(157 days)
K182497 OsteoCool™ RF Ablation System
No
The summary describes a standard radiofrequency ablation system and does not mention any AI or ML components in the device description, intended use, or performance studies.
Yes
The device is described as providing "palliative treatment" and performing "coagulation and ablation of tissue in bone during surgical procedures," which are clear therapeutic actions.
No
The device is an RF generator system used for ablation and coagulation of tissue, particularly for palliative treatment of metastatic malignant lesions and benign bone tumors. Its function is to destroy tissue, not to diagnose conditions.
No
The device description explicitly states it is a "bipolar, high frequency electrosurgical system" and includes hardware components such as an RF generator, splitter cable, temperature sensor, probes, and infusion devices. While it mentions software performance testing, the core of the device is hardware-based.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a therapeutic procedure involving the direct application of radiofrequency energy to tissue within the body for ablation and coagulation. This is an in vivo (within the living body) procedure, not an in vitro (outside the living body) diagnostic test.
- Device Description: The description details a system that generates and delivers energy to tissue via probes inserted into the body. This is consistent with a surgical or therapeutic device, not a device used to analyze samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. The device's function is to directly treat tissue.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians (IR), Scrub Techs/Nurses, Central Sterile Techs
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)
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 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:
- 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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K182497 OsteoCool™ RF Ablation System
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.
K170242 MultiGen™ 2 RF Generator System, K080451 Uniblate® System, K040989 RITA® System
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
§ 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.
0
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
1
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
2
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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3
510(K) SUMMARY
| Date Prepared: | September 09, 2022 |
|---|---|
| Submitter Information: | Stryker Corporation |
| 1941 Stryker Way | |
| Portage, MI 49002 | |
| Establishment Registration: | 1811755 |
| Contact Information: | Bruce Backlund |
| Principal Regulatory Affairs Specialist | |
| (763) 762-5902 | |
| bruce.backlund@stryker.com | |
| Device Information: | |
| Trade Name: | OptaBlate™ Radiofrequency (RF) Generator |
| System | |
| Common Name: | |
| Classification Name: | RF Generator |
| Electrosurgical cutting and coagulation device and | |
| accessories | |
| 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 System |
| K080451 Uniblate® System | |
| K040989 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
4
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 TEMPERATURE
SENSOR | To be sold a la carte |
| 9700-015-100 | OptaBlate 15MM PROBE SINGLE KIT | (1) 15MM PROBE
(1) MICROINFUSER INFUSION DEVICE
The kit components will not be available a la carte,
only available as a kit
Kit components are individually pouched and
sterilized |
| 9700-015-200 | OptaBlate 15MM PROBE DUAL KIT | (2) 15MM PROBE
(2) MICROINFUSER INFUSION DEVICE
The kit components will not be available a la carte,
only available as a kit
Kit components are individually pouched and
sterilized |
| 9700-020-100 | OptaBlate 20MM PROBE SINGLE KIT | (1) 20MM PROBE
(1) MICROINFUSER INFUSION DEVICE
The kit components will not be available a la carte,
only available as a kit
Kit components are individually pouched and
sterilized |
| 9700-020-200 | OptaBlate 20MM PROBE DUAL KIT | (2) 20MM PROBE
(2) Microinfuser INFUSION DEVICE
The kit components will not be available a la carte,
only available as a kit
Kit components are individually pouched and
sterilized |
| 8400-800-000 | MULTIGEN 2 SPLITTER CABLE | Currently available in an a la carte non -sterile
configuration.
The splitter cable will be included in the OptaBlate
system IFU under the 'For use with' section. The
splitter 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 -sterile
configuration. |
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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
6
| 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
7
| A | Channel Receptacle (four)- Allows
for the installation of a disposable
probe(s) or a reusable temperature
sensor(s). | B | Splitter Cable Housing- Provides
for the connection interface between
the generator and a maximum of four
accessories (probes/temperature
sensors). |
|---|-------------------------------------------------------------------------------------------------------------------------------|---|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| C | Garment Clamps (four)- Provides
the means to support the cable when
connected to surgical drape material. | D | Splitter Cable Connector- Allows
for the installation of the splitter
cable 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 and
transmit temperature data from the
surgical site. | B | Sensor Hub- Provides the
connection interface between
the probe and cable. |
|---|-------------------------------------------------------------------------------------------------------------------------|---|---------------------------------------------------------------------------------------------------------------------------|
| C | Sensor Probe Strain Relief (color-
coded)- Provides cable strain relief
and identifies the compatible
cannula. | D | Sensor Cable- Used to transmit
temperature data from
the surgical site to the generator. |
| E | Connector-end Strain Relief
(color-coded)- Provides cable strain
relief. | F | Connector Release Collar-Used to
remove connector from connector
receptacle. |
| G | Connector Alignment Mark- Used
to properly orient and install the
connector into the connector
receptable. | H | Push-Pull Connector- Used to
install and release the temperature
sensor into the generator connector
receptacle. |
| I | Protective Sleeve- Provides
protection for probe tip. | | |
8
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. |
9
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 to
store NaCl saline. | B | Syringe Port — Allows connection
of saline-filled syringe. |
|---|-----------------------------------------------------------------------------------------------------------|---|-----------------------------------------------------------------------------------------------------------|
| C | Clamp — Used to stop the regulated
saline flow from the reservoir to
prevent leakage during set up. | D | Micro-catheter Connector — Used
to connect the micro-catheter to the
probe saline port. |
| E | Filter — Used to remove air from
the saline flowing to the ablation
zone. | F | Micro-catheter — Allows for the
automatic delivery of a regulated
saline flow to the ablation zone. |
| G | 6 mL Syringe — Used to fill the
Microinfuser 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.
10
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 Ablation | |||
| System | |||
| SUBJECT DEVICE | OsteoCool RF Ablation | ||
| System | |||
| PREDICATE DEVICE | EXPLANATION OF | ||
| DIFFERENCES | |||
| 510(k) Clearance | Subject Device of current | ||
| Submission | K182497 | Identical | |
| Regulation Number | 878.4400 | 878.4400 | Identical |
| Product Code | GEI | GEI | Identical |
| Product Class | II | II | Identical |
| Indication for Use | The OptaBlate ™ 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 | The OsteoCool ™ 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 | Identical |
11
| Intended Use Comparison | |||
|---|---|---|---|
| OptaBlate™ RF Ablation | |||
| System | OsteoCool RF Ablation | ||
| System | EXPLANATION OF | ||
| DIFFERENCES | |||
| SUBJECT DEVICE | PREDICATE DEVICE | ||
| surgical | |||
| procedures | |||
| including | |||
| palliation of pain | |||
| associated with | |||
| metastatic lesions | |||
| involving bone in | |||
| patients whohave failed or are | |||
| not candidates | |||
| for standard | |||
| therapy. | |||
| • Ablation of | |||
| benign bone | |||
| tumors such as | |||
| osteoid osteoma. | 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 (IR), Scrub | ||
| Techs/Nurses, Central | |||
| Sterile Techs | Physicians familiar with RF | ||
| lesion techniques | Similar | ||
| Anatomical Site | Bone | Bone | Identical |
| Method of Access | Percutaneous | Percutaneous | Identical |
| RF System Technical Comparison | |||
|---|---|---|---|
| FEATURE | Stryker OptaBlate™ RF System | ||
| SUBJECT DEVICE | OsteoCool RF Ablation System | ||
| PREDICATE 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 System | ||
| SUBJECT DEVICE | OsteoCool RF Ablation System | ||
| PREDICATE 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 | Similar |
| OptaBlate 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 | Similar |
| Both 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™ RF | ||
| System | OsteoCool RF Ablation | ||
| System | EXPLANATION OF | ||
| DIFFERENCES | |||
| SUBJECT DEVICE | PREDICATE DEVICE | ||
| Electrode Diameter | 13 Gauge | 17 Gauge | Similar |
| Both sizes are considered | |||
| percutaneous | |||
| Electrode Length | 16 cm | 16 cm | Identical |
| Electrode Sterilization | EO, Single Use | EO, Single Use | Identical |
| Compatible RF | |||
| Generator | OptaBlate RF Generator | OsteoCool RF Generator | N/A |
| Generator Power Output | |||
| Channels | 4 | 2 | Similar |
| OptaBlate has a flexible | |||
| configuration that allows 1 | |||
| to 4 channels for power | |||
| output. | |||
| Generator Maximum | |||
| Output Energy | System: 30 W | System: 40 W | Similar |
| Per Channel: 7.5 W | Per Channel: 20W | ||
| Optablate requires less | |||
| power output. | |||
| Generator Maximum | |||
| Voltage | System: 48.5 VRMS | System: 130 VRMS | Different |
| OptaBlate requires much | |||
| less power per channel, | |||
| which necessitates less | |||
| system voltage. | |||
| RF System Technical Comparison | |||
| FEATURE | Stryker OptaBlate™ RF | ||
| System | OsteoCool RF Ablation | ||
| System | EXPLANATION OF | ||
| DIFFERENCES | |||
| SUBJECT DEVICE | PREDICATE DEVICE | ||
| Generator Output | |||
| Frequency | 500 kHz | 465 kHz | Similar |
| Both frequencies are | |||
| considered within the band | |||
| for typical RF ablation and | |||
| create equivalent lesion | |||
| sizes. | |||
| Verification and Validation | |||
| was successfully conducted | |||
| on the subject device and | |||
| there were no questions of | |||
| safety and efficacy raised. | |||
| Generator Maximum | |||
| Current | System: 1.7 ARMS | ||
| Per Channel: 0.433 ARMS | System: 1.0 ARMS | ||
| Per Channel: 0.5 ARMS | Similar | ||
| OptaBlate has a higher | |||
| system current due to the | |||
| increased number of | |||
| output channels. | |||
| Default Ablation | |||
| Temperature | 95°C | 70°C | Similar |
| OsteoCool has a lower | |||
| setpoint due to active tip | |||
| cooling. Both systems will | |||
| achieve up to 95°C in the | |||
| RF System Technical Comparison | |||
| FEATURE | Stryker OptaBlate™ RF | ||
| System | |||
| SUBJECT DEVICE | OsteoCool RF Ablation | ||
| System | |||
| PREDICATE DEVICE | EXPLANATION OF | ||
| DIFFERENCES | |||
| tissue adjacent to the | |||
| electrode. | |||
| Verification and Validation | |||
| was successfully conducted | |||
| on the subject device and | |||
| there were no questions of | |||
| safety and efficacy raised. | |||
| Other System | |||
| Components | • Splitter Cable 8400- | ||
| 800-000 | |||
| • 15 mm Ablation Probe | |||
| Single Kit 9700-015- | |||
| 100 | |||
| • 15 mm Ablation Probe | |||
| Dual Kit 9700-015-200 | |||
| • 20 mm Ablation Probe | |||
| Single Kit 9700-020- | |||
| 100 | |||
| • 20 mm Ablation Probe | |||
| Dual Kit 9700-020-200 | |||
| • Temperature Sensor | |||
| 9700-815-015 | |||
| • 11G Drill 9700-811- | |||
| 000 | • Hub OC04 | ||
| • Single Probe Kit 7 | |||
| mm OCP107 | |||
| • Single Probe Kit 10 | |||
| mm OCP110 | |||
| • Single Probe Kit 15 | |||
| mm OCP115 | |||
| • Single Probe Kit 20 | |||
| mm OCP120 | |||
| • Dual Probe Kit 7 mm | |||
| x2 OCP207 | |||
| • Dual Probe Kit 10 mm | |||
| x2 OCP210 | |||
| • Dual Probe Kit 15 mm | |||
| x2 OCP215 | |||
| • Dual Probe Kit 20 mm | |||
| x2 OCP220 | |||
| • OCP220RF Pump | |||
| OC02 | |||
| • ITC 28G OCN001 | Verification and Validation | ||
| was successfully conducted | |||
| on the subject device and | |||
| there were no questions of | |||
| safety and efficacy raised. |
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| Infusion device Technical Comparison | |||
|---|---|---|---|
| FEATURE | OptaBlate™ Infusion | ||
| Device | |||
| SUBJECT DEVICE | RITA® infusion device | ||
| (K040989) | |||
| REFERENCE DEVICE | EXPLANATION OF | ||
| DIFFERENCES | |||
| Infuser | 15 mm Probe Single Kit | ||
| 9700-015-100 | |||
| 20 mm Probe Single Kit | |||
| 9700-020-100 | |||
| 15 mm Probe Dual Kit | |||
| 9700-015-200 | |||
| 20 mm Probe Dual Kit | |||
| 9700-020-200 | 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 OptaBlate | |||
| Microinfuser operates | |||
| within a smaller window | |||
| of the reference device | |||
| infusion range. | |||
| Verification and | |||
| Validation was | |||
| successfully conducted on | |||
| the subject device and | |||
| there were no questions | |||
| of safety and efficacy | |||
| raised. | |||
| Disposable | Yes | Pump: No | |
| Tubing Set: Yes | Similar. | ||
| Infusion device Technical Comparison | |||
| FEATURE | OptaBlate™ Infusion | ||
| Device | |||
| SUBJECT DEVICE | RITA® infusion device | ||
| (K040989) | |||
| REFERENCE DEVICE | EXPLANATION OF | ||
| DIFFERENCES | |||
| The OptaBlate | |||
| Microinfuser and the | |||
| RITA tubing set are both | |||
| disposable items. The | |||
| OptaBlate Microinfuser is | |||
| completely disposable, | |||
| while the RITA system | |||
| utilizes a reusable | |||
| peristaltic 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
18
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:
-
- 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
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.