(297 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety standards of a laser applicator, with no mention of AI or ML capabilities.
Yes
The intended use explicitly states the device is used to "necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy," which are therapeutic actions.
No
The device is indicated for use to "necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy," which describes a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components like a fiber, introducer, stylet, catheter, and connector, indicating it is a hardware device used to deliver laser energy.
Based on the provided information, the TRANBERG® Laser Applicator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy." This is a therapeutic procedure performed directly on the patient's tissue, not a test performed on a sample taken from the body (which is the hallmark of an IVD).
- Device Description: The device is a laser applicator designed to deliver laser energy for treatment. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the TRANBERG® Laser Applicator is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
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, for wavelengths 980nm through 1064nm.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat, gastroenterology, general surgery, gynecology, head and neck, neurosurgery, plastic surgery, pulmonology, radiology, and urology)
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)
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. There are no clinical data submitted with this Notification.
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.
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.
Not Found
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.
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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.
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); 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)
3
510(K) SUMMARY
| Date | May 23, 2020 |
|---|---|
| SUBMITTER | Lars-Erik Eriksson, CEO |
| Clinical Laserthermia Systems, AB | |
| Scheelevagen 2 | |
| Lund, Sweden 22381 | |
| CONTACT PERSON | Lars-Erik Eriksson, CEO |
| Clinical Laserthermia Systems, AB | |
| Scheelevagen 2 | |
| Lund, Sweden 22381 | |
| Tel: +4646152100 | |
| Email: lee@clinicallaser.se | |
| DEVICE NAME | |
| Classification | |
| Trade Name | |
| Common Name | |
| Classification | |
| Product Code | |
| Review Panel | Class II |
| TRANBERG® Laser Applicator | |
| TRANBERG® Laser Applicator | |
| 21 CFR 878.4810 | |
| GEX - Powered Laser Surgical Instrument | |
| General and Plastic Surgery | |
| PREDICATE DEVICE: | K163103, Clinical LaserThermia Systems Tranberg® |
| Laser Diffuser Fiber | |
| INTENDED USE: | 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. |
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
4
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 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 | |
| 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 | ||
| Device Regulatory | ||
| Classification | Accessory to powered surgical laser | |
| instrument | ||
| FDA 878.4810 | Accessory to powered surgical laser | |
| instrument | ||
| FDA 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 instrument | |
| Class 2 | Accessory to powered surgical laser instrument | |
| Class 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.