(297 days)
The TRANBERG® Laser Applicator 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, for wavelengths 980nm through 1064nm.
The TRANBERG® Laser Applicator is used to transfer laser energy from the laser unit to the location for the treatment. The laser Applicator is designed with a core of 550 μm. The fiber length is 3 and 12m and it has a standard connector SMA 905 to fit the laser unit. The numerical aperture is at 0.22. The Laser Applicator is used with an introducer and both (fiber and introducer), are delivered sterile and for single use only. The introducer consists of an introducer stylet and introducer catheter with a fiber lock.
The provided document, a 510(k) summary for the TRANBERG® Laser Applicator, describes a medical device and its substantial equivalence to a predicate device. It primarily focuses on the device's technical specifications and non-clinical performance testing.
It is crucial to note that the document does not include information on acceptance criteria, clinical studies to prove device performance against those criteria, or details regarding AI/algorithm performance. The document explicitly states: "There are no clinical data submitted with this Notification."
Therefore, I cannot provide the requested information regarding acceptance criteria, AI/algorithm performance, multi-reader multi-case studies, or detailed ground truth establishment for a test set, as this information is not present in the provided text.
However, I can extract the information that is present and indicate what is missing:
Device: TRANBERG® Laser Applicator
Type of Review: 510(k) Premarket Notification (for substantial equivalence, not full clinical efficacy or AI performance).
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, explicit performance acceptance criteria are not defined, nor is there a table of reported device performance against such criteria. The document focuses on demonstrating substantial equivalence to a predicate device through shared technological characteristics and non-clinical (bench) testing.
The "performance" described is about meeting safety and design specifications, not clinical efficacy or diagnostic accuracy.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicit in document. The primary "acceptance" is demonstrating substantial equivalence to the predicate device. | Non-clinical (Bench) Testing:- Determined through engineering testing to support substantial equivalence.- Showed the Tranberg® Laser Applicator to meet applicable ISO, IEC and FDA safety and performance standards. |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not applicable/Not provided. The document describes non-clinical (bench) engineering testing to meet safety and performance standards, not a "test set" of clinical data or images for an algorithm.
- Data Provenance: The document does not specify the origin of any data (e.g., country) as it discusses engineering and design parameters, not clinical data sets. The manufacturer is Clinical Laserthermia Systems, AB, located in Lund, Sweden.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable/Not provided. The document does not describe any expert-established ground truth for a test set, as it does not involve clinical data or diagnostic/AI performance evaluation.
4. Adjudication Method for the Test Set
- Not applicable/Not provided. No adjudication method is mentioned as there is no clinical test set requiring ground truth establishment through expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document explicitly states: "There are no clinical data submitted with this Notification." Therefore, no MRMC study was conducted or reported here.
6. Standalone (Algorithm Only) Performance
- No. This device is a laser applicator, a hardware medical device, not a software algorithm. Therefore, "standalone (algorithm only) performance" is not relevant to this submission.
7. Type of Ground Truth Used
- Not applicable/Not provided. The document describes a hardware device and its physical/engineering characteristics. There is no mention of "ground truth" in terms of clinical outcomes, pathology, or expert consensus, as this is not a diagnostic device or AI algorithm being validated against such benchmarks.
8. Sample Size for Training Set
- Not applicable/Not provided. As this is a hardware device and not an AI/ML algorithm, there is no "training set" in the computational sense.
9. How Ground Truth for Training Set Was Established
- Not applicable/Not provided. As there is no AI/ML algorithm or training set, this information is not relevant or available.
In summary, the provided FDA 510(k) document is for a physical medical device (laser applicator) seeking substantial equivalence, not a diagnostic device or an AI/ML product. Consequently, it does not contain the information typically associated with validation studies for AI/ML algorithms, such as acceptance criteria against clinical performance metrics, test set characteristics, expert ground truth establishment, or multi-reader studies. The focus is on technical specifications and non-clinical safety/performance testing to demonstrate equivalence to an existing device.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
March 26, 2021
Clinical Laserthermia Systems, AB % David Makanani CEO OMEDtech, LLC 1725 Signal Ridge Drive, Suite 150 Edmond, Oklahoma 73013
Re: K201466
Trade/Device Name: Tranberg CLS Laser Applicator 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 22, 2021 Received: February 26, 2021
Dear David 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. 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); 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.
For 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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Indication for Use
510(k) Number: K201466
Device Name: TRANBERG에 Laser Applicator
Indications for Use:
The TRANBERGOS| Laser Applicator 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, earnose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology, for wavelengths 980nm through 1064nm.
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 | May 23, 2020 |
|---|---|
| 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 IITRANBERG® Laser ApplicatorTRANBERG® Laser Applicator21 CFR 878.4810GEX - Powered Laser Surgical InstrumentGeneral and Plastic Surgery |
| PREDICATE DEVICE: | K163103, Clinical LaserThermia Systems Tranberg®Laser Diffuser Fiber |
| INTENDED USE: | The TRANBERG® Laser Applicator is indicated for useto 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, forwavelengths 980nm through 1064nm. |
DEVICE DESCRIPTION:
The TRANBERG® Laser Applicator 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 Applicator is designed with a core of 550 μm. The fiber length is 3 and 12m and it has a standard connector SMA 905 to fit the laser unit. The numerical aperture is at 0.22.
The Laser Applicator is used with an introducer and both (fiber and introducer), are delivered sterile and for single use only. The introducer consists of an introducer stylet and introducer catheter with a fiber lock
TECHNOLOGICAL CHARACTERISTIC AND SUBSTANTIAL EQUIVALENCE:
This device is identical in construction and design as the predicate device.
The following table provides more detailed information regarding the basis for the determination of substantial equivalence:
| Parameter | Predicate | Device |
|---|---|---|
| Laser Fiber | ||
| Product name | Tranberg® Laser Diffuser Fiber | Tranberg® Laser Applicator |
| Manufacturer | Clinical LaserThermia Systems CLS,Sweden | Clinical LaserThermia Systems CLS,Sweden |
| Indications for use | The Tranberg® Laser fiber is indicated foruse to necrotize or coagulate soft tissuethrough interstitial irradiation or thermaltherapy in medicine and surgery incardiovascular thoracic surgery (excludingthe heart and the vessels in thepericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, generalsurgery, gynecology, head and necksurgery, neurosurgery, plastic surgery,pulmonology, radiology, and urology, forwavelengths 980nm through 1064nm | The Tranberg® Laser Applicator isindicated for use to necrotize orcoagulate soft tissue through interstitialirradiation or thermal therapy inmedicine 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 980nm through 1064nm |
| Device RegulatoryClassification | Accessory to powered surgical laserinstrumentFDA 878.4810 | Accessory to powered surgical laserinstrumentFDA 878.4810 |
| Product Code | GEX | GEX |
Clinical Laserthermia Systems, AB ● 223 81 Lund, Sweden
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| Parameter | Predicate | Device |
|---|---|---|
| Device Class | Accessory to powered surgical laser instrumentClass 2 | Accessory to powered surgical laser instrumentClass 2 |
| 510(k) number | K163013 | To be obtained |
| Fiber core diameter: | 550 μm | 550 μm |
| Numerical aperture: | 0.22 | 0.22 |
| Fiber length: | 3m, 12m standard | 3m, 12m standard |
| Proximal connector: | SMA 905 | SMA 905 |
| Wavelength: | 980nm-1064 nm | 980nm-1064 nm |
| Laser operation mode: | Continuous Wave | Continuous Wave |
| Diffusing region length: | 10-15 mm | 1-25 mm |
| Diffusing tip assembly diameter: | 1.55 mm | 1.55 mm |
| Lesion Shape: | Elliptical shape | Elliptical or Round shape |
PERFORMANCE TESTING - (NON-CLINICAL) BENCH
The Tranberg® Laser Applicator has been determined through engineering testing to support substantial equivalence with this device and the predicate. This testing showed the Tranberg® Laser Applicator to meet applicable ISO, IEC and FDA safety and performance standards.
PERFORMANCE TESTING - CLINICAL
There are no clinical data submitted with this Notification.
CONCLUSION:
Based on the results of non-clinical testing, the TRANBERG® Laser Applicator 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® Laser Applicator is substantially equivalent to the predicate device.
§ 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.