(15 days)
Not Found
No
The 510(k) summary describes a passive laser fiber for energy delivery and does not mention any AI/ML components or functionalities.
Yes
The device is used in laser-based surgical applications for vaporization, ablation, and fragmentation of calculi, as well as procedures involving soft and cartilaginous tissue, which are direct interventions to treat conditions or achieve a therapeutic outcome.
No
The device is described as a laser fiber used for surgical procedures like vaporization, ablation, and fragmentation of tissues and calculi, which are therapeutic actions, not diagnostic ones.
No
The device description clearly states it is a fiber optic laser energy delivery device, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during surgical procedures on a patient's body (in vivo). It's used for delivering laser energy to perform actions like vaporization, ablation, and fragmentation of tissues and calculi.
- Device Description: The description details a fiber optic laser energy delivery device, designed to be connected to a surgical laser system. This is consistent with a surgical tool, not a device used to test samples outside the body (in vitro).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver energy for surgical intervention, not to analyze samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Straight Fire Holmium Laser Fiber is indicated for use in laser-based surgical applications, including, but not limited to endoscopic, laparascopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue.
The Straight Fire Holmium Laser Fiber is designed for use with holmium (Ho:YAG) lasers with a standard SMA-905 connector that have been cleared for surgical use.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Straight Fire Holmium Laser Fiber is a fiber optic laser energy delivery device consisting of a silica core fiber jacketed with ethelylene tetraflouroethylene (ETFE) and a SMA 905 connector. It is equipped with a polished, flat output tip. This fiber may be used in a variety of laser based surgical cases as an integral part of laser systems.
For use with Ho:YAG laser systems with a standard SMA 905 connector that have been cleared for surgical use. Recommended Ho: YAG lasers are Dornier and New Star.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Calculi (urinary and biliary) and soft and cartilaginous 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)
Not Found
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
Boston Scientific Corporation
510(k) Summary for Straight Fire Holmium Laser Fiber
A. Sponsor
Boston Scientific Corporation Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01756
B. Contact
Lauren B. Anderson Specialist, Regulatory Affairs 508-683-4707
or Donna Gardner Director, Regulatory Affairs 508-683-4398
C. Device Name
| Trade name: | To Be Determined
*Although the Trade Name is to be determined, for
purposes of this submission the proposed device will be
referred to as the Straight Fire Holmium Laser Fiber |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/usual name: | Laser Instrument, Surgical, Powered |
| Classification Name: | GEX - Laser surgical instrument for use in general and
plastic surgery and in dermatology
21 CFR 878.4810, Class II |
D. Predicate Device(s)
| Trade name: | AccuFlexTM Laser Lithotripsy Fibers |
|---|---|
| Common/usual name: | Laser Instrument, Surgical, Powered |
| Classification Name: | GEX - Laser surgical instrument for use in general and |
| plastic surgery and in dermatology | |
| 21 CFR 878.4810, Class II | |
| Premarket Notification: | InnovaQuartz, Inc., K050108 |
and
SlimLineEZ™ Fiber Device Trade name: Common/usual name: Laser Instrument, Surgical, Powered Classification Name: GEX - Laser surgical instrument for use in general and plastic surgery and in dermatology 21 CFR 878.4810, Class II Premarket Notification: Lumenis, K011703
Traditional 510(k) Straight Fire Holmium Laser Fiber August 25, 2008
1
Boston Scientific Corporation
E. Device Description
The Straight Fire Holmium Laser Fiber is a fiber optic laser energy delivery device consisting of a silica core fiber jacketed with ethelylene tetraflouroethylene (ETFE) and a SMA 905 connector. It is equipped with a polished, flat output tip. This fiber may be used in a variety of laser based surgical cases as an integral part of laser systems.
For use with Ho:YAG laser systems with a standard SMA 905 connector that have been cleared for surgical use. Recommended Ho: YAG lasers are Dornier and New Star.
F. Intended Use
The Straight Fire Holmium Laser Fiber is intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparascopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue.
The Straight Fire Holmium Laser Fiber is designed for use with holmium (Ho:YAG) lasers with a standard SMA 905 connector that have been cleared for surgical use.
G. Technological Characteristics
The Straight Fire Holmium Laser Fiber has the same technological characteristics (i.e. SMA 905 connector, length of fiber optic cable, and strain relief) as the predicate devices.
H. Substantial Equivalence
Utilizing FDA's Guidance for Industry and FDA Staff "Format for Traditional and Abbreviated 510(k)s" a direct comparison of key characteristics demonstrates that the proposed laser fiber is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and performance characteristics. The Straight Fire Holmium Laser Fiber is as safe, as effective, and performs as well as the predicate devices.
Traditional 510(k) Straight Fire Holmium Laser Fiber August 25, 2008
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
OCT 1 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corporation % Intertek Testing Services Kachi C. Enyinna Staff Engineer - Medical Devices 2307 East Aurora Road Twinsburg, Ohio 44087 .
Re: K082928
Trade/Device Name: Undetermined 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: September 30, 2008 Received: October 1, 2008
Dear Kachi Enyinna:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
3
Page 2 -- Kachi C. Enyinna
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Boston Scientific Corporation
Indications for Use Statement
510(k) Number (if Known): K082923
Device Name: Undetermined
Indications For Use:
The Straight Fire Holmium Laser Fiber is indicated for use in laser-based surgical applications, including, but not limited to endoscopic, laparascopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue.
The Straight Fire Holmium Laser Fiber is designed for use with holmium (Ho:YAG) lasers with a standard SMA-905 connector that have been cleared for surgical use.
Prescription Use X (21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
Hilke Olds for mixer
Division of General, Restorative. and Neurological Devices
Traditional 510(k) Straight Fire Holmium Laser Fiber August 25, 2008
510(k) Number K082928