(139 days)
No
The summary describes a standard RF energy system for surgical procedures with a user interface and controls. There is no mention of AI/ML terms, image processing, or data training/testing, which are typical indicators of AI/ML integration.
Yes
The device is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels, which are procedures aimed at treating or improving a medical condition.
No
The device is indicated for surgical procedures involving resection, ablation, and coagulation of soft tissue, not for diagnosis.
No
The device description explicitly lists hardware components such as a radiofrequency (RF) generator, probes/electrodes, a dispersive pad, and foot controls. The performance studies also include testing of these hardware components.
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 surgical procedures." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a radiofrequency (RF) generator, probes, and controls used for surgical purposes.
- 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 outside the body to analyze samples and provide diagnostic information. This device is used inside the body during surgery.
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 (comma separated list FDA assigned to the subject device)
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was completed to confirm that the Arthroscopic Energy System provides equivalent results in resection, ablation, coagulation and hemostasis in comparison to the predicate device, ArthroCare ® System 12000 (K082666). Testing completed included -
- Probe testing
- Functional testing
- System testing
- Suction rate
- Ablation rate
- Temperature accuracy
- Decibel level
- Short detection testing
- Comparative testing for dissection, ablation, and hemostatis
- Standards testing
- Biocompatibility (ISO 10993-1)
- Packaging (ISO 11607-1)
- Sterilization (ISO 11135-1)
- Shelf-life (ISO 10993-7)
- Electromagnetic compatibility (IEC 60601-1-2; IEC 60601-2-2)
- Electrical safety (IEC 60601-1)
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.
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 for Conmed Corporation. The logo consists of a stylized "C" in a black square on the left, followed by the word "CONMED" in large, bold letters. Below "CONMED" is the word "CORPORATION" in smaller letters. The logo is simple and professional, and it is likely used to represent the company in its marketing and branding materials.
510(k) SUMMARY
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) Number K140578 .
Date Prepared: April 10, 2014
A. Submitter
ConMed Corporation 525 French Road Utica, NY 13502 Establishment Registration Number: 1320894
B. Company Contact
Dionne Sanders, RAC Regulatory Affairs Specialist Tel: (727) 399-5564 Fax: (727) 399-5264
C. Device Name
| Trade Name: | Arthroscopic Energy System |
|---|---|
| Common Name: | Electrosurgical Device and Accessories |
| Classification Names: | Electrosurgical Cutting and Coagulation Device and |
| Accessories | |
| Proposed Class/Device: | Class II |
| Product Codes: | GEI |
| Regulation: | 21 CFR Part 878.4400 |
D. Predicate/Legally Marketed Devices
| Device Name: | ArthroCare® System 12000 |
|---|---|
| Company Name: | ArthroCare Corporation |
| 510(k) #: | K082666 |
| Device Name: | ConMed Sabre Genesis Electrosurgical Generator |
| Company Name: | ConMed Electrosurgery |
| 510(k) #: | K103665 |
1
Image /page/1/Picture/0 description: The image shows the logo for CONMED Corporation. The logo consists of a stylized black square with a white curved shape inside, followed by the word "CONMED" in bold, sans-serif font. Below the word "CONMED" is a horizontal line, and below that is the word "CORPORATION" in a smaller, sans-serif font.
Device Description II.
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.
F. Intended Use / Indications
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.
G. Summary of Technological Characteristics
The following table represents a summary of the technological characteristics of the ConMed Arthroscopic Energy System, ConMed Electrosurgery Sabre Genesis, and the ArthroCare System 12000.
| | PROPOSED DEVICE
ConMed Corporation | PREDICATE DEVICE
ArthroCare System 12000 | REFERENCE DEVICE
Sabre Genesis |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| | Arthroscopic Energy System
(AES-1) | (Quantum)
K082666 | K103665 |
| 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 bipolar, high frequency,
electrosurgical generator
called the Controller that is
intended to be used with a
family of disposable, bipolar,
single use Wands. | An electrosurgical generator
with the basic modes of
operation being conventional
electrosurgical cutting and
coagulation. |
| 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 procedures. | Intended for use in open and
laparoscopic surgery and in
office based surgical
procedures. |
| Functionality | Bipolar and Monopolar
radiofrequency | Bipolar
radiofrequency | Bipolar and Monopolar
radiofrequency |
| Operating
modes | Cut and Coagulation | Cut and Coagulation | Cut and Coagulation |
| Probes | Single-use, disposable bipolar
and monopolar probes | Single-use, disposable
bipolar wands | Single-use, disposable bipolar
and monopolar probes |
Page 2 of 3
2
Image /page/2/Picture/0 description: The image shows the logo for CONMED Corporation. The logo consists of a stylized, curved shape on the left, followed by the word "CONMED" in bold, sans-serif font. Below "CONMED" is the word "CORPORATION" in a smaller, sans-serif font. A horizontal line underlines the word "CONMED".
Testing was completed to confirm that the Arthroscopic Energy System provides equivalent results in resection, ablation, coagulation and hemostasis in comparison to the predicate device, ArthroCare ® System 12000 (K082666). Testing completed included -
-
Probe testing
- o Functional testing
- A System testing
- O Suction rate
- o Ablation rate
- Temperature accuracy O
- Decibel level 0
- Short detection testing o
- Comparative testing for dissection, ablation, and hemostatis o
-
Standards testing
- Biocompatibility (ISO 10993-1) 0
- Packaging (ISO 11607-1) 0
- Sterilization (ISO 11135-1) ಂ
- Shelf-life (ISO 10993-7) 0
- Electromagnetic compatibility (IEC 60601-1-2; IEC 60601-2-2) 0
- Electrical safety (IEC 60601-1) o
H. Substantial Equivalence
The Arthroscopic Energy System is substantially equivalent in design, manufacturing materials, intended use, principles of operation, technological characteristics to the ArthroCare® System 12000 (K082666) with the exception of the absence of a monopolar functionality. The subject device and predicate device systems provides bipolar functionality for cutting and coagulation using hand and foot controls which provide the ability to change power settings and measure joint fluid temperature. The Arthroscopic Energy System also provides monopolar functionality and is substantially equivalent in design, principles of operation, technological characteristics, and modes of operation to the ConMed Sabre Genesis (K103665).
I. Conclusion
Based upon the testing and analysis performed, the Arthroscopic Energy is as safe, as effective, and performs as well as the ArthroCare® System 12000 (K082666) for bipolar functionality and the ConMed Sabre Genesis (K103665) for monopolar functionality.
3
Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & 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 an abstract symbol resembling an eagle or bird with three wave-like lines extending from its body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 23, 2014
ConMed Corporation Ms. Dionne Sanders, RAC Regulatory Affairs Specialist 525 French Road Utica, New York 13502
Re: K140578
Trade/Device Name: Arthroscopic Energy" System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: April 10, 2014 Received: April 11, 2014
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
4
Page 2 - Ms. Dionne Sanders, RAC
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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" (21CFR 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,
David Krause -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
5
INDICATIONS FOR USE
510(k) Number (if known): _K140578
Device Name: Arthroscopic Energy™ System
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.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page _ of _
Module A- Page 4