(37 days)
The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile 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.
The OmniGuide OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile 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 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 a 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 stainless steel tip that is used as a continuation of the waveguide, which enhances visualization in tight areas.
The provided 510(k) summary for the OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile Tip indicates that formal clinical trials were not deemed necessary. Instead, the device's performance was evaluated through non-clinical testing and comparison to predicate devices, claiming substantial equivalence.
Therefore, many of the specific questions about clinical study design, sample sizes, expert involvement, and ground truth establishment cannot be answered from this document as such a study was not conducted.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Laser Power Output | Evaluated through testing |
| Beam Quality | Evaluated through testing |
| Energy Transmission Levels | Similar or equivalent to predicate devices |
| Intended Use | Similar or equivalent to predicate devices |
| Major Performance Parameters | Similar or equivalent to predicate devices |
Explanation of "Inferred" Acceptance Criteria: The document states that performance characteristics were evaluated through "testing and analysis of laser power output and beam quality." It also mentions "energy transmission levels and beam quality" as major performance parameters that are "similar or equivalent to the characteristics of above mentioned legally marketed devices." This implies that the acceptance criteria for these parameters were met if they were found to be comparable to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. Formal clinical trials or test sets with human data were not conducted. The evaluation was based on non-clinical performance data (testing) and comparison to predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth for a clinical test set was not established as no such test set was used.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set was used that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. No clinical study, MRMC or otherwise, was conducted.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical medical instrument (laser fiber), not an algorithm or AI. The performance evaluation was for the physical characteristics of the device.
7. Type of Ground Truth Used
The "ground truth" for the device's performance was established through non-clinical performance testing (laser power output and beam quality) and comparison to the characteristics and intended use of legally marketed predicate devices. No pathology, expert consensus, or outcomes data from a clinical setting were used as ground truth for this submission.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set or its associated ground truth establishment.
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Image /page/0/Picture/0 description: The image shows a sequence of handwritten characters, specifically "K073313". The characters are written in a simple, slightly irregular style, giving them a hand-drawn appearance. The numbers are easily readable, and the letter K is distinct from the numbers.
JAN 0 2 2007
510(k) Summary
| Submitter: | OmniGuide, Inc.One Kendall Square, Building 100 3rd FloorCambridge, MA 02139 |
|---|---|
| Contact Person:Telephone: | Douglas W. Woodruff617-551-8404 |
| Fax: | 617-551-8445 |
| Proprietary Name: | OmniGuide Beam Path CO2 Mark III WaveGuide Fiberwith Low Profile Tip |
| Common Name: | CO2 Laser Powered Surgical Instrument |
| Classification: | 878.4810 |
| Product Code: | GEX |
| Classification Name: | Laser surgical instrument for use in general and plasticsurgery and in dermatology. |
Substantial Equivalence Claimed To:
OmniGuide
K050541, OmniGuide Beam Path CO2 Mark I Laser Beam Delivery System K070157, OmniGuide Beam Path CO2 Mark III WaveGuide Fiber
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Description:
The OmniGuide OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile 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 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 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 a 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 stainless steel tip that is used as a continuation of the waveguide, which enhances visualization in tight areas.
Performance Data:
Non-clinical Performance Data: The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile 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 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.
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 Tip are similar or equivalent to the characteristics of above mentioned legally marketed devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OmniGuide, Inc. % Regulatory Technology Services Mr. Mark Job 1394 25th Street, NW Buffalo, MN 55313
JAN - 2 2008
Re: K073313
Trade/Device Name: OmniGuide Beam Path CO2 Mark III WageGuide Fiber With Low Profile Tip 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 15, 2007 Received: December 17, 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 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.
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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) 276-0120. 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 Millhusan
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Not yet assigned
Device Name: OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile Tip
Indications For Use:
The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile 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.
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)
FOR M.NEAKERSON
and Neurologica
510(k) Number K073313
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Page 13
§ 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.