(125 days)
No
The summary describes a radiofrequency ablation device and its clinical performance, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is used to create lesions in nervous tissue to manage moderate to severe knee pain, which directly treats a medical condition.
No
Explanation: The device is used to create lesions in nervous tissue for pain management, which is a therapeutic intervention, not a diagnostic one. While its indication for use mentions a "diagnostic genicular nerve block," the device itself (COOLIEF Cooled Radiofrequency Probe) is not performing the diagnostic block; rather, the block is a prerequisite for using this therapeutic device.
No
The device description explicitly states it is a sterile, single-use hardware device (probe) that delivers RF energy and circulates sterile water. It is used in conjunction with an RF generator.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to create lesions in nervous tissue using radiofrequency energy for pain management. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a probe that delivers energy to tissue. It does not analyze samples of human origin (like blood, urine, or tissue) outside of the body to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on in vitro testing.
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 a therapeutic intervention.
N/A
Intended Use / Indications 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 radiologically-confirmed osteoarthritis (grade 2-4) and a positive response (≥50% reduction in pain) to a diagnostic genicular nerve block.
Product codes (comma separated list FDA assigned to the subject device)
GXI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nervous tissue, genicular nerves (knee)
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)
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 6 month 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.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Primary Effectiveness Endpoint: proportion of subjects whose knee pain is reduced by ≥ 50% based on the Numeric Rating Scale (NRS) at the 6 month study time point.
- 67.2% of the COOLIEF* Cooled RF study group vs. 15.7% of the comparison group (corticosteroid injection)
- Mean drop in NRS for study group: 4.9 points (from 7.3 to 2.5)
- Mean drop in NRS for comparison group: 1.3 points (from 7.2 to 5.9)
- Satisfactory Joint Function: 39.7% for study group vs. 3% for comparison group
- Global Perceived Effect Knee condition "improved": 91.4% for study group vs. 23.9% for comparison group
Adverse Events:
- CRFA Group: 45% (34/76)
- IAS Group: 40% (30/75)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/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.
1
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 Parkway | |
| Alpharetta, GA 30004 | |
| www.halyardhealth.com | |
| Applicant Contact Person | Monica King |
| Associate Director, Regulatory Affairs | |
| Phone: (678) 477-4165 | |
| FAX: (678) 254-0347 | |
| Email: 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 RF
Probe
(K163461) | Pain
Management
Cooled Probe
(K053082) | Comments |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended 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 radiologically-
confirmed osteoarthritis
(grade 2-4) and a positive
response (≥50% reduction
in pain) to a diagnostic
genicular nerve block. | Used in conjunction
with a radiofrequency
generator to create
radiofrequency lesions
in nervous tissue. | Clinical data to support the
proposed indication is
submitted in the Protocol A
Prospective, Multi-center,
Randomized, Clinical Trial
Evaluating the Safety and
Effectiveness of Using
Coolief™ Cooled
Radiofrequency Probe to
Create Lesions of the
Genicular Nerves and
Comparing Corticosteroid
Injection in the Management
of Knee Pain |
| Probe Shaft
Length | Overall Useable Length
150mm, 100mm, 75mm,
50mm
Shaft Outer Diameter
18Ga | Overall Useable Length
150mm, 100mm, 75mm,
50mm
Shaft Outer Diameter
18Ga | Equivalent |
| Distal Tip
Length | 6mm probe electrode
with various active
lengths when combined
with a mating introducer
of 2, 4, and 5.5mm | 6mm probe electrode
with various active
lengths when combined
with a mating introducer
of 2, 4, and 5.5mm | Equivalent |
| Lesion Size | 10-12mm,
Spherical | 10-12mm,
Spherical | Equivalent |
| Temperature
Measurement
Accuracy | ± 3° C | ± 3° C | Equivalent |
| Temperature
Measurement
Device | Thermocouple | Thermocouple | Equivalent |
| Characteristic | COOLIEF*
Cooled RF
Probe
(K163461) | Pain Management
Cooled Probe
(K053082) | Comments |
| Temperature
Range | 38° - 95° C | 38° - 95° C | Equivalent |
| Temperature
Increment | 1°C | 1°C | Equivalent |
| Single Use | Yes | Yes | Equivalent |
| Compatible RF
System | Halyard
COOLIEF*
System Only | Halyard
COOLIEF*
System Only | Equivalent |
| Disposable | Yes | Yes | Equivalent |
| Biocompatibility | Conforms to
ISO10993 | Conforms to
ISO10993 | Equivalent |
| Sensitization
ISO 10993-10 | Conforms to
ISO10993-10 | Conforms to
ISO10993-
10 | Equivalent |
| Irritation
ISO 10993-20 | Conforms to
ISO10993-20 | Conforms to
ISO10993-
20 | Equivalent |
| Cytotoxicity
ISO 10993-5 | Conforms to
ISO10993-5 | Conforms
to
ISO10993-5 | Equivalent |
| Characteristic | COOLIEF*
Cooled RF
Probe
(K163461) | Pain Management
Cooled Probe
(K053082) | Comments |
| Systemic
toxicity
ISO 10993-11 | Conforms to
ISO10993-11 | Conforms to
ISO10993-11 | Equivalent |
| Sterility | Sterilized by EO
SAL = 10-6 | Sterilized by EO
SAL = 10-6 | Equivalent |
| Packaging | Device contained in a
single use Tyvek sealed
tray | Device contained in a
single use Tyvek sealed
tray | Equivalent |
6
7
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.
8
| Comparison to Reference Device | |
|---|---|
| Subject Device: COOLIEF* Cooled RF Probe | Reference Device: TransDiscal* RF probe |
| K163481 | K031951 |
| 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 Transdiscal system, in combination with |
| the Baylis Pain Management Generator-TD | |
| (PMG-TD), is indicated for the coagulation and | |
| decompression of disc material to treat | |
| symptomatic patients with contained herniated | |
| discs. | |
| Sterility: Sterilized by | Sterility: Sterilized |
| EO SAL = 10-6 | by EO SAL = 10-6 |
| Packaging: Device contained in a single use | |
| Tyvek sealed tray | Packaging: Device contained in a single use |
| Tyvek 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 = 0 | |||
| Quantitative = cell death |