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.

Device Description

The OsteoCool™ RF Ablation System includes the following components:

OsteoCool Radiofrequency Generator
OsteoCool RF Ablation Kit:
i. OsteoCool RF Ablation Probe
ii. OsteoCool Tube Kit
OsteoCool Thermocouple Kit:
i. Osteocool Thermocouple Monitor
ii. Osteocool Thermocouple Monitor Introducer
Osteocool Peristaltic Pump & OsteoCool Pump Cable
OsteoCool Connector Hub
OsteoCool Cart

The OsteoCool™ RF Ablation System delivers controlled radiofrequency (RF) energy in a bipolar manner with a cooling mechanism to facilitate RF lesions in target tissue. The OsteoCool Radiofrequency (RF) Generator operates together with the OsteoCool RF Ablation Probe to deliver the RF energy to the target ablation site(s). The OsteoCool Tube Kit is used with the Osteocool Peristaltic Pump to circulate water internally through the OsteoCool RF Ablation Probe(s) during RF energy delivery. The OsteoCool Pump Cable connects the Osteocool Peristaltic Pump to the OsteoCool RF Generator, which controls the pump speed. The OsteoCool Connector Hub connects the OsteoCool RF Ablation Probe(s) and OsteoCool Thermocouple Monitor(s) to the OsteoCool RF Generator. The OsteoCool Thermocouple Monitor is used with the OsteoCool Thermocouple Monitor Introducer and enables temperature monitoring around the thermal ablation zones during procedures.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Medtronic OsteoCool™ RF Ablation System, specifically focusing on a modification to its indications for use to include the ablation of benign bone tumors such as osteoid osteoma.

Based on the provided text, the device itself is an RF ablation system. The study described focuses on demonstrating "substantial equivalence" of the modified device (with the new indication) to previously cleared predicate devices, rather than establishing direct acceptance criteria for a new, unproven device against specific performance metrics for that new indication.

Therefore, the "acceptance criteria" here are primarily about demonstrating that the expanded indication for use (ablation of osteoid osteoma) for the OsteoCool™ RF Ablation System does not raise new questions of safety and effectiveness compared to its predicate devices, especially the Uniblate Electrosurgical Device which already had an osteoid osteoma indication.

Here's an analysis of the provided information concerning acceptance criteria and studies:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of quantitative acceptance criteria for the expanded indication. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" is shown through various verification and validation tests and a comparative bench-top study to show the device performs similarly to the predicate devices and that the new indication is supported.

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness (General)	The manufacturer concludes that "The results of verification and validation testing support the substantial equivalence of the subject OsteoCool™ RF Ablation System to the predicate devices."
Mechanical Requirements (IEC 60601-1, IEC 60601-2-2)	"Mechanical verification testing was conducted... to ensure compliance." (Conclusion: Compliant)
Electrical Standards (Current electrical standard requirements)	"Electrical verification testing was conducted... to ensure compliance." (Conclusion: Compliant)
Electromagnetic Compatibility (IEC 60601-1-2)	"The results demonstrated compliance of the subject system to current IEC 60601-1-2 standard requirements." (Conclusion: Compliant)
Biocompatibility (ISO 10993-1)	"Biocompatibility verification was performed..." (Conclusion: Compliant)
Thermocouple Temperature Accuracy	"Verification testing demonstrated that the relevant components... achieves accurate temperature measurements as per specified test requirements." (Conclusion: Accurate)
Usability	"Testing was performed to verify and validate the usability requirements..." (Conclusion: Verified and Validated)
Software V&V (FDA Guidance on Software, Major Level of Concern)	"The applicable software verification and validation was completed... based on a Major Level of Concern classification." (Conclusion: V&V completed as per guidance)
Comparative Ablation Performance	"The results demonstrated that the lesion dimensions achieved by the subject device are substantially equivalent to those obtained with the predicate device under the same test setup and conditions."
Performance in Dry Bone (Osteoid Osteoma Environment)	"Impedance Testing with dry bovine bone verified that the OsteoCool™ RF Ablation Probe can be used to adequately perform ablations in dry bone, as often seen in Osteoid Osteoma." "Impedance tests in patients with osteoid osteoma confirmed that the patient data is similar to the bench testing result with dry bovine bone tissue and the subject device is safe and effective for the intended use." (Conclusion: Performs adequately in target environment, patient data supports bench test findings)
Non-Pyrogenic (FDA and USP pyrogen limit specifications)	"LAL testing... will be conducted on every lot to verify that devices are non-pyrogenic. The devices meet current FDA and USP pyrogen limit specifications." (Conclusion: Meets specifications)
New Risks for Osteoid Osteoma Indication	"Medtronic's examined both the published use of RFA in OO regardless of manufacturer and irrespective of patient demographic or tumor location and patient outcomes to determine if any new patient risks are created. Medtronic maintains that the potential benefits provided by these devices outweigh the potential risks." (Conclusion: No new risks identified that outweigh benefits; literature supports RFA for OO generally)
Overall Substantial Equivalence	"Based on the data provided... the intended use of the subject OsteoCool™ RF Ablation System is substantially equivalent to the predicate devices. The subject and predicate devices share the same fundamental scientific technology, including principles of operation and mechanism of action. Differences in design and technological characteristics... do not raise any new types of questions of safety and effectiveness." (Overall conclusion: Substantially Equivalent)

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Comparative bench-top validation testing: The sample size is not explicitly stated. It mentions "For each test, temperature response curves..." and "Following lesion formation, the tissue samples were cross-sectioned and lesion dimensions directly measured." This implies multiple tests were conducted, but a concrete number is missing. The data provenance is a "soft tissue model consisted of fresh bovine liver placed in shell of bovine bone." This is a lab/benchtop study, not a clinical study.
Impedance Testing: Again, specific sample sizes are not given for the bench tests ("dry bovine bone"). For the patient data, it states "Impedance tests in patients with osteoid osteoma confirmed that the patient data is similar to the bench testing result..." The number of patients is not specified. This appears to be retrospective use of existing patient data (implied by "confirmed that the patient data is similar to the bench testing result"), but this is not explicitly stated as retrospective Vs. prospective. No country of origin is mentioned.
Clinical Literature Review: This is a review of published literature on RFA for Osteoid Osteoma. This is not a direct study with a specific "test set" sample size for the device itself but rather a synthesis of existing clinical evidence on the therapy. Data provenance is "published use of RFA in OO regardless of manufacturer."
Other tests (Mechanical, Electrical, EMC, Biocompatibility, Usability, Software, Pyrogen): These are lab-based verification/validation tests. Specific sample sizes for these engineering tests are not provided in this summary, but they would typically involve a specific number of units/components tested to defined protocols.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the use of experts to establish a "ground truth" for the test sets in the typical sense of a human-AI study or a clinical trial. The "truth" for the performance tests (e.g., lesion dimensions, electrical parameters) is established by direct measurement against engineering specifications and comparison to the predicate device, not by expert consensus on clinical findings.

For the literature review, no specific experts are detailed beyond the general understanding that published literature (e.g., peer-reviewed studies) represents a form of accepted evidence within the medical community, likely generated by and reviewed by medical experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study comparing interpretations or classifications that would require adjudication (e.g., imaging reads). The performance tests are objective measurements or comparisons to established standards/predicate devices.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This document is for an ablative device, not an AI-assisted diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is an electrosurgical device, not a software algorithm for diagnosis. The "standalone" performance here refers to the device's ability to achieve its intended physical effect (ablation) as demonstrated through bench testing and its similarities to the predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this submission is multi-faceted:

Bench-top performance data: Direct physical measurements (e.g., lesion dimensions, temperature response curves) are the "ground truth" for comparing the device's functional performance to the predicate.
Engineering Standards: Compliance with international and self-enforced standards (IEC, ISO) served as the "ground truth" for mechanical, electrical, EMC, biocompatibility, and pyrogenicity.
Predicate Device Performance: The established, cleared performance of the OsteoCool V-3 RF Ablation System (K161949) and the Uniblate Electrosurgical Device (K080451) served as the "ground truth" for comparison to demonstrate substantial equivalence.
Published Clinical Literature: For the new osteoid osteoma indication, the "ground truth" on safety and effectiveness was derived from a review of existing clinical literature on RFA for Osteoid Osteoma. This represents a form of pooled "outcomes data" and clinical experience.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI/machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established

Not applicable for the same reason as above.

Summary

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Image /page/0/Picture/0 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 15, 2019

Medtronic Sofamor Danek USA, Inc. Ms. Laveeda Leflore Principal Regulatory Affairs Specialist 1800 Pvramid Place Memphis, Tennessee 38132

Re: K182497

Trade/Device Name: OsteoCool 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: December 14, 2018 Received: December 17, 2018

Dear Ms. Leflore:

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/cfpmr/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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jennifer R. Stevenson -S3

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182497

Device Name OsteoCool™ RF Ablation System

Indications for Use (Describe)
--------------------------------	--

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 surgical procedures including palliation of pain associated with

metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.

· Ablation of benign bone tumors such as osteoid osteoma.

Type of Use (Select one or both, as applicable)
✓ Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Medtronic Sofamor Danek USA, Inc.

January 14, 2019

Submitter	Medtronic Sofamor Danek USA, Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901) 396-3133Fax: (901) 346-9738
Contact	Laveeda LefloreRegulatory Affairs SpecialistDirect Telephone: 901-399-2953Jeff SpragueSr. Regulatory Affairs Program ManagerDirect Telephone: 901-344-1326
Date Prepared	January 14, 2019
Common Name	OsteoCool™ RF Ablation System
Regulatory Class	Class II
Regulation Number	21 CFR 878.4400
Regulation Name and Device	Electrosurgical cutting and coagulation device and accessories
Product Classification Code	GEI
Predicate Devices	OsteoCool® V-3 RF Ablation SystemK161949 (S.E. 01/24/2017) – primary predicateUniblate Electrosurgical DeviceK080451 (S.E. 07/03/2008)The predicate devices have not been subject to a design related recall.

Description of Device

The current 510(k) submission is only for a modification to the indications for use of the cleared OsteoCool™ RF Ablation System (K161949). The subject device is identical in all other aspects cleared in OsteoCool® V-3 RF Ablation System (K161949, S.E. 01/24/2017).

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The OsteoCool™ RF Ablation System includes the following components:

1. OsteoCool Radiofrequency Generator
1. OsteoCool RF Ablation Kit:
- i. OsteoCool RF Ablation Probe
- ii. OsteoCool Tube Kit
1. OsteoCool Thermocouple Kit:
- i. Osteocool Thermocouple Monitor
- ii. Osteocool Thermocouple Monitor Introducer
1. Osteocool Peristaltic Pump & OsteoCool Pump Cable
1. OsteoCool Connector Hub
1. OsteoCool Cart

Indications for Use:

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 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.

Comparison to Predicate Devices

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The indications for use of the subject device represents a modification to the indications for use of the primary predicate OsteoCool V- 3 RF Ablation System (K161949, S.E. 01/24/2017) to enable ablation of benign bone tumors such as osteoid osteoma. The proposed modification to the indications for use does not impact any of these device characteristics because the fundamental scientific technology, principles of operation and mechanism of action, and design and technological aspects is substantially equivalent.

In order to demonstrate substantial equivalence, previously FDA cleared 510(k)s OsteoCool V-3 RF Ablation System (K161949, S.E. 01/24/2017) K161949 (S.E. 01/24/2017) and Uniblate Electrosurgical Device K080451 (S.E. 07/03/2008), which are listed below, in Table 12-1, for the OsteoCool V-3 RF Ablation System are being used as the predicates.

	PREDICATE	PREDICATE	SUBJECT DEVICE
	OsteoCool V-3 RF	Uniblate	OsteoCool TM RF
	Ablation System	ElectrosurgicalDevice	Ablation System
	(K161949, S.E.01/24/2017)	K080451 (S.E.07/03/2008)
Class	II	II	Identical
Product Code	GEI, 878.4400	GEI, 878.4400	Identical
	PREDICATEOsteoCool V-3 RFAblation System(K161949, S.E.01/24/2017)	PREDICATEUniblateElectrosurgicalDeviceK080451 (S.E.07/03/2008)	SUBJECT DEVICEOsteoCool™ RFAblation System
Indications for Use	The OsteoCool V-3RF Ablation Systemis 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.	The AngioDynamicsUniblateElectrosurgical Deviceis intended forcoagulation andablation of tissueduring percutaneous,laparoscopic, andintraoperative surgicalprocedures such aspartial or completeablation of non-resectable liverlesions, osteoidosteoma, andpalliation of painassociated withmetastatic lesionsinvolving bone inpatients who havefailed or are notcandidates forstandard therapy.	The OsteoCool™ RFAblation System isintended 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.
User	Physicians familiar withRF lesion techniques	Physicians familiarwith RF lesiontechniques	Identical
	PREDICATEOsteoCool V-3 RFAblation System(K161949, S.E.01/24/2017)	PREDICATEUniblateElectrosurgicalDeviceK080451 (S.E.07/03/2008)	SUBJECT DEVICEOsteoCool™ RFAblation System
Anatomical siteof use	Bone	Bone, Soft tissue	Identical to OsteoCool V-3RF Ablation System(K161949, S.E. 01/24/2017)
Access method	Percutaneous	Percutaneous,laparoscopic,intraoperative	Identical to OsteoCool V-3RFAblation System(K161949, S.E. 01/24/2017)
Energy type	Radiofrequency Energy	Radiofrequency Energy	Identical
Principle ofoperation	Operator controlled; RFdelivered fromcompatible RF generator	Operator controlled; RFdeliveredfrom compatible RFgenerator	Identical
Mechanism of action	Cellular necrosisthrough thermalcoagulation	Cellular necrosis throughthermalcoagulation	Identical
Rate of temperaturerise in sample tissues	Controlled by RFgenerator energyoutput mechanism	Controlled by RFgeneratorenergy output mechanism	Identical
Feedbackmechanism	Temperature-controlled	Temperature-controlled	Identical
Operating mode	Bipolar RF energy	Monopolar RF energy	Identical to OsteoCool V-3RFAblation System(K161949, S.E.01/24/2017).
Activeelectrodelengths	7, 10, 20 mm	1.0 to 3.0 cm (adjustable)	7, 10, 15, 20 mm (withincleared range of predicateK161949)
Activeelectrodematerial	Stainless steel	Stainless steel	Identical
Electrodeinsulation material	Polyimide	Polyimide	Identical
	PREDICATE	PREDICATE	SUBJECT DEVICE
	OsteoCool V-3 RFAblation System(K161949, S.E.01/24/2017)	UniblateElectrosurgicalDeviceK080451 (S.E.07/03/2008)	OsteoCool™ RFAblation System
Availableelectrode length(s)	16 cm	10, 15, 25 cm	Identical to OsteoCool V-3RFAblation System(K161949, S.E.01/24/2017).
Electrode diameter	17 Gauge	17 Gauge	Identical
Sterilization(Electrode)	EO, Single use	EO, Single use	Identical
CompatibleRF generator	OsteoCoolRadiofrequency (RF)Generator	RITA Medical Systems1500XGenerator	Identical to OsteoCool V-3RFAblation System(K161949, S.E.01/24/2017).
Other systemcomponents	Thermocouple monitorand introducer,peristaltic pump andtube kit, connector hub,footswitch	Peristaltic pump andinfusiontubing, connector cable,grounding pad,footswitch	Similar to OsteoCool V-3RFAblation System(K161949, S.E.01/24/2017). SubjectOsteoCool™ RF AblationSystem does not include theoptional footswitch.

Table 5-1: Comparison Table of Predicate and Subject Devices

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Performance Testing

Performance testing has been completed to demonstrate substantial equivalence of the subject OsteoCool™ RF Ablation System to the predicate devices. The system components were subject to the following verification and validation tests, as applicable:

Mechanical testing

Mechanical verification testing was conducted for the subject OsteoCool™ RF Ablation System to ensure compliance with mechanical requirements of IEC 60601-1: 2005, IEC 60601-2-2: 2009, and self-enforced requirements.

Electrical testing

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Electrical verification testing was conducted for the relevant components of the subject OsteoCool™ RF Ablation System to ensure compliance with current electrical standard requirements.

Electromagnetic compatibility

Electromagnetic compatibility (EMC) testing was completed for the applicable components of the subject OsteoCool™ RF Ablation System. The results demonstrated compliance of the subject system to current IEC 60601-1-2 standard requirements.

Biocompatibility

Biocompatibility verification was performed for patient-contacting components of the OsteoCool™ RF Ablation System in accordance with current ISO 10993-1 requirements.

Thermocouple temperature accuracy

Verification testing demonstrated that the relevant components of the subject OsteoCool™ RF Ablation system achieves accurate temperature measurements as per specified test requirements.

Usabilitv

Testing was performed to verify and validate the usability requirements of the subject OsteoCool™ RF Ablation System.

Software

The applicable software verification and validation was completed for the OsteoCool Radiofrequency Generator and OsteoCool Peristaltic Pump based on a Major Level of Concern classification for the devices. 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.

Comparative bench-top validation testing

Direct comparative bench top validation testing was completed to demonstrate the substantially equivalent ablation performance of the subject device and predicate Uniblate Electrosurgical Device (K080451, S.E. 07/03/2008). The soft tissue model consisted of fresh bovine liver placed in shell of bovine bone. For each test, temperature response curves showing temperature and power over time were generated from procedural data obtained from each respective RF generator. Following lesion formation, the tissue samples were cross-sectioned and lesion dimensions directly measured. The results demonstrated that the lesion dimensions achieved by the subject device are substantially equivalent to those obtained with the predicate device under the same test setup and conditions.

Impedance Testing

The purpose of this study was to evaluate the performance of OsteoCool in dry (low electrolyte) fresh bovine bone that contained cartilaginous tissue and periosteum, an environment similar to osteoid osteomas. Impedance Testing with dry bovine bone verified

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that the OsteoCool™ RF Ablation Probe can be used to adequately perform ablations in dry bone, as often seen in Osteoid Osteoma.

Impedance tests in patients with osteoid osteoma confirmed that the patient data is similar to the bench testing result with dry bovine bone tissue and the subject device is safe and effective for the intended use. Multiple mitigation measures are adopted to reduce risks related associated with abrupt impedance rise or impedance higher than the preset threshold value.

Clinical

The purpose of the literature review provided here is to demonstrate the performance and safety of radiofrequency ablation (RFA) to treat Osteoid Osteoma (OO). Performance was assessed using reported outcomes such as technical success, clinical success, changes in pain, and repeat RFA procedures. Safety was conservatively assessed by review of all reported complications regardless of time of onset or reported relatedness to the device/therapy/or procedure. Medtronic's examined both the published use of RFA in OO regardless of manufacturer and irrespective of patient demographic or tumor location and patient outcomes to determine if any new patient risks are created. Medtronic maintains that the potential benefits provided by these devices outweigh the potential risks.

Pyrogen testing

The OsteoCool™ RF Ablation Kit and OsteoCool Thermocouple Monitor Kit are supplied non-pyrogenic. LAL testing using the Kinetic Chromogenic method will be conducted on every lot to verify 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.

Conclusions

Based on the data provided in the premarket notification, the intended use of the subject OsteoCool™ RF Ablation System is substantially equivalent to the predicate devices. The subject and predicate devices share the same fundamental scientific technology, including principles of operation and mechanism of action. Differences in design and technological characteristics between the subject device and predicate Uniblate Electrosurgical Device (K080451, S.E. 07/03/2008) do not raise any new types of questions of safety and effectiveness. The results of verification and validation testing support the substantial equivalence of the subject OsteoCool™ RF Ablation System to the predicate devices.

Regulation Number and Section

§ 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.