(200 days)
Not Found
No
The device description and intended use focus on a manual surgical device utilizing plasma energy for tissue ablation and hemostasis. There is no mention of AI or ML in the description, performance studies, or key metrics.
Yes
The device is used for the ablation and hemostasis of tissues, and the cutting, coagulation, and vaporization of tissues, which are all therapeutic actions.
No
The device is described as a "manual surgical device" used for "ablation and hemostasis of tissues" and "cutting, coagulation and vaporization of tissues." Its intended use is for therapeutic procedures like "Transurethral resection of prostate (TURP)" and "Transurethral resection of bladder tumors (TURBT)," not for diagnosing conditions.
No
The device description explicitly states it is a "manual surgical device, consisting of a single-use electrode with cable range, an active and passive working element reusable and an adaptator to an HF generator compatible." This indicates it is a hardware device with physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Plasma Edge System is a surgical device used for the ablation, hemostasis, cutting, coagulation, and vaporization of tissues within the body during endoscopic procedures. It directly interacts with and modifies tissue.
- Intended Use: The intended use clearly describes surgical procedures performed on the patient's internal organs (prostate, bladder).
- Device Description: The description details a surgical electrode and associated components for delivering energy to tissue.
- Lack of Sample Analysis: There is no mention of analyzing samples taken from the body. The device operates directly on the tissue in situ.
Therefore, the Plasma Edge System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Plasma Edge System single use bipolar resection electrodes are used for the ablation and hemostasis of tissues under endoscopic control, in association with endoscopic accessories. They are intended for endoscopic surgeries with saline irrigation, in the field of urology. The use of the Plasma Edge System is restricted to surgeons, specialized in urological surgery, for specific use in:
- Transurethral resection of prostate (TURP) for benign prostatic hyperplasia
- Transurethral incision of the prostate (TUIP) or bladder neck
- Transurethral resection of bladder tumors (TURBT)
- Cystodiathermy
- Transurethral Vaporization of the prostate (TUVP/TVP) for benign prostatic hyperplasia, and for Transurethral Vaporization of bladder tumors. (MVVS and MVV models only)
Product codes (comma separated list FDA assigned to the subject device)
FAS, GEI, FDC
Device Description
The Plasma Edge system is a manual surgical device, consisting of a single-use electrode with cable range, an active and passive working element reusable and an adaptator to an HF generator compatible.
The electrodes consist of an active tip, two wires threaded through ceramic tubes to connect the active tip to the body of the loop, allowing the HF energy to reach the active tip. It has to be used with continuous flow irrigation of saline solution (NaCl 0,9%) that reaches the operative site through a resectoscope. The HF energy delivered from the generator to the electrode ionizes the gas of the saline solution, creating a plasma for the cutting, coagulation and vaporization of tissues.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Prostate, Bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons, specialized in urological surgery
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)
Performance tests were carried out to ensure that the system functions as intended and meets design specifications. The following performance tests and usability studies were conducted:
Biocompatibility testing: The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, `Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995. The testing included the following tests: Biological Safety – toxicology: AAMI ANSI ISO 10993-1:2009; Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process; Cytotoxicity: AAMI ANSI ISO 10993-5:2009; Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity; Chemical Analysis: AAMI ANSI ISO 10993-12:2012; Biological evaluation of medical devices - Part 12: Sample Preparation and Reference Materials.
Electrical safety: Electrical Safety was tested by an independent laboratory according to AAMI/ANSI ES 60601-1:2005 and C1:2009 and A2:2010; Medical Electrical Equipment - Part 1.1 General requirements for safety and essential performance.
Electromagnetic compatibility (EMC): Electromagnetic compatibility with the existing HF generator was tested by an independent laboratory according to IEC 60601-1-2:2007.
Cleaning and sterilization validation for the reusable working element range: Steam sterilization validation was tested by an independent laboratory following AAMI TIR No.12, ISO 17664, and ISO 17665. Cleaning and disinfection validation was tested by an independent laboratory following AAMI TIR No.30.
Bench top validation testing: End of life simulation report, breakdown simulation report, working element compatibility report, and test on ex vivo tissues have been tested on the Plasma Edge System to demonstrate the product safety and the efficiency.
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.
Not Found
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
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image is a black and white 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 a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 23, 2017
Chirurgie Innovation % Mark Job Official Correspondent Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313
Re: K163090 Trade/Device Name: Plasma EDGE System Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FAS, GEI, FDC Dated: May 15, 2017 Received: May 16, 2017
Dear Mark Job:
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.
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 (reporting of medical devicerelated 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" (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,
Charles Viviano -S
For
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Plasma EDGE System
Indications for Use (Describe)
The Plasma Edge System single use bipolar resection electrodes are used for the ablation and hemostasis of tissues under endoscopic control, in association with endoscopic accessories. They are intended for endoscopic surgeries with saline irrigation, in the field of urology. The use of the Plasma Edge System is restricted to surgeons, specialized in urological surgery, for specific use in:
· Transurethral resection of prostate (TURP) for benign prostatic hyperplasia
- · Transurethral incision of the prostate (TUIP) or bladder neck
- · Transurethral resection of bladder tumors (TURBT)
- · Cystodiathermy
· Transurethral Vaporization of the prostate (TUVP/TVP) for benign prostatic hyperplasia, and for Transurethral Vaporization of bladder tumors. (MVVS and MVV models only)
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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Form Approved: OMB No. 0910-0120
3
K163090 Page 1 of 7
| Section 5: 510(k) Summary | |||
|---|---|---|---|
| Applicant | Chirurgie Innovation | ||
| Device : | Plasma Edge System | Traditional 510(k) application | |
| Rev. 4 | Page 1 / 7 |
SECTION 5:
510(K) SUMMARY
| Submitter | Chirurgie Innovation
27 Place Victor Schoelcher
F-91300 Massy FRANCE |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts | Guillaume Noury
CEO
regulatory@orange.fr
Phone : +33 6 16 16 63 30 |
| Date | 07/29/2016 |
| Trade Name | Plasma EDGE System |
| Common name | Bipolar electrodes |
| Classification Name | Electrosurgical cutting and coagulation device and accessories
Resectoscope, working element |
| Class | II |
| Product Code | Classification product code : FAS
Subsequent product code : GEI / FDC |
| CFR section | 876.4300 / 878.4400 / 876.1500 |
| Device panel | Regulation Medical Specialty : Gastroenterology / Urology
510k Review Panel : General & Plastic Surgery |
| Legally marketed
predicate devices | K994166: Axipolar Resectoscope Electrode - manufactured by
Gyrus Medical Ltd.
K120567: Gyrus ACMI PK® Button Electrode - manufactured by
Gyrus Medical Ltd. |
Product Description
The Plasma Edge system is a manual surgical device, consisting of a single-use electrode with cable range, an active and passive working element reusable and an adaptator to an HF generator compatible.
The electrodes consist of an active tip, two wires threaded through ceramic tubes to connect the active tip to the body of the loop, allowing the HF energy to reach the active tip.
4
| Section 5: 510(k) Summary | |
|---|---|
| Applicant | Chirurgie Innovation |
| Device : | Plasma Edge System |
| Traditional 510(k) application | |
| Rev. 4 | Page 2 / 7 |
It has to be used with continuous flow irrigation of saline solution (NaCl 0,9%) that reaches the operative site through a resectoscope. The HF energy delivered from the generator to the electrode ionizes the gas of the saline solution, creating a plasma for the cutting, coagulation and vaporization of tissues.
Electrodes range:
The list of electrodes is divided in 2 ranges: SIDE LOAD and FRONT LOAD.
Each range got is specific way to be assembly into the working element. The only physical difference between both ranges is the electrode cable connexion.
End user can be used to both versions so we decided to offer the choice between them.
Working element range:
The working elements are compatible with the 3 main existing optics brands: STORZ, ACMI and OLYMPUS.
The working elements will be divided in 2 families: side load connection and front load connection.
Adaptor:
This will allow to connect the Plasma EDGE electrode range to a bipolar HF generator system
Indications for use
The Plasma Edge System single use bipolar resection electrodes are used for the ablation and hemostasis of tissues under endoscopic control, in association with endoscopic accessories. They are intended for endoscopic surgeries with saline irrigation, in the field of urology. The use of the Plasma Edge System is restricted to surgeons, specialized in urological surgery, for specific use in:
- Transurethral resection of prostate (TURP) for benign prostatic hyperplasia
- Transurethral incision of the prostate (TUIP) or bladder neck
- Transurethral resection of bladder tumors (TURBT)
5
| Section 5: 510(k) Summary | ||||
|---|---|---|---|---|
| Applicant | Chirurgie Innovation | |||
| Device : | Plasma Edge System | Traditional 510(k) application | ||
| Rev. 4 | Page 3 / 7 |
- Cystodiathermy
• Transurethral Vaporization of the prostate (TUVP/TVP) for benign prostatic hyperplasia, and for Transurethral Vaporization of bladder tumors. (MVVS and MVV models only)
Performance testing
Risk analysis:
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO-14971:2007
Performance tests were carried out to ensure that the system functions as intended and meets design specifications. The following performance tests and usability studies were conducted:
Biocompatibility testing
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, `Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995. The testing included the following tests: • Biological Safety – toxicology: AAMI ANSI ISO 10993-1:2009; Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process · Cytotoxicity: AAMI ANSI ISO 10993-5:2009; Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity • Chemical Analysis: AAMI ANSI ISO 10993-12:2012; Biological evaluation of medical devices - Part 12: Sample Preparation and Reference Materials
Electrical safety
Electrical Safety was tested by an independent laboratory according to AAMI/ANSI ES 60601-1:2005 and C1:2009 and A2:2010; Medical Electrical Equipment - Part 1.1 General requirements for safety and essential performance.
Electromagnetic compatibility (EMC)
6
| Section 5: 510(k) Summary | ||
|---|---|---|
| Applicant | Chirurgie Innovation | |
| Device : | Plasma Edge System | |
| Traditional 510(k) application | ||
| Rev. 4 Rev. 4 | Page 4 / 7 |
Electromagnetic compatibility with the existing HF generator was tested by an independent laboratory according to IEC 60601-1 -2 : 2007
Cleaning and sterilization validation for the reusable working element range:
Steam sterilization validation was tested by an independent laboratory following AAMI TIR N°12, ISO 17664 and ISO 17665
Cleaning and disinfection validation was tested by an independent laboratory following AAMI TIR Nº30
Bench top validation testing
End of life simulation report, breakdown simulation report, working element compatibility report and test on ex vivo tissues have been tested on the Plasma Edge System to demonstrate the product safety and the efficiency.
Summary of Sterilization and Shelf Life Discussion
The electrodes are delivered in a sterile state and are intended for single patient use only. The validated sterilization method used is ethylene oxide. The product has a shelf life of three (3) years.
List of standards
| Standards | Description |
|---|---|
| ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and testing |
| within a risk management process | |
| ISO 10993-5 | Biological evaluation of medical devices -- Part 5: Tests for In Vitro |
| cytotoxicity | |
| ISO 10993-7 | Biological evaluation of medical devices - part 7: ethylene oxide |
| sterilization residuals [including: technical corrigendum 1 (2009)] | |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for irritation |
| and skin sensitization |
7
K163090
Page 5 of 7
| Section 5: 510(k) Summary | |
|---|---|
| Applicant | Chirurgie Innovation |
| Device : | Plasma Edge System |
| Traditional 510(k) application | |
| Rev. 4 | Page 5 / 7 |
| Standards | Description |
|---|---|
| ISO 10993-11 | Biological evaluation of medical devices - Part 11: Tests for systemic |
| toxicity | |
| ISO 11135 | Sterilization of health-care products - ethylene oxide - requirements for |
| the development, validation and routine control of a sterilization process | |
| for medical devices | |
| ISO 11607-1 | Packaging for terminally sterilized medical devices - Part 1: |
| Requirements for materials, sterile barrier systems and packaging | |
| systems | |
| ISO 11607-2 | Packaging for terminally sterilized medical devices - Part 2: Validation |
| requirements for forming, sealing and assembly processes | |
| ISO 17664 | |
| ISO 17665-1 | |
| AAMI TIR | |
| N°12 | Sterilization of medical devices - Information to be provided by the |
| manufacturer for the processing of resterilizable medical devices | |
| Sterilization of health care products -- Moist heat -- Part 1: | |
| Requirements for the development, validation and routine control of a | |
| sterilization process for medical devices | |
| AAMI TIR | |
| N°30 | Cleaning and disinfection validation: following FDA guidance |
| "Reprocessing medical device in health care settings: validation | |
| methods and labeling guidance for industry and food administration | |
| staff issued March 17, 2015" | |
| IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for basic |
| safety and essential performance | |
| IEC 60601-1-2 | General requirements for basic safety and essential performance - |
| Collateral Standard: Electromagnetic disturbances |
- Requirements and tests |
| IEC 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements for basic
safety and essential performance - Collateral standard: Usability |
| IEC 60601-2-2 | Medical electrical equipment - Part 2-2: Particular requirements for the
basic safety and essential performance of high frequency surgical
equipment and high frequency surgical accessories |
8
| Section 5: 510(k) Summary | ||
|---|---|---|
| Applicant | Chirurgie Innovation | |
| Device : | Plasma Edge System | Traditional 510(k) application |
| Rev. 4 | Page 6 / 7 |
| Standards | Description |
|---|---|
| IEC 60601-2-18 | Medical electrical equipment - Part 2-18: Particular requirements for the |
| basic safety and essential performance of endoscopic equipment | |
| IEC 62366 | Medical devices – Application of usability engineering to medical devices |
| ISO 14971 | Medical devices - application of risk management to medical devices. |
| ISO 15223-1 | Medical devices - symbols to be used with medical device labels, |
| labeling, and information to be supplied - part 1 : general requirements |
Comparison of Technological characteristics:
| ELECTRODE | Proposed device | Predicate device | Predicate device |
|---|---|---|---|
| Plasma Edge (cutting loop electrode / vaporization electrode) | Axipolar | ||
| Resectoscope | |||
| Electrode | |||
| (K994166) | Gyrus ACMI PK® | ||
| Button Electrode | |||
| (K120567) | |||
| Indications for use | - Transurethral resection of prostate (TURP) |
- Transurethral incision of the prostate (TUIP) or bladder neck
- Transurethral resection of bladder tumours (TURBT)
- Cystodiathermy
-Transurethral electrovaporization of the prostate | - Transurethral resection of prostate (TURP) - Transurethral incision of the prostate (TUIP) or bladder neck
- Transurethral resection of bladder tumours (TURBT)
- Cystodiathermy
- | - Transurethral electrovaporization of the prostate |
| Sterilization | Eto | Eto | Eto |
9
K163090 Page 7 of 7
| Section 5: 510(k) Summary | |||||
|---|---|---|---|---|---|
| Applicant | Chirurgie Innovation | ||||
| Device : | Plasma Edge System | Traditional 510(k) application | |||
| Rev. 4 | Page 7 / 7 |
| ELECTRODE | Proposed device | Predicate device | Predicate device |
|---|---|---|---|
| Plasma Edge (cutting loop electrode / vaporization electrode) | Axipolar | ||
| Resectoscope | |||
| Electrode | |||
| (K994166) | Gyrus ACMI PK® | ||
| Button Electrode | |||
| (K120567) | |||
| Disposable | Yes | Yes | |
| Energy type | High frequency | High frequency | |
| Mode | Bipolar | Bipolar | |
| User interface | Footswitch | Footswitch | |
| Use only in | |||
| Conductive | |||
| Media | The electrode is to be activated only when immersed in a conductive media such as standard saline solution | The electrode is to be activated only when immersed in a conductive media such as standard saline solution | |
| Electrode | |||
| manipulation | Working element | Working element | |
| Working | |||
| element | |||
| compatibility | Storz | ||
| Olympus | |||
| ACMI | Storz | ||
| Olympus | |||
| ACMI | |||
| Sterilization of | |||
| working | |||
| element | Autoclave | Autoclave |
Conclusion:
There is no difference between the Plasma EDGE resection system and the predicate devices in terms of intended use, principle of operation, and the technology used for device performance. In other words, there is no difference technically, clinically and biologically.
The Plasma EDGE resection system was subjected to verification testing to confirm device performance. There is no new technology and no difference that would raise new or different questions of safety or efficiency. Comparative performance testing demonstrate that the device performed as well as, or better than, the predicate device.