(247 days)
No
The 510(k) summary describes a laser fiber used to deliver energy. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on bench testing of the fiber's physical properties and biocompatibility.
Yes
The device is indicated for use "to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy," which are therapeutic actions.
No
The device is used for therapeutic purposes (necrotizing or coagulating soft tissue) by transferring laser energy, not for diagnosing conditions.
No
The device description clearly states it is a physical optical fiber used to transfer laser energy, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy." This describes a therapeutic intervention performed directly on the patient's tissue.
- Device Description: The device is a laser fiber used to deliver energy for treatment. It is in contact with human tissue.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to be used in vitro (outside the living body) to analyze samples and provide diagnostic information. This device is used in vivo (within the living body) for therapeutic purposes.
N/A
Intended Use / Indications for Use
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.
Product codes
GEX
Device Description
The TRANBERG46|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 TRANBERGCS|Laser fiber is delivered sterile and for single use only.
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 pericardial sac), dermatology, ear-nose-throat, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology, 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 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, often associated with healthcare.
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
1
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, 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 |
| TRANBERGCLS Laser fiber | |
| TRANBERGCLS Laser fiber | |
| 21 CFR 878.4810 | |
| GEX - Powered Laser Surgical Instrument | |
| General and Plastic Surgery | |
| PREDICATE DEVICE: | K053087, Visualase Cooled Laser Application System (VCLAS) |
| INTENDED USE: | The TRANBERGCLS 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 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
4
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 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. | The LDF 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 800nm through 1064nm. | ||
| Device Regulatory | ||
| Classification | Accessory to powered surgical laser | |
| instrument | Accessory to powered surgical laser | |
| instrument |
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 instrument | |
| Class 2 | Accessory to powered surgical laser instrument | |
| Class 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 to | ||
| Report 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.