OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)
Device Facts
| Record ID | K250213 |
|---|---|
| Device Name | OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) |
| Applicant | Stryker Instruments |
| Product Code | GXI · Neurology |
| Decision Date | May 15, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4725 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Stryker OptaBlate BVN Intraosseous Nerve Ablation System is intended for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).
Device Story
System uses bipolar, high-frequency electrosurgical energy to ablate basivertebral nerves for chronic low back pain relief. Components include BVN probe, Microinfuser, introducer handpiece/conduit, and access cannulas. Operated by physician in clinical setting. Probe inserted percutaneously into vertebral body; RF energy delivered via compatible generator (K221074) to create thermal lesions. Microinfuser delivers saline to ablation site to maintain electrical connection; impedance monitoring ensures safety; generator stops if impedance exceeds thresholds. Thermal coagulation of nerve tissue provides pain relief. System benefits patients by addressing specific vertebral endplate/marrow pathologies.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Bipolar RF electrosurgical system. Probe: Stainless steel with gold plating, Pebax insulation, 1.75mm diameter, 10mm active length. Energy: RF, 95°C target. Connectivity: Compatible with OptaBlate RF generator and Microinfuser. Sterilization: Ethylene Oxide (probes/kits), Radiation (Microinfuser/syringe). Standards: IEC 60601-1, 60601-1-2, 60601-1-8, 60601-2-2.
Indications for Use
Indicated for patients with chronic low back pain (≥6 months) unresponsive to ≥6 months of conservative care, presenting with Type 1 or Type 2 Modic changes on MRI (e.g., inflammation, edema, endplate disruption, marrow fat replacement) at L3-S1 vertebrae.
Regulatory Classification
Identification
A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.
Predicate Devices
- Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator (K190504)
Reference Devices
- OptaBlate RF Generator (K221074)
- MultiGen2 Splitter Cable (K170242)
- OptaBlate Microinfuser (K221074)
- Stockert Neuro N50 Generator (K070336)
- Relievant Medsystems RF Generator (K171143)
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
May 15, 2025
Stryker Instruments
Dayana Manganese
Staff Specialist, Regulatory Affairs
1941 Stryker Way
Portage, Michigan 49002
Re: K250213
Trade/Device Name: OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit);
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)
Regulation Number: 21 CFR 882.4725
Regulation Name: Radiofrequency Lesion Probe
Regulatory Class: Class II
Product Code: GXI
Dated: January 24, 2025
Received: January 24, 2025
Dear Dayana Manganese:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K250213 - Dayana Manganese
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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" (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 QS 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K250213 - Dayana Manganese
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assistance/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,
Adam D.
Pierce -S
Digitally signed by Adam
D. Pierce -S
Date: 2025.05.15 16:23:56
-04'00'
Adam Pierce, Ph.D.
Assistant Director
DHT5A: Division of Neurosurgical,
Neurointerventional, and
Neurodiagnostic Devices
OHT5: Office of Neurological and
Physical Medicine Devices
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
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
K250213
Device Name
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit );
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)
Indications for Use (Describe)
The Stryker OptaBlate BVN Intraosseous Nerve Ablation System is intended for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).
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)
## CONTINUE ON A SEPARATE PAGE IF NEEDED.
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K250213 Page 1 of 8
# 510(k) Summary
Submitter Information
| 510(k) Owner/Submitter: | Stryker Instruments 1941 Stryker Way
Portage, MI 49002
USA |
| --- | --- |
| Contact Person: | Dayana Manganese Staff Regulatory Affairs Specialist |
| Registration Number: | 3015967359 |
| Date Summary Prepared: | 5/12/2025 |
Device Name
| Trade Name(s): | OptaBlate BVN Intraosseous Nerve Ablation System |
| --- | --- |
| Regulation | Radiofrequency lesion probe (21 CFR 882.4725) |
| Device Class: | Class 2 |
| Product Code: | GXI |
Predicate Device
| Predicate Device | |
| --- | --- |
| Device Name | Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator |
| 510(k) Number | K190504 |
# Device Description
The subject device Stryker Optablate® BVN Intraosseous Nerve Ablation System is a bipolar, high frequency electrosurgical system comprising the BVN probe, Microinfuser, syringe, introducer handpiece, introducer conduit, 10 G access cannula with diamond tip stylet, and 10 G bevel tip stylet.
The subject device is intended to be used in conjunction with the existing Optablate radiofrequency (RF) generator (K221074), MultiGen2 Splitter Cable (K170242), and Optablate Microinfuser (K221074) to produce lesions by the direct application of radiofrequency currents for the relief of chronic low back pain. The subject 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 conduit that is within an access cannula. The application of RF energy causes a thermal reaction at the targeted tissue site to ablate the basivertebral nerve. It is indicated for the L3 through S1 vertebrae.
When used, the subject OptaBlate BVN probes are connected to the splitter cable, which is connected to the generator, to deliver RF energy to the target tissue. The OptaBlate Microinfuser is connected to the probe to deliver a small amount of saline to the ablation site. The saline exits the probe between the emitters and helps ensure there is good electrical connection between the emitters and the tissue. The quality of the connection is measured in units called impedance. Impedance goes up if the connection is poor. If the impedance goes to high, the generator will trigger an error and stop the ablation. The Microinfuser slowly introduces saline to prevent impedance rises.
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K250213 Page 2 of 8
# Indications for Use
The Stryker OptaBlate BVN Intraosseous Nerve Ablation System is intended for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).
# Substantial Equivalence Comparison
The predicate device has been identified as the Intracept Intraosseous Nerve Ablation System Relievant Medsystems RF Generator (RFG) (K190504). Both subject and predicate devices share the same intended use, and similar indications for use and technological characteristics. Results of verification and validation demonstrate that these differences do not introduce new questions of safety and effectiveness. The subject devices are at least as safe and effective as the predicate device.
Intended Use Comparison
| | Subject | Predicate |
| --- | --- | --- |
| | Stryker OptaBlate BVN Intraosseous Nerve Ablation System | Intracept Intraosseous Nerve Ablation System Relievant Medsystems RF Generator (RFG) (K190504) |
| Product Code | GXI | GXI |
| Indications for Use | The Stryker OptaBlate BVN Intraosseous Nerve Ablation System is intended for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change). | The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change). |
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| | Subject | Predicate |
| --- | --- | --- |
| | Stryker OptaBlate BVN Intraosseous Nerve Ablation System | Intracept Intraosseous Nerve Ablation System Relievant Medsystems RF Generator (RFG) (K190504) |
| | | Ablation System for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change). |
| Single Use? | Single Use | Single Use |
| Anatomical Site | Basivertebral nerves of the L3 through S1 vertebrae. | Basivertebral nerves of the L3 through S1 vertebrae |
| Method of Access | Percutaneous | Percutaneous |
## Technological Characteristics Comparison
| | Subject | Predicate |
| --- | --- | --- |
| | Stryker OptaBlate BVN Intraosseous Nerve Ablation System | Intracept Intraosseous Nerve Ablation System Relievant Medsystems RF Generator (RFG) (K190504) |
| Energy Type | Radiofrequency Energy | Radiofrequency Energy |
| Principle of Operation | Operator-controlled; RF delivered from compatible generator. | Operator-controlled; RF delivered from compatible generator. |
| Mechanism of Action | Cellular necrosis through thermal coagulation. | Cellular necrosis through thermal coagulation. |
| Compatible RF Generator | OptaBlate RF Generator (K221074) | Stockert Neuro N50 Generator (K070336) Relievant Medsystems RF Generator (K171143) |
| Temperature | 95°C | 85°C |
| Temperature Ramp | ~0.27°/second | 1°/second |
| RF Duration | 7 minutes | 15 minutes |
| Saline Infusion | 6 ml/hour | None |
| Active Electrode Length | 10mm | 10mm |
| Active Electrode Material | Stainless Steel with Gold Plating | Stainless Steel |
| Electrode Insulation | Polyether Block Amide (Pebax) | Polyether Block Amide (Pebax) |
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K250213 Page 4 of 8
| | Subject | Predicate |
| --- | --- | --- |
| | Stryker OptaBlate BVN Intraosseous Nerve Ablation System | Intracept Intraosseous Nerve Ablation System Relievant Medsystems RF Generator (RFG) (K190504) |
| Material | | |
| Electrode Diameter | 1.75mm | 2.0mm |
| Components | | |
| Cannula | 10G Access Cannula with Diamond Point Stylet | 8G Access Cannula with Diamond Point Stylet |
| Stylet | 10G Bevel Stylet | 8G Bevel Stylet |
| Curved Access Introducer | Introducer Handpiece | Introducer |
| Access Conduit | 10G Introducer Conduit Peek | 10G Introducer Conduit Peek |
| Saline Infusion | Microinfuser | Not used. |
## Summary of Non-Clinical Testing
A suite of performance testing, including Sterilization, Biocompatibility, Electrical Safety and EMC Testing, was conducted to demonstrate substantial equivalence with the predicate device. The following performance data were provided in support of the substantial equivalence determination.
## Sterilization
Sterilization of the Stryker OptaBlate BVN Kits is completed using Ethylene Oxide. Sterilization validation was completed with conformance with ISO 11135:2014 and ISO 10993-7:2008/Amd 1:2019
Sterilization of the Microinfuser with Syringe is completed using Radiation. Sterilization validation was completed with conformance with ISO 11137-1:2006, ISO 11137-2:2013 and ISO 11137-3:2017.
## Biocompatibility
Patient contact materials are classified as tissue/bone/dentin < 24 hours and tested for compliance with applicable ISO 10993 standards.
This table summarizes the biocompatibility testing done and the results.
| Stryker OptaBlate BVN Intraosseous Nerve Ablation System: Probe Tests | Test Method Summary | Results |
| --- | --- | --- |
| Cytotoxicity – MEM Elution | Standards: ISO 10993-5:2009 ISO 10993- 12:2021 Acceptance Criteria: Test article to be considered non-cytotoxic. | Pass |
| Cytotoxicity – MEM Elution (Aged) | Standards: ISO 10993-5:2009 ISO 10993- 12:2021 Acceptance Criteria: Test article to be considered non-cytotoxic. | Pass |
| Cytotoxicity- MTT | Standards: ISO 10993-5:2009 ISO 10993- 12:2021 Acceptance Criteria: Test article to be considered non-cytotoxic. | Pass |
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| Stryker OptaBlate BVN Intraosseous Nerve Ablation System: Probe Tests | Test Method Summary | Results |
| --- | --- | --- |
| Irritation – Intracutaneous Reactivity | Standards: ISO 10993-23:2021 ISO 10993-12:2021 Acceptance Criteria: Difference between the test article and control is less than or equal to 1.0 | Pass |
| Acute Systemic Toxicity | Standards: ISO 10993-11:2017 ISO 10993-12:2021 Acceptance Criteria: Test article shows no greater biological reaction than animals treated with control | Pass |
| Sensitization – Guinea Pig Maximization | Standards: ISO 10993-10:2010 ISO 10993-12:2021 Acceptance Criteria: Test article causes no sensitization reaction based on scoring and comparison to control | Pass |
| Stryker OptaBlate BVN Intraosseous Nerve Ablation System: Access Cannula/ Bevel Stylet Tests | Test Method Summary | Results |
| --- | --- | --- |
| Cytotoxicity – MEM Elution | Standards: ISO 10993-5:2009 ISO 10993- 12:2021 Acceptance Criteria: Test article to be considered non-cytotoxic. | Pass |
| Irritation – Intracutaneous Reactivity | Standards: ISO 10993-10:2010 ISO 10993-12:2012 Acceptance Criteria: Difference between the test article and control is less than or equal to 1.0 | Pass |
| Acute Systemic Toxicity | Standards: ISO 10993-11:2017 ISO 10993-12:2012 Acceptance Criteria: Test article shows no greater biological reaction than animals treated with control | Pass |
| Sensitization – Guinea Pig Maximization | Standards: ISO 10993-10:2010 ISO 10993-12:2012 Acceptance Criteria: Test article causes no sensitization reaction based on scoring and comparison to control | Pass |
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| Stryker OptaBlate BVN Intraosseous Nerve Ablation System: Introducer handpiece/Introducer conduit Tests | Test Method Summary | Results |
| --- | --- | --- |
| Cytotoxicity – MEM Elution | Standards: ISO 10993-5:2009 ISO 10993-12:2012 Acceptance Criteria: Test article to be considered non- cytotoxic. | Pass |
| Irritation – Intracutaneous Reactivity | Standards: ISO 10993-10:2010 ISO 10993-12:2012 Acceptance Criteria: Difference between the test article and control is less than or equal to 1.0 | Pass |
| Acute Systemic Toxicity | Standards: ISO 10993-11:2017 ISO 10993-12:2012 Acceptance Criteria: Test article shows no greater biological reaction than animals treated with control | Pass |
| Sensitization – Guinea Pig Maximization | Standards: ISO 10993-10:2010 ISO 10993-12:2012 Acceptance Criteria: Test article causes no sensitization reaction based on scoring and comparison to control | Pass |
# Electromagnetic compatibility and Electrical Safety Testing
Stryker OptaBlate BVN Intraosseous Nerve Ablation System was evaluated for compliance with the following standards and was found to be complying:
- IEC 60601-1; Medical electrical equipment; Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2; Medical electrical equipment; Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility
- IEC 60601-1-8; Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 60601-2-2; Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
| Tests | Test Method Summary | Results |
| --- | --- | --- |
| High Frequency Surgical Equipment and Accessories – Safety Testing | Type testing/conformity testing per IEC 60601-2-2 Ed. 6.1: Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories | Pass All applicable clauses from the standard were |
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K250213 Page 7 of 8
| Medical Electrical Equipment – Safety Testing | Type testing/conformity testing per IEC 60601-1 Ed. 3.2: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | tested and conform to safety and effectiveness requirements |
| --- | --- | --- |
| Alarms | Type testing/conformity testing per IEC 60601-1-8 Ed. 2.2: Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems | |
| Electromagnetic Compatibility | Type testing/conformity testing per IEC 60601-1-2 Ed. 4.1: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | |
## Performance Testing
A range of design verification testing was conducted to confirm the subject devices perform as intended and are safe and effective for their intended use. Results of performance testing are summarized below.
| Stryker OptaBlate BVN Intraosseous Nerve Ablation System Test | Test Method Summary | Results |
| --- | --- | --- |
| Transit | ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems | Pass |
| Bubble Test | ASTM F2096 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) | Pass |
| Seal Peel Test | ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials | Pass |
| Mechanical Testing | Probe Insertion Force
Conduit Retraction Force
Infusion Flow Rate
Tensile Strength
Twist Cycle
Torsional Stiffness
Impact Force | Pass |
| Dimensional | Meet dimensional specs per product specifications | Pass |
| Visual Inspection | Ensure non-aged and aged samples free from surface defects and material degradation | Pass |
| Temperature Accuracy (BVN probe testing) | Accuracy verified by measurements and performance testing covering full functional use range | Pass |
| Lesion (BVN probe testing) | Measured RF lesion size in ex vivo tissue model (Bovine bone and chicken) | Pass |
## Clinical Testing
No clinical testing was required to support this submission.
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## Conclusion
The subject devices, in comparison with the legally marketed predicate, share the same intended use and operating principles. Performance testing demonstrate that the subject devices are at least as safe and effective as the predicate. Any differences between the subject and predicate devices do not raise any new or different types of questions of safety and effectiveness. A determination of substantial equivalence is supported.
