(90 days)
Not Found
No
The device description focuses on the physical components and function of a laser beam delivery system, with no mention of AI or ML technologies.
No
The device is described as an accessory for CO2 laser systems, designed to deliver laser energy with minimal degradation, rather than directly providing a therapeutic effect. Its therapeutic use is dependent on the connected laser system and accessories.
No
The device is described as an accessory for CO2 laser systems, designed to deliver laser energy, not to diagnose medical conditions.
No
The device description explicitly details physical components: a laser system interface adapter and a fiber cable assembly made of hollow silica fiber with connectors. This indicates a hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver laser energy for therapeutic purposes, not to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device is a laser beam delivery system, an accessory for CO2 laser systems used in medical procedures. It does not involve the analysis of biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Diagnostic purposes
- Measurement of analytes
- Use in a laboratory setting for diagnostic testing
The device is clearly intended for use in medical procedures involving the application of laser energy to the body, which falls under the category of therapeutic or surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The intended use of the Clinicon WaveGuide Platform is to deliver carbon dioxide laser energy from a CO2 laser source to a CO2 laser accessory, with minimal beam degradation. The waveguide platform can be used with various manufacturers' CO2 lasers and laser accessories, including Clinicon accessories. The specific indications are dependent upon the cleared indications for use of the laser system and laser accessories to which the waveguide platform is attached.
The Clinicon Interconnect enables Luxar accessories that are designed to be used with the standard Luxar cables to be connected with the Clinicon WaveGuide Platform.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Clinicon WaveGuide Platform (K992472, SureGuide CO2 Laser Beam Delivery System now marketed as Clinicon WaveGuide Platform) is an accessory for CO2 laser systems. Its two primary components are a laser system interface adapter and a fiber cable assembly consisting of a hollow silica fiber having an internal coating that reflects and propagates CO2 laser energy and a flexible protective outer cover.
The WaveGuide CO2 Fiber Cable has FSMA 905 series fiber optic connectors on each end and may be used with CO2 laser systems that provide such connectors between the laser system and various beam delivery accessories.
The Clinicon Interconnect (Distal Adapter) is an accessory to the WaveGuide Platform that duplicates the termination end & laser beam characteristics of the Standard Luxar Fiber. This allows Luxar accessories to be attached to the WaveGuide Platform and used in the same manner.
The Clinicon WaveGuide Platform is an accessory for CQ2 laser systems. Its two primary components are a turret adapter and a fiber cable assembly. A secondary component is the Interconnect accessory.
The fiber cable assembly consist of a hollow silica fiber with an internal coating that reflects and propagates the CO2 laser energy and a flexible protective outer covering. The fiber cable has a fiber optic connector on each end and may be used with CO2 laser systems that provide such connectors between the laser system and various beam delivery accessories. The fiber cable is available in various standard lengths between 0.5 m and 3.0 m, and functions over the wavelength range of 9 - 11 um.
The Turret Adapter is the interface between the fiber cable and the CO2 laser system, and houses a focusing lens to align the beam from the CO2 laser system into the waveguide.
The Interconnect duplicates the distal termination end and laser beam characteristics of the Standard Luxar Cables. The Clinicon Interconnect contains a segment of the same coherent waveguide used throughout the Clinicon Waveguide Platform. Uniquely in the Interconnect, however, this waveguide segment is held in a manner that "scrambles" the spatial coherence of the input laser beam, so that the output laser beam is spatially incoherent. The particular distortion has been chosen so that the Clinicon Fiber Cable with the Clinicon Interconnect has the same beam divergence and multimode character as does the output of the Luxar Fiber [cable]. This allows Luxar accessories to be used with the Clinicon Fiber Cable plus Clinicon Interconnect.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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 Clinicon Corporation. The logo consists of a stylized "C" shape on the left, followed by the word "Clinicon" in a blocky font. To the right of "Clinicon" is the word "CORPORATION" in a similar font. Below the logo is the address "5825 AVENIDA ENCINAS" followed by "CARLSBAD, CA 92008".
K014236
510(k) Summary
| Submitter: | Clinicon Corporation
5825 Avenida Encinas
Carlsbad, CA 92008 |
|----------------------|-----------------------------------------------------------------------------------------|
| Contact person: | Sean M. Curry
16787 Bernardo Center Drive, Suite A
San Diego, CA 92128 |
| Phone: | (858) 675-8200 |
| FAX: | (858) 675-8201 |
| Proprietary name: | Clinicon WaveGuide Platform with Interconnect for Luxar
Accessories |
| Common name: | CO2 Laser Powered Surgical Instrument |
| Classification: | 878.4810 |
| Product Code: | GEX |
| Classification name: | Laser surgical instrument for use in general and plastic surgery and
in dermatology. |
Substantial equivalence claimed to:
K992472, Clinicon's SureGuide CO2 Laser Beam Delivery System K960475, Modified Luxar LX-20
Description:
The Clinicon WaveGuide Platform (K992472, SureGuide CO2 Laser Beam Delivery System now marketed as Clinicon WaveGuide Platform) is an accessory for CO2 laser systems. Its two primary components are a laser system interface adapter and a fiber cable assembly consisting of a hollow silica fiber having an internal coating that reflects and propagates CO2 laser energy and a flexible protective outer cover.
The WaveGuide CO2 Fiber Cable has FSMA 905 series fiber optic connectors on each end and may be used with CO2 laser systems that provide such connectors between the laser system and various beam delivery accessories.
The Clinicon Interconnect (Distal Adapter) is an accessory to the WaveGuide Platform that duplicates the termination end & laser beam characteristics of the Standard Luxar
1
Fiber. This allows Luxar accessories to be attached to the WaveGuide Platform and used in the same manner.
Intended use:
The intended use of the Clinicon WaveGuide Platform is to deliver carbon dioxide laser energy from a CO2 laser source to a CO2 laser accessory, with minimal beam degradation. The waveguide platform can be used with various manufacturers' CO2 lasers and laser accessories, including Clinicon accessories. The specific indications are dependent upon the cleared indications for use of the laser system and laser accessories to which the waveguide platform is attached.
The Clinicon Interconnect (Distal Adapter) enables Luxar accessories that are designed to be used with the standard Luxar fiber cables to be connected with the Clinicon WaveGuide Platform.
Summary of technological characteristics:
The Clinicon WaveGuide Platform is an accessory for CQ2 laser systems. Its two primary components are a turret adapter and a fiber cable assembly. A secondary component is the Interconnect accessory.
The fiber cable assembly consist of a hollow silica fiber with an internal coating that reflects and propagates the CO2 laser energy and a flexible protective outer covering. The fiber cable has a fiber optic connector on each end and may be used with CO2 laser systems that provide such connectors between the laser system and various beam delivery accessories. The fiber cable is available in various standard lengths between 0.5 m and 3.0 m, and functions over the wavelength range of 9 - 11 um.
The Turret Adapter is the interface between the fiber cable and the CO2 laser system, and houses a focusing lens to align the beam from the CO2 laser system into the waveguide.
The Interconnect duplicates the distal termination end and laser beam characteristics of the Standard Luxar Cables. The Clinicon Interconnect contains a segment of the same coherent waveguide used throughout the Clinicon Waveguide Platform. Uniquely in the Interconnect, however, this waveguide segment is held in a manner that "scrambles" the spatial coherence of the input laser beam, so that the output laser beam is spatially incoherent. The particular distortion has been chosen so that the Clinicon Fiber Cable with the Clinicon Interconnect has the same beam divergence and multimode character as does the output of the Luxar Fiber [cable]. This allows Luxar accessories to be used with the Clinicon Fiber Cable plus Clinicon Interconnect.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 6 2002
Clinicon Corporation c/o Mr. Sean Curry Certified Software Solutions, Inc. 16787 Bernardo Center Drive, Suite A San Diego, CA 92128
Re: K014236
Trade/Device Name: Clinicon WaveGuide Platform with Interconnect for Luxar Accessories
Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: II Product Code: GEX Dated: December 21, 2001 Received: December 26, 2001
Dear Mr. Curry:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 - Mr, Sean Curry
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ogen maineng of substantial equivalence of your device to a legally premarket notincation. The PDF maining of castination for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and IT you desire specific advice to: your avitro diagnostic devices), please contact the Office of additionally 21 CFR Fall 807.10 for in This Chapters on the promotion and advertising of Compliance at (301) 594 1037. The newslangy, liance at (301) 594-4639. Also, please note the your dones, prease vollaborading by reference to premarket notification" (21CFR Part 807.97). regulation chititied, "Misoranaing of esponsibilities under the Act may be obtained from the Other general information on your respectional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KO14236 510(k) Number (if known):
Device Name:
Indications for Use:
The intended use of the Clinicon WaveGuide Platform is to deliver carbon dioxide laser The meendou ase of the ennoource to a CO2 laser accessory, with minimal beam degradation. The waveguide platform can be used with various manufacturers' CO2 dogradulton. - The Waves, including Clinicon accessories. The specific indications are dependent upon the cleared indications for use of the laser system and laser accessories to which the waveguide platform is attached.
The Clinicon Interconnect enables Luxar accessories that are designed to be used with the standard Luxar cables to be connected with the Clinicon WaveGuide Platform.
Miriam C. Provost
ion Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number K014236
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-the-Counter Use