(23 days)
Not Found
No
The document describes a family of surgical laser fibers, which are passive devices for delivering laser energy. There is no mention of any computational or analytical capabilities, let alone AI or ML.
Yes
The device is described as "surgical fiber optic laser delivery devices" intended for applications like "incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue" and "lithotripsy," which are specific medical treatments.
No
The device is described as a "Fiber Optic Laser Delivery System" intended for delivering laser radiation for surgical procedures like incision, excision, vaporization, and coagulation, which are therapeutic rather than diagnostic actions.
No
The device description explicitly states it is a "Fiber Optic Laser Delivery System" and describes physical components like silica core/clad fiber, jacket, connector, and distal tip configurations, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used in conjunction with surgical lasers for various surgical procedures on soft and osseous tissue. This involves direct interaction with the patient's body during surgery.
- Device Description: The device is described as a "Fiber Optic Laser Delivery System" intended for delivering laser radiation to tissue. This is a surgical tool, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue samples, etc.) outside of the body to provide information about a patient's health.
IVD devices are used to perform tests on samples taken from the human body to diagnose diseases or other conditions. This device is a surgical instrument used during a procedure.
N/A
Intended Use / Indications for Use
Quanta System Surgical Laser Fibers are intended to be used in coniunction with any cleared surgical laser manufactured by Quanta System equipped with SMA 905 or SMA 906 or compatible connector.
Quanta System Surgical Laser Fibers are indicated for use in general surqical applications for: incision, excision, vaporization. ablation, hemostasis or coagulation of soft tissue in a contact or non-contact mode (with a compatible laser marketed for use in the desired application).
Quanta System Surgical Laser Fibers (surgical fiber optic laser delivery devices) are indicated for use in general surgery urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT/otolaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, or lesions, tissue vaporization, hemostasis and or coagulation may be indicated with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are also indicated for use in lithotripsy with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are indicated for use with laser devices emitting radiation from 532 nm to 2100 nm, with pulsed and continuous wave (CW) emission mode.
Quanta System Surgical Laser Fibers are indicated, but not limited, for use with Diode laser, Argon, KTP/532, Ho;YAG, Nd:YAG, Tm:YAG pulsed and continuous wave CW laser devices.
Quanta System Surgical Laser Fibers may be used in surgical specialty or procedures for which compatible lasers have received regulatory clearance: for a complete information about applications, contraindications, precautions and warnings when using fiber optic it is necessary to refer to the applicable laser device User Manual.
Product codes
GEX
Device Description
The Quanta System Surgical Laser Fibers are a family of medical devices. The Quanta System 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 and non-contact mode during surgical procedures including via endoscopes and cystoscopes. The Quanta System Surgical Laser Fibers are surgical fiber optic laser delivery devices based on a silica core/silica clad fiber jacketed with ethylene tetraffluoroethylene (ETFE). The devices are 3.0 meters (9.8 ft) in length and are terminated with a laser specific SMA 905 connector plus a strain relief on the proximal end. Different distal tip configurations and various core diameter sizes (150, 200, 272, 365, 400, 550, 600, 800 and 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, external tumors and lesions, internal organs, tumors or lesions, osseous tissue, greater saphenous vein
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)
Nonclinical performance tests demonstrate that the modified device is as safe and effective as the unmodified device.
In addition to the performance data provided for the unmodified device (K131473), the modified device reprocessing instructions have been validated.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines above them. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18, 2016
Quanta System SPA Francesco Dell'antonio Head of Regulatory Affairs Via IV Novembre, 116 Solbiate Olona (VA), 21058 IT
Re: K160513
Trade/Device Name: Quanta System 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: February 11, 2016 Received: February 24, 2016
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. 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 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 yours.
Jennifer R. Stevenson -A
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) K160513
Device Name Quanta System Surgical Laser Fibers
Indications for Use (Describe)
Quanta System Surgical Laser Fibers are intended to be used in conjunction with any cleared surgical laser manufactured by Quanta System equipped with SMA 905 or SMA 906 or compatible connector.
Quanta System Surgical Laser Fibers are indicated for use in general surgical applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact mode (with a compatible laser marketed for use in the desired application).
Quanta System Surgical Laser Fibers (surgical fiber optic laser delivery devices) are indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT/
otolaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are also indicated for use in lithotripsy with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are indicated for use with laser devices emitting radiation from 532 mm to 2100 om, with pulsed and continuous wave (CW) emission mode.
Quanta System Surgical Laser Fibers are indicated, but not limited, for use with Diode laser, Argon, KTP/532, Ho;YAG, Nd;YAG, Tm:YAG pulsed and continuous wave CW laser devices.
Quanta System Surgical Laser Fibers may be used in surgical specialty or procedures for which compatible lasers have received regulatory clearance: for a complete information about applications, precautions and warnings when using fiber optic it is necessary to refer to the applicable laser device User Manual.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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4
5. SPECIAL SIO{K) SUMMARY-DEVICE-MODIFICATIONS
Introduction:
This document contains the 510(k) Summaryfor the Surgical laser fibers. The basis of this submission is Modifications to Device already cleared. The content of this summary is based on the requirements of 21CFR 807.92(c).
| Applicant/Manufacturer
Name and Address: | Quanta System SPA
Via IV Novembre;116
Solbiate Olona (VA)
Italy, 21058 |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SIO{k) Contact Person: | Francesco Dell'Antonio
Head of Regulatory Affairs
Quanta System SPA
Email: francesco.dellantonio@quantasystem.com
Phone: +39-0331-376797
Fax: +39-0331-367815 |
| Date Prepared: | February 12 2016 |
| Device Name: | Surgical laser fibers |
| Classification: | Class II |
| Classification Name: | laser surgical instrument for use in general and plastic surgery
and in dermatology. |
| Regulation Number: | 21CFR 878.4810 |
| Product Code: | GEX |
| Basis for Submission: | change to labeling information |
| Ident. of the legally marketed devices | Surgical laser fibers (K131473).
The modified device Surgical Laser fibers is claimed to be derived
from the legally marketed (unmodified) device Surgical Laser
fibers (K131473). |
| Performance Standards: | There are no mandatory performance standards for this device. |
| Description of the device: | The Description of the modified device and the unmodified
device are exactly the same, as follows. The Quanta System
Surgical Laser Fibers are a family of medical devices. |
5
The Quanta System 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 and non-contact mode during surgical procedures including via endoscopes and cystoscopes.
The Quanta System Surgical Laser Fibers are surgical fiber optic laser delivery devices based on a silica core/silica clad fiber jacketed with ethylene tetraffluoroethylene (ETFE). The devices are 3.0 meters (9.8 ft) in length and are terminated with a laser specific SMA 905 connector plus a strain relief on the proximal end. Different distal tip configurations and various core diameter sizes (150, 200, 272, 365, 400, 550, 600, 800 and 1000 microns) are offered.
Description of the modifications: The difference between modified and unmodified devices is limited to the labeling information regarding reprocessing instructions.
The intended use and the indications for use of the modified Intended use device and the unmodified device are exactly the same, as follows -
Quanta System Surgical Laser Fibers are intended to be used in coniunction with any cleared surgical laser manufactured by Quanta System equipped with SMA 905 or SMA 906 or compatible connector.
Quanta System Surgical Laser Fibers are indicated for use in general surqical applications for: incision, excision, vaporization. ablation, hemostasis or coagulation of soft tissue in a contact or non-contact mode (with a compatible laser marketed for use in the desired application).
Quanta System Surgical Laser Fibers (surgical fiber optic laser delivery devices) are indicated for use in general surgery urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT/otolaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, or lesions, tissue vaporization, hemostasis and or coagulation may be indicated with an approved compatible laser marketed for use in the desired application.
6
| Performance data: | In addition to the performance data provided for the unmodified device (K131473), the modified device reprocessing instructions have been validated. |
|---|---|
| Biocompatibility: | The materials of the modified and unmodified device have no differences that affect biocompatibility. |
| Substantial Equivalence: | The modified Surgical Laser fibers has the same intended use, the same indications for use and the same fundamental scientific technology as the unmodified Surgical Laser fibers (K131473). |
Quanta System Surgical Laser Fibers are also intended as an aid
for otologic procedures, for use in incision, excision, coagulation
and vaporization of soft and fibrous tissue including osseous
tissue with an approved compatible laser marketed for use in the
desired application.
Quanta System Surgical Laser Fibers are also indicated for use in
lithotripsy with an approved compatible laser marketed for use in
the desired application.
Quanta System Surgical Laser Fibers are indicated for use with
laser devices emitting radiation from 532 nm to 2100 nm, with
pulsed and continuous wave (CW) emission mode.
Quanta System Surgical Laser Fibers are indicated, but not
limited, for use with Diode laser, Argon, KTP/532, Ho;YAG,
Nd:YAG, Tm:YAG pulsed and continuous wave CW laser devices.
Quanta System Surgical Laser Fibers may be used in surgical
specialty or procedures for which compatible lasers have received
regulatory clearance: for a complete information about
applications, contraindications, precautions and warnings when
using fiber optic it is necessary to refer to the applicable laser
device User Manual.
Quanta System Surgical Laser Fibers have the same components
and the same technological characteristics -as the predicate
devices. The fiber core and cladding are made from silica which is
the same - material used in all the predicate devices. The fiber is
jacketed with ethylene tetraffluoroethylene (ETFE) which is the
same patient-contacting material used in all the predicate
devices .
Quanta System Surgical Laser Fibers do not have any
technological difference compared to predicate devices.
Quanta System Surgical Laser Fibers have the same intended use
as the predicate devices.
Nonclinical performance tests demonstrate that the modified
device is as safe and effective as the unmodified device.5-3
7
Thus Quanta System Surgical Laser Fibers are substantially equivalent to the legally marketed predicate devices