Spinery™ RF Ablation System

K223303 · Axon Spine Medical System · GEI · Aug 30, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K223303
• Device Name: Spinery™ RF Ablation System
• Applicant: Axon Spine Medical System
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 30, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Spinery™ RF Ablation System is an active, surgically invasive device for radiofrequency (RF) thermal ablation of spinal metastatic tumors. System components include an RF generator with a peristaltic pump, bipolar cooled needles, connection pipes, a manual infusion system, and a bone access kit. Used in hospitals or clinics by physicians familiar with RF lesion techniques. The device is inserted percutaneously into the target bone under imaging guidance. The generator delivers RF energy to the needle, inducing cellular necrosis through thermal coagulation. A cooling system circulates fluid to manage tissue temperature during the ~20-minute procedure. The physician monitors temperature and impedance via the system to control the ablation volume. The device provides pain relief by destroying metastatic tissue. It is not intended for use on the central nervous system.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including mechanical integrity (post-sterilization/aging), electrical safety (IEC 60601-1, IEC 60601-2-2), EMC (IEC 60601-1-2), biocompatibility (ISO 10993-1), pyrogenicity (LAL testing), and verification of thermocouple temperature accuracy, impedance, and ablation volume.

Technological Characteristics

Active RF ablation system. Components: RF generator, peristaltic pump, bipolar cooled needles (7mm/10mm electrodes), connection pipes, manual infusion system, bone access kit. Energy: Radiofrequency. Feedback: Temperature-controlled via thermocouple. Sterilization: Ethylene Oxide (ISO 11135:2020). Shelf life: 5 years (ASTM F1980). Software: Major Level of Concern.

Indications for Use

Indicated for palliative treatment of metastatic malignant lesions in a vertebral body and coagulation/ablation of bone tissue for pain palliation in patients with metastatic bone lesions who failed or are not candidates for standard therapy.

Regulatory Classification

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.

Predicate Devices

• Medtronic OsteoCool RF Ablation System (K182497)
• Stryker OptaBlate™ RF Ablation System (K221074)

Submission Summary (Full Text)

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August 30, 2023

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

Axon Spine Medical System % Tawney Schwarz Senior Quality & Regulatory Consultant Quality Solutions and Support, LLC. 7728 Greenbrier Circle Port Saint Lucie, Florida 34986

Re: K223303

Trade/Device Name: Spinery™ RF Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: August 2, 2023 Received: August 2, 2023

Dear Tawney Schwarz:

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Jesse Muir -S

Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K223303

Device Name Spinery™ RF Ablation System

Indications for Use (Describe) SpineryTM RF Ablation System is intended for:

· Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.

· Coagulation and ablation of tissue in bone during surgical procedures including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.

Type of Use (Select one or both, as applicable)

| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
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## K223303

### 510k Summary

# Spinery™ RF Ablation System by
Axon Spine Medical Systems

### Contact Details and Device Name

| Submitter: | Axon Spine Medical Systems<br>Piazza Vanvitelli, 5<br>80127 Napoli NA, Italy<br>Contact Person: Stefano Pasquino<br>Phone: [phone] |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Tawney Schwarz<br>Senior Quality & Regulatory Consultant<br>Simple Path LLC (formerly Quality Solutions and Support, LLC)<br>Phone: [phone]<br>Email: [e-mail] (former email: [e-mail]) |
| Device Trade Name: | Spinery™ RF Ablation System |
| Common Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification Number: | 21 CFR 878.440 |
| Classification Name: | Electrosurgical, Cutting and Coagulation Device And Accessories |
| Product Code: | GEI |

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## K223303

### 510k Summary

Spinery™ RF Ablation System by Axon Spine Medical Systems

#### Legally Marketed Predicate Devices

#### Primary Predicate

Predicate Name - Medtronic OsteoCool RF Ablation System Predicate Number: K182497

Secondary Predicate

Predicate Name - Stryker OptaBlateTM RF Ablation System Predicate Number: K221074

#### Device Description Summary

Spinery™ RF Ablation System is an active medical device, intended for radiofrequency thermal ablation of spine metastation tumors.

It is a surgically invasive device intended for transient use, as the catheter percutaneously the human body in the target bone through a surgical incision, aided by other access kit), and remains in the body for the treatment time, estimated in about 20 minutes as a maximum time length.

It is an active therapeutic device because it is intended to provide treatment and pain alleviation of the human bone.

It is not intended to be used on the central nervous system.

The Spinery™ RF Ablation System includes the following components:

- 1. SpineryTM Radiofrequency Generator (REF: SPINERY)
- a. Peristaltic Pump
- 2. Spinery™ Needles:
- a. Bipolar cooled needle with electrodes length of 7 mm and intra-electrodes length of 4 mm (REF: SP-B10704)
- b. Bipolar cooled needle with electrodes length of 10 mm and intra-electrodes length of 5 mm (REF: SP-B11005)
- 3. Spinery™ Connections
- a. Cooling system connection pipe for double needle approach (REF: SP-CD)

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## K223303

### 510k Summary

### Spinery™ RF Ablation System by Axon Spine Medical Systems

- b. Cooling system connection pipe for single needle approach (REF: SP-CS)
- 4. Manual Infusion System
- న. Bone Access Kit
- a. The SP-BI0704 needle has the access kit with code AXONKIT-22
- b. The SP-BI1005 needle has the access kit with code AXONKIT-29

#### Intended Use/ Indications for Use

The SPINERY™ RF Ablation System is intended for:

- Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body. ●
- Coagulation and ablation of tissue in bone during surgical procedures including palliation of pain assatic . lesions involving bone in patients who have failed or are not candidates for standard therapy.

| | SUBJECT DEVICE<br>SpineryTM RF Ablation<br>System | PRIMARY PREDICATE<br>OsteoCool™ RF Ablation<br>System<br>(K182497) | SECONDARY PREDICATE<br>OptaBlate™ RF Ablation<br>System<br>(K221074) | Identical/<br>Substantially<br>Equivalent (SE) |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Manufacturer | Axon Spine Medical Systems | Medtronic Sofamor Danek<br>USA, Inc | Stryker Corporation | N/A |
| 510(K) # | TBD | K182497 | K221074 | N/A |
| Class | II | II | II | Identical |
| Product Code | GEI, 878.4400 | GEI, 878.4400 | GEI, 878.4400 | Identical |
| User | Physicians familiar with RF<br>lesion techniques | Physicians familiar with RF<br>lesion techniques | Physicians (IR), Scrub<br>Techs/Nurses, Central Sterile | Identical |
| | SUBJECT DEVICE | PRIMARY PREDICATE | SECONDARY PREDICATE | Identical/<br>Substantially<br>Equivalent (SE) |
| | Spinery™ RF Ablation<br>System | OsteoCool™ RF Ablation<br>System<br>(K182497) | OptaBlate™ RF Ablation<br>System<br>(K221074) | |
| | | | Techs | |
| Environment Of Use | Intended for use in<br>hospitals or clinics by<br>specialized medical staff | Intended for use in<br>hospitals or clinics by<br>specialized medical staff | Intended for use in<br>hospitals or clinics by<br>specialized medical staff | Identical |
| Indications For Use | The Spinery™ RF Ablation<br>System is intended for:<br>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. | The OsteoCool™ RF Ablation<br>System is intended for:<br>Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body. Coagulation and ablation of tissue during surgical procedures such as palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy. Ablation of benign bone tumors such as osteoid osteoma. | The intended use of the<br>OptaBlate™ Radiofrequency<br>(RF) Generator System is as<br>follows:<br>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 | SE |
| | SUBJECT DEVICE<br>Spinery™ RF Ablation<br>System | PRIMARY PREDICATE<br>OsteoCool™ RF Ablation<br>System<br>(K182497) | SECONDARY PREDICATE<br>OptaBlate™ RF Ablation<br>System<br>(K221074) | Identical/<br>Substantially<br>Equivalent (SE) |
| Anatomical Site Of<br>Use | Bone | Bone | Bone | Identical |
| Access Method | Percutaneous | Percutaneous | Percutaneous | Identical |
| Energy Type | Radiofrequency Energy | Radiofrequency Energy | Radiofrequency Energy | Identical |
| Principle Of Operation | Operator controlled; RF<br>delivered from compatible<br>RF generator via connector<br>cable | Operator controlled; RF<br>delivered from compatible RF<br>generator via connector cable | Operator controlled; RF<br>delivered from compatible RF<br>generator | Identical |
| Mechanism Of Action | Cellular necrosis through<br>thermal coagulation | Cellular necrosis through<br>thermal coagulation | Cellular necrosis through<br>thermal coagulation | Identical |
| Rate Of Temperature<br>Rise In Sample Tissues | Controlled by RF generator<br>energy output mechanism | Controlled by RF generator<br>energy output mechanism | Controlled by RF Generator | Identical |
| Feedback Mechanism | Temperature- controlled | Temperature- controlled | Temperature-controlled | Identical |
| Electrode Cooling<br>System | Cooling system included and<br>available during RF ablation | Cooling system included and<br>available during RF ablation | Cooling system included and<br>available during RF ablation | Identical |
| | SUBJECT DEVICE | PRIMARY PREDICATE | SECONDARY PREDICATE | Identical/<br>Substantially<br>Equivalent (SE) |
| | Spinery™ RF Ablation<br>System | OsteoCool™ RF Ablation<br>System<br>(K182497) | OptaBlate™ RF Ablation<br>System<br>(K221074) | |
| Infusion System | Manual Infusion System<br>Included | No Infusion System | Manual Infusion System<br>Included | Identical to<br>Secondary<br>Predicate |
| System Components | Thermocouple monitor and<br>introducer, peristaltic pump<br>and tube kit, connector hub,<br>footswitch, bone access kit | Thermocouple monitor and<br>introducer, peristaltic pump and<br>tube kit, connector hub,<br>footswitch, bone access kit | Introducer, Ablation Probes,<br>tube kit, connector cable, 11G<br>drill, Temperature Sensor | Identical |

#### Technological Comparison (SE Table)

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# Spinery™ RF Ablation System by by by
Axon Spine Medical Systems

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# Spinery™ RF Ablation System by by by
Axon Spine Medical Systems

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Spinery™ RF Ablation System by Axon Spine Medical Systems

#### Non-Clinical Testing Summary

Performance testing has been completed to demonstrate substantial equivalence of the subject Spinery™ RF Ablation System to the predicate devices, as well as demonstrates the safety of the subject device and that it complies with the recognized standards as specified. The system components were subject to the following verification and validation tests, as applicable:

- Mechanical: Mechanical testing was completed on the Spinery™ RF Ablation System after sterilization and shelf life ● testing including both 1 and 5 year accelerated aging verifying functional integrity of the system. These test included both the Bone Access Kit and the SpineryTM RF Needles.
- Electrical: Electrical verification testing was conducted for the subject Spinery™ RF Ablation System to ensure ● compliance with mechanical requirements of IEC 60601-1: 2014, IEC 60601-2-2: 2018.
- Electromagnetic Compatibility: Electromagnetic compatibility (EMC) testing was completed for the applicable ● components of the subject Spinery™ RF Ablation System. The results demonstrated compliance of the subject system to current IEC 60601-1-2 standard requirements.

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Spinery™ RF Ablation System by Axon Spine Medical Systems

- Sterilization and Shelf Life: Sterilization validation and shelf life verification testing were conducted for the applicable ● components of subject Spinery™ RF Ablation System to ensure the components and packaging meet an SAL of 10° and meet the sterile barrier requirements at the proposed 5 year shelf life per ISO 11607-1 and ASTM F1980 and Ethylene Oxide sterilization requirements per ISO 11135:2020.
- Biocompatibility: Biocompatibility verification was performed for patient-contacting components of the Spinery™ ● RF Ablation System in accordance with current ISO 10993-1 requirements per GLP.
- Pyrogen: The Spinery™ RF Ablation Kit and Spinery Thermocouple Monitor Kit are supplied non-pyrogenic. LAL ● testing using the Kinetic Chromogenic method will be conducted on every that devices are non-pyrogenic. The devices meet current FDA and USP pyrogen limit specifications. All test requirements were met as specified by applicable standards and the test protocols.
- Thermocouple temperature accuracy and Impedance: Verification testing demonstrated that the relevant components . of the subject Spinery™ RF Ablation system achieves accurate temperature measurements, expected impedance measurements and intended area and volume of ablation as per specified test requirements.
- Usability: Testing was performed to verify and validate the usability requirements of the subject Spinery™ RF ● Ablation System.
- Software: The applicable software verification was completed for the Spinery RF Generator based on a ● Major Level of Concern classification for the device. FDA's "Guidance for the content of premarket submissions for software contained in Medical Devices" (May-2005) was used to determine the Level of Concern for the devices.

### Conclusions

The performance data supports the safety of the device and demonstrates that the subject device complies with the recognized standards as specified. In summary, we believe the Spinery is substantially equivalent to the predicate devices with respect to the general design approach, function, and the intended use. Differences between subject device and predicated affect the safety and effectiveness of the subject device and raise no new questions of safety or effectiveness.