(89 days)
Not Found
No
The description focuses on radiofrequency ablation technology and hardware components, with no mention of AI or ML.
Yes
The device is indicated for palliative treatment, coagulation, and ablation of tissue in bone, which are therapeutic interventions.
No
The OsteoCool™ 2.0 RF Ablation System is described as a treatment device that delivers radiofrequency energy for ablation and coagulation of tissue, particularly for palliative treatment of metastatic lesions and benign bone tumors. It is not indicated for diagnostic purposes.
No
The device description explicitly lists multiple hardware components, including a generator, pump, connector hub, and cart, in addition to disposable probes and thermocouples. This indicates it is a hardware-based system, not software-only.
Based on the provided information, the OsteoCool™ 2.0 RF Ablation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for the ablation and coagulation of tissue in bone during surgical procedures. This is a therapeutic intervention performed in vivo (within the living body).
- Device Description: The description details a system that delivers radiofrequency energy and uses a cooling mechanism to create lesions in target tissue. This is a direct treatment method, not a method for analyzing samples in vitro (outside the living body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health. The OsteoCool™ 2.0 RF Ablation System is a therapeutic device used to treat conditions directly within the body.
N/A
Intended Use / Indications for Use
The OsteoCool™ 2.0 RF Ablation System is indicated 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The current 510(k) submission is for a line extension to the cleared OsteoCool™ RF Ablation System (K182497 S.E. 12/17/2018).
The subject OsteoCool™ 2.0 RF Ablation System includes the following hardware components:
- OsteoCool™ 2.0 Radiofrequency Generator
- OsteoCool™ 2.0 Peristaltic Pump & Pump Cable
- OsteoCool™ 2.0 Connector Hub
- OsteoCool™ 2.0 Cart
The OsteoCool™ 2.0 RF Ablation System line extension includes the following commercially available sterile disposables that remain unchanged from the OsteoCool™ RF Ablation System K182497 (S.E. 12/17/2018): - OsteoCool™ RF Ablation Probe with Tube Kit
- OsteoCool™ Independent Thermocouple with Introducer Kit:
The OsteoCool™ 2.0 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™ 2.0 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™ 2.0 Peristaltic Pump to circulate water internally through the OsteoCool™ RF Ablation Probe(s) during RF energy delivery. The OsteoCool™ 2.0 Pump Cable connects the OsteoCool™ 2.0 Peristaltic Pump to the OsteoCool™ 2.0 RF Generator, which controls the pump flowrate.
The OsteoCool™ 2.0 Connector Hub connects the OsteoCool RF Ablation Probe(s) and OsteoCool™ Thermocouple (s) to the OsteoCool™ 2.0 RF Generator. The OsteoCool™ Thermocouple Monitor is used with the OsteoCool™ Thermocouple Introducer and enables temperature monitoring around the thermal ablation zones during procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians trained in the use of OsteoCool RF ablation system
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench top testing was performed to demonstrate substantial equivalence of the OsteoCool™ 2.0 RF Ablation System to the predicate device. The system components were subjected to the following verification and validation tests, as applicable: mechanical, electrical, biocompatibility, data integrity, temperature accuracy, cleaning, connectivity, and usability. Bench-top validation testing was performed for the OsteoCool™ 2.0 RF Ablation System using ex-vivo tissue and product usage in cadaveric bone as per the guidance. Lesion size (length and width) was measured during ex-vivo testing at the 50 degree C isotherm. Color change due to blood coagulation at elevated temperatures between thermally affected tissue and raw tissue was evaluated.
The subject and predicate devices share the same fundamental scientific technology, including principles of operation and mechanism of action. The subject OsteoCool™ 2.0 RF Ablation System has been shown through technological comparison and comparison testing to be substantially equivalent to the identified predicate system for the requested indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
February 28, 2024
Medtronic Sofamor Danek USA Inc. Denise Gaston Sr. Regulatory Affairs Specialist 1800 Pvramid Place Memphis, Tennessee 38132
Re: K233830
Trade/Device Name: OsteoCool™ 2.0 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: November 30, 2023 Received: December 1, 2023
Dear Denise Gaston:
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.
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"
1
(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 OS 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 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-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 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.
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-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, Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.02.28
14-05'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Submission Number (if known)
Device Name
OsteoCool™ 2.0 RF Ablation System
Indications for Use (Describe)
· 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.
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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4
510(k) Summary Medtronic Sofamor Danek USA, Inc.
February 27, 2024
| Submitter | Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901) 498-2697 |
|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Jeff Sprague
Sr. Prin. Regulatory Affairs Lead
Direct Telephone: 901-498-2697
Email: jeffrey.a.sprague@medtronic.com
Or
Denise Gaston
Sr. Regulatory Affairs Specialist
Direct Telephone: 416-576-8749
Email: denise.gaston@medtronic.com |
| Date Prepared | February 27, 2024 |
| Common Name | OsteoCool™ 2.0 RF Ablation System |
| Regulatory Class | Class II |
| Regulation Number | 21 CFR 878.4400 |
| Regulation Name and Device
Product Classification Code | Electrosurgical cutting and coagulation device and accessories
GEI |
| Predicate Devices | OsteoCool™ RF Ablation System
K182497 (S.E. 12/17/2018) – primary predicate |
| Description of Device | The predicate devices have not been subject to a design related recall.
The current 510(k) submission is for a line extension to the cleared
OsteoCool™ RF Ablation System (K182497 S.E. 12/17/2018).
The subject OsteoCool™ 2.0 RF Ablation System includes
the following hardware components:
- OsteoCool™ 2.0 Radiofrequency Generator
- OsteoCool™ 2.0 Peristaltic Pump & Pump Cable
- OsteoCool™ 2.0 Connector Hub
- OsteoCool™ 2.0 Cart
The OsteoCool™ 2.0 RF Ablation System line extension includes the
following commercially available sterile disposables that remain
unchanged from the OsteoCool™ RF Ablation System K182497 (S.E.
12/17/2018): |
| Description of Device | 5. OsteoCool™ RF Ablation Probe with Tube Kit - OsteoCool™ Independent Thermocouple with Introducer Kit: |
| | The OsteoCool™ 2.0 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™ 2.0
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™ 2.0 Peristaltic
Pump to circulate water internally through the OsteoCool™ RF Ablation
Probe(s) during RF energy delivery. The OsteoCool™ 2.0 Pump Cable
connects the OsteoCool™ 2.0 Peristaltic Pump to the OsteoCool™ 2.0
RF Generator, which controls the pump flowrate.
The OsteoCool™ 2.0 Connector Hub connects the OsteoCool RF
Ablation Probe(s) and OsteoCool™ Thermocouple (s) to the
OsteoCool™ 2.0 RF Generator. The OsteoCool™ Thermocouple
Monitor is used with the OsteoCool™ Thermocouple Introducer and
enables temperature monitoring around the thermal ablation zones
during procedures. |
| Indications for Use: | The OsteoCool™ 2.0 RF Ablation System is indicated 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 of Technological
Characteristics with the
Predicate Device | The intended use of the subject device is substantially equivalent to those
of the predicate device. This includes the fundamental scientific
technology, principles of operation and mechanism of action, and design |
5
6
| and technological aspects. |
|---|
| ---------------------------- |
| Comparison Table of Subject and Predicate Devices: | ||
|---|---|---|
| OsteoCool TM 2.0 | ||
| RF Ablation System | OsteoCool RF Ablation System | |
| SUBJECT DEVICE | PREDICATE DEVICE | |
| 510(k) Clearance | ||
| Regulation Number | TBD | |
| 21 CFR 878.4400 | K182497 (S.E. 12/17/2018) | |
| 21 CFR 878.4400 | ||
| Product Code | GEI | GEI |
| Product Class | Class II | Class II |
| Indication for Use | The OsteoCool TM 2.0 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. | The OsteoCool TM 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. | ||
| User | Physicians trained in the use of OsteoCool RF ablation system | Physicians trained in the use of OsteoCool RF ablation system |
| Anatomical Site of Use | Bone | Bone |
| Method of Access | Percutaneous | Percutaneous |
| TECHNICAL DETAILS - System | ||
|---|---|---|
| FEATURE | OsteoCoolTM 2.0 | |
| RF Ablation System |
SUBJECT DEVICE | OsteoCool RF Ablation System
PREDICATE DEVICE |
| Energy Type | Radiofrequency | Radiofrequency |
| Principle of Operation | Radiofrequency energy delivered by operator from generator | Radiofrequency energy delivered by operator from generator |
| Mechanism of Action | Thermal coagulation necrosis | Thermal coagulation necrosis |
| Energy Delivery Control Mechanism | Temperature controlled | Temperature controlled |
| Probe Active Tip Size | 7mm, 10mm, 15mm, 20mm | 7mm, 10mm, 15mm, 20mm |
| Probe Outer Diameter | 17Gauge | 17Gauge |
| Probe length | 16 cm | 16 cm |
| Probe Electrodes
Material | Stainless Steel | Stainless Steel |
| Probe Dielectric
Materials | Polyimide | Polyimide |
| Electrode Sterilization | EtO, single use | EtO, single use |
| Compatible RF
Generator | OsteoCool 2.0 | OsteoCool |
| Number of independent
thermocouples | 4 | 2 |
| Number of probes | 4 | 2 |
| Generator Power Output
Channels | 4 | 2 |
| Generator Maximum
Output Power | 80 Watts total20 W/channel | 40 Watts total20 W/channel |
| Generator Maximum
Voltage | 224 VRMS | 130 VRMS |
| Generator Maximum
Current | 1.2 ARMS | 1.0 ARMS |
| Generator Output
Frequency | 465.1 kHz | 465.1 kHz |
| Default Ablation
Temperature | 70C (Gradual) | 70C |
| | 75C (Accelerated) | N/A |
| Cooling medium | Sterile water | Sterile water |
| System
components | Pump OC02-100
Hub OC04-100
Single Probe Kit 7 mm -OCP107
Single Probe Kit 10 mm -OCP110
Single Probe Kit 15 mm -OCP115
Single Probe Kit 20 mm -OCP120
Dual Probe Kit 7 mm x2 -OCP207
Dual Probe Kit 10 mm x2 -OCP210
Dual Probe Kit 15 mm x2 -OCP215
Dual Probe Kit 20 mm x2 -OCP220
RF Pump - OC02
ITC 28G - OCN001 | Pump OC02
Hub OC04
Single Probe Kit 7 mm -OCP107
Single Probe Kit 10 mm -OCP110
Single Probe Kit 15 mm - OCP115
Single Probe Kit 20 mm -OCP120
Dual Probe Kit 7 mm x2 -OCP207
Dual Probe Kit 10 mm x2 -OCP210
Dual Probe Kit 15 mm x2 -OCP215
Dual Probe Kit 20 mm x2 -OCP220
RF Pump - OC02
ITC 28G - OCN001 |
7
8
| Performance Data | Bench top testing was performed to demonstrate substantial equivalence of
the OsteoCool™ 2.0 RF Ablation System to the predicate device. The
system components were subjected to the following verification and
validation tests, as applicable: mechanical, electrical, biocompatibility,
data integrity, temperature accuracy, cleaning, connectivity, and usability.
Bench-top validation testing was performed for the OsteoCool™ 2.0 RF
Ablation System using ex-vivo tissue and product usage in cadaveric bone
as per the guidance. Lesion size (length and width) was measured during
ex-vivo testing at the 50 degree C isotherm. Color change due to blood
coagulation at elevated temperatures between thermally affected tissue and
raw tissue was evaluated. |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The subject and predicate devices share the same fundamental scientific
technology, including principles of operation and mechanism of action.
The subject OsteoCool™ 2.0 RF Ablation System has been shown
through technological comparison and comparison testing to be
substantially equivalent to the identified predicate system for the
requested indications for use. |