(13 days)
No
The summary describes a laser beam delivery system with no mention of AI or ML capabilities, image processing, or data-driven performance metrics.
Yes
The device is indicated for the incision, excision, ablation, vaporization, and coagulation of body soft tissues for surgical and aesthetic applications, which are therapeutic actions.
No
The device is described as a CO2 laser beam delivery system for incision, excision, ablation, vaporization, and coagulation, indicating a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly outlines physical components such as a laser adapter, fiber cable, optical fiber handpiece, cooling devices, and a movable cart, indicating it is a hardware-based system.
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 the "incision, excision, ablation, vaporization and coagulation of body soft tissues." This describes a surgical tool used directly on the patient's body.
- Device Description: The description details a laser beam delivery system that transmits a CO2 laser beam for surgical procedures. It involves a handpiece used to direct the laser onto tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical instrument used for therapeutic purposes directly on the patient.
N/A
Intended Use / Indications for Use
The Highland Beam Delivery System is intended for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues.
The indications for use for which the delivery system is used are dependent upon the cleared indications for use of the laser system and those laser system accessories to which it is attached.
The OmniGuide's Highland Beam Delivery System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral / maxillofacial surgery, dentistry, dermatology, endoscopic surgical procedures related to gynecology, otorhinolaryngology, neurosurgery, gastroenterology, and pulmonary surgery for surgical and aesthetic applications. The indications for use for which the device is used are also dependant upon the cleared indications for use of the laser system and the laser system accessories to which it is attached.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Highland Beam Delivery System is the CO2 laser beam delivery system that can be retrofitted to Luxar LX-20 or Lumenis NovaPulse CO2 laser. It consists of a laser adapter with a fiber cable and optical fiber handpiece that propagate CO2 laser beam, cooling devices for fiber cable and movable cart that houses all system components.
The optical fiber handpiece consists of optical fiber integrated with a handpiece. It is supplied sterile and is intended for single procedure use. The laser adapter and fiber cable are re-usable devices that transmit CO2 laser radiation from the laser to the fiber assembly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body soft tissues including intraoral tissues
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)
Non-clinical Performance Data: The Highland Beam Delivery System performance characteristics have been evaluated through bench testing and analysis of laser power output and beam quality. This type of testing complies with the respective section of the FDA Guidance on the Content and Organization of a Premarket Notification for a Medical Laser (1995) and IEC 60601-1 and 2 and is similar to the predicate device tests. The performance of the Highland Beam Delivery System and related parameters of predicate devices (as specified in comparison table) are comparable. The materials of optical fiber handpiece have passed biocompatibility testing as performed by an independent laboratory in accordance with ISO 10993-1:2003 Standards. Clinical Performance Data: Formal clinical trials were not deemed necessary as the device has the same core technology and intended use as predicate devices. The market surveillance of previously cleared OmniGuide device (K050541) that is using the same core fiber technology and has the same intended use and tissue interaction mechanism indicated that the devices performed as intended.
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.
K992472, K014048, K924664, K921671, K896478, K031440, K963189
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 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.
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Image /page/0/Picture/1 description: The image shows the word "OmniGuide" in a sans-serif font. The text is positioned inside of a double-lined circle. The text is centered horizontally, but slightly above the vertical center of the circle.
JUL 1 9 2006
510(k) Summary
| Submitter: | OmniGuide Inc.
One Kendall Square, Building 100 3rd Floor
Cambridge, MA 02139 |
|-------------------------------|-----------------------------------------------------------------------------------------|
| Contact Person:
Telephone: | Irina Kulinets
617-551-8404 |
| Fax: | 617-551-8445 |
| Proprietary Name: | Highland Beam Delivery System |
| 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 SureGuide CO2 Laser Beam Delivery System. K014048 Clinicon Universal WaveGuide Handpiece and Fiber Tips K924664 Surgilase Fiberlase CO2 Laserwave Guide K921671 Surgilase Fiberlase V CO2 Laser Waveguide K896478 Luxar LX-20 Minilase CO2 Surgical Laser K031440 Cynosure Smart CO2 Medical Laser System K963189 ERBE APC 300 Argon Plasma Coagulator
K050541 OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System
1
Description:
The Highland Beam Delivery System is the CO2 laser beam delivery system that can be retrofitted to Luxar LX-20 or Lumenis NovaPulse CO2 laser. It consists of a laser adapter with a fiber cable and optical fiber handpiece that propagate CO2 laser beam, cooling devices for fiber cable and movable cart that houses all system components.
The optical fiber handpiece consists of optical fiber integrated with a handpiece. It is supplied sterile and is intended for single procedure use. The laser adapter and fiber cable are re-usable devices that transmit CO2 laser radiation from the laser to the fiber assembly.
Intended Use:
The Highland Beam Delivery System is intended for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues
The indications for use for which the delivery system is used are dependent upon the cleared indications for use of the laser system and those laser system accessories to which it is attached.
Summary of Technological Characteristics:
The device consists of the optical fiber handpiece, the laser adapter with fiber cable for connecting the fiber assembly to the laser and the unit regulating the amount of cooling gas entering the fiber core and providing the liquid coolant for fiber cable cooling. The system components are mounted on the movable cart. The main functional component of the optical fiber handpiece and fiber cable is a photonic bandgap optical fiber. Its hollow core contains highly reflective lining and it thereby guides CO2 laser energy. The optical fiber handpiece and fiber cable connected together are about 2.1 m long and transmit at the CO2 laser emission wavelength of 10.6 um. To maintain high transmission power capacity and reliability of multiple use fiber cable, it is actively cooled by recirculated liquid coolant supplied by recirculating chiller.
Performance Data:
Non-clinical Performance Data: The Highland Beam Delivery System performance characteristics have been evaluated through bench testing and analysis of laser power output and beam quality. This type of testing complies with the respective section of the FDA Guidance on the Content and Organization of a Premarket Notification for a Medical Laser (1995) and IEC 60601-1 and 2 and is similar to the predicate device tests. The performance of the Highland Beam Delivery System and related parameters of predicate devices (as specified in comparison table) are comparable. The materials of optical fiber handpiece have passed biocompatibility testing as performed by an independent laboratory in accordance with ISO 10993-1:2003 Standards. Clinical Performance Data: Formal clinical trials were not deemed necessary as the device has the same core technology and intended use as predicate devices. The market surveillance of previously cleared OmniGuide device (K050541) that is using the same core fiber technology and has the same intended use and tissue interaction mechanism indicated that the devices performed as intended.
2
Conclusions Drawn from Tests and Analysis:
The current version of the device does not present any differences in the delivery, quality and / or control of laser beam and does not change the interaction between the laser beam and human tissue. The only differences presented in this submission in comparison to OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System previously cleared via K050541 are improvements in the device reliability and convenience for use, introduced by utilization of actively cooled fiber cable and better controlled cooling methods for fiber.
The intended use and major performance parameters (energy transmission levels and beam quality) of the Highland Beam Delivery System are similar or equivalent to same characteristics of above mentioned legally marketed devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 9 2006
OmniGuide, Inc. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street NW Buffalo, Minnesota 55313
Re: K061909
Trade/Device Name: Highland Beam Delivery System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: July 3, 2006 Received: July 6, 2006
Dear Mr. Job:
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
4
Page 2 - Mr. Mark Job
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sincerely yours,
Barbara Buchur
Mark N. Mellersen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): 1x 06 | 909
Device Name: _ Highland Beam Delivery System
Indications for Use:
The OmniGuide's Highland Beam Delivery System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral / maxillofacial surgery, dentistry, dermatology, endoscopic surgical procedures related to gynecology, otorhinolaryngology, neurosurgery, gastroenterology, and pulmonary surgery for surgical and aesthetic applications. The indications for use for which the device is used are also dependant upon the cleared indications for use of the laser system and the laser system accessories to which it is attached.
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ambare Buchm
leral Restault Pa and Neurological Devices
Page 1 of 1
510(k) Number K061909