(253 days)
No
The device description and performance studies focus on the physical properties and functionality of a catheter for delivering analgesics, with no mention of AI or ML.
Yes
The device is described as providing "continuous and/or intermittent infusion of local anesthetics and analgesics for subcutaneous infiltration local anesthesia, peripheral plexus anesthesia and pain management," which directly addresses the treatment of pain and provides a therapeutic effect.
No
The device is described as a catheter for delivering local anesthetics and analgesics, not for identifying or diagnosing a disease or condition.
No
The device description clearly indicates a physical catheter and needle kit, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "continuous and/or intermittent infusion of local anesthetics and analgesics for subcutaneous infiltration local anesthesia, peripheral plexus anesthesia and pain management". This describes a therapeutic intervention (delivering medication to a patient), not a diagnostic test performed on samples outside the body.
- Device Description: The description details a "fenestrated catheter" for delivering "local analgesics into the human body". This further reinforces its role in direct patient treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information for diagnosis or monitoring of a disease or condition based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / 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 periods associated with surgical procedures.
Product codes
BSO
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.
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
The SubQKath Catheter and Needle Kit is intended for use in adult patients.
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)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PAINfusor Catheter (K111031)
Reference Device(s)
PAJUNK Wound Infiltration Catheter Kit (K080675)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
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) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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
Catheter and
Needle Kit | PAINfusor
Catheter
(K111031)
Primary
Predicate | PAJUNK Wound
Infiltration
Catheter Kit
(K080675)-
Reference
Predicate |
|---------------------------------|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Principle of
Operation | Insertion of
catheter at or near
the surgical site
and infusion of
analgesia/
anesthetics | SAME | SAME |
| Patient population | Adults | SAME | SAME |
| Catheter placement
technique | Over-the-needle | SAME | SAME |
| Materials | Medical grade
polymers, metals | SAME | SAME |
| Catheter Diameter
(OD) | 16G | 19G | 19G |
| Catheter Length | 5.67" (14.40 cm) | 37.5cm
42.5cm
50cm
57.5cm
65cm | 420mm
500mm
600mm
700mm
900mm |
| Tip type | Fenestrated | SAME | SAME |
| Fenestration length | (length of
fenestration, 4.3-
4.5 inches
number of holes,
11
diameter of holes
0.040") | Fenestration
length:
2.5cm
7.5cm
15cm
22.5cm
30cm | Fenestration
length:
25mm-300mm |
| Placement duration | Up to 72 hours | SAME | SAME |
| Needle
Configuration | Straight
length
gauge: | Straight | Straight |
| Luer engagement | Yes | SAME | SAME |
5
| | SubQKath
Catheter and
Needle Kit | PAINfusor
Catheter
(K111031)
Primary
Predicate | PAJUNK Wound
Infiltration
Catheter Kit
(K080675)-
Reference
Predicate |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Flow Rate | Flow rate is
dependent on the
infiltration pump
used and the
associated flow
rates. The
differences in
fenestration
pattern did not
affect flow
characteristics, as
demonstrated by
flow performance
testing. | Flow rate is
dependent on the
infiltration pump
used and the
associated flow
rates. Fenestration
features do not
affect flow
characteristics as
demonstrated by
flow performance
testing | Flow rate is
dependent on the
infiltration pump
used and the
associated flow
rates.
Fenestration
features do not
affect flow
characteristics as
demonstrated by
flow performance
testing |
| Components of
Device Kit | • Catheter
• Needle
introducer | • Catheter
• Needle
introducer
• Dressing | • Infiltration
Catheter
• Puncture
cannula (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
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.