(29 days)
The HALYARD* COOLIEF* Cooled Radiofrequency Kit, in combination with the HALYARD* Radiofrequency (RF) Generator (PMG-BASIC/PMG-ADVANCED) (formerly Baylis Pain Management Generator or KIMBERLY-CLARK® Pain Management Generator) is intended for the creation of Radio-Frequency (RF) heat lesions in nervous tissue for the relief of pain, and includes a fluid delivery system for commonly used fluid agents limited to contrast medium, saline, and/or anesthetic solution delivery at the target site.
The COOLIEF* Cooled Radiofrequency (RF) Kit is similar in construction, materials, energy source, and intended use to the predicate TransDiscal Cooled Radiofrequency Kit, which is a part of the cleared TransDiscal System (K062937) that also includes a "Y connector cable for the probes, a cooling pump, and a pump connector cable that connects to the RF generator. The COOLIEF* Cooled RF Kit includes fluid delivery introducers, cooled probes, and a burette tubing assembly. The subject COOLIEF* Cooled Radiofrequency Kit is available in several configurations based on the anatomic region of use (i.e., available in various introducer and probe lengths, and active tip lengths). The kit is sterilized to a SAL of 10-6 by EO terminal sterilization. The Fluid Delivery Introducer is a sterile, non-pyrogenic single-use cannula with a fluid delivery port. It is used with cooled radiofrequency probes in conjunction with the Halyard Radiofrequency Pain Management Generator, with cooling pump, to create lesions in nervous tissue for the relief of pain.
This document is a 510(k) Pre-Market Notification for the HALYARD* COOLIEF* Cooled Radiofrequency Kit, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the new device meets specific acceptance criteria in the way a clinical trial or algorithm validation study would.
The information provided describes the device, its intended use, and comparisons to a predicate device (TransDiscal Cooled RF Kit, K062937) and a reference device (Diros OWL Sterile Single-Use Trident R.F. Insulated Cannula models DTR and DTRH, K150371). The "acceptance criteria" here are implicitly the standards and features of the predicate device and the relevant biocompatibility and mechanical test standards.
Here's an analysis of the provided text in the context of your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical sense of numerical thresholds for clinical efficacy or diagnostic accuracy. Instead, it demonstrates substantial equivalence through comparisons of technological characteristics, materials, and a series of non-clinical performance tests against established standards and the predicate device.
The "acceptance criteria" can be inferred as:
- Compliance with ISO standards for biocompatibility, sterility, mechanical properties, and electrical safety.
- Similar performance to the predicate device in terms of RF lesion creation, if not explicitly quantified.
- Functionality of the new fluid delivery system (side port with extension tubing).
Here’s a summary table based on the provided "Summary of Non-Clinical Testing (Performance Testing)" and "Biocompatibility Testing":
| Acceptance Criteria (Inferred from Standards & Predicate) | Reported Device Performance (Non-Clinical Testing) |
|---|---|
| Biocompatibility (ISO 10993 Series) | |
| Cytotoxicity (ISO 10993-5): Non-cytotoxic | Passed |
| Sensitization (ISO 10993-10): Non-sensitizing | Passed |
| Irritation (ISO 10993-20): Non-irritant | Passed |
| Systemic Toxicity (ISO 10993-11): No signs of systemic toxicity | Passed |
| Material Mediated Pyrogenicity (ISO 10993-11): Non-pyrogenic | Passed |
| EO Residuals (ISO 10993-7): Below limits | Passed |
| Electrical Safety & EMC | |
| Electrical safety & High Frequency testing (as K062937) | "Same as existing cleared product (K062937)" |
| EMC (Emissions & Immunity) testing (as K062937) | "Same as existing cleared product (K062937)" |
| Mechanical Testing | |
| ISO 9626: Stainless steel needle tubing | Implied compliance by testing |
| ISO 7864: Bond force (hub-needle, extension-hub/Luer) | Tested |
| ISO 594-2:1998: Conical fittings (Luer) | Tested |
| ISO 11070:2014(E) Annex C: Tensile Strength | Tested |
| ISO 80369-20: Small-bore connectors | Tested |
| Dimensional Testing: To Specification | Tested |
| Fluid Flow: To Design Requirement of side lumen | Tested |
| Performance Testing | |
| Compatibility: Probe Luer and cannula hub Luer | Verified by measurements and performance testing |
| Temperature Accuracy | Verified by measurements and performance testing |
| RF Lesion Size: In tissue model | Measured |
| Injection Force: Comparison of fluid viscosity | Compared |
| Human Factors Usability | |
| Usability of device user interface for safety/effectiveness | Study conducted |
| Extension tubing with Luer connector functionality | Simulated use in intended environment |
The "study that proves the device meets the acceptance criteria" is the collection of non-clinical tests summarized, demonstrating compliance with various ISO standards and equivalence in performance to the predicate and reference devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes non-clinical (bench) testing. For such tests, "sample size" refers to the number of units tested for mechanical properties, biocompatibility, etc. This specific numerical sample size is not explicitly provided in the summary for individual tests (e.g., how many cannulas were tested for bond strength). The data provenance is from internal testing conducted by the manufacturer (Halyard Health, Inc.), implicitly in the USA. These are prospective tests conducted on the newly designed device components.
3. 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)
This section is not applicable. The "ground truth" concept is typically relevant for diagnostic or AI-based devices where human expert interpretation is compared to device output. For a physical medical device like a radiofrequency kit, performance is evaluated against engineering specifications, material standards, and functional tests, not against expert-established ground truth in a clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the reasons stated above (non-clinical testing of a physical device).
5. 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
This section is not applicable. An MRMC study is relevant for diagnostic imaging devices or AI tools involving human interpretation. This submission is for a therapeutic radiofrequency ablation kit.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. This is not an AI algorithm. The device performance is the physical device's ability to create lesions and deliver fluids, which is tested directly.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
As mentioned, true "ground truth" as typically defined for AI or diagnostic devices is not applicable. The "ground truth" for this device's performance validation is its adherence to:
- Established ISO standards for biocompatibility and mechanical properties.
- Functional requirements (e.g., fluid flow, lesion size in a tissue model).
- Equivalence to the predicate device's known performance.
8. The sample size for the training set
This section is not applicable. There is no "training set" as this is not an AI/machine learning device. The device is validated through engineering and bench testing, not through training on data.
9. How the ground truth for the training set was established
This section is not applicable for the reasons stated above.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 16, 2016
Halyard Health, Inc. % Dave Yungvirt Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041
Re: K163236
Trade/Device Name: COOLIEF Cooled Radiofrequency Kit Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: Class II Product Code: GXI Dated: November 16, 2016 Received: November 17, 2016
Dear Mr. Yungvirt:
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. 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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Hoffmann -S
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163236
Device Name COOLIEF* Cooled Radiofrequency Kit
Indications for Use (Describe)
The HALYARD* COOLIEF* Cooled Radiofrequency Kit, in combination with the HALYARD* Radiofrequency (RF) Generator (PMG-BASIC/PMG-ADVANCED) (formerly Baylis Pain Management Generator or KIMBERLY-CLARK® Pain Management Generator) is intended for the creation of Radio-Frequency (RF) heat lesions in nervous tissue for the relief of pain, and includes a fluid delivery system for commonly used fluid agents limited to contrast medium, saline, and/or anesthetic solution delivery at the target site.
| 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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Image /page/3/Picture/0 description: The image contains the logo for Halyard. The logo consists of a blue circle with a white and green abstract design inside, followed by the word "HALYARD" in blue, block letters. The abstract design inside the circle appears to be two overlapping shapes, one white and one green.
510(k) Summary as Required by 21 CFR §807.92(c)
As required by the Safe Medical Devices Act (SMDA) of 1990 and in accordance with 21 CFR §807.92(a), this 510(k) Summary is of sufficient detail to provide an understanding of the basis for a determination of substantial equivalence.
510(k) Summary
| [807.92 (a)(1,2)] | |
|---|---|
| Date Summary Prepared | December 15, 2016 |
| 510(k) SponsorAddress | Halyard Health, Inc.5405 Windward ParkwayAlpharetta, GA 30004 |
| Contact Person | Mary Ann B. KinardAssociate Director Regulatory AffairsPhone: (470) 448-5805Email:maryann.kinard@hyh.com |
| Trade Name | COOLIEF* Cooled Radiofrequency Kit |
| Common Name | Cannula, Radiofrequency Probe |
| Classification Name | Probe, Radiofrequency lesion |
| Regulation Number | 21 CFR §882.4725 |
| Product Code | GXI |
| Device Classification | II |
| Review Panel | (84) Neurology |
5405 Windward Parkway Alpharetta, Georgia 30004
1-844-HALYARD
halyardhealth.com
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Predicate Marketed Devices:
| [807.92(a)(3)] | ||
|---|---|---|
| Manufacturer Name | Trade Name | 510(k) Number |
| BaylisMedicalCompany | TransDiscal System including modelsTDP-17-150-6, TDI-17-150, TDA-PPU-1,TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU | K062937 |
Prior Submission:
There was no prior submission for the COOLIEF* Cooled Radiofrequency Kit.
Reference Device
A reference device is included in the substantial equivalence discussion; namely, Diros OWL Sterile Single-Use Trident R.F. Insulated Cannula models DTR and DTRH, cleared under K150371.
| ManufacturerName | Trade Name | 510(k) Number |
|---|---|---|
| DirosTechnology, Inc | Diros OWL Sterile Single-Use Trident R.F.Insulated Cannula models DTR and DTRH | K150371 |
[(807.92(a)(4)]
Description of Device:
The COOLIEF* Cooled Radiofrequency (RF) Kit is similar in construction, materials, energy source, and intended use to the predicate TransDiscal Cooled Radiofrequency Kit, which is a part of the cleared TransDiscal System (K062937) that also includes a "Y connector cable for the probes, a cooling pump, and a pump connector cable that connects to the RF generator.
The following table compares the components of the subject Cooled RF Kit with the predicate TransDiscal Cooled RF Kit. The modified component in the subject COOLIEF* Cooled RF Kit is only the Fluid Delivery Introducer, which was changed to include a fluid delivery port.
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| COOLIEF* Cooled RF Kit(Subject Kit) | TransDiscal System K062937(Predicate) | |
|---|---|---|
| Description | Description | TransDiscalCooled RF Kit |
| Cooled Probe, 17 gauge, 150 mmlength, 6 mm active tip | Cooled Probe, 17 gauge, 150 mm length,6 mm active tip | |
| Fluid Delivery Introducer, 17 gauge,150 mm length | Introducer, 17 gauge, 150 mm length | |
| Burette and tubing assembly forcooling pump | Burette and tubing assembly for coolingpump | |
| Cable for TransDiscal Probes | ||
| Probe "Y" connector cable | ||
| Cooling Pump and Cable | ||
| Pump to Generator connector cableCooling pump |
Description of COOLIEF* Cooled RF Kit Compared to Predicate
The COOLIEF* Cooled RF Kit includes fluid delivery introducers, cooled probes, and a burette tubing assembly. The subject COOLIEF* Cooled Radiofrequency Kit is available in several configurations based on the anatomic region of use (i.e., available in various introducer and probe lengths, and active tip lengths). The kit is sterilized to a SAL of 10-6 by EO terminal sterilization.
The Fluid Delivery Introducer is a sterile, non-pyrogenic single-use cannula with a fluid delivery port. It is used with cooled radiofrequency probes in conjunction with the Halyard Radiofrequency Pain Management Generator, with cooling pump, to create lesions in nervous tissue for the relief of pain. The Fluid Delivery Introducer consists of a sharp trocar shaped solid stylet with a plastic Luer-lock handle that is surrounded by a fully insulated stainless steel hypotube and an over molded plastic hub that is Luer-lock compliant. The stylet handle securely connects to the introducer hub that also acts as a handle to guide the introducer through tissue while the stylet is engaged. The non-coring stylet protrudes from the end of the insulated introducer to tunnel a path for introducer placement in percutaneous tissue. Removal of the stylet gives access to the introducer lumen for insertion of a cooled thermocouple probe. Once fully inserted, the distal tip of the probe extends beyond the distal end of the introducer based on the desired active tip size, which determines the size of the lesion. The introducer hub incorporates a side lumen with extension tubing attached to accept a syringe connection to deliver low volume of fluid agents limited to saline, contrast material, and/or local anesthetics into the target tissue.
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The Fluid Delivery Introducer will replace the current introducer in the Cooled RF Kit configuration marketed under clearance K062937. The following Cooled Radiofrequency Kits are the subject of this 510(k) and include the RF Introducers and RF Cooled probes listed below.
- RF Cooled RF Kits (Cooled RF)
- CRK-xx-XXX-##, where xx is the gauge, XXX is the length in mm, and ## is the o active tip length in mm -CRK indicates Cooled Radiofrequency Kit
-xx is 17 gauge
- -XXX is 50, 75, 100, 150 mm length
- -## is 2, 4, or 5.5 active tip exposure length in mm
- O SIK-xx-XXX-##, where xx is the gauge, XXX is the length in mm, and ## is the active tip length in mm
-SIK indicates SInergy* Cooled Radiofrequency Kit (for Sacroiliac anatomy) -xx is 17 gauge -XXX is 75, 150 mm length -## is 4 active tip exposure or length in mm
- o MCKy-xx-XXX-##, where y is either 2 or 3 to indicate the number of probes, xx is the gauge, XXX is the length in mm, and ## is the active tip length in mm -MCKy indicates "Multi Cooled" Radiofrequency Kit -xx is 17 gauge -XXX is 50, 75, 100, 150 mm length -## is 2, 4, or 5.5 active tip exposure length in mm
- RF Introducers (Cooled RF) ●
- o FDI-xx-XXX-##, where xx is the gauge, XXX is the length in mm, and ## is the active tip length in mm
-FDI indicates Fluid Delivery Introducer -xx is 17 gauge -XXX is 50, 75, 100, 150 mm length -## is 2, 4, or 5.5active tip exposure length in mm
- RF Cooled Probes (Cooled RF) ●
- o CRP-xx-XXX; where xx is the gauge, XXX is the length in mm, -CRP indicates Cooled Radiofrequency Probe -xx is 17 gauge -XXX is 50, 75, 100, 150 mm length
The Cooled RF kits that include the Fluid Delivery Introducer may include a single probe or multiple probes. The contents of COOLIEF* Cooled Radiofrequency Kits containing one cooled probe are summarized in the following Table.
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| Kit Model → | SIK-17-75-4 | SIK-17-150-4 | CRK-17-50-2 | CRK-17-50-4 | CRK-17-75-2 | CRK-17-75-4 | CRK-17-75-5.5 | CRK-17-100-4 | CRK-17-150-4 |
|---|---|---|---|---|---|---|---|---|---|
| Fluid Delivery Introducer (FDI) with protective sheath | 3 | 3 | 2 | 3 | 2 | 3 | 2 | 3 | 3 |
| Cooled RF Probe with protective sheath | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| Burette/Tube Kit for Pump | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
The contents of COOLIEF* Cooled Radiofrequency Kits containing multiple cooled probe are summarized in the following Table.
| Kit Model → | MCK3-17-100-4 | MCK-3-17-75-4 | MCK2-17-100-4 | MCK2-17-75-4 |
|---|---|---|---|---|
| Fluid Delivery Introducer (FDI) with protective sheath | 6 | 6 | 4 | 4 |
| Cooled RF Probe with protective sheath | 3 | 3 | 2 | 2 |
| Burette/Tube Kit for Pump | 2 | 2 | 2 | 2 |
Packaging for the COOLIEF* Cooled Radiofrequency Kit containing the modified Fluid Delivery Introducer is the same as the current COOLIEF* kits (both single and multiprobe kits).
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| Component | Material | Body Contact (Y/N) |
|---|---|---|
| Stylet | 304 Stainless Steel | Y |
| Stylet handle | ABS Plastic | N |
| Cannula / Hypotube | 304 Stainless Steel | Y |
| Insulation | Polyimide | Y |
| Adhesive for cannula to hub | Loctite | Indirect through injectedfluid |
| Extension tubing with Luerport | PVC | Indirect through injectedfluid |
| Adhesive for polyimide tocannula tip | Loctite CA | Y |
| Adhesive for polyimide tocannula body | Loctite Epoxy | N |
| Depth Indicator | Green Hytrel | Y |
| Cannula Hub | Acrylic based multipolymer | Indirect through injectedfluid |
| Luer connector on extensiontubing | PC Makrolon | Indirect through injectedfluid |
| Luer cap | HDPE | Indirect through injectedfluid |
The materials and patient contact status of the Fluid Delivery Introducer are summarized in the following table.
Energy Type
The Fluid Delivery Introducer uses RF energy supplied by the Halyard Pain Management Radiofrequency generator through the inserted internally cooled probe. The generator applies temperature-controlled, radiofrequency (RF) energy into targeted nerve tissue surrounding the active tip of the device. The radiofrequency energy creates a heat lesion in the nervous tissue to inactivate the nerve pathway resulting in pain relief.
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[(807.92(a)(5)]
Indications for Use:
| COOLIEF* Cooled Radiofrequency (RF) Kit(Subject Device) | TransDiscal Cooled RF KitBaylis TransDiscal System(Predicate K062937) |
|---|---|
| The HALYARD* COOLIEF* CooledRadiofrequency Kit, in combination with theHALYARD* Radiofrequency (RF) Generator(PMG-BASIC/PMG-ADVANCED) (formerlyBaylis Pain Management Generator orKIMBERLY-CLARK® Pain ManagementGenerator) is intended for the creation of Radio-Frequency (RF) heat lesions in nervous tissue forthe relief of pain, and includes a fluid deliverysystem for commonly used fluid agents limited tocontrast medium, saline, and/or anesthetic solutiondelivery at the target site. | The Baylis TransDiscal System, used incombination with the Baylis PainManagement Generator, is intended for thecreation of Radio Frequency (RF) lesionsin nervous tissue including that which issituated in intervertebral disc material. |
Both the subject and predicate devices are intended for use with the same Pain Management Generator (i.e., current Halyard Generator was formerly the Baylis Generator) to produce radio frequency heat lesions in nervous tissues. The indications for use of the subject device no longer references use within the intervertebral disc material, which raises no new issues of safety or effectiveness. The indications for use of the subject device further limits use to relief of pain, which does not raise new issues of safety or effectiveness since it further limits the population to patients experiencing pain. The indications for use of the subject device adds reference to fluid delivery for use with fluid agents that are limited to contrast medium, saline, and/or anesthetic solution to the Current medical practice and use of the predicate device involves target site. administration of the same fluids, and the results of performance testing of the subject device that allows low-volume fluid delivery through a side-port raise no new issues of safety or effectiveness.
[(807.92(a)(6)] Technological Characteristics:
The COOLIEF* Cooled Radiofrequency Kit contains a Fluid Delivery Introducer which consists of a sharp trocar shaped solid stylet surrounded by a fully insulated cannula. The stylet is removable via an attached stylet cap. The tip of the cannula is placed near the target nerve and the stylet is then removed. A separate cooled radiofrequency probe is inserted to deliver the radiofrequency energy, which may also include nerve stimulation for assurance of target placement which is also verified by fluoroscopy. Fluid may be injected using the side extension tubing while the probe is engaged and before or after energy delivery. The probe can be removed, and the cannula hub can be sealed with the Luer cap from the side extension tubing Luer, while a syringe delivers the desired fluid
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using the side port. The third method for fluid delivery is attaching a syringe to the Luer top of the cannula hub while the Luer cap is secure to the side port tubing. The feature of the side port extension set allows three ways to deliver fluid compared to current practice of removing the probe to access the cannula hub top to inject fluid.
Comparison of Technological Characteristics with the Predicate Device
The COOLIEF* Cooled Radiofrequency Kit described in this submission is similar to the predicate device kit.
The principle of operation for the subject and predicate device kit is identical. Both kits contain introducers, cooled probes, and a burette tubing assembly. The introducer component of both devices tunnel through tissue to allow the probe conductive metal shaft to deliver the RF energy to target nervous tissue to create a lesion. Both device kits are used in conjunction with the RF generator and cooling pump to create the heat lesion in the tissue surrounding the bare tip (uninsulated metal) of the probe while engaged in the introducer. Both devices have the capability of delivering fluid through the introducer. The predicate introducer (K062937) provides a lumen starting at the cannula hub Luer lock in which a syringe can be attached to deliver fluid while the probe is disengaged. The subject device provides two lumens in which a syringe can be attached to deliver fluid: a cannula hub Luer lock connection (probe is disengaged), the side port with extension tubing Luer lock connector (Probe is either engaged or disengaged in the cannula.) The two lumens are not used simultaneously, but as two alternate access ports.
The only modified component in the COOLIEF* Cooled RF Kit compared to the predicate kit is the Fluid Delivery Introducer (FDI). The FDI device contains a side port with extension tubing and a Luer lock connector that is not included on the introducer in the predicate kit.
Technological elements that are the same between the subject kit and predicate kit:
Intended Use Where used (nervous tissue) Energy used (radiofrequency) Fluid path from top of introducer hub Design features (hypotube, gauge, insulation, stylet) Performance to Standards Standards Applicable Materials used Biocompatibility Compatibility with other devices (probes) Sterility Electrical Safety Mechanical Safety
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Technological elements that are different between the subject kit and predicate kit:
Indications for Use (delivery fluids listed) Lengths of Introducer (additional shorter lengths)
The Fluid Delivery Introducer contained in the COOLIEF* Cooled RF Kit contains a side port with extension tubing and a Luer lock connector that is not included on the introducer in the predicate TransDiscal Cooled RF kit. There are no other modifications to the remaining components in the COOLIEF* Cooled RF kit compared to the predicate TransDiscal Cooled RF Kit. The subject kit will be available with the same and shorter lengths of Fluid Delivery Introducers with matched size length probes.
Rationale for Use of a Reference Device
The reference device (K150371) was selected to demonstrate that the addition of the extension tubing and Luer connector does not raise new questions or issues of safety or effectiveness.
The reference device has the same indications for use as the modified subject device (FDI): a) the indication for use with injection fluids, b) radiofrequency lesioning procedures, but also includes c) nerve stimulation. The fluids described in the reference device indication are: local anesthetic solution, and contrast medium. The local anesthetic solution or contrast medium are delivered through the needle hypotube to the target site. The subject device indication includes saline as a fluid for delivery to the target site in addition to the reference device fluids of contrast or local anesthetic. Physiologic saline (0.9%) has the same density and fluid characteristics as local anesthetic, and since there is no significant difference between the density of local anesthetic and saline, the addition of saline to the indication for use does not affect the safety and effectiveness of the subject device when used as labeled. The addition of saline in the indications for use for the subject device do not change the intended therapeutic or minimally invasive surgical use of the device because low volumes of physiologic (0.9%) saline is a commonly used fluid during radiofrequency ablation procedures as a mechanism to keep the target tissue hydrated before the energy is applied.
Biocompatibility Testing
| Clearance | Classification | ContactDuration |
|---|---|---|
| SubjectDevice | Externally Communicating DeviceTissue / Bone / Dentin | < 24 hourscontact |
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| Biocompatibility Test | Results | Subject Device Results |
|---|---|---|
| CytotoxicityISO 10993-5 | Non-cytotoxic | Passed |
| SensitizationISO 10993-10 | Non-Sensitizing | Passed |
| IrritationISO 10993-20 | Non-Irritant | Passed |
| Systemic toxicityISO 10993-11 | No signs of systemictoxicity | Passed |
| Material Mediated PyrogenicityISO 10993-11 | Non-Pyrogenic | Passed |
| EO ResidualsISO 10993-7 | Residuals below limits | Passed |
The scientific biocompatibility studies according to international standards demonstrate that the additional materials in the subject device do not raise new questions about safety and effectiveness.
Summary of Non-Clinical Testing (Performance Testing)
The following performance data are provided in support of the substantial equivalence determination for the component. Fluid Delivery Introducer.
Biocompatibility testing on the final finished subject Fluid Delivery Introducer
- Cytotoxicity
- Sensitization
- Irritation
- Systemic toxicity
- Material Mediated Pyrogen Testing ●
Electrical Safety and electromagnetic compatibility (EMC)
- Electrical safety and High Frequency testing is the same as the existing cleared product (K062937) on the market. The addition of PVC tubing, epoxy, and plastic Luer lock does not change the electrical characteristics of the device, and does not influence the operations of the radiofrequency transmission.
- EMC (Emissions and Immunity) testing is the same as the existing cleared . product (K062937) on the market. The addition of PVC tubing, epoxy, and plastic Luer lock does not alter the electromagnetic compatibility.
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Mechanical testing
- ISO 9626 Stainless steel needle tubing for the manufacture of medical devices .
- . ISO 7864 Bond force is tested between hub handle and needle tubing, as well as the bond force of the extension tubing attached to the introducer hub and Luer connector
- ISO 594-2:1998: Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
- ISO 11070:2014(E) Annex C Tensile Strength ●
- ISO 80369-20 Small-bore connectors for liquids and gases in healthcare applications —Part 20:Common test methods
- Dimensional Testing to Specification ●
- Fluid Flow to Design Requirement of side lumen ●
Performance testing
- Compatibility between probe Luer and cannula hub Luer is verified by ● measurements and performance testing
- . Temperature accuracy, accuracy verified by measurements and performance testing
- Measured RF lesion size in tissue model
- Injection force comparison of fluid viscosity for fluids for delivery
Human Factors Usability study
- Usability of the device user interface for safety and effectiveness
- . Extension tubing with Luer connector attached to the hub with ability to attach a syringe through simulated use in its intended environment
All non-clinical testing performed on the subject final finished FDI sterilized device is identical to testing performed on existing cleared product (K062937) on the market with additional testing specific to the added tubing and Luer connector on the subject device, viscosity comparison, and human factors usability studies. Test setup and execution are performed in accordance with applicable standards. Results of the tests demonstrate the compliance to the standards as appropriate and match the performance of the subject device to predicate device.
[(807.92(b)(1)]
Non-Clinical Performance Data:
The Fluid Delivery Introducer, as part of the COOLIEF* Cooled Radiofrequency Kit is manufactured in accordance with the requirements of the Current Good Manufacturing Practices for Medical Devices and the testing performed which support a determination of substantial equivalence includes:
{14}------------------------------------------------
- appropriate biocompatibility tests,
- sterility tests. ●
- predicate product comparative tests ●
- performance tests.
- fluid viscosity and injection force and
- . Human factors usability
The test results are in compliance with existing domestic and international standards. Based on the above test parameter results, the COOLIEF* Cooled Radiofrequency Kit containing the fluid delivery introducer does not raise any different questions or new issues of safety and effectiveness.
[(807.92(b)(2)] Clinical Performance Data:
Clinical data is not required.
[(807.92(b)(3)] Conclusion:
The predicate kit was cleared based on the results of non-clinical data. The only modification to the subject kit is the Fluid Delivery Introducer. The Fluid Delivery Introducer component and the introducer component in the predicate kit were compared with performance data to support the safety of the subject device and demonstrate that the Fluid Delivery Introducer should perform as intended in the specified use conditions in the COOLIEF* Cooled Radiofrequency Kit and is equivalent to the predicate comparator TransDiscal Cooled RF Kit. Based on the comparisons to the predicate device and reference device as provided within this 510(k) Summary, the COOLIEF* Cooled Radiofrequency Kit does not raise any different questions or new issues of safety and effectiveness.
[(807.92(d)] Other Information:
None
End of 510(k) Summary
§ 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).