthe surgical siteand infusion ofanalgesia/anesthetics	SAME	SAME
Patient population	Adults	SAME	SAME
Catheter placementtechnique	Over-the-needle	SAME	SAME
Materials	Medical gradepolymers, metals	SAME	SAME
Catheter Diameter(OD)	16G	19G	19G
Catheter Length	5.67" (14.40 cm)	37.5cm42.5cm50cm57.5cm65cm	420mm500mm600mm700mm900mm
Tip type	Fenestrated	SAME	SAME
Fenestration length	(length offenestration, 4.3-4.5 inchesnumber of holes,11diameter of holes0.040")	Fenestrationlength:2.5cm7.5cm15cm22.5cm30cm	Fenestrationlength:25mm-300mm
Placement duration	Up to 72 hours	SAME	SAME
NeedleConfiguration	Straightlengthgauge:	Straight	Straight
Luer engagement	Yes	SAME	SAME

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	SubQKathCatheter andNeedle Kit	PAINfusorCatheter(K111031)PrimaryPredicate	PAJUNK WoundInfiltrationCatheter Kit(K080675)-ReferencePredicate
Flow Rate	Flow rate isdependent on theinfiltration pumpused and theassociated flowrates. Thedifferences infenestrationpattern did notaffect flowcharacteristics, asdemonstrated byflow performancetesting.	Flow rate isdependent on theinfiltration pumpused and theassociated flowrates. Fenestrationfeatures do notaffect flowcharacteristics asdemonstrated byflow performancetesting	Flow rate isdependent on theinfiltration pumpused and theassociated flowrates.Fenestrationfeatures do notaffect flowcharacteristics asdemonstrated byflow performancetesting
Components ofDevice Kit	• Catheter• Needleintroducer	• Catheter• Needleintroducer• Dressing	• InfiltrationCatheter• Puncturecannula (needle)• Filter• Syringe• 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

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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.

Regulation Number and Section

§ 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).