LCCS VC-S RF Cannula by LCCS Products Limited

The LCCS VC-S RF Cannula is used in conjunction with the RF electrode for the use in RF heat lesion procedures. The LCCS VC-S RF Cannulas are offered in a variety of lengths, gauges to accommodate various anatomical locations and differences in patients' anatomy. The LCCS VC-S RF Cannula is a stainless steel cannula with an insulated shaft having one exposed tip and one side port located at the end of the cannula to diffuse the anesthesia closer to the lesion site and deliver the RF energy to the tissue. When RF Electrode was inserted into LCCS VC-S RF Cannula and came out from the side port, both active tip and RF Electrode section stuck out of side port can deliver Radio Frequency energy. This RF cannula is provided as a sterile, single use, disposable device. This RF Cannula is offered in a variety of length and Needle outside Dimension to accommodate various anatomical locations and differences in patient anatomy. The LCCS VC-S RF Cannula is consisted of: Protection Sleeve, Needle Tube, Insulating layer, Needle hub, Stylet, Stylet Hub.

AI/ML Overview

The provided text is a 510(k) summary for the LCCS VC-S RF Cannula, which is a medical device. This document focuses on demonstrating the substantial equivalence of the proposed device to existing predicate devices, primarily through a comparison of design features, intended use, technology, and non-clinical testing.

Crucially, this document does not contain information about a clinical study involving human patients or a study comparing the device's performance to specific acceptance criteria related to a machine learning or AI algorithm's performance (e.g., sensitivity, specificity, or AUC). The "acceptance criteria" discussed in this document refer to the device's design specifications and performance against established safety and engineering standards (e.g., sterilization, biocompatibility, mechanical safety), not diagnostic or predictive performance metrics of an AI system.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria for an AI algorithm's performance, a test set, ground truth establishment, MRMC studies, or training sets, as that information is not present in the provided context.

The document's "conclusion" (on page 8) states that the device is considered "as safe, as effective, and performance is substantially equivalent to the predicate devices." This substantial equivalence is based on the comparison table and non-clinical tests, not on a human-in-the-loop or standalone AI study.

To directly answer your numbered points based on the provided text:

A table of acceptance criteria and the reported device performance:
The document includes a "Comparison to Predicate Devices" table (pages 5-6) that lists features like intended use, material, needle gauge, needle tube length, structure, method of sterilization, and biocompatibility. The "reported device performance" is essentially that these features are "identical" or "equivalent" to the predicate devices and that the device complies with certain voluntary standards (e.g., AAMI/ANSI ES 60601-2-2, ISO 7864, ISO 10993-1). There is also a "Summary of Non-Clinical Tests" table (page 7-8) which shows test results for biocompatibility (Cytotoxicity, Acute Systemic Toxicity, Sensitization, Intracutaneous Reactivity, Pyrogen) and concludes "Non-Cytotoxic," "Non-Acute Systemic Toxicity," etc. This is the closest the document comes to defining acceptance criteria and performance, but it's for the physical device, not an AI.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set for an AI algorithm is mentioned. The testing refers to non-clinical, biocompatibility, and engineering tests of the device itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. No ground truth for an AI algorithm is established.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for an AI algorithm is mentioned.
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. No AI algorithm or MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No AI algorithm performance is discussed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth for an AI algorithm is mentioned. The "ground truth" for this device's acceptance is its conformity to design specifications, material properties, and safety standards demonstrated through non-clinical testing.
The sample size for the training set: Not applicable. No training set for an AI algorithm is mentioned.
How the ground truth for the training set was established: Not applicable. No training set for an AI algorithm is mentioned.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 24, 2020

LCCS Products Limited Nick Xu Regulatory Affairs Office 3a-7, 12/F, Kaiser Center, No.18 Center Street, Sai Ying Pun Hong Kong, China

Re: K191293

Trade/Device Name: LCCS VC-S RF Cannula Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency Lesion Probe Regulatory Class: Class II Product Code: GXI Dated: December 23, 2019 Received: December 26, 2019

Dear Nick Xu:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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,

Matthew Krueger, M.S.E. Assistant Director DHT5A: Division of Neurosurgical. Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for LCCS. The logo consists of a green diamond shape on the left, with the letters "LCCS" in green to the right of the diamond. A registered trademark symbol is located in the upper right corner of the logo.

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration06/30/2020		Form Approved: OMB No. 0910-0120Expiration Date:
Indications for Use	See PRA Statement below.

510(k) Number (if known)

K191293

Device Name

LCCS VC-S RF Cannula

Indications for Use (Describe)

The LCCS VC-S RF Cannula is intended for use in RF heat lesion procedures for the relief of pain.

Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995. 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: Department of Health and Human Services

Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881(1/14)

Page 1 of 1

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510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

1. Date:	February 28, 2019
2. Submitter:	LCCS Products LimitedOffice 3a-7, 12/F, Kaiser Center, No.18 Center Street, SaiYing Pun, Hong Kong
Contact person:	Nick XURegulatory AffairsLCCS Products LimitedOffice 3a-7, 12/F, Kaiser Center, No.18 Center Street, SaiYing Pun, Hong KongTelephone: +852 82321050Email: xu.nick@qq.com

1. Device Name:
  LCCS VC-S RF Cannula

Product Code	Classification	Regulation Section	Panel
GXI	Class II	21 CFR 882.4725Probe, Radiofrequency Lesion	Neurology

4. Predicate Devices:

Predicate Device 510 (k)number	Predicate Device name
K112231	LCCS Insulated Spinal Needle (RF Cannula)
K123178	Stryker® Venom™ Electrodes and Cannulae

5. Device Description:

The LCCS VC-S RF Cannula is used in conjunction with the RF electrode for the use in RF heat lesion procedures. The LCCS VC-S RF Cannulas are offered in a variety of lengths, gauges to accommodate various anatomical locations and differences in patients' anatomy. The LCCS VC-S RF Cannula is a stainless steel cannula with an insulated shaft having one exposed tip and one side port located at the end of the cannula to diffuse the anesthesia closer to the lesion site and deliver the RF energy to the tissue. When RF Electrode was inserted into LCCS VC-S RF Cannula and came out from the side port, both active tip and RF Electrode section stuck out of side port can deliver Radio Frequency energy. Please refer to Figure 5-1 RF energy outlet indicator diagram.

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Image /page/4/Picture/1 description: The image shows the logo for LCCS, which is a green color. The logo consists of a stylized diamond shape on the left, followed by the letters "LCCS" in a sans-serif font. A registered trademark symbol is located to the right of the letters. The logo is simple and modern, and the green color suggests a connection to nature or sustainability.

This RF cannula is provided as a sterile, single use, disposable device. This RF Cannula is offered in a variety of length and Needle outside Dimension to accommodate various anatomical locations and differences in patient anatomy.

RF energy outlet

Figure 5-1 RF energy outlet indicator diagram

The LCCS VC-S RF Cannula is consisted of:

Protection Sleeve a)
Needle Tube b)
Insulating layer c)
Needle hub d)
Stylet e)
Stylet Hub f)
1. Intended Use/Indications for Use:

The LCCS VC-S RF Cannula is intended for use in RF heat lesion procedures for the relief of pain.

1. Technology:
  The LCCS VC-S RF Cannula employs the same fundamental scientific technology as its predicate devices.

LCCS VC-S RF Cannula is the same usage as its predicated devices, which is used in conjunction with RF denervation probes and RF Generator to create Radiofrequency (RF) Lesions of nerve tissue or for use in percutaneous nerve blocks.

Radiofrequency heat lesion procedure is a common technique used in the treatment of chronic pain. The LCCS VC-S RF Cannula and its predicate devices are offered in a variety of lengths, gauges to accommodate various anatomical locations and differences in patients' anatomy. The LCCS VC-S RF Cannula is a stainless steel cannula with an insulated shaft having one exposed tip and one side port located at the end of the cannula to diffuse the anesthesia closer to the lesion site and deliver the RF energy to the tissue. The tip and the side port constitute Y-shaped energy channels

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and RF energy can be delivered both from these two channels.

1. Determination of Substantial Equivalence:
  Comparison to Predicate Devices:

Below table is the summary comparison of features of the LCCS VC-S RF Cannula and the predicate devices.

Feature	Proposed Device:LCCS VC-S RFCannula	Predicate Device:LCCS Insulated SpinalNeedle (RF Cannula)(K112231)	Predicate Device:Stryker® Venom™Electrodes and Cannulae(K123178)	Discussion ofDifferences
Intended/Indications for use	The LCCS VC-S RFCannula is intended foruse in RF heat lesionprocedures for therelief of pain.	LCCS Insulated SpinalNeedle (RF Cannula) isindicated for use in RFheat lesion procedures forthe relief of pain.	The Stryker RF electrodesand cannulae, in combinationwith the Stryker RFGenerator/Multigen, areintended for coagulation ofsoft tissues in orthopedic,spinal, and neurosurgicalapplications. These productsare also used for selectivedenervation and tissuedestruction procedures whichmay be performed on thelumbar, thoracic, and cervicalregions of the peripheralnerves, and nerve roots for therelief of pain. Examplesinclude, but are not limited to,Facette Denervation,Trigeminus Neuralgia,Peripheral Neuralgia andRhizotomy.	Identical
Materialtype	Stainless Steel	Stainless Steel	Stainless Steel	Identical
NeedleGauge	18G, 20G, 22G	18G, 20G, 22G	18G, 20G	Identical. TheNeedle Gauge ofproposed device isidentical to thepredicate device:LCCS InsulatedSpinal Needle (RFCannula)(K112231)
NeedleTubeLength	50mm,100mm,150mm	50mm,100mm,150mm	100mm,150mm	Identical. TheNeedle Tube Lengthof proposed deviceis identical to thepredicate device:LCCS InsulatedSpinal Needle (RFCannula)(K112231)
Feature	Proposed Device:LCCS VC-S RFCannula	Predicate Device:LCCS Insulated SpinalNeedle (RF Cannula)(K112231)	Predicate Device:Stryker® Venom™Electrodes and Cannulae(K123178)	Discussion ofDifferences
Structure	A bevel tip and oneside port locate at thedistal end of thecannula. There aretwo channels todeliver the RF energy.	A bevel tip locates at thedistal end of the cannula.There is no side port andonly one channel todeliver the RF energy.	A bevel tip and a side port arecreated at the distal end of thecannula.	Identical. Theproposed device isidentical to thepredicate device:Stryker® Venom™Electrodes andCannulae (K123178)
Method ofSterilization	Single use, EthyleneOxide sterilization	Single use, EthyleneOxide sterilization	Single use, Ethylene Oxidesterilization	Identical
Biocompatibility	Non-CytotoxicityNon-Acute SystemicToxicityNon-IntracutaneousReactivityNon-Material PyrogenNon- SkinSensitization	Non-CytotoxicityNon-IntracutaneousReactivityNon- Skin Sensitization	Unknown	Equivalent. Thesubject device is alsocomply with ISO10993-11:2012 withnon-Material Pyrogenand non- Non-AcuteSystemic Toxicity.

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Image /page/6/Picture/1 description: The image shows the logo for LCCS. The logo consists of a green diamond shape on the left, with the letters "LCCS" in green to the right of the diamond. There is a small "R" in a circle in the upper right corner of the logo, indicating that the logo is a registered trademark.

From the comparison summary table, the LCCS VC-S RF Cannula is substantially equivalent to the predicated devices with regard to intended use, technological characteristics, safety and effectiveness.

. The devices are all intended for used in conjunction with the RF denervation Probes for the use in RF heat lesion procedures.
The devices are all offered in a variety of lengths, gauges to accommodate ● various anatomical locations and differences in patient anatomy.
The proposed device and predicated devices are all have the same material of the needle, the needle of the devices are all made of stainless steel.
The proposed device has the same structure of a bevel tip and a side port at the distal end of the cannula with its predicated device Stryker® Venom™ Electrodes and Cannulae (K123178). The proposed device and this predicated device both can provide two channels to deliver the RF energy.
The devices are all offered with single use, and the methods of sterilization ● are all Ethylene Oxide sterilization.
1. Summary of Non-Clinical Tests:

LCCS VC-S RF Cannula has been evaluated for insulation inspection, biocompatibility, accelerated aging test as well as shelf life, sterilization, and mechanical safety, and has been found to conform to applicable medical device safety standards. The LCCS VC-S RF Cannula complies with below voluntary standards:

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1. AAMI/ANSI ES 60601-2-2, Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
1. ISO 7864. Sterile hypodermic needles for single use Requirements and test methods
1. ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
1. ANSI AAMI ISO 11607-1, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
1. ANSI AAMI ISO 11135, Sterilization of health care products Ethylene oxide -Requirements for development, validation and routine control of a sterilization process for medical devices.
1. ISO 14971, Medical devices Applications of risk management to medical devices
1. ASTM F1980-16, Sterile hypodermic needles for single use Requirements and test methods

The following quality assurance measures are applied to the development of the system:

. Risk Analysis
Performance testing (Verification)
Safety testing (Verification) ●

The LCCS VC-S RF Cannula is provided with sterilization and is biocompatible.

Components	Test	Results	Conclusions
Needle tube,Stylet,Needle Hub	Cytotoxicity	The extract did not show potential toxicityto L-929 cells.	Non-Cytotoxic
	Acute SystemicToxicity	The sample extracts showed no significantevidence of causing acute systemic toxicityin the mouse.	Non-AcuteSystemicToxicity
	Sensitization	The sample extract showed no significantevidence of causing skin sensitization in theguinea pig.	Non-Sensitization
	IntracutaneousReactivity	The test result showed that the extract of thetest article did not induce Intracutaneousreactivity in rabbit.	Non-IntracutaneousReactivity
	Pyrogen	The animals' body temperature changedless than 0.5 degree C. The test article metthe requirement of the absence of pyrogens.	Non- Pyrogen

The Biocompatibility test details information as below:

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Image /page/8/Picture/1 description: The image shows the logo for LCCS, which is a green diamond shape with the letters LCCS in green next to it. The letters are in a sans-serif font. There is a registered trademark symbol next to the letters. Below the logo is the text "10. Conclusion".

LCCS Products Limited considers the LCCS VC-S RF Cannula to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 882.4725 Radiofrequency lesion probe.

(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).