(157 days)
The intended use of the OptaBlate™ Radiofrequency (RF) Generator System is as follows:
- 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 OptaBlate™ Radiofrequency (RF) Generator system is a bipolar, high frequency electrosurgical system. The OptaBlate™ RF Generator will be used in conjunction with OptaBlate™ Probes, OptaBlate™ Microinfuser™ Infusion Device, OptaBlate 150 mm Temperature Sensor, MultiGen 2 Splitter Cable, and other currently marketed Stryker compatible accessories to produce lesions by the direct application of radiofrequency currents. The generator applies temperature-controlled, radiofrequency (RF) energy into the probe. During lesion creation, targeted tissue is exposed to RF energy using an active probe inserted into a cannula. The application of RF energy causes a thermal reaction at the targeted tissue site to create a lesion. Each OptaBlate™ Radiofrequency (RF) Generator System is composed of a RF generator, a Splitter Cable, Temperature Sensor, and a choice of 4 disposable kit options. The kits contain disposable probes and infusion devices.
This submission is for a Radiofrequency Generator System, which is an electrosurgical cutting and coagulation device. This type of device does not typically involve AI/ML and therefore the concept of training and test sets, ground truth establishment by experts, and MRMC studies does not apply in the context of diagnostic AI/ML devices. Therefore, I will focus on the performance testing carried out to demonstrate substantial equivalence to the predicate device.
**1. A table of acceptance criteria and the reported device performance.
**
The document does not explicitly present a table of "acceptance criteria" against which "reported device performance" is measured in the classical sense of an AI/ML model's performance metrics (e.g., accuracy, sensitivity, specificity). Instead, substantial equivalence is demonstrated through comparative bench-top verification testing and a literature review. The performance testing focuses on demonstrating that the subject device produces similar ablation characteristics to the predicate device and that the technology is safe and effective for its intended uses.
| Acceptance Criteria (Implied by Comparison) | Reported Device Performance |
|---|---|
| Functional Equivalence | |
| - Similar energy type (Radiofrequency Energy) | Confirmed: Both subject and predicate use Radiofrequency Energy. |
| - Similar principle of operation (Operator controlled; RF delivered) | Confirmed: Both subject and predicate use operator-controlled RF delivery from a compatible generator. |
| - Similar mechanism of action (Cellular necrosis through thermal coagulation) | Confirmed: Both subject and predicate cause cellular necrosis through thermal coagulation. |
| - Similar control of temperature rise in tissues | Confirmed: Controlled by RF Generator for both. |
| - Similar feedback mechanism (Temperature Controlled) | Confirmed: Both use temperature-controlled feedback. |
| - Compatible with similar accessories | Confirmed: Subject device uses connecting cables, probes, and cannulae similar to the predicate. |
| Performance in Tissue Models (Bench-top) | |
| - Achieve substantially equivalent lesion dimensions (length and width) in chicken muscle to predicate device. | Result: "The results demonstrated that lesion dimensions achieved by the subject device are substantially equivalent to those obtained with the predicate device." (Page 18) |
| - Achieve substantially equivalent tissue temperature at ablation zone boundary in bovine bone compared to predicate device. | Result: "Bovine bone lesions were indirectly measured via tissue temperature at a given ablation zone boundary... The results demonstrated that lesion dimensions achieved by the subject device are substantially equivalent to those obtained with the predicate device." (Page 18) |
| - Accurate temperature measurements by relevant components. | Result: "Verification testing demonstrated that the relevant components of the subject OptaBlate RF Ablation system achieves accurate temperature measurements as per specified test requirements." (Page 18) |
| Safety and Efficacy (Through Literature Review) | |
| - Radiofrequency ablation devices are safe and effective for indicated uses. | Result: "Results from the literature search conclude that RF ablation devices are safe and effective. RF ablation consistently resulted in decreased patient pain post procedure regardless of indication. Furthermore, safety events were primarily due to underlying conditions or the use of cement post procedure." (Page 19) |
| - Potential benefits outweigh potential risks. | Result: Overall, this search supports that the potential benefits from this device / treatment outweigh the potential risks." (Page 19) |
| Electrode and Generator Specifications | |
| - Active Electrode Length: 15, 20 mm | Predicate: 7, 10, 15, 20 mm. Subject device has fewer options but still within the range, considered "Similar". (Page 12) |
| - Active Electrode Material: Stainless Steel (304 or 304L) | Predicate: Stainless Steel (304 or 304L). Considered "Similar". (Page 12) |
| - Electrode Insulation Material: Polyetheretherketone | Predicate: Polyimide. Considered "Similar" as both are high-performance plastics with high heat resistance. (Page 12) |
| - Electrode Diameter: 13 Gauge | Predicate: 17 Gauge. Considered "Similar" as both are percutaneous sizes. (Page 12) |
| - Electrode Length: 16 cm | Predicate: 16 cm. "Identical". (Page 12) |
| - Electrode Sterilization: EO, Single Use | Predicate: EO, Single Use. "Identical". (Page 12) |
| - Generator Power Output Channels: 4 | Predicate: 2. Considered "Similar" as OptaBlate allows flexible 1 to 4 channels. (Page 12) |
| - Generator Maximum Output Energy: System: 30W, Per Channel: 7.5W | Predicate: System: 40W, Per Channel: 20W. Considered "Similar" as OptaBlate requires less power output. (Page 12) |
| - Generator Maximum Voltage: System: 48.5 VRMS | Predicate: System: 130 VRMS. Considered "Different" but explained by OptaBlate requiring less power per channel. (Page 12) |
| - Generator Output Frequency: 500 kHz | Predicate: 465 kHz. Considered "Similar" as both frequencies are within the typical band for RF ablation and create equivalent lesion sizes. (Page 12) |
| - Default Ablation Temperature: 95°C | Predicate: 70°C. Considered "Similar" as both systems achieve up to 95°C in adjacent tissue, with predicate's lower setpoint due to active tip cooling. (Page 12) |
| Infusion Device Performance | |
| - Infusion Liquid: Saline | Predicate: Saline. "Identical". (Page 17) |
| - Flow Rate Range: 6 to 10 ml/hr | Reference: 3 to 42 ml/hr. Considered "Similar" as OptaBlate operates within a smaller window of the reference device infusion range. (Page 17) |
| - Disposable: Yes | Reference: Pump: No, Tubing Set: Yes. Considered "Similar" as OptaBlate Microinfuser is completely disposable versus reusable pump/disposable tubing. (Page 17) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Bench-top Verification Testing: The document states that "Tissue models consisted of fresh chicken muscle and bovine bone." However, the exact sample size (number of tissues/ablations) used for this testing is not specified in the provided text.
- Clinical Literature Review: For the clinical evaluation, Stryker identified 175 unique publications, which were screened based on predefined criteria. A "thorough full-text review of 41 manuscripts" was performed. This represents a retrospective analysis of existing published data. The provenance of this data (e.g., specific countries of origin of the studies) is not detailed, but peer-reviewed publications are generally global in nature.
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 in the traditional sense for this device as it is not an AI/ML diagnostic device requiring ground truth labeled by experts for a test set. The performance evaluation relies on physical measurements in bench-top models and a systematic review of existing clinical literature on RF ablation.
- For the bench-top testing, lesion dimensions and temperature measurements were the "ground truth", which are directly measurable physical quantities.
- For the literature review, the "ground truth" on safety and efficacy is derived from reported outcomes in peer-reviewed clinical studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is not applicable for this type of device and study design. Adjudication methods are typically used in AI/ML performance studies where multiple human readers assess cases and their interpretations need to be reconciled to establish a ground truth or resolve discrepancies.
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 as the OptaBlate RF Generator System is not an AI-assisted diagnostic or treatment planning device, and therefore, no MRMC study was performed to assess human reader improvement with AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable as the OptaBlate RF Generator System is a medical device, not a standalone algorithm. Its function is to deliver RF energy for ablation, which is a clinician-performed procedure.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Bench-top Verification Testing: For the in-vitro comparison study, the ground truth was direct physical measurement. For chicken muscle, lesion lengths and widths were directly measured. For bovine bone, tissue temperature at a given ablation zone boundary was indirectly measured as an indicator of lesion size.
- Clinical Efficacy/Safety: The "ground truth" for clinical efficacy and safety was established through a literature review of reported clinical outcomes and vigilance databases. This includes "clinical and technical success, improvements in pain through validated measures (VAS), and the need for repeat procedures" for efficacy, and "reported complications" for safety.
8. The sample size for the training set
This section is not applicable as the OptaBlate RF Generator System is a hardware device, not an AI/ML model that undergoes "training."
9. How the ground truth for the training set was established
This section is not applicable as there is no "training set" for this type of device.
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September 16, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Stryker Corporation Bruce Backlund Principal Regulatory Affairs Specialist 1941 Stryker Way Portage, Michigan 49002
Re: K221074
Trade/Device Name: OptaBlate RF Generator, OptaBlate Microinfuser Infusion Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: August 10, 2022 Received: August 12, 2022
Dear Bruce Backlund:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
for
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221074
Device Name
OptaBlate™ Radiofrequency (RF) Generator System
Indications for Use (Describe)
The intended use of the OptaBlate™ Radiofrequency (RF) Generator System is as follows:
- 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.
| 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
| Date Prepared: | September 09, 2022 |
|---|---|
| Submitter Information: | Stryker Corporation1941 Stryker WayPortage, MI 49002 |
| Establishment Registration: | 1811755 |
| Contact Information: | Bruce BacklundPrincipal Regulatory Affairs Specialist(763) 762-5902bruce.backlund@stryker.com |
| Device Information:Trade Name: | OptaBlate™ Radiofrequency (RF) GeneratorSystem |
| Common Name:Classification Name: | RF GeneratorElectrosurgical cutting and coagulation device andaccessories |
| Product Code: | GEI |
| Regulation Number: | Class II 21 CFR 878.4400 |
| Predicate Devices: | K182497 OsteoCool™ RF Ablation System |
| Reference Devices: | K170242 MultiGen™ 2 RF Generator SystemK080451 Uniblate® SystemK040989 RITA® System |
Device Description:
The OptaBlate™ Radiofrequency (RF) Generator system is a bipolar, high frequency electrosurgical system. The OptaBlate™ RF Generator will be used in conjunction with OptaBlate™ Probes, OptaBlate™ Microinfuser™ Infusion Device, OptaBlate 150 mm Temperature Sensor, MultiGen 2 Splitter Cable, and other currently marketed Stryker compatible accessories to produce lesions by the direct application of radiofrequency currents. The generator applies temperature-controlled, radiofrequency (RF) energy into the probe. During lesion creation, targeted tissue is exposed to RF energy using an active probe inserted into a cannula. The application of RF energy causes a thermal reaction at the targeted tissue site to
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create a lesion. Each OptaBlate™ Radiofrequency (RF) Generator System is composed of a RF generator, a Splitter Cable, Temperature Sensor, and a choice of 4 disposable kit options. The kits contain disposable probes and infusion devices.
| Part Number | Item Name | Items Comprising Kit (if applicable, list PN &name) |
|---|---|---|
| 9700-000-000 | OptaBlate RF GENERATOR | Includes Generator |
| 9700-815-015 | OptaBlate 150MM TEMPERATURESENSOR | To be sold a la carte |
| 9700-015-100 | OptaBlate 15MM PROBE SINGLE KIT | (1) 15MM PROBE(1) MICROINFUSER INFUSION DEVICEThe kit components will not be available a la carte,only available as a kitKit components are individually pouched andsterilized |
| 9700-015-200 | OptaBlate 15MM PROBE DUAL KIT | (2) 15MM PROBE(2) MICROINFUSER INFUSION DEVICEThe kit components will not be available a la carte,only available as a kitKit components are individually pouched andsterilized |
| 9700-020-100 | OptaBlate 20MM PROBE SINGLE KIT | (1) 20MM PROBE(1) MICROINFUSER INFUSION DEVICEThe kit components will not be available a la carte,only available as a kitKit components are individually pouched andsterilized |
| 9700-020-200 | OptaBlate 20MM PROBE DUAL KIT | (2) 20MM PROBE(2) Microinfuser INFUSION DEVICEThe kit components will not be available a la carte,only available as a kitKit components are individually pouched andsterilized |
| 8400-800-000 | MULTIGEN 2 SPLITTER CABLE | Currently available in an a la carte non -sterileconfiguration.The splitter cable will be included in the OptaBlatesystem IFU under the 'For use with' section. Thesplitter cable does not have its own IFU |
| Part Number | Item Name | Items Comprising Kit (if applicable, list PN &name) |
| 9700-811-000 | 11 G Hand Drill | To be sold a la carte |
| 0306-330-000 | 11 G (gauge) Access Cannula | To be sold a la carte |
| 0406-650-400 | RF Sterilization Case | To be sold a la carte |
| 0406-630-225 | CURVED CANNULA, 150MM, 20G,10.0MM | To be sold a la carte |
| 0406-620-325 | STRAIGHT CANNULA, 150MM, 20G,10.0MM | To be sold a la carte |
| 0995-851-010 | Power Cord, shielded, 3.7 m length,plug type B | Currently available in an a la carte non -sterileconfiguration. |
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Image /page/5/Picture/2 description: The image shows a device with labeled parts. On the front of the device, there is a screen labeled B, a light labeled A, and three ports labeled C, D, and E. On the back of the device, there are two ports labeled F and G, a panel labeled H, and a power input labeled I and J.
OptaBlate™ Radiofrequency (RF) Generator
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| A | Power Button- Allows generator to be switched to ready for use or standby power. | B | Display Screen- Provides a color, touch sensitive screen to select settings, enter data, and view status. The display screen provides operational status and messages. |
|---|---|---|---|
| C | Grounding Pad Cable Receptacle- Not active or used. | D | Splitter Cable Receptacle- Allows for the installation of the splitter cable connector. |
| E | RF Hand Controller Cable Receptable- Not active or used. | F | Ethernet Receptacle- Not active or used. |
| G | USB Receptable- Not active or used. | H | Specification Label- Contains model, part number and serial number information. |
| I | Power Cord Receptable | J | Equipotential Grounding Lug- Provides for the connection of a equipotential ground. The lug shall be used as a protective earth connection. |
Image /page/6/Figure/2 description: The image shows a device with multiple components labeled A, B, C, and D. Component A appears to be a series of four input ports on the side of the device labeled B with the numbers 1 through 4. Component C is a series of clips along a cable that connects to the device, and component D is a connector at the end of the cable.
Splitter Cable
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| A | Channel Receptacle (four)- Allowsfor the installation of a disposableprobe(s) or a reusable temperaturesensor(s). | B | Splitter Cable Housing- Providesfor the connection interface betweenthe generator and a maximum of fouraccessories (probes/temperaturesensors). |
|---|---|---|---|
| C | Garment Clamps (four)- Providesthe means to support the cable whenconnected to surgical drape material. | D | Splitter Cable Connector- Allowsfor the installation of the splittercable into the generator. |
Image /page/7/Figure/2 description: The image shows a diagram of a device with several labeled parts. Part A is a long, thin component, possibly a wire or tube, shown with dashed lines indicating its full length. Part B is a connector or housing, likely made of plastic or similar material, attached to a cable labeled C. Part D is another cable connected to a larger connector labeled E, which has a textured section labeled F, possibly for grip. The device also includes a component labeled G with a cross-hatched pattern, and a part labeled H with a hole or opening, while I is a cylindrical component.
Temperature Sensor
| A | Sensor Probe- Used to monitor andtransmit temperature data from thesurgical site. | B | Sensor Hub- Provides theconnection interface betweenthe probe and cable. |
|---|---|---|---|
| C | Sensor Probe Strain Relief (color-coded)- Provides cable strain reliefand identifies the compatiblecannula. | D | Sensor Cable- Used to transmittemperature data fromthe surgical site to the generator. |
| E | Connector-end Strain Relief(color-coded)- Provides cable strainrelief. | F | Connector Release Collar-Used toremove connector from connectorreceptacle. |
| G | Connector Alignment Mark- Usedto properly orient and install theconnector into the connectorreceptable. | H | Push-Pull Connector- Used toinstall and release the temperaturesensor into the generator connectorreceptacle. |
| I | Protective Sleeve- Providesprotection for probe tip. |
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Image /page/8/Figure/1 description: The image shows a diagram of a medical device with several labeled parts. The device consists of a long, thin probe labeled E, connected to a handle labeled F. A cable labeled H extends from the handle to a connector labeled I. An inset shows a close-up of the probe tip, with labels A, B, C, and D indicating different sections or features of the tip.
Probe
| A | Active Tip Length — Describes the length of the emitting surface used to transmit RF energy to the ablation zone. | B | Thermocouple Tip — Allows measurement of the temperature in the ablation zone. |
|---|---|---|---|
| C | Radiopaque Probe Bands — Allows for the visualization of the emitting RF energy surfaces using X-ray or fluoroscopic imaging technology. | D | Microinfusion Orifice — Provides saline from the Microinfuser to the ablation zone. |
| E | Probe — Provides the pathway for RF energy and saline to the ablation zone. Also allows temperature information to be collected at the ablation zone and provided to the generator. | F | Probe Hub (color-coded) — Provides the connection interface to the generator and the microinfuser. |
| G | Probe Saline Port — Allows for the connection of the micro-catheter connector and the Microinfuser saline source. Saline is provided to the tip of the probe to cool and hydrate the ablation zone. | H | Probe Electrical Cable — Provides for the electrical connection between the generator and the probe. |
| I | Probe Cable Connector — Allows for the installation of the probe cable into the splitter cable housing. |
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Image /page/9/Picture/1 description: This image shows a medical device with several labeled parts. Part A is a handheld device with a grip. Part B is a connector on the handheld device, and part C is a clip attached to a tube. Part E is a circular device with a knob, connected to the tube labeled F. Part G is a syringe.
Microinfuser with 6 mL Syringe
| A | Saline Reservoir (6 mL) — Used tostore NaCl saline. | B | Syringe Port — Allows connectionof saline-filled syringe. |
|---|---|---|---|
| C | Clamp — Used to stop the regulatedsaline flow from the reservoir toprevent leakage during set up. | D | Micro-catheter Connector — Usedto connect the micro-catheter to theprobe saline port. |
| E | Filter — Used to remove air fromthe saline flowing to the ablationzone. | F | Micro-catheter — Allows for theautomatic delivery of a regulatedsaline flow to the ablation zone. |
| G | 6 mL Syringe — Used to fill theMicroinfuser reservoir with saline. |
Indications for Use:
The intended use of the OptaBlate™ RF System is as follows:
• 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.
Contraindications:
Use of the OptaBlate™ RF System is contraindicated in vertebral body levels of C1 through C7.
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Comparison of Technological Characteristics with the Predicate Device
The technological characteristics of the subject and predicate devices are equivalent. Both the subject device and the primary predicate device use the same modes of operation, types of control, energy delivery and type of energy output. None of the changes alter the operating principle, modes of operation, or temperature range. Both systems use the same type of accessories (connecting cables, probes and cannulae). The user interaction with the devices is similar. As demonstrated by the performance testing the subject device has similar performance specifications as the predicate device.
| Intended Use Comparison | |||
|---|---|---|---|
| OptaBlate ™ RF AblationSystemSUBJECT DEVICE | OsteoCool RF AblationSystemPREDICATE DEVICE | EXPLANATION OFDIFFERENCES | |
| 510(k) Clearance | Subject Device of currentSubmission | K182497 | Identical |
| Regulation Number | 878.4400 | 878.4400 | Identical |
| Product Code | GEI | GEI | Identical |
| Product Class | II | II | Identical |
| Indication for Use | The OptaBlate ™ RFAblation System isintended for:• Palliativetreatment inspinal proceduresby ablation ofmetastaticmalignant lesionsin a vertebralbody.• Coagulation andablation of tissuein bone during | The OsteoCool ™ RFAblation System isintended for:• Palliativetreatment inspinal proceduresby ablation ofmetastaticmalignant lesionsin a vertebralbody.• Coagulation andablation of tissuein bone during | Identical |
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| Intended Use Comparison | |||
|---|---|---|---|
| OptaBlate™ RF AblationSystem | OsteoCool RF AblationSystem | EXPLANATION OFDIFFERENCES | |
| SUBJECT DEVICE | PREDICATE DEVICE | ||
| surgicalproceduresincludingpalliation of painassociated withmetastatic lesionsinvolving bone inpatients whohave failed or arenot candidatesfor standardtherapy.• Ablation ofbenign bonetumors such asosteoid osteoma. | surgicalproceduresincludingpalliation of painassociated withmetastatic lesionsinvolving bone inpatients whohave failed or arenot candidatesfor standardtherapy.• Ablation ofbenign bonetumors such asosteoid osteoma. | ||
| User | Physicians (IR), ScrubTechs/Nurses, CentralSterile Techs | Physicians familiar with RFlesion techniques | Similar |
| Anatomical Site | Bone | Bone | Identical |
| Method of Access | Percutaneous | Percutaneous | Identical |
| RF System Technical Comparison | |||
|---|---|---|---|
| FEATURE | Stryker OptaBlate™ RF SystemSUBJECT DEVICE | OsteoCool RF Ablation SystemPREDICATE DEVICE | EXPLANATION OF DIFFERENCES |
| Energy Type | Radiofrequency Energy | Radiofrequency Energy | Identical |
| Principle of Operation | Operator controlled; RF delivered from compatible generator | Operator controlled; RF delivered from compatible generator | Identical |
| RF System Technical Comparison | |||
| FEATURE | Stryker OptaBlate™ RF SystemSUBJECT DEVICE | OsteoCool RF Ablation SystemPREDICATE DEVICE | EXPLANATION OF DIFFERENCES |
| Mechanism of Action | Cellular necrosis through thermal coagulation | Cellular necrosis through thermal coagulation | Identical |
| Rate of Temperature Rise in Sample Tissues | Controlled by RF Generator | Controlled by RF Generator | Identical |
| Feedback Mechanism | Temperature Controlled | Temperature Controlled | Identical |
| Active Electrode Length | 15, 20 mm | 7, 10, 15, 20 mm | SimilarOptaBlate has fewer length options |
| Active Electrode Material | Stainless Steel per EN 1.4301 or EN 1.4307 (304 or 304L) | Stainless Steel per EN 1.4301 or EN 1.4307 (304 or 304L) | Similar |
| Electrode Insulation Material | Polyetheretherketone | Polyimide | SimilarBoth materials are common high-performance plastics known for high heat resistance.Verification and Validation was successfully conducted on the subject device and there were no questions of safety and efficacy raised. |
| RF System Technical Comparison | |||
| FEATURE | Stryker OptaBlate™ RFSystem | OsteoCool RF AblationSystem | EXPLANATION OFDIFFERENCES |
| SUBJECT DEVICE | PREDICATE DEVICE | ||
| Electrode Diameter | 13 Gauge | 17 Gauge | Similar |
| Both sizes are consideredpercutaneous | |||
| Electrode Length | 16 cm | 16 cm | Identical |
| Electrode Sterilization | EO, Single Use | EO, Single Use | Identical |
| Compatible RFGenerator | OptaBlate RF Generator | OsteoCool RF Generator | N/A |
| Generator Power OutputChannels | 4 | 2 | Similar |
| OptaBlate has a flexibleconfiguration that allows 1to 4 channels for poweroutput. | |||
| Generator MaximumOutput Energy | System: 30 W | System: 40 W | Similar |
| Per Channel: 7.5 W | Per Channel: 20W | ||
| Optablate requires lesspower output. | |||
| Generator MaximumVoltage | System: 48.5 VRMS | System: 130 VRMS | Different |
| OptaBlate requires muchless power per channel,which necessitates lesssystem voltage. | |||
| RF System Technical Comparison | |||
| FEATURE | Stryker OptaBlate™ RFSystem | OsteoCool RF AblationSystem | EXPLANATION OFDIFFERENCES |
| SUBJECT DEVICE | PREDICATE DEVICE | ||
| Generator OutputFrequency | 500 kHz | 465 kHz | Similar |
| Both frequencies areconsidered within the bandfor typical RF ablation andcreate equivalent lesionsizes. | |||
| Verification and Validationwas successfully conductedon the subject device andthere were no questions ofsafety and efficacy raised. | |||
| Generator MaximumCurrent | System: 1.7 ARMSPer Channel: 0.433 ARMS | System: 1.0 ARMSPer Channel: 0.5 ARMS | Similar |
| OptaBlate has a highersystem current due to theincreased number ofoutput channels. | |||
| Default AblationTemperature | 95°C | 70°C | Similar |
| OsteoCool has a lowersetpoint due to active tipcooling. Both systems willachieve up to 95°C in the | |||
| RF System Technical Comparison | |||
| FEATURE | Stryker OptaBlate™ RFSystemSUBJECT DEVICE | OsteoCool RF AblationSystemPREDICATE DEVICE | EXPLANATION OFDIFFERENCES |
| tissue adjacent to theelectrode. | |||
| Verification and Validationwas successfully conductedon the subject device andthere were no questions ofsafety and efficacy raised. | |||
| Other SystemComponents | • Splitter Cable 8400-800-000• 15 mm Ablation ProbeSingle Kit 9700-015-100• 15 mm Ablation ProbeDual Kit 9700-015-200• 20 mm Ablation ProbeSingle Kit 9700-020-100• 20 mm Ablation ProbeDual Kit 9700-020-200• Temperature Sensor9700-815-015• 11G Drill 9700-811-000 | • Hub OC04• Single Probe Kit 7mm OCP107• Single Probe Kit 10mm OCP110• Single Probe Kit 15mm OCP115• Single Probe Kit 20mm OCP120• Dual Probe Kit 7 mmx2 OCP207• Dual Probe Kit 10 mmx2 OCP210• Dual Probe Kit 15 mmx2 OCP215• Dual Probe Kit 20 mmx2 OCP220• OCP220RF PumpOC02• ITC 28G OCN001 | Verification and Validationwas successfully conductedon the subject device andthere were no questions ofsafety and efficacy raised. |
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| Infusion device Technical Comparison | |||
|---|---|---|---|
| FEATURE | OptaBlate™ InfusionDeviceSUBJECT DEVICE | RITA® infusion device(K040989)REFERENCE DEVICE | EXPLANATION OFDIFFERENCES |
| Infuser | 15 mm Probe Single Kit9700-015-10020 mm Probe Single Kit9700-020-10015 mm Probe Dual Kit9700-015-20020 mm Probe Dual Kit9700-020-200 | Intelliflow Pump 700-102941 | N/A |
| Infusion Liquid | Saline | Saline | Identical. |
| Flow Rate Range | 6 to 10 ml/hr | 3 to 42 ml/hr | Similar.The OptaBlateMicroinfuser operateswithin a smaller windowof the reference deviceinfusion range.Verification andValidation wassuccessfully conducted onthe subject device andthere were no questionsof safety and efficacyraised. |
| Disposable | Yes | Pump: NoTubing Set: Yes | Similar. |
| Infusion device Technical Comparison | |||
| FEATURE | OptaBlate™ InfusionDeviceSUBJECT DEVICE | RITA® infusion device(K040989)REFERENCE DEVICE | EXPLANATION OFDIFFERENCES |
| The OptaBlateMicroinfuser and theRITA tubing set are bothdisposable items. TheOptaBlate Microinfuser iscompletely disposable,while the RITA systemutilizes a reusableperistaltic pump. |
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Substantial Equivalence
The indications for use and intended use of the subject device are the same as the predicate devices. The technological characteristics of the subject device are similar to the predicate devices, including: principle of operation, design, function, materials, biocompatibility, and sterility.
Performance Testing
Performance testing involved biocompatibility, design verification (dimensional, strength, HFE/UE verification testing), electrical safety and electromagnetic compatibility, software, packaging, shelf life, design validation and Human Factors Engineering. Performance testing showed that the device meets design specifications and performs as intended.
Thermocouple Effects
Verification testing demonstrated that the relevant components of the subject OptaBlate RF Ablation system achieves accurate temperature measurements as per specified test requirements.
Comparative bench-top verification testing
Direct comparative bench top verification testing was completed to demonstrate the substantially equivalent ablation performance of the subject device and predicate OsteoCool™ RF Ablation System (K182497, S.E. 01/15/2019). Tissue models consisted of fresh chicken muscle and bovine bone. Following ablation, chicken muscle lesion length and width were
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directly measured. Bovine bone lesions were indirectly measured via tissue temperature at a given ablation zone boundary. The results demonstrated that lesion dimensions achieved by the subject device are substantially equivalent to those obtained with the predicate device.
Clinical:
The purpose of the literature review provided herein is to demonstrate the safety and efficacy of radiofrequency ablation in for the following indications in eligible patients:
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- Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body
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- 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
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- Ablation of benign bone tumors, such as osteoid osteoma
A thorough review of the literature explored 1) the medical field and targeted treated populations applicable for the Optablate RF Generator System; 2) clinical data for predicate and similar devices; and 3) vigilance databases to assess safety. Performance was assessed using reported outcomes including clinical and technical success, improvements in pain through validated measures (VAS), and the need for repeat procedures. Safety was assessed through both peerreviewed publications and vigilance databases for reported complications, with events that were specifically related to the device or procedure clearly highlighted.
Stryker identified a total of 175 unique publications utilizing search criteria specific to predefined indications. These were screened for inclusion using predetermined criteria and a weighted appraisal scoring system. In addition to vigilance databases, a thorough full-text review of 41 manuscripts was performed providing supportive clinical efficacy and safety data that covered all stated intended indications.
Results from the literature search conclude that RF ablation devices are safe and effective. RF ablation consistently resulted in decreased patient pain post procedure regardless of indication. Furthermore, safety events were primarily due to underlying conditions or the use of cement post procedure. Overall, this search supports that the potential benefits from this device / treatment outweigh the potential risks.
Conclusion
Based on the comparison of intended use and technological characteristics, the device is similar to the predicate device. The hardware and software verification and validation testing demonstrate that the subject device meets its performance specifications and will perform as intended in the specified use conditions and that any differences between the subject device and predicate device do not raise new questions of safety and effectiveness. Therefore, the subject device can be found substantially equivalent to the predicate device.
§ 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.