(35 days)
Not Found
No
The device description focuses on mechanical components and their function in guiding a fiber optic cable for surgical procedures. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies are based on bench testing and comparison to predicate devices, not on algorithmic performance metrics.
Yes
The device is indicated for medical procedures such as incision, excision, ablation, vaporization, and coagulation of body soft tissues, which are therapeutic actions.
No
The device is indicated for surgical procedures (incision, excision, ablation, vaporization, and coagulation) of soft tissues, which are treatment functions, and does not mention any diagnostic capabilities.
No
The device description explicitly details physical components like a handle, sealing cap, fiber gripper, lumen, and sterilization tray, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The OmniGuide BeamPath® Fiber Optic HandPiece System is a surgical tool used directly on body soft tissues during surgical procedures. It facilitates the use of a laser fiber for cutting, removing, or modifying tissue within the body.
- Intended Use: The intended use clearly describes surgical procedures performed on the patient's body, not the analysis of specimens taken from the body.
Therefore, the device's function and intended use fall under the category of a surgical instrument used for direct intervention on the patient, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The OmniGuide BeamPath® Fiber Optic HandPiece System and Sterilization Tray is indicated for use in conjunction with OmniGuide's waveguide fibers to enable the surgeon to perform 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The OmniGuide BeamPath® Fiber Optic HandPiece System and Sterilization Tray is indicated for use in conjunction with OmniGuide's waveguide fibers.
The objectives of the hand-piece are to enable precision control and to stabilize surgeon hand motion. The waveguide fiber is inserted through the proximal end of the hand-piece and fixated so that it is observed at the hand-piece's distal tip. The surgeon wields the hand-piece as a pencil, and advances the hand-piece so that its distal tip is in close proximity to the target tissue to exert the desired effect of the waveguide fiber: incision. excision, ablation, vaporization and coagulation. The surgeon may use the hand-piece distal tip in either non-contact mode or contact mode, and may use the distal tip to enable tissue manipulation.
The sterilization tray is purchased from SYMMETRY MEDICAL USA INC. and sold as a storage and sterilization tray for use with the OmniGuide Fiber Optic Handpieces,
The handpieces consist of a handle and sealing cap consisting of either SS or aluminum, a silicone rubber fiber gripper and a lumen to guide the fiber made of SS hypodermic tubing. The handle/lumen are welded or adhesive bonded to for the unit. Lumen may be bent or straight to facilitate the aiming of the fiber. The tip is may be beveled or straight to improve the fiber visibility, fiber tip protection and blunt dissection.
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
surgeon
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: OmniGuide BeamPath® Fiber Optic HandPiece System and Sterilization Tray performance characteristics have been evaluated through testing and bench top testing. The handpieces are used to allow the physician to manipulate the flexible fiber through a surgical endoscope. The performance of the OmniGuide BeamPath® Fiber Optic HandPiece and similar related parameters of predicate device are comparable.
Clinical Performance Data: Formal clinical trials were not deemed necessary as the device is using the same technology and intended use as predicate device.
Conclusions Drawn from Tests and Analysis: The intended use and major performance parameters of the OmniGuide BeamPath® Fiber Optic HandPiece System and Sterilization Tray are similar or equivalent to the characteristics of above mentioned legally marketed device. The sterilization tray used is the identified predicated device.
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
081939
1 =4 3 รุ
AUG 1 2 2008
Image /page/0/Picture/3 description: The image shows the logo for OmniGuide. The logo consists of the word "OmniGuide" in a sans-serif font, with the first letter "O" being stylized as two concentric circles. The word "OmniGuide" is placed in the center of the circles.
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 BeamPath® Fiber Optic HandPiece System and
Sterilization Tray |
| 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:
K952006, ACCU-Beam Fiber Optic Handpeice K040223 PolyVac Surgical Instrument Delivery System
1
N 16081939
Description:
The OmniGuide BeamPath® Fiber Optic HandPiece System and Sterilization Tray is indicated for use in conjunction with OmniGuide's waveguide fibers.
The objectives of the hand-piece are to enable precision control and to stabilize surgeon hand motion. The waveguide fiber is inserted through the proximal end of the hand-piece and fixated so that it is observed at the hand-piece's distal tip. The surgeon wields the hand-piece as a pencil, and advances the hand-piece so that its distal tip is in close proximity to the target tissue to exert the desired effect of the waveguide fiber: incision. excision, ablation, vaporization and coagulation. The surgeon may use the hand-piece distal tip in either non-contact mode or contact mode, and may use the distal tip to enable tissue manipulation.
The sterilization tray is purchased from SYMMETRY MEDICAL USA INC. and sold as a storage and sterilization tray for use with the OmniGuide Fiber Optic Handpieces,
Intended Use:
The OmniGuide BeamPath® Fiber Optic HandPiece System and Sterilization Tray is indicated for use in conjunction with OmniGuide's waveguide fibers to enable the surgeon to perform 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.
Summary of Technological Characteristics:
The handpieces consist of a handle and sealing cap consisting of either SS or aluminum, a silicone rubber fiber gripper and a lumen to guide the fiber made of SS hypodermic tubing. The handle/lumen are welded or adhesive bonded to for the unit. Lumen may be bent or straight to facilitate the aiming of the fiber. The tip is may be beveled or straight to improve the fiber visibility, fiber tip protection and blunt dissection.
Performance Data:
Non-clinical Performance Data: OmniGuide BeamPath® Fiber Optic HandPiece System and Sterilization Tray performance characteristics have been evaluated through testing and bench top testing. The handpieces are used to allow the physician to manipulate the flexible fiber through a surgical endoscope . The performance of the OmniGuide BeamPath® Fiber Optic HandPiece and similar related parameters of predicate device are comparable.
Clinical Performance Data: Formal clinical trials were not deemed necessary as the device is using the same technology and intended use as predicate device.
Conclusions Drawn from Tests and Analysis: The intended use and major performance parameters of the OmniGuide BeamPath® Fiber Optic HandPiece System and
2
K - 319 - 319 11
Sterilization Tray are similar or equivalent to the characteristics of above mentioned legally marketed device. The sterilization tray used is the identified predicated device.
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 eagle or bird-like symbol with three overlapping, curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. The text is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 2008
Omniguide, Inc. % Regulatory Technology Services, Inc. Mr. Mark Job 1394 25th Street, Northwest Buffalo, Minnesota 55313
Re: K081939
Trade/Device Name: OmniGuide BeamPath® Fiber Optic HandPiece System and Steril 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 26 2008 Received: July 28, 2008
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 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.
4
Page 2 Mr. Mark Job
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance 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 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 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 yours,
Mark N. Milburn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
- 1.4
1
Indications for Use
510(k) Number (if known): Not yet assigned
Device Name: OmniGuide BeamPath® Fiber Optic HandPiece System and Sterilization Tray
Indications For Use:
The OmniGuide BeamPath® Fiber Optic HandPiece System and Sterilization Tray is indicated for use in conjunction with OmniGuide's waveguide fibers to enable the surgeon to perform 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.
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)
Mark A. Millenson
sion Sign-Of and Neurological
510(k) Number
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