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.

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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called "ACE Electrosurgical Resection and Vaporization Electrodes Series." This document primarily discusses the substantial equivalence of the new device to a predicate device, rather than presenting a study that establishes acceptance criteria and then proves the device meets those criteria through performance data.

Here's an analysis of the information, addressing your points where possible, and noting when the information is not present in this type of FDA submission:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria or specific device performance metrics in the way you might expect from a clinical study report. Instead, it relies on demonstrating equivalence to an existing predicate device and conformance to recognized consensus standards.

Acceptance Criteria (Implied / Stated):

Substantial Equivalence: The device must be substantially equivalent to a legally marketed predicate device (K120418, Olympus Winter & Ibe GmbH Electrosurgical Resection and Vaporization Electrodes Series) in terms of:
- Indications for Use
- Principles of Operation
- Technological Characteristics
- Materials
- Performance (demonstrated through bench testing and conformance to standards)
Safety and Effectiveness: Does not raise new issues of safety or effectiveness.
Electrical Safety: Conforms to IEC 60601-1.
Thermal Safety: Conforms to IEC 60601-2-2.
Biocompatibility: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity.
Sterilization: Ethylene Oxide (EO) with a Sterility Assurance Level (SAL) of 10-6.
Risk Analysis: Performed in accordance with ISO 14971:2007.

Reported Device Performance:

The document states that "Design verification was performed to ensure the device functions according to its intended use, and the results met their acceptance criteria." However, it does not provide the specific numerical results of this design verification. It only confirms that the testing was performed and met the criteria.

The "Comparison of Characteristics" table (Table 5A) highlights the similarities between the applicant's device and the predicate device across various attributes. This comparison serves as the performance data in terms of demonstrating equivalence.

Characteristic	ACE Electrosurgical Resection and Vaporization Electrodes Series (Applicant Device)	Electrosurgical Resection and Vaporization Electrodes Series (Predicate Device, K120418)
Indications for Use	Endoscopic urological surgical procedures involving resection, ablation, removal of soft tissue, and coagulation for hemostasis; specific urological indications (prostate, bladder, bladder neck) including TURis, TURP (for BPH), TUIP, TURBT, cystodiathermy; uses vaporization, ablation, cutting, removal of soft tissue and coagulation for hemostasis; specific soft tissue indications (prostate, bladder, bladder neck) including BPH, bladder cancer, tumors, lesions, neoplasms; TUVP/TVP/TUEVP/TUVRP/TUVis; irrigated environment (0.9% Sodium Chloride); not for treating prostate cancer.	HF-Resection Electrodes: Similar indications including resection, ablation, removal for hemostasis; prostate, bladder, bladder neck; TURis, TURP (for BPH), TUIP, TURBT, cystodiathermy; irrigated environment; not for prostate cancer. HF-Resection Electrode for Plasma Vaporization: Similar indications including vaporization, ablation, coagulation, cutting, removal for hemostasis; prostate, bladder, bladder neck; BPH, bladder cancer, tumors, lesions, neoplasms; TUVP/TVP/TUEVP/TUVRP/TUVis; irrigated environment; not for prostate cancer.
Principles of Operation	Uses energy for cutting and removal of tissue during urologic procedures; uses bipolar energy to perform electrocautery.	Uses energy for cutting and removal of tissue during urologic procedures; uses bipolar energy to perform electrocautery.
Energy Type	Bipolar electrocautery	Bipolar electrocautery
Materials	Tungsten, Tungsten alloy, Aluminum Oxide, Stainless Steel 304, Polytetrafluoroethylene (PTFE)	Tungsten, Tungsten alloy, Aluminum Oxide, Stainless Steel 304, Polytetrafluoroethylene (PTFE)
Biocompatibility Testing	Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Implantation	Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity
Sterility	Sterile packed, Ethylene Oxide (EO), SAL 10-6	Sterile packed, Ethylene Oxide (EO), SAL 10-6
Overall Design	Active tip, PTFE color code identification, insulator between electrode tube, guiding tube, telescope clip, and arm (shaft).	Active tip, PTFE color code identification, insulator between electrode and electrode tube, guiding tube, telescope clip, and arm (shaft).
Electrode Tips	Loops, bands, needles, or buttons	Loops, bands, rollers, needles, or buttons
Single-Use	Electrodes are intended for single use only.	Electrodes are intended for single use only. (HF bipolar Cable is reusable).
Shelf Life	3 years	3 years
Electrical Safety	Conforms to IEC 60601-1	Conforms to IEC 60601-1
Thermal Safety	Conforms to IEC 60601-2-2	Conforms to IEC 60601-2-2

2. Sample size used for the test set and the data provenance

This document describes a 510(k) submission, which relies heavily on non-clinical (bench) testing and comparison to a predicate device, rather than a clinical trial with a "test set" of patients.

Sample Size for Test Set: Not applicable in the context of human subjects or "test sets" as you might find in an AI/imaging study. The "test set" in this context refers to the samples used in bench testing (e.g., electrical safety tests, biocompatibility tests), the number of which is not specified in this summary.
Data Provenance: Not applicable in terms of country of origin of patient data or retrospective/prospective studies, as no human clinical data is presented here to support the device's safety and effectiveness. The data provenance discussed relates to the manufacturer (Ace Medical Devices Pvt. Ltd., India) and the predicate device manufacturer (Olympus Winter & Ibe GmbH).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study involving expert review for establishing ground truth from patient data. The "ground truth" for this device's safety and effectiveness is established by its similarity to a device already on the market and its conformance to recognized engineering and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there is no "test set" in the context of human data requiring expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an electrosurgical tool, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI assistance in that way.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable for the same reasons as above. This is an electrosurgical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the substantial equivalence claim is multi-faceted:

Predicate Device Performance: The primary ground truth is that the predicate device (Olympus K120418) has a history of safe and effective use in the market.
Consensus Standards: Adherence to recognized consensus standards like IEC 60601-1 (electrical safety) and IEC 60601-2-2 (thermal safety), and ISO 14971:2007 (risk management).
Bench Testing: Internal design verification testing results (not detailed here) that confirmed the device functions as intended and met acceptance criteria for engineering specifications.
Biocompatibility Testing: Results indicating the materials are biocompatible.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning study.

9. How the ground truth for the training set was established

Not applicable.

Summary

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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)

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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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 & AccessoriesElectrode, Electrosurgical, Active, Urological
Regulation Number:	21 CFR §878.440021 CFR §878.4300
Product Code:	GEI, Electrosurgical Cutting, and Coagulation Device & AccessoriesFAS, 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

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 andVaporization Electrodes Series	Electrosurgical Resection and VaporizationElectrodes 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§876.1500
Regulation Name	Endoscopic electrosurgical unit andaccessories	Endoscopic electrosurgical unit andaccessories
Indications for Use	The ACE Electrosurgical Resection andVaporization Electrodes Series is a single usebipolar electrode series designed andintended for use in endoscopic urologicalsurgical procedures involving the resection,ablation or removal of soft tissue andcoagulation where hemostasis is required.The specific urological indications include usein the prostate, bladder and bladder neck.The procedures for which the devices can be	The HF-Resection Electrodes are a bipolarinstrument series designed and intended foruse in endoscopic urological surgicalprocedures involving the resection, ablationor removal of soft tissue arid wherehemostasis is required. The specific urologicalindications include use in the prostate,bladder and bladder neck. The procedures forwhich the devices can be used aretransurethral resection in saline (TURis),
Manufacturer	Ace Medical Devices Pvt. Ltd.	Olympus Winter & Ibe GmbH
Trade Name	ACE Electrosurgical Resection andVaporization Electrodes Series	Electrosurgical Resection and VaporizationElectrodes Series
	used are transurethral resection in saline(TURis), transurethral prostatectomy (TURP),transurethral resection of the prostate (TURP)for benign prostatic hyperplasia, transurethralincision of the prostate (TUIP) or bladderneck, transurethral resection of bladdertumors (TURBT) and cystodiathermy. Thesedevices are intended to be used in anirrigated environment (0.9% SodiumChloride). These devices are not intended tobe used to treat cancer of the prostate.The ACE Electrosurgical Resection andVaporization Electrode Series are single usebipolar electrodes designed and intended foruse in urological surgical procedures involvingthe vaporization, ablation, cutting, removal ofsoft tissue and coagulation where hemostasisis required. The specific soft tissue indicationsinclude use in the prostate, bladder andbladder neck. The specific treatment indications include benign prostatehyperplasia (BPH) bladder cancer, tumors,lesions, and neoplasms. The specificurological indications include transurethralelectro vaporization (TUVP, TVP, TUEVP), alsoknown as transurethral vapor resection of theprostate (TUVRP) or transurethralvaporization in saline (TUVis). These devicesare intended to be used in an irrigatedenvironment (0.9% Sodium Chloride). Thesedevices are not intended to be used intreating cancer of the prostate.	transurethral prostatectomy, transurethralresection of the prostate (TURP) for benignprostatic hyperplasia, transurethral incision ofthe prostate (TUIP) or bladder neck,transurethral resection of bladder tumors(TURBT) and cystodiathermy. These devicesare intended to be used in an irrigatedenvironment. These devices are not intendedto be used to treating cancer of the prostate.The HF-Resection Electrode for PlasmaVaporization is a bipolar instrument designedand intended for use in urological surgicalprocedures involving the vaporization,ablation, coagulation, cutting, removal of softtissue and coagulation where hemostasis isrequired. The specific soft tissue indicationsinclude use in the prostate, bladder andbladder neck. The specific treatmentindications include benign prostatehyperplasia BPH, bladder cancer, tumors,lesions, and neoplasms. The specificurological indications include transurethralelectrovaporization (TUVP, TVP, TUEVP), alsoknown as transurethral vapor resection of theprostate (TUVRP) or transurethralvaporization in saline (TUVis). These devicesare intended to be used in an irrigatedenvironment. These devices are not intendedto be used in treating cancer of the prostate.
Principles ofOperation	Uses energy for cutting and removal of tissueduring urologic procedures	Uses energy for cutting and removal of tissueduring urologic procedures
Energy Type	Use bipolar energy to perform electrocautery	Use bipolar energy to perform electrocautery
Materials	Tungsten, Tungsten alloy, Aluminum Oxide,Stainless Steel 304, Polytetrafluoroethylene(PTFE)	Tungsten, Tungsten alloy, Aluminum Oxide,Stainless Steel 304, Polytetrafluoroethylene(PTFE)
Biocompatibility	Cytotoxicity, Sensitization, IntracutaneousReactivity, Acute Systemic Toxicity,	Cytotoxicity, Sensitization, Irritation orIntracutaneous 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 andVaporization Electrodes Series	Electrosurgical Resection and VaporizationElectrodes Series
	Implantation
Sterile	Electrodes are Sterile packed.Ethylene Oxide (EO)SAL 10-6	Electrodes are Sterile packed.Ethylene Oxide (EO)SAL 10-6
Overall Design	The ACE Electrosurgical Resection andVaporization Electrodes Series consist of anactive tip, PTFE color code identification, andinsulator between the electrode tube, aguiding tube, telescope clip and arm (shaft).	The HF-Resection Electrodes and HFResection Button Electrode for PlasmaVaporization consist of an active tip, PTFEcolor code identification, an insulatorbetween the electrode and electrode tube, aguiding tube, telescope clip and arm (shaft).
System	The system includes Electrodes that can beconnected to an electrical surgical unit.	The system includes Electrodes, workingelements, and an HF bipolar cable that can beconnected to an electrical surgical unit.
Electrode Tips	The design and dimensions of the electrodesvary to accommodate various proceduralconditions. The active tips of the variouselectrodes may consist of loops, bands,needles or buttons	The design and dimensions of the electrodesvary to accommodate various proceduralconditions. The active tips of the variouselectrodes may consist of loops, bands,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 onlyHF bipolar Cable is reusable
Packaging	Simple Tyvek pouch with retaining card andprotective sheath over sharp end	Simple Tyvek pouch with retaining card andprotective 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.

Regulation Number and Section

§ 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.