(17 days)
Not Found
No
The summary describes a laser fiber accessory with a sensor for obstruction detection, but there is no mention of AI or ML for data processing, analysis, or decision-making.
Yes
The device is indicated for medical procedures such as incision, excision, ablation, vaporization, and coagulation of body soft tissues, which are therapeutic interventions.
No
Explanation: The device is an accessory for CO2 laser systems used for incision, excision, ablation, vaporization, and coagulation of soft tissues, which are therapeutic rather than diagnostic actions. While it has a sensor, its purpose is to detect debris obstruction of the lens, not to diagnose a patient's condition.
No
The device description clearly states it is a fiber assembly with physical components like an optical fiber, lens, and sensor, which are hardware.
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.
- Device Function: The OmniGuide Zero Flow ZF-T WaveGuide Fiber is a surgical accessory used to deliver CO2 laser energy for cutting, excising, ablating, vaporizing, and coagulating soft tissues within the body. It is used during surgical procedures.
- Intended Use: The intended use clearly describes surgical procedures on body tissues, not the analysis of samples taken from the body.
- Device Description: The description focuses on the physical components and how it transmits laser energy, not on analyzing biological samples.
Therefore, the device's function and intended use fall under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
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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 Floor
Cambridge, MA 02139 |
|-------------------------------|-----------------------------------------------------------------------------------------|
| Contact Person:
Telephone: | Douglas W. Woodruff
617-551-8404 |
| 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 plastic
surgery and in dermatology. |
Substantial Equivalence Claimed To:
K063141, OmniGuide ZeroFlow ZF-T 150 WaveGuide Fiber
K992472, SureGuide CO2 Laser Beam Delivery System
1
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.
2
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
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, 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
5
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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