The Tranberg 65 Thermal Therapy System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including: gastroenterology, general surgery, plastic surgery, genitourinary (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT) head and neck, orthopedics, ophthalmology, pulmonology, and thoracic surgery.

Device Description

The TRANBERGCSS|Thermal Therapy System consists of three parts:

TRANBERGCSS|Mobile Laser
TRANBERGCLS|Temperature Sensor ●
Applicator Kit (The Applicator kit is not included)
The mobile laser unit is provided with a laser generator operating at the wavelength 1064 nm. The generated laser light is locally applied by means of a single use applicator kit through a less invasive surgical or percutaneous procedure. The energy within the laser light is absorbed by the tissue resulting in increased tissue temperature. Tissue heating and lesion formation is controlled by a tissue temperature feedback system integrated into the TRANBERGCS | Thermal Therapy System.

AI/ML Overview

The document describes the TRANBERG® CLS Thermal Therapy System and its substantial equivalence to a predicate device, the PhoTex 30 Diode Laser Series (K092197). The device is a laser surgical instrument for soft tissue ablation, vaporization, excision, incision, and coagulation.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance & Equivalence:

The document doesn't present "acceptance criteria" in the typical format of a threshold to be met, but rather compares the technological characteristics of the TRANBERG® CLS Thermal Therapy System with its predicate device to demonstrate substantial equivalence. The "Acceptance Criteria" here are implicitly the predicate device's existing characteristics and performance, which the new device aims to match or exceed for safety and effectiveness.

Parameter	Predicate Device (PhoTex 30 Diode Laser Series, K092197)	TRANBERG® CLS Thermal Therapy System (New Device)
Intended Use / Indications	"The PhoTex30 Diode Laser Series is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including: gastroenterology, general surgery, plastic surgery, genitourinary (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT) head and neck, orthopedics, ophthalmology, pulmonology, and thoracic surgery."	"The Tranberg CLS Thermal Therapy System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including: gastroenterology, general surgery, plastic surgery, genitourinary (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT) head and neck, orthopedics, ophthalmology, pulmonology, and thoracic surgery."
Wavelength	980nm, 810nm or 940 nm	1064nm (Adapted to indication for use of the laser applicator/hand piece)
Output power	3W – 30W at output port	1W - 25W at output port
Output power accuracy	+/- 20% of selected value	+/- 10% of selected value
Mode of operation	Continuous wave (CW), pulsed, or external modulation modes.	Continuous wave or controlled by tissue temperature monitored by a temperature sensor
Output power increments	0.5 W	1W
Operating temperature	10-35 °C	15°C to 28°C
Weight	20 lbs (9.1kg)	18 Kg
Audio Warning Signal Level	HIGH, MEDIUM, LOW, and OFF	Fixed at HIGH
Temperature sensors	No	Yes
Performance	The BioTex device is verified and validated together with the Applicator kit cleared under K053087.	The CLS device is verified and validated to have the same performance when used together with the Applicator kit cleared under K053087.
Other Parameters	Mostly identical elements like Product Code (GEX), Device Class (2), Manufacturer (BioTex, US vs. Clinical LaserThermia Systems CLS, Sweden), Cooling (TEC), Channel(s) (1), Output port (SMA 905), Aiming wavelength (650 nm vs. 635 nm), Laser type IEC60825-1 (Class IV), Power source (100-240 V AC / 50-60 Hz), Foot switch operation (On/Off), Emergency switch (Yes), Key activation of laser output (Yes), Remote Interlock (Yes), Power ON/OFF Visual Indicator (Yes), Laser Emission Indicator (Yes), Internal Laser Power Monitor (Yes), Manual Reset (Yes), Fiber Insertion Interlock (Yes), Laser Emission Energy Monitoring (Yes), Safety classification FDA (Class II), Pump for cooling liquid for applicator (Yes), and Applicator kit interface.

Study Proving Acceptance Criteria (Substantial Equivalence):

The study to prove the device meets the acceptance criteria is a non-clinical bench testing comparison to a legally marketed predicate device (K092197: BioTex, Inc.; PhoTex30 Diode Laser).

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated as a numerical sample size. The "test set" for this type of submission typically refers to the testing conducted on the device itself against various standards and specifications. It does not involve a human patient data test set in the way a clinical study would.
Data Provenance: The testing was non-clinical bench testing, meaning it was conducted in a lab environment. The document does not specify a country of origin for the data beyond "Non-clinical bench performance testing." It is implied to be from a controlled lab environment. The testing is prospective in the sense that it evaluates the new device's performance against predefined standards and the predicate.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable to this type of submission. Ground truth, in the context of expert consensus, pathology, or outcomes data, is relevant for AI/ML device evaluations or diagnostic devices where human interpretation or definitive medical findings are being compared. For this laser device, the "ground truth" is defined by established engineering and safety standards (e.g., ISO, IEC, FDA) and the functional characteristics of the predicate device.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert opinions or interpretations, typically in clinical evaluations or ground truth establishment for diagnostic algorithms. Since no expert panel was used for ground truth for this non-clinical submission, no adjudication method was needed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic or imaging devices where human readers interpret cases, and AI assistance is being assessed. This submission is for a surgical laser device based on substantial equivalence to an existing device through non-clinical testing.

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

Yes, in essence, standalone performance (non-clinical bench testing) was done. The device's performance characteristics (e.g., wavelength, output power accuracy, operating modes, safety features) were evaluated directly through engineering bench tests to ensure they meet applicable standards and are comparable to the predicate. There is no "algorithm" in the sense of AI/ML, but the device's operational parameters were tested without human intervention in the loop of the device's core function during these bench tests.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is based on:

Established engineering standards: Applicable ISO, IEC, and FDA safety and performance standards.
Predicate device characteristics: The established and legally marketed characteristics and performance of the PhoTex 30 Diode Laser Series (K092197).
Product Requirement Specifications: The device was tested against its own documented design and functional requirements.

8. The Sample Size for the Training Set:

This information is not applicable. This is a medical device clearance based on substantial equivalence, not an AI/ML algorithm requiring a training set. The device manufacturing processes and designs would undergo validation, but there isn't a "training set" in the machine learning context.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as there is no training set for an AI/ML algorithm.

Summary

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Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healing. The logo also includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 21, 2015

Clinical Laserthermia Systems AB % Mr. David Makanani OMEDtech, LLC 1725 Signal Ridge Drive, Suite 150 Edmond, Oklahoma 73013

Re: K142216

Trade/Device Name: Tranberg 65 Thermal Therapy System 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: March 20, 2015 Received: March 24, 2015

Dear Mr. Makanani:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -S

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

Enclosure

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K142216

Indication for Use

510(k) Number: K142216

Device Name: Tranberg CLS Thermal Therapy System

Intended Use/Indications for Use:

"The Tranberg 65 Thermal Therapy System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including: gastroenterology, general surgery, plastic surgery, genitourinary (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT) head and neck, orthopedics, ophthalmology, pulmonology, and thoracic surgery."

Prescription Use: X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use: NO (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

510(k)

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510(K) SUMMARY

Date	April 17, 2015
SUBMITTER:	Lars-Erik Eriksson, CEOClinical Laserthermia Systems, ABScheelevagen 2Lund, Sweden 22381
CONTACT PERSON:	David Makanani, CEOOMEDtech, L.L.C.1725 Signal Ridge Drive, Suite 150Edmond, Oklahoma 73013Tel: (405) 826-0713Email: dmakanani@omedtech.com
DEVICE NAME:ClassificationTrade NameCommon NameClassificationProduct CodeReview PanelPREDICATE DEVICE:	Class IITRANBERGCLS Thermal Therapy SystemTRANBERGCLS Thermal Therapy System21 CFR 878.4810GEX - Powered Laser Surgical InstrumentGeneral and Plastic SurgeryK092197: BioTex, Inc.; PhoTex30 Diode Laser.
INTENDED USE:	The Tranberg CLS Thermal Therapy System is indicatedfor use in surgical applications requiring the ablation,vaporization, excision, incision, and coagulation of softtissue in areas of surgery including: gastroenterology,general surgery, plastic surgery, genitourinary(urology), gynecology (GYN), neurosurgery,otolaryngology (ENT) head and neck, orthopedics,ophthalmology, pulmonology, and thoracic surgery.

DEVICE DESCRIPTION:

The TRANBERGCSS|Thermal Therapy System consists of three parts:

TRANBERGCSS|Mobile Laser

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TRANBERGCLS|Temperature Sensor ●
Applicator Kit (The Applicator kit is not included)

The mobile laser unit is provided with a laser generator operating at the wavelength 1064 nm. The generated laser light is locally applied by means of a single use applicator kit through a less invasive surgical or percutaneous procedure. The energy within the laser light is absorbed by the tissue resulting in increased tissue temperature. Tissue heating and lesion formation is controlled by a tissue temperature feedback system integrated into the TRANBERGCS | Thermal Therapy System.

For a detailed description of the function and the usage of the laser module and its accessories, view the IFU.

TECHNOLOGICAL CHARACTERISTIC AND SUBSTANTIAL EQUIVALENCE:

Substantial equivalence of the TRANBERGSSSSSThermal Therapy System is claimed to the PhoTex 30 Diode Laser Series, cleared under K092197.

The CLS device is verified and validated to have the same performance as the predicate device when used together with the Applicator kit cleared under K053087

The following table provides more detailed information regarding the basis for the determination of substantial equivalence:

Parameter
Product name	TRANBERGCLS Thermal Therapy System	PhoTex 30 Diode Laser Series
Manufacturer	Clinical LaserThermia Systems CLS, Sweden	BioTex, US
Intended use /Indications for use	"The Tranberg CLS Thermal TherapySystem is indicated for use in surgicalapplications requiring the ablation,vaporization, excision, incision, andcoagulation of soft tissue in areas ofsurgery including: gastroenterology,general surgery, plastic surgery,genitourinary (urology),gynecology (GYN), neurosurgery,otolaryngology (ENT) head and neck,orthopedics, ophthalmology,pulmonology, and thoracic surgery."	"The PhoTex3 Diode Laser Series isindicated for use in surgical applicationsrequiring the ablation, vaporization,excision, incision, and coagulation of softtissue in areas of surgery including:gastroenterology, general surgery, plasticsurgery, genitourinary (urology),gynecology (GYN), neurosurgery,otolaryngology (ENT) head and neck,orthopedics, ophthalmology, pulmonology,and thoracic surgery."
Device RegulatoryClassification	FDA 878.4810	FDA 878.4810
Product code	GEX	GEX
Device class	2	2
510(k) No	To be obtained	K092197
Diode lasergenerator
Wavelength	1064nmAdapted to indication for use of the laserapplicator / hand piece	980nm, 810nm or 940 nm
Output power	1W - 25W at output port	3W – 30W at output port
Output poweraccuracy	+/- 10% of selected value	+/- 20% of selected value
Mode of operation	Continuous wave or controlled by tissuetemperature monitored by a temperaturesensor	Continuous wave (CW), pulsed, or externalmodulation modes.
Output powerincrements	1W	0.5 W
Cooling	TEC	TEC
Channel(s)	1	1
Output port	SMA 905	SMA 905
Aiming wavelength	635 nm	650 nm
Laser typeIEC60825-1	Class IV	Class IV
General technicalcharacteristics
Power source	100-240 V AC / 50-60 Hz	100-240 V AC / 50-60 Hz
Operatingtemperature range	15°C to 28°C	10-35 °C
Average dimensions	540, 450, 180mm (width, depth, height)	16.0"x12,5"x8,0" (406x318x203)
Weight	18 Kg	20 lbs (9,1kg)
Foot switchoperation	On/Off	On/Off
Emergency switch	Yes	Yes
Key activation oflaser output	Yes	Yes
Remote Interlock	Yes	Yes
Power ON/OFFVisual Indicator	Yes	Yes
Laser EmissionIndicator	Yes	Yes
Internal Laser PowerMonitor	Yes	Yes
Manual Reset	Yes	Yes
Fiber InsertionInterlock	Yes	Yes
Laser EmissionEnergy Monitoring	Yes	Yes
Audio WarningSignal Level	Fixed at HIGH	HIGH, MEDIUM, LOW, and OFF
Safety classificationFDA	Class II	Class II
Pump for coolingliquid for applicator	Yes	Yes
Temperaturesensors included	Yes	No
Applicator kit(Laser fiber andTrochar)
Interface	Compatible with fiber optic deliveryaccessory with a standard SMA905connector having a core fiber diameter of400 or 600 microns and a numericalaperture of at least 0.37.	Compatible with fiber optic deliveryaccessory with a standard SMA905connector having a core fiber diameter of400 or 600 microns and a numericalaperture of at least 0.37.
Performance	The CLS device is verified and validatedto have the same performance when usedtogether with the Applicator kit clearedunder K053087	The BioTex device is verified and validatedtogether with the Applicator kit clearedunder K053087

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PERFORMANCE TESTING - (NON-CLINICAL) BENCH:

The TRANBERG®|Thermal Therapy System has been determined through engineering bench testing to support substantial equivalence with this device and the predicates. This testing showed the TRANBERGSS|Thermal Therapy System to meet applicable ISO, IEC and FDA safety and performance standards,

Non-clinical bench performance testing completed:

Engineering comparative temperature testing
. Engineering Verification and Validation Testing to the Product Requirement Specification

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Software testing ●
Usability Engineering Testing - ISO 62366
Electromagnetic Compatibility – IEC 60601-1-2 Collateral Standard
Electrical Safety for Laser Equipment — IEC 60601-2-22 Particular Standard
Medical Device Sterilization of Health Care Products – ISO 11135-1; Ethylene Oxide

PERFORMANCE TESTING - CLINICAL:

There are no clinical data submitted with this Notification.

CONCLUSION:

Based on the results of non-clinical testing, the TRANBERGSS|Thermal Therapy System performs safely, as intended, and the comparative discussion of intended use, principle of operation, and technological characteristics, it is determined that the TRANBERGSSS|Thermal Therapy System is substantially equivalent to predicate devices.

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.