(31 days)
Not Found
No
The 510(k) summary describes a laser fiber optic cable and its intended use with specific laser systems. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The description focuses solely on the physical components and function of the fiber.
Yes
The device is described as being used in surgical procedures for various therapeutic actions such as vaporization, ablation, coagulation, hemostasis, excision, resection, incision of tissue, and fragmentation of calculi. These actions directly treat medical conditions.
No
The device is described as a laser fiber used for surgical procedures like vaporization, ablation, and fragmentation, indicating a therapeutic rather than a diagnostic purpose.
No
The device description explicitly states it is a "fiber optic laser energy delivery device consisting of a silica core fiber jacketed with ethelylene tetraflouroethylene (ETFE) and a SMA 905 connector." This describes physical hardware components, not software.
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 for surgical procedures involving the delivery of laser energy for actions like vaporization, ablation, coagulation, etc., on soft and cartilaginous tissue and fragmentation of calculi. This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The description details a fiber optic laser energy delivery device, which is consistent with a surgical tool, not a device used for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue samples, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. This device's function is to deliver laser energy directly to tissue or calculi within the body during a surgical procedure.
N/A
Intended Use / Indications for Use
The Straight Fire Laser 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 have been cleared for surgical use.
Product codes
GEX
Device Description
The proposed modified Straight Fire 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 holmium (Ho:YAG) and neodymium (Nd:YAG) lasers with a standard SMA 905 connector that have been cleared for surgical use. Recommended lasers are Lumenis VeraPulse® PowerSuite™ Laser Systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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.
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100078
FEB 1 2 2010
Boston Scientific Corporation
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CONFIDENTIAL
| 510(k) Summary for Modified Straight Fire Laser Fiber | |
|---|---|
| A. Sponsor | Boston Scientific Corporation |
| Urology and Women's Health Division | |
| 100 Boston Scientific Way | |
| Marlborough, MA 01756 | |
| B. Contact | Janet A. McGrath |
| Specialist, Regulatory Affairs | |
| 508-683-4726 | |
| 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 Modified Straight Fire | |
| Laser Fiber | |
| Common/usual name: | |
| Classification Name: | Laser Instrument, Surgical, Powered |
| 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: | 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 | |
| Premarket Notification: | Boston Scientific; K082928 |
| Trade name: | SlimLineEZTM 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: | Lumenis; K011703 |
| Traditional 510(k) | |
| Modified Straight Fire Laser Fiber | |
| February 1, 2010 |
P. 1 of 2
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Boston Scientific Corporation
E. Device Description
The proposed modified Straight Fire 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 holmium (Ho:YAG) and neodymium (Nd:YAG) lasers with a standard SMA 905 connector that have been cleared for surgical use. Recommended lasers are Lumenis VeraPulse® PowerSuite™ Laser Systems.
F. Intended Use
The Straight Fire Laser 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 have been cleared for surgical use.
G. Technological Characteristics
The proposed modified Straight Fire Laser Fiber has the same technological characteristics (i.e. SMA 905 connector, length of fiber connector type, fiber core, and strain relief) as the predicate device.
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 proposed modified Straight Fire Laser Fiber is as safe, as effective, and performs as well as the predicate device.
Traditional 510(k) Modified Straight Fire Laser Fiber February 1, 2010
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 1 2 2010
Boston Scientific Corp. % Intertek Testing Services Mr. Daniel W. Lehtonen 2307 East Aurora Road Unit B7 Twinsburg, Ohio 44087
Re: K100078
Krood76
Trade/Device Name: Modified Straight Fire Laser Fiber Regulation Number: 21 CFR 878.4810 Regulation Number. 21 CFR 876.4616
Regulation Name: Laser surgerical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: Class II Product Code: GEX Dated: February 2, 2010 Received: February 3, 2010
1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dear Mr. Lehtonen:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(t) premained is substantially equivalent (for the indications
referenced above and have determined the device is substancements in interstat referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to legally manced promises and Device Amendments, or to commerce prior to May 28, 1970, the chaculence with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance who was and application (PMA).
and Cosmetic Act (Act) that do not require approval sentrals provisions of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The You may, therefore, market the device, stolect to the gentlations of the mained with and general controls provisions of the Act mender requirement as a sunst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
in the states the started and main major resultstips affecting your d If your device is classified (see adver) micr ciass in (epicisms affecting your device can be
may be subject to additional controls. Existing major regulation FDA may may be subject to additional controls. Existing major regarations on and one of the Sederal Register found in the Code of Federal Regulations, This 2017-11-2017
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 Please be advised that FDA s issuance of a substance organies with other requirements of the Act
that FDA has made a determination that your device and agencies. You must that FDA has made a determination that your device compiles Federal agencies. You must
and the first of the states
. . .
: " :'
:
.'
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Page 2 - Mr. Daniel W. Lehtonen
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-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 forth in the quant by over 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 n 70d abblic upvw.fda.gov/AboutFDA/CentersOffices/CDRHOffices/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 note the for questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ 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 r out may obtain only general reservers, 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/cdrh/industry/support/index.html.
Sincerely yours,
For Rh m
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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Boston Scientific Corporation
CONFIDENTIAL
Indications for Use Statement
K/000 510(k) Number (if Known):
Device Name: Undetermined
Indications For Use:
The Straight Fire Laser Fiber is designed for use with Ho: Y AG and Nd: Y AG 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 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) | |||
|---|---|---|---|
| (Division Sign-Off) | |||
| Division of Surgical, Orthopedic, | |||
| and Restorative Devices. | |||
| Traditional 510(k) | |||
| Modified Straight Fire Laser Fiber | |||
| February 1, 2010 | 510(k) Number1400078 | 510(k) Number | 1400078 |
| 510(k) Number | 1400078 |
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