(336 days)
No
The 510(k) summary describes a passive fiber optic delivery system for surgical lasers and does not mention any AI or ML components or functionalities.
No.
The device is an accessory (fiber optic delivery system) intended to deliver optical energy from a surgical laser to tissue; it is not a therapeutic device itself.
No
Explanation: The device is described as a fiber optic delivery system intended to deliver optical energy for laser-based surgical applications and procedures. Its purpose is therapeutic (surgical), not diagnostic.
No
The device description clearly states the device is composed of physical materials (silicon, polyimide, acrylate, and polyamide) and is a fiber optic delivery system, which is a hardware component. The performance studies also focus on physical characteristics and sterilization, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the fibers are for "laser-based surgical applications and procedures" to deliver optical energy to tissue. This is a therapeutic or surgical application, not a diagnostic one.
- Device Description: The description focuses on the physical components and how they deliver laser energy for surgical purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the fibers (power delivery, mechanical strength, sterilization, shelf life, biocompatibility) in the context of surgical use, not diagnostic accuracy.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
LEONI™ Laser Fibers (BareFiber Disposable and Endoprobe Disposable) are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors and are indicated for use in laser-based surgical applications and procedures that are performed with compatible lasers operating at wavelengths between 500nm and 2200nm, which have been cleared.
Product codes
GEX
Device Description
The fiber optic delivery systems are accessories designed to deliver optical energy to soft or fibrous tissue in general surgical applications, in combination with any SMA-compatible laser system also indicated for the same applications.
They are composed of silicon, polyimide, acrylate, and polyamide.
The device systems are available in multiple sizes and with multiple tip shapes and handpiece configurations.
The fiber optics are available in reusable, and single use disposable devices that are prepackaged sterile. The reusable fiber optic systems may be reused only after the optical fiber tip is cleaned according to the Instructions for Use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft or fibrous tissue
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)
Animal Testing: This product category does not require animal testing.
Clinical Testing: This product category does not require human clinical testing.
Laboratory Testing: The following technological characteristics of the fibers were evaluated and data reports submitted in the 510(k): Laser power testing in relaxed and strained/bent configurations using a cleared surgical laser generator. Pull testing of the connector bond Optical performance (transmission) Mechanical performance, including tensile and bending testing
Sterilization Validation: Testing according to ISO 14973 has been performed to validate the ethylene oxide sterilization method assures a SAL of 10-6. Further testing was conducted to validate the reprocessing methods for cleaning and sterilization of the devices labeled for reuse.
Shelf Life: The shelf life has been established, via real time and accelerated testing, to be 5 years.
Biocompatibility Testing: Testing, according to ISO 10993 confirms the LEONITM Laser Fiber is biocompatible and non-toxic and safe for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 2, 2021
LEONI Fiber Optics, Inc. % Patsy Trisler Regulatory Consultant Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, Indiana 46250
Re: K201171
Trade/Device Name: LEONI 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 2, 2021 Received: March 4, 2021
Dear Patsy Trisler:
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 U. Pandya -S
Purva Pandya 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) K201171
Device Name
LEONI™ Laser Fibers
Indications for Use (Describe)
LEONI™ Laser Fibers (BareFiber Risposable and Endoprobe Disposable) are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors and are indicated for use in laser-based surgications and procedures that are performed with compatible lasers operating at wavelengths between 500nm and 2200nm, which have been cleared.
| 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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3
510(k) Summary – K201171
| I. SUBMITTER | |
|---|---|
| Submitter Name: | LEONI Fiber Optics, Inc. |
| Submitter Address: | 209 Bulifants Blvd. |
| Williamsburg, VA 23188 | |
| Contact Person: | Donnie Cobb, Regulatory Affairs and Quality Manager |
| Contact Phone: | 757-258-4805 |
| Date Prepared: | 30 March 2021 |
| II. DEVICE | |
| Trade Name: | LEONITM Laser Fibers |
| Common Name | Fiber Optic Delivery System |
| Regulatory Name | Powered Laser Surgical Instrument |
| Classification | 21 CFR 878.4810 |
| Class | 2 |
| Product Codes | GEX |
| III. PREDICATE DEVICE | |
| Primary Predicate Device: | K170366, Laser Peripherals Family of Bare Laser Fibers, Laser |
| Peripherals, LLC | |
| Reference Device: | K050738, FT Fiber Optic Delivery Systems, FiberTech GmbH |
| IV. INTENDED USE AND INDICATIONS FOR USE | |
| LEONITM Laser Fibers (BareFiber Disposable, BareFiber Reusable and Endoprobe | |
| Disposable) are intended for use with any cleared surgical laser with an SMA 905 connector, | |
| SMA 906 connector, or manufacturer specific connectors and adaptors and are indicated for | |
| use in laser-based surgical applications and procedures that are performed with compatible | |
| lasers operating at wavelengths between 500nm and 2200nm, which have been cleared. | |
| V. DEVICE DESCRIPTION | |
| Device | |
| Identification | |
| and | |
| Technological | |
| Characteristics | The fiber optic delivery systems are accessories designed to deliver |
| optical energy to soft or fibrous tissue in general surgical applications, in | |
| combination with any SMA-compatible laser system also indicated for the | |
| same applications. |
They are composed of silicon, polyimide, acrylate, and polyamide.
The device systems are available in multiple sizes and with multiple tip
shapes and handpiece configurations.
The fiber optics are available in reusable, and single use disposable
devices that are prepackaged sterile. The reusable fiber optic systems
may be reused only after the optical fiber tip is cleaned according to the
Instructions for Use. |
4
| VI. SUBSTANTIAL EQUIVALENCE COMPARISON TABLE | |||
|---|---|---|---|
| NEW DEVICE | PRIMARY PREDICATE | REFERENCE | |
| 510(k) NUMBER | K201171 | K170366 | K050738 |
| DEVICE NAME | |||
| MANUFACTURER | LEONI™ Laser Fibers | ||
| LEONI Fiber Optics, Inc. | Laser Peripherals Family | ||
| of Bare Laser Fibers | |||
| Laser Peripherals, LLC | FT Fiber Optic Delivery | ||
| Systems | |||
| FiberTech GmbH | |||
| PRODUCT CODE | GEX | GEX | GEX |
| REGULATORY | |||
| NAME | |||
| COMMON NAME | Powered Laser Surgical | ||
| Instrument | |||
| Fiber Optic Delivery | Powered Laser Surgical | ||
| Instrument | |||
| Fiber Optic Delivery | Powered Laser Surgical | ||
| Instrument | |||
| Fiber Optic Delivery | |||
| System | System | System | |
| CLASSIFICATION | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 |
| INTENDED USE/ | |||
| INDICATIONS | |||
| FOR USE | LEONI™ Laser Fibers | ||
| (BareFiber Disposable, | |||
| BareFiber Reusable and | |||
| Endoprobe Disposable) | |||
| are intended for use with | |||
| any cleared surgical laser | |||
| with an SMA 905 | |||
| connector, SMA 906 | |||
| connector, or | |||
| manufacturer specific | |||
| connectors and adaptors | |||
| and are indicated for use | |||
| in laser-based surgical | |||
| applications and | |||
| procedures that are | |||
| performed with lasers | |||
| operating at wavelengths | |||
| between 500nm and | |||
| 2200nm, which have | |||
| been cleared. | 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 | |||
| 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. | The disposable contact | ||
| and the reusable non- | |||
| contact Fiber Optic | |||
| Delivery System is | |||
| intended to vaporize, | |||
| coagulate and incise and | |||
| excise tissue and are | |||
| cleared for any indication | |||
| for which compatible Nd: | |||
| YAG, Ho YAG, KTP and | |||
| Diode Laser Systems have | |||
| been cleared by the FDA. | |||
| The Laser peripherals bare | |||
| laser fibers, ENT fibers | |||
| and Endoprobes are | |||
| intended for use in laser | |||
| surgical procedures for | |||
| cutting, coagulating, or | |||
| vaporizing in any soft | |||
| tissue application for which | |||
| compatible Nd: YAG, Ho: | |||
| YAG, KTP and Diode | |||
| lasers have been cleared | |||
| 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 | SMA 905 and adapters | ||
| Fiber | Core - Fused Silica | Core - Fused Silica | Core - Fused Silica |
| Construction | Clad - Fused Silica or | ||
| Fluoropolymer Hard | |||
| Cladding | Clad - Fused Silica or | ||
| Fluoropolymer Hard | |||
| Cladding | Clad - Fused Silica or | ||
| Fluoropolymer Hard | |||
| Cladding | |||
| Buffer – Fluoropolymer | |||
| Hard Cladding or Silicone | |||
| Acrylate | Buffer – Fluoropolymer | ||
| Hard Cladding or Silicone | |||
| Acrylate | Buffer – Fluoropolymer | ||
| Hard Cladding or Silicone | |||
| Acrylate | |||
| Jacket - Nylon, | |||
| Polyimide, or Teflon | Jacket - Nylon, Polyimide, | ||
| or Teflon | Jacket - Nylon, Polyimide, | ||
| or Teflon | |||
| Fiber Numerical Aperture | 0.22 - 0.48 | 0.22 - 0.48 | 0.22 - 0.37 |
| Fiber Wavelength Range | 500nm - 2200nm | 500nm - 2200nm | 532 - 2127nm |
| Fiber Core 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 | 200 - 1000μm |
| 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 |
| Sterilization | Sterile, via Ethylene Oxide | Sterile, via Ethylene Oxide | Sterile, via Ethylene Oxide |
| Single Use or Reusable | Both for BareFiber | ||
| Single Use for Endoprobe | Both | Both | |
| Biocompatible | Biocompatible, according to ISO 10993 testing | Biocompatible, according to ISO 10993 testing | Biocompatible, according to ISO 10993 testing |
| 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 |
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| VII PERFORMANCE AND SAFETY TESTING | |
|---|---|
| Animal Testing: | This product category does not require animal testing. |
| Clinical Testing: | This product category does not require human clinical testing. |
| Laboratory Testing: | The following technological characteristics of the fibers were evaluated and data reports submitted in the 510(k): Laser power testing in relaxed and strained/bent configurations using a cleared surgical laser generator. Pull testing of the connector bond Optical performance (transmission) Mechanical performance, including tensile and bending testing |
| Sterilization Validation | Testing according to ISO 14973 has been performed to validate the ethylene oxide sterilization method assures a SAL of 10-6. Further testing was conducted to validate the reprocessing methods for cleaning and sterilization of the devices labeled for reuse. |
6
| Shelf Life | The shelf life has been established, via real time and accelerated testing, to be 5 years. |
|---|---|
| Biocompatibility Testing: | Testing, according to ISO 10993 confirms the LEONITM Laser Fiber is biocompatible and non-toxic and safe for its intended use. |
VIII COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The intended use, composition, specifications, and modes of operation are substantially equivalent to the Primary Predicate Device.
The differences are noted in the Substantial Equivalence Comparison Table (above). Those differences, when compared to the Primary Predicate, do not raise new questions related to safety and effectiveness.
VIX CONCLUSION
Based on the comparisons provided and the data submitted in this 510(k), it can be concluded the LEONI™ Laser Fibers are substantially equivalent to the Predicate devices.