(252 days)
No
The description focuses on a laser-based thermal therapy system with a temperature feedback control. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text. The performance studies are standard engineering and safety tests, not AI/ML model validation.
Yes.
The device is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue, which are therapeutic interventions.
No
The device is described as a thermal therapy system used for ablation, vaporization, excision, incision, and coagulation of soft tissue, which are all treatment functions, not diagnostic ones.
No
The device description explicitly states it consists of a mobile laser unit and a temperature sensor, which are hardware components. While software is mentioned in the performance testing, the core device is a hardware system for thermal therapy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is used for "ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery". This describes a therapeutic or surgical intervention performed directly on the patient's body.
- Device Description: The device description details a laser system that applies energy to tissue to cause heating and lesion formation. This is a physical interaction with the tissue in vivo, not an analysis of a sample in vitro.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
The device is a surgical laser system used for therapeutic purposes, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
"The Tranberg 65 Thermal Therapy System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including: gastroenterology, general surgery, plastic surgery, genitourinary (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT) head and neck, orthopedics, ophthalmology, pulmonology, and thoracic surgery."
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The TRANBERGCSS|Thermal Therapy System consists of three parts:
- TRANBERGCSS|Mobile Laser
- TRANBERGCLS|Temperature Sensor ●
- Applicator Kit (The Applicator kit is not included)
The mobile laser unit is provided with a laser generator operating at the wavelength 1064 nm. The generated laser light is locally applied by means of a single use applicator kit through a less invasive surgical or percutaneous procedure. The energy within the laser light is absorbed by the tissue resulting in increased tissue temperature. Tissue heating and lesion formation is controlled by a tissue temperature feedback system integrated into the TRANBERGCS | Thermal Therapy System.
For a detailed description of the function and the usage of the laser module and its accessories, view the IFU.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue in areas of surgery including: gastroenterology, general surgery, plastic surgery, genitourinary (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT) head and neck, orthopedics, ophthalmology, pulmonology, and thoracic surgery.
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®|Thermal Therapy System has been determined through engineering bench testing to support substantial equivalence with this device and the predicates. This testing showed the TRANBERGSS|Thermal Therapy System to meet applicable ISO, IEC and FDA safety and performance standards,
Non-clinical bench performance testing completed:
- Engineering comparative temperature testing
- Engineering Verification and Validation Testing to the Product Requirement Specification
- Software testing ●
- Usability Engineering Testing - ISO 62366
- Electromagnetic Compatibility – IEC 60601-1-2 Collateral Standard
- Electrical Safety for Laser Equipment — IEC 60601-2-22 Particular Standard
- Medical Device Sterilization of Health Care Products – ISO 11135-1; Ethylene Oxide
PERFORMANCE TESTING - CLINICAL:
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.
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.
0
Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healing. The logo also includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 21, 2015
Clinical Laserthermia Systems AB % Mr. David Makanani OMEDtech, LLC 1725 Signal Ridge Drive, Suite 150 Edmond, Oklahoma 73013
Re: K142216
Trade/Device Name: Tranberg 65 Thermal Therapy System 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: March 20, 2015 Received: March 24, 2015
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
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/Resourcesfor You/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
2
Indication for Use
510(k) Number: K142216
Device Name: Tranberg CLS Thermal Therapy System
Intended Use/Indications for Use:
"The Tranberg 65 Thermal Therapy System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including: gastroenterology, general surgery, plastic surgery, genitourinary (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT) head and neck, orthopedics, ophthalmology, pulmonology, and thoracic surgery."
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 | April 17, 2015 |
|---|---|
| SUBMITTER: | Lars-Erik Eriksson, CEO |
| Clinical Laserthermia Systems, AB | |
| Scheelevagen 2 | |
| Lund, Sweden 22381 | |
| CONTACT PERSON: | David Makanani, CEO |
| OMEDtech, L.L.C. | |
| 1725 Signal Ridge Drive, Suite 150 | |
| Edmond, Oklahoma 73013 | |
| Tel: (405) 826-0713 | |
| Email: dmakanani@omedtech.com | |
| DEVICE NAME: | |
| Classification | |
| Trade Name | |
| Common Name | |
| Classification | |
| Product Code | |
| Review Panel | |
| PREDICATE DEVICE: | Class II |
| TRANBERGCLS Thermal Therapy System | |
| TRANBERGCLS Thermal Therapy System | |
| 21 CFR 878.4810 | |
| GEX - Powered Laser Surgical Instrument | |
| General and Plastic Surgery | |
| K092197: BioTex, Inc.; PhoTex30 Diode Laser. | |
| INTENDED USE: | The Tranberg CLS Thermal Therapy System is indicated |
| for use in surgical applications requiring the ablation, | |
| vaporization, excision, incision, and coagulation of soft | |
| tissue in areas of surgery including: gastroenterology, | |
| general surgery, plastic surgery, genitourinary | |
| (urology), gynecology (GYN), neurosurgery, | |
| otolaryngology (ENT) head and neck, orthopedics, | |
| ophthalmology, pulmonology, and thoracic surgery. |
DEVICE DESCRIPTION:
The TRANBERGCSS|Thermal Therapy System consists of three parts:
- TRANBERGCSS|Mobile Laser
4
- TRANBERGCLS|Temperature Sensor ●
- Applicator Kit (The Applicator kit is not included)
The mobile laser unit is provided with a laser generator operating at the wavelength 1064 nm. The generated laser light is locally applied by means of a single use applicator kit through a less invasive surgical or percutaneous procedure. The energy within the laser light is absorbed by the tissue resulting in increased tissue temperature. Tissue heating and lesion formation is controlled by a tissue temperature feedback system integrated into the TRANBERGCS | Thermal Therapy System.
For a detailed description of the function and the usage of the laser module and its accessories, view the IFU.
TECHNOLOGICAL CHARACTERISTIC AND SUBSTANTIAL EQUIVALENCE:
Substantial equivalence of the TRANBERGSSSSSThermal Therapy System is claimed to the PhoTex 30 Diode Laser Series, cleared under K092197.
The CLS device is verified and validated to have the same performance as the predicate device when used together with the Applicator kit cleared under K053087
The following table provides more detailed information regarding the basis for the determination of substantial equivalence:
| Parameter | ||
|---|---|---|
| Product name | TRANBERGCLS Thermal Therapy System | PhoTex 30 Diode Laser Series |
| Manufacturer | Clinical LaserThermia Systems CLS, Sweden | BioTex, US |
| Intended use / | ||
| Indications for use | "The Tranberg CLS Thermal Therapy | |
| System is indicated for use in surgical | ||
| applications requiring the ablation, | ||
| vaporization, excision, incision, and | ||
| coagulation of soft tissue in areas of | ||
| surgery including: gastroenterology, | ||
| general surgery, plastic surgery, | ||
| genitourinary (urology), | ||
| gynecology (GYN), neurosurgery, | ||
| otolaryngology (ENT) head and neck, | ||
| orthopedics, ophthalmology, | ||
| pulmonology, and thoracic surgery." | "The PhoTex3 Diode Laser Series is | |
| indicated for use in surgical applications | ||
| requiring the ablation, vaporization, | ||
| excision, incision, and coagulation of soft | ||
| tissue in areas of surgery including: | ||
| gastroenterology, general surgery, plastic | ||
| surgery, genitourinary (urology), | ||
| gynecology (GYN), neurosurgery, | ||
| otolaryngology (ENT) head and neck, | ||
| orthopedics, ophthalmology, pulmonology, | ||
| and thoracic surgery." | ||
| Device Regulatory | ||
| Classification | FDA 878.4810 | FDA 878.4810 |
| Product code | GEX | GEX |
| Device class | 2 | 2 |
| 510(k) No | To be obtained | K092197 |
| Diode laser | ||
| generator | ||
| Wavelength | 1064nm | |
| Adapted to indication for use of the laser | ||
| applicator / hand piece | 980nm, 810nm or 940 nm | |
| Output power | 1W - 25W at output port | 3W – 30W at output port |
| Output power | ||
| accuracy | +/- 10% of selected value | +/- 20% of selected value |
| Mode of operation | Continuous wave or controlled by tissue | |
| temperature monitored by a temperature | ||
| sensor | Continuous wave (CW), pulsed, or external | |
| modulation modes. | ||
| Output power | ||
| increments | 1W | 0.5 W |
| Cooling | TEC | TEC |
| Channel(s) | 1 | 1 |
| Output port | SMA 905 | SMA 905 |
| Aiming wavelength | 635 nm | 650 nm |
| Laser type | ||
| IEC60825-1 | Class IV | Class IV |
| General technical | ||
| characteristics | ||
| Power source | 100-240 V AC / 50-60 Hz | 100-240 V AC / 50-60 Hz |
| Operating | ||
| temperature range | 15°C to 28°C | 10-35 °C |
| Average dimensions | 540, 450, 180mm (width, depth, height) | 16.0"x12,5"x8,0" (406x318x203) |
| Weight | 18 Kg | 20 lbs (9,1kg) |
| Foot switch | ||
| operation | On/Off | On/Off |
| Emergency switch | Yes | Yes |
| Key activation of | ||
| laser output | Yes | Yes |
| Remote Interlock | Yes | Yes |
| Power ON/OFF | ||
| Visual Indicator | Yes | Yes |
| Laser Emission | ||
| Indicator | Yes | Yes |
| Internal Laser Power | ||
| Monitor | Yes | Yes |
| Manual Reset | Yes | Yes |
| Fiber Insertion | ||
| Interlock | Yes | Yes |
| Laser Emission | ||
| Energy Monitoring | Yes | Yes |
| Audio Warning | ||
| Signal Level | Fixed at HIGH | HIGH, MEDIUM, LOW, and OFF |
| Safety classification | ||
| FDA | Class II | Class II |
| Pump for cooling | ||
| liquid for applicator | Yes | Yes |
| Temperature | ||
| sensors included | Yes | No |
| Applicator kit | ||
| (Laser fiber and | ||
| Trochar) | ||
| Interface | Compatible with fiber optic delivery | |
| accessory with a standard SMA905 | ||
| connector having a core fiber diameter of | ||
| 400 or 600 microns and a numerical | ||
| aperture of at least 0.37. | Compatible with fiber optic delivery | |
| accessory with a standard SMA905 | ||
| connector having a core fiber diameter of | ||
| 400 or 600 microns and a numerical | ||
| aperture of at least 0.37. | ||
| Performance | The CLS device is verified and validated | |
| to have the same performance when used | ||
| together with the Applicator kit cleared | ||
| under K053087 | The BioTex device is verified and validated | |
| together with the Applicator kit cleared | ||
| under K053087 |
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6
PERFORMANCE TESTING - (NON-CLINICAL) BENCH:
The TRANBERG®|Thermal Therapy System has been determined through engineering bench testing to support substantial equivalence with this device and the predicates. This testing showed the TRANBERGSS|Thermal Therapy System to meet applicable ISO, IEC and FDA safety and performance standards,
Non-clinical bench performance testing completed:
- Engineering comparative temperature testing
- . Engineering Verification and Validation Testing to the Product Requirement Specification
7
- Software testing ●
- Usability Engineering Testing - ISO 62366
- Electromagnetic Compatibility – IEC 60601-1-2 Collateral Standard
- Electrical Safety for Laser Equipment — IEC 60601-2-22 Particular Standard
- Medical Device Sterilization of Health Care Products – ISO 11135-1; Ethylene Oxide
PERFORMANCE TESTING - CLINICAL:
There are no clinical data submitted with this Notification.
CONCLUSION:
Based on the results of non-clinical testing, the TRANBERGSS|Thermal Therapy System performs safely, as intended, and the comparative discussion of intended use, principle of operation, and technological characteristics, it is determined that the TRANBERGSSS|Thermal Therapy System is substantially equivalent to predicate devices.