The SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

Device Description

The SOLTIVE Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is a thulium laser. producing a pulsed beam of coherent near-infrared light (1940 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. The SOLTIVE Laser System is equipped with a 550 nm aiming beam.

The SOLTIVE Laser System is produced in two models, the SOLTIVE™ Premium SuperPulsed Laser and SOLTIVE™ Pro SuperPulsed Laser. The Premium has a maximum power output of 60 Watts and a maximum Frequency output of 2400 Hz. A secondary, foldable screen is provided. The Pro can operate at a maximum power of 35 Watts and Frequency limited to 100Hz. Both systems are operated with a wireless footswitch or wired footswitch, and both systems can utilize an auxiliary video monitor to display operating parameters. The Premium and Pro Laser must be used with a SOLTIVE Laser Fiber, offered in diameters from 150 - 940 microns.

The system includes:

Laser console
Laser fibers sterile single use and reusable
Foot pedal, wireless or wired
Accessories power cord. HDMI cable, safety goggles/glasses, fiber cutter, fiber cleaver, fiber stripper and cart

The devices do not incorporate medicinal substances, tissues, or blood products. The laser fibers are single-use and reusable, and both single-use and reusable are initially sterilized by Ethylene Oxide. Fibers are compatible with the Olympus endoscope models as listed on the IFU.

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness for the SOLTIVE Laser System. It focuses on demonstrating substantial equivalence to a predicate device, primarily through a labeling modification. This document does not contain the information requested regarding acceptance criteria and the results of a study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop system.

The study described here is limited to performance testing of the laser system, which is stated to be identical to the predicate device. The changes are solely in updated labeling to clarify existing cleared Instructions for Use.

Therefore, I cannot provide the requested information. The document explicitly states:

"The subject of this 510(k) is a labeling modification to the SOLTIVE Laser Systems. The device hardware and software design is identical to the predicate. The subject change to the labeling clarifies currently cleared Instructions for Use." (Page 5)
"Performance testing was conducted in support of the predicate devices and equivalently applies to the subject device as the labeling clarifications fall within the existing performance envelope of the laser system. Testing demonstrated that all performance requirements met the prescribed acceptance criteria, including the proposed labeling change." (Page 9)

No information specific to a clinical study, AI performance, or human reader effectiveness is present in this document. The acceptance criteria mentioned refer to the intrinsic performance specifications of the laser system itself, not to a diagnostic or assistive AI's performance as would be detailed in an MRMC or standalone study.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.

January 27, 2023

Gyrus ACMI, Inc. Jon Gilbert Regulatory Affairs Consultant to Gyrus ACMI, Inc. 800 West Park Drive Westborough, MA 01581

Re: K221306 Trade/Device Name: SOLTIVE Laser System Regulation Number: 21 CFR§ 878.4810 Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology Regulatory Class: II Product Code: GEX Dated: December 16, 2022 Received: December 19, 2022

Dear Jon Gilbert:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark J. Antonino -S

Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221306

Device Name SOLTIVE Laser System

Indications for Use (Describe)

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Urology

· Ablation of Benign Prostatic Hypertrophy) | BPH] · Laser Resection of the Prostrate (LRP) · Laser Enucleation of the Prostate (LEP)• Laser Ablation of the Prostate (LAP) • Transurethral Incision of the Prostate (TUIP) · Condylomas · Urethral/ureteral strictures · Lesions of external genitalia · Bladder neck incisions (BNI) · Ablation and resection of bladder tumors, and ureteral tumors, Endoscopic fragmentation of urethral, ureteral, bladder, and renal calcul · Treatment of distal impacted fragments remaining in the ureters following lithotripsy.

Lithotripsy and Percutaneous Urinary Lithotripsy Indications

· Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones• Endoscopic fragmentation of renal calculi• Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.

Type of Use (Select one or both, as applicable)

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."

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Gastroenterology

Open and endoscopic gastroenterology surgery (incision, excision, ablation, vaporization, coagulation and haemostasis) including:

· Appendectomy
Polyps
Biopsy
Gall Bladder calculi
Biliary/Bile duct calculi
Ulcers
· Gastric ulcers
Duodenal ulcers
· Non Bleeding Ulcers
· Pancreatitis
· Haemorrhoids
· Cholecystectomy
Benign and Malignant Neoplasm
Gynecology

Open, endoscopic (including hysteroscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue.

Type of Use (Select one or both, as applicable)

Use (Part 21 CFR 801 Subpart D)

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 STAF

The burden time for this collection of information is estimated to avera time to review instructions, search existing data sources, gather and n and review the collection of information. Send comments regarding of this information collection, including suggestions for reducin

enartment of Health ar tion Act (

"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 valio

EF 00 11: 443-6740
46
· Angiodysplasia
Colorectal cancer
· Telangiectasias
· Telangiectasias of the Osler-Weber-Renu disease
Vascular Malformation
· Gastritis
· Esophagitis
· Esophageal ulcers
· Varices
Colitis
· Mallory-Weiss tear
· Gastric Erosions

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K221306 Page 1 of 7

510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. SOLTIVE™ LASER SYSTEM (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories)

General Information

Contract Manufacturer:	IPG Medical Corporation377 Simarano Drive Marlborough,MA 01752, USA
510(k) Submitter:	Gyrus ACMI, Inc.800 West Park Drive Westborough,MA 01581
Establishment Registration Number:	3003790304
Contact Person:	Jon Gilbert fbo Julie AckerRegulatory Affairs ConsultantPhone: 906.361.3237Email: jgilb.raca@gmail.com
Date Prepared:	May 3, 2022

Device Description

Trade Name:	SOLTIVE Laser System
Generic/Common Name:	Laser Instrument for Use inGeneral Surgery
Classification Name:	Laser Surgical Instrument for Usein General and Plastic Surgery andin Dermatology
Regulation/CFR Citation Number:	21 CFR 878.4810
Product Code:	GEX
Classification:	Class II
Review Panel:	Gastroenterology/Urology

Predicate Devices

SOLTIVE Laser Systems	K211401, K183647
-----------------------	------------------

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K221306 Page 2 of 7

Comparison to Predicate Device:

The subject of this 510(k) is a labeling modification to the SOLTIVE Laser Systems. The device hardware and software design is identical to the predicate. The subject change to the labeling clarifies currently cleared Instructions for Use.

Product Description

The system includes:

Laser console ●
Laser fibers sterile single use and reusable .
. Foot pedal, wireless or wired
Accessories power cord. HDMI cable, safety goggles/glasses, fiber . cutter, fiber cleaver, fiber stripper and cart

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Technological Characteristics

The proposed SOLTIVE Laser System with modified labeling has the same intended use, design, and scientific technology as the predicate SOLTIVE Laser System (K183647). The subject modification is solely an update to clarify the use of the laser system in urological and gynecological tissues.

Material

No material changes were made to the SOLTIVE Laser System cleared under the predicate devices.

Indications for Uses

The indications for use of the modified device, as described in its labeling, have not changed the intended clinical applications as a result of the modification.

The SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVETM Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope. in the following indications: urology. lithotripsy, gastroenterological surgery and gynecological surgery.

Urology

Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH] ●
. Laser Resection of the Prostrate (LRP)
. Laser Enucleation of the Prostate (LEP)
Laser Ablation of the Prostate (LAP)
Transurethral Incision of the Prostate (TUIP)
Condylomas
Urethral / ureteral strictures
Lesions of external genitalia
. Bladder neck incisions (BNI)
Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors
. Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
. Treatment of distal impacted fragments remaining in the ureters following lithotripsy

Lithotripsy and Percutaneous Urinary Lithotripsy Indications

• Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones

· Endoscopic fragmentation of calculi

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· Treatment of distal impacted fragments of steinstrasse when guide wire cannot be Passed

Gastroenterology

Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including:

· Appendectomy
• Gall Bladder calculi
Polyps · Biopsy
· Angiodysplasia • Colorectal cancer
Telangiectasias of the Osler-Weber-Renu disease
Biliary/Bile duct calculi
Ulcers
Gastric ulcers
Duodenal ulcers
Non Bleeding Ulcers
Pancreatitis
Mallory-Weiss tear
Cholecystectomy
Benign and Malignant Neoplasm

Gynecology

Open, endoscopic (including hysteroscopic) and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue

Compliance to Voluntary Standards

Standard	Title
EN ISO 14971:2019	Medical devices -- Application of risk management to medical devices
ISO 15223-1:2016	Medical devices -- Symbols to be used with medical device labels, labeling and information to be supplied -- Part 1: General requirements
IEC 60601-1:2005+A1:2012	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60825-1:2014	Safety of laser products - Part 1: Equipment classification and requirements
IEC 62366-1:2015	Medical devices - Part 1: Application of usability engineering to medical devices
IEC 60601-2-	Medical electrical equipment - Part 2-22: Particular
Standard	Title
22:2007+A1:2012	requirements for basic safety and essential performance ofsurgical, cosmetic, therapeutic and diagnostic laserequipment
IEC 60601-1-6:2010+A1:2013	Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essential performance -Collateral standard: Usability
IEC62304:2006+A1:2015	Medical device software - Software life cycle processes
ISO 11607-1:2019	Packaging for terminally sterilized medical devices -- Part 1:Requirements for materials, sterile barrier systems andpackaging systems
ISO 11135:2014	Sterilization of health care products -- Ethylene oxide:Requirements for development, validation and routinecontrol of a sterilization process for medical devices
ISO 10993-1:2018	Biological evaluation of medical devices -- Part 1:Evaluation and testing
ISO 10993-5:2009	Biological evaluation of medical devices -- Part 5: Tests forin vitro cytotoxicity
ISO 10993-7:2008+COR1:2009	Biological evaluation of medical devices -- Part 7: Ethyleneoxide sterilization residuals
ISO 10993-10:2010	Biological evaluation of medical devices -- Part 10: Testsfor irritation and delayed-type hypersensitivity
ISO 10993-11:2017	Biological evaluation of medical devices -- Part 11: Testsfor systemic toxicity
ASTM F 1980-16	Standard Guide for Accelerated Aging of Sterile BarrierSystems for Medical Devices
ASTMF1886/F1886M:2016	Standard Test Method for Determining Integrity of Seals forFlexible Packaging by Visual Inspection
ASTM F88-15/F88M-15	Standard Test Method for Seal Strength of Flexible BarrierMaterials
ISO 17665-1:2006/R2013	Sterilization of health care products -- Moist heat -- Part 1:Requirements for the development, validation and routinecontrol of a sterilization process for medical devices
ISO14937:2009/R2013	Sterilization of health care products -- General requirementsfor characterization of a sterilizing agent and thedevelopment, validation and routine control of a sterilizationprocess for medical devices
ISTA Procedure 3A2018	Packaged Products for Parcel Delivery System Shipment 70kg(150 lb) or less
ASTM D4169-16	Performance Testing of Shipping Containers and Systems
ASTM F2096-11	Standard Test Method for Detecting Gross Leaks in PorousMedical Packaging by Internal Pressurization (Bubble Leak)

• Telangiectasias

Vascular Malformation
Gastritis
Esophagitis
Esophageal ulcers
Varices • Colitis
Haemorrhoids
· Gastric Erosions

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Summary of Sterilization and Shelf-Life Discussion

SOLTIVE SuperPulsed Laser Fibers Single-use and SOLTIVE SuperPulsed Laser Fibers Reusable are provided sterile. The devices are sterilized by Ethylene Oxide to a provide sterility assurance level of 10-6.

The Shelf-Life period for the Single-use fibers was determined via testing and through an analysis of the shelf-life stability of the materials used in the design of the device, as well as an analysis of the packaging materials and processes used with other Gyrus ACMI devices. Shelf-life studies are on file to support the labeled shelf life.

Summary of All Performance Testing (bench, clinical, non-clinical)

Performance testing was conducted in support of the predicate devices and equivalently applies to the subject device as the labeling clarifications fall within the existing performance envelope of the laser system. Testing demonstrated that all performance requirements met the prescribed acceptance criteria, including the proposed labeling change.

Substantial Equivalence

Substantial equivalence is demonstrated by acknowledged verification/validation activities. The subject devices have identical technology, performance, dimensions, and materials. The differences to the predicate device SOLTIVE Laser Systems are:

Clarified labeling for urological and gynecological surgery. ●
. Updated Instructions for Use to align with updated labeling.

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K221306 Page 7 of 7

Equivalence Comparison Table:

Gyrus ACMI SOLTIVE Laser System
DesignFeature	Proposed	Predicate K211401	Comparison
Intended Use	The SOLTIVE LaserSystem is intended for usein surgical procedures suchas open laparoscopic andendoscopic, involvingendoscopic ablation,vaporization, excision,incision, resection,coagulation and hemostasisof soft tissue in medicalspecialties including:Urology, lithotripsy,gastroenterology,arthroscopy, discectomy,gynecology, ENT andgeneral surgery.	The SOLTIVE LaserSystem is intended for usein surgical procedures suchas open laparoscopic andendoscopic, involvingendoscopic ablation,vaporization, excision,incision, resection,coagulation and hemostasisof soft tissue in medicalspecialties including:Urology, lithotripsy,gastroenterology,arthroscopy, discectomy,gynecology, ENT andgeneral surgery.	Equivalent
Function ofDevice	Thulium Lasergenerator with fiberoptic delivery	Thulium Lasergenerator with fiberoptic delivery	Identical
Mechanics ofAction	Light/energy absorptionby target tissues	Light/energy absorptionby target tissues	Identical
Laser Source	Thulium	Thulium	Identical
Accessories	Surgical fibers (reusableand single use) available infollowing nominal corediameters (150, 200, 365,550, 940 μm)	Surgical fibers (reusable andsingle use) available infollowing nominal corediameters (150, 200, 365,550, 940 μm)	Identical
Biocompatible	Yes	Yes	Identical
Sterilization(Single-usefibers)	Ethylene Oxide 10-6	Ethylene Oxide 10-6	Identical
Single Use &ReusableFibers	Yes	Yes	Identical

Conclusion:

In summary, the Gyrus ACMI SOLTIVE Laser System is substantially equivalent to the predicate device and presents no new questions of safety or effectiveness.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.