For resection, ablation, and coagulation of soft tissues and hemostasis in orthopedic, arthroscopic, spinal and neurological procedures. For soft tissue resection and ablation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist.

Cutting

Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, Blepharoplasty.

Blended Cutting and Coagulation

Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinoma. Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps.

Hemostasis and Nonablative Coagulation Control of bleeding, Epilation, Telangiectasia

Bipolar

Pinpoint, Precise Coagulation, Pinpoint Hemostasis, in any field (wet or dry), snoring, sub-mucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.

Device Description

The elliquence Surgi-Max® Ultra (IEC6-SP170, IEC6-SU170, & IEC6-SV170) is a modification to the existing Surgi-Max® / Surgi-Max® Plus (K100390) line of radiofrequency (RF) electrosurgical generators. It is a compact source of high-frequency RF energy employed for cutting and coagulation of soft tissue in a variety of surgical procedures. It is designed to enable the performance of monopolar and bipolar functions in conjunction with separatelymarketed electrosurgical accessories and ancillary equipment which have been developed by elliquence for mutually-exclusive use with the Surgi-Max® line of generators.

The Surgi-Max® Ultra (IEC6-SP170, IEC6-SU170, & IEC6-SV170) is the result of an update to internal electrical components of the Surgi-Max® / Surgi-Max® Plus. As a result of this equipment update, device design as it relates to internal electrical system framework was simplified in many respects and overall efficiency was greatly improved upon. This increase in efficiency enabled an increase in the maximum power output of the device from 120W to 170W. Aside from this increase in maximum power output, all other operational aspects of the device were conserved. The only other modifications made to the device were aesthetic in nature.

The modifications enacted do not affect the device's intended use or alter its fundamental scientific technology.

AI/ML Overview

The provided document is a 510(k) summary for the Elliquence Surgi-Max® Ultra, an electrosurgical cutting and coagulation device. The purpose of this submission is to demonstrate substantial equivalence to existing predicate devices, not to present a study proving the device meets specific acceptance criteria in the way a clinical trial for a new drug or a diagnostic AI would.

Therefore, many of the requested criteria for reporting on an AI/diagnostic device study (like sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment) are not applicable to this type of regulatory submission. This submission focuses on engineering testing and comparison to predicate devices to ensure safety and effectiveness.

However, I can extract information related to the acceptance criteria (in terms of performance characteristics and compliance) and the "study" (non-clinical testing) that supports these criteria.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the substantial equivalence comparison to the predicate devices and compliance with relevant electrical safety and usability standards. The "reported device performance" is primarily demonstrated through non-clinical testing ensuring it meets these standards and functions similarly to its predicates, with documented improvements/changes.

Acceptance Criterion (Implicit)	Reported Device Performance
Intended Use Equivalence	The Surgi-Max® Ultra shares the same intended use as its predicate device (Surgi-Max® / Surgi-Max® Plus K100390) and similar to the Bovie® IDS-310 Electrosurgical Generator (K134054).Specific Indications for Use:- Orthopedic, arthroscopic, spinal, and neurological procedures for resection, ablation, coagulation of soft tissues, and hemostasis.- Soft tissue resection and ablation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip, and wrist.- Cutting: Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, Blepharoplasty.- Blended Cutting and Coagulation: Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps.- Hemostasis and Nonablative Coagulation: Control of bleeding, Epilation, Telangiectasia.- Bipolar: Pinpoint, Precise Coagulation, Pinpoint Hemostasis, in any field (wet or dry), snoring, sub-mucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage.
Technological Characteristics Equivalence (General)	The device is a compact source of high-frequency RF energy for cutting and coagulation of soft tissue, enabling monopolar and bipolar functions, consistent with predicates.
Specific Performance/Technical Parameters Equivalence/Safety	Output Frequency: 4 MHz (monopolar), 1.7 MHz (bipolar) - Identical to primary predicate (K100390).Maximum Power Output: 170W - Increased from primary predicate's 120W (K100390), but within safe operating parameters and efficiency improvements documented.Voltage (peak-to-peak): 1,200V - Lower than primary predicate's 1,600V (K100390), indicating potential safety benefit or efficiency change.Duty Cycle: 10 sec On / 30 sec OFF - Identical to predicates.Supply Input Power: 100 V AC – 240 V AC, 50/60 Hz - Identical to predicates.Power Activation Control: Footswitch and/or fingerswitch - Identical to predicates.Electrical Safety & EMC Compliance: AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-2 - Compliance demonstrated through testing.Applied Part Type: CF - Different from primary predicate's BF, but within acceptable safety standards for medical devices.Modes of Operation: Cut, Blend, Hemo, Bipolar, Bipolar Turbo - Identical to primary predicate.
Safety and Effectiveness	Demonstrated through compliance with design control requirements (21 CFR 820.30) and verification/validation testing including electrical safety, EMC, usability, software, energy output verification, and thermal effect comparison.

Study Details (Non-Clinical Testing for Substantial Equivalence)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of patient data samples. The "test set" here refers to physical testing performed on the device and ex-vivo tissue samples.
- Data Provenance: Non-clinical (bench) testing. The document explicitly states "ex-vivo bovine tissue" for thermal effect comparison. No geographical or patient-specific provenance is relevant for this type of testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for electrosurgical device performance is established by engineering specifications, international safety standards (e.g., IEC 60601 series), and documented functional capabilities of the predicate devices. Testing against these standards and comparing to predicate performance does not typically involve expert clinical consensus for "ground truth" in this specific regulatory context.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation). This submission relies on objective engineering measurements and comparisons to established standards and predicate device specifications.
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:
- No. This is an electrosurgical generator, not an AI or diagnostic device that involves human readers interpreting cases.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an electrosurgical unit, not an algorithm, and is intended for use by a human surgeon. Its performance is inherent in its electrical output and tissue interaction, which was assessed via non-clinical testing.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this submission is based on established engineering specifications, international electrical safety and usability standards (e.g., IEC 60601 series, IEC 62366, IEC 62304), and the documented performance characteristics of legally marketed predicate devices. The non-clinical testing verified that the modified device met these engineering and safety benchmarks, and its performance characteristics were comparable or improved (e.g., increased power output) relative to the predicates in a safe manner.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The text is left-aligned and in a simple font.

May 3, 2017

Elliquence, LLC Mr. Paul Buhrke IV QA/RA Manager 2455 Grand Avenue Baldwin, New York 11510

Re: K170107

Trade/Device Name: Surgi-Max® Ultra (IEC6-SP170, IEC6-SU170, & IEC6-SV170) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: April 03, 2017 Received: April 04, 2017

Dear Mr. Buhrke:

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 Actinclude 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. 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

{1}------------------------------------------------

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,

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K170107

Device Name

Surgi-Max Ultra (IEC6-SU170, IEC6-SV170, IEC6-SP170)

Indications for Use (Describe)

Orthopedic, arthroscopic, spinal, and neurological

Cutting

Blended Cutting and Coagulation

Hemostasis and Nonablative Coagulation Control of bleeding, Epilation, Telangiectasia

Bipolar

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a logo of a person. The person is drawn in white lines on a dark blue background. The person is facing away from the viewer and has their right arm raised. The logo is circular in shape and has a glossy appearance.

510 (k) Summary

(As required by 21 CFR 807.92(a))

Date Prepared

May 1, 2017

Submitter's Information (807.92(a)(1))

Company Name and Address:

Elliquence, LLC 2455 Grand Avenue Baldwin, NY 11510 Phone: (516) 277-9000 Fax: (516) 277-9001 www.elliquence.com

Establishment Registration for Elliquence, LLC is 3007024186.

Contact Information:

Daniel Connell - Requlatory Affairs Associate Phone: (516) 277-9036 Fax: (516) 277-9011 Email: dconnell@elliquence.com

Paul D. Buhrke IV- QA/RA Manager Phone: (516) 277-9010 Fax: (516) 277-9011 Email: pbuhrke@elliquence.com

Device Information (807.92(a)(2))

Trade Name Surgi-Max® Ultra (IEC6-SP170, IEC6-SU170, & IEC6-SV170)

Common/Usual Name Electrosurgical unit and accessories, electrosurgical cutting and coagulation device and accessories

elliquence, LLC. 2455 Grand Avenue · Baldwin, New York 11510 (516) 277.9000 · Fax: (516) 277.9001 · www.elliquence.com

{4}------------------------------------------------

Classification Name and Regulation Electrosurgical Cutting and Coagulation Device and Accessories; 21 CFR 878.4400

K170107 Page 2 of 5

Class FDA Classification: Class II FDA Product Code: GEI

Predicate Devices (807.92(a)(3))

Surgi-Max® / Surgi-Max® Plus (K100390) ●
. Bovie® IDS-310 Electrosurgical Generator (K134054)

Device Description (807.92(a)(4))

The modifications enacted do not affect the device's intended use or alter its fundamental scientific technology.

{5}------------------------------------------------

Intended Use (807.92(a)(5))

Orthopedic, arthroscopic, spinal, and neurological

For resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurological procedures. For soft tissue resection and ablation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist.

Cutting

Blended Cutting and Coagulation

Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps.

Hemostasis and Nonablative Coagulation

Control of bleeding, Epilation, Telangiectasia

Bipolar

Substantial Equivalence Comparison (807.92(a)(6))

The Surgi-Max® Ultra is substantially equivalent in both intended use and technological characteristics to the Surgi-Max® / Surgi-Max® Plus (K100390) as well as the Bovie® IDS-310 Electrosurgical Generator (K134054). An extensive comparison chart concerning key characteristics is provided on the following pages (Table 5.1).

{6}------------------------------------------------

Table 5.1 Substantial Equivalence Comparison Chart

	Surgi-Max® Ultra(K170107) - SUBJECTDEVICE	Surgi-Max® / Surgi-MaxPlus (K100390) –PREDICATE	Bovie® IDS-310Electrosurgical Generator(K134054) - PREDICATE
Manufacturer	elliquence, LLC	elliquence, LLC	Bovie Medical Corp.
Product code	GEI	GEI	GEI
Regulationnumber	21 CFR 878.4400	21 CFR 878.4400	21 CFR 878.4400
Regulationname	Electrosurgical Cutting andCoagulation Device andaccessories	Electrosurgical Cutting andCoagulation Device andaccessories	Electrosurgical Cutting andCoagulation Device andaccessories
Indications foruse	See previous page	See previous page	The IDS-310 HighFrequency ElectrosurgicalGenerator is used to deliverRF energy via an assortmentof surgical devices to cut andcoagulate different kinds oftissue.
Prescriptiondevice(21 CFR801.109)	Yes	Yes	Yes
Principle ofOperation	Conversion of electricalenergy to high-frequency RFenergy(monopolar and bipolar)	Conversion of electricalenergy to high-frequency RFenergy(monopolar and bipolar)	Conversion of electricalenergy to high-frequency RFenergy(monopolar and bipolar)
Modes ofoperation	CutBlendHemoBipolarBipolar Turbo	CutBlendHemoBipolarBipolar Turbo	9 Monopolar and 4 bipolarmodes
Outputfrequency	4 MHz (monopolar)1.7 MHz (bipolar)	4 MHz (monopolar)1.7 MHz (bipolar)	350 - 490 kHz (monopolar)490 kHz (bipolar)
Maximum poweroutput	170W	120W	300W
Voltage(peak-to-peak)	1,200V	1,600V	8,000V
Duty Cycle	10 sec On / 30 sec OFF	10 sec On / 30 sec OFF	10 sec On / 30 sec OFF
Supply inputpower	100 V AC – 240 V AC, 50/60Hz	100 V AC – 240 V AC, 50/60Hz	100 V AC – 240 V AC, 50/60Hz

elliquence, LLC. 2455 Grand Avenue • Baldwin, New York 11510 (516) 277.9000 • Fax: (516) 277.9001 • www.elliquence.com

{7}------------------------------------------------

	Surgi-Max® Ultra(K170107) – SUBJECTDEVICE	Surgi-Max® / Surgi-MaxPlus (K100390) –PREDICATE	Bovie® IDS-310Electrosurgical Generator(K134054) - PREDICATE
Poweractivationcontrol	Footswitch and/orfingerswitch	Footswitch and/orfingerswitch	Footswitch and/orfingerswitch
Electrical safetyand EMC testingstandards	AAMI ANSI ES60601-1IEC 60601-1-2IEC 60601-2-2	AAMI ANSI ES60601-1IEC 60601-1-2IEC 60601-2-2	IEC 60601-1IEC 60601-1-2IEC 60601-2-2
Applied parttype	CF	BF	CF

Non-Clinical Testing (807.92(b)(1))

The modifications enacted for the Surgi-Max® Ultra were made in accordance with the design control requirements of 21 CFR 820.30. Appropriate non-clinical verification and validation activities were planned and conducted in order to address identified risks and ensure the safety and effectiveness of the device with the modifications enacted. This testing included:

. Electrical safety and EMC testing in accordance with AAMI ANSI ES60601-1, IEC 60601-1-2. and IEC 60601-2-2
Usability assessment in accordance with IEC 62366
Software verification and validation in accordance with IEC 62304 and the FDA Final . Guidance document titled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
Energy output verification of each of the five modes and comparison to predicate ●
. Thermal effect comparison for representative modes of the subject device and predicate on ex-vivo bovine tissue

Clinical Testing (807.92(b)(2))

This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.

Conclusion (807.92(b)(3))

Based upon a comparison of the intended uses, technological characteristics, and performance testing, we have concluded that the subject device is substantially equivalent to the selected predicate devices.

elliquence, LLC. 2455 Grand Avenue · Baldwin, New York 11510 (516) 277.9000 · Fax: (516) 277.9001 · www.elliquence.com

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.