(15 days)
Not Found
No
The summary describes a laser fiber accessory for delivering CO2 laser energy and does not mention any AI or ML components or functionalities.
Yes.
The device is used for incision, excision, ablation, vaporization, and coagulation of body soft tissues, which are therapeutic medical procedures.
No
Explanation: The device is indicated for surgical procedures like incision, excision, ablation, vaporization, and coagulation, which are therapeutic actions, not diagnostic ones.
No
The device description clearly states it is a "flexible fiber assembly" and a "metal tip," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this device is an accessory for CO2 laser systems used for surgical procedures (incision, excision, ablation, vaporization, and coagulation of body soft tissues). It delivers laser energy directly to the tissue during surgery.
- Lack of Sample Analysis: There is no mention of this device analyzing any biological samples taken from the patient. Its function is to deliver energy for surgical manipulation of tissue in situ.
Therefore, the OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy.
The indications for use for which the delivery system is used for are dependent upon the cleared indications for use of the laser system and those laser system accessories to which it is attached.
Product codes
GEX
Device Description
The OmniGuide OmniGuide BeamPath CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip is an accessory for CO2 laser systems. It consists of a flexible fiber assembly that delivers CO2 laser energy that enables minimally invasive surgery. OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss metal tip is supplied sterile and is intended for single procedure use in conjunction with the OmniGuide Laser Adapter.
The device consists of an optical fiber assembly. The main functional component of the fiber assembly is a photonic bandgap reflector lining its hollow core that reflects and thereby guides CO2 laser energy and an internally coated, stainless steel waveguide distal tip. The fiber assembly is 1 to 2 m long and transmits at the CO2 laser emission wavelength of 10.6 um. The fiber has 14 mm long, internally coated, stainless steel tip that is coated internally and acts as an efficient continuation of the waveguide. The new tip configuration reduces tip heating allowing the fiber to be used in continuous wave mode without heating the tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body soft tissues including intra-oral 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
Non-clinical Performance Data: The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile /Low Loss Tip performance characteristics have been evaluated through 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 is similar to the predicate device tests. The performance of OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip and the related parameters of the predicate devices are comparable.
Clinical Performance Data: Formal clinical trials were not deemed necessary as the device is using the same technology and intended use as the predicate devices.
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.
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1093451
Image /page/0/Picture/1 description: The image shows the logo for OmniGuide. The logo consists of two concentric circles, with the word "OmniGuide" written in a sans-serif font across the center of the circles. The text is black, and the circles are also black.
NOV 2 0 2009
510(k) Summary
| Submitter: | OmniGuide, Inc.
One Kendall Square, Building 100 3rd Floor
Cambridge, MA 02139 |
|-------------------------------|-----------------------------------------------------------------------------------------|
| Contact Person:
Telephone: | Douglas W. Woodruff
617-551-8404 |
| Fax: | 617-551-8445 |
| Proprietary Name: | OmniGuide Beam Path CO2 Mark III WaveGuide Fiber
with Low Profile/Low Loss Tip |
| 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:
K070157, OmniGuide Beam Path CO2 Mark III WaveGuide Fiber K073313, OmniGuide BeamPath CO2 Mark III WaveGuide Fiber With Low Profile Tip
1
Description :
The OmniGuide OmniGuide BeamPath CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip is an accessory for CO2 laser systems. It consists of a flexible fiber assembly that delivers CO2 laser energy that enables minimally invasive surgery. OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss metal tip is supplied sterile and is intended for single procedure use in conjunction with the OmniGuide Laser Adapter.
Intended Use:
The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy.
The indications for use for which the delivery system is used for 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 an optical fiber assembly. The main functional component of the fiber assembly is a photonic bandgap reflector lining its hollow core that reflects and thereby guides CO2 laser energy and an internally coated, stainless steel waveguide distal tip. The fiber assembly is 1 to 2 m long and transmits at the CO2 laser emission wavelength of 10.6 um. The fiber has 14 mm long, internally coated, stainless steel tip that is coated internally and acts as an efficient continuation of the waveguide. The new tip configuration reduces tip heating allowing the fiber to be used in continuous wave mode without heating the tip.
Performance Data:
Non-clinical Performance Data: The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile /Low Loss Tip performance characteristics have been evaluated through 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 is similar to the predicate device tests. The performance of OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip and the related parameters of the predicate devices are comparable.
Clinical Performance Data: Formal clinical trials were not deemed necessary as the device is using the same technology and intended use as the predicate devices.
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Image /page/2/Picture/0 description: The image shows a black and white graphic of what appears to be a water droplet. The droplet is connected to a larger, irregular black shape on the left side of the image. The droplet is round and smooth, while the shape on the left is jagged and uneven.
Conclusions Drawn from Tests and Analysis: The intended use and major performance parameters (energy transmission levels and beam quality) of the OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip are similar or equivalent to the characteristics of above mentioned legally marketed devices.
3
Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or bird-like figure, with its wings spread, symbolizing the department's mission related to health and human welfare.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
OmniGuide, Inc. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street NW Buffalo, Minnesota 55313
Re: K093451
Trade/Device Name: OmniGuide BeamPath CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip 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: November 4, 2009 Received: November 5, 2009
NOV 2 0 2009
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 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
4
Page 2 - Mr. Mark Job
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours.
Sincerely yours,
Mark N. Mcllhinney
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): Not yet assigned
Device Name: OmniGuide BeamPath CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip
Indications For Use:
The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical snecialti os of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatlogy, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endosconic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy.
The indications for use for which the delivery system is used for are dependent upon the cleared indications for use of the laser system and those 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)
Neilheblen for mta
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number K093451
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