(62 days)
No reference devices were used in this submission.
No
The description focuses on the physical characteristics and function of laser fibers for transmitting energy, with no mention of AI or ML capabilities.
Yes
The device is a laser fiber designed to transmit laser energy to tissue during surgical procedures, which are inherently therapeutic interventions.
No
The device is described as a fiber optic laser delivery system used to transmit laser energy for surgical procedures, not to diagnose conditions.
No
The device description clearly outlines physical components (fiber optic cable, SMA-905 connector, polymeric jacket, tips) and mentions mechanical testing and sterilization, 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 fibers are for use in "all surgical specialties" to "transmit laser energy to soft and hard tissue in contact and non-contact mode during surgical laser procedures." This describes a device used in vivo (within the body) for surgical intervention, not in vitro (outside the body) for diagnostic testing of samples.
- Device Description: The description details a fiber optic laser delivery device designed to transmit laser energy for surgical purposes. This aligns with a surgical tool, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver laser energy for surgical treatment.
N/A
Intended Use / Indications for Use
The SabreLine™ and SabreGuard™ Laser Fibers are in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm - 2200mm have received regulatory clearance. Coloplast surgical fiber optic laser delivery devices are intended for use with any cleared surgical laser with an SMA 905 connector.
Product codes
GEX
Device Description
The Coloplast SabreGuard™ and SabreLine™ Laser Fibers are fiber optic laser delivery devices that transmit laser energy to soft and hard tissue in contact and non-contact mode during surgical laser procedures. The devices are 3.0 meters in length and are terminated with a SMA-905 connector on the proximal end.
A laser fiber is made of silica inner core, with a primary and secondary cladding surrounded by a polymeric jacket. The laser fibers are compatible with laser systems operating in wavelengths between 500 nm - 2200 nm. The laser delivery devices are intended for use with any cleared surgical laser with a SMA-905 connector.
Coloplast reference SUNXXX are equipped with a round tip, Coloplast reference SUEXXX are equipped with a radius tip; Coloplast reference SUDXXXX and RUSXXXX are equipped with a straight tip.
Single use laser fibers are delivered sterile in a retail box of 3, with an instruction for use in paper version. Reusable laser fibers are delivered sterile in a retail box of 1, with an instruction for use in paper version.
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
The following performance data was provided in support of the substantial equivalence determination.
Biocompatibility Testing
Biocompatibility testing was conducted based upon ISO 10993-1 (2009): Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and FDA Guidance for Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process - Guidance for Industry and Food and Drug Administration Staff - June 16, 2016. A comprehensive regimen of testing for the SabreLine™ and SabreGuard™ Laser Fibers included:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic toxicity
- Material-mediated pyrogenicity
Mechanical Testing
Mechanical testing was completed as follows to verify the product design performance.
- Tip Diameter
- Bend Radius
- Deflected Ureteroscope Bend Navigation Test
- Energy Transfer/Transmission Testing
- Spot Check
- Connector Bond Strength
Sterilization
The SabreLine™ and SabreGuard™ Laser Fibers are sterilized using ethylene oxide in a validated cycle demonstrating a sterility assurance level (SAL) of 10-9.
Packaging and Distribution
The SabreLine™ and SabreGuard™ Laser Fibers were subjected to distribution testing and verification testing to demonstrate that the product and package would be undamaged throughout the product life and maintain the device sterility.
No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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
Indications for Use
510(k) Number (if known) K182831
Device Name SabreLine™ Laser Fibers SabreGuard™ Laser Fibers
Indications for Use (Describe)
The SabreLine™ and SabreGuard™ Laser Fibers are in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm - 2200mm have received regulatory clearance. Coloplast surgical fiber optic laser delivery devices are intended for use with any cleared surgical laser with an SMA 905 connector.
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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510(k) SUMMARY
SUBMITTER I.
| 510(K) Owner's Name: | Coloplast A/S |
|---|---|
| Address: | Holtedam 1 |
| 3050 Humlebaek, Denmark | |
| Phone/Fax/Email: | Office: 612.597.5106 |
| Email: usclr@coloplast.com | |
| Name of Contact Person: | Cori Ragan |
| Regulatory Affairs Manager | |
| Address/Contact: | 1601 West River Road |
| Minneapolis, MN 55411 | |
| Date Prepared: | October 4, 2018 |
| II. | |
| DEVICE | |
| Trade or Proprietary Name: | SabreLine™ and SabreGuard™ Laser Fibers |
| Common or Usual Name: | Bare Laser Fibers |
| Classification Name: | Laser Surgical Instrument for Use in General and Plastic |
| Surgery and in Dermatology | |
| (21CFR section 878.4810) | |
| (Product Code: GEX) | |
| Device Class: 2 |
III. PREDICATE DEVICE
The SabreLine™ and SabreGuard™ Laser Fibers are substantially equivalent in performance, indication, design and materials to the Laser Peripherals, LLC family of Bare Laser Fibers (K170366).
This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
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IV. DEVICE DESCRIPTION
The Coloplast SabreGuard™ and SabreLine™ Laser Fibers are fiber optic laser delivery devices that transmit laser energy to soft and hard tissue in contact and non-contact mode during surgical laser procedures. The devices are 3.0 meters in length and are terminated with a SMA-905 connector on the proximal end.
A laser fiber is made of silica inner core, with a primary and secondary cladding surrounded by a polymeric jacket. The laser fibers are compatible with laser systems operating in wavelengths between 500 nm - 2200 nm. The laser delivery devices are intended for use with any cleared surgical laser with a SMA-905 connector.
Coloplast reference SUNXXX are equipped with a round tip, Coloplast reference SUEXXX are equipped with a radius tip; Coloplast reference SUDXXXX and RUSXXXX are equipped with a straight tip.
Single use laser fibers are delivered sterile in a retail box of 3, with an instruction for use in paper version. Reusable laser fibers are delivered sterile in a retail box of 1, with an instruction for use in paper version.
V. INDICATIONS FOR USE
The SabreLine™ and SabreGuard™ Laser Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm - 2200nm have received regulatory clearance. Coloplast surgical fiber optic laser delivery devices are intended for use with any cleared surgical laser with an SMA 905 connector.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The SabreLine™ and SabreGuard™ Laser Fibers are substantially equivalent in performance, design and materials to the predicate, Laser Peripherals, LLC family of Bare Laser Fibers, cleared under premarket notification number K170366.
The SabreLine™ and SabreGuard™ Laser Fibers are a standard silica core fiber, silica cladding, fluoropolymer coating, and Tefzel buffer. The technological characteristics of the proposed device, which allow use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm - 2200nm have received regulatory clearance, is substantially equivalent to the predicate device.
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PERFORMANCE DATA VII.
The following performance data was provided in support of the substantial equivalence determination.
Biocompatibility Testing
Biocompatibility testing was conducted based upon ISO 10993-1 (2009): Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management processand FDA Guidance for Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process - Guidance for Industry and Food and Drug Administration Staff - June 16, 2016. A comprehensive regimen of testing for the SabreLine™ and SabreGuard™ Laser Fibers included:
- o Cytotoxicity
- o Sensitization
- Irritation ●
- Acute Systemic toxicity ●
- Material-mediated pyrogenicity o
Mechanical Testing
Mechanical testing was completed as follows to verify the product design performance.
- Tip Diameter
- o Bend Radius
- Deflected Ureteroscope Bend Navigation Test
- Energy Transfer/Transmission Testing ●
- o Spot Check
- Connector Bond Strength ●
Sterilization
The SabreLine™ and SabreGuard™ Laser Fibers are sterilized using ethylene oxide in a validated cycle demonstrating a sterility assurance level (SAL) of 10-9.
Packaging and Distribution
The SabreLine™ and SabreGuard™ Laser Fibers were subjected to distribution testing and verification testing to demonstrate that the product and package would be undamaged throughout the product life and maintain the device sterility.
No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices.
VIII. CONCLUSIONS
The SabreLine™ and SabreGuard™ Laser Fibers have been demonstrated to be substantially equivalent to the predicate, Laser Peripherals, LLC family of Bare Laser Fibers based on the non-clinical data provided, similar intended use, materials, design and construction, biocompatibility, and technological characteristics.
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Image /page/4/Picture/0 description: The image contains 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.
Coloplast Corp Cori Ragan Regulatory Affairs Manager 1601 West River Road North Minneapolis, Minnesota 55411
December 10, 2018
Re: K182831
Trade/Device Name: SabreLine and SabreGuard 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: October 4, 2018 Received: October 9, 2018
Dear Cori Ragan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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