ACE Electrosurgical Resection and Vaporization Electrodes Series
Device Facts
| Record ID | K153055 |
|---|---|
| Device Name | ACE Electrosurgical Resection and Vaporization Electrodes Series |
| Applicant | Ace Medical Devices Pvt. , Ltd. |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Jul 11, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The ACE Electrosurgical Resection and Vaporization Electrodes Series is a single use bipolar electrode series designed and intended for use in endoscopic urological surgical procedures involving the resection, ablation or removal of soft tissue and coagulation where hemostasis is required. The specific urological indications include use in the prostate, bladder and bladder neck. The procedures for which the devices can be used are transurethral resection in saline (TURis), transurethral prostatectomy (TURP), transurethral resection of the prostate (TURP) for benign prostatic hyperplasia, transurethral incision of the prostate (TUIP) or bladder neck, transurethral resection of bladder tumors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment (0.9% Sodium Chloride). These devices are not intended to be used to treat cancer of the prostate. The ACE Electrosurgical Resection and Vaporization Electrode Series are single use bipolar electrodes designed and intended for use in urological surgical procedures involving the vaporization, ablation, cutting, removal of soft tissue and coagulation where hemostasis is required. The specific soft tissue indications include use in the prostate, bladder and bladder neck. The specific treatment indications include benign prostate hyperplasia (BPH) bladder cancer, tumors, lesions, and neoplasms. The specific urological indications include transurethral electro vaporization (TUVP, TVP, TUEVP), also known as transurethral vapor resection of the prostate (TUVRP) or transurethral vaporization in saline (TUVis). These devices are intended to be used in an irrigated environment (0.9% Sodium Chloride). These devices are not intended to be used in treating cancer of the prostate.
Device Story
Single-use bipolar electrosurgical electrodes; designed for endoscopic urological procedures (prostate, bladder, bladder neck). Input: bipolar electrical energy from compatible electrosurgical generators (100-240V, 310-380 kHz). Operation: energy delivered via active tip (loops, buttons, needles, bands) to perform tissue resection, vaporization, or coagulation in saline-irrigated environment. Used in clinical/OR settings by urologists. Output: physical tissue removal/hemostasis. Benefits: enables minimally invasive treatment of BPH, bladder tumors, and neoplasms. Device connects to working elements or compatible cables.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by bench testing and established history of predicate device safety and efficacy.
Technological Characteristics
Bipolar electrosurgical electrodes. Materials: Tungsten, Tungsten alloy, Aluminum Oxide, Stainless Steel 304, PTFE. Dimensions vary by tip type (loops, buttons, needles, bands). Energy: Bipolar RF (310-380 kHz). Connectivity: Compatible with standard electrosurgical generators and working elements. Sterilization: Ethylene Oxide (EO), SAL 10^-6. Standards: IEC 60601-1, IEC 60601-2-2.
Indications for Use
Indicated for endoscopic urological procedures including resection, ablation, removal of soft tissue, and coagulation in prostate, bladder, and bladder neck. Procedures include TURis, TURP (for BPH), TUIP, TURBT, cystodiathermy, and electrovaporization (TUVP/TUVRP/TUVis). Contraindicated for prostate cancer treatment. Used in 0.9% NaCl irrigated environment.
Regulatory Classification
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.
Predicate Devices
- Electrosurgical Resection and Vaporization Electrodes Series (K120418)
Reference Devices
Submission Summary (Full Text)
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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 stylized eagle or bird symbol, with three profiles of human faces incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2016
Ace Medical Devices Pvt. Ltd. % Traves Brady Managing Member Pacific Surgical Specialties, LLC 428 W 21st Ave Spokane, WA 99203
- Re: K153055
Trade/Device Name: ACE Electrosurgical Resection and Vaporization Electrodes Series Regulation Number: 21 CFR§ 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: II Product Code: GEI, FAS Dated: June 2, 2016 Received: June 3, 2016
Dear Traves Brady:
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.
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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 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 vours.
# Joyce M. Whang -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
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### Indications for Use
510(k) Number (if known) K153055
#### Device Name
ACE Electrosurgical Resection and Vaporization Electrodes Series
#### Indications for Use (Describe)
The ACE Electrosurgical Resection and Vaporization Electrodes Series is a single use bipolar electrode series designed and intended for use in endoscopic urological procedures involving the resection, ablation or removal of soft tissue and coagulation where hemostasis is required. The specific urological indications include use in the prostate, bladder and bladder neck. The procedures for which the devices can be used are transurethral resection in saline (TURis). transurethral prostatectomy (TURP), transurethral resection of the prostate (TURP) for benign prostatic hyperplasia, transurethral incision of the prostate (TUIP) or bladder neck, transurethral resection of bladder turnors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment (0.9% Sodium Chloride). These devices are not intended to be used to treat cancer of the prostate.
The ACE Electrosurgical Resection and Vaporization Electrode Series are single use bipolar electrodes designed and intended for use in urological surgical procedures involving the vaporization, cutting, removal of soft tissue and coagulation where hemostasis is required. The specific soft tissue include use in the prostate, bladder and bladder neck. The specific treatment indications include benign prostate hyperplasia (BPH) bladder cancer, tumors, lesions, and neoplasms. The specific urological indications include transurethral electro vaporization (TUVP, TVP, TUEVP), also known as transurethral vapor resection of the prostate (TUVRP) or transurethral vaporization in saline (TUVis). These devices are intended to be used in an irrigated environment (0.9% Sodium Chloride). These devices are not intended to be used in treating cancer of the prostate.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| | <span> <span style="text-decoration:overline">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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## Section 5 – 510(k) Summary
## ACE Electrosurgical Resection and Vaporization Electrodes Series
K153055
#### 1. Submission Sponsor
Ace Medical Devices Pvt. Ltd.
E-1/7, Neptune Society
Kalyani Nagar
Pune - 411006
Maharashtra, India
Phone number: +91-20-26681483
Contact: Mr. Vikas Sethi
Title: Managing Director
#### 2. Submission Correspondent
Pacific Surgical Specialties, LLC
428 W 21st Ave
Spokane
WA, 99203
USA
855.447.3222
Contact: Traves Brady
Title: Managing Member
#### 3. Date Prepared
July 7, 2016
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#### 4. Device Identification
| Trade/Proprietary Name: | ACE Electrosurgical Resection and Vaporization Electrodes Series |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Endoscopic electrosurgical unit and accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation Device & Accessories<br>Electrode, Electrosurgical, Active, Urological |
| Regulation Number: | 21 CFR §878.4400<br>21 CFR §878.4300 |
| Product Code: | GEI, Electrosurgical Cutting, and Coagulation Device & Accessories<br>FAS, Endoscopic electrosurgical unit, and accessories |
| Device Class: | Class II |
| Classification Panel: | Gastroenterology arid Urology |
#### 5. Legally Marketed Predicate Device(s)
K120418, Electrosurgical Resection and Vaporization Electrodes Series, Olympus Winter & Ibe GmbH
#### 6. Device Description
The ACE Electrosurgical Resection and Vaporization Electrodes Series consist of an active tip, PTFE color code identification, and an insulator between the electrode tube, a guiding tube, telescope clip and arm (shaft). The design and dimensions of the electrode tips vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops or buttons. The system includes single-use electrodes that can be connected to a working element (only WA22366A – K100275), or the use of the single-use electrodes together other compatible electrosurgical cables as applicable. Compatible Generators to any of the electrodes include generators with output specifications that meet the following criteria: 100-120/220-240V, ~50-60Hz/1000VA, 310-380 kHz, 320W/200 Ω, Int 10s/30s.
#### 7. Indication for Use Statement
The ACE Electrosurgical Resection and Vaporization Electrodes Series is a single use bipolar electrode series designed and intended for use in endoscopic urological surgical procedures involving the resection, ablation or removal of soft tissue and coagulation where hemostasis is required. The specific urological indications include use in the prostate, bladder neck. The procedures for which the devices can be used are transurethral resection in saline (TURis), transurethral prostatectomy (TURP), transurethral resection of the prostate (TURP) for benign prostatic hyperplasia, transurethral incision of the prostate (TUIP) or bladder neck, transurethral resection of bladder tumors (TURBT) and
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cystodiathermy. These devices are intended to be used in an irrigated environment (0.9% Sodium Chloride). These devices are not intended to be used to treat cancer of the prostate.
The ACE Electrosurgical Resection and Vaporization Electrode Series are single use bipolar electrodes designed and intended for use in urological surgical procedures involving the vaporization, ablation, cutting, removal of soft tissue and coagulation where hemostasis is required. The specific soft tissue indications include use in the prostate, bladder neck. The specific treatment indications include benign prostate hyperplasia (BPH) bladder cancer, tumors, lesions, and neoplasms. The specific urological indications include transurethral electro vaporization (TUVP, TVP, TUEVP), also known as transurethral vapor resection of the prostate (TUVRP) or transurethral vaporization in saline (TUVis). These devices are intended to be used in an irrigated environment (0.9% Sodium Chloride). These devices are not intended to be used in treating cancer of the prostate.
#### 8. Substantial Equivalence Discussion
The following table compares the ACE Electrosurgical Resection and Vaporization Electrodes Series 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 | Ace Medical Devices Pvt. Ltd. | Olympus Winter & Ibe GmbH |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | ACE Electrosurgical Resection and<br>Vaporization Electrodes Series | Electrosurgical Resection and Vaporization<br>Electrodes Series |
| 510(k) Number | K153055 | K120418 |
| Product Code | FAS, GEI | FAS, GEI, FJL, FDC |
| Regulation Number | 21 CFR §876.4400, 21 CFR §876.4300 | 21 CFR §876.4400, 21 CFR §876.4300, 21 CFR<br>§876.1500 |
| Regulation Name | Endoscopic electrosurgical unit and<br>accessories | Endoscopic electrosurgical unit and<br>accessories |
| Indications for Use | The ACE Electrosurgical Resection and<br>Vaporization Electrodes Series is a single use<br>bipolar electrode series designed and<br>intended for use in endoscopic urological<br>surgical procedures involving the resection,<br>ablation or removal of soft tissue and<br>coagulation where hemostasis is required.<br>The specific urological indications include use<br>in the prostate, bladder and bladder neck.<br>The procedures for which the devices can be | The HF-Resection Electrodes are a bipolar<br>instrument series designed and intended for<br>use in endoscopic urological surgical<br>procedures involving the resection, ablation<br>or removal of soft tissue arid where<br>hemostasis is required. The specific urological<br>indications include use in the prostate,<br>bladder and bladder neck. The procedures for<br>which the devices can be used are<br>transurethral resection in saline (TURis), |
| Manufacturer | Ace Medical Devices Pvt. Ltd. | Olympus Winter & Ibe GmbH |
| Trade Name | ACE Electrosurgical Resection and<br>Vaporization Electrodes Series | Electrosurgical Resection and Vaporization<br>Electrodes Series |
| | used are transurethral resection in saline<br>(TURis), transurethral prostatectomy (TURP),<br>transurethral resection of the prostate (TURP)<br>for benign prostatic hyperplasia, transurethral<br>incision of the prostate (TUIP) or bladder<br>neck, transurethral resection of bladder<br>tumors (TURBT) and cystodiathermy. These<br>devices are intended to be used in an<br>irrigated environment (0.9% Sodium<br>Chloride). These devices are not intended to<br>be used to treat cancer of the prostate.<br>The ACE Electrosurgical Resection and<br>Vaporization Electrode Series are single use<br>bipolar electrodes designed and intended for<br>use in urological surgical procedures involving<br>the vaporization, ablation, cutting, removal of<br>soft tissue and coagulation where hemostasis<br>is required. The specific soft tissue indications<br>include use in the prostate, bladder and<br>bladder neck. The specific treatment indications include benign prostate<br>hyperplasia (BPH) bladder cancer, tumors,<br>lesions, and neoplasms. The specific<br>urological indications include transurethral<br>electro vaporization (TUVP, TVP, TUEVP), also<br>known as transurethral vapor resection of the<br>prostate (TUVRP) or transurethral<br>vaporization in saline (TUVis). These devices<br>are intended to be used in an irrigated<br>environment (0.9% Sodium Chloride). These<br>devices are not intended to be used in<br>treating cancer of the prostate. | transurethral prostatectomy, transurethral<br>resection of the prostate (TURP) for benign<br>prostatic hyperplasia, transurethral incision of<br>the prostate (TUIP) or bladder neck,<br>transurethral resection of bladder tumors<br>(TURBT) and cystodiathermy. These devices<br>are intended to be used in an irrigated<br>environment. These devices are not intended<br>to be used to treating cancer of the prostate.<br>The HF-Resection Electrode for Plasma<br>Vaporization is a bipolar instrument designed<br>and intended for use in urological surgical<br>procedures involving the vaporization,<br>ablation, coagulation, cutting, removal of soft<br>tissue and coagulation where hemostasis is<br>required. The specific soft tissue indications<br>include use in the prostate, bladder and<br>bladder neck. The specific treatment<br>indications include benign prostate<br>hyperplasia BPH, bladder cancer, tumors,<br>lesions, and neoplasms. The specific<br>urological indications include transurethral<br>electrovaporization (TUVP, TVP, TUEVP), also<br>known as transurethral vapor resection of the<br>prostate (TUVRP) or transurethral<br>vaporization in saline (TUVis). These devices<br>are intended to be used in an irrigated<br>environment. These devices are not intended<br>to be used in treating cancer of the prostate. |
| Principles of<br>Operation | Uses energy for cutting and removal of tissue<br>during urologic procedures | Uses energy for cutting and removal of tissue<br>during urologic procedures |
| Energy Type | Use bipolar energy to perform electrocautery | Use bipolar energy to perform electrocautery |
| Materials | Tungsten, Tungsten alloy, Aluminum Oxide,<br>Stainless Steel 304, Polytetrafluoroethylene<br>(PTFE) | Tungsten, Tungsten alloy, Aluminum Oxide,<br>Stainless Steel 304, Polytetrafluoroethylene<br>(PTFE) |
| Biocompatibility | Cytotoxicity, Sensitization, Intracutaneous<br>Reactivity, Acute Systemic Toxicity, | Cytotoxicity, Sensitization, Irritation or<br>Intracutaneous Reactivity |
#### Table 5A - Comparison of Characteristics
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| Manufacturer | Ace Medical Devices Pvt. Ltd. | Olympus Winter & Ibe GmbH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Trade Name | ACE Electrosurgical Resection and<br>Vaporization Electrodes Series | Electrosurgical Resection and Vaporization<br>Electrodes Series | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Implantation | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Sterile | Electrodes are Sterile packed.<br>Ethylene Oxide (EO)<br>SAL 10-6 | Electrodes are Sterile packed.<br>Ethylene Oxide (EO)<br>SAL 10-6 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Overall Design | The ACE Electrosurgical Resection and<br>Vaporization Electrodes Series consist of an<br>active tip, PTFE color code identification, and<br>insulator between the electrode tube, a<br>guiding tube, telescope clip and arm (shaft). | The HF-Resection Electrodes and HF<br>Resection Button Electrode for Plasma<br>Vaporization consist of an active tip, PTFE<br>color code identification, an insulator<br>between the electrode and electrode tube, a<br>guiding tube, telescope clip and arm (shaft). | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| System | The system includes Electrodes that can be<br>connected to an electrical surgical unit. | The system includes Electrodes, working<br>elements, and an HF bipolar cable that can be<br>connected to an electrical surgical unit. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Electrode Tips | The design and dimensions of the electrodes<br>vary to accommodate various procedural<br>conditions. The active tips of the various<br>electrodes may consist of loops, bands,<br>needles or buttons | The design and dimensions of the electrodes<br>vary to accommodate various procedural<br>conditions. The active tips of the various<br>electrodes may consist of loops, bands,<br>rollers, needles or buttons | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PTFE Color Code | Yellow, Gray, Blue, Red, White | Yellow, Gray, Blue, Red, White | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Color Inner sheath [Fr.] Outer Sheath Yellow 24 26/27 White 24/26/28 26/27/28.5 Gray 24/26/28 26/27/28.5 Direction of view Red 30° Blue 12° White 12°/30°/45° | | | | | | | | | | | | | | | | | | | | | | | | | Color Inner sheath [Fr.] Outer Sheath Yellow 24 26/27 Gray 24/26/28 27/28.5 Blue For resection with saline solution Direction of view Red 30° White 12°/30° | | | | | | | | | | | | | | | | | | | | | |
| Single-Use | Electrodes are intended for single use only | Electrodes are intended for single use only<br>HF bipolar Cable is reusable | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Packaging | Simple Tyvek pouch with retaining card and<br>protective sheath over sharp end | Simple Tyvek pouch with retaining card and<br>protective sheath over sharp end | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Shelf Life | 3 years | 3 years | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Electrical Safety | Conforms to IEC 60601 | Conforms to IEC 60601 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Thermal Safety | Conforms to IEC 60601-2-2 | Conforms to IEC 60601-2-2 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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#### 9. Comparison of Technological Characteristics
The ACE Electrosurgical Resection and Vaporization Electrodes Series are identical to the predicate devices in intended use, design and material specification.
When the electrodes are used with the UES-40 (K030194 and K100275), and the ESG-400 (K103032) the standard reusable Olympus cables are used.
#### 10. Non-Clinical Performance Data
Design verification was performed to ensure the device functions according to its intended use, and the results met their acceptance criteria. Risk analysis was carried out in accordance with established inhouse acceptance criteria based on ISO 14971:2007.
Bench Testing according to the FDA-recognized consensus standards IEC 60601-1 and IEC 60601-2-2 was conducted to demonstrate that the design change does not raise any new concerns regarding electrical safety.
#### 11. Clinical Performance Data
There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
#### 12. Statement of Substantial Equivalence
The ACE Electrosurgical Resection and Vaporization Electrodes Series, as designed and manufactured, is determined to be substantially equivalent to the currently legally marketed devices. It does not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.
