The Optica XT Thulium Fiber Laser 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 Optica XT Thulium Fiber Laser is a thulium fiber laser radiation at 1940 nm with a laser output power of 60 Watts. Laser activation is by footswitch. The overall weight of the laser is 95 lbs., and the size is 20" W x 24" L x 16" H. The Optica XT Thulium Fiber Laser has an electrical requirement of 100-240 VAC, 50/60 Hz. Laser energy is delivered to the target site using a fiber optic delivery system with diameters from 150-1000 micron.

AI/ML Overview

The provided text describes a 510(k) submission for the Optica XT Thulium Fiber Laser and Accessories. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through clinical studies with specific acceptance criteria as one might find for a new drug or a de novo medical device. Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, human reader performance, training data, and specific ground truth establishment is not present in this document.

Instead, this submission focuses on demonstrating that the new device (Optica XT) performs similarly to an already cleared device (Olympus SOLTIVE™ Laser System) and does not raise new questions of safety or effectiveness. The "acceptance criteria" here are largely met through adherence to recognized performance standards and comparative analysis of technological characteristics.

Here's an analysis based on the provided text, addressing your points where applicable and explaining the absence of other information:

1. A table of acceptance criteria and the reported device performance

The document does not present a table of quantitative performance acceptance criteria in the way a clinical study might (e.g., minimum sensitivity/specificity). Instead, the "acceptance criteria" are implicitly met by demonstrating compliance with recognized electrical, safety, and electromagnetic compatibility (EMC) standards, as well as showing comparable technological characteristics and performance to the predicate device.

The reported device performance is primarily described through the comparison table of technological characteristics.

Acceptance Criteria (Implicit)	Reported Device Performance (Optica XT)
Electrical Safety Standard Compliance	AAMI/ANSI ES60601-1:2005+A1 and IEC 60601-1:2005+C1;C2;A1 compliant.
Laser Safety Standard Compliance	IEC 60825-1:2014, Edition 3.0 compliant.
Medical Electrical Equipment Laser-Specific Standard Compliance	IEC 60601-2-22:2012, Edition 3.1 compliant.
Electromagnetic Compatibility (EMC) Standard Compliance	IEC 60601-1-2:2014, Edition 4 compliant.
Usability Standard Compliance	IEC 60601-1-6:2013, Edition 3.1 compliant.
Software Life Cycle Process Compliance	IEC 62304:2006, Ed. 1.0 + A1 compliant.
Biocompatibility Standard Compliance	ISO 10993-1 compliant for cytotoxicity, acute systemic toxicity, sensitization, material-mediated pyrogenicity, hemocompatibility, and irritation/intracutaneous reactivity.
Fiber Performance (Bending Stress)	Bench testing demonstrates comparable fiber performance to predicate.
Technological Characteristics	Similar or within range of predicate device for wavelength, power, pulse duration, frequency, pulse energy, fiber diameter, control methods, and safety features.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "This premarket submission for the Optica XT Thulium Fiber Laser and Accessories does not require clinical studies to support substantial equivalence."

Therefore, there is no test set of patient data, no sample size, and no data provenance in the context of clinical performance evaluation. The data presented is non-clinical performance data (bench testing, standards compliance).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical test set requiring expert ground truth was used.

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

Not applicable, as no clinical test set requiring adjudication was used.

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

Not applicable. This is a laser surgical instrument, not an AI-assisted diagnostic or therapeutic device that involves "human readers."

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

Not applicable. This is a laser surgical instrument, not an algorithm.

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

Not applicable, as no clinical ground truth was established for this submission. The "ground truth" for this device's safety and effectiveness is established through compliance with established engineering and safety standards and comparison to a legally marketed predicate device.

8. The sample size for the training set

Not applicable, as this is not a machine learning or AI device that requires a training set.

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

Not applicable, as this is not a machine learning or AI device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 9, 2021

Convergent Laser Technologies Jennifer Mok Business Manager 1660 South Loop Road Alameda, California 94502

Re: K211517

Trade/Device Name: Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE 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: September 14, 2021 Received: September 15, 2021

Dear Jennifer Mok:

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.

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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 and Part 809); 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-regulatory-information/postmarketing-safety-reportingcombination-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 medical devices and radiation-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,

Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K211517

Device Name

Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories

Indications for Use (Describe)

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 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 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

Gastroenterology

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

· Appendectomy
· Polyps
· Biopsv
Gall Bladder calculi
Biliary/Bile duct calculi
· Ulcers
Gastric ulcers
· Duodenal ulcers
· Non Bleeding Ulcers
· Pancreatitis
Haemorrhoids
· Cholecystectomy
· Benign and Malignant Neoplasm
· Angiodysplasia
Colorectal cancer

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· Telangiectasias
Telangiectasias of the Osler-Weber-Renu disease
Vascular Malformation
Gastritis
· Esophagitis
Esophageal ulcers
· Varices
Colitis
· Mallory-Weiss tear
· Gastric Erosions

Gynecology

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

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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510(k) Summary

I. General Information

Submitter/Manufacturer:	Xintec Corporation, dba, Convergent Laser Technologies1660 South Loop RoadAlameda, California 94502
Contact Person:	Jennifer MokRegulatory Affairs & Quality Assurance ManagerDirect: 510-280-7207Fax: 510-832-1600
Date Prepared:	October 28, 2021
II. Device
Trade/Device Name:	Optica XT Thulium Fiber Laser and Accessories, also known asOptica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT60 Thulium Fiber Laser 1940 nm, Optica XT SuperpulseThulium Fiber Laser 1940 nm, OptiLITE Laser Fibers andAccessories
Common or Usual Name	Surgical laser
Classification Name:	Laser surgical instrument for use in general and plastic surgeryand in dermatology (21 CFR 878.4810)
Regulatory Class:	II
Product Code:	GEX
III. Predicate Device

Manufacturer	Olympus Surgical Technologies America
Trade/Device Name:	SOLTIVETM Laser System (SOLTIVETM Pro SuperPulsed Laser,SOLTIVETM Premium SuperPulsed Laser, SOLTIVETM LaserFibers and Accessories)
510(k) Number	K183647
Regulatory Class:	II
Product Code:	GEX

This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

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IV. Device Description

V. Indications For Use

The Optica XT Thulium Fiber Laser and Accessories is intended for incision, excision, 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 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 renal 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
Polyps
Biopsy
Gall Bladder calculi ●
Biliary/Bile duct calculi
Vascular Malformation ●

Angiodysplasia

Telangiectasias

Colorectal cancer

Telangiectasias of the Osler-Weber-Renu disease

Ulcers
Gastritis ●

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Gastric ulcers ●
Duodenal ulcers
. Non Bleeding Ulcers
Pancreatitis
Haemorrhoids
Cholecystectomy
Benign and Malignant Neoplasm ●

Gynecology

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

VI. Comparison of Technological Characteristics

The Optica XT Thulium Fiber Laser and Accessories share or similar indications for use, device operation, overall technical and functional capabilities, and therefore is the same or similar to the predicate device. The design and function of the Optica XT Thulium Fiber Laser and Accessories are similar to the predicate device for the modes of operation and use.

Summary of the technological characteristics

Manufacturer	Convergent LaserTechnologies	Olympus SurgicalTechnologies America	SignificantDifferences
Trade/DeviceName	Optica XT™Thulium Fiber Laserand Accessories	SOLTIVE™ LaserFibers, andAccessories	N/A
510(k) Number	K211517	K183647	N/A
Product Code	GEX	GEX	Same
CFR CitationNumber	21 CFR 878.4810	21 CFR 878.4810	Same
Classification	Class II	Class II	Same
Generic/CommonName	Laser SurgicalInstrument for use inGeneral and PlasticSurgery and inDermatology	Laser SurgicalInstrument for use inGeneral and PlasticSurgery and inDermatology	Same
Manufacturer	Convergent LaserTechnologies	Olympus SurgicalTechnologies America	SignificantDifferences
Trade/DeviceName	Optica XTTMThulium Fiber Laserand Accessories	SOLTIVETM LaserFibers, andAccessories	N/A
Electrical Power	100-240 VAC, 50/60 Hz	100-240 VAC, 50/60 Hz	Same
Size ofComponents(H x W x L)	16 x 20 x 24 inches	11.6 x 14.6 x 22 inches	Similar; componentsmay be larger andneeds a largerenclosure. Noadditional safety orefficacy concern asthe componentconfiguration issimilar for a workinglaser.
Cooling	Air Cool	Air Cool	Same
Aiming Beam	532 nm, 3 mW	500-550 nm, poweradjustable 0-5 mW	Similar, within rangeof the predicatedevice
Portability	Portable and can beplaced on a medicalcart	Portable and can beplaced on a medicalcart	Same
Fail Safe ControlSystem	Master and Slavecontroller to verifyfail-safe control.Master and slavecontrol to verify laseractions for errorwarning and fail-safeconditions.	Software Fail SafeControl System	Similar; both devices'fail-safe controlsystem passed theElectrical SafetyTesting. No safety orefficacy concern havebeen identified.
Metal Enclosure	Aluminum enclosure	Aluminum enclosure	Same
Manufacturer	Convergent Laser Technologies	Olympus Surgical Technologies America	Significant Differences
Trade/Device Name	Optica XTTM Thulium Fiber Laser and Accessories	SOLTIVETM Laser Fibers, and Accessories	N/A
Fiber Delivery Diameter	150 micron - 1000 micron multimode fiber optic delivery	150 micron - 1000 micron multimode fiber optic delivery	Same
Fiber Length	3 m	3 m	Same
Material of Fiber	Quartz, silicone protective coating	Quartz, silicone protective coating	Same
Control Method	Laser power monitor and verification	Laser power monitor and verification	Similar, both devices' software and energy monitoring system passed the Electrical Safety Testing. No safety or efficacy concern have been identified.
Laser Source	Thulium laser	Thulium laser	Same
Wavelength	1940 nm	1920 – 1960 nm	Within the range of the predicate.
Pulse Duration	100 µs	200 µs to 50 ms	Within the range of the predicate.
Frequency	5 to 1000 Hz	1 to 2,400 Hz	Within the range of the predicate.
Pulse Energy	0.1 to 6 J	0.025 to 6 J	Within the range of the predicate.
Range of laser power	60 Watts	60 Watts	Same
Manufacturer	Convergent LaserTechnologies	Olympus SurgicalTechnologies America	SignificantDifferences
Trade/DeviceName	Optica XTTMThulium Fiber Laserand Accessories	SOLTIVE™ LaserFibers, andAccessories	N/A
Weight	43 kg	40 kg	Similar, the deviceweighs more than thepredicate device.Increased weight ofthe device does notadd any concern orsafety or efficacy.
TrainingProgram	Yes	Yes	Same
Fail Safe Feature	Laser shuts down orgo to STANDBYwhen detects failure orerror	Laser shuts down or goto STANDBY whendetects failure or error	Same
Electrical SafetyTesting	AAMI/ANSI ES60601-1:2005+A1IEC 60601-1:2005+C1;C2;A1	AAMI/ANSI ES60601-1:2005+A1IEC 60601-1:2005	Same- AAMI/ANSIES 60601-1:2005+A1Similar, IEC 60601-1:2005, both systemsmeet IEC 60601-1standards, the devicewas tested based onthe current standardat the time of testing.
ElectromagneticCompatibilityTesting	IEC 60601-1-2:2014,4th Edition	IEC 60601-1-2:2007,3rd Edition	Similar, both systemsmeet IEC 60601-1-2standards, the devicewas tested based onthe Edition current atthe time of testinghence the Edition isnot the same.

Esophagitis ●
Esophageal ulcers ●
Varices ●
Colitis ●
Mallory-Weiss tear
Gastric Erosions

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VII. Performance Data

Non-clinical performance data support safety of the device in accordance to the following standards:

AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012, Medical Electrical Equipment Part 1: . General Requirements for Basic Safety and Essential Performance
IEC 60825-1:2014, Edition 3.0, Safety of Laser Products - Part 1: Equipment Classification and Requirements
IEC 60601-2-22:2012, Edition 3.1, Medical Electrical Equipment – Part 2-22: Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment
IEC 60601-1-2:2014, Edition 4, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests
IEC 60601-1-6:2013, Edition 3.1, Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability
IEC 62304:2006, Ed. 1.0 + A1, Medical Device Software Software Life Cycle Processes ●

Hardware and software verification and validation demonstrate that the Optica XT Thulium Fiber Laser and Accessories should perform as intended in the specified use conditions. Additionally, bench testing assessing the effect of bending stress on energy transmission in the optical fibers demonstrate comparable fiber performance.

Biocompatibility is in compliance with ISO 10993-1 - Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process. Optical fibers demonstrate compliance for the following biological endpoints:

Cytotoxicity
. Acute systemic toxicity
Sensitization ●
Material-mediated pyrogenicity ● . Hemocompatibility
Irritation or intracutaneous reactivity

This premarket submission for the Optica XT Thulium Fiber Laser and Accessories does not require clinical studies to support substantial equivalence.

VIII. Conclusions

Based on the nonclinical testing conducted, the Optica XT is the same or similar to its predicate device in regards to EMC and electrical safety. The differences in technological characteristics between the Optica XT and predicate device present no new questions of safety or effectiveness for the "indications for use" specified. Thus, the Optica XT is as safe, as effective, and performs as well as the legally marketed 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.