(113 days)
Not Found
No
The description details a standard electrosurgical generator with manual controls and fixed operating modes, with no mention of adaptive algorithms or learning capabilities.
Yes
The device is used for cutting and coagulation of soft tissue in neurosurgical procedures, which are therapeutic actions to treat medical conditions.
No.
The device description clearly states its purpose is for "cutting and coagulation of soft tissue during surgical procedures" by generating high radiofrequency RF energy. It functions as a surgical tool, not to diagnose conditions.
No
The device description explicitly details hardware components such as pushbuttons, knobs, indicator lights, digital displays, and connections for instruments and foot pedals, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cutting and coagulation of soft tissue in neurosurgical procedures." This describes a surgical intervention performed directly on a patient's body.
- Device Description: The device is an "electrosurgical generator" that uses radiofrequency energy to cut and coagulate tissue. This is a therapeutic device used during surgery.
- 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 any such analysis of biological specimens.
Therefore, the Codman Electrosurgical Generator is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Generator is indicated for use for cutting and coagulation of soft tissue in neurosurgical procedures.
Product codes
GEI
Device Description
The Codman Electrosurgical Generator is a compact source of high radiofrequency RF energy to be used with monopolar and bipolar instruments to cut and coagulate tissue during surgical procedures. This is achieved by the selection of electrosurgical accessories (e. g. monopolar or bipolar instruments), different operating modes and power levels on the front panel of the device. All selections are effected through pushbuttons and knobs. Indicator lights give the operator feedback on the status.
The power level for each mode is indicated by front-panel digital displays. During self-test or for error messages these digital displays also serve as indicators. Activation of output power is performed through an instrument's finger switch and/or a foot pedal.
The maximum power output of the device in CUT mode is 80 watts (at 600 Ohms load), and 80 watts in COAG mode (at 400 Ohms load). Operating frequency of the device is maintained at 4.0 MHz.
The device offers both monopolar and bipolar output wave forms. Both monopolar mode and bipolar mode offers one CUT and one COAG wave form, translating into a total of 4 operating modes for the user.
The Codman Electrosurgical Generator is packaged together with power cord and instruction manual. Typical accessories are a foot pedal with cable (part of this 510(k) submission) and appropriate monopolar and bipolar cables, electrodes and instruments, which are cleared and available separately.
The Codman Electrosurgical Generator is a prescription device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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
Non-clinical performance tests were conducted against applicable standards:
- Electrical safety: Compliance to IEC 60601-1:2005 + A1:2012; ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Passed); Compliance to IEC 60601-2-2:2017 (Generator) and IEC 60601-2-2:2009 (Foot Pedal) (Passed)
- Electromagnetic compatibility: Compliance to IEC 60601-1-2:2014 (Passed)
- Risk Management: Compliance to ISO 14971:2007 (Passed)
- Software Performance: Compliance to IEC 62304:2006 (Passed)
Other subject areas for tests included:
- System Performance Testing
- Thermal effects on tissue
- Usability
- Transport simulation
Internal verification and validation testing confirms that product specifications are met which are equivalent to the predicate device in technological characteristics. The testing results support that the requirements for performance and electrical safety testing were met for the acceptance of the device. The Codman Electrosurgical Generator passed all testing and supports the claims of substantial equivalence to the predicate device.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 11, 2019
KLS Martin GmbH + Co. KG Hanna Huttmeyer Regulatory Affairs Manager Am Flughafen 18 Freiburg im Breisgau, 79108 DE
Re: K183526
Trade/Device Name: Codman Electrosurgical Generator, Foot Pedal Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: March 8, 2019 Received: March 12, 2019
Dear Hanna Huttmeyer:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Integra LifeSciences Corporation Traditional 510(k) Premarket Submission Codman® Electrosurgical Generator
Image /page/2/Picture/2 description: The image shows the Integra logo. The word "INTEGRA" is written in gray, with the tagline "LIMIT UNCERTAINTY" written in a smaller font size below it. To the right of the text is a graphic of several green squares of varying sizes.
Section 6 - 510(k) Summary
510(k) Summary Codman Electrosurgical Generator K183526
1. Submission Sponsor (Owner)
Integra LifeSciences Corporation 11 Cabot Boulevard Mansfield, MA 02048
Phone: +1 781-971-5692 Contact: Jennifer Siu Title: Sr. Regulatory Affairs Specialist Email: Jennifer.siu@integralife.com
2. Submission Correspondent
KLS Martin GmbH + Co. KG Am Flughafen 18 79108 Freiburg, Germany
Phone: +49 761 557 997-0 Fax: +49 761 557 997-137
Contact: Hanna Hüttmeyer Title: Regulatory Affairs Email: hanna.huettmeyer@klsmartin.com
3. Date Prepared
December 17th, 2018
4. Device Identification
| Trade/Proprietary Name: | Codman Electrosurgical Generator |
|---|---|
| Common/Usual Name: | Electrosurgical Generator |
| Classification Name: | Electrosurgical, cutting & coagulation & accessories |
| Regulation Number: | 21 CFR 878.4400 |
| Product Code: | GEI |
| Device Class: | Class II |
| Classification Panel: | General and Plastic Surgery |
5. Legally Marketed Predicate Device
Sutter CURIS® RF Generator by Sutter Medizintechnik GmbH; K171869
3
Integra LifeSciences Corporation Traditional 510(k) Premarket Submission Codman® Electrosurgical Generator
Image /page/3/Picture/2 description: The image shows the word "INTEGRA" in gray font. Below the word "INTEGRA" is the phrase "LIMIT UNCERTAINTY" in a smaller, green font. To the right of the word "INTEGRA" are four green squares of varying sizes. The squares are arranged in a diagonal line, with the largest square at the top and the smallest square at the bottom.
6. Indication for Use Statement
The Generator is indicated for use for cutting and coagulation of soft tissue in neurosurgical procedures.
7. Device Description
The Codman Electrosurgical Generator is a compact source of high radiofrequency RF energy to be used with monopolar and bipolar instruments to cut and coagulate tissue during surgical procedures. This is achieved by the selection of electrosurgical accessories (e. g. monopolar or bipolar instruments), different operating modes and power levels on the front panel of the device. All selections are effected through pushbuttons and knobs. Indicator lights give the operator feedback on the status.
The power level for each mode is indicated by front-panel digital displays. During self-test or for error messages these digital displays also serve as indicators. Activation of output power is performed through an instrument's finger switch and/or a foot pedal.
The maximum power output of the device in CUT mode is 80 watts (at 600 Ohms load), and 80 watts in COAG mode (at 400 Ohms load). Operating frequency of the device is maintained at 4.0 MHz.
The device offers both monopolar and bipolar output wave forms. Both monopolar mode and bipolar mode offers one CUT and one COAG wave form, translating into a total of 4 operating modes for the user.
The Codman Electrosurgical Generator is packaged together with power cord and instruction manual. Typical accessories are a foot pedal with cable (part of this 510(k) submission) and appropriate monopolar and bipolar cables, electrodes and instruments, which are cleared and available separately.
The Codman Electrosurgical Generator is a prescription device.
8. Substantial Equivalence Discussion
The following table compares the Codman Electrosurgical Generator to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.
| Manufacturer | Integra LifeSciences Corporation | Sutter Medizintechnik GmbH |
|---|---|---|
| Trade Name | Codman® Electrosurgical | |
| Generator | ||
| (Subject Device) | CURIS® RF Generator | |
| (Predicate Device) | ||
| Manufacturer | Integra LifeSciences Corporation | Sutter Medizintechnik GmbH |
| Trade Name | Codman® Electrosurgical | |
| Generator | ||
| (Subject Device) | CURIS® RF Generator | |
| (Predicate Device) | ||
| 510(k) Number | TBD | K171869 |
| Product Code | GEI | GEI |
| Regulation Number | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Regulation Name | Electrosurgical, cutting & coagulation | |
| & accessories | Electrosurgical, cutting & coagulation & | |
| accessories | ||
| Indications for Use | The Generator is indicated for use for | |
| cutting and coagulation of soft tissue | ||
| in neurosurgical procedures. | Orthopedic, arthroscopic, spinal and | |
| neurosurgical: | ||
| For resection and coagulation of soft | ||
| tissues and hemostasis of blood vessels in | ||
| orthopedic, arthroscopic, spinal and | ||
| neurosurgical procedures | ||
| For soft tissue resection and coagulation | ||
| during arthroscopic surgical procedures of | ||
| knee, shoulder, ankle, elbow, hip and wrist. |
Cutting:
Snoring, submucosal palatal shrinkage,
traditional uvulopalatoplasty (RAUP),
myringotomy with effective hemorrhage
control, epistaxis treatment and turbinate
shrinkage, skin incisions, biopsy, cysts,
abscesses, tumors, cosmetic repairs,
development of skin flaps, skin tags,
blepharoplasty
Blended Cutting and Coagulation:
Snoring, submucosal palatal shrinkage,
traditional uvulopalatoplasty (RAUP),
myringotomy with effective hemorrhage
control, epistaxis treatment and turbinate
shrinkage, skin tags, papilloma keloids,
keratosis, verrucae, basal cell carcinoma,
nevi, fistulas, epithelioma, cosmetic repairs,
cysts, abscesses, development of skin
flaps
Hemostasis and nonablative Coagulation:
Control of bleeding, epilation,
teleangiectasia
Bipolar:
Pinpoint, precise coagulation, pinpoint
hemostasis in any field (wet or dry),
snoring, submucosal palatal shrinkage,
traditional uvulopalatoplasty (RAUP),
myringotomy with effective hemorrhage
control, epistaxis treatment and turbinate
shrinkage |
| Premarket Submission
surgical Generator | | |
| | Integra LifeSciences Corporation | Sutter Medizintechnik GmbH |
| | Codman® Electrosurgical
Generator
(Subject Device) | CURIS® RF Generator
(Predicate Device) |
| | Metal & plastics | Metal & plastics |
| | No | no |
| | Yes | yes |
| | IEC 60601-1 all applicable
requirements met | IEC 60601-1 all applicable requirements
met |
Table 6A - Comparison of Characteristics
4
Integra LifeSciences Corporation
Traditional 510(k) Premarket Submission Codman® Electrosurgical Generator
Image /page/4/Picture/3 description: The image shows the Integra logo. The word "INTEGRA" is in large, gray, sans-serif font. Below it, in smaller green font, is the phrase "LIMIT UNCERTAINTY". To the right of the text are three green squares of varying sizes, arranged in a column.
5
Manufacturer Trade Name
Battery Operated AC Powered Electrical Safety
Electromagnetic
Compatibility
HF Electrical Safety
Material
met
met
IEC 60601-1-2 all applicable requirements
IEC 60601-2-2 all applicable requirements
9. Non-Clinical Performance Data
IEC 60601-1-2 all applicable
IEC 60601-2-2 all applicable
requirements met
requirements met
As part of demonstrating safety and effectiveness of Codman Electrosurgical Generator and in showing substantial equivalence to the predicate device that is subject to this 510(k) submission, Integra LifeSciences Corporation completed a number of non-clinical performance tests against applicable standards.
| Test | Pass / fail criteria | Results | |
|---|---|---|---|
| 1 | Electrical safety | Compliance to IEC 60601-1:2005 + A1:2012; | |
| ANSI AAMI ES60601-1:2005/(R)2012 and | |||
| A1:2012, C1:2009/(R)2012 and | |||
| A2:2010/(R)2012 | Passed | ||
| 2 | Electrical safety | Compliance to IEC 60601-2-2:2017 (Generator) | |
| Compliance to IEC 60601-2-2:2009 (Foot Pedal) | Passed | ||
| 3 | Electromagnetic compatibility | Compliance to IEC 60601-1-2:2014 | Passed |
| 4 | Risk Management | Compliance to ISO 14971:2007 | Passed |
| 5 | Software Performance | Compliance to IEC 62304:2006 | Passed |
Table 6B - Performance Standards Testing Summary
To demonstrate that the Codman Electrosurgical Generator meets all design specifications and performance requirements, nonclinical bench testing has been performed in accordance with the internal R&D process in compliance with the proposals and recommendations of FDA guidance: "Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery" - Guidance for Industry and Food and Drug Administration Staff, August 15, 2016.
In particular, tests have been carried out with respect to the following subject areas:
- Electromagnetic Compatibility and Electrical Safety
- System Performance Testing ●
- Thermal effects on tissue ●
- Usability
- Transport simulation ●
6
Image /page/6/Picture/1 description: The image shows the text "K183526 - Page 5 of 5" in blue font. Below the text is the word "INTEGRA" in gray font, with the words "LIMIT UNCERTAINTY" in smaller font below it. To the right of the word "INTEGRA" are four green squares of varying sizes.
Internal verification and validation testing confirms that product specifications are met which are equivalent to the predicate device in technological characteristics. The testing results support that the requirements for performance and electrical safety testing were met for the acceptance of the device. The Codman Electrosurgical Generator passed all testing and supports the claims of substantial equivalence to the predicate device.
10. Statement of Substantial Equivalence
Based upon the intended use, design, operating principles, patient/user interface, comparison to the predicate device, and testing conducted, it is concluded that the subject device, Codman Electrosurgical Generator, is substantially equivalent to the predicate device, Sutter CURIS® RF Generator (K171869), and therefore does not raise different questions of safety and effectiveness.
7
Indications for Use
510(k) Number (if known) K183526
Device Name Codman Electrosurgical Generator
Indications for Use (Describe)
The Generator is indicated for use for cutting and coagulation of soft tissue in neurosurgical procedures.
Type of Use (Select one or both, as applicable)
|X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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