The TRANBERG CLS/Diffusor 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, pulmonology, radiology, and urology, for wavelengths 980mm through 1064nm.

Device Description

The TRANBERG45| Diffusor Laser fiber is used to transfer laser energy from the laser unit to the location for the treatment. The diffusor laser fiber is designed with a core of 550 µm. The fiber length is 3 to 12m and it has a standard connector SMA 905 to fit the laser unit. The numerical aperture is at 0.22. The TRANBERGCS|Diffusor Laser fiber is delivered sterile and for single use only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the TRANBERG CLS Diffusor Laser Fiber. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive human studies often required for new technologies or higher-risk devices.

Therefore, the document does not contain information about:

Acceptance criteria in the context of clinical performance metrics like sensitivity, specificity, accuracy for an AI/algorithm-driven device.
A test set size or its data provenance for an AI/algorithm.
Number of experts or their qualifications for establishing ground truth for an AI/algorithm.
Adjudication methods for an AI/algorithm's test set.
MRMC comparative effectiveness studies.
Standalone performance for an AI/algorithm.
Sample size for a training set.
How ground truth for a training set was established.

The document primarily focuses on bench testing (non-clinical) to demonstrate that the device meets performance specifications and is substantially equivalent to its predicate.

Here's the information that can be extracted, framed within the context of a medical device submission, though it doesn't align with the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" for an AI/algorithm.

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

The document details performance testing for the device itself (laser fiber), not an AI algorithm. The "acceptance criteria" here are implied by the successful completion of specified engineering and bench tests, validating the device's physical and functional properties.

Parameter Tested (Implicit Acceptance Criteria: Meets Specification)	Reported Device Performance
Engineering Comparative Temperature Testing	Shows ability to necrotize/coagulate soft tissue.
Lesions size (in ex vivo bovine cardiac tissue)	Achieved 4.6 cm³ at 2min/15W (compared to predicate's 0.8 cm³ at 1min/8W; 2.7 cm³ at 2min/8W)
Occurrence of carbonization	Studied, but specific performance details not quantified here.
Integrity of the laser fiber	Studied, but specific performance details not quantified here.
Biocompatibility Testing (ISO 10993-1, -5, -10)	Performed to specification (implies acceptable biocompatibility profile)
Sterilization/Shelf Life Testing (ISO 11135-1, 10993-7, 11607-1, -2)	Performed to specification (implies device is sterile and stable over shelf life)

2. Sample sizes used for the test set and the data provenance

For the non-clinical bench testing:

Sample size for ex vivo model: Not explicitly stated but mentions using "bovine cardiac tissue." The precise number of tissue samples or runs is not given.
Data provenance: Ex vivo model. Implied to be lab-based, not patient-derived, and likely conducted in Sweden (location of the manufacturer). The document does not specify if it was retrospective or prospective, but as it's bench testing, it's generally a controlled, prospective experimental setup.

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 device submission. Ground truth for the laser fiber's performance is established through physical measurements and observations during bench testing, not expert interpretation of image data.

4. Adjudication method for the test set

Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant for bench testing of a laser fiber.

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. The device is a laser fiber for surgery, not an AI-assisted diagnostic tool. No MRMC study was conducted or relevant for this submission.

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

Not applicable. There is no algorithm to evaluate. The device is a physical instrument.

7. The type of ground truth used

For the bench testing, the ground truth was direct physical measurement and observation of the laser fiber's effects on ex vivo tissue and its adherence to engineering and safety standards (e.g., lesion size measurements, visual inspection for carbonization, results of standardized ISO tests for biocompatibility and sterilization).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; 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.

Summary

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

March 23, 2017

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

Re: K163103

Trade/Device Name: Tranberg CLS Diffusor 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: February 6, 2017 Received: February 21, 2017

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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" (21 CFR 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,

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) K163103

Device Name The TRANBERG CLS/Diffusor Laser Fiber

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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☑ 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	March 22, 2017
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 NAME
Classification	Class II
Trade Name	TRANBERGCLS Diffusor Laser fiber
Common Name	TRANBERGCLS Diffusor Laser fiber
Classification	21 CFR 878.4810
Product Code	GEX - Powered Laser Surgical Instrument
Review Panel	General and Plastic Surgery
PREDICATE DEVICE:	K151569, Clinical LaserThermia Systems TranbergCLSLaser Fiber
INTENDED USE:	The TRANBERGCLS Diffusor Laser Fiber is indicated foruse to necrotize or coagulate soft tissue throughinterstitial irradiation or thermal therapy in medicineand surgery in cardiovascular thoracic surgery(excluding the heart and the vessels in the pericardialsac), dermatology, ear-nose-throat surgery,gastroenterology, general surgery, gynecology, headand neck surgery, neurosurgery, plastic surgery,pulmonology, radiology, and urology, for wavelengths980nm through 1064nm.

DEVICE DESCRIPTION:

The TRANBERG45| Diffusor 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 diffusor laser fiber is designed with a core of 550 µm. The fiber length is 3 to 12m and it has a standard connector SMA 905 to fit the laser unit. The numerical aperture is at 0.22.

The TRANBERGCS|Diffusor 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:

Parameter
Laser Fiber	Image: Laser Fiber	Image: Laser Fiber
Product name	Tranberg CLS Laser fiber	Tranberg CLS Diffusor Laser Fiber
Manufacturer	Clinical LaserThermia Systems CLS,Sweden	Clinical LaserThermia Systems CLS,Sweden
Indications for use	The Tranberg CLS 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, for wavelengths 800nm through1064nm.	The Tranberg CLS 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, for wavelengths 980nm through1064nm.
Device Regulatory	Accessory to powered surgical laserinstrument	Accessory to powered surgical laserinstrument
Classification	FDA 878.4810	FDA 878.4810
Product Code	GEX	GEX

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Parameter
Device Class	Accessory to powered surgical laserinstrumentClass 2	Accessory to powered surgical laserinstrumentClass 2
510(k) number	K151569	To be obtained
Fiber core diameter:	550 μm	550 μm
Numerical aperture:	0.22	0.22
Fiber length:	3 m	3 - 12m
Proximal connector:	SMA 905	SMA 905
Wavelength:	1064 nm	1064 nm
Laser operation mode:	Continuous Wave	Continuous Wave
Diffusing region length:	1 mm	15 mm
Diffusing tip assemblydiameter:	1.55 mm	1.55 mm
Lesion Shape:	Ring shape	Cylindrical shape
Max power:	8 W for 550 μm	20 W for 550 μm
Lesion volume	0.8 cm³ at 1min/8W;2.7 cm³ at 2min/8W	4.6 cm³ at 2min/15W

PERFORMANCE TESTING - (NON-CLINICAL) BENCH

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

Non-clinical bench testing showed the device performed to specification and included:

Engineering comparative temperature testing
Performance testing of the fiber was performed in an ex vivo model using bovine cardiac tissue kept at 37 ℃. At a wavelength of 1064 nm using different power settings and exposure times the following parameters where studied:
o Lesions size
o Occurrence of carbonization
o Integrity of the laser fiber
Biocompatibility Testing
- o ISO 10993-1, Biological Evaluation of Medical Devices
- ISO 10993-5, Tests for in vitro cytotoxicity o
- ISO 10993-10, Tests for irritation and skin sensitization o
Sterilization/Shelf Life Testing
- o ISO 11135-1, Sterilization of Health-Care Products: Ethylene Oxide

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ISO 10993-7, Biological Evaluation of Medical Devices: Ethylene Oxide O
O ISO 11607-1, Packaging for Terminally Sterilized Medical Devices: Requirements
ISO 11607-2, Packaging for Terminally Sterilized Medical Devices: Validation O

PERFORMANCE TESTING - CLINICAL

There are no clinical data submitted with this Notification.

CONCLUSION:

Based on the results of non-clinical testing, the TRANBERGCSS| Diffusor 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 65 Diffusor 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.