(122 days)
K#124003, K#142638
No
The device description and performance studies focus on the physical properties and performance of the laser fiber itself, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a surgical laser fiber optic delivery system intended for use in laser surgical procedures, including ablation, coagulation, incision, excision, or vaporizing of soft/hard tissue. These are all therapeutic actions.
No
The device description clearly states its purpose is for "delivering the energy to the patient" for "laser surgical procedures including open, laparoscopic ablation, coagulation, incision, and excision or vaporizing." This indicates a therapeutic, rather than a diagnostic, function.
No
The device description clearly details physical components like fiber optic cables, connectors, and coatings, indicating 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 use in surgical specialties for procedures like ablation, coagulation, incision, excision, and vaporizing of soft/hard tissue. This describes a therapeutic or surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a fiber optic laser delivery system designed to transmit laser energy to a patient's tissue. This is a surgical tool, not a device for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Use in a laboratory setting
The device is a surgical laser fiber, which is a medical device used for delivering energy during surgical procedures.
N/A
Intended Use / Indications for Use
The Laser Peripherals Laser Fiber is in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm -2200nm have received regulatory clearance. Laser Peripherals surgical fiber optic laser delivery devices are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors.
Product codes
GEX
Device Description
The Family of 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 open, laparoscopic 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 and reusable can be found in Section 11 of this 510(k) Premarket Notification.
The key components of this system are the SMA-905, SMA-906 and Manufacturer's specific connectors and the Fiber Optic.
Laser Peripherals is responsible for the design, testing and manufacturing of the Family of Surgical Laser Fibers. The Family of Surgical Laser Fibers are broken down into different models, e.g., Wavelength/Laser Compatible and Disposable versus Re-usable. A detailed description of the different families can be found in Section 11 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 35 years. 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 technology of inputting light energy into a fiber optic cable in order to provide a workable tool for physicians has been relatively unchanged since the inception of medical lasers.
Laser fiber technology can be reduced to three basic functions: Fiber to Laser interface, Energy propagation through fiber, and energy output. These functions are mechanically supported by the fiber through the proximal connector (fiber to laser interface), the fiber optic cable (propagation), and the distal tip configuration (energy output). Discussion of these 3 features is below.
The proximal end of the laser fiber always features a connector. The main purpose of the connector is to 1) provide a robust connection to the laser and 2) align the fiber to the laser energy output beam. This connector is specific to the model of laser in which the fiber is attached. Most systems will use an interface that allows the use of an SMA-905, SMA-906 and Manufacturer's specific connector style connectors, yet some manufacturers have decided to develop proprietary connection systems.
The fiber optic in the laser fiber is the main component in the assembly and is what allows for delivering the energy to the patient. The fiber portion of the laser fiber is comprised of several different materials; these can be thought of as: 1) the fiber core, 2) fiber cladding and coating layers, and 3) the outside coating or the jacket. All fibers featured in this submission have a core consisting of a silica (glass) material. The core is the main light pipe which offers a path for the light energy. The fiber cladding and coating layers are placed over the core and shield the fiber from losing energy over the length of the fiber and guide the energy to exit the distal tip. The material of the cladding and coating layer has a different index of refraction, which directs the light back into the core. This is typically another layer of silica, but may include a chemical layer (e.g., Fluoropolymer). Fiber selection is based on the ability to transmit the light wavelength that the laser is producing. The outside of the laser fiber is coated with a flexible material to offer abrasion and breakage resistance. This coating is typically an ETFE, but some models offer a Polyimide coating for superior resistance.
The distal tip of the laser fiber offers the user an opportunity to configure the output energy to suit the needs of the application. The most predominate distal tip configuration is a flat, polished surface. The flat end face of the fiber allows the energy to exit the fiber unaltered. Other configurations manage the light in different ways. This allows the user to use the fiber where a different method of treatment is appropriate. Fibers can be divided into two categories: Contact and Non-contact. This refers to whether the distal tip is touching the subject matter at the worksite or whether it is held back, away from the target. Contact fibers are generally shaped into configurations intended to maximize the effectiveness of the procedure. These shapes include cone tips, ball tips, spherical tips, etc. A third type of distal tip offers further treatment of the laser energy as it exits the fiber. These distal tips utilize added components to either direct the laser light (i.e., ScatterFree™ (SideFire)) or lens the light (focus or dispersed).
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 (see Section 18) on the subject device to perform as intended with the same or similar results as predicate device design was qualified through the following tests and assessments:
- . Performance
- . Biocompatibility Assessment
- . Packaging and Shipping
- . Sterilization
The performance test reports focus on the key features of the fiber. These may include 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 is 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.
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate devices. Substantial equivalence of the device is supported by non-clinical testing. The verification and validation testing of the device and electrical safety of the device was found to be acceptable and supports the claims of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#124003, K#142638
Reference Device(s)
K961516, K011207, K030959, K961079, K972272, K974229, K992083
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, overlaid on three human profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 8, 2017
Laser Peripherals, LLC Jeff Stein General Manager 13355 10th Ave. Suite 110 Plymouth, Minnesota 55441
Re: K170366
Trade/Device Name: Laser Peripherals, Llc Family Of Bare 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: January 20, 2017 Received: February 6, 2017
Dear Jeff Stein:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Actinclude 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170366
Device Name
Laser Peripherals Family of Laser Fibers
Indications for Use (Describe)
The Laser Peripherals Laser Fiber is in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm -2200nm have received regulatory clearance. Laser Peripherals surgical fiber optic laser delivery devices are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors.
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)
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3
510(k) Summary
[As required by 21 CFR 807.92]
510(k) Number: K170366______________________________________________________________________________________________________________________________________
| Submitter/Manufacturer | Laser Peripherals, LLC
13355 10th Avenue North, Suite 110
Plymouth, MN 55441, USA
Telephone: 763. 525.8460; Fax: 763.525.8461
Establishment Registration # 1221543 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jeff Stein
Vice President
Telephone: 763.525.8483
Email: jstein@laserperipherals.com |
| Trade Name | Laser Peripherals Family of Bare Laser Fibers |
| Regulation Name | Laser surgical instrument for use in general and plastic surgery and in
dermatology |
| Classification | II |
| Product Code/ Regulation # | GEX / 21 CFR Part 878.4810 |
| Predicate Devices | Med-Fibers Surgical Laser Fibers; K#124003
InnovaQuartz LLC Proflex™ Laser Fibers (Proflex 200 and Proflex 273);
K#142638 |
4
Introduction
Laser Peripherals has been producing surgical fiberoptics for more than 30 years. These devices have been marketed both in the US and internationally in accordance with their specific regulatory clearances. Specific to the United States the products are cleared and remain actively marketed according the 510(k) pre-market notification process. As the surgical laser market has grown to include new applications, wavelengths, and power levels, so to have our devices been cleared to meet this demand. Laser Peripherals has continued to improve its products to meet the evolving market, and over time has acquired numerous 510(k) clearances for the products included in our product line. For reference purposes, there are six (6)(see 510k #'s K961516, K011207, K030959, K961079, K972272, K974229 and K992083) existing 510(k)'s pertaining to our products attached to this application in Appendix 5 (see summation letters within Appendix 5); These 510(k)'s remain valid and continue to be in effect.
In this newest 510(k) application, Laser Peripherals is both expanding the current clearance of our products to be used in accordance with advancements within the surgical laser field, while solidifying some of the previous clearances into a new 510(k) for a more clear understanding of how are devices can be utilized. The change in use will include expanded wavelength range and increasing power/energy levels, at the same time we will also continue to market the products in accordance will all previous 510(k) clearances. While our devices remain generally the same, we have incorporated some value added changes to the devices (e.g., navigating tip for ease of use in a deflected endoscope).
Device Description
The Family of 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 open, laparoscopic 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 and reusable can be found in Section 11 of this 510(k) Premarket Notification.
The key components of this system are the SMA-905, SMA-906 and Manufacturer's specific connectors and the Fiber Optic.
Laser Peripherals is responsible for the design, testing and manufacturing of the Family of Surgical Laser Fibers. The Family of Surgical Laser Fibers are broken down into different models, e.g., Wavelength/Laser Compatible and Disposable versus Re-usable. A detailed description of the different families can be found in Section 11 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 35 years. 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
5
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 tool for physicians has been relatively unchanged since the inception of medical lasers.
Laser fiber technology can be reduced to three basic functions: Fiber to Laser interface, Energy propagation through fiber, and energy output. These functions are mechanically supported by the fiber through the proximal connector (fiber to laser interface), the fiber optic cable (propagation), and the distal tip configuration (energy output). Discussion of these 3 features is below.
The proximal end of the laser fiber always features a connector. The main purpose of the connector is to 1) provide a robust connection to the laser and 2) align the fiber to the laser energy output beam. This connector is specific to the model of laser in which the fiber is attached. Most systems will use an interface that allows the use of an SMA-905, SMA-906 and Manufacturer's specific connector style connectors, yet some manufacturers have decided to develop proprietary connection systems.
The fiber optic in the laser fiber is the main component in the assembly and is what allows for delivering the energy to the patient. The fiber portion of the laser fiber is comprised of several different materials; these can be thought of as: 1) the fiber core, 2) fiber cladding and coating layers, and 3) the outside coating or the jacket. All fibers featured in this submission have a core consisting of a silica (glass) material. The core is the main light pipe which offers a path for the light energy. The fiber cladding and coating layers are placed over the core and shield the fiber from losing energy over the length of the fiber and guide the energy to exit the distal tip. The material of the cladding and coating layer has a different index of refraction, which directs the light back into the core. This is typically another layer of silica, but may include a chemical layer (e.g., Fluoropolymer). Fiber selection is based on the ability to transmit the light wavelength that the laser is producing. The outside of the laser fiber is coated with a flexible material to offer abrasion and breakage resistance. This coating is typically an ETFE, but some models offer a Polyimide coating for superior resistance.
The distal tip of the laser fiber offers the user an opportunity to configure the output energy to suit the needs of the application. The most predominate distal tip configuration is a flat, polished surface. The flat end face of the fiber allows the energy to exit the fiber unaltered. Other configurations manage the light in different ways. This allows the user to use the fiber where a different method of treatment is appropriate. Fibers can be divided into two categories: Contact and Non-contact. This refers to whether the distal tip is touching the subject matter at the worksite or whether it is held back, away from the target. Contact fibers are generally shaped into configurations intended to maximize the effectiveness of the procedure. These shapes include cone tips, ball tips, spherical tips, etc. A third type of distal tip offers further treatment of the laser energy as it exits the fiber. These distal tips utilize added components to either direct the laser light (i.e., ScatterFree™ (SideFire)) or lens the light (focus or dispersed).
6
The Laser Peripherals family of fibers comply with the following standards:
| Document
| Number | Title |
|---|---|
| ISO 11135-1 | Sterilization of Health Care Products - Ethylene Oxide - Requirements for the |
| development, validation and routine control of a 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 TR12 | 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 resterilizable 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 |
All Laser Peripherals 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. Often sold in quantities of 1-5 for single
7
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.
Intended Use:
The Laser Peripherals Laser Fiber is indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm – 2200nm have received regulatory clearance. Laser Peripherals surgical fiber optic laser delivery devices are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors.
| Table 5-1. Summary of Predicate Comparisons | ||||
|---|---|---|---|---|
| Characteristic | Laser Peripherals' Family of | |||
| Surgical Fiber Optic Laser | ||||
| Delivery Devices | Med-Fibers, Inc. | InnovaQuartz LLC Proflex™ | ||
| Laser Fibers (Proflex 200 and | ||||
| Proflex 273 | Similar | |||
| or | ||||
| Different | ||||
| 510(k) | ||||
| Number | Pending | K124003 | K142638 | N/A |
| Product Code | GEX | GEX | GEX | Similar |
| Regulation | ||||
| Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Similar |
| 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 | Laser surgical instrument for | |||
| use in general and plastic | ||||
| surgery and in dermatology | Similar | |||
| Components | Connector configurations | |||
| offered suitable to multiple | ||||
| laser platforms | Connector configurations | |||
| offered suitable to multiple | ||||
| laser platforms | Connector configurations | |||
| offered suitable to multiple | ||||
| laser platforms | Similar | |||
| Table 5-1. Summary of Predicate Comparisons | ||||
| Characteristic | Laser Peripherals' Family of | |||
| Surgical Fiber Optic Laser | ||||
| Delivery Devices | Med-Fibers, Inc. | InnovaQuartz LLC Proflex™ | ||
| Laser Fibers (Proflex 200 and | ||||
| Proflex 273 | Similar or | |||
| Different | ||||
| Fiber | Fiber | Fiber | ||
| • Standard silica core | ||||
| fiber optic | ||||
| w/fluoropolymer | ||||
| hard cladding, | ||||
| w/acrylate, Teflon, | ||||
| nylon, or polyimide | ||||
| buffer | ||||
| • Standard silica core | ||||
| fiber w/silica | ||||
| cladding, | ||||
| w/fluoropolymer | ||||
| coating, w/acrylate, | ||||
| Teflon, nylon, or | ||||
| polyimide buffer | • Standard silica core | |||
| fiber optic | ||||
| w/fluoropolymer | ||||
| hard cladding, | ||||
| w/acrylate, Teflon, | ||||
| nylon, or polyimide | ||||
| buffer | ||||
| • Standard silica core | ||||
| fiber w/silica | ||||
| cladding, | ||||
| w/fluoropolymer | ||||
| coating, w/acrylate, | ||||
| Teflon, nylon, or | ||||
| polyimide buffer | • Standard silica core | |||
| fiber optic | ||||
| w/fluoropolymer | ||||
| hard cladding, | ||||
| w/acrylate, Teflon, | ||||
| nylon, or polyimide | ||||
| buffer | ||||
| • Standard silica core | ||||
| fiber w/silica | ||||
| cladding, | ||||
| w/fluoropolymer | ||||
| coating, w/acrylate, | ||||
| Teflon, nylon, or | ||||
| polyimide buffer | ||||
| Jacket is Teflon, Peek, or | ||||
| similar sleeve provided for | ||||
| protection during handling. | Jacket is Teflon, Peek, or | |||
| similar sleeve provided for | ||||
| protection during handling. | Jacket is Teflon, Peek, or | |||
| similar sleeve provided for | ||||
| protection during handling. | ||||
| 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 | High OH or Low OH silica | |||
| material w/low attenuation | ||||
| of light wavelengths | ||||
| between 500nm - 2200nm | Similar | |||
| Silica/Silica | ||||
| fibers | Fiber having a Numerical | |||
| Aperture (NA) between 0.22 | ||||
| – 0.48 | Fiber having a Numerical | |||
| Aperture (NA) between 0.22 |
- 0.48 | Fiber having a Numerical
Aperture (NA) between 0.22 - 0.48 | Similar |
| Silica/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 | Fiber having a Numerical
Aperture (NA) between 0.22 - 0.48 | Similar |
| 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 | Multiple configurations of
distal tips offered to provide
the most suitable
performance for the
application | Similar |
| Used with
attachments | Fibers can be used in hand-
pieces, flexible or rigid
endoscopes, cannulas,
introducers | Fibers can be used in hand-
pieces, flexible or rigid
endoscopes, cannulas,
introducers | Fibers can be used in hand-
pieces, flexible or rigid
endoscopes, cannulas,
introducers | Similar |
| Core sizes | 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 | Core diameters are offered
in a range of sizes suitable to
user needs | Similar |
| Table 5-1. Summary of Predicate Comparisons | | | | |
| Characteristic | Laser Peripherals' Family of Surgical Fiber Optic Laser Delivery Devices | Med-Fibers, Inc. | InnovaQuartz LLC Proflex™ Laser Fibers (Proflex 200 and Proflex 273 | Similar or Different |
| Power ranges | 1-300 Watts | 1-300 Watts | The maximum power for ProFlex laser fibers is: 30W for ProFlex 200, 50W for ProFlex 273. | Similar |
| Peak and Continuous Wave lengths | 500nm – 2200nm | 532nm - 2100nm | 500nm – 2200nm | Similar |
| 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 | Fibers are compatible with any cleared laser system with an appropriate connection system | Similar |
8
9
Substantial Equivalence and Summary of Studies
The Laser Peripherals family of laser fibers are substantially equivalent to the predicate devices. Table 5-1 compares the intended use, features, and technological characteristics of the subject device and the predicates.
The Intended uses for the Laser Peripherals family of laser fibers are similar; the difference is that the Laser Peripherals indication articulates more specificity and accuracy. E.g., the term "Diode" was removed for the generic term of Laser Fiber (since the term "Diode" specifies the method in which energy is generated, Laser Peripherals believes addressing the light wavelength is more appropriate). This does not raise any new issues of safety or efficacy.
The Laser Peripherals family of laser fibers is similar to the predicate devices in that all make almost identical claims. These differences are not critical to the intended therapeutic, surgical use of the device and do not raise any new issues of safety or efficacy. Wavelength range varies slightly between the predicate devices. The difference of both predicate devices is descriptive of the spectral signature (transmission) of the fiber raw material and is representative of standard industry practice.
Technological Characteristics
Substantial equivalence is based on the two predicate devices (however, this 510(k) is also leveraged from previous LP 510(k)s; see K030959, K992083, K974229, K961516, and K961079 already on file with FDA).
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The Laser Peripherals family of laser fibers is equivalent in operational characteristics to the predicate devices.
The Laser-Peripherals' family of laser fibers contain the same components and the same technological characteristics as the predicate devices. The fiber core and cladding or fibers with no cladding are made from silica which is the same material used in all the predicate devices. As mentioned, the optical fiber is made out of silica with a coaxially mounted protective sheath. The fiber distal tip can be several configurations and the fiber can be used independently, with hand pieces or other ancillary instrumentation such as endoscopes. The Laser- Peripherals family of laser fibers have no differences in technology and as such, do not raise any new questions on safety or efficacy. Various core diameter sizes (150, 200, 272, 365, 550, 600, 800, 940, and 1000 microns) are offered.
Performance Testing/ Non-clinical testing
Bench testing (see Section 18) on the subject device to perform as intended with the same or similar results as predicate device design was qualified through the following tests and assessments:
- . Performance
- . Biocompatibility Assessment
- . Packaging and Shipping
- . Sterilization
Performance Testing Summary
Testing of features offered in the Laser Peripherals Family of laser fibers has been conducted and shown to meet relevant internal and external standards. Much of the testing was conducted under prior submissions (see 510k #'s K030959, K992083, K974229, K972272, K961516 and K961079) by Laser Peripherals. These reports are available upon request. The testing of those features that are new to this submission has been identified in Section 18.
The performance test reports focus on the key features of the fiber. These may include the following testing (depending on need):
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- Power & Energy input versus output
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- Homogeneity of output light (spot check, beam profile)
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- High-power testing
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- Bend radius testing
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- Pull testing
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- Feature specific testing (i.e. Nav Tip tested for ability to traverse deflected endoscope)
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Much of the testing performed is 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.
Clinical Testing
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate devices. Substantial equivalence of the device is supported by non-clinical testing. The verification and validation testing of the device and electrical safety of the device was found to be acceptable and supports the claims of substantial equivalence.
Conclusion
A direct comparison of key characteristics demonstrates that Laser-Peripherals' family of laser fibers are substantially equivalent to both predicate devices in terms of materials of construction, intended uses, technological considerations and performance characteristics. Laser-Peripherals' family of laser fibers are as safe, as effective and perform as well as the predicate devices.
The Laser Peripherals family of laser fibers are substantially equivalent to the predicate devices (see K#'s K030959, K992083, K974229, K972272, K961516 and K961079 on file with FDA) based on comparisons of indications for use and technological characteristics.
These tests and assessments did not raise new safety or efficacy questions.