LCCS VC-S RF Cannula

K191293 · Lccs Products Limited · GXI · Jan 24, 2020 · Neurology

Device Facts

• Record ID: K191293
• Device Name: LCCS VC-S RF Cannula
• Applicant: Lccs Products Limited
• Product Code: GXI · Neurology
• Decision Date: Jan 24, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The LCCS VC-S RF Cannula is a sterile, single-use, stainless steel needle used in conjunction with an RF electrode and RF generator to perform radiofrequency heat lesion procedures for chronic pain relief. The device features an insulated shaft with a bevel tip and a side port at the distal end, creating Y-shaped energy channels. During operation, an RF electrode is inserted into the cannula; when the electrode extends through the side port, both the active tip and the electrode section protruding from the side port deliver RF energy to the target nerve tissue. The side port also allows for the diffusion of anesthesia near the lesion site. The device is available in various lengths and gauges to accommodate different anatomical locations and patient anatomies. It is intended for use by clinicians in a clinical setting.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included insulation inspection, biocompatibility (cytotoxicity, acute systemic toxicity, sensitization, intracutaneous reactivity, pyrogenicity), accelerated aging, shelf life, and mechanical safety testing in accordance with ISO 10993-1, ISO 7864, and AAMI/ANSI ES 60601-2-2.

Technological Characteristics

Stainless steel cannula with insulated shaft; bevel tip and side port configuration; Y-shaped energy delivery channels. Available in 18G, 20G, 22G gauges and 50mm, 100mm, 150mm lengths. Single-use, sterile, ethylene oxide sterilized. Complies with ISO 10993-1, ISO 7864, and AAMI/ANSI ES 60601-2-2.

Indications for Use

Indicated for use in RF heat lesion procedures for the relief of pain in patients requiring percutaneous nerve blocks or RF denervation of nerve tissue.

Regulatory Classification

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.

Predicate Devices

• LCCS Insulated Spinal Needle (RF Cannula) (K112231)
• Stryker® Venom™ Electrodes and Cannulae (K123178)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 SERVICES<br>Food and Drug Administration<br>06/30/2020 | | Form Approved: OMB No. 0910-0120<br>Expiration 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)

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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 Limited<br>Office 3a-7, 12/F, Kaiser Center, No.18 Center Street, Sai<br>Ying Pun, Hong Kong |
| Contact person: | Nick XU<br>Regulatory Affairs<br>LCCS Products Limited<br>Office 3a-7, 12/F, Kaiser Center, No.18 Center Street, Sai<br>Ying Pun, Hong Kong<br>Telephone: [phone]<br>Email: [e-mail] |

- 3. Device Name:
LCCS VC-S RF Cannula

| Product Code | Classification | Regulation Section | Panel |
|--------------|----------------|-------------------------------------------------|-----------|
| GXI | Class II | 21 CFR 882.4725<br>Probe, Radiofrequency Lesion | Neurology |

#### 4. Predicate Devices:

| Predicate Device 510 (k)<br>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

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)
- 6. 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.

- 7. 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.

- 8. 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:<br>LCCS VC-S RF<br>Cannula | Predicate Device:<br>LCCS Insulated Spinal<br>Needle (RF Cannula)<br>(K112231) | Predicate Device:<br>Stryker® Venom™<br>Electrodes and Cannulae<br>(K123178) | Discussion of<br>Differences |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended/<br>Indication<br>s for use | The LCCS VC-S RF<br>Cannula is intended for<br>use in RF heat lesion<br>procedures for the<br>relief of pain. | LCCS Insulated Spinal<br>Needle (RF Cannula) is<br>indicated for use in RF<br>heat lesion procedures for<br>the relief of pain. | The Stryker RF electrodes<br>and cannulae, in combination<br>with the Stryker RF<br>Generator/Multigen, are<br>intended for coagulation of<br>soft tissues in orthopedic,<br>spinal, and neurosurgical<br>applications. These products<br>are also used for selective<br>denervation and tissue<br>destruction procedures which<br>may be performed on the<br>lumbar, thoracic, and cervical<br>regions of the peripheral<br>nerves, and nerve roots for the<br>relief of pain. Examples<br>include, but are not limited to,<br>Facette Denervation,<br>Trigeminus Neuralgia,<br>Peripheral Neuralgia and<br>Rhizotomy. | Identical |
| Material<br>type | Stainless Steel | Stainless Steel | Stainless Steel | Identical |
| Needle<br>Gauge | 18G, 20G, 22G | 18G, 20G, 22G | 18G, 20G | Identical. The<br>Needle Gauge of<br>proposed device is<br>identical to the<br>predicate device:<br>LCCS Insulated<br>Spinal Needle (RF<br>Cannula)<br>(K112231) |
| Needle<br>Tube<br>Length | 50mm,<br>100mm,<br>150mm | 50mm,<br>100mm,<br>150mm | 100mm,<br>150mm | Identical. The<br>Needle Tube Length<br>of proposed device<br>is identical to the<br>predicate device:<br>LCCS Insulated<br>Spinal Needle (RF<br>Cannula)<br>(K112231) |
| Feature | Proposed Device:<br>LCCS VC-S RF<br>Cannula | Predicate Device:<br>LCCS Insulated Spinal<br>Needle (RF Cannula)<br>(K112231) | Predicate Device:<br>Stryker® Venom™<br>Electrodes and Cannulae<br>(K123178) | Discussion of<br>Differences |
| Structure | A bevel tip and one<br>side port locate at the<br>distal end of the<br>cannula. There are<br>two channels to<br>deliver the RF energy. | A bevel tip locates at the<br>distal end of the cannula.<br>There is no side port and<br>only one channel to<br>deliver the RF energy. | A bevel tip and a side port are<br>created at the distal end of the<br>cannula. | Identical. The<br>proposed device is<br>identical to the<br>predicate device:<br>Stryker® Venom™<br>Electrodes and<br>Cannulae (K123178) |
| Method of<br>Sterilization | Single use, Ethylene<br>Oxide sterilization | Single use, Ethylene<br>Oxide sterilization | Single use, Ethylene Oxide<br>sterilization | Identical |
| Biocompati<br>bility | Non-Cytotoxicity<br>Non-Acute Systemic<br>Toxicity<br>Non-Intracutaneous<br>Reactivity<br>Non-Material Pyrogen<br>Non- Skin<br>Sensitization | Non-Cytotoxicity<br>Non-Intracutaneous<br>Reactivity<br>Non- Skin Sensitization | Unknown | Equivalent. The<br>subject device is also<br>comply with ISO<br>10993-11:2012 with<br>non-Material Pyrogen<br>and non- Non-Acute<br>Systemic 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.
- 9. 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
- 2. ISO 7864. Sterile hypodermic needles for single use Requirements and test methods
- 3. ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- 4. ANSI AAMI ISO 11607-1, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- 5. 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.
- 6. ISO 14971, Medical devices Applications of risk management to medical devices
- 7. 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,<br>Stylet,<br>Needle Hub | Cytotoxicity | The extract did not show potential toxicity<br>to L-929 cells. | Non-Cytotoxic |
| | Acute Systemic<br>Toxicity | The sample extracts showed no significant<br>evidence of causing acute systemic toxicity<br>in the mouse. | Non-Acute<br>Systemic<br>Toxicity |
| | Sensitization | The sample extract showed no significant<br>evidence of causing skin sensitization in the<br>guinea pig. | Non-<br>Sensitization |
| | Intracutaneous<br>Reactivity | The test result showed that the extract of the<br>test article did not induce Intracutaneous<br>reactivity in rabbit. | Non-<br>Intracutaneous<br>Reactivity |
| | Pyrogen | The animals' body temperature changed<br>less than 0.5 degree C. The test article met<br>the 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.