(47 days)
Not Found
No
The document describes a laser fiber optic cable and its physical characteristics and performance testing. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is designed for surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection, incision of tissues, and fragmentation of calculi, which are all therapeutic actions.
No
The device description indicates that the Flexiva SF is a fiber optic laser energy delivery device used for surgical procedures like vaporization, ablation, and coagulation, which are therapeutic actions, not diagnostic.
No
The device description explicitly details physical components such as an SMA-905 connector, coated silica core fiber, ETFE jacket, metal cap, adjustable hand piece, and rigid tubing, indicating it is a hardware device for delivering laser energy.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures involving the direct application of laser energy to tissue and calculi within the body. This is a therapeutic and surgical application, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a fiber optic laser energy delivery device designed to transmit laser energy for surgical purposes. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a surgical tool for delivering laser energy during procedures, which falls under the category of therapeutic or surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Flexiva SF Side-Firing Single-Use Laser Fiber is designed for use with Ho:YAG lasers for indications that are cleared for these laser systems, including, but not limited to endoscopic, and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision of soft and cartitaginous tissue, and fragmentation of urinary and biliary calculi (Ho:YAG wavelength only). The fiber is designed for use with a standard SMA-905 connector that has been cleared for surgical use.
Product codes
GEX
Device Description
The Flexiva SF Side-Firing Single-Use Laser Fibers (Flexiva SF) are fiber optic laser energy delivery devices consisting of an SMA-905 connector and a coated silica core fiber jacketed with ethylene tetrafluoroethylene (ETFE). The Flexiva SF fibers are equipped with a metal cap with circumferential solid black line guides, an adjustable hand piece and rigid tubing. The laser aperture is located near the tip of the metal cap. Laser energy is delivered at an approximately 70° angle to tissue from the tip of the fiber. The line guides assist with correct positioning of the fiber tip within the endoscope. The adjustable hand piece enables manipulation of the laser fiber tip at the treatment site. The rigid tubing aids in control of the fiber tip. These fibers may be used in a variety of laserbased surgical cases as an integral part of laser systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft and cartilaginous tissue, urinary and biliary (calculi)
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)
Boston Scientific has conducted performance testing with samples aged at T=0 and T=6 months accelerated aging in support of the proposed laser device. The following testing was completed to evaluate the effects of the design change:
- Operating Life .
- Hand-Piece Retention Strength ●
- Initial Fiber Power Transmission .
- Fiber Power Transmission .
- Fiber Control .
- Protective Cap Retention Strength .
- Fiber Length .
- Distal Fiber Max OD .
- . Aiming Beam
- . Connector Temperature/Durability
- Connector Tensile . .
- Seal Integrity .
- Seal Strength .
The results of the performance testing demonstrate that the Flexiva SF fiber is considered safe and effective for its intended use.
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
APR 1 5 2014
Side-Firing Laser Fiber Traditional 510(k)
K140503 Boston Scientific
510K SUMMARY SECTION 5 . .
510(k) Summary for Flexiva™ SF Side-Firing Single-Use Laser Fiber
A. Sponsor
Boston Scientific Corporation Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01756
B. Contact
Jeanne O'Toole Senior Specialist, Regulatory Affairs' ·508-683-4271 jeanne.otoole@bsci.com
or
Nichole Riek Manager, Regulatory Affairs 508-683-4175 nichole.riek@bsci.com
C. Device Name
Flexiva™ SF Side-Firing Single-Use Laser Fiber Trade name: Common usual/name: Laser Instrument, Surgical, Powered GEX - Laser surgical instrument for use in general and Classification: plastic surgery and in dermatology 21 CFR 878.4810. Class II
D. Predicate Device(s)
| Trade name: | DuoTome™ SideLite™ Fiber (cleared under K011703 as
Lumenis delivery devices) |
|--------------------|---------------------------------------------------------------------------------------------------------------------------|
| Common usual/name: | Laser Instrument, Surgical, Powered |
| Classification: | GEX - Laser surgical instrument for use in general and
plastic surgery and in dermatology
21 CFR 878.4810, Class II |
Premarket Notification: Lumenis, K011703
and
| Trade name: | Flexiva™ High Power Single-Use Laser Fiber (cleared under K100078 as Modified Straight Fire Laser Fiber) |
|---|---|
| Common usual/name: | Laser Instrument, Surgical, Powered |
| Classification: | GEX - Laser surgical instrument for use in general and plastic surgery and in dermatology |
| 21 CFR 878.4810, Class II | |
| Premarket Notification: | Boston Scientific K100078 |
Premarket Notification: Boston Scientific, K 100078
1
510K SUMMARY SECTION 5
E. Device Description
The Flexiva SF Side-Firing Single-Use Laser Fibers (Flexiva SF) are fiber optic laser energy delivery devices consisting of an SMA-905 connector and a coated silica core fiber jacketed with ethylene tetrafluoroethylene (ETFE). The Flexiva SF fibers are equipped with a metal cap with circumferential solid black line guides, an adjustable hand piece and rigid tubing. The laser aperture is located near the tip of the metal cap. Laser energy is delivered at an approximately 70° angle to tissue from the tip of the fiber. The line guides assist with correct positioning of the fiber tip within the endoscope. The adjustable hand piece enables manipulation of the laser fiber tip at the treatment site. The rigid tubing aids in control of the fiber tip. These fibers may be used in a variety of laserbased surgical cases as an integral part of laser systems.
F. Intended Use
The Flexiva SF fiber is designed for use with Ho:YAG and Nd:YAG lasers for indications that are cleared for these laser systems, including, but not limited to endoscopic, laparoscopic, and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection, incision of soft and cartilaginous tissue, and fragmentation of urinary and biliary calculi (Ho:YAG wavelength only). The fiber is designed for use with a standard SMA-905 connector that has been cleared for surgical use.
G. Technological Characteristics
The Flexiva SF fiber has the same technological characteristics and fundamental design as the predicate devices. The proposed Flexiva SF fiber is available in a single configuration.
H. Substantial Equivalence
A direct comparison of key characteristics demonstrates that the Flexiva SF fiber is substantially equivalent to the predicate devices in terms of intended use, technological characteristics, and performance characteristics. The Flexiva SF fiber is as safe and effective as the predicate devices.
I. Performance Testing (Bench Evaluation)
Boston Scientific has conducted performance testing with samples aged at T=0 and T=6 months accelerated aging in support of the proposed laser device. The following testing was completed to evaluate the effects of the design change:
- Operating Life .
- Hand-Piece Retention Strength ●
- Initial Fiber Power Transmission .
- Fiber Power Transmission .
- Fiber Control .
2
Side-Firing Laser Fiber Traditional 510(k)
SECTION 5 -510K SUMMARY 11
- Protective Cap Retention Strength .
- Fiber Length .
- Distal Fiber Max OD .
- . Aiming Beam
- . Connector Temperature/Durability
- Connector Tensile . .
- Seal Integrity .
- Seal Strength .
The results of the performance testing demonstrate that the Flexiva SF fiber is considered safe and effective for its intended use.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 15, 2014
Boston Scientific Corporation Ms. Jeanne O'Toole Senior Specialist, Regulatory Affairs 100 Boston Scientific Way Marlborough, Massachusetts 01756
Re: K140503
Trade/Device Name: Flexiva" SF Side-Firing Single-Use Laser Fiber 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 31, 2014 Received: April 1, 2014
Dear Ms. O'Toole:
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 10 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 docs 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 that I Dri has made a and regulations administered by other Federal agencies. You must or any Federal 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
4
Page 2 - Ms. Jeanne O'Toole
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 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.
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K140503
Device Name
Flexiva™ SF Side-Firing Single-Use Laser Fiber
Indications for Use (Describe)
The Flexiva SF Side-Firing Single-Use Laser Fiber is designed for use with Ho:Y AG lasers for indications that are cleared for these laser systems, including, but not limited to endoscopic, and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision of soft and cartitaginous tissue, and fragmentation of urinary and biliary calculi (Ho:Y AG wavelength only). The fiber is designed for use with a standard SMA-905 connector that has been cleared for surgical use.
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)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Consistence of Center for Devices and Radiological Health (CDRH) (original)
Neil R Oga 2014.04.14 1
FORM FDA 3881 (1/14) For BSA