(11 days)
Not Found
No
The description focuses on standard RF energy delivery and control mechanisms (generator, probes, foot controls, LCD interface) without mentioning any AI/ML components or functionalities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
Explanation: The device is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in surgical procedures, which are therapeutic actions.
No
The device is described as an energy system for surgical procedures (resection, ablation, coagulation, hemostasis) and does not mention any diagnostic functions or the collection of data for diagnostic purposes.
No
The device description explicitly lists hardware components such as a radiofrequency (RF) generator, probes/electrodes, a dispersive pad, and foot controls. It is a system that includes both hardware and software (the generator's LCD touch screen user interface).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic surgical procedures." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a radiofrequency energy system with probes and a generator used for surgical manipulation of tissue.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on specimens.
Therefore, the Arthroscopic Energy System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GEI
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 user interface. Control is accomplished via probe or electrode hand-piece controls, wired foot control or wireless foot control.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, blood vessels in arthroscopic and orthopedic surgical procedures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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
- Validation
- Standards evaluation
- Electromagnetic compatibility
- Electrical safety
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/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
1
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 and |
| accessories | |
| 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) | |
| Brief | ||
| Description | A radiofrequency generator that is | |
| intended to be used with a selection | ||
| of bipolar or monopolar probes and | ||
| electrodes, a dispersive pad (as | ||
| needed), and wired or wireless foot | ||
| controls. | A radiofrequency generator that is | |
| intended to be used with a selection | ||
| of bipolar or monopolar probes and | ||
| electrodes, a dispersive pad (as | ||
| needed), and wired or wireless foot | ||
| controls. | ||
| Intended | ||
| Use/ | ||
| Indications | ||
| for Use | Indicated for resection, ablation, | |
| and coagulation of soft tissue and | ||
| hemostasis of blood vessels in | ||
| arthroscopic and orthopedic | ||
| surgical procedures. | Indicated for resection, ablation, | |
| and coagulation of soft tissue and | ||
| hemostasis of blood vessels in | ||
| arthroscopic and orthopedic | ||
| surgical procedures. | ||
| Functionality | Bipolar and Monopolar | |
| radiofrequency | Bipolar and Monopolar | |
| radiofrequency | ||
| Operating | ||
| modes | Cut and Coagulation | Cut and Coagulation |
| Probes | Single-use, disposable bipolar and | |
| monopolar probes | Single-use, disposable bipolar and | |
| monopolar probes | ||
| Footswitch, | ||
| Extension | ||
| cable | 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.