(26 days)
No
The device description and performance studies focus on the physical properties and biocompatibility of the fiber optic cable, with no mention of AI or ML capabilities.
Yes
The device is described as a "Fiber Optic Laser Delivery System" intended for "the delivery of laser radiation to soft tissue in the contact mode during surgical procedures," indicating a direct application of energy to tissues for therapeutic purposes.
No
Explanation: The device is described as a "Surgical Laser Fiber" used for the "delivery of laser radiation to soft tissue in the contact mode during surgical procedures." Its function is to deliver laser energy for treatment, not to diagnose medical conditions.
No
The device description clearly states it is a "Fiber Optic Laser Delivery System" and describes physical components like silica core/clad fiber, jacketing, length, connectors, and distal tip configurations. This indicates 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 that the surgical laser fibers are used to "deliver the target tissue" when used with a surgical laser. This describes a device used during a surgical procedure on a patient's body.
- Device Description: The description reinforces this by stating it's a "Fiber Optic Laser Delivery System meaning a device intended for the delivery of laser radiation to soft tissue in the contact mode during surgical procedures".
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used outside the body to analyze biological samples. This device is designed to be used inside or on the body during surgery.
N/A
Intended Use / Indications for Use
Surgical Laser fibers are intended to be used to deliver the target tissue when used with any cleared/ certified surgical laser with operational wavelengths between 500mm equipped with SMA 905 or SMA 906 or compatible connector, as per the indications of the laser device used with.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Surgical Laser Fibers are a Fiber Optic Laser Delivery System meaning a device intended for the delivery of laser radiation to soft tissue in the contact mode during surgical procedures including via endoscopes and cystoscopes.
The Surgical Laser Fibers are surgical fiber optic laser delivery devices based on a silica core/silica clad fiber. These devices are typically jacketed with ETFE, but some models are characterized by the presence of Nylon coating. The devices are 3.0 meters (9.8 ft) or 5.0 meters (16.4 ft) long and are terminated with a laser specific SMA 905 connector plus a strain relief on the proximal end. Different distal tip configurations and several core diameter sizes (from 200 to 1000 microns) are offered.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft 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)
Bench testing:
Due to the product modifications, the device was subject and successfully passed biocompatibility testing, reprocessing validation testing and initial EtO validation testing to the following consensus standards:
- . ISO 10993-1
- ISO 17664
- . ISO 11135
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.
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
Quanta System Spa Francesco Dell'antonio Vice President Regulatory Affairs and QA Via Acquedotto 109 Samarate (Va), 21017 It
Re: K200234
Trade/Device Name: Surgical 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 15, 2020 Received: January 30, 2020
Dear Francesco Dell'antonio:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801 and Part 809); 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,
Jessica Mavadia-Shukla, Ph.D. Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200234
Device Name Surgical Laser Fibers
Indications for Use (Describe)
Surgical Laser fibers are intended to be used to deliver the target tissue when used with any cleared/ certified surgical laser with operational wavelengths between 500mm equipped with SMA 905 or SMA 906 or compatible connector, as per the indications of the laser device used with.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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5. 510(K) SUMMARY
SUBMITTER:
| Manufacturer
Name and Address: | Quanta System SPA
Via Acquedotto, 109
21017, Samarate (VA)
Italy | |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510(k) Contact Person: | Francesco Dell'Antonio
Vice President Regulatory Affairs and QA
Quanta System SPA
Email: francesco.dellantonio@quantasystem.com
Phone: +39-0331-376797
Fax: +39-0331-367815 | |
| Date Prepared: | January 15th 2020 | |
| DEVICE: | | |
| Device Name: | Surgical Laser Fibers | |
| Common Name: | Surgical Laser Fibers | |
| Regulatory Class: | Class II | |
| Classification Name: | Laser surgical instrument for use in general and plastic
surgery and in dermatology. | |
| Regulation Number: | 21 CFR 878.4810 | |
| Product Code: | GEX | |
| Basis for Submission: | change to labeling information, product modification | |
| PREDICATE DEVICE: | | |
| Primary predicate device | Laser Peripherals Family of Laser Fibers (K170366), Laser
Peripherals, LLC | |
| Reference Predicate (unmodified) device | Quanta System Surgical Laser fibers (K160513), Quanta
System SpA | |
The subject device Surgical Laser Fibers is derived from the legally marketed devices Quanta System Surgical Laser fibers (K160513) and Laser Peripherals Family of Laser Fibers (K170366).
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DESCRIPTION OF THE DEVICE:
The Surgical Laser Fibers are a Fiber Optic Laser Delivery System meaning a device intended for the delivery of laser radiation to soft tissue in the contact mode during surgical procedures including via endoscopes and cystoscopes.
The Surgical Laser Fibers are surgical fiber optic laser delivery devices based on a silica core/silica clad fiber. These devices are typically jacketed with ETFE, but some models are characterized by the presence of Nylon coating. The devices are 3.0 meters (9.8 ft) or 5.0 meters (16.4 ft) long and are terminated with a laser specific SMA 905 connector plus a strain relief on the proximal end. Different distal tip configurations and several core diameter sizes (from 200 to 1000 microns) are offered.
DESCRIPTION OF THE MODIFICATIONS:
The subject device intended use is a sub-set of the intended use of the Reference predicate (UNMODIFIED) device, with a simplified wording and no significant difference, based on the intended use of the Primary predicate device.
The subject device has the same technological characteristics (design, material, specifications) as the predicate devices except for the differences shown in the table below.
| Primary predicate device (K170366) | Reference predicate (UNMODIFIED) device (K160513) | Subject modified device | |
|---|---|---|---|
| Diameter of core [µm] | 150 to 1000 | 200 to 1000 | 200 to 1000 |
| Length | 3 m | 3 m | 3 m or 5 m |
| Connector | SMA 905 | SMA 905 | SMA 905 |
| Patient contacting materials | ETFE, Polymide | ETFE | ETFE or Nylon |
| Provided STERILE | Yes (EtO) | Yes (EtO) | Yes (EtO) |
| Number of Uses | Single Use or Reusable | Single use or re-usable | |
| 10x | Single use or re-usable 10x |
Based on the nature of the changes implemented, the subject device underwent and successfully passed performance testing according to the relevant standards.
The subject device differs from the unmodified device due to the addition of fibers 5.0 meters long and to the addition of nylon jacketed fibers. These changes can be considered as minor since they do not imply any safety or effectiveness questions, considering the performance verification performed.
5
INDICATIONS FOR USE_
Surgical Laser fibers are intended to be used to deliver the laser radiation to the target tissue when used with any cleared/certified surgical laser with operational wavelengths between 500nm - 2200nm equipped with SMA 905 or SMA 906 or compatible connector, as per the indications of the laser device used with.
6
PERFORMANCE DATA:
Same as the Reference predicate device, the Surgical Laser fibers devices comply with the applicable recognized consensus standards.
Performance Standards:
There are no mandatory performance standards for this device.
Bench testing:
Due to the product modifications, the device was subject and successfully passed biocompatibility testing, reprocessing validation testing and initial EtO validation testing to the following consensus standards:
- . ISO 10993-1
- ISO 17664
- . ISO 11135
COMPARISON WITH PREDICATE DEVICE:
Even though the intended use is expressed in a simplified wording, it has the same substantial meaning of the reference predicate (unmodified) device (K160513) and it is mainly supported by the Primary predicate device (K170366).
The technical changes do not change the basic physical features and characteristic of the device in a way that any concern could raise about safety and efficacy.
The working principle of the subject devices bases on the same fundamental scientific technology of the main predicate device.
SUMMARY
The subject device Surgical Laser fibers is substantially equivalent to its identified predicate devices.