(28 days)
Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm – 2200nm have received regulatory clearance.
Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers devices are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adapters
Omni-Guide Holding, Inc. OmniGuide Prima Surgical Laser Fibers are individually packed sterile devices indicated to provide high quality surgical laser fiber optic delivery systems for laser surgery. The Fibers are intended for use in laser surgical procedures including, but not limited to open, laparoscopic, or endoscopic ablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue application for which compatible lasers are applicable. Product description, length, laser wavelength compatibility can be found in Section 15 of this 510(k) Premarket Notification. The key components of this system are the SMA-905, SMA-906 with RFID and Manufacturer's specific RFID connectors and the Fiber Optic, these fibers may be used in a variety of laser-based surgical cases. Per [807.92(a)(4)].
The provided text describes the OmniGuide RFID Surgical Laser Fibers and seeks to establish substantial equivalence to a predicate device, the OmniGuide LISA Laser Family of Surgical Laser Fibers (K220189). The document outlines various performance tests and compliance with recognized standards.
However, it's crucial to understand that this document describes a 510(k) submission, which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This is different from a typical clinical study with a detailed description of acceptance criteria, statistical analysis, and ground truth establishment you might expect for a novel AI device.
Let's break down the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present acceptance criteria in the traditional sense of numerical thresholds for a specific clinical outcome for the new device itself. Instead, it outlines a comparison between the subject device (OmniGuide Prima Surgical Laser Fibers) and the predicate device (OmniGuide LISA Laser Surgical Fibers) to demonstrate substantial equivalence. The "acceptance criteria" here are essentially that the new device performs as well as or similarly to the predicate device across various technical and safety characteristics.
| Characteristic | Acceptance Criteria (Demonstrated Equivalence to Predicate) | Reported Device Performance (Subject Device - OmniGuide Prima Surgical Laser Fibers) |
|---|---|---|
| Indications for Use | Same as predicate, covering all surgical specialties with compatible laser systems (500nm - 2200nm) and use with SMA 905/906 or manufacturer-specific connectors. | Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm - 2200nm have received regulatory clearance. Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers devices are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adapters. (Same/Equivalent) |
| Intended Use | Same as predicate. | Provision of high quality surgical laser fiber optic delivery systems for laser surgery, including ablation, coagulation, incision, excision, or vaporizing in any soft/hard-tissue application. (Same/Equivalent) |
| Regulatory Information | Product Code (GEX), Regulation Number (21 CFR 878.4810), Regulation Name (Laser surgical instrument for use in general and plastic surgery and in dermatology) must be the same. | GEX, 21 CFR 878.4810, Laser surgical instrument for use in general and plastic surgery and in dermatology. (Same/Equivalent) |
| Technological Characteristics | Components, Wavelength Compatibility (High OH or Low OH silica material w/low attenuation between 532nm - 2100nm), Numerical Aperture (between 0.22 - 0.48), Fiber Distal Tip configurations, compatibility with attachments (core diameters suitable to user needs), Connectors, Fiber Construction, Peak/Continuous Wavelengths, Power Ranges, Diameter, Compatibility with surgical laser systems must be the same/equivalent. | Components (Connector configurations suitable to multiple laser platforms), High OH or Low OH silica material w/low attenuation of light wavelengths between 532nm - 2100nm, Fiber having a Numerical Aperture (NA) between 0.22 - 0.48, Multiple configurations of distal tips offered, Core diameters are offered in a range of sizes suitable to user needs, SMA 905/906/manufacturer specific connectors, Fiber Construction (Core - Fused Silica, Clad - Fused Silica or Fluoropolymer Hard Cladding, Buffer - Fluoropolymer Hard Cladding or Silicone Acrylate, Jacket - Nylon, Polyimide, or Teflon), Peak and Continuous Wave lengths (500nm-2200nm), Power Ranges (1-300 Watts), Diameter (Core diameters offered in a range of sizes), Fiber Distal Tip (Multiple configurations), Compatibility with surgical laser systems (Fibers compatible with any cleared laser system with appropriate connection system). (All listed as Same/Equivalent) |
| Sterilization Technique | Same as predicate (EtO). | EtO (Ethylene Oxide). (Same/Equivalent) |
| Performance Characteristics | Demonstrate comparable performance (e.g., Power & Energy input/output, homogeneity of output light, high-power testing, bend radius, pull testing). | Bench testing (Section 21) included: Power & Energy input versus output, Homogeneity of output light (spot check, beam profile), High-power testing, Bend radius testing, Pull testing. Feature-specific testing conducted to demonstrate equivalence, including safety, performance, integrity, stability, transport, and label integrity. Specific tests mentioned: Performance test of Prima 150/1000/Sidefire laser fiber on RevoLix HTL; Test of mechanical stability of Prima 150/1000/550 micron laser fiber. Additional feature testing referenced from predicate K220189: Scatter Free Fiber, Expanded transmission of laser wavelength/energy, distal tip configuration, Nav Tip ability to traverse deflected endoscope. (Results indicated device performs in accordance with requirements and specifications, in similarity to predicate, not raising new safety or efficacy risks/questions). |
| Biocompatibility & Other Safety | Demonstrate biocompatibility and compliance with relevant safety standards (e.g., ISO 10993 series, ISO 14971). | Compliance with ISO 10993-1, 10993-5, 10993-7, 10993-10, 10993-11, ISO 14971, ASTM F56-13, ASTM F619-14. (All standards listed as complied with.) |
| Packaging & Shelf-Life | Demonstrate comparable packaging integrity and shelf-life through testing (e.g., ISO 11607-1, ASTM D4169, ASTM F88-09, ASTM F2096-11, ASTM F1980-07, ISTA Project 2A). | Compliance with ISO 11607-1, ASTM D4169, ASTM F88-09, ASTM F2096-11, ASTM F1980-07, ISTA Project 2A. (All standards listed as complied with.) |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "bench testing" and "performance testing" rather than a clinical test set with human subjects.
- Sample Size: The exact sample size for each specific bench test (e.g., how many fibers were subjected to pull testing) is not explicitly stated in the provided text. It generally refers to "the subject device" and "the predicate device."
- Data Provenance: The testing appears to be retrospective in the sense that it's evaluating a product against established benchmarks and a predicate device. The testing was conducted by or for Omni-Guide Holdings, Inc. (the device manufacturer) and its contract manufacturer, LightGuide Optics International Ltd. No specific country of origin for the data is mentioned beyond this, but given the company's address is in Massachusetts, USA, and the FDA submission, the testing would generally align with US regulatory context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable in the context of this 510(k) submission. For devices like laser fibers, "ground truth" is typically established through engineering specifications, material science properties, and performance standards, not through expert clinical consensus as would be the case for an AI diagnostic tool.
4. Adjudication Method for the Test Set:
This is not applicable. The evaluation of laser fiber performance is based on physical measurements, technical specifications, and adherence to engineering standards, not on subjective interpretations requiring an adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI devices that assist human readers in tasks like image interpretation. This document describes a medical device (laser fibers), not an AI diagnostic or assistance tool. The study focuses on the physical and performance equivalence of the laser fibers themselves.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical surgical tool (laser fiber), not an algorithm or software. It requires a human operator (surgeon) to use it with a laser system.
7. The Type of Ground Truth Used:
The "ground truth" for evaluating these laser fibers is based on engineering specifications, material science properties, and compliance with recognized industry standards. This includes:
- Documented chemical and physical properties of materials (silica, fluoropolymer, etc.).
- Performance measures like power output, beam homogeneity, bend radius tolerance, and pull strength, measured against design specifications.
- Compliance with various ISO and ASTM standards for sterilization, packaging, biocompatibility, and risk management.
- Comparison data from the predicate device (OmniGuide LISA Laser Surgical Fibers, K220189), which serves as a benchmark for "safe and effective" performance.
8. The Sample Size for the Training Set:
The concept of a "training set" is not applicable here. This device development does not involve machine learning or AI models that require training data.
9. How the Ground Truth for the Training Set was Established:
Not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 21, 2023
Omni-Guide Holdings, Inc. Carlos Acosta Global Director Regulatory Affairs & Ouality Assurance 43 Manning Road Billerica, Massachusetts 01821
Re: K230819
Trade/Device Name: OmniGuide RFID Surgical Laser Fibers 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 Dated: March 17, 2023 Received: March 24, 2023
Dear Carlos Acosta:
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
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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the name "Jianting Wang -S" in a large, sans-serif font. The text is black and appears to be centered. The background is a light blue color, with a faint watermark-like design.
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230819
Device Name OmniGuide PRIMA Surgical Laser fibers
Indications for Use (Describe)
Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500mm - 2200mm have received regulatory clearance.
Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers are intended for use with any cleared surgical laser with an SMA 905 connector, or manufacturer specific connectors and adapters.
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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Image /page/3/Picture/0 description: The image shows three logos. The first logo is for "OmniGuide Surgical", the second logo is for "Domain Surgical an OmniGuide Company", and the third logo is for "LISA Laser Products an OmniGuide Company". All three logos have a similar design, with the company name in gray text surrounded by a blue circle.
008_510(k)_Summary
| Classification Name | Common Name | Trade Name/Proprietary Name |
|---|---|---|
| Part 878 General and Plastic Surgery21 CFR §874.4680 | Laser Instrument, Surgical | OmniGuide Prima Surgical Laser Fibers |
This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of Omni Guide knowledge.
Omni-Guide Holdings, Inc. is submitting this 510(k) of equivalent OmniGuide Prima Surgical Laser Fibers equivalent to our predicate devices, LISA Laser Surgical Fibers and cleared under Omni-Guide Holdings, Inc. own 510(k) K220189. LightGuide Optics International Ltd., is our Contract Manufacturer (CMO), a CMO of equivalent fibers (reference FDA Establishment Registration & Device Listing ID# 3012669557: - Powered Laser Surgical Instrument - Slimline Endo Fibers; Slimline Endo SIS Fibers; Slimline EZ SIS Fiber; Slimline Fibers; Slimline GI SIS Fiber; Slimline SIS Fibers). The manufacturing process of OmniGuide Prima Surgical Laser Fibers and sterilization are the same process to current FDA fibers manufactured by LGO, as well as the predicate device LISA Laser Surgical Fibers.
OmniGuide Prima Family of Surgical Laser Fibers and the Primary Predicate Device, share the same intended use, indication for use, human factors, design, performance, materials, manufacturing, mechanical safety, biocompatibility, sterilization. There minor difference in the technological characteristics do not raise any questions of safety or performance data demonstrates the OmniGuide are as safe and effective as the listed predicate. OmniGuide Prima Surgical Laser Fibers are substantially equivalent to its predicate device.
| Submitter: | Omni-Guide Holdings, Inc.43 Manning DriveBillerica, MA 01821 |
|---|---|
| Contact: | Carlos O. AcostaPhone: 617-551-4400 Ext. 563Fax: 888-490-6020 |
| Date ofPreparation: | February 22, 2023 |
| Type of 510(k)Submission: | Special |
| DeviceIdentification: | Device Name and Classification 807.92(a)(2):Trade Name: OmniGuide Prima Surgical Laser FibersClassification Name: Laser surgical instrument for use in general and plastic surgery and indermatology |
| RegulatoryClass: | II |
| Product Code: | GEX |
| PanelClassification | General and Plastic Surgery (21 CFR §878.4810) |
| PredicateDevice: | Primary Predicate Device:OmniGuide LISA Laser Family of Surgical Laser FibersDelivery Device 510(k) = K220189 |
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Image /page/4/Picture/0 description: The image shows three logos. The first logo is for "OmniGuide Surgical", the second logo is for "Domain Surgical an OmniGuide Company", and the third logo is for "LISA Laser Products an OmniGuide Company". All three logos have a similar design, with the company name in gray text and a blue circle around the name.
| DeviceDescription: | Omni-Guide Holding, Inc. OmniGuide Prima Surgical Laser Fibers are individually packed sterile devices indicated to provide high qualitysurgical laser fiber optic delivery systems for laser surgery. The Fibers are intended for use in laser surgical procedures including, but notlimited to open, laparoscopic, or endoscopic ablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue applicationfor which compatible lasers are applicable. Product description, length, laser wavelength compatibility can be found in Section 15 of this510(k) Premarket Notification. The key components of this system are the SMA-905, SMA-906 with RFID and Manufacturer's specificRFID connectors and the Fiber Optic, these fibers may be used in a variety of laser-based surgical cases. Per [807.92(a)(4)]. | |||
|---|---|---|---|---|
| IntendedUse:IndicationsFor Use: | Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers are indicated for use in all surgical specialties in whichcompatible laser systems with operational wavelengths between 500nm – 2200nm have received regulatory clearance.Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers devices are intended for use with any cleared surgicallaser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adapters | |||
| Substantial | Comparison Table: Subject vs. Primary Predicate Devices | |||
| EquivalenceComparisonTable | Characteristic | Subject DeviceOmniGuide Prima Surgical Laser Fibers | Primary Predicate, OmniGuide LISALaser Surgical Fibers, K220189 | Equivalence |
| 510(k) Number | Pending | K220189 | N/A | |
| Product Code | GEX | GEX | Same/Equivalent | |
| RegulationNumber | 21 CFR 878.4810 | 21 CFR 878.4810 | Same | |
| Regulation Name | Laser surgical instrument for use in generaland plastic surgery and in dermatology | Laser surgical instrument for use in generaland plastic surgery and in dermatology | Same/equivalent | |
| Components | Connector configurations offered suitable tomultiple laser platforms | Connector configurations offered suitable tomultiple laser platforms | Same/Equivalent | |
| Technologicalcharacteristics | High OH or Low OH silica material w/lowattenuation of light wavelengths between532nm - 2100nm | High OH or Low OH silica material w/lowattenuation of light wavelengths between532nm - 2100nm | Same/Equivalent | |
| Silica/Silicafibers/hard cladfibers | Fiber having a NumericalAperture (NA) between 0.22 - 0.48 | Fiber having a NumericalAperture (NA) between 0.22 - 0.48 | Same/Equivalent | |
| Fiber distal tip | Multiple configurations of distal tipsoffered to provide the most suitableperformance for the application | Multiple configurations of distal tipsoffered to provide the most suitableperformance for the application | Same/Equivalent | |
| Used withattachments | Core diameters are offered in a range ofsizes suitable to user needs | Core diameters are offered in a range ofsizes suitable to user needs | Same/Equivalent | |
| Intended Use | Same/Equivalent | |||
| Indication for Use | Omni-Guide Holdings, Inc. single-useOmniGuide PRIMA Surgical Laser fibers areindicated for use in all surgical specialties inwhich compatible laser systems withoperational wavelengths between 500nm -2200nm have received regulatory clearance.Omni-Guide Holdings, Inc. single-useOmniGuide PRIMA Surgical Laser fibersdevices are intended for use with anycleared surgical laser with an SMA 905connector, SMA 906 connector, ormanufacturer specific connectors andadapters. | OmniGuide LISA Laser Surgical Fibers areintended for use with any cleared surgicallaser with an SMA 905 connector, SMA906 connectors, or manufacturer specificconnectors and adaptorsOmniGuide LISA Laser Surgical Fibers areindicated for use in all surgical specialtiesin which compatible laser systems withoperational wavelengths between 500nm -2200nm have received regulatoryclearance. | Same/Equivalent | |
| Connectors | SMA 905 connector, SMA 906 connector,or manufacturer specific connectors andadaptors | SMA 905 connector, SMA 906 connector,or manufacturer specific connectors andadaptors | Same/Equivalent | |
| FiberConstruction | Core - Fused SilicaClad - Fused Silica or Fluoropolymer HardCladdingBuffer - FluoropolymerHard Cladding or Silicone Acrylate Jacket -Nylon, Polyimide, or Teflon | Core - Fused SilicaClad - Fused Silica or Fluoropolymer HardCladdingBuffer - FluoropolymerHard Cladding or Silicone Acrylate Jacket -Nylon, Polyimide, or Teflon | Same/Equivalent | |
| Fiber NumericalAperture | Fiber having a numerical Aperture (NA)between 0.22-048 | Fiber having a Numerical Aperture (NA)between0.22-048 | Same/Equivalent | |
| Peak andContinuousWave lengths | 500nm-2200nm | 500nm-2200nm | Same/Equivalent | |
| Power Ranges | 1-300 Watts | 1-300 Watts | Same/Equivalent | |
| Diameter | Core diameters are offered in a range ofsizes suitable to user needs | Core diameters are offered in a range ofsizes suitable to user needs | Same/Equivalent | |
| Fiber Distal Tip | Multiple configurations of distal tips offeredto provide the most suitable performance forthe application | Multiple configurations of distal tipsoffered to provide the most suitableperformance for the application | Same/Equivalent | |
| Compatibilitywith surgical lasersystems | Fibers are compatible with any cleared lasersystem with an appropriate connectionsystem | Fibers are compatible with any cleared lasersystem with an appropriate connectionsystem | Same/Equivalent | |
| Sterilization | EtO | EtO | Same/Equivalent |
Omni-Guide Holdings, Inc.
43 Manning Road
Billerica, MA 01821 web omni-guide.com
office 617.551.4400
fax 888.490.6020
Confidential
Page 2 of 7
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Image /page/5/Picture/0 description: The image shows three logos. The first logo is for OmniGuide Surgical, with the word "OmniGuide" in a sans-serif font above the word "Surgical". The second logo is for Domain Surgical, with the word "Domain" in a sans-serif font above the word "Surgical". The third logo is for LISAL Pro, with the word "LISAL" in a sans-serif font above the word "Pro". All three logos have a blue circle around the words.
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Image /page/6/Picture/0 description: The image shows three logos. The first logo is for OmniGuide Surgical, the second logo is for Domain Surgical, and the third logo is for LISA Laser Products. All three logos have a blue circle around the name of the company.
Omni-Guide Holdings, Inc.
43 Manning Road
Billerica, MA 01821 web omni-guide.com
office 617.551.4400
fax 888.490.6020
Confidential
Page 4 of 7
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Image /page/7/Picture/0 description: The image shows three logos. The first logo is for "OmniGuide Surgical", the second logo is for "Domain Surgical An OmniGuide Company", and the third logo is for "LISALaser Products An OmniGuide Company". All three logos have a similar design, with the company name inside of a double-lined circle.
| Non-ClinicalPerformanceData: | Bench testing (see Section 21) on the subject device has shown the device to perform as intendedwith the same technological principle, fit, form, function, method of operating, including but notlimited to the listed date below. The subject device is substantially equivalent to the predicatedevice and reference devices in the following attributes: | |||||
|---|---|---|---|---|---|---|
| ➤ Indications for Use➤ Intended Use➤ Sterilization Technique➤ Performance Characteristics➤ Energy used and delivered | ➤ Design➤ Materials➤ Packaging➤ Shelf-Life➤ Safety | ➤ Manufacturing➤ Clinical setting➤ Mechanism Action➤ Anatomical Site➤ Biocompatibility | ||||
| PerformanceTestingSummary | The performance test reports focus on the key features of the fiber. These included the followingtesting (depending on need):1. Power & Energy input versus output2. Homogeneity of output light (spot check, beam profile)3. High-power testing4. Bend radius testing5. Pull testing6. Feature specific testing was conducted to demonstrate equivalence to the predicate device andreference devices: safety, performance, integrity, stability, transport, label integrity, packaging ofsterilized fibers. Reference section 21 for the following tests: Performance test of Prima 150 laserfiber on RevoLix HTL; Performance test of Prima 1000 laser fiber on RevoLix HTL; Performancetest of PrimaSidefire laser fiber on RevoLix HTL; Test of mechanical stability of Prima 150 micronlaser fiber, Test of mechanical stability of Prima 1000 micron laser fiber, and Test of mechanicalstability of Prima 550 micron laser fiber,Additional Feature testing conducted in the predicate Device LISA Laser Surgical Fiber K220189.Much of the testing performed was based on a specific feature approach. Those features indicated inK220189 performance testing were 1) Scatter Free Fiber, 2) Expanded transmission of laserwavelength/energy, and 3) distal tip configuration, 4 Nav Tip tested for ability to traverse deflectedendoscope. These test reports show the features identified are proven to be safe and effective. Otherreports are similar in that they indicate passed testing of specific features or overall products | |||||
| Animal Testing | This product category does not require animal testing. | |||||
| ClinicalPerformanceData: | This product category does not require clinical testing. | |||||
| Compliance toStandards | DocumentNumber | Title | ||||
| ISO 11135-1 | Sterilization of Health Care Products - Ethylene Oxide - Requirements forthe development, validation and routine control of a sterilization process formedical devices | |||||
| ISO 11607-1 | Packaging for terminally sterilized medical devices - Part 1: Requirementsfor materials, sterile barrier systems and packaging systems | |||||
| ISO 10993-1 | Biological Evaluation of Medical Devices - Part 1: Evaluation and testing | |||||
| ISO 10993-5 | Biological Evaluation of Medical Devices - Part 5: Tests for in vitrocytotoxicity | |||||
| ISO 10993-7 | Biological Evaluation of Medical Devices - Part 7: Tests for EthyleneOxide Sterilization Residuals | |||||
| ISO 10993-10 | Biological Evaluation of Medical Devices – Part 5: Tests for Irritation andSkin Sensitization | |||||
| ISO 10993-11 | Biological Evaluation of Medical Devices - Part 5: Tests for Systemic |
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Image /page/8/Picture/0 description: The image shows three logos for different surgical companies. The first logo is for OmniGuide Surgical, the second logo is for Domain Surgical, and the third logo is for LISA Laser Products. All three logos have a similar design, with a blue circle around the company name. The text below the company name indicates that LISA Laser Products and Domain Surgical are OmniGuide companies.
| ISO 14971 | Medical devices -- Application of Risk Management to Medical Devices |
|---|---|
| ASTM D4169 | Standard Practice for Performance Testing of Shipping Containers and Systems |
| ASTM F88-09 | Standard Test Method for Seal Strength of Flexible Barrier Materials |
| ASTM F2096-11 | Standard Test Method for Detecting Gross Leaks in Packaging by InternalPressurization (Bubble Test) |
| ASTM F1980-07 | Standard Guide for Accelerated Aging of Sterile Barrier Systems forMedical Devices |
| ISO 14644-1 | Cleanrooms and associated controlled environments - Part 1: Classificationof air cleanliness by particle concentration |
| AAMI TR12 | Designing, Testing, and Labeling Reusable Medical Devices forReprocessing in Health Care Facilities |
| ISO 17664 | Sterilization of medical devices-Information to be provided by themanufacturer for the processing of sterilizable medical devices |
| ISTA Project 2A | Series, Partial-Simulation Performance Test |
| ASTM F56-13 | Standard Practice for Assessment of Hemolytic Properties of Materials,2013 |
| ASTM F619-14 | Standard Practice for Extraction of Medical Plastics |
| DeviceDescription | The Family of OmniGuide Prima Surgical Laser Fibers are individually packed sterile devicesindicated to provide high quality surgical laser fiber optic delivery systems for laser surgery. TheFibers are intended for use in laser surgical procedures including open, laparoscopic or endoscopicablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue application forwhich compatible lasers are applicable. Product description, length, laser wavelength compatibilitycan be found in Section 14 of this 510(k) Premarket Notification.The history of laser fibers originated with the development of lasers used in the medical community.They have been prevalent in surgical applications for the past 63 years. The fibers allow energy to bedelivered to the surgical site through the use of glass fiber optic cable. Propagation of the light energythrough the glass provides users the ability to direct the energy to the appropriate areas in the body.The technology of inputting light energy into a fiber optic cable in order to provide a workable toolfor physicians has been relatively unchanged since the inception of medical lasers. |
All Omni Guide Surgical Holding, Inc. OmniGuide Prima Surgical Laser Fibers are marketed to physicians as a sterile device within a typical Tyvek/poly pouch. Internally, the fiber secured in a coil circle with a Tyvek band, backer-card, or placed in a polyethylene tubing hoop to allow ease of removal. Often sold in quantities of 1-5 for single use, they are packaged in a shelf box and distributed in a separate shipper. The reusable fibers are marketed in single unit shelf boxes.
The construction of the fibers is dependent of the application to which it's marketed. There are two main methods of attaching the connector - crimp and adhesive. The crimp offers a reliable connection that will not be affected by heat whereas the epoxy allows a lower cost alternative where high temperatures are not an issue. All fibers offer various connector nuts, heat shrinks, abrasion jackets, strain reliefs or caps that best serve the environment where they are utilized.
| Conclusion: | A direct comparison of key characteristics demonstrates that Omni Guide Surgical Holding, Inc. OmniGuide Prima Surgical Laser Fibers are substantially equivalent/same as the predicate device in terms of materials of construction, energy use and delivery, chemical/electrical/mechanical/thermal safety, manufacturing, intended uses, surgical use of the devices, technological considerations, packaging, safety and performance characteristics [807.92(a)(4)]. Omni Guide Surgical Holding, Inc. OmniGuide Prima Surgical Laser Fibers family of laser fibers as safe, as effective and perform as well as the predicate devices. The small difference to the predicate device does not raise different questions of safety and efficacy, rather guarantees trained clinicians the use of validated FDA cleared laser fibers. |
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Image /page/9/Picture/0 description: The image shows three logos. The first logo is for "OmniGuide Surgical", the second logo is for "Domain Surgical", and the third logo is for "LISA Laser Products". All three logos have a similar design, with the company name in gray text and a blue circle around the name. The logos appear to be for medical or surgical companies.
Performance testing was conducted in order to demonstrate the specifications and performance of OmniGuide Prima Surgical Laser Fibers and to verify that no different questions of safety and effectiveness have been raised due to the small modification's introduction. Test and assessment results indicated that the subject OmniGuide Prima Surgical Laser Fibers perform in accordance with its requirements and specifications, in similarity to its predicate family and do not raise new safety or efficacy risks/questions.
§ 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.