Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard electrosurgical device with electrodes for tissue resection and vaporization. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities that would suggest the use of these technologies. The performance studies focus on electrical safety and functional verification, not algorithmic performance.

Therapeutic

Yes
The device is used for surgical procedures such as resection, ablation, and removal of soft tissue, as well as coagulation for hemostasis, to treat specific medical conditions like benign prostate hyperplasia (BPH) and bladder cancer, which are therapeutic actions.

Diagnostic

No.
The ACE Electrosurgical Resection and Vaporization Electrodes Series is designed for surgical procedures involving resection, ablation, removal, and coagulation of soft tissue, not for diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as an active tip, insulator, guiding tube, telescope clip, and arm (shaft), indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided text, 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.
Device Function: The description clearly states that the ACE Electrosurgical Resection and Vaporization Electrodes Series is a surgical device used during endoscopic urological procedures. It is used to resect, ablate, remove, and coagulate soft tissue within the body.
Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly interacts with tissue within the body.

Therefore, the function and intended use of this device fall under the category of a surgical instrument, not an in vitro diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes

GEI, FAS

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

prostate, bladder, bladder neck

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

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.

Key Metrics

Not Found

Predicate Device(s)

K120418

Reference Device(s)

K030194, K100275, K103032

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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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.

1

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)
	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 & Accessories
Electrode, Electrosurgical, Active, Urological
Regulation Number:	21 CFR §878.4400
21 CFR §878.4300
Product Code:	GEI, Electrosurgical Cutting, and Coagulation Device & Accessories
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

5

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
Vaporization Electrodes Series	Electrosurgical Resection and Vaporization
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
§876.1500
Regulation Name	Endoscopic electrosurgical unit and
accessories	Endoscopic electrosurgical unit and
accessories
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	The HF-Resection Electrodes are a bipolar
instrument series designed and intended for
use in endoscopic urological surgical
procedures involving the resection, ablation
or removal of soft tissue arid 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),
Manufacturer	Ace Medical Devices Pvt. Ltd.	Olympus Winter & Ibe GmbH
Trade Name	ACE Electrosurgical Resection and
Vaporization Electrodes Series	Electrosurgical Resection and Vaporization
Electrodes Series
	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.	transurethral prostatectomy, 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. These devices are not intended
to be used to treating cancer of the prostate.
The HF-Resection Electrode for Plasma
Vaporization is a bipolar instrument designed
and intended for use in urological surgical
procedures involving the vaporization,
ablation, coagulation, 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
electrovaporization (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. These devices are not intended
to be used in treating cancer of the prostate.
Principles of
Operation	Uses energy for cutting and removal of tissue
during urologic procedures	Uses energy for cutting and removal of tissue
during 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, Intracutaneous
Reactivity, Acute Systemic Toxicity,	Cytotoxicity, Sensitization, Irritation or
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
Vaporization Electrodes Series	Electrosurgical Resection and Vaporization
Electrodes 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 and
Vaporization Electrodes Series consist of an
active tip, PTFE color code identification, and
insulator between the electrode tube, a
guiding tube, telescope clip and arm (shaft).	The HF-Resection Electrodes and HF
Resection Button Electrode for Plasma
Vaporization consist of an active tip, PTFE
color code identification, an insulator
between the electrode and electrode tube, a
guiding tube, telescope clip and arm (shaft).
System	The system includes Electrodes that can be
connected to an electrical surgical unit.	The system includes Electrodes, working
elements, and an HF bipolar cable that can be
connected to an electrical surgical unit.
Electrode Tips	The design and dimensions of the electrodes
vary to accommodate various procedural
conditions. The active tips of the various
electrodes may consist of loops, bands,
needles or buttons	The design and dimensions of the electrodes
vary to accommodate various procedural
conditions. The active tips of the various
electrodes 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 only
HF bipolar Cable is reusable
Packaging	Simple Tyvek pouch with retaining card and
protective sheath over sharp end	Simple Tyvek pouch with retaining card and
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.