(93 days)
Not Found
No
The document describes a standard electrosurgical system for tissue ablation and coagulation, with no mention of AI or ML capabilities in its function or description.
Yes
The device is intended for the "resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels," which directly involves treating or managing medical conditions within the body.
No
Explanation: The device is intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures, all of which are treatment functions, not diagnostic ones.
No
The device description explicitly lists hardware components like a generator/console, probe/ablator, and footswitch, indicating it is a hardware-based system with potential software control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures." This describes a surgical intervention performed directly on the patient's body.
- Device Description: The description details a system for electrosurgery, involving a generator, probe, and footswitch used for surgical procedures.
- 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 treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgical procedures.
N/A
Intended Use / Indications for Use
RF Console: The Arthrex Synergy RF System, when used with an Apollo RF Ablation Device (Probe), is intended for use as a complete system in the resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Specifically, the ablation devices, electrosurgical generator and their accessories are used for arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, foot and ankle.
RF Probe: The RF Probe are accessories to the Synergy RF Console and are intended for use as a complete system in the resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels and tissue in arthroscopic and orthopedic procedures. Specifically, the RF probes, Synergy RF Console and their accessories are used for arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, foot and ankle.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Arthrex Synergy RF System consists of the Arthrex Synergy RF Generator/Console, Apollo RF probe/ablator and the Synergy RF Footswitch. The system is designed specifically to work together and is not compatible with any other electrosurgical generator.
The aspirating RF probe/ablator provides a bipolar RF probe/ablator handle, the black button adjusts the default power setting for the specific RF probe/ablator connected to the Synergy RF console; the button with the yellow ablate invokes the Ablate function and the blue coagulation button invokes the Coagulation function. A Synergy RF Footswitch can be connected to the front panel of the console to override the control buttons. The user has the option to override this feature through the console touch screen options.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
shoulder, wrist, hand, elbow, hip, knee, foot and ankle
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance testing of the Arthrex Synergy RF System has been shown to be substantially equivalent to the predicate ArthroCare 12000 system by evaluation of coagulation/ablation zone measurements and/or visual similarity of coagulation/ablation of tissue samples, and with respect to the measured temperatures of adjacent tissue, in-vitro.
The submitted performance testing data demonstrated that the coagulation and ablation of the proposed device is substantially equivalent to the coagulation and ablation of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 9, 2016
Arthrex, Inc. Mr. William Heard Regulatory Affairs Project Manager 1370 Creekside Blvd. Naples, Florida 34108-1945
Re: K161581
Trade/Device Name: Arthrex Synergy RF 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 25, 2016 Received: August 29, 2016
Dear Mr. Heard:
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. 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth
1
in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Christopher J. Ronk -S
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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| Traditional 510(k) | K161581 |
|---|---|
| Device Name | Arthrex Synergy RF System |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| Form Approved: OMB No. | 0910-0120 |
|---|---|
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number ( if known ) | K161581 |
|---|---|
| Device Name | Arthrex Synergy RF System |
| Indications for Use (Describe) | |
| RF Console | The Arthrex Synergy RF System, when used with an Apollo RF Ablation Device (Probe), is intended for use as a complete system in the resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Specifically, the ablation devices, electrosurgical generator and their accessories are used for arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, foot and ankle. |
| RF Probe | The RF Probe are accessories to the Synergy RF Console and are intended for use as a complete system in the resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels and tissue in arthroscopic and orthopedic procedures. Specifically, the RF probes, Synergy RF Console and their accessories are used for arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, foot and ankle. |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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| FORM FDA 3881 (8/14) | Page 1 of 1 |
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510(k) Summary
| Date Summary
| Prepared | August 25, 2016 |
|---|---|
| Manufacturer/ | |
| Distributor/ | |
| Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | William Heard |
| Regulatory Affairs Project Manager | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643-5553, ext.71813 | |
| Fax: 239/598-5508 | |
| Email: William.Heard@arthrex.com | |
| Trade Name | Arthrex Synergy RF System |
| Common Name | Electrosurgical, Cutting & Coagulation device and accessories |
| Product Code | GEI |
| Classification Name | Electrosurgical cutting and coagulation device and accessories |
| CFR | 21 CFR 878.4400: 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. | |
| Classification | Class II |
| Review Panel | General & Plastic Surgery |
| Predicate Devices | ArthroCare System 12000 (K082666) |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to |
| obtain clearance for the Arthrex Synergy RF System. | |
| Device Description | The Arthrex Synergy RF System consists of the Arthrex Synergy |
| RF Generator/Console, Apollo RF probe/ablator and the Synergy | |
| RF Footswitch. The system is designed specifically to work | |
| together and is not compatible with any other electrosurgical | |
| generator. | |
| The aspirating RF probe/ablator provides a bipolar | |
| RF probe/ablator handle, the black button adjusts the default | |
| power setting for the specific RF probe/ablator connected to the | |
| Synergy RF console; the button with the yellow ablate invokes | |
| the Ablate function and the blue coagulation button invokes the | |
| Coagulation function. A Synergy RF Footswitch can be | |
| connected to the front panel of the console to override the | |
| control buttons. The user has the option to override this feature | |
| through the console touch screen options. | |
| Intended Use | RF Console |
| The Arthrex Synergy RF System, when used with an Apollo RF | |
| Ablation Device (Probe), is intended for use as a complete | |
| system in the resection, ablation, and coagulation of soft tissue | |
| and hemostasis of blood vessels in arthroscopic and orthopedic | |
| procedures. Specifically, the ablation devices, electrosurgical | |
| generator and their accessories are used for arthroscopic surgery | |
| of the shoulder, wrist, hand, elbow, hip, knee, foot and ankle. | |
| RF Probe | |
| The RF Probe are accessories to the Synergy RF Console and are | |
| intended for use as a complete system in the resection, ablation, | |
| and coagulation of soft tissue and hemostasis of blood vessels | |
| and tissue in arthroscopic and orthopedic procedures. | |
| Specifically, the RF probes, Synergy RF Console and their | |
| accessories are used for arthroscopic surgery of the shoulder, | |
| wrist, hand, elbow, hip, knee, foot and ankle. | |
| Summary of | |
| Performance Testing | The performance testing of the Arthrex Synergy RF System has |
| been shown to be substantially equivalent to the predicate | |
| ArthroCare 12000 system by evaluation of coagulation/ablation | |
| zone measurements and/or visual similarity of | |
| coagulation/ablation of tissue samples, and with respect to the | |
| measured temperatures of adjacent tissue, in-vitro. | |
| Substantial | |
| Equivalence Summary | Arthrex Synergy RF System is substantially equivalent to the |
| predicate device ArthroCare System 12000 based on the same | |
| indications, FDA product code, CFR Regulation number, | |
| classification and indications for use. Any differences between | |
| the Arthrex Synergy RF System and the predicate are considered | |
| minor and do not raise questions concerning safety and | |
| effectiveness. | |
| The proposed device is substantially equivalent to the predicate | |
| device in regards to its intended use, design, energy source and | |
| function. | |
| The submitted performance testing data demonstrated that the | |
| coagulation and ablation of the proposed device is substantially | |
| equivalent to the coagulation and ablation of the predicate | |
| device. | |
| Conclusion | Based on the indications for use, intended use, biocompatibility, |
| technological characteristics, and the comparison of the | |
| performance testing to the predicate device, Arthrex, Inc. has | |
| determined that the Arthrex Synergy RF System is substantially | |
| equivalent to the currently marketed predicate device. |
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