(10 days)
No
The 510(k) summary describes a sterile adapter system for connecting a CO2 laser to fibers. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on laser power output and beam quality, not algorithmic performance.
Yes
The device is described as being used for the "incision, excision, ablation, vaporization and coagulation of body soft tissues," which are therapeutic procedures.
No
The device is indicated for surgical procedures (incision, excision, ablation, vaporization, and coagulation of body soft tissues), not for diagnosis.
No
The device description clearly outlines physical components (adapter, hose, filter) that connect a laser to fibers, requiring sterilization and performance testing related to laser power and beam quality. This indicates a hardware-based medical device, not software-only.
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 Function: The OmniGuide Sterile WaveGuide Adapter System is a surgical accessory that connects a CO2 laser to fibers for the direct incision, excision, ablation, vaporization, and coagulation of body soft tissues. It is used during surgical procedures to physically alter tissue.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. Its function is to deliver laser energy for surgical intervention.
Therefore, the device's intended use and description clearly indicate it is a surgical tool, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OmniGuide Sterile WaveGuide Adapter System 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 Sterile WaveGuide Adapter System connects a hospitals CO2 laser to the OmniGuide WaveGuide Fibers. The additional filter and autoclave sterilization of the adapter and hose allows for use in sterile surgical procedures.
The output tube and gas hose will be sold non-sterile and the hospital will autoclave sterilize. The filter element may be provided as a gamma sterilized device (high Pressure option) or as a non sterile device for autoclave sterilization. The low pressure filter may be autoclave sterilized or provided sterile at the end users request. See section S for sterilization validation activites.
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 Sterile WaveGuide Adapter System 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 the OmniGuide Sterile WaveGuide Adapter System and the related parameters of the predicate device is 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 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
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:
DEC 1 4 2007
K073409
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 Sterile WaveGuide Adapter 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:
K062423, OmniGuide Beam Delivery System
1
Description:
Intended Use:
The OmniGuide Sterile WaveGuide Adapter System 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 OmniGuide Sterile WaveGuide Adapter System connects a hospitals CO2 laser to the OmniGuide WaveGuide Fibers. The additional filter and autoclave sterilization of the adapter and hose allows for use in sterile surgical procedures.
The output tube and gas hose will be sold non-sterile and the hospital will autoclave sterilize. The filter element may be provided as a gamma sterilized device (high Pressure option) or as a non sterile device for autoclave sterilization. The low pressure filter may be autoclave sterilized or provided sterile at the end users request. See section S for sterilization validation activites.
Performance Data:
Non-clinical Performance Data:
The OmniGuide Sterile WaveGuide Adapter System 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 the OmniGuide Sterile WaveGuide Adapter System and the related parameters of the predicate device is 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 device.
2
Conclusions Drawn from Tests and Analysis:
The intended use and major performance parameters (energy transmission levels and beam quality) of the OmniGuide Sterile WaveGuide Adapter System are similar or equivalent to the characteristics of above mentioned legally marketed devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Public Health Service
DEC 1 4 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OmniGuide, Inc. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, Northwest Buffalo, Minnesota 55313
Re: K073409
Trade/Device Name: OmniGuide Sterile WaveGuide Adapter 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: December 3, 2007 Received: December 4, 2007
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, permitts 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliary, at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events, (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistances of 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 yours.
Mark N. Mulhearn
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): Not yet assigned
Device Name: OmniGuide Sterile WaveGuide Adapter System
Indications For Use:
The OmniGuide Sterile WaveGuide Adapter System 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, 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) | X |
|---|---|
| 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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| Page | 1 of 1 |
|---|---|
| 510(k) Number | 1073469 |
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