(60 days)
Not Found
No
The 510(k) summary describes a passive laser energy delivery fiber and does not mention any AI or ML components or functionalities.
No
The device is described as a "light-conducting delivery fiber" designed to transmit laser energy for surgical procedures (ablation, vaporization, excision, incision, and coagulation of soft tissue). It is an accessory to a laser system and does not itself provide a therapeutic effect but rather delivers the energy for treatment.
No
The device is described as a surgical tool used for ablation, vaporization, excision, incision, and coagulation of soft tissue, transmitting laser energy for treatment. There is no mention of it being used for diagnosis or identifying diseases/conditions.
No
The device description explicitly states it is a "hollow, semi rigid, lightconducting delivery fiber," which is a physical hardware component designed to transmit laser energy.
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 is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The description details a fiber designed to transmit laser energy for tissue treatment. This aligns with a surgical tool, not a device used to examine samples outside the body for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is used directly on the patient's tissue during surgery.
N/A
Intended Use / Indications for Use
The FiberLase Endure CO2 Fiber is intended for use in surgical procedures requiring ablation, vaporization, excision, incision and coagulation of soft tissue. The FiberLase Endure CO2 Fiber is indicated for use in open surgical procedures such as ENT surgery and laparoscopy and endoscopic procedures.
Product codes
GEX
Device Description
The FiberLase Endure CO2 Fiber is a hollow, semi rigid, lightconducting delivery fiber, 2 meter length, designed to transmit laser energy from the CO2 laser system to the treatment site. The fiber also transmits a low power red diode or helium neon laser aiming beam to assist in targeting the tissue to be treated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue (for ablation, vaporization, excision, incision, and coagulation). Specifically mentioned for ENT surgery and laparoscopic and endoscopic procedures.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgical procedures. Intended user is likely a surgeon or other medical professional.
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
Performance testing demonstrated that the FiberLase Endure CO2 Fiber is as safe and effective as the cleared predicate device.
Key Metrics
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
ENIS®
510(K) SUMMARY
MAR 2 4 2013
ነ
FiberLase Endure CO2 Fiber 510(k) Number K 130 1 64
| Applicant's Name: | Lumenis Ltd. |
|---|---|
| 13 Hayetzira Street | |
| Yokneam Industrial Park | |
| Yokneam 20692 Israel | |
| Tel. (972)4-959-9000 | |
| Fax: (972)4-959-9050 | |
| Contact Person: | Yoram Levy, Qsite |
| 31 Haavoda St. | |
| Binyamina, Israel 30500 | |
| Tel (972)4-638-8837 | |
| Fax (972)4-638-0510 | |
| Yoram@qsitemed.com | |
| Trade Name: | FiberLase Endure CO2 Fiber |
| Device Type: | CO2 Laser fiber |
| Preparation Date: | January 20, 2013 |
| Classification: | Regulatory Name: Laser surgical instrument for use in general and |
| plastic surgery and in dermatology | |
| Product Code: GEX | |
| Regulation No: 21 CFR 878.4810 | |
| Class: II | |
| Classification Panel: General & Plastic Surgery |
Device Description:
: 上一篇:
1
Image /page/1/Picture/0 description: The image shows the word "LUMENIS" in a bold, sans-serif font. The "L" is stylized with a circle around it. There is a small "c" in a circle to the right of the word, indicating a copyright or trademark symbol.
The FiberLase Endure CO2 Fiber is a hollow, semi rigid, lightconducting delivery fiber, 2 meter length, designed to transmit laser energy from the CO2 laser system to the treatment site. The fiber also transmits a low power red diode or helium neon laser aiming beam to assist in targeting the tissue to be treated.
Intended Use Statement:
The FiberLase Endure CO2 Fiber is intended for use in surgical procedures requiring ablation, vaporization, excision, incision and coagulation of soft tissue. The FiberLase Endure CO2 Fiber is indicated for use in open surgical procedures such as ENT surgery and laparoscopy and endoscopic procedures.
Predicate Devices:
Substantial equivalence to the following predicate device is claimed:
| Device Name | 510k No | Date of Clearance |
|---|---|---|
| FiberLase CO2 Laser WaveGuide | K100384 | April 12, 2010 |
Performance Standards
FiberLase Endure CO2 Fiber was tested and complies with the following standards:
- ANSI/AAMI/ISO 11135-1:2007 Sterilization of health care products . - Ethylene oxide
- AAMI TIR30:2001 Product adoption and process equivalency for . ethylene oxide sterilization
- ISO 14971-1:2007 Risk management for medical devices .
- IEC 60601-2-22 ed3.0:2007 Medical Electrical Equipment Part 2-. 22: Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment.
- IEC 60825-1:2007 Safety of Laser Products Part 1: Equipment . Classification. Requirements and User's Guide
- · ANSI/AAMI/ISO 17665-1:2006 Sterilization of health care products - Moist Heat.
FiberLase ENDURE CO2 Fiber - 510k Notification
2
તાલુ
A detailed description follows in Section 14.
Performance Testing
Performance testing demonstrated that the FiberLase Endure CO2 Fiber is as safe and effective as the cleared predicate device.
Comparison with the Predicate Devices
The FiberLase Endure CO2 Fiber is a modification to its predicate device, the FDA-cleared Lumenis Fiberlase CO2 laser WaveGuide (K100384).
The intended use of the FiberLase Endure CO2 Fiber is identical to the intended use of its predicate.
Both the FiberLase Endure CO2 Fiber and the Lumenis Fiberlase CO2 laser WaveGuide systems are fibers that transmit laser energy from the laser system to the treatment site. Both devices are comprised of a laser connector and a 2 meter long delivery fiber.
The structures, the materials and the dimensions of the FiberLase Endure CO2 Fiber are identical to the cleared Lumenis Fiberlase CO2 laser WaveGuide fiber.
The minor difference between the FiberLase Endure CO2 Fiber System and its predicate device is an addition of an Autoclave sterilization method for reprocessing the fiber instead of single use ETO. The minor differences do not raise any new questions of safety or efficacy. Moreover, performance testing demonstrated that the FiberLase Endure CO2 Fiber is as safe and effective as the predicate device. Thus, the FiberLase Endure CO2 Fiber is substantially equivalent to Lumenis FiberLase CO2 Laser WaveGuide (K100384).
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Lumenis, Limited % Osite Mr. Yoram Levy General Manager 31 Haavoda Street Binyamina, Israel 30500
March 24, 2012
Re: K130164
Trade/Device Name: FiberLase Endure CO2 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: March 06. 2013 Received: March 11, 2013
Dear Mr. Levy:
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. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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
4
LUMENIS
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K130164
Device Name:
FiberLase Endure C02 Fiber
Indications for Use:
The FiberLase Endure C02 Fiber is intended for use in surgical procedures requiring ablation, vaporization, excision, incision and coagulation of soft tissue. FiberLase Endure C02 Fiber is indicated for use in open surgical procedures such as ENT surgery and laparoscopy and endoscopic procedures.
Prescription Use: × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use: _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Neil R Ogden==================================================================================================================================================================
(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number _K130164
l of l FiberLase ENDURE C02 Fiber - 5/0k Notification