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 is a thulium fiber laser, producing a pulsed beam of coherent nearinfrared 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 comprised of a choice of two models - Premium Laser System and Pro Laser System, laser fibers and accessories. The Premium laser has a maximum power output of 60 Watts and a maximum Frequency output of 2400 Hz and a secondary, foldable screen is provided. The Pro laser can operate at a maximum power of 35 Watts and Frequency output limited to 100Hz. Both systems are compact, designed to fit onto an optional laser cart and are operated with a footswitch (wired or wireless). The Soltive Laser System must be operated with a Soltive Laser Fiber, offered in quartz core diameters from 150 - 940 microns.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the SOLTIVE™ Laser System. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria through a traditional clinical study with a defined test set and ground truth.

The "Performance Data" section (Section VII) describes non-clinical testing and software verification. Since this is a 510(k) submission, the primary goal is to show the device is as safe and effective as a legally marketed predicate, not necessarily to establish de novo "acceptance criteria" against clinical outcomes in the same way one might for a novel AI diagnostic device.

Therefore, many of the requested details (like sample size for a test set, expert involvement for ground truth, MRMC studies, and standalone performance) are not applicable or not provided in the context of this 510(k) for a medical laser system. The "study" here is primarily non-clinical and software-based to support the claim of substantial equivalence despite minor changes.

However, I can extract the relevant information from the provided text regarding the closest equivalent to "acceptance criteria" and the "study" conducted.

Here's a breakdown of the available information based on your request:

1. Table of acceptance criteria and the reported device performance:

The document describes "acceptance criteria" within the context of design verification testing.

Acceptance Criteria (from Design Verification testing)	Reported Device Performance
Tissue thermal effect from accidental exposure over the range of laser settings has remained unchanged despite changes to energy parameters.	"All data sets demonstrated statistical equivalency with p-value greater than 0.05 between the data set containing the predicate preset and the data set containing revised presets, meeting the acceptance criteria of the Design Verification testing. This demonstrates the tissue effect from accidental exposure over the range of laser settings has remained unchanged despite the changes to the preset energy parameters."
Implicit acceptance: Software is verified and validated to industry guidelines.	"Software verification and validation regression testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff. 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'"

Acceptance Criteria (from Design Verification testing)

Reported Device Performance

Tissue thermal effect from accidental exposure over the range of laser settings has remained unchanged despite changes to energy parameters.

"All data sets demonstrated statistical equivalency with p-value greater than 0.05 between the data set containing the predicate preset and the data set containing revised presets, meeting the acceptance criteria of the Design Verification testing. This demonstrates the tissue effect from accidental exposure over the range of laser settings has remained unchanged despite the changes to the preset energy parameters."

Implicit acceptance: Software is verified and validated to industry guidelines.

"Software verification and validation regression testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff. 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'"

2. Sample sized used for the test set and the data provenance:

Sample Size: Not explicitly stated as a "sample size" for a typical test set. The non-clinical testing involved "porcine ureter tissue" for thermal effect testing and "simulated stones" for ablation testing. The number of samples/tests is not quantified in the provided text.
Data Provenance:
- Country of Origin: Not specified for the non-clinical testing data.
- Retrospective/Prospective: These were non-clinical, in-vitro tests, so the concept of retrospective or prospective doesn't directly apply in the same way as for human clinical data. They were conducted specifically for this submission.

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

Not Applicable. For this type of submission (510(k) for a laser, with non-clinical and software testing), expert-established ground truth on a test set (e.g., for diagnostic accuracy) is not typically required or reported. The "ground truth" for the non-clinical tests would be the measured physical properties (e.g., thermal effect depth, ablation rate).

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

Not Applicable. This is not a diagnostic device or a study involving human readers/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:

No. This is a surgical laser system, not an AI diagnostic device. MRMC studies are not relevant here.

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

Not applicable in the AI sense. The "device" itself (the laser system) was tested in a standalone fashion in a lab setting (non-clinical tissue and simulated stone testing), but this is "device performance" rather than "algorithm only" in the context of an AI-driven device.

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

Measured Physical Properties:
- For Soft Tissue Thermal Effect Testing: The "ground truth" involved measurements of "tissue thermal effect depths and widths."
- For Simulated Stone Ablation Testing: The "ground truth" involved characterizing the "stone ablation rate."

8. The sample size for the training set:

Not Applicable. This device is a laser system and its software manages system parameters; it does not employ machine learning that would require a "training set" in the typical sense of AI/ML.

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

Not Applicable. (See point 8).

Summary

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

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 logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 23, 2024

Olympus Surgical Technologies America Apurva Joshi Regulatory Affairs Specialist II 800 W Park Drive Westborough, Massachusetts 01581

Re: K242191

Trade/Device Name: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: July 25, 2024 Received: July 25, 2024

Dear Apurva Joshi:

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 (the 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 available 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.

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

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).

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

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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sharon M. Andrews -S

for Mark Antonino 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

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

Indications for Use

510(k) Number (if known)

K242191

Device Name

SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)

Indications for Use (Describe)

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 (BN) • Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors• Endoscopic fragmentation of ureteral, bladder, and renal calculi v 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 reatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.

Gastroenterology

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

• Appendectorny • Polyps • Biopsy • Gall Bladder calculi • Ulcers • Gastric ulcers • Gastric ulcers • Duodenal ulcers

• Non Bleeding Ulcers • Pancreatitis • Haemorrhoids • Cholecystectory • Benign and Malignant Neoplasm Gynecology • Angiodysplasia • Colorectal cancer • Telangiectasias • Telangiectasias of the Osler-Weber-Renu disease • Vascular Malformation · Gastritis · Esophageal ulcers · Varices · Colitis · Mallory-Weiss tear · Gastric Erosions

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)
-------------------------------------------------

🇿 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."

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

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)

I. Submitter

Contract Manufacturer:	IPG Medical Corporation377 Simarano DriveMarlborough, MA 01752, USA
510(k) Submitter:	Gyrus ACMI, Inc.9600 Louisiana Ave. NorthBrooklyn Park, MN 55445 USA
Establishment Registration Number:	3011050570
Contact Person:	Apurva JoshiRegulatory Affairs Specialist IIPhone: 1-617-512-5935Email: apurva.joshi@olympus.com
Alternate Contact:	Julie AckerProgram Manager, Regulatory AffairsPhone: 1-(484)294-6981Email: julie.acker@olympus.com
Date Prepared:	August 22, 2024
II.Device
Trade Name:	SOLTIVE™ Laser System (SOLTIVE™ ProSuperPulsed Laser, SOLTIVE™ PremiumSuperPulsed Laser, SOLTIVE™ Laser Fibers,and Accessories)
Generic/Common Name:	Laser surgical instrument for use in general andplastic surgery and in dermatology
Classification Name:Regulation/CFR Citation Number:	Powered Laser Surgical Instrument21 CFR 878.4810
Product Code:	GEX
Classification:	Class II
Review Panel:III.Predicate Device	General Surgery Devices
SOLTIVE Laser Systems	K221306

This predicate has been subject to design-related recalls.

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

IV. Device Description:

The SOLTIVE Laser System is comprised of a choice of two models - Premium Laser System and Pro Laser System, laser fibers and accessories. The Premium laser has a maximum power output of 60 Watts and a maximum Frequency output of 2400 Hz and a secondary, foldable screen is provided. The Pro laser can operate at a maximum power of 35 Watts and Frequency output limited to 100Hz. Both systems are compact, designed to fit onto an optional laser cart and are operated with a footswitch (wired or wireless). The Soltive Laser System must be operated with a Soltive Laser Fiber, offered in quartz core diameters from 150 - 940 microns.

The system includes:

. Laser console
. Sterile laser fibers - single-use and reusable options in sizes 150um, 200um, 365um, 550um, and 940um
Footswitch, wireless or wired options. ●
Accessories power cord, HDMI cable, safety goggles/glasses, fiber strippers, fiber ● cleaver, blast shields, cart

The devices do not incorporate medicinal substances, tissues, or blood products. The Soltive laser fibers are provided in single-use and reusable options, and both single-use and reusable fibers are initially sterilized by Ethylene Oxide.

V. Indications For Use

The SOLTIVE™ Laser System (SOLTIVETM Pro SuperPulsed Laser, SOLTIVE™ 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)

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

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
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
. Angiodysplasia
Polyps
. Colorectal cancer
. Biopsy
. Telangiectasias
. Gall Bladder calculi
. Telangiectasias of the Osler-Weber-Renu disease
. Biliary/Bile duct calculi
Vascular Malformation
Ulcers
. Gastritis
. Gastric ulcers
. Esophagitis
. Duodenal ulcers
. Esophageal ulcers
. Non Bleeding Ulcers
. Varices
Pancreatitis
Colitis
Haemorrhoids

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

Mallory-Weiss tear •
. Cholecystectomy
Gastric Erosions •
Benign and Malignant Neoplasm •

Gynecology

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

VI. Comparison of technological characteristics with the predicate device

Gyrus ACMI SOLTIVE Laser System
Design Feature	K242191	K221306 Predicate	Comparison
Indications for Use comparison	The SOLTIVE™ LaserSystem (SOLTIVE™ ProSuperPulsed Laser,SOLTIVE™ PremiumSuperPulsed Laser,SOLTIVE™ Laser Fibers,and Accessories) is intendedfor incision, excision,resection, ablation,coagulation, hemostasis, andvaporization of soft tissue,with or without anendoscope, in the followingindications: urology,lithotripsy,gastroenterological surgeryand gynecological surgery.	The SOLTIVE™ LaserSystem (SOLTIVE™ ProSuperPulsed Laser,SOLTIVE™ PremiumSuperPulsed Laser,SOLTIVE™ Laser Fibers, andAccessories) is intended forincision, excision, resection,ablation, coagulation,hemostasis, and vaporizationof soft tissue, with or withoutan endoscope, in the followingindications: urology,lithotripsy, gastroenterologicalsurgery and gynecologicalsurgery.	Same
Function of Device	Thulium Fiber Lasergenerator with fiberoptic delivery	Thulium Fiber Lasergenerator with fiberoptic delivery	Same
Mechanics of Action	Light/energyabsorption by targettissues	Light/energy absorptionby target tissues	Same
Laser Source	Thulium	Thulium	Same
Accessories	Surgical fibers (reusable andsingle 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)	Same
Major Software version	2.2	2.2	Same
Configuration file version	V5.1	V5.0	Different
IFU Soltive Laser System	PN0015551 Revision AI	PN0015551 Revision AH	Different

{8}------------------------------------------------

Design Feature	K242191	K221306Predicate	Comparison
Preset Treatment Parameter	Average Power 2 W- 18 W	Average Power 8 W- 56 W	Different
	Left Pedal	Right Pedal
Lithotripsy 1	DecreasedAveragePower(DecreasedFrequency)	DecreasedAverage Power(DecreasedFrequency,IncreasedEnergy)
Lithotripsy 2	DecreasedAveragePower(DecreasedFrequency,IncreasedEnergy)	DecreasedAverage Power(DecreasedFrequency,IncreasedEnergy)	For different Lithotripsyoptions frequency and energyhave average power in the rangeof 8W-56W	Different
Lithotripsy 3	DecreasedAveragePower(DecreasedFrequency,DecreasedEnergy)	No Change
Manual Mode	Decreased Average Power(Decreased Frequency,Increased Energy )

The subject device has similar technological characteristics (i.e., design, material, chemical composition, principle of operation, energy source, etc.) as the predicate device. The difference between subject and predicate is the values of energy and/or frequency programmed in the software configuration file representing Preset Treatment Parameters. These technological differences between the subject and predicate devices do not raise different questions of safety and effectiveness.

{9}------------------------------------------------

VII. Performance Data

1. Non-Clinical Tissue testing
  Soft Tissue Thermal Effect Testing was performed to demonstrate that the laser system delivers clinically acceptable tissue thermal effect depths and widths due to accidental tissue exposure during lithotripsy. Each revised Preset Treatment Parameter was tested in comparison to the corresponding current Preset Treatment Parameter using porcine ureter tissue and 150um and 940um core diameter fibers. Laser setting values tested consist of a combination of minimum average power values, maximum average power values, and the preset treatment parameter values. All data sets demonstrated statistical equivalency with p-value greater than 0.05 between the data set containing the predicate preset and the data set containing revised presets, meeting the acceptance criteria of the Design Verification testing. This demonstrates the tissue effect from accidental exposure over the range of laser settings has remained unchanged despite the changes to the preset energy parameters.

Simulated Stone Ablation Testing was performed using 150um and 940um core diameter fibers and simulated stones to characterize stone ablation rate of revised preset energy parameters.

1. Software Verification and Validation
  Software verification and validation regression testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software documentation for this device was considered as a "enhanced", since a failure or flaw of any device software function(s) could present a hazardous situation with a probable risk of death or serious injury, either to a patient, user of the device, or others in the environment of use.

VIII. Conclusion:

Based on the non-clinical tissue testing and software validation and verification testing, the modified device was found to be substantially equivalent to the predicate device.

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.