(95 days)
Not Found
No
The device description and performance studies focus on the physical properties and performance of laser surgical fibers, with no mention of AI or ML technology.
Yes
Explanation: The device is used in laser surgical procedures, including ablation, coagulation, incision, excision, or vaporizing of tissue, which are therapeutic interventions.
No
Explanation: The device is a surgical laser fiber, intended to deliver laser energy for procedures like ablation, coagulation, incision, and excision. It is used for therapeutic purposes, not for diagnosing conditions.
No
The device description clearly outlines physical components like fiber optics, connectors, and packaging, indicating it is a hardware device, not software-only.
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 fibers are for use in "all surgical specialties" for procedures like "ablation, coagulation, incision, and excision or vaporizing, in soft/hard-tissue application." This describes a therapeutic or surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical components and function of the fibers in delivering laser energy for surgical procedures. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
- Performance Studies: The performance studies described are focused on the physical and functional performance of the fibers in delivering laser energy, not on the accuracy or reliability of diagnostic results.
Therefore, the Omni-Guide Holdings, Inc. single-use LISA Laser Surgical Fibers are a surgical device used for therapeutic purposes, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
Omni-Guide Holding, Inc. LISA Laser Surgical Fibers are individually packed sterile devices to provide high quality surgical laser fiber optic delivery systems for laser surgery. The Fibers are for use in laser surgical procedures, including open, laparoscopic, or endoscopic ablation, coagulation, incision, and excision or vaporizing, in soft/hard-tissue application for which compatible surgical lasers are applicable. The key components are the fiber optic, and either an SMA-905, SMA-906, or manufacturer's specific connector. The fibers allow energy to be delivered to the surgical site through the use of glass fiber optic cable. Propagation of the light energy through the glass provides users the ability to direct the energy to the appropriate areas in the body. The Omni Guide Surgical Holding, Inc. single-use LISA Laser Surgical Fibers family of fibers are marketed to physicians as a sterile device within a typical Tyvek/poly pouch. Internally, the fiber is either secured in a wound circle with a Tyvek band, backer-card, or placed in a polyethylene tubing hoop to allow ease of removal. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Bench testing on the subject device has shown the device to perform as intended with the same technological principle, fit, form, function and method of operating, as the single use fibers of K170366. Fibers included in this premarket notification were tested for conformance to the following performance standards:
ISO 11135-1: Sterilization of Health Care Products - Ethylene Oxide - Requirements for the development, validation and routine control sterilization process for medical devices
ISO 11607-1: Packaging for terminally sterilized medical devices - Part 1: Requirements for 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 vitro cytotoxicity
ISO 10993-7: Biological Evaluation of Medical Devices - Part 7: Tests for Ethylene Oxide Sterilization Residuals
ISO 10993-10: Biological Evaluation of Medical Devices - Part 5: Tests for Irritation and Skin Sensitization
ISO 10993-11: Biological Evaluation of Medical Devices - Part 5: Tests for Systemic Toxicity
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 Internal Pressurization (Bubble Test)
ASTM F1980-07: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ISO 14644-1: Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
AAMI TIR12: Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities
ISO 17664: Sterilization of medical devices—Information to be provided by the manufacturer 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
The performance test reports focus on the key features of the fiber. These included the following testing (depending on need): Power & Energy input versus output, Homogeneity of output light (spot check, beam profile), High-power testing, Bend radius testing, Pull testing, Feature specific testing (i.e. Nav Tip tested for ability to traverse deflected endoscope). Much of the testing performed was based on a specific (usually new) feature approach. Those features indicated in the attachments are 1) Scatter Free Fiber, 2) Expanded transmission of laser wavelength/energy, and 3) LaseGuide Nav distal tip configuration. These test reports show the features identified are proven to be safe and effective. Other reports are similar in that they indicate passed testing of specific features or overall products.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | ||
|---|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| X Prescription Use (Part 21 CFR 801 Subpart D) | ||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
| 008_510(k)_Summary | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | -------------------- |
| Classification Name | Common Name | Trade Name/Proprietary Name |
|---|---|---|
| Part 878 General and Plastic Surgery 21 CFR | ||
| §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.
46 Manning Drive
Billerica, MA 01821 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Carlos O. Acosta
Phone: 617-551-4400 Ext. 563
Fax: 888-490-6020 |
| 510(k) Co-
Author | Irina Fedorov
Phone: 617-551-4400 Ext.
Fax: 888-490-6020 |
| Date of
Preparation: | December 16, 2021 |
| Type of 510(k)
Submission: | Traditional |
| Device
Identification: | Trade Name: LISA Laser Surgical Fibers
Classification Name: Laser surgical instrument for use in general and plastic surgery and in
dermatology |
| Regulatory
Class: | II |
| Product Code: | GEX |
| Panel
Classification | General and Plastic Surgery (21 CFR §878.4810) |
4
K220189
| Predicate Device: | Primary Predicate Device:
Laser Peripherals' Family of Surgical Fiber Optic Laser Delivery
Device 510(k) = K170366 | | | |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|---------------------|
| Device
Description: | Omni-Guide Holding, Inc. LISA Laser Surgical Fibers are individually packed sterile devices to provide high
quality surgical laser fiber optic delivery systems for laser surgery. The Fibers are for use in laser surgical
procedures, including open, laparoscopic, or endoscopic ablation, coagulation, incision, and excision
or vaporizing, in soft/hard-tissue application for which compatible surgical lasers are applicable. The key
components are the fiber optic, and either an SMA-905, SMA-906, or manufacturer's specific
connector. The fibers allow energy to be delivered to the surgical site through the use of glass fiber optic cable.
Propagation of the light energy through the glass provides users the ability to direct the energy to the appropriate
areas in the body.
The Omni Guide Surgical Holding, Inc. single-use LISA Laser Surgical Fibers family of fibers are marketed to
physicians as a sterile device within a typical Tyvek/poly pouch. Internally, the fiber is either secured in a wound
circle with a Tyvek band, backer-card, or placed in a polyethylene tubing hoop to allow ease of removal. 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. | | | |
| Indications For
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 500nm – 2200nm 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. | | | |
| Substantial
Equivalence
Comparison
Table | Characteristic | Subject Device
LISA Laser Surgical Fiber | Primary Predicate, Laser
Peripherals surgical fiber
optic laser delivery devices
K170366 | Equivalence |
| | 510(k) Number | Pending | K170366 | N/A |
| | Product Code | GEX | GEX | Same/
Equivalent |
| | Regulation
Number | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| | Regulation
Name | Laser surgical instrument for
use in general and plastic
surgery and in dermatology | Laser surgical instrument for
use in general and plastic
surgery and in dermatology | Same/equivalent |
| | Components | Connector configurations
offered suitable to
multiple laser platforms | Connector configurations
offered suitable to
multiple laser platforms | Same/Equivalent |
| | Technological
characteristics | High OH or Low OH silica
material w/low attenuation of
light wavelengths between
532nm - 2100nm | High OH or Low OH silica
material w/low attenuation of
light wavelengths between
532nm - 2100nm | Same/Equivalent |
| | Silica/Silica
fibers/hard clad
fibers | Fiber having a Numerical
Aperture (NA) between
0.22 - 0.48 | Fiber having a Numerical
Aperture (NA) between 0.22
- 0.48 | Same/Equivalent |
| | Fiber distal tip | Multiple configurations of
distal tips offered to provide
the most suitable performance
for the application | Multiple configurations of
distal tips offered to provide
the most suitable performance
for the application | Same/Equivalent |
| | Used with
attachments | Core diameters are offered
in a range of sizes suitable to
user needs | Core diameters are offered
in a range of sizes suitable to
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
Construction | Core - Fused Silica
Clad – Fused Silica or Fluoropolymer Hard Cladding
Buffer – Fluoropolymer Hard Cladding or Silicone Acrylate
Jacket - Nylon, Polyimide, or Teflon | Core - Fused Silica
Clad – Fused Silica or Fluoropolymer Hard Cladding
Buffer – Fluoropolymer Hard Cladding or Silicone Acrylate
Jacket - Nylon, Polyimide, or Teflon | Same/Equivalent | |
| Fiber
Numerical
Aperture | Fiber having a numerical
Aperture (NA) between 0.22-
048 | Fiber having a Numerical
Aperture (NA) between 0.22-
048 | Same/Equivalent | |
| Peak and
Continuous
Wave
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 of sizes
suitable to user needs | Core diameters are
offered in a range of sizes
suitable to user needs | Same/Equivalent | |
| Fiber Distal
Tip | Multiple configurations of
distal tips offered to provide
the most suitable performance
for the application | Multiple configurations of
distal tips offered to provide
the most suitable performance
for the application | Same/Equivalent | |
| Compatibility
with surgical
laser systems | Fibers are compatible
with any cleared laser
system with an
appropriate connection
system | Fibers are compatible
with any cleared laser
system with an
appropriate connection
system | Same/Equivalent | |
| | Sterilization | EtO | EtO | Same/Equivalent |
| Non-Clinical
Performance
Data: | Bench testing on the subject device has shown the device to perform as intended with the same technological
principle, fit, form, function and method of operating, as the single use fibers of K170366. Fibers included
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
Oxide - Requirements for the development, validation and routine
control sterilization process for medical devices | | |
| | ISO 11607-1 | Packaging for terminally sterilized medical devices - Part 1:
Requirements for 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 vitro cytotoxicity | | |
| | ISO 10993-7 | Biological Evaluation of Medical Devices - Part 7:
Tests for Ethylene Oxide Sterilization Residuals | | |
| | ISO 10993-10 | Biological Evaluation of Medical Devices - Part 5:
Tests for Irritation and Skin Sensitization | | |
| | ISO 10993-11 | Biological Evaluation of Medical Devices - Part 5: Tests for Systemic
Toxicity | | |
| | 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 Internal Pressurization (Bubble Test) | | |
| | ASTM F1980-07 | Standard Guide for Accelerated Aging of Sterile
Barrier Systems for Medical Devices | | |
| | ISO 14644-1 | Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration | | |
| | AAMI TIR12 | Designing, Testing, and Labeling Reusable Medical Devices for
Reprocessing in Health Care Facilities | | |
| | ISO 17664 | Sterilization of medical devices—Information to be provided by the
manufacturer 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 | | |
| | The performance test reports focus on the key features of the fiber. These included the following testing
(depending on need):
Power & Energy input versus output | | | |
| | Homogeneity of output light (spot check, beam profile)
High-power testing
Bend radius testing | | | |
| | Pull testing
Feature specific testing (i.e. Nav Tip tested for ability to traverse deflected endoscope)
Much of the testing performed was based on a specific (usually new) feature approach. Those features
indicated in the attachments are 1) Scatter Free Fiber, 2) Expanded transmission of laser wavelength/energy,
and 3) LaseGuide Nav distal tip configuration. These test reports show the features identified are proven to
be safe and effective. Other reports are similar in that they indicate passed testing of specific features or
overall products | | | |
| Animal
Testing | Animal testing is not needed to support the safety and efficacy of the single use fibers that are subject of this
premarket notification. | | | |
| Clinical
Performance | Clinical testing is not needed to support the safety and efficacy of the single use fibers that are subject of this
premarket notification. | | | |
5
K220189
Page 3 of 5
6
7
| Conclusion: | The single-use optical fibers that are the subject of this premarket notification use identical or similar technology as that of the single-use fibers of the K170366 510(k). Testing of key performance characteristics demonstrates that the single-use optical fibers that are the subject of this premarket notification can be used safely and effectively for the proposed indications for use. The Omni Guide single-use Surgical Holding, Inc. LISA Laser Surgical Fibers are considered to be substantially equivalent to the single-use fibers of the predicate K170366. |
|---|---|
| ------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |