The TRANBERG CLS Laser fiber is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology, and urology, at a wavelength of 1064nm.

Device Description

The TRANBERG CLS Laser fiber is used to transfer laser energy from the laser unit to the location for the treatment. The laser fiber is an optical fiber with a core of 550 mic and radial diffusor. The length is 3m and it has a standard connector SMA 905 to fit the laser unit. The numerical aperture is at 0.22. The material in contact with human tissue is biocompatible. The TRANBERG CLS Laser fiber is delivered sterile and for single use only.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the TRANBERG CLS Laser Fiber, which is a medical device used for necrotizing or coagulating soft tissue through interstitial irradiation or thermal therapy.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner. Instead, the demonstration of substantial equivalence relies on comparing the device's technological characteristics and performance (as assessed through bench testing) to a legally marketed predicate device. The performance is assessed against general safety and performance standards rather than specific numerical criteria.

Feature / Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (TRANBERG CLS Laser Fiber)
Intended Use	Necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in various surgical specialties at 800nm-1064nm wavelength.	Necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in various surgical specialties at 1064nm wavelength. (Matches predicate, but narrower wavelength range for the new device).
Regulatory Class	Class II, GEX Product Code	Class II, GEX Product Code
Fiber Core Diameter	400 µm (range 200 – 1000 µm)	550 µm
Numerical Aperture	0.37	0.22
Fiber Length	3-12m standard	3m
Proximal Connector	SMA 905	SMA 905
Wavelength	532-1064nm	1064 nm
Laser Operation Mode	Continuous Wave	Continuous Wave
Diffusing Region Length	7.5-30mm	1 mm
Diffusing Tip Assembly Diameter	0.6-1.4mm	1.55 mm
Lesion Shape	Ellipsoidal / Round	Round
Max Power	8W for 400µm	8W for 550µm (Indicated higher power capacity for larger fiber)
Lesion Volume	0.8 cm³	0.8 cm³ (Refer to Report DV-2015-024)
Biocompatibility	Biocompatible materials	Meets biocompatibility standards
Safety and Performance	Meets applicable ISO, IEC, and FDA standards	Meets applicable ISO, IEC, and FDA safety and performance standards (demonstrated via engineering bench testing)

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

Sample Size for Test Set: Not applicable in the traditional sense of a clinical test set with human subjects. The testing described is non-clinical bench testing.
Data Provenance: The document does not specify the country of origin for the non-clinical bench testing data, but the manufacturer is Clinical Laserthermia Systems, AB, in Lund, Sweden. The testing appears to be retrospective in the sense that it was conducted before the 510(k) submission to demonstrate equivalence.

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

Not applicable. This was a non-clinical bench study. There was no "ground truth" derived from expert review of data in a clinical context.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication process for clinical or image data is mentioned.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "There are no animal or clinical data submitted with this Notification." This type of study would involve human readers and AI assistance, neither of which is relevant to the data submitted.

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

Yes, in a conceptual sense, a "standalone" performance assessment of the device was done, but not in the context of an AI algorithm. The device itself (the laser fiber) was tested on a benchtop to ensure it met performance specifications and was substantially equivalent to its predicate. This is a standalone assessment of the physical device's functionality.

7. The Type of Ground Truth Used

For the non-clinical bench testing, the "ground truth" was established by engineering measurements and compliance with industry standards. For example, lesion volume was measured and compared to the predicate's reported lesion volume. Biocompatibility was assessed against established standards.

8. The Sample Size for the Training Set

Not applicable. This device is a physical laser fiber, not an AI/ML algorithm. Therefore, there is no "training set."

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

Not applicable. As there is no training set for an AI/ML algorithm, no ground truth was established for it.

Summary

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

February 12, 2016

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

Re: K151569 Trade/Device Name: Tranberg CLS Laser Fiber 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: January 4, 2016 Received: January 7, 2016

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/ResourcesforYou/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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Indications for Use

510(k) Number (if known) K151569

Device Name TRANBERG CLS Laser fiber

Indications for Use (Describe)

The TRANBERG CLS Laser fiber is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the pericardial sac), dermatology, ear nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, and urology at a wavelength of 1064nm.

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)

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510(K) SUMMARY

Date	June 1, 2015
SUBMITTER	Lars-Erik Eriksson, CEOClinical Laserthermia Systems, ABScheelevagen 2Lund, Sweden 22381
CONTACT PERSON	Lars-Erik Eriksson, CEOClinical Laserthermia Systems, ABScheelevagen 2Lund, Sweden 22381Tel: +4646152100Email: lee@clinicallaser.se
DEVICE NAMEClassificationTrade NameCommon NameClassificationProduct CodeReview Panel	Class IITRANBERGCLS Laser fiberTRANBERGCLS Laser fiber21 CFR 878.4810GEX - Powered Laser Surgical InstrumentGeneral and Plastic Surgery
PREDICATE DEVICE:	K053087, Visualase Cooled Laser Application System (VCLAS)
INTENDED USE:	The TRANBERGCLS Laser fiber is indicated for use to necrotize orcoagulate soft tissue through interstitial irradiation or thermal therapyin medicine and surgery in cardiovascular thoracic surgery (excludingthe heart and the vessels in the pericardial sac), dermatology, ear-nosethroat surgery, gastroenterology, general surgery, gynecology, headand neck surgery, neurosurgery, plastic surgery, pulmonology,radiology, and urology, at a wavelength of 1064nm.

DEVICE DESCRIPTION:

The TRANBERG46|Laser fiber is used to transfer laser energy from the laser unit to the location for the treatment.

Clinical Laserthermia Systems, AB ● 223 81 Lund, Sweden

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The laser fiber is an optical fiber with a core of 550 mic and radial diffusor. The length is 3m and it has a standard connector SMA 905 to fit the laser unit. The numerical aperture is at 0.22. The material in contact with human tissue is biocompatible.

The TRANBERGCS|Laser fiber is delivered sterile and for single use only.

TECHNOLOGICAL CHARACTERISTIC AND SUBSTANTIAL EQUIVALENCE:

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

Laser fiber
Product name	Tranberg CLS Laser fiber	Visualase Laser fiber LDF
Manufacturer	Clinical LaserThermia Systems CLS,Sweden	BioTex Inc., US
Intended use /Indications for use.	The Tranberg CS Laser fiber is indicatedfor use to necrotize or coagulate softtissue through interstitial irradiation orthermal therapy in medicine and surgeryin cardiovascular thoracic surgery(excluding the heart and the vessels inthe pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology,general surgery, gynecology, head andneck surgery, neurosurgery, plasticsurgery, pulmonology, radiology, andurology, at a wavelength of 1064nm.	The LDF is indicated for use to necrotizeor coagulate soft tissue throughinterstitial irradiation or thermal therapyin medicine and surgery in cardiovascularthoracic surgery (excluding the heart andthe vessels in the pericardial sac),dermatology, ear-nose-throat surgery,gastroenterology, general surgery,gynecology, head and neck surgery,neurosurgery, plastic surgery,pulmonology, radiology, and urology, forwavelengths 800nm through 1064nm.
Device RegulatoryClassification	Accessory to powered surgical laserinstrument	Accessory to powered surgical laserinstrument

Table 5-1 Equivalence Comparison

Clinical Laserthermia Systems, AB ● 223 81 Lund, Sweden

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	FDA 878.4810	FDA 878.4810
Product code	GEX	GEX
Device class	Accessory to powered surgical laser instrumentClass 2	Accessory to powered surgical laser instrumentClass 2
510(k) No		K053087
Fiber core diameter:	$550 \mu m$	$400 \mu m$ (200 – 1000)
Numerical aperture:	0.22	0.37
Fiber length:	3 m	3-12m standard
Proximal connector:	SMA 905	SMA 905
Wavelength:	1064 nm	532-1064nm
Laser operation mode:	Continuous Wave	Continuous Wave
Diffusing region length:	1 mm	7,5-30mm
Diffusing tip assembly diameter:	1.55 mm	0.6-1.4mm
Lesion Shape:	Round	Ellipsoidal / Round
Max power:	8 W for $550 \mu m$	8 W for $400\mu m$
Lesion volume (refer toReport DV-2015-024)	$0,8 cm^3$	$0,8 cm^3$

PERFORMANCE TESTING - (NON-CLINICAL) BENCH

The Tranberg 65 Laser fiber has been determined through engineering bench testing to support substantial equivalence with this device and the predicates. This testing showed the Tranberg CSS Laser fiber to meet applicable ISO, IEC and FDA safety and performance standards,

Non-clinical bench performance testing completed:

Engineering comparative temperature testing ●
Biocompatibility .

PERFORMANCE TESTING - ANIMAL/CLINICAL

There are no animal or clinical data submitted with this Notification.

CONCLUSION:

Based on the results of non-clinical testing, the TRANBERG-55|Laser Fiber performs according to specifications, and as intended, and the comparative discussion of intended use, principle of operation, and technological characteristics, has determined that the Tranberg 955 Laser fiber is 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.