(255 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, materials, and safety of a radiofrequency cannula, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used in RF heat lesion procedures for the relief of pain, which is a therapeutic intervention.
No.
The device description and intended use clearly state that it is used for "RF heat lesion procedures for the relief of pain" and to "deliver the RF energy to the tissue," indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly details a physical, sterile, single-use, disposable cannula made of stainless steel with an insulated shaft, a stylet, and a hub, intended for delivering RF energy and anesthesia. This is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "RF heat lesion procedures for the relief of pain." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a physical device (cannula) used to deliver RF energy to tissue. It's a tool for a medical procedure, not for analyzing samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for treatment.
N/A
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.
Product codes
GXI
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. 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 a) - Needle Tube b) - Insulating layer c) - Needle hub d) - Stylet e) - Stylet Hub f)
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
Not Found
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)
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:
- 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
- ISO 7864. Sterile hypodermic needles for single use Requirements and test methods
- ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- ANSI AAMI ISO 11607-1, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- 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.
- ISO 14971, Medical devices Applications of risk management to medical devices
- ASTM F1980-16, Sterile hypodermic needles for single use Requirements and test methods
The LCCS VC-S RF Cannula is provided with sterilization and is biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Biocompatibility Test Results:
- Cytotoxicity: The extract did not show potential toxicity to L-929 cells. (Non-Cytotoxic)
- Acute Systemic Toxicity: The sample extracts showed no significant evidence of causing acute systemic toxicity in the mouse. (Non-Acute Systemic Toxicity)
- Sensitization: The sample extract showed no significant evidence of causing skin sensitization in the guinea pig. (Non-Sensitization)
- Intracutaneous Reactivity: The test result showed that the extract of the test article did not induce Intracutaneous reactivity in rabbit. (Non-Intracutaneous Reactivity)
- Pyrogen: The animals' body temperature changed less than 0.5 degree C. The test article met the requirement of the absence of pyrogens. (Non- Pyrogen)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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
Food and Drug Administration
06/30/2020 | | Form Approved: OMB No. 0910-0120
Expiration Date: |
|---------------------------------------------------------------------------------------|--------------------------|------------------------------------------------------|
| Indications for Use | See PRA Statement below. | |
510(k) Number (if known)
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
3
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 |
| Office 3a-7, 12/F, Kaiser Center, No.18 Center Street, Sai | |
| Ying Pun, Hong Kong | |
| Contact person: | Nick XU |
| Regulatory Affairs | |
| LCCS Products Limited | |
| Office 3a-7, 12/F, Kaiser Center, No.18 Center Street, Sai | |
| Ying Pun, Hong Kong | |
| Telephone: +852 82321050 | |
| Email: xu.nick@qq.com |
-
- Device Name:
LCCS VC-S RF Cannula
- Device Name:
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| GXI | Class II | 21 CFR 882.4725 | |
| Probe, 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.
4
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)
-
- 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.
-
- Technology:
The LCCS VC-S RF Cannula employs the same fundamental scientific technology as its predicate devices.
- Technology:
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
5
and RF energy can be delivered both from these two channels.
-
- Determination of Substantial Equivalence:
Comparison to Predicate Devices:
- Determination of Substantial Equivalence:
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 RF
Cannula | Predicate Device:
LCCS Insulated Spinal
Needle (RF Cannula)
(K112231) | Predicate Device:
Stryker® Venom™
Electrodes and Cannulae
(K123178) | Discussion of
Differences |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended/
Indication
s for use | The LCCS VC-S RF
Cannula is intended for
use in RF heat lesion
procedures for the
relief of pain. | LCCS Insulated Spinal
Needle (RF Cannula) is
indicated for use in RF
heat lesion procedures for
the relief of pain. | The Stryker RF electrodes
and cannulae, in combination
with the Stryker RF
Generator/Multigen, are
intended for coagulation of
soft tissues in orthopedic,
spinal, and neurosurgical
applications. These products
are also used for selective
denervation and tissue
destruction procedures which
may be performed on the
lumbar, thoracic, and cervical
regions of the peripheral
nerves, and nerve roots for the
relief of pain. Examples
include, but are not limited to,
Facette Denervation,
Trigeminus Neuralgia,
Peripheral Neuralgia and
Rhizotomy. | Identical |
| Material
type | Stainless Steel | Stainless Steel | Stainless Steel | Identical |
| Needle
Gauge | 18G, 20G, 22G | 18G, 20G, 22G | 18G, 20G | Identical. The
Needle Gauge of
proposed device is
identical to the
predicate device:
LCCS Insulated
Spinal Needle (RF
Cannula)
(K112231) |
| Needle
Tube
Length | 50mm,
100mm,
150mm | 50mm,
100mm,
150mm | 100mm,
150mm | Identical. The
Needle Tube Length
of proposed device
is identical to the
predicate device:
LCCS Insulated
Spinal Needle (RF
Cannula)
(K112231) |
| Feature | Proposed Device:
LCCS VC-S RF
Cannula | Predicate Device:
LCCS Insulated Spinal
Needle (RF Cannula)
(K112231) | Predicate Device:
Stryker® Venom™
Electrodes and Cannulae
(K123178) | Discussion of
Differences |
| Structure | A bevel tip and one
side port locate at the
distal end of the
cannula. There are
two channels to
deliver the RF energy. | A bevel tip locates at the
distal end of the cannula.
There is no side port and
only one channel to
deliver the RF energy. | A bevel tip and a side port are
created at the distal end of the
cannula. | Identical. The
proposed device is
identical to the
predicate device:
Stryker® Venom™
Electrodes and
Cannulae (K123178) |
| Method of
Sterilization | Single use, Ethylene
Oxide sterilization | Single use, Ethylene
Oxide sterilization | Single use, Ethylene Oxide
sterilization | Identical |
| Biocompati
bility | Non-Cytotoxicity
Non-Acute Systemic
Toxicity
Non-Intracutaneous
Reactivity
Non-Material Pyrogen
Non- Skin
Sensitization | Non-Cytotoxicity
Non-Intracutaneous
Reactivity
Non- Skin Sensitization | Unknown | Equivalent. The
subject device is also
comply with ISO
10993-11:2012 with
non-Material Pyrogen
and non- Non-Acute
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.
-
- 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:
7
-
- 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
-
- ISO 7864. Sterile hypodermic needles for single use Requirements and test methods
-
- ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
-
- ANSI AAMI ISO 11607-1, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
-
- 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.
-
- ISO 14971, Medical devices Applications of risk management to medical devices
-
- 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 toxicity | |
| to L-929 cells. | Non-Cytotoxic | ||
| Acute Systemic | |||
| Toxicity | The sample extracts showed no significant | ||
| evidence of causing acute systemic toxicity | |||
| in the mouse. | Non-Acute | ||
| Systemic | |||
| Toxicity | |||
| Sensitization | The sample extract showed no significant | ||
| evidence of causing skin sensitization in the | |||
| guinea pig. | Non- | ||
| Sensitization | |||
| Intracutaneous | |||
| Reactivity | The test result showed that the extract of the | ||
| test article did not induce Intracutaneous | |||
| reactivity in rabbit. | Non- | ||
| Intracutaneous | |||
| Reactivity | |||
| Pyrogen | The animals' body temperature changed | ||
| less than 0.5 degree C. The test article met | |||
| 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.