(136 days)
Not Found
No
The summary describes a laser fiber used to deliver energy for tissue treatment and does not mention any AI or ML components or functions.
Yes
The device is used to "necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy," which constitutes a medical treatment.
No
The device is described as a laser fiber used to transfer laser energy for treatment (necrotizing or coagulating soft tissue), not for identifying or diagnosing medical conditions.
No
The device description clearly outlines a physical laser fiber with specific dimensions, materials, and connectors, indicating it is a hardware component designed to deliver laser energy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Device Function: The TRANBERG CLS/Diffusor Laser fiber is described as a device used to transfer laser energy for the purpose of necrotizing or coagulating soft tissue through interstitial irradiation or thermal therapy. This is a direct therapeutic intervention on the patient's body, not an analysis of a specimen taken from the body.
- Intended Use: The intended use clearly states its application in various surgical and medical procedures for tissue treatment, not for diagnostic testing of samples.
Therefore, the function and intended use of this device fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue
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 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
- ISO 10993-10, Tests for irritation and skin sensitization
- Sterilization/Shelf Life Testing
- o ISO 11135-1, Sterilization of Health-Care Products: Ethylene Oxide
- 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
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other. The profiles are stylized and appear to be connected, forming a single, flowing shape.
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
1
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
2
Indications for Use
510(k) Number (if known) K163103
Device Name The TRANBERG CLS/Diffusor Laser Fiber
Indications for Use (Describe)
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.
| 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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3
510(K) SUMMARY
| Date | March 22, 2017 |
|---|---|
| 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 | 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 TranbergCLS |
| Laser Fiber | |
| INTENDED USE: | The TRANBERGCLS 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, plastic surgery, | |
| pulmonology, radiology, and urology, for wavelengths | |
| 980nm 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
4
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 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. | 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, for wavelengths 980nm through | ||
| 1064nm. | ||
| Device Regulatory | Accessory to powered surgical laser | |
| instrument | Accessory to powered surgical laser | |
| instrument | ||
| Classification | FDA 878.4810 | FDA 878.4810 |
| Product Code | GEX | GEX |
5
| Parameter | ||
|---|---|---|
| Device Class | Accessory to powered surgical laser | |
| instrument | ||
| Class 2 | Accessory to powered surgical laser | |
| instrument | ||
| Class 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 assembly | ||
| diameter: | 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
6
- 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.