(164 days)
Not Found
No
The description focuses on the mechanical and electrical functions of the device (laser waveguide holder, suction, bipolar cautery) and does not mention any computational or learning capabilities.
Yes.
The device is used for electrosurgical coagulation, incision, excision, ablation, vaporization, and fluid suction on soft body tissues, all of which are considered therapeutic actions aimed at treating or alleviating medical conditions.
No
The device is described as a surgical instrument for electrosurgical coagulation, suction, incision, excision, ablation, and vaporization of soft body tissues. Its purpose is therapeutic (to treat conditions), not diagnostic (to identify or analyze conditions).
No
The device description clearly outlines a physical, handheld surgical instrument with components for fluid suction, bipolar cautery, and laser energy delivery via a fiber. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the electrosurgical coagulation of soft body tissues, suction of fluids, and when used with a laser waveguide, for incision, excision, ablation, vaporization, and coagulation of soft body tissues. These are all surgical procedures performed on the body, not on samples taken from the body for diagnostic purposes.
- Device Description: The description details a surgical handpiece used for delivering laser energy, providing suction, and performing bipolar cautery. It's a tool for performing surgical interventions.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
- Surgical Setting: The device is intended for use by licensed surgeons in open surgical procedures in a hospital or office setting. This is consistent with a surgical device, not a diagnostic one.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not perform any of these functions on biological samples.
N/A
Intended Use / Indications for Use
The OmniGuide® TRIO™ handpiece is indicated for the electrosurgical coagulation of soft body tissues and suction of fluids in general and ENT surgical procedures for the specialties of General Surgery, Head and Neck Surgery, Otolaryngology, and Oral surgery (including intra-oral tissues). When used with the OmniGuide® Laser waveguide, it is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues for the added specialties of Dermatology, Neurosurgery, Orthopedic Surgery, Plastic & Reconstructive Surgery, Podiatry and Urology.
Product codes (comma separated list FDA assigned to the subject device)
GEX, GEI
Device Description
The TRIO™ handpiece is a handheld single use device designed to act as a laser waveguide guide/holder for previously cleared waveguides. The TRIO™ handpiece combines three fundamental surgical instrument functions into one lightweight and compact handheld disposable surgical instrument. If enables a surgeon to provide fluid suction, bipolar cautery, and CO2 laser energy without the necessity of changing instruments, saving surgical time for both physician and patient and a corresponding reduction in cost. Laser energy is delivered via a flexible OmniGuide® fiber for minimally invasive surgery.
The instrument is provided sterile and is intended for single use only. The package has an accelerated shelf life of two years.
The sterile package includes a cable to connect the handpiece to an electrosurgical generator. The cables are generic in nature and several varieties available at a hospital/ office will function. The package also includes a small brush for cleaning coagulation tips with adhered material. The TRIO™ handpiece is intended to be used only with the family of OmniGuide® CO2 Laser fibers including Velocity™, Elite™ and Select™ fibers previously cleared in 510(k) K070157.
The OmniGuide® handpiece is intended for use by licensed surgeons only for open surgical procedures listed in the indications for use. The objective of the handpiece is to enable precision control and to stabilize surgeon hand motion. The waveguide fiber is inserted through the proximal end of the handpiece and fixated so that it is observed at the handpiece's distal tip. The surgeon wields the handpiece as a pencil and advances the handpiece so that its distal tip is near the target tissue to exert the desired effect of the waveguide fiber: suction and coagulation. The surgeon may use the handpiece distal tip in either non-contact mode or contact mode and may use the distal tip to enable tissue manipulation, electrosurgical portion is used for coagulation due to bleeding during laser surgery or tissue manipulation.
The TRIO™ handpiece can be used with any Electro-Surgical Unit (ESU) with output power of up to 750 peak to peak voltage (Vp-p) and footswitch actuation. The instrument is provided with a 12-foot bipolar cable with fixed leads. The TRIO™ handpiece instrument can be used with any hospital or office suction apparatus. Fluid aspiration is controlled via a suction control port on the handle of the instrument.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft body tissues, intra-oral tissues.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Licensed surgeons only for open surgical procedures / hospital or office
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)
Safety and effectiveness of TRIO™ handpiece was established to be the same as the predicate devices and other similar devices on the market by performance testing. The ability of the handpiece was tested by performing user validation and bench-top testing such as beam clipping, suction, fiber retention, reliability, mechanical robustness and thermal profile.
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.
K081939, K962396/K960009, K965241/K900533
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font, also in blue. The logo is simple and professional, and it is easily recognizable.
OmniGuide, Inc. Samuel Wade VP, Quality Assurance/Regulatory Affairs 4 Maguire Road Lexington, Massachusetts 02412
May 2, 2019
Re: K183199
Trade/Device Name: TRIO Handpiece Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology Regulatory Class: Class II Product Code: GEX, GEI Dated: April 18, 2019 Received: April 19, 2019
Dear Samuel Wade:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Jennifer Stevenson, Acting Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K183199
Device Name TRIO™ handpiece
Indications for Use (Describe)
The OmniGuide® TRIO™ handpiece is indicated for the electrosurgical coagulation of soft body tissues and suction of fluids in general and ENT surgical procedures for the specialties of General Surgery, Head and Neck Surgery, Otolaryngology, and Oral surgery (including intra-oral tissues). When used with the OmniGuide® Laser waveguide, it is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues for the added specialties of Dermatology, Neurosurgery, Orthopedic Surgery, Plastic & Reconstructive Surgery, Podiatry and Urology.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Attachment 1 Premarket Submission: OmniGuide TRIO" handpiece
Confidential and Proprietary Information
SECTION 7: 510(K) SUMMARY
General Provisions:
| 510(k) Owner's Name: | OmniGuide®, Inc. |
|---|---|
| Address: | 4 Maguire Road |
| Lexington, | |
| MA 02421, USA | |
| Contact Person | Samuel D Wade, Vice President of Quality Assurance and Regulatory |
| Affairs | |
| Phone Number: | (617) 551-8410 |
| Cell: (978) 844-7515 | |
| Fax Number: | (617) 551-8445 |
| Classification Name: | Powered Laser Surgical Instrument (21 CFR §878.4810 Laser surgical |
| instrument for use in general and plastic surgery and in dermatology, | |
| Product Code GEX/ 21 CFR §878.4400 Electrosurgical cutting and | |
| coagulation device and accessories, Product code GEI) | |
| Proprietary Name: | OmniGuide® TRIO™ handpiece (Proposed name) |
| Common Name: | Powered Laser Surgical Instrument |
Name of Predicate Devices:
- . OmniGuide® BeamPath® Fiber Optic handpiece (Product Code: GEX, 510(k) Number: K081939)
- . Karl Storz Endoscopy - America. Inc., Briner Bipolar Coagulation Suction Cannula (Product code: EOB, 510(k) Number: K962396/K960009)1
- Kirwan Surgical Products, Inc., Kirwan Bipolar Coagulation Forceps (Product code: GEI, 510(k) ● Number: K965241/K900533)2
Indications for Use:
The OmniGuide® TRIOTM handpiece is indicated for the electrosurgical coagulation of soft body tissues and suction of fluids in general and ENT surgical procedures for the specialties of General Surgery, Head and Neck Surgery, Otolaryngology, and Oral surgery (including intraoral tissues). When used with the OmniGuide® BeamPath® Laser waveguide, it is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues for the added specialties of Dermatology, Gynecology, Neurosurgery, Orthopedic Surgery, Plastic & Reconstructive Surgery, Podiatry and Urology.
1 Both 510(k) Numbers are included as we could not find the complete Summaries on the FDA releasable 510(k) database or FOI records
2 Both 510(k) Numbers are included as we could not find the 510(k) Summary for K900533 on the FDA release or FOI records
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Attachment 1 Premarket Submission: OmniGuide TRIO" handpiece
Confidential and Proprietary Information
Device Description:
The TRIO™ handpiece is a handheld single use device designed to act as a laser waveguide guide/holder for previously cleared waveguides. The TRIO™ handpiece combines three fundamental surgical instrument functions into one lightweight and compact handheld disposable surgical instrument. If enables a surgeon to provide fluid suction, bipolar cautery, and CO2 laser energy without the necessity of changing instruments, saving surgical time for both physician and patient and a corresponding reduction in cost. Laser energy is delivered via a flexible OmniGuide® fiber for minimally invasive surgery.
The instrument is provided sterile and is intended for single use only. The package has an accelerated shelf life of two years.
The sterile package includes a cable to connect the handpiece to an electrosurgical generator. The cables are generic in nature and several varieties available at a hospital/ office will function. The package also includes a small brush for cleaning coagulation tips with adhered material. The TRIO™ handpiece is intended to be used only with the family of OmniGuide® CO2 Laser fibers including Velocity™, Elite™ and Select™ fibers previously cleared in 510(k) K070157.
The OmniGuide® handpiece is intended for use by licensed surgeons only for open surgical procedures listed in the indications for use. The objective of the handpiece is to enable precision control and to stabilize surgeon hand motion. The waveguide fiber is inserted through the proximal end of the handpiece and fixated so that it is observed at the handpiece's distal tip. The surgeon wields the handpiece as a pencil and advances the handpiece so that its distal tip is near the target tissue to exert the desired effect of the waveguide fiber: suction and coagulation. The surgeon may use the handpiece distal tip in either non-contact mode or contact mode and may use the distal tip to enable tissue manipulation, electrosurgical portion is used for coagulation due to bleeding during laser surgery or tissue manipulation.
The TRIO™ handpiece can be used with any Electro-Surgical Unit (ESU) with output power of up to 750 peak to peak voltage (Vp-p) and footswitch actuation. The instrument is provided with a 12-foot bipolar cable with fixed leads. The TRIO™ handpiece instrument can be used with any hospital or office suction apparatus. Fluid aspiration is controlled via a suction control port on the handle of the instrument.
Image /page/4/Figure/9 description: The image shows four boxes with text and arrows pointing to different parts of a device. The first box reads "CO2 laser energy delivered at the distal tip", and an arrow points to the lower left. The second box reads "Hole for suction control", and an arrow points down. The third box reads "Channel for OmniGuide® laser fiber", and an arrow points down. The fourth box reads "Proximal end of the Handpiece for fiber", and an arrow points down and to the right. The text "Section 7:510(k) Summary" and "7-2" are also visible.
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Attachment 1 Premarket Submission: OmniGuide TRIO" handpiece
Confidential and Proprietary Information
Image /page/5/Picture/3 description: The image shows a medical device with a white handle and a blue tip. The device has a long, slender body that curves slightly at the end. The handle is wider and has several ports for connecting to other equipment. The device is labeled with the words "OmniGuide Surgical".
Figure 1: OmniGuide® TRIO™ Handpiece
Technological Characteristics:
The OmniGuide® TRIO™ handpiece has similar technological characteristics of the Briner Bipolar Coagulation Suction Cannula (K962396/K960009) and the Kirwan Bipolar Coagulation Forceps (K965241/K900533).
All use an electrosurgical generator to supply RF to the electrodes are similar in terms of dimensions and location at the distal end of the device. All three devices are designed to be handheld and use the same operating principles for electrocautery by bringing the electrodes into contact with the tissue.
BRINER and TRIO™ devices use wall suction through a 3/8" tube attached to the unit. Suction is performed by bringing the tip into contact with the fluid in the surgical field. Suction is controlled by closing or opening an aperture in the handle.
The TRIO™ is similar in function to the OmniGuide® BeamPath® fiber optic handpiece (K081939) in that both are used to facilitate delivery of laser energy through a previously cleared fiber optic waveguide (K140378 OmniGuide® Laser System with FlexGuide Ultra) allowing the surgeon to hold the waveguide and direct laser energy from the tip of the waveguide to the tissue. Both handpieces do not generate laser energy, they merely act as a support and guide the laser fiber to the surgical field.
The OmniGuide® TRIO™ handpiece system differs from the OmniGuide® BeamPath® fiber optic handpiece (K081939) in the use of construction materials. The TRIO™ is manufactured with materials suitable for disposable devices while the OmniGuide® BeamPath® fiber optic handpiece is constructed of stainless steel to allow for resterilization and multiple uses.
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Confidential and Proprietary Information
The TRIO™ handpiece differs from the Karl Storz Briner device and the Kirwan Bipolar Coagulation Forceps in the use of different construction materials and slightly different design characteristics, such as length, outer diameter of the cannula and geometry of the handle.
Electrical Safety and Electromagnetic Compatibility and other standard testing:
Evaluation of the device was conducted by an independent testing laboratory (Intertek) and was to be found in compliance with:
- . IEC 60601-1, Medical electrical equipment, Part 1 General requirements for basic safety and essential performance
- . IEC 60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances --Requirements and tests
- IEC 62366 Medical devices- Application of usability engineering to medical devices
- IEC 14971:2007/(R) 2010 Medical Devices- Application of Risk Management to Medical . Devices
- IEC 60601-1 Medical Electrical Equipment, Part 1-6 General requirement for Safety: Collateral ● Standard Usability
Performance Testing Summary:
Safety and effectiveness of TRIO™ handpiece was established to be the same as the predicate devices and other similar devices on the market by performance testing. The ability of the handpiece was tested by performing user validation and bench-top testing such as beam clipping, suction, fiber retention, reliability, mechanical robustness and thermal profile.
Sterilization:
Sterilization Validation was performed which was successful and acceptable. It met the protocol and requirements specified in ISO 11135:2014.
Biocompatibility:
The following list of tests were performed to establish biocompatibility:
- Cytotoxicity: MEM Elution Test Serum MEM Extract in conformance with ISO 10993-5:2009 . (Recognition Number 2-153), Biological evaluation of medical devices – Part 5: Tests for invitro cytotoxicity.
- ISO 10993-10:2010 Sensitization: Guinea Pig Maximization Test, Saline and Vegetable Oil Extracts ●
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Attachment 1 Premarket Submission: OmniGuide TRIO" handpiece
Confidential and Proprietary Information
- ISO 10993-10:2002 (Recognition Number 2-87) Irritation: Intracutaneous Reactivity Test, Saline . and Vegetable Oil Extracts
- . ISO 10993-11:2006 (Recognition Number 2-118) Acute Systemic Toxicity: Systemic Injection Test, Saline and Vegetable Oil Extracts
The patient-contacting materials in the OmniGuide® TRIO™ handpiece passed these tests.
Packaging and Labeling:
The OmniGuide® TRIO™ handpiece is a sterile, single use only, prescription device, in a thermoformed tray along with a suitable cable to allow attachment to the handpiece and electrosurgical generator and the tray is heat sealed to a Tyvek lid. The tray with the Instructions for Use are inserted into a cardboard box imprinted with product information and labeling. The Package has a proposed shelf life of two vears.
Conclusion:
The OmniGuide® TRIO™ Handpiece is as safe and effective as its predicates. The new device has similar intended use and indications for use, technological characteristics and principle of operation as the predicate devices. The differences in the indications for use do not alter the intended surgical use of the device and do not affect the safety or efficacy when used as labeled. The minor design differences raise no new issues of safety or efficacy. Thus, the OmniGuide® TRIO™ Handpiece and its predicates are substantially equivalent.