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K Number
K211517
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
Manufacturer
Convergent Laser Technologies
Date Cleared
2021-11-09

(176 days)

Product Code
GEX
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

K183647

No reference devices were used in this submission.

No
The summary describes a laser system for surgical procedures and does not mention any AI or ML components or functionalities.

Yes
The device is described as intended for "incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue," which are all therapeutic actions.

No
The "Intended Use / Indications for Use" section specifies the device's purpose as "incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue," which are all therapeutic or surgical interventions, not diagnostic functions.

No

The device description explicitly details a physical laser system with specific dimensions, weight, electrical requirements, and a fiber optic delivery system. It also mentions hardware verification and validation.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
  • Device Function: The Optica XT Thulium Fiber Laser is a surgical laser system used for directly treating soft tissue within the body (in vivo). It performs procedures like incision, resection, ablation, and coagulation.
  • Lack of Specimen Analysis: The description does not mention the device being used to analyze any biological specimens. Its function is to deliver laser energy to tissue for therapeutic purposes.

The information provided clearly describes a surgical device, not a diagnostic one that analyzes samples.

N/A

Intended Use / Indications for Use

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.

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
  • 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.

Product codes (comma separated list FDA assigned to the subject device)

GEX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Soft tissue, prostate, urethra, ureters, bladder, kidneys, external genitalia, appendix, colon, GI tract, bile duct, gallbladder, pancreas, rectum, anus, esophagus, stomach, female reproductive organs.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K183647

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

No reference devices were used in this submission.

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

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.

1

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

2

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)

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.

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

3

  • · 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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4

510(k) Summary

I. General Information

| Submitter/Manufacturer: | Xintec Corporation, dba, Convergent Laser Technologies
1660 South Loop Road
Alameda, California 94502 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Mok
Regulatory Affairs & Quality Assurance Manager
Direct: 510-280-7207
Fax: 510-832-1600 |
| Date Prepared: | October 28, 2021 |
| II. Device | |
| 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 |
| Common or Usual Name | Surgical laser |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery
and in dermatology (21 CFR 878.4810) |
| Regulatory Class: | II |
| Product Code: | GEX |
| III. Predicate Device | |

ManufacturerOlympus Surgical Technologies America
Trade/Device Name:SOLTIVETM Laser System (SOLTIVETM Pro SuperPulsed Laser,
SOLTIVETM Premium SuperPulsed Laser, SOLTIVETM Laser
Fibers and Accessories)
510(k) NumberK183647
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.

5

IV. 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.

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 ●

6

  • 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 Laser
Technologies | Olympus Surgical
Technologies America | Significant
Differences |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade/Device
Name | Optica XT™
Thulium Fiber Laser
and Accessories | SOLTIVE™ Laser
Fibers, and
Accessories | N/A |
| 510(k) Number | K211517 | K183647 | N/A |
| Product Code | GEX | GEX | Same |
| CFR Citation
Number | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Classification | Class II | Class II | Same |
| Generic/Common
Name | Laser Surgical
Instrument for use in
General and Plastic
Surgery and in
Dermatology | Laser Surgical
Instrument for use in
General and Plastic
Surgery and in
Dermatology | 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 |
| Electrical Power | 100-240 VAC, 50/60 Hz | 100-240 VAC, 50/60 Hz | Same |
| Size of
Components
(H x W x L) | 16 x 20 x 24 inches | 11.6 x 14.6 x 22 inches | Similar; components
may be larger and
needs a larger
enclosure. No
additional safety or
efficacy concern as
the component
configuration is
similar for a working
laser. |
| Cooling | Air Cool | Air Cool | Same |
| Aiming Beam | 532 nm, 3 mW | 500-550 nm, power
adjustable 0-5 mW | Similar, within range
of the predicate
device |
| Portability | Portable and can be
placed on a medical
cart | Portable and can be
placed on a medical
cart | Same |
| Fail Safe Control
System | Master and Slave
controller to verify
fail-safe control.
Master and slave
control to verify laser
actions for error
warning and fail-safe
conditions. | Software Fail Safe
Control System | Similar; both devices'
fail-safe control
system passed the
Electrical Safety
Testing. No safety or
efficacy concern have
been 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 Laser
Technologies | Olympus Surgical
Technologies America | Significant
Differences |
| Trade/Device
Name | Optica XTTM
Thulium Fiber Laser
and Accessories | SOLTIVE™ Laser
Fibers, and
Accessories | N/A |
| Weight | 43 kg | 40 kg | Similar, the device
weighs more than the
predicate device.
Increased weight of
the device does not
add any concern or
safety or efficacy. |
| Training
Program | Yes | Yes | Same |
| Fail Safe Feature | Laser shuts down or
go to STANDBY
when detects failure or
error | Laser shuts down or go
to STANDBY when
detects failure or error | Same |
| Electrical Safety
Testing | AAMI/ANSI ES
60601-1:2005+A1
IEC 60601-
1:2005+C1;C2;A1 | AAMI/ANSI ES
60601-1:2005+A1
IEC 60601-1:2005 | Same- AAMI/ANSI
ES 60601-1:2005+A1
Similar, IEC 60601-
1:2005, both systems
meet IEC 60601-1
standards, the device
was tested based on
the current standard
at the time of testing. |
| Electromagnetic
Compatibility
Testing | IEC 60601-1-2:2014,
4th Edition | IEC 60601-1-2:2007,
3rd Edition | Similar, both systems
meet IEC 60601-1-2
standards, the device
was tested based on
the Edition current at
the time of testing
hence the Edition is
not the same. |

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

7

8

9

10

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.