(307 days)
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 associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.
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:
- SpineryTM Radiofrequency Generator (REF: SPINERY)
a. Peristaltic Pump - 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) - Spinery™ Connections
a. Cooling system connection pipe for double needle approach (REF: SP-CD)
b. Cooling system connection pipe for single needle approach (REF: SP-CS) - Manual Infusion System
- 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
The provided text does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria. The document is a 510(k) summary for the Spinery™ RF Ablation System, primarily focusing on its substantial equivalence to predicate devices and a summary of non-clinical testing performed.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what information is not available in the provided text, and what minimal information can be inferred:
Information NOT available in the provided text:
- A table of acceptance criteria and the reported device performance: This detailed information is typically found in specific study reports, not in a 510(k) summary. The summary only broadly states that "performance data supports the safety of the device and demonstrates that the subject device complies with the recognized standards as specified."
- Sample size used for the test set and the data provenance: No details on sample sizes or data origin (country, retrospective/prospective) for any specific performance study are given.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no human-expert-based ground truth is discussed for device performance.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This device is an RF ablation system, not an AI diagnostic or assistance tool for human readers. Therefore, an MRMC study in this context is irrelevant and not mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No specific ground truth for performance metrics is detailed. The non-clinical testing mentioned involves mechanical, electrical, EMC, sterilization, biocompatibility, pyrogen, thermocouple accuracy, impedance, usability, and software verification.
- The sample size for the training set: Not applicable, as this is not a machine learning/AI device that requires a training set in that context.
- How the ground truth for the training set was established: Not applicable.
Minimal Information that can be inferred from the provided text regarding "acceptance criteria" and "study":
The "studies" mentioned are non-clinical verification and validation tests, not a single overarching performance study with specific acceptance criteria that would fall into a simple table format. The acceptance criteria for these tests are generally compliance with recognized standards or meeting specified test requirements.
Summary of Non-Clinical Testing (implies meeting "acceptance criteria" of relevant standards):
| Acceptance Criteria (Implied: Compliance with Standards/Requirements) | Reported Device Performance (Summary Statement) |
|---|---|
| Mechanical Integrity (after sterilization & shelf life - 1 & 5 years accelerated aging) | Functional integrity of the system verified (Bone Access Kit and Spinery™ RF Needles) |
| Electrical Safety (IEC 60601-1: 2014, IEC 60601-2-2: 2018) | Compliance with mechanical requirements of cited standards |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2) | Compliance with current IEC 60601-1-2 standard requirements |
| Sterilization and Shelf Life (SAL of 10⁻⁶, ISO 11607-1, ASTM F1980, ISO 11135:2020 for EO sterilization) | Components and packaging meet SAL and sterile barrier requirements at 5-year shelf life |
| Biocompatibility (ISO 10993-1) | Verification performed in accordance with ISO 10993-1 requirements per GLP |
| Pyrogenicity (FDA and USP pyrogen limit specifications) | Non-pyrogenic (LAL testing using Kinetic Chromogenic method) |
| Thermocouple Temperature Accuracy & Impedance (Specified test requirements for accurate temperature, expected impedance, intended ablation area/volume) | Achieves accurate temperature measurements, expected impedance measurements, and intended area and volume of ablation |
| Usability Requirements | Usability requirements verified and validated |
| Software Verification (FDA's "Guidance for the content of premarket submissions for software contained in Medical Devices" (May-2005), Major Level of Concern) | Applicable software verification completed for the Spinery RF Generator |
Overall Conclusion from the text:
The "Conclusions" section in the document states: "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." This statement implies that all the non-clinical tests successfully met their respective acceptance criteria based on established standards and requirements.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| Prescription Use (Part 21 CFR 801 Subpart D) | 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 SystemsPiazza Vanvitelli, 580127 Napoli NA, ItalyContact Person: Stefano PasquinoPhone: +39 3494463940 |
|---|---|
| Contact: | Tawney SchwarzSenior Quality & Regulatory ConsultantSimple Path LLC (formerly Quality Solutions and Support, LLC)Phone: 910-515-0918Email: Tawney@SimplePath.Solutions (former email: tas@qss-llc.com) |
| 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:
-
- SpineryTM Radiofrequency Generator (REF: SPINERY)
- a. Peristaltic Pump
-
- 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)
-
- 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)
-
- 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 DEVICESpineryTM RF AblationSystem | PRIMARY PREDICATEOsteoCool™ RF AblationSystem(K182497) | SECONDARY PREDICATEOptaBlate™ RF AblationSystem(K221074) | Identical/SubstantiallyEquivalent (SE) | |
|---|---|---|---|---|
| Manufacturer | Axon Spine Medical Systems | Medtronic Sofamor DanekUSA, 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 RFlesion techniques | Physicians familiar with RFlesion techniques | Physicians (IR), ScrubTechs/Nurses, Central Sterile | Identical |
| SUBJECT DEVICE | PRIMARY PREDICATE | SECONDARY PREDICATE | Identical/SubstantiallyEquivalent (SE) | |
| Spinery™ RF AblationSystem | OsteoCool™ RF AblationSystem(K182497) | OptaBlate™ RF AblationSystem(K221074) | ||
| Techs | ||||
| Environment Of Use | Intended for use inhospitals or clinics byspecialized medical staff | Intended for use inhospitals or clinics byspecialized medical staff | Intended for use inhospitals or clinics byspecialized medical staff | Identical |
| Indications For Use | The Spinery™ RF AblationSystem 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. | The OsteoCool™ RF AblationSystem is intended for: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 theOptaBlate™ Radiofrequency(RF) Generator System is asfollows: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 DEVICESpinery™ RF AblationSystem | PRIMARY PREDICATEOsteoCool™ RF AblationSystem(K182497) | SECONDARY PREDICATEOptaBlate™ RF AblationSystem(K221074) | Identical/SubstantiallyEquivalent (SE) | |
| Anatomical Site OfUse | Bone | Bone | Bone | Identical |
| Access Method | Percutaneous | Percutaneous | Percutaneous | Identical |
| Energy Type | Radiofrequency Energy | Radiofrequency Energy | Radiofrequency Energy | Identical |
| Principle Of Operation | Operator controlled; RFdelivered from compatibleRF generator via connectorcable | Operator controlled; RFdelivered from compatible RFgenerator via connector cable | Operator controlled; RFdelivered from compatible RFgenerator | Identical |
| Mechanism Of Action | Cellular necrosis throughthermal coagulation | Cellular necrosis throughthermal coagulation | Cellular necrosis throughthermal coagulation | Identical |
| Rate Of TemperatureRise In Sample Tissues | Controlled by RF generatorenergy output mechanism | Controlled by RF generatorenergy output mechanism | Controlled by RF Generator | Identical |
| Feedback Mechanism | Temperature- controlled | Temperature- controlled | Temperature-controlled | Identical |
| Electrode CoolingSystem | Cooling system included andavailable during RF ablation | Cooling system included andavailable during RF ablation | Cooling system included andavailable during RF ablation | Identical |
| SUBJECT DEVICE | PRIMARY PREDICATE | SECONDARY PREDICATE | Identical/SubstantiallyEquivalent (SE) | |
| Spinery™ RF AblationSystem | OsteoCool™ RF AblationSystem(K182497) | OptaBlate™ RF AblationSystem(K221074) | ||
| Infusion System | Manual Infusion SystemIncluded | No Infusion System | Manual Infusion SystemIncluded | Identical toSecondaryPredicate |
| System Components | Thermocouple monitor andintroducer, peristaltic pumpand tube kit, connector hub,footswitch, bone access kit | Thermocouple monitor andintroducer, peristaltic pump andtube kit, connector hub,footswitch, bone access kit | Introducer, Ablation Probes,tube kit, connector cable, 11Gdrill, 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
{8}------------------------------------------------
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.
§ 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.