(73 days)
No
The description focuses on the physical components and optical properties of a fiber optic delivery system for laser energy, with no mention of AI or ML capabilities.
Yes
The device is described as a "delivery accessory used to deliver optical energy" for "hemostasis, ablation and vaporization of soft or fibrous tissue," which are therapeutic actions.
No
This device is a delivery accessory for optical energy, used in surgical applications like hemostasis, ablation, and vaporization of tissue. It does not perform any diagnostic function.
No
The device description explicitly details physical components like fiber optic cables, cladding, jacketing, and a bent tip, indicating it is a hardware device for delivering optical energy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Twister™ Side-Fire Fiber Optic Delivery System is a surgical accessory used to deliver laser energy to soft or fibrous tissue for hemostasis, ablation, and vaporization. It is a tool used during a surgical procedure, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states its purpose in surgical applications for tissue modification, not for analyzing biological samples.
Therefore, the device's function and intended use fall outside the scope of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Twister™ Side-Fire Fiber Optic Delivery System is a delivery accessory used to deliver optical energy and is indicated for use in general surgical applications in combination with any SMA-compatible laser system also indicated for the same applications. It is indicated for use in hemostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline in contact or non-contact mode with a compatible laser marketed for the desired application. The system can be used with or without a standard viewing scope. It can be inserted through the working channel of a cystoscope, urethroscope, or any other viewing scope.
The Twister™ Side-Firing Fiber Optic Delivery System is intended for use as a fiber optic delivery system in conjunction with any surgical laser with SMA 905 compatible connector. The Twister™ Side-Firing Fiber Optic Delivery System is indicated for hemostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline in contact or non contact mode with a compatible laser, marketed for the desired application. The system can be used with or without a standard viewing scope. It can be inserted through the working channel of a cystoscope, urethroscope, or any other viewing scope.
Product codes
GEX
Device Description
The Biolitec SIA Twister™ Side-Fire Fiber Optic Delivery System contains identical components and identical patient contact materials as the cleared Biolitec Medical Devices, Inc. Twister™ Side Fire Fiber Optic Delivery System.
Twister is a fiber optic delivery system designed to deliver optical energy from a surgical laser to soft or fibrous tissue for the indicated uses. The distal end of the Twister possesses a slight bend at the capillary tip, producing 30° lateral firing which is identical to the predicate. The fiber makeup remains silica, silica cladding, hard plastic cladding, and Tefzel jacketing as is the predicate. The numerical aperture (NA) of the fiber however is 0.26/ 0.37 (whereas the predicate is 0.22/ 0.37) giving a better coupling efficiency and correcting for the truncation in power transmission seen with the predicate fiber when using larger NA lasers.
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)
Since the performance of the Twister™ Side-Fire Fiber Optic Delivery System is well established and documented on soft tissue no performance testing is being specifically included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
K120437 - 510(k) Summary ister™ Side-Firing Fiber Optic Delivery System
Submitter's Name Biolitec SIA
Address
Kaniera iela 10a, Riga, LV-1063 Latvia
Telephone Number, Contact Person and Date Prepared Phone: (413) 525-0600/ 413 250-0779 (Cell) Facsimile: (413) 525-0611
Contact Person: Harry Hayes, Ph.D. - Regulatory Consultant Date prepared: February 10, 2012
Name of Device and Name/Address of Sponsor
Twister™ Side-Firing Fiber Optic Delivery System
Biolitec SIA Kaniera iela 10a, Riga, LV-1063 Latvia
Classification Name
Surgical laser & accessories
Common Name of Device
Twister™, SF & L
Predicate Devices
Twister™ Side Fire Fiber Optic Delivery System, (K112987) Evolve® 980-1470nm Multiwavelength Diode Laser, (K112013)
Intended Use/Indication for Use
The Twister™ Side-Fire Fiber Optic Delivery System is a delivery accessory used to deliver optical energy and is indicated for use in general surgical applications in combination with any SMA-compatible laser system also indicated for the same applications. It is indicated for use in hemostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline in contact or non-contact mode with a compatible laser marketed for the desired application. The system can be used with
1
or without a standard viewing scope. It can be inserted through the working channel of a cystoscope, urethroscope, or any other viewing scope.
Technological Characteristics
The Biolitec SIA Twister™ Side-Fire Fiber Optic Delivery System contains identical components and identical patient contact materials as the cleared Biolitec Medical Devices, Inc. Twister™ Side Fire Fiber Optic Delivery System.
Twister is a fiber optic delivery system designed to deliver optical energy from a surgical laser to soft or fibrous tissue for the indicated uses. The distal end of the Twister possesses a slight bend at the capillary tip, producing 30° lateral firing which is identical to the predicate. The fiber makeup remains silica, silica cladding, hard plastic cladding, and Tefzel jacketing as is the predicate. The numerical aperture (NA) of the fiber however is 0.26/ 0.37 (whereas the predicate is 0.22/ 0.37) giving a better coupling efficiency and correcting for the truncation in power transmission seen with the predicate fiber when using larger NA lasers.
Performance Data
Since the performance of the Twister™ Side-Fire Fiber Optic Delivery System is well established and documented on soft tissue no performance testing is being specifically included in this submission.
Substantial Equivalence
The Twister™ Side-Fire Fiber Optic Delivery System is as safe and effective for these Indications for Use as the Biolitec Medical Devices, Inc's Side Fire Fiber Optic Delivery System. Thus, the Twister™ Side-Fire Fiber Optic Delivery System for Biolitec SIA is substantially equivalent to its predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biolitec SIA % Genmarhay BDA Harry Hayes, Ph.D. 1349 Main Road Granville, Massachusetts 01034
APR 2 6 2012
Re: K120437
Trade/Device Name: Twister™ Side-Firing Fiber Optic Delivery System Regulation Number: 21 CFR 878.4810
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: II Product Code: GEX Dated: April 11, 2012 Received: April 13, 2012
Dear Dr. Hayes:
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
3
Page 2 - Harry Hayes, Ph.D.
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K120437
Device Name:
Twister™ Side-Firing Fiber Optic Delivery System
Indications for Use:
The Twister™ Side-Firing Fiber Optic Delivery System is intended for use as a fiber optic delivery system in conjunction with any surgical laser with SMA 905 compatible connector. The Twister™ Side-Firing Fiber Optic Delivery System is indicated for hemostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline in contact or non contact mode with a compatible laser, marketed for the desired application. The system can be used with or without a standard viewing scope. It can be inserted through the working channel of a cystoscope, urethroscope, or any other viewing scope.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ ·(Per 21 C.F.R. 801:109) OR
Over The Counter Use (Optional Format 1-2-96)
.l. RP Oyler for mxn
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120437
GBDA/ BioSIA-TW-021012-01