(93 days)
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.
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.
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.
The provided text describes the Arthrex Synergy RF System, an electrosurgical cutting and coagulation device. It includes a 510(k) summary, which details the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, the document does NOT contain detailed information about specific acceptance criteria (numerical thresholds for performance metrics) or a comprehensive study plan with sample sizes, ground truth establishment, or expert qualifications as requested in the prompt.
The document indicates that "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." It also states, "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." This suggests a comparative study was performed, but the specifics are not provided.
Therefore, many of the requested details cannot be extracted from the given text.
Here's an attempt to answer based on the available information and noting what is missing:
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Not Explicitly Stated as Numerical Thresholds) | Reported Device Performance |
|---|---|---|
| Coagulation/Ablation Zone Measurement | Substantially equivalent to predicate device (ArthroCare 12000 system) | Shown to be substantially equivalent to the predicate ArthroCare 12000 system by evaluation of coagulation/ablation zone measurements. |
| Visual Similarity of Coagulation/Ablation of Tissue Samples | Substantially equivalent to predicate device (ArthroCare 12000 system) | Shown to be substantially equivalent to the predicate ArthroCare 12000 system by evaluation of visual similarity of coagulation/ablation of tissue samples. |
| Measured Temperatures of Adjacent Tissue | Substantially equivalent to predicate device (ArthroCare 12000 system) | Shown to be substantially equivalent to the predicate ArthroCare 12000 system with respect to the measured temperatures of adjacent tissue, in-vitro. |
Note: The document uses "substantially equivalent" as the primary acceptance criterion, rather than specific numerical thresholds. The methods used to determine this equivalence are briefly mentioned.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified, but the testing was conducted "in-vitro," suggesting laboratory-based testing rather than clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The evaluation involved "evaluation of coagulation/ablation zone measurements and/or visual similarity," which implies expert assessment but no details are given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: No, this does not appear to be an AI-assisted diagnostic device, but rather an electrosurgical device for cutting and coagulation. Therefore, an MRMC study related to human reader performance with AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not an AI algorithm; it's a medical device. The "performance testing" described refers to the device's physical capabilities in tissue, not an algorithm's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" implicitly would be the objective measurements of coagulation/ablation zones and temperatures in tissue, and visual assessment of the tissue samples. This is determined through in-vitro testing.
8. The sample size for the training set
- Not applicable/Not specified. This is a medical device, not a machine learning model requiring a training set in the typical sense. Performance was compared to a predicate device.
9. How the ground truth for the training set was established
- Not applicable.
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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
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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) |
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510(k) Summary
| Date SummaryPrepared | August 25, 2016 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | William HeardRegulatory Affairs Project ManagerArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643-5553, ext.71813Fax: 239/598-5508Email: 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 coagulationdevice and accessories is a device intended to remove tissue andcontrol 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 toobtain clearance for the Arthrex Synergy RF System. |
| Device Description | The Arthrex Synergy RF System consists of the Arthrex SynergyRF Generator/Console, Apollo RF probe/ablator and the SynergyRF Footswitch. The system is designed specifically to worktogether and is not compatible with any other electrosurgicalgenerator.The aspirating RF probe/ablator provides a bipolar |
| RF probe/ablator handle, the black button adjusts the defaultpower setting for the specific RF probe/ablator connected to theSynergy RF console; the button with the yellow ablate invokesthe Ablate function and the blue coagulation button invokes theCoagulation function. A Synergy RF Footswitch can beconnected to the front panel of the console to override thecontrol buttons. The user has the option to override this featurethrough the console touch screen options. | |
| Intended Use | RF Console |
| The Arthrex Synergy RF System, when used with an Apollo RFAblation Device (Probe), is intended for use as a completesystem in the resection, ablation, and coagulation of soft tissueand hemostasis of blood vessels in arthroscopic and orthopedicprocedures. Specifically, the ablation devices, electrosurgicalgenerator and their accessories are used for arthroscopic surgeryof the shoulder, wrist, hand, elbow, hip, knee, foot and ankle. | |
| RF Probe | |
| The RF Probe are accessories to the Synergy RF Console and areintended for use as a complete system in the resection, ablation,and coagulation of soft tissue and hemostasis of blood vesselsand tissue in arthroscopic and orthopedic procedures.Specifically, the RF probes, Synergy RF Console and theiraccessories are used for arthroscopic surgery of the shoulder,wrist, hand, elbow, hip, knee, foot and ankle. | |
| Summary ofPerformance Testing | The performance testing of the Arthrex Synergy RF System hasbeen shown to be substantially equivalent to the predicateArthroCare 12000 system by evaluation of coagulation/ablationzone measurements and/or visual similarity ofcoagulation/ablation of tissue samples, and with respect to themeasured temperatures of adjacent tissue, in-vitro. |
| SubstantialEquivalence Summary | Arthrex Synergy RF System is substantially equivalent to thepredicate device ArthroCare System 12000 based on the sameindications, FDA product code, CFR Regulation number,classification and indications for use. Any differences betweenthe Arthrex Synergy RF System and the predicate are consideredminor and do not raise questions concerning safety andeffectiveness.The proposed device is substantially equivalent to the predicatedevice in regards to its intended use, design, energy source andfunction. |
| The submitted performance testing data demonstrated that thecoagulation and ablation of the proposed device is substantiallyequivalent to the coagulation and ablation of the predicatedevice. | |
| Conclusion | Based on the indications for use, intended use, biocompatibility,technological characteristics, and the comparison of theperformance testing to the predicate device, Arthrex, Inc. hasdetermined that the Arthrex Synergy RF System is substantiallyequivalent to the currently marketed predicate device. |
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§ 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.