(125 days)
The COOLIEF* Cooled Radiofrequency Probe is to be used in conjunction with a radiofrequency generator to create lesions in nervous tissue. This device is also indicated for creating radiofrequency lesions of the genicular nerves for the management of moderate to severe knee pain of more than 6 months with conservative therapy, including medication, in patients with radiologically-confirmed osteoarthritis (grade 2-4) and a positive response (≥50% reduction in pain) to a diagnostic genicular nerve block.
The COOLIEF* Cooled Radiofrequency (RF) Probe is a sterile, single-use device that delivers RF energy within the area of the active probe tip, while the probe tip is cooled by sterile water that circulates within the probe. Cooling the probe tip creates a larger. more homogenous RF heating area that results in a larger RF lesion in the target tissue. COOLIEF* Cooled RF Probe is used in conjunction with the Halyard RF Generator to create RF lesions in nervous tissue. The shaft of the probe is insulated with a polyimide sheath, and the distal tip consists of a medical grade stainless steel electrode. Sterile water circulates through a cavity in the electrode to cool the electrode tip during the cooled RF ablation procedure. The COOLIEF* Cooled Radiofrequency (RF) Probe is sterilized by ethylene oxide.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a singular section for clinical performance. Instead, it describes the effectiveness endpoint and provides the results.
| Characteristic / Test Type | Acceptance Criteria (Implied) | Reported Device Performance (COOLIEF* Cooled RF Probe) |
|---|---|---|
| Clinical Effectiveness (Primary Endpoint) | Superiority to corticosteroid injection in achieving ≥ 50% pain reduction at 6 months post-treatment in patients with moderate to severe knee pain due to radiologically-confirmed osteoarthritis (grade 2-4) and a positive response (≥50% reduction in pain) to a diagnostic genicular nerve block. | 67.2% of the COOLIEF* Cooled RF study group achieved ≥50% pain relief at 6 months, compared to 15.7% of the corticosteroid injection group (p-value for superiority not explicitly stated but implied by "superior to steroid injection").Mean NRS pain reduction: 4.9 points (from 7.3 to 2.5) at 6 months.Significant functional improvement: 39.7% reported "Satisfactory Joint Function" vs. 3% in comparison group.Global Perceived Effect: 91.4% reported "improved" knee condition vs. 23.9% in comparison group. |
| Cytotoxicity | Qualitative Grade = 0; Quantitative = cell death < 30% | Pass: No Cytotoxic effect |
| Sensitization | Challenge Phase = Less than Grade 1 and less than the controls | Pass: No signs of sensitization |
| Irritation or Intracutaneous Reactivity | Test sample score < 1.0 for Erythema and Edema grading | Pass: No signs of Irritation |
| Systemic Toxicity (acute) | No animal death | Pass: No signs of systemic toxicity |
| Electrical Safety | Conformance to IEC 60601-1:2005 | Passed |
| High Frequency Surgical Equipment | Conformance to IEC 60601-2-2: 2009 (Fifth Ed.) | Passed |
| Electromagnetic Compatibility (EMC) | Conformance to IEC 60601-1-2:2007 / AC 2010 | Passed |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Study Test Set Sample Size: The document indicates an Intent-to-Treat (ITT) population for the primary effectiveness endpoint.
- COOLIEF* Cooled RF (CRFA) group: 76 subjects
- Corticosteroid Injection (IAS) group: 75 subjects
- Data Provenance: The clinical study was a prospective, multicenter, randomized comparative human study. The document does not specify the country of origin, but given the FDA submission, it's typically a US-based or international study adhering to US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable in the context of this device and study. The "ground truth" for the clinical study was based on patient-reported outcomes (Numeric Rating Scale for pain, "Satisfactory Joint Function" report, Global Perceived Effect) and a diagnostic genicular nerve block response for patient selection, not expert consensus on images or pathology.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in studies where subjective assessments (e.g., image interpretation) need to be resolved. This clinical study focused on patient-reported outcomes and objective measures (like pain scale changes), so a formal adjudication method as commonly understood in imaging studies would not be directly applicable. The "ground truth" was directly from the patient or objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The study was a randomized controlled trial comparing the device (COOLIEF Cooled RF Probe) to a control treatment (corticosteroid injection)* for pain management in patients, not a study evaluating human readers' performance with and without an AI algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not an AI/algorithm-based device. The COOLIEF* Cooled RF Probe is a medical device that physically delivers radiofrequency energy. Therefore, the concept of a "standalone algorithm performance" does not apply. The study evaluated the device's therapeutic effect.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The primary ground truth for the clinical effectiveness study was:
- Outcomes Data (Patient-Reported Outcomes): Numeric Rating Scale (NRS) for pain reduction, patient reports of "Satisfactory Joint Function," and Global Perceived Effect of knee condition.
- Diagnostic Response: Patients were selected based on a positive response (≥50% reduction in pain) to a diagnostic genicular nerve block, serving as an inclusion criterion rather than a "ground truth" for the clinical outcome itself.
For the non-clinical tests, the ground truth was derived from established scientific and regulatory standards (e.g., ISO guidelines) and laboratory measurements (e.g., cell death percentage for cytotoxicity, animal responses for sensitization/irritation/toxicity).
8. The Sample Size for the Training Set
This is not an AI/machine learning device, so there is no "training set" in the conventional sense for an algorithm. The clinical study was a prospective comparative trial to evaluate the device's performance directly on human subjects.
9. How the Ground Truth for the Training Set Was Established
As noted above, there is no "training set" for an algorithm. The clinical data was collected from the prospective human study to directly assess the safety and effectiveness of the device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a family, with three profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 13, 2017
Halyard Health, Inc. Monica King Associate Director, Regulatory Affairs 5405 Windward Parkway Alpharetta, Georgia 30004
Re: K163461
Trade/Device Name: Coolief* Cooled RF Probe Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency Lesion Probe Regulatory Class: Class II Product Code: GXI Dated: March 13, 2017 Received: March 14, 2017
Dear Ms. King:
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 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.
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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
Carlos L. Peña, PhD, MS for 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) K163461
Device Name COOLIEF* Cooled RF Probe
Indications for Use (Describe)
The COOLIEF* Cooled Radiofrequency Probe is to be used in conjunction with a radiofrequency generator to create lesions in nervous tissue. This device is also indicated for creating radiofrequency lessons of the management of moderate to severe knee pain of more than 6 months with conservative therapy, including medication, in patients with radiologically-confirmed osteoarthritis (grade 2-4) and a possitive response (≥50% reduction in pain) to a diagnostic genicular nerve block.
| 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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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), the 510(k)-summary provided below is of sufficient detail to provide an understanding of the basis for a determination of substantial equivalence.
510(k) Summary
1. Contact Details
| Date Summary Prepared | 04/05/2017 |
|---|---|
| 510(k) Applicant Name,Address,Website | Halyard Health, Inc.5405 Windward ParkwayAlpharetta, GA 30004www.halyardhealth.com |
| Applicant Contact Person | Monica KingAssociate Director, Regulatory AffairsPhone: (678) 477-4165FAX: (678) 254-0347Email: monica.king@hyh.com |
2. Device Information
| Trade Name | COOLIEF* Cooled RF Probe |
|---|---|
| Common Name | Radiofrequency Lesion Probe |
| Models | CRP-, CRK-, MCK- |
| Classification | II |
| Classification Name | Probe, Radiofrequency Lesion |
| Regulation Number | 21 CFR §882.4725 |
| Product Code | GXI |
| Review Panel | 84 Neurology |
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3. Legally Marketed Predicate Device:
| Trade Name | Pain Management Cooled Probe |
|---|---|
| 510(k) Number | K053082 |
| Product Code | GXI |
| Manufacturer | Halyard Health |
4. Description of Device:
The COOLIEF* Cooled Radiofrequency (RF) Probe is a sterile, single-use device that delivers RF energy within the area of the active probe tip, while the probe tip is cooled by sterile water that circulates within the probe. Cooling the probe tip creates a larger. more homogenous RF heating area that results in a larger RF lesion in the target tissue. COOLIEF* Cooled RF Probe is used in conjunction with the Halyard RF Generator to create RF lesions in nervous tissue. The shaft of the probe is insulated with a polyimide sheath, and the distal tip consists of a medical grade stainless steel electrode. Sterile water circulates through a cavity in the electrode to cool the electrode tip during the cooled RF ablation procedure. The COOLIEF* Cooled Radiofrequency (RF) Probe is sterilized by ethylene oxide.
Proposed Indication for Use:
The COOLIEF* Cooled Radiofrequency Probe is to be used in conjunction with a radiofrequency generator to create lesions in nervous tissue. This device is also indicated for creating radiofrequency lesions of the genicular nerves for the management of moderate to severe knee pain of more than 6 months with conservative therapy, including medication, in patients with radiologicallyconfirmed osteoarthritis (grade 2-4) and a positive response (≥50% reduction in pain) to a diagnostic genicular nerve block.
5. Substantial Equivalence Comparison
The following table compares the subject COOLIEF* Cooled RF Probe to the predicate Pain Management Cooled Probe (K053082) to support substantial equivalence.
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| Characteristic | COOLIEF*Cooled RFProbe(K163461) | PainManagementCooled Probe(K053082) | Comments |
|---|---|---|---|
| Intended Use | The COOLIEF* CooledRadiofrequency Probe is tobe used in conjunctionwith a radiofrequencygenerator to create lesionsin nervous tissue. Thisdevice is also indicated forcreating radiofrequencylesions of the genicularnerves for the managementof moderate to severe kneepain of more than 6months with conservativetherapy, includingmedication, in patientswith radiologically-confirmed osteoarthritis(grade 2-4) and a positiveresponse (≥50% reductionin pain) to a diagnosticgenicular nerve block. | Used in conjunctionwith a radiofrequencygenerator to createradiofrequency lesionsin nervous tissue. | Clinical data to support theproposed indication issubmitted in the Protocol AProspective, Multi-center,Randomized, Clinical TrialEvaluating the Safety andEffectiveness of UsingCoolief™ CooledRadiofrequency Probe toCreate Lesions of theGenicular Nerves andComparing CorticosteroidInjection in the Managementof Knee Pain |
| Probe ShaftLength | Overall Useable Length150mm, 100mm, 75mm,50mmShaft Outer Diameter18Ga | Overall Useable Length150mm, 100mm, 75mm,50mmShaft Outer Diameter18Ga | Equivalent |
| Distal TipLength | 6mm probe electrodewith various activelengths when combinedwith a mating introducerof 2, 4, and 5.5mm | 6mm probe electrodewith various activelengths when combinedwith a mating introducerof 2, 4, and 5.5mm | Equivalent |
| Lesion Size | 10-12mm,Spherical | 10-12mm,Spherical | Equivalent |
| TemperatureMeasurementAccuracy | ± 3° C | ± 3° C | Equivalent |
| TemperatureMeasurementDevice | Thermocouple | Thermocouple | Equivalent |
| Characteristic | COOLIEF*Cooled RFProbe(K163461) | Pain ManagementCooled Probe(K053082) | Comments |
| TemperatureRange | 38° - 95° C | 38° - 95° C | Equivalent |
| TemperatureIncrement | 1°C | 1°C | Equivalent |
| Single Use | Yes | Yes | Equivalent |
| Compatible RFSystem | HalyardCOOLIEF*System Only | HalyardCOOLIEF*System Only | Equivalent |
| Disposable | Yes | Yes | Equivalent |
| Biocompatibility | Conforms toISO10993 | Conforms toISO10993 | Equivalent |
| SensitizationISO 10993-10 | Conforms toISO10993-10 | Conforms toISO10993-10 | Equivalent |
| IrritationISO 10993-20 | Conforms toISO10993-20 | Conforms toISO10993-20 | Equivalent |
| CytotoxicityISO 10993-5 | Conforms toISO10993-5 | ConformstoISO10993-5 | Equivalent |
| Characteristic | COOLIEF*Cooled RFProbe(K163461) | Pain ManagementCooled Probe(K053082) | Comments |
| SystemictoxicityISO 10993-11 | Conforms toISO10993-11 | Conforms toISO10993-11 | Equivalent |
| Sterility | Sterilized by EOSAL = 10-6 | Sterilized by EOSAL = 10-6 | Equivalent |
| Packaging | Device contained in asingle use Tyvek sealedtray | Device contained in asingle use Tyvek sealedtray | Equivalent |
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The difference in the Indications for Use statements do not raise new questions of safety and effectiveness. Cooled radiofrequency (RF) is a well-established method for delivering lesions into nervous tissue to accomplish neurotomy procedures. The use of the Cooled RF probe to perform the genicular neurotomy procedure is like the other minimally invasive cooled radiofrequency ablation procedures in that lesions are created in targeted sensory nerves to block the transmission of pain signals. The RF lesions created in the genicular neurotomy procedure are the same size and shape as in other RF procedures. The clinical data collected to support the proposed indication demonstrate that the COOLIEF* Cooled RF Probe does not present safety or effectiveness issues related to the proposed indication for use. Data collected at the primary endpoint supports the conclusion that the COOLIEF* Cooled RF Probe used for genicular nerve ablation is superior to corticosteroid injection in osteoarthritic subjects for managing knee pain.
Reference Device
A reference device is presented below regarding the biocompatibility data set for this device. Biocompatibility testing data is derived from testing conducted on the representative Halyard* TransDiscal* RF probe (K031951): the TransDiscal* RF probe and the Cooled Radiofrequency Probe are composed of the same raw materials, manufactured using similar processes within the same facility, sterilized using the same Ethylene Oxide cycles and chambers, and packaged using the same packaging materials.
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| Comparison to Reference Device | |
|---|---|
| Subject Device: COOLIEF* Cooled RF Probe | Reference Device: TransDiscal* RF probe |
| K163481 | K031951 |
| The COOLIEF* CooledRadiofrequency Probe is to be used inconjunction with a radiofrequencygenerator to create lesions in nervoustissue. This device is also indicatedfor creating radiofrequency lesions ofthe genicular nerves for themanagement of moderate to severeknee pain of more than 6 months withconservative therapy, includingmedication, in patients withradiologically-confirmedosteoarthritis (grade 2-4) and apositive response (≥50% reduction inpain) to a diagnostic genicular nerveblock. | The Transdiscal system, in combination withthe Baylis Pain Management Generator-TD(PMG-TD), is indicated for the coagulation anddecompression of disc material to treatsymptomatic patients with contained herniateddiscs. |
| Sterility: Sterilized by | Sterility: Sterilized |
| EO SAL = 10-6 | by EO SAL = 10-6 |
| Packaging: Device contained in a single useTyvek sealed tray | Packaging: Device contained in a single useTyvek sealed tray |
6. Non-Clinical Testing
The table below describes the test type, standard reference, acceptance criteria, and result summary.
| Test Type | Standard | Test Name | Criteria | Result |
|---|---|---|---|---|
| Cytotoxicity | ISO 10993-5 | In Vitro Cytotoxicity,Direct and Extract | Qualitative Grade = 0Quantitative = cell death< 30% | Pass: NoCytotoxic effect |
| Sensitization | ISO 10993-10 | In Vivo, Animal GPMT | Challenge Phase = Lessthan Grade 1 and lessthan the controls | Pass: No signsof sensitization |
| Irritation orIntracutaneousreactivity | ISO 10993-10 | In Vivo, AnimalIrritation (Rabbits) | Test sample score < 1.0for Erythema and Edemagrading | Pass: No signsof Irritation |
| Systemic Toxicity(acute) | ISO 10993-11 | In Vivo, AnimalToxicity (Mice) | No animal death | Pass: No signsof systemictoxicity |
Biocompatibility Testing
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| Test | Test Description | Results |
|---|---|---|
| Electrical safety | IEC 60601-1:2005Medical electrical equipmentPart 1: General requirements for basic safety and essential performance | Passed |
| High Frequency surgical equipment | IEC 60601-2-2: 2009 (Fifth Ed.)Medical electrical equipmentPart 2-2: Requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories | Passed |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2007 / AC 2010Medical electrical equipmentPart 1-2: General requirements for safety –Collateral standard: Electromagnetic compatibility | Passed |
Summary of IEC 60601 Compliance
7. Clinical Testing
Halyard conducted a prospective, multicenter, randomized comparative human study, to confirm the safety and effectiveness of COOLIEF* Cooled RF Probe for creating lesions of the genicular nerves for pain management of the knee. The COOLIEF* Cooled RF Probe was compared to corticosteroid injection.
The primary effectiveness endpoint of the clinical study was the proportion of subjects whose knee pain is reduced by ≥ 50% based on the Numeric Rating Scale (NRS) at the 6month study time point. At the 6-month study time point, based on Intention to Treat (ITT) ≥50% pain relief over baseline was experienced by 67.2% of the COOLIEF* Cooled RF study group vs. 15.7% of the comparison group (i.e., corticosteroid injection), using the Numeric Rating Scale (Pain rating scale 1 to 10).
Significant and sustained pain reduction was observed in the study group: subjects had a 4.9-point mean drop in NRS from a baseline mean of 7.3 to a mean of 2.5 at 6 months, while the comparison group had a 1.3-point mean drop in NRS from a baseline of 7.2 to a mean of 5.9 at 6 months. Significant functional improvement occurred in the study group: 39.7% reported "Satisfactory Joint Function" vs. 3% in comparison group. Global Perceived Effect Knee condition was reported as "improved" in 91.4% of the study group vs. 23.9% in the comparison group.
Adverse Events
The proportion of study subjects that had adverse events (AEs) in each cohort was: CRFA, 45% (34/76); IAS, 40% (30/75). The number of AEs reported in each study group was similar (CRFA = 61 events, IAS = 65 events). Most AEs during the study were non-serious, mild or moderate in severity, and were determined to be not related to study treatment. The AEs with Possible, Probable, or Definite relationship to procedure are:
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- CRFA Group (14 events in 13 subjects): post-procedure pain (9 events), ecchymosis (1), pruritic skin lesion (1), swelling and redness - infection (1), mild tenderness to touch (1), increased knee pain - severe (1)
- IAS Group (2 events in 2 subjects): white discoloration at injection site (1), ● fluctuating blood sugar levels (1)
- Post-procedural "fall" incidence: ■
- CRFA Group (2 events in 1 subject) ●
- . IAS Group (4 events in 4 subjects)
- I Serious AEs:
- . CRFA Group (4 events in 2 subjects): 1) pyelonephritis, 2) exacerbation of asthma, 3) severe acute asthma, and 4) acute respiratory failure
- IAS Group (8 events in 7 subjects): 1) opioid overdose, 2) heart attack (two ● subjects), 3) death, 4) nausea and vomiting, 5) worsening of hiatal hernia, 6) gastric volvulus, and 7) abdominal pain secondary to small bowel obstruction.
Medication Use
The study demonstrated a reduction in non-opioid pain medication that was consistent with the clinically relevant improvements demonstrated in the primary endpoint. Table 76 below describes the pain medication usage for subjects taking non-morphine medication at the baseline through 6 months' visits.
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| Baseline | 1 Month | 3 Month | 6 Month | |||||
|---|---|---|---|---|---|---|---|---|
| CRFA | IAS | CRFA | IAS | CRFA | IAS | CRFA | IAS | |
| Non-Morphine Pain MedicationUsage - Total Daily Dose (mg) | ||||||||
| N | 33 | 35 | 33 | 34 | 32 | 34 | 29 | 35 |
| Mean | 899.5 | 497.4 | 899.5 | 537.9 | 865.2 | 561.2 | 834.8 | 621.4 |
| SD | 625.1 | 437.3 | 625.1 | 484.4 | 636.4 | 461.4 | 682.0 | 497.5 |
| Median | 700.0 | 470.0 | 700.0 | 472.5 | 675.0 | 498.0 | 650.0 | 545.0 |
| Minimum | 150.0 | 0.0 | 150.0 | 0.0 | 150.0 | 0.0 | 0.0 | 0.0 |
| Maximum | 3000.0 | 2000.0 | 3000.0 | 2000.0 | 3000.0 | 2000.0 | 3000.0 | 2000.0 |
| Difference between means(CRFA-IAS) and 95% Cl | 402.1 (138.7, 685.5) | 361.7 (89.3, 634.0) | 304.0 (31.8, 576.1) | 213.5 (-81.7, 508.6) | ||||
| P-value (difference betweengroups) | 0.0012** | 0.0038** | 0.0250** | 0.2143** | ||||
| Change from Baseline in Non-Morphine Pain MedicationUsage - Total Daily Dose (mg) | ||||||||
| N | - | - | 33 | 34 | 32 | 34 | 29 | 35 |
| Mean | - | - | 0.0 | 44.9 | -15.6 | 60.9 | -34.5 | 123.9 |
| SD | - | - | 0.0 | 226.3 | 88.4 | 277.7 | 128.9 | 375.4 |
| Median | - | - | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Minimum | - | - | 0.0 | 0.0 | -500.0 | 0.0 | -500.0 | -440.0 |
| Maximum | - | - | 0.0 | 1307.5 | 0.0 | 1600.0 | 0.0 | 1600.0 |
| Difference between means(CRFA-IAS) and 95% Cl | - | -44.9 (-124, 34.0) | -76.5 (-178, 24.8) | -158 (-295, -21.7) | ||||
| P-value (difference betweengroups) | - | 0.1668** | 0.0506** | 0.0229** | ||||
| P-value (change fromBaseline) | - | - | 0.2552§ | 0.3251§ | 0.2100§ | 0.1609§ | 0.0591§ |
Table 76. Pain Medication Usage for Subjects Taking Non-Morphine Pain Medication at Any Visit Through 6 Months - TDD
Table disclays total daily dose of normally for the subjects taking nor-morphine pan medication at any follow-up visit. Subjects with only the Baseine visit are excluded.
T-test for two independent means, Wilcoxon rank sum test for two Independent samples, 3paired t-test
Program: HYHOS outout TDD Non-Morphine At Any Visit OM SBS Data Source: hyh03 painmedsub} Date Run: 01MAR2017 - 15:30
An analysis of the primary endpoint for the patients who were opioid dependent at baseline and were evaluated for the primary endpoint demonstrated that there was no relationship between outcome and opioid status as described in Table 82 below. Of the 43 Cooled Radiofrequency Ablation (CRFA) successes, only 10 patients were on opioids at Baseline (23.3%) as compared to 46.7% of the CRFA group who failed the primary endpoint (7/15). Overall, opioid status did not influence the outcomes (p= 0.4073).
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| Cooled RadiofrequencyAblation (CRFA) | IntraarticularSteroid (IAS) | Overall | |
|---|---|---|---|
| Subjects that are PrimaryEndpoint success | 10/43 (23.3) | 5/11 (45.5) | 15/54(27.8) |
| Subjects that are PrimaryEndpoint failure | 7/15 (46.7) | 18/57 (31.6) | 25/72 (34.7) |
| P-value | 0.1073† | 0.4889† | 0.4073†† |
Table 82: Primary Endpoint Success or Failure for Subjects Taking Opioids at Baseline n/N%
+Fisher exact test for proportions, ++Chi-square test for proportions
The results of the pre-planned statistical analysis of the primary endpoint supports the conclusion that the COOLIEF* Cooled Radiofrequency Probe used for genicular nerve ablation is superior to corticosteroid injection in osteoarthritic subjects for managing knee pain.
8. Conclusion
The non-clinical data demonstrate that the COOLIEF* Cooled RF probe devices perform equivalently to the predicate device that is currently marketed. The clinical data demonstrate that the COOLIEF* Cooled RF probe does not present safety or effectiveness issues related to the proposed indication for use. Data collected at the primary endpoint supports the conclusion that the COOLIEF* Cooled Radiofrequency Probe used for genicular nerve ablation is superior to corticosteroid injection in osteoarthritic subjects for managing knee pain. The change to the indications for use does not raise different questions of safety or effectiveness.
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).