LISA Laser Surgical Fibers

K220189 · Omni-Guide Holdings, Inc. · GEX · Apr 29, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K220189
• Device Name: LISA Laser Surgical Fibers
• Applicant: Omni-Guide Holdings, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 29, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Omni-Guide Holdings, Inc. single-use LISA Laser Surgical Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500mm have received regulatory clearance. Omni-Guide Holdings, Inc. single-use LISA Laser Surgical 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.

Device Story

LISA Laser Surgical Fibers are sterile, single-use fiber optic delivery systems for surgical lasers. Input: laser energy from compatible surgical laser systems. Transformation: propagation of light energy through glass fiber optic cable to the surgical site. Output: directed laser energy for tissue ablation, coagulation, incision, excision, or vaporization. Used in open, laparoscopic, or endoscopic procedures by physicians. Construction includes fused silica core, fused silica or fluoropolymer hard cladding, and various jackets (nylon, polyimide, Teflon). Connectors (SMA-905, SMA-906, or proprietary) attach via crimp or adhesive. Benefits include precise energy delivery to target tissue, facilitating various surgical applications.

Clinical Evidence

Bench testing only. No clinical or animal data required. Performance testing included power/energy transmission, beam profile/homogeneity, high-power testing, bend radius, pull testing, and feature-specific testing (e.g., navigation tip deflection). Packaging and sterilization validated per ISO 11135-1, ISO 11607-1, and ASTM standards.

Technological Characteristics

Single-use fiber optic delivery system. Materials: Fused silica core, fused silica or fluoropolymer hard cladding, silicone acrylate buffer, nylon/polyimide/Teflon jacket. Numerical Aperture: 0.22-0.48. Wavelengths: 500nm-2200nm. Power: 1-300W. Connectors: SMA 905, SMA 906, or manufacturer-specific. Sterilization: Ethylene Oxide (EtO). Standards: ISO 10993 (biocompatibility), ISO 11135-1 (sterilization), ISO 11607-1 (packaging), ASTM F88/F2096/F1980 (seal/leak/aging).

Indications for Use

Indicated for use in all surgical specialties requiring laser energy delivery (500nm–2200nm) for ablation, coagulation, incision, excision, or vaporization of soft/hard tissue. Compatible with cleared surgical lasers using SMA 905, SMA 906, or manufacturer-specific connectors.

Regulatory Classification

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.

Predicate Devices

• Laser Peripherals' Family of Surgical Fiber Optic Laser Delivery Device (K170366)

Submission Summary (Full Text)

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April 29, 2022

Omni-Guide Holdings, Inc. Carlos Acosta Global Director Regulatory Affairs & Quality Assurance 46 Manning Road Billerica, Massachusetts 01821

Re: K220189

Trade/Device Name: LISA Laser Surgical 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: January 12, 2022 Received: January 24, 2022

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.

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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 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Purva Pandya, D.Eng. 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) K220189

Device Name Omni-Guide LISA Laser Surgical Fibers

#### Indications for Use (Describe)

Omni-Guide Holdings, Inc. single-use LISA Laser Surgical Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500mm have received regulatory clearance. Omni-Guide Holdings, Inc. single-use LISA Laser Surgical 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.

| Type of Use (Select one or both, as applicable) | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------|
| <table border="0"><tr><td><span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </td></tr><tr><td> Over-The-Counter Use (21 CFR 801 Subpart C) </td></tr></table> | <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | | |

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| | | | | 008_510(k)_Summary |
|--|--|--|--|--------------------|
|--|--|--|--|--------------------|

| Classification Name | Common Name | Trade Name/Proprietary Name |
|----------------------------------------------------------|----------------------------|-----------------------------|
| Part 878 General and Plastic Surgery 21 CFR<br>§874.4680 | LISA Laser Surgical Fibers | Surgical 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.

| Submitter: | Omni-Guide Holdings, Inc.<br>46 Manning Drive<br>Billerica, MA 01821 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Carlos O. Acosta<br>Phone: [phone] Ext. 563<br>Fax: [phone] |
| 510(k) Co-<br>Author | Irina Fedorov<br>Phone: [phone] Ext.<br>Fax: [phone] |
| Date of<br>Preparation: | December 16, 2021 |
| Type of 510(k)<br>Submission: | Traditional |
| Device<br>Identification: | Trade Name: LISA Laser Surgical Fibers<br>Classification Name: Laser surgical instrument for use in general and plastic surgery and in<br>dermatology |
| Regulatory<br>Class: | II |
| Product Code: | GEX |
| Panel<br>Classification | General and Plastic Surgery (21 CFR §878.4810) |

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# K220189

| Predicate Device: | Primary Predicate Device:<br>Laser Peripherals' Family of Surgical Fiber Optic Laser Delivery<br>Device 510(k) = K170366 | | | |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|---------------------|
| Device<br>Description: | Omni-Guide Holding, Inc. LISA Laser Surgical Fibers are individually packed sterile devices to provide high<br>quality surgical laser fiber optic delivery systems for laser surgery. The Fibers are for use in laser surgical<br>procedures, including open, laparoscopic, or endoscopic ablation, coagulation, incision, and excision<br>or vaporizing, in soft/hard-tissue application for which compatible surgical lasers are applicable. The key<br>components are the fiber optic, and either an SMA-905, SMA-906, or manufacturer's specific<br>connector. The fibers allow energy to be delivered to the surgical site through the use of glass fiber optic cable.<br>Propagation of the light energy through the glass provides users the ability to direct the energy to the appropriate<br>areas in the body.<br>The Omni Guide Surgical Holding, Inc. single-use LISA Laser Surgical Fibers family of fibers are marketed to<br>physicians as a sterile device within a typical Tyvek/poly pouch. Internally, the fiber is either secured in a wound<br>circle with a Tyvek band, backer-card, or placed in a polyethylene tubing hoop to allow ease of removal. The<br>construction of the fibers is dependent of the application to which it's marketed. There are two main<br>methods of attaching the connector : crimp and adhesive. The crimp offers a reliable connection that will not<br>be affected by heat whereas the epoxy allows a lower cost alternative where high temperatures are not an<br>issue. All fibers offer various connector nuts, heat shrinks, abrasion jackets, strain reliefs or caps that best serve<br>the environment where they are utilized. | | | |
| Indications For<br>Use: | Omni-Guide Holdings, Inc. single-use LISA Laser Surgical Fibers are indicated for use in all surgical<br>specialties in which compatible laser systems with operational wavelengths between 500nm – 2200nm have<br>received regulatory clearance. Omni-Guide Holdings, Inc. single-use LISA Laser Surgical Fibers devices are<br>intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or<br>manufacturer specific connectors and adapters. | | | |
| Substantial<br>Equivalence<br>Comparison<br>Table | Characteristic | Subject Device<br>LISA Laser Surgical Fiber | Primary Predicate, Laser<br>Peripherals surgical fiber<br>optic laser delivery devices<br>K170366 | Equivalence |
| | 510(k) Number | Pending | K170366 | N/A |
| | Product Code | GEX | GEX | Same/<br>Equivalent |
| | Regulation<br>Number | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| | Regulation<br>Name | Laser surgical instrument for<br>use in general and plastic<br>surgery and in dermatology | Laser surgical instrument for<br>use in general and plastic<br>surgery and in dermatology | Same/equivalent |
| | Components | Connector configurations<br>offered suitable to<br>multiple laser platforms | Connector configurations<br>offered suitable to<br>multiple laser platforms | Same/Equivalent |
| | Technological<br>characteristics | High OH or Low OH silica<br>material w/low attenuation of<br>light wavelengths between<br>532nm - 2100nm | High OH or Low OH silica<br>material w/low attenuation of<br>light wavelengths between<br>532nm - 2100nm | Same/Equivalent |
| | Silica/Silica<br>fibers/hard clad<br>fibers | Fiber having a Numerical<br>Aperture (NA) between<br>0.22 - 0.48 | Fiber having a Numerical<br>Aperture (NA) between 0.22<br>- 0.48 | Same/Equivalent |
| | Fiber distal tip | Multiple configurations of<br>distal tips offered to provide<br>the most suitable performance<br>for the application | Multiple configurations of<br>distal tips offered to provide<br>the most suitable performance<br>for the application | Same/Equivalent |
| | Used with<br>attachments | Core diameters are offered<br>in a range of sizes suitable to<br>user needs | Core diameters are offered<br>in a range of sizes suitable to<br>user needs | Same/Equivalent |
| Connectors | SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors | SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors | Same/Equivalent | |
| Fiber<br>Construction | Core - Fused Silica<br>Clad – Fused Silica or Fluoropolymer Hard Cladding<br>Buffer – Fluoropolymer Hard Cladding or Silicone Acrylate<br>Jacket - Nylon, Polyimide, or Teflon | Core - Fused Silica<br>Clad – Fused Silica or Fluoropolymer Hard Cladding<br>Buffer – Fluoropolymer Hard Cladding or Silicone Acrylate<br>Jacket - Nylon, Polyimide, or Teflon | Same/Equivalent | |
| Fiber<br>Numerical<br>Aperture | Fiber having a numerical<br>Aperture (NA) between 0.22-<br>048 | Fiber having a Numerical<br>Aperture (NA) between 0.22-<br>048 | Same/Equivalent | |
| Peak and<br>Continuous<br>Wave<br>lengths | 500nm-2200nm | 500nm-2200nm | Same/Equivalent | |
| Power Ranges | 1-300 Watts | 1-300 Watts | Same/Equivalent | |
| Diameter | Core diameters are<br>offered in a range of sizes<br>suitable to user needs | Core diameters are<br>offered in a range of sizes<br>suitable to user needs | Same/Equivalent | |
| Fiber Distal<br>Tip | Multiple configurations of<br>distal tips offered to provide<br>the most suitable performance<br>for the application | Multiple configurations of<br>distal tips offered to provide<br>the most suitable performance<br>for the application | Same/Equivalent | |
| Compatibility<br>with surgical<br>laser systems | Fibers are compatible<br>with any cleared laser<br>system with an<br>appropriate connection<br>system | Fibers are compatible<br>with any cleared laser<br>system with an<br>appropriate connection<br>system | Same/Equivalent | |
| | Sterilization | EtO | EtO | Same/Equivalent |
| Non-Clinical<br>Performance<br>Data: | Bench testing on the subject device has shown the device to perform as intended with the same technological<br>principle, fit, form, function and method of operating, as the single use fibers of K170366. Fibers included<br>in this premarket notification were tested for conformance to the following performance standards: | | | |
| | Document Number | Title | | |
| | ISO 11135-1 | Sterilization of Health Care Products - Ethylene<br>Oxide - Requirements for the development, validation and routine<br>control sterilization process for medical devices | | |
| | ISO 11607-1 | Packaging for terminally sterilized medical devices - Part 1:<br>Requirements for materials, sterile barrier systems and packaging<br>systems | | |
| | ISO 10993-1 | Biological Evaluation of Medical Devices - Part 1:<br>Evaluation and testing | | |
| | ISO 10993-5 | Biological Evaluation of Medical Devices - Part 5:<br>Tests for in vitro cytotoxicity | | |
| | ISO 10993-7 | Biological Evaluation of Medical Devices - Part 7:<br>Tests for Ethylene Oxide Sterilization Residuals | | |
| | ISO 10993-10 | Biological Evaluation of Medical Devices - Part 5:<br>Tests for Irritation and Skin Sensitization | | |
| | ISO 10993-11 | Biological Evaluation of Medical Devices - Part 5: Tests for Systemic<br>Toxicity | | |
| | ISO 14971 | Medical devices - Application of Risk Management<br>to Medical Devices | | |
| | ASTM D4169 | Standard Practice for Performance Testing of<br>Shipping Containers and Systems | | |
| | ASTM F88-09…