(11 days)
The Arthroscopic Energy System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic surgical procedures.
The ConMed Arthroscopic Energy System consists of a radiofrequency (RF) generator, probes or electrodes, a dispersive pad (as needed), and wired or wireless foot controls. The probes or electrodes are single-use devices used with the Arthroscopic Energy System for the purpose of wet field arthroscopic and orthopedic soft tissue resection (dissection), ablation (removal) and coagulation (hemostasis). The generator is compatible with ConMed monopolar and bipolar probes or electrodes. The generator outputs are delivered to the probes or electrode handpieces within the specification ranges currently cleared and marketed by generators that have equivalent indications. The generator has a liquid crystal display (LCD) touch screen user interface. Power levels are assigned numeric values and are adjustable via the user interface. Control is accomplished via probe or electrode hand-piece controls, wired foot control or wireless foot control.
The provided document pertains to a 510(k) premarket notification for the ConMed Arthroscopic Energy System. The document focuses on establishing substantial equivalence to a predicate device (K140578) rather than presenting a detailed study proving the device meets specific acceptance criteria based on performance metrics.
Therefore, much of the requested information regarding acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML-based devices or devices demonstrating novel performance, is not present in this regulatory submission.
Here's what can be extracted and inferred from the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria or detailed reported device performance in terms of clinical or technical metrics (e.g., accuracy, precision, efficacy rates) for the Arthroscopic Energy System itself.
Instead, the performance data presented is focused on demonstrating the functionality and safety of a modification (Footswitch, Extension Cable) and adherence to regulatory standards:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Footswitch, Extension Cable Functionality | Verification and Validation completed. (Details not provided) |
| Electromagnetic Compatibility (EMC) | "Standards evaluation" completed. (Compliance implied) |
| Electrical Safety | "Standards evaluation" completed. (Compliance implied) |
| Substantial Equivalence to Predicate Device (K140578) | Demonstrated in design, manufacturing materials, intended use, principles of operation, and technical characteristics. Raises no new issues of safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of clinical data or AI/ML performance. The "testing" mentioned refers to verification and validation of the footswitch/extension cable and standards evaluations. No sample sizes for devices or patients are provided for these types of tests. Data provenance (country, retrospective/prospective) is also not applicable or mentioned for these engineering-focused tests.
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)
Not applicable. The document does not describe a study involving expert-established ground truth for a test set, as it is not validating a diagnostic or AI-driven device with such requirements. The "ground truth" for the engineering and electrical safety tests would be the established engineering specifications and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is described as there is no clinical test set requiring expert consensus.
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
Not applicable. This is not an AI-assisted device, and no MRMC study is mentioned or relevant to this type of device (electrosurgical system).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an electrosurgical system, not an algorithm, and therefore the concept of standalone algorithmic performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the conventional sense for clinical or AI/ML ground truth. The "ground truth" for the described testing would be adherence to:
* Engineering Specifications: For the footswitch and extension cable verification/validation.
* International Standards: For Electromagnetic Compatibility and Electrical Safety (e.g., IEC standards for medical electrical equipment).
8. The sample size for the training set
Not applicable. This device does not involve a "training set" as it is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a "training set" or corresponding ground truth establishment process.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing right, with flowing lines that resemble hair or ribbons.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ConMed Corporation Ms. Dionne Sanders Manager, Regulatory Affairs 525 French Road Utica, New York 13502
December 18, 2015
Re: K153499
Trade/Device Name: Arthroscopic Energy System with Accessory Probes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 4, 2015 Received: December 7, 2015
Dear Ms. Sanders:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 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 yours.
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For 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) K153499
Device Name
Arthroscopic Energy System with Accessory Probes
Indications for Use (Describe)
The Arthroscopic Energy System is indicated for resection, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic surgical procedures.
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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Image /page/3/Picture/0 description: The image shows the logo for Conmed Corporation. The logo consists of a blue square with a white "C" shape inside, followed by the word "CONMED" in black, with the word "CORPORATION" in smaller black letters underneath. The logo is clean and professional, and the colors are simple and effective.
510(k) SUMMARY
I. SUBMITTER
ConMed Corporation 525 French Road Utica, NY 13502
Phone: 727-399-5564 Fax: 727-399-5264
Contact Person: Dionne Sanders, RAC Date Prepared: December 4, 2015
II. DEVICE
| Name of Device: | Arthroscopic Energy System |
|---|---|
| Common Name: | Electrosurgical Device and Accessories |
| Classification Name: | Electrosurgical cutting and coagulation device andaccessories |
| Regulatory Class: | Class II, per 21 CFR Part 878.4400 |
| Review Panel: | General and Plastic Surgery Devices |
| Product Codes: | GEI |
III. PREDICATE DEVICE
| Device Name: | Arthroscopic Energy System |
|---|---|
| Company Name: | ConMed Corporation |
| 510(k) #: | K140578 |
IV. DEVICE DESCRIPTION
The ConMed Arthroscopic Energy System consists of a radiofrequency (RF) generator, probes or electrodes, a dispersive pad (as needed), and wired or wireless foot controls. The probes or electrodes are single-use devices used with the Arthroscopic Energy System for the purpose of wet field arthroscopic and orthopedic soft tissue resection (dissection), ablation (removal) and coagulation (hemostasis).
The generator is compatible with ConMed monopolar and bipolar probes or electrodes. The generator outputs are delivered to the probes or electrode handpieces within the specification ranges currently cleared and marketed by generators that have equivalent indications. The generator has a liquid crystal display (LCD) touch screen user interface. Power levels are assigned numeric values and are adjustable via the
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Image /page/4/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a stylized blue square with a white curved shape inside on the left. To the right of the square is the company name, "CONMED," in a bold, sans-serif font, with a horizontal line underneath. Below the line, the word "CORPORATION" is printed in a smaller, sans-serif font.
user interface. Control is accomplished via probe or electrode hand-piece controls, wired foot control or wireless foot control.
INTENDED USE / INDICATIONS FOR USE V.
The Arthroscopic Energy System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic surgical procedures.
VI. COMPARISION OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The following table represents a summary of the technological characteristics between the proposed and the predicate device.
| PROPOSED DEVICE | PREDICATE DEVICE | |
|---|---|---|
| ConMed Corporation | ConMed Corporation | |
| Arthroscopic Energy System | Arthroscopic Energy System | |
| (AES-1) | (AES-1) | |
| BriefDescription | A radiofrequency generator that isintended to be used with a selectionof bipolar or monopolar probes andelectrodes, a dispersive pad (asneeded), and wired or wireless footcontrols. | A radiofrequency generator that isintended to be used with a selectionof bipolar or monopolar probes andelectrodes, a dispersive pad (asneeded), and wired or wireless footcontrols. |
| IntendedUse/Indicationsfor Use | Indicated for resection, ablation,and coagulation of soft tissue andhemostasis of blood vessels inarthroscopic and orthopedicsurgical procedures. | Indicated for resection, ablation,and coagulation of soft tissue andhemostasis of blood vessels inarthroscopic and orthopedicsurgical procedures. |
| Functionality | Bipolar and Monopolarradiofrequency | Bipolar and Monopolarradiofrequency |
| Operatingmodes | Cut and Coagulation | Cut and Coagulation |
| Probes | Single-use, disposable bipolar andmonopolar probes | Single-use, disposable bipolar andmonopolar probes |
| Footswitch,Extensioncable | Yes | N/A |
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Image /page/5/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a blue square with a white abstract shape on the left. To the right of the square is the company name, "CONMED," in bold, black letters. Below the company name is the word "CORPORATION" in smaller, black letters.
VII. PERFORMANCE DATA
Testing has been completed to demonstrate that the device performs as intended given the modification, and is substantially equivalent to the predicate device.
Completed test data includes the following:
-
Footswitch, Extension Cable
- Verification о
- Validation o
-
Standards evaluation
- Electromagnetic compatibility O
- Electrical safety 0
VIII. CONCLUSION
The Arthroscopic Energy System is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the Arthroscopic Energy System (K140578) and raises no new issues 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.