(89 days)
The OsteoCool™ 2.0 RF Ablation System is indicated for:
• Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
• Coagulation and ablation of tissue in bone during surgical procedures including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.
• Ablation of benign bone tumors such as osteoid osteoma.
The subject OsteoCool™ 2.0 RF Ablation System includes the following hardware components:
- OsteoCool™ 2.0 Radiofrequency Generator
- OsteoCool™ 2.0 Peristaltic Pump & Pump Cable
- OsteoCool™ 2.0 Connector Hub
- OsteoCool™ 2.0 Cart
The OsteoCool™ 2.0 RF Ablation System line extension includes the following commercially available sterile disposables that remain unchanged from the OsteoCool™ RF Ablation System K182497 (S.E. 12/17/2018): - OsteoCool™ RF Ablation Probe with Tube Kit
- OsteoCool™ Independent Thermocouple with Introducer Kit:
The OsteoCool™ 2.0 RF Ablation System delivers controlled radiofrequency (RF) energy in a bipolar manner with a cooling mechanism to facilitate RF lesions in target tissue. The OsteoCool™ 2.0 Radiofrequency (RF) Generator operates together with the OsteoCool™ RF Ablation Probe to deliver the RF energy to the target ablation site(s). The OsteoCool™ Tube Kit is used with the OsteoCool™ 2.0 Peristaltic Pump to circulate water internally through the OsteoCool™ RF Ablation Probe(s) during RF energy delivery. The OsteoCool™ 2.0 Pump Cable connects the OsteoCool™ 2.0 Peristaltic Pump to the OsteoCool™ 2.0 RF Generator, which controls the pump flowrate.
The OsteoCool™ 2.0 Connector Hub connects the OsteoCool RF Ablation Probe(s) and OsteoCool™ Thermocouple (s) to the OsteoCool™ 2.0 RF Generator. The OsteoCool™ Thermocouple Monitor is used with the OsteoCool™ Thermocouple Introducer and enables temperature monitoring around the thermal ablation zones during procedures.
This document describes the OsteoCool™ 2.0 RF Ablation System and its substantial equivalence to a predicate device (OsteoCool™ RF Ablation System, K182497 S.E. 12/17/2018). The information provided focuses on the device's characteristics and the testing performed, rather than a study proving the device meets acceptance criteria in the context of an AI/ML model for medical imaging, as might be implied by the prompt's structured questions.
However, interpreting "acceptance criteria" as the criteria for demonstrating substantial equivalence for a medical device and "device performance" as the data presented to support this claim, I will attempt to answer the questions based on the provided text.
The provided text does NOT describe an AI/ML device or a study involving human readers and AI assistance for an imaging application. Therefore, many of the questions regarding AI/ML specific criteria, ground truth establishment, expert adjudication, MRMC studies, and training/test set details are not applicable (N/A) to this document.
The document details the physical device's technical specifications and bench-top testing to demonstrate substantial equivalence to a prior version.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the document, the "acceptance criteria" are implied by the substantial equivalence demonstration, which relies on showing that the new device has "the same fundamental scientific technology, including principles of operation and mechanism of action" and performs comparably to the predicate device through various tests.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate Device) | Reported Device Performance (Summary from "Performance Data") |
|---|---|
| Functional Equivalence: Device delivers controlled RF energy for ablation. | The OsteoCool™ 2.0 RF Ablation System delivers controlled radiofrequency (RF) energy in a bipolar manner with a cooling mechanism to facilitate RF lesions in target tissue. The generator, pump, and probes work together to deliver RF energy and circulate cooling water, consistent with the principle of operation. |
| Safety and Performance Compliance: Meets mechanical, electrical, biocompatibility, data integrity, temperature accuracy, cleaning, connectivity, and usability requirements. | Bench top testing was performed to demonstrate substantial equivalence. System components were subjected to the following verification and validation tests, as applicable: mechanical, electrical, biocompatibility, data integrity, temperature accuracy, cleaning, connectivity, and usability. The document states these tests were performed and implies successful completion to support substantial equivalence. |
| Comparative Ablation Characteristics: Produces comparable lesion size and thermal effects to the predicate device. | Bench-top validation testing was performed for the OsteoCool™ 2.0 RF Ablation System using ex-vivo tissue and product usage in cadaveric bone as per the guidance. Lesion size (length and width) was measured during ex-vivo testing at the 50 degree C isotherm. Color change due to blood coagulation at elevated temperatures between thermally affected tissue and raw tissue was evaluated. (The document states these measurements were taken but does not provide the specific numerical results of the lesion sizes or a direct comparison to the predicate's performance, only that it "demonstrated substantial equivalence" through these tests). |
The product being reviewed is an RF ablation system, a physical medical device, not a software/AI system for diagnostics from imaging data. Therefore, the following AI/ML-specific questions are largely not applicable.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document mentions "ex-vivo tissue" and "cadaveric bone" were used for bench-top validation testing. It does not specify the number of samples (e.g., number of tissue blocks, cadaveric segments) used.
- Data Provenance: The testing was "bench-top testing" performed by the manufacturer (Medtronic Sofamor Danek USA Inc.). It is laboratory testing; thus, it is not "country of origin of the data" in the sense of patient data, nor is it retrospective or prospective in the clinical study sense. It is laboratory product validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This is a physical device being tested for its functional performance (e.g., lesion creation, electrical safety), not an AI/ML system requiring expert-annotated ground truth from medical images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Not applicable to physical device bench testing.
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:
- N/A. This is a physical RF ablation device, not an AI/ML software for image interpretation or diagnosis.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical device designed for human use in a medical procedure. It is not an algorithm that functions in a "standalone" capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance would be the physical measurements of the lesions created (length, width, temperature isotherm), electrical parameters, and material biocompatibility, as determined by standard laboratory techniques and instruments, not expert consensus on medical images or pathology from human subjects.
8. The sample size for the training set:
- N/A. This device is not an AI/ML model that undergoes "training." Its performance is based on its engineered design and physical properties.
9. How the ground truth for the training set was established:
- N/A. Not applicable as there is no "training set" for this physical device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
February 28, 2024
Medtronic Sofamor Danek USA Inc. Denise Gaston Sr. Regulatory Affairs Specialist 1800 Pvramid Place Memphis, Tennessee 38132
Re: K233830
Trade/Device Name: OsteoCool™ 2.0 RF Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: November 30, 2023 Received: December 1, 2023
Dear Denise Gaston:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.02.28
14-05'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Submission Number (if known)
Device Name
OsteoCool™ 2.0 RF Ablation System
Indications for Use (Describe)
· Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
· Coagulation and ablation of tissue during surgical procedures such as palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.
· Ablation of benign bone tumors such as osteoid osteoma.
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 Medtronic Sofamor Danek USA, Inc.
February 27, 2024
| Submitter | Medtronic Sofamor Danek USA, Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901) 498-2697 |
|---|---|
| Contact | Jeff SpragueSr. Prin. Regulatory Affairs LeadDirect Telephone: 901-498-2697Email: jeffrey.a.sprague@medtronic.comOrDenise GastonSr. Regulatory Affairs SpecialistDirect Telephone: 416-576-8749Email: denise.gaston@medtronic.com |
| Date Prepared | February 27, 2024 |
| Common Name | OsteoCool™ 2.0 RF Ablation System |
| Regulatory Class | Class II |
| Regulation Number | 21 CFR 878.4400 |
| Regulation Name and DeviceProduct Classification Code | Electrosurgical cutting and coagulation device and accessoriesGEI |
| Predicate Devices | OsteoCool™ RF Ablation SystemK182497 (S.E. 12/17/2018) – primary predicate |
| Description of Device | The predicate devices have not been subject to a design related recall.The current 510(k) submission is for a line extension to the clearedOsteoCool™ RF Ablation System (K182497 S.E. 12/17/2018).The subject OsteoCool™ 2.0 RF Ablation System includesthe following hardware components:1. OsteoCool™ 2.0 Radiofrequency Generator2. OsteoCool™ 2.0 Peristaltic Pump & Pump Cable3. OsteoCool™ 2.0 Connector Hub4. OsteoCool™ 2.0 CartThe OsteoCool™ 2.0 RF Ablation System line extension includes thefollowing commercially available sterile disposables that remainunchanged from the OsteoCool™ RF Ablation System K182497 (S.E.12/17/2018): |
| Description of Device | 5. OsteoCool™ RF Ablation Probe with Tube Kit6. OsteoCool™ Independent Thermocouple with Introducer Kit: |
| The OsteoCool™ 2.0 RF Ablation System delivers controlledradiofrequency (RF) energy in a bipolar manner with a coolingmechanism to facilitate RF lesions in target tissue. The OsteoCool™ 2.0Radiofrequency (RF) Generator operates together with the OsteoCool™RF Ablation Probe to deliver the RF energy to the target ablation site(s).The OsteoCool™ Tube Kit is used with the OsteoCool™ 2.0 PeristalticPump to circulate water internally through the OsteoCool™ RF AblationProbe(s) during RF energy delivery. The OsteoCool™ 2.0 Pump Cableconnects the OsteoCool™ 2.0 Peristaltic Pump to the OsteoCool™ 2.0RF Generator, which controls the pump flowrate.The OsteoCool™ 2.0 Connector Hub connects the OsteoCool RFAblation Probe(s) and OsteoCool™ Thermocouple (s) to theOsteoCool™ 2.0 RF Generator. The OsteoCool™ ThermocoupleMonitor is used with the OsteoCool™ Thermocouple Introducer andenables temperature monitoring around the thermal ablation zonesduring procedures. | |
| Indications for Use: | The OsteoCool™ 2.0 RF Ablation System is indicated for:• Palliative treatment in spinal procedures by ablation of metastaticmalignant lesions in a vertebral body.• Coagulation and ablation of tissue in bone during surgical proceduresincluding palliation of pain associated with metastatic lesions involvingbone in patients who have failed or are not candidates for standardtherapy.• Ablation of benign bone tumors such as osteoid osteoma. |
| Comparison of TechnologicalCharacteristics with thePredicate Device | The intended use of the subject device is substantially equivalent to thoseof the predicate device. This includes the fundamental scientifictechnology, principles of operation and mechanism of action, and design |
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| and technological aspects. |
|---|
| ---------------------------- |
| Comparison Table of Subject and Predicate Devices: | ||
|---|---|---|
| OsteoCool TM 2.0RF Ablation System | OsteoCool RF Ablation System | |
| SUBJECT DEVICE | PREDICATE DEVICE | |
| 510(k) ClearanceRegulation Number | TBD21 CFR 878.4400 | K182497 (S.E. 12/17/2018)21 CFR 878.4400 |
| Product Code | GEI | GEI |
| Product Class | Class II | Class II |
| Indication for Use | The OsteoCool TM 2.0 RF Ablation System is intended for:Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.Coagulation and ablation of tissue in bone during surgical procedures including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.Ablation of benign bone tumors such as osteoid osteoma. | The OsteoCool TM RF Ablation System is intended for:Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.Coagulation and ablation of tissue in bone during surgical procedures including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.Ablation of benign bone tumors such as osteoid osteoma. |
| User | Physicians trained in the use of OsteoCool RF ablation system | Physicians trained in the use of OsteoCool RF ablation system |
| Anatomical Site of Use | Bone | Bone |
| Method of Access | Percutaneous | Percutaneous |
| TECHNICAL DETAILS - System | ||
|---|---|---|
| FEATURE | OsteoCoolTM 2.0RF Ablation SystemSUBJECT DEVICE | OsteoCool RF Ablation SystemPREDICATE DEVICE |
| Energy Type | Radiofrequency | Radiofrequency |
| Principle of Operation | Radiofrequency energy delivered by operator from generator | Radiofrequency energy delivered by operator from generator |
| Mechanism of Action | Thermal coagulation necrosis | Thermal coagulation necrosis |
| Energy Delivery Control Mechanism | Temperature controlled | Temperature controlled |
| Probe Active Tip Size | 7mm, 10mm, 15mm, 20mm | 7mm, 10mm, 15mm, 20mm |
| Probe Outer Diameter | 17Gauge | 17Gauge |
| Probe length | 16 cm | 16 cm |
| Probe ElectrodesMaterial | Stainless Steel | Stainless Steel |
| Probe DielectricMaterials | Polyimide | Polyimide |
| Electrode Sterilization | EtO, single use | EtO, single use |
| Compatible RFGenerator | OsteoCool 2.0 | OsteoCool |
| Number of independentthermocouples | 4 | 2 |
| Number of probes | 4 | 2 |
| Generator Power OutputChannels | 4 | 2 |
| Generator MaximumOutput Power | 80 Watts total20 W/channel | 40 Watts total20 W/channel |
| Generator MaximumVoltage | 224 VRMS | 130 VRMS |
| Generator MaximumCurrent | 1.2 ARMS | 1.0 ARMS |
| Generator OutputFrequency | 465.1 kHz | 465.1 kHz |
| Default AblationTemperature | 70C (Gradual) | 70C |
| 75C (Accelerated) | N/A | |
| Cooling medium | Sterile water | Sterile water |
| Systemcomponents | Pump OC02-100Hub OC04-100Single Probe Kit 7 mm -OCP107Single Probe Kit 10 mm -OCP110Single Probe Kit 15 mm -OCP115Single Probe Kit 20 mm -OCP120Dual Probe Kit 7 mm x2 -OCP207Dual Probe Kit 10 mm x2 -OCP210Dual Probe Kit 15 mm x2 -OCP215Dual Probe Kit 20 mm x2 -OCP220RF Pump - OC02ITC 28G - OCN001 | Pump OC02Hub OC04Single Probe Kit 7 mm -OCP107Single Probe Kit 10 mm -OCP110Single Probe Kit 15 mm - OCP115Single Probe Kit 20 mm -OCP120Dual Probe Kit 7 mm x2 -OCP207Dual Probe Kit 10 mm x2 -OCP210Dual Probe Kit 15 mm x2 -OCP215Dual Probe Kit 20 mm x2 -OCP220RF Pump - OC02ITC 28G - OCN001 |
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| Performance Data | Bench top testing was performed to demonstrate substantial equivalence ofthe OsteoCool™ 2.0 RF Ablation System to the predicate device. Thesystem components were subjected to the following verification andvalidation tests, as applicable: mechanical, electrical, biocompatibility,data integrity, temperature accuracy, cleaning, connectivity, and usability.Bench-top validation testing was performed for the OsteoCool™ 2.0 RFAblation System using ex-vivo tissue and product usage in cadaveric boneas per the guidance. Lesion size (length and width) was measured duringex-vivo testing at the 50 degree C isotherm. Color change due to bloodcoagulation at elevated temperatures between thermally affected tissue andraw tissue was evaluated. |
|---|---|
| Conclusion | The subject and predicate devices share the same fundamental scientifictechnology, including principles of operation and mechanism of action.The subject OsteoCool™ 2.0 RF Ablation System has been shownthrough technological comparison and comparison testing to besubstantially equivalent to the identified predicate system for therequested indications for use. |
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.