(55 days)
No
The device description focuses on the physical properties and function of a laser delivery system, with no mention of AI or ML capabilities.
Yes
The device is used in surgical procedures for ablation, vaporization, excision, incision, and coagulation of soft tissue, which are all therapeutic actions.
No
The device description clearly states its purpose as a laser delivery system for surgical procedures, focusing on ablation, vaporization, excision, incision, and coagulation of soft tissue. It does not mention any function related to diagnosing medical conditions.
No
The device description clearly details physical components such as a hollow, semi-rigid tube, hand pieces, cleaving and cutting tools, and mentions compatibility with a gas purge system. These are all hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "surgical procedures requiring ablation, vaporization, excision, incision and coagulation of soft tissue." This describes a therapeutic or surgical intervention performed directly on the patient's body.
- Device Description: The description details a "laser delivery system" that transmits laser energy to tissue. This is a surgical tool, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to deliver energy for surgical purposes.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The FiberLase CO2 Laser WaveGuide is intended for use in surgical procedures requiring ablation, vaporization, excision, incision and coagulation of soft tissue. The FiberLase CO2 Laser WaveGuide is indicated for use in open surgical procedures such as ENT surgery and laparoscopy and endoscopic procedures. The device is limited to carbon dioxide lasers having a SMA-905 connector.
Product codes
GEX
Device Description
The CO2 Laser WaveGuide is a laser delivery system for use in surgical procedures requiring ablation, vaporization, excision, incision and coagulation of soft tissue. The CO2 Laser WaveGuide device is indicated for use in open surgical procedures such as ENT surgery and laparoscopy and endoscopic procedures. The CO2 Laser WaveGuide is a hollow, semi-rigid, light-conducting tube designed to operate at wavelengths of 10.6 um and 0.6328 um. These wavelengths correspond to the output of the CO2 laser device and the helium-neon laser aiming beam, thereby allowing both laser radiations to be simultaneously and efficiently transmitted through the same channel. Laser energy entering the waveguide travels down the tube by multiple bounces off the inner reflective surface, and is delivered to the tissue at the distal end.
The CO2 Laser WaveGuide is compatible for use with any laser system that has a 905 SMA connector. The WaveGuide is supplied in several configurations with the dimensions specified in the following table:
Core diameter [µm]: 300; Outer diameters [µm]: 700, 800; Lengths [cm]: 60, 100, 150
Core diameter [µm]: 500; Outer diameters [µm]: 900, 1040; Lengths [cm]: 60, 100, 150, 200
Core diameter [µm]: 750; Outer diameters [µm]: 1200, 1400; Lengths [cm]: 100, 150, 200
The CO2 Laser WaveGuide is supplied with a set of eight hand pieces through which the WaveGuide may be inserted for easy handling in surgical procedures. The hand pieces are available with various features at the distal end to provide angled beam deflection with a highly polished metal surface. The WaveGuide is also provided with cleaving and cutting tools. The WaveGuide accessories are all provided as reusable tools. The CO2 Laser WaveGuide may be used with a gas purge system providing a flow of air of 2 liters per minute and a regulator pressure of 4.5 psi. The gas purge system keeps the inner channel of the waveguide free of debris. The gas purge system is not supplied with the waveguide.
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 modified waveguide and new handpieces were bench tested to establish percent transmission using the longest length fiber optic waveguide as the worse case test scenario.
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.
0
SECTION 7 - SUMMARY OF SAFETY AND EFFECTIVENESS
K100384 (Premarket Notification [510(k)] Number)
APR 1 2 2010
1. Applicant
Lumenis Ltd. 13 Hayetzira Str. (POB 240) Yokneam Industrial Park Yokneam 20692 Israel
Corresponding Official:
| Name: | Ahava Stein |
|---|---|
| Title: | Regulatory Consultant |
| Address: | A. Stein - Regulatory Affairs Consulting |
| Beit Hapa'amon (Box 124) | |
| 20 Hata'as St. | |
| 44425 Kfar Saba | |
| ISRAEL | |
| Tel: | +972-9-767-0002 |
| Fax: | +972-9-766-8534 |
2. Device Name
| Device Name: | CO2 Laser WaveGuide |
|---|---|
| Device trade or proprietary name: | FiberLase CO2 Laser WaveGuide |
| Common Name: | CO2 Laser WaveGuide |
| Classification Name: | Laser Surgical Instrument, 21 CFR Section 878.4810 |
3. Predicate Devices
The modified CO2 Laser WaveGuide is substantially equivalent to the following device:
| Device | Manufacturer | 510(k) No. |
|---|---|---|
| CO2 Laser WaveGuide | Surgilase Inc. (acquired by Lumenis Ltd.) | K921671 |
1
4. Intended Use
The CO2 Laser WaveGuide Delivery System is intended for use in open and laparoscopic surgical procedures for ablation, vaporization, excision, and coagulation of soft tissue.
5. Description of the Device
The CO2 Laser WaveGuide is a laser delivery system for use in surgical procedures requiring ablation, vaporization, excision, incision and coagulation of soft tissue. The CO2 Laser WaveGuide device is indicated for use in open surgical procedures such as ENT surgery and laparoscopy and endoscopic procedures. The CO2 Laser WaveGuide is a hollow, semi-rigid, light-conducting tube designed to operate at wavelengths of 10.6 um and 0.6328 um. These wavelengths correspond to the output of the CO2 laser device and the helium-neon laser aiming beam, thereby allowing both laser radiations to be simultaneously and efficiently transmitted through the same channel. Laser energy entering the waveguide travels down the tube by multiple bounces off the inner reflective surface, and is delivered to the tissue at the distal end.
The CO2 Laser WaveGuide is compatible for use with any laser system that has a 905 SMA connector. The WaveGuide is supplied in several configurations with the dimensions specified in the following table:
| Core diameter [µm] | Outer diameters [µm] | Lengths [cm] |
|---|---|---|
| 300 | 700, 800 | 60, 100, 150 |
| 500 | 900, 1040 | 60, 100, 150, 200 |
| 750 | 1200, 1400 | 100, 150, 200 |
Table 1 - CO2 Laser WaveGuide Dimensions
The CO2 Laser WaveGuide is supplied with a set of eight hand pieces through which the WaveGuide may be inserted for easy handling in surgical procedures. The hand pieces are available with various features at the distal end to provide angled beam deflection
2
with a highly polished metal surface. The WaveGuide is also provided with cleaving and cutting tools. The WaveGuide accessories are all provided as reusable tools. The CO2 Laser WaveGuide may be used with a gas purge system providing a flow of air of 2 liters per minute and a regulator pressure of 4.5 psi. The gas purge system keeps the inner channel of the waveguide free of debris. The gas purge system is not supplied with the waveguide.
6. Performance Testing
The modified waveguide and new handpieces were bench tested to establish percent transmission using the longest length fiber optic waveguide as the worse case test scenario.
7. Technological Characteristics Compared to Predicate Device
The technological characteristics of the modified device, e.g., overall design, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the new CO2 Laser WaveGuide are substantially equivalent to the previously cleared CO2 Laser WaveGuide cited above.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is black against a white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
APR 1 2 2010
Lumenis Ltd. % A. Stein Regulatory Affairs Consulting Ltd. Ms. Ahava Stein, Regulatory Consultant Beit Hapa'amon (Box 124) 20 Hata'as St. Kfar Saba 44425, Israel
Re: K100384
Trade/Device Name: CO2 Laser WaveGuide 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 25, 2010 Received: April 05, 2010
Dear Ms. Stein:
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
4
Page 2 - Ms. Ahava Stein
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours.
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SECTION 1 - INDICATIONS FOR USE STATEMENT
Page 1 of 1
510(k) Number (if known): K100384
Device Name:
FiberLase CO2 Laser WaveGuide
Indications for use: The FiberLase CO2 Laser WaveGuide is intended for use in surgical procedures requiring ablation, vaporization, excision, incision and coagulation of soft tissue. The FiberLase CO2 Laser WaveGuide is indicated for use in open surgical procedures such as ENT surgery and laparoscopy and endoscopic procedures. The device is limited to carbon dioxide lasers having a SMA-905 connector.
Prescription Use V (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
NetRPodsk
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Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100384