(15 days)
The OmniGuide Mark III WaveGuide Fiber 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 Beam Path CO2 Mark III WaveGuide Fiber is an accessory for CO2 laser systems. It consists of a flexible fiber assembly that delivers CO2 laser energy that enables minimally invasive surgery. The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber 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. The fiber assembly is 1 to 2 m long and transmits at the CO2 laser emission wavelength of 10.6 um.
The provided text describes the OmniGuide Beam Path CO2 Mark III WaveGuide Fiber, but it does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria.
Instead, it states that:
- Clinical Performance Data: "Formal clinical trials were not deemed necessary as the device is using the same technology and intended use as predicate device."
- Non-clinical Performance Data: "The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber 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 and related parameters of predicate device are comparable."
- Conclusion: "The intended use and major performance parameters (energy transmission levels and beam quality) of the OmniGuide Beam Path CO2 Mark III WaveGuide Fiber are similar or equivalent to the characteristics of above mentioned legally marketed device."
Based on this, I cannot fill out the requested table or provide details about a study proving specific acceptance criteria. The device's approval appears to be based on substantial equivalence to a predicate device (K050541), rather than meeting predefined acceptance criteria through a specific study with a test set, ground truth, or expert review.
Therefore, many of the requested fields cannot be answered from the provided text.
Here's an attempt to answer the questions based only on the provided information, highlighting what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from study) | Reported Device Performance (from study) |
|---|---|
| Not specified. | "laser power output and beam quality" |
| Not specified. | "energy transmission levels" |
| Not specified. | "beam quality" |
| Not specified. | Performance is "similar or equivalent to the characteristics of above mentioned legally marketed device." |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not applicable/Not provided. The document states "Formal clinical trials were not deemed necessary." Non-clinical testing focused on device characteristics and comparability to a predicate.
- Data provenance: Not applicable/Not provided in the context of a "test set" for a clinical study. The non-clinical data would be laboratory-generated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. No clinical "test set" requiring ground truth establishment by experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No clinical "test set" requiring adjudication is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a medical device (CO2 laser fiber), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not provided, as no clinical study with a "ground truth" is described. The performance evaluation was primarily non-clinical, comparing technical specifications to a predicate.
8. The sample size for the training set
- Not applicable/Not provided. No machine learning training set is mentioned.
9. How the ground truth for the training set was established
- Not applicable/Not provided. No machine learning training set or ground truth establishment is mentioned.
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FEB - 1 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 Fiber |
| 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:
11
K050541, OmniGuide Beam Path CO2 Mark I Laser Beam Delivery System
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Description:
The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber is an accessory for CO2 laser systems. It consists of a flexible fiber assembly that delivers CO2 laser energy that enables minimally invasive surgery. The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber is supplied sterile and is intended for single procedure use in conjunction with the OmniGuide Laser Adapter.
Intended Use:
The OmniGuide Mark III WaveGuide Fiber 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. The fiber assembly is 1 to 2 m long and transmits at the CO2 laser emission wavelength of 10.6 um.
Performance Data:
Non-clinical Performance Data: The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber 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 and 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 (energy transmission levels and beam quality) of the OmniGuide Beam Path CO2 Mark III WaveGuide Fiber are similar or equivalent to the characteristics of above mentioned legally marketed device.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" in a circular arrangement.
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
FEB - 1 2007
Re: K070157
Trade/Device Name: OmniGuide Beam Path CO2 Mark III WaveGuide Fiber 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: January 15, 2007 Received: January 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
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Page 2 - Mr. Mark Job
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic fordi in the quality systems (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) This ictici witi anow you to begin matically of substantial equivalence of your device to a legally premaired 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 rr you desire specific at notialiance at (240) 276-0115. Also, please note the regulation entitled, Contact the Ories of Court Court Court (21CFR Part 807.97). You may obtain Wholfanding of reference to presence to presensibilities under the Act from the Division of Small other Echerers, 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. 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
Indications For Use:
The OmniGuide Mark III WaveGuide Fiber 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) |
|---|
| -------------------------------------------------------- |
Division of General, Restoratings 1 of __1__1 and Neurological Devices
510(k) Number 11070157
Page 14
§ 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.