(17 days)
The OmniGuide Zero Flow ZF-T 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 Zero Flow ZF-T WaveGuide fiber is an accessory for CO2 laser systems. It consists of a fiber assembly that propagates CO2 laser beams and vents the cooling gases outside of the body. The OmniGuide ZF-T wave guide fiber is supplied sterile and is intended for single procedure use.
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 incorporates a lens at the tip which is transparent to the laser beam. The fiber also incorporates a sensor on the fiber tip that allows physicians to determine when the lens becomes obstructed by debris. The fiber assembly is 1 to 2 m long and transmits at the CO2 laser emission wavelength of 10.6 um.
Here's an analysis of the provided text regarding the OmniGuide Zero Flow ZF-T WaveGuide Fiber, focusing on acceptance criteria and study information.
It's important to note that this 510(k) summary does not contain the level of detail typically found in a clinical study report for AI/machine learning devices. The information provided is for a traditional medical device (a fiber for CO2 laser systems) and therefore, many of the requested data points (like sample size for test sets, number of experts, MRMC studies, training set details) are simply not applicable or not present.
Description of the Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria
The OmniGuide Zero Flow ZF-T WaveGuide Fiber is an accessory for CO2 laser systems. Its acceptance criteria are primarily related to its physical performance characteristics, specifically its ability to transmit CO2 laser energy effectively and maintain beam quality, demonstrating substantial equivalence to predicate devices. The study conducted was non-clinical in nature.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Laser Power Output: Comparable to predicate devices. | Evaluated through testing and analysis; deemed comparable to predicate devices. |
| Beam Quality: Comparable to predicate devices. | Evaluated through testing and analysis; deemed comparable to predicate devices. |
| Safety and Effectiveness: No new issues raised compared to predicate devices. | Evaluation and testing completed did not raise any new issues of safety and effectiveness. |
| Intended Use: Similar to predicate devices. | Intended use is similar/equivalent to legally marketed predicate devices. |
| Technological Characteristics: Similar to predicate devices. | Device uses similar technology as predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. This was a non-clinical, bench-top performance study, not a clinical trial with human subjects. Thus, "test set" in the context of clinical data or AI systems is not applicable.
- Data Provenance: Not applicable. The data is from laboratory testing of the device itself, not from patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this type of device (laser fiber performance) is established through technical specifications and physical measurements, not expert consensus interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies to the reconciliation of expert opinions on clinical data, which was not part of this submission.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices where human interpretation is a key component, which is not the case for this laser fiber.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical instrument for laser delivery, not an algorithm or an AI system.
7. The type of ground truth used
The "ground truth" for this device's performance is based on engineering specifications and direct physical measurements of laser power output and beam quality. This aligns with the "non-clinical performance data" described.
8. The sample size for the training set
Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable, for the same reasons as point 8.
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Image /page/0/Picture/1 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 a double-lined circle. The text is positioned to the right of the circle, creating a visually balanced design. The logo is contained within a rectangular border.
JAN 2 5 2007 1
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 Zero Flow ZF-T 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:
K063141, OmniGuide ZeroFlow ZF-T 150 WaveGuide Fiber
K992472, SureGuide CO2 Laser Beam Delivery System
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Description:
The OmniGuide Zero Flow ZF-T WaveGuide fiber is an accessory for CO2 laser systems. It consists of a fiber assembly that propagates CO2 laser beams and vents the cooling gases outside of the body. The OmniGuide ZF-T wave guide fiber is supplied sterile and is intended for single procedure use.
Intended Use:
The OmniGuide Zero Flow ZF-T 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 incorporates a lens at the tip which is transparent to the laser beam. The fiber also incorporates a sensor on the fiber tip that allows physicians to determine when the lens becomes obstructed by debris. 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 Zero Flow ZF-T 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 Zero Flow ZF-T WaveGuide Fiber and related parameters of predicate devices are comparable.
Clinical Performance Data: Formal clinical trials were not deemed necessary as the device is using the similar technology and intended use as predicate devices.
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Conclusions Drawn from Tests and Analysis:
The intended use and major performance parameters (energy transmission levels and beam quality) of the OmniGuide Zero Flow ZF-T WaveGuide Fiber are similar or equivalent to same characteristics of above mentioned legally marketed devices. The evaluation and testing completed by OmniGuide did not raise any new issues of safety and effectiveness.
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three horizontal lines below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the eagle.
ood 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
Received: January 8, 2007
JAN 2 5 2007
Re: K070071
:
Trade/Device Name: OmniGuide Zero Flow ZF-T 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 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
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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 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, 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 Office of Compliance at (240) 276-0115. Also, please note (24 - 21 re are very), proc "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
For
Mark N. Mallonee
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
Not yet assigned 510(k) Number (if known):
Device Name:
OmniGuide Zero Flow ZF-T WaveGuide Fiber
Indications for Use:
The OmniGuide Zero Flow ZF-T 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) | 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,
Page 1 of
510(k) Number-
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§ 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.