(17 days)
Not Found
No
The document describes a laser fiber optic cable and its intended use in surgical procedures. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is a laser energy delivery system used for surgical procedures like vaporization, ablation, and fragmentation, and does not provide therapy itself.
No
Explanation: The device description and intended use focus on surgical applications (vaporization, ablation, fragmentation, coagulation, hemostasis, excision, resection, and incision) rather than diagnosis. It delivers laser energy for therapeutic purposes.
No
The device description explicitly states it is a "fiber optic laser energy delivery device consisting of a SMA-905 connector, strain relief, and a silica core fiber jacketed with ethylene tetrafluoroethylene (ETFE)." 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 during surgical procedures to deliver laser energy for various tissue and calculus treatments. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically on biological samples).
- Device Description: The description details a fiber optic laser energy delivery device, which is consistent with a surgical tool, not a diagnostic test performed on samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the AccuTrac Laser Fibers are a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AccuTrac Laser Fibers are 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 AccuTrac Laser Fibers are 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 AccuTrac Laser Fibers are fiber optic laser energy delivery devices consisting of a SMA-905 connector, strain relief, and a silica core fiber jacketed with ethylene tetrafluoroethylene (ETFE). The AccuTrac fibers are equipped with a polished and reinforced ball-shaped TracTip. These fibers 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. Please refer to the laser system User Manual for complete information regarding applications, contraindications, precautions and warnings.
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)
Boston Scientific has conducted performance testing with samples aged at T=0 and T=13 months accelerated aging in support of the distal ball tip design change. The following testing was completed to evaluate the effects of the design change:
- Tip Fracture Resistance .
- . Scope Testing
- Power Rating/Output Efficiency Testing .
- Aiming Beam Testing .
The results of the performance testing demonstrate equivalence of the AccuTrac to the predicate AccuMax and Flexiva laser fibers. The AccuTrac fibers are considered safe and effective for their intended use.
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
510(k) Summary for AccuTrac Laser Fiber
A. Sponsor
MAR 2 8 2011
Boston Scientific Corporation Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01756
B. Contact
Lauren Anderson Senior Specialist, Regulatory Affairs 508-683-4707 lauren.anderson@bsci.com
or
Nichole Riek Manager, Regulatory Affairs 508-683-4175 riekn@bsci.com
C. Device Name
AccuTracTM 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
D. Predicate Device(s)
AccuMax™ (Straight Fire Holmium Laser Fiber) 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: Boston Scientific, K082928
And
FlexivaTM (Modified Straight Fire Laser Fiber) 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: Boston Scientific, K100078
E. Device Description
The AccuTrac Laser Fibers are fiber optic laser energy delivery devices consisting of a SMA-905 connector, strain relief, and a silica core fiber jacketed
1
with ethylene tetrafluoroethylene (ETFE). The AccuTrac fibers are equipped with a polished and reinforced ball-shaped TracTip. These fibers 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. Please refer to the laser system User Manual for complete information regarding applications, contraindications, precautions and warnings.
F. Intended Use
The AccuTrac Laser Fibers are 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 AccuTrac Laser Fibers are 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 AccuTrac Laser Fiber has the same technological characteristics (i.e. SMA 905 connector, length of fiber optic cable, and strain relief) as the predicate devices. It is equipped with a polished and reinforced ball-shaped output tip, whereas the predicate devices have a polished flat tip.
H. Substantial Equivalence
A direct comparison of key characteristics demonstrates that the proposed laser fiber is substantially equivalent to the predicate devices in terms of intended use, technological characteristics, and performance characteristics. The AccuTrac Laser Fiber is as safe, as effective, and performs as well as the predicate devices.
I. Performance Testing (Bench and User Evaluation)
Boston Scientific has conducted performance testing with samples aged at T=0 and T=13 months accelerated aging in support of the distal ball tip design change. The following testing was completed to evaluate the effects of the design change:
- Tip Fracture Resistance .
- . Scope Testing
- Power Rating/Output Efficiency Testing .
- Aiming Beam Testing .
The results of the performance testing demonstrate equivalence of the AccuTrac to the predicate AccuMax and Flexiva laser fibers. The AccuTrac fibers are considered safe and effective for their intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines, suggesting a sense of care and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Boston Scientific Corporation % Ms. Lauren B. Anderson Senior Regulatory Affairs Specialist 100 Boston Scientific Way, M21 Marlborough, Massachusetts 01752
*** 2 8 300
Re: K110686 Trade/Device Name: AccuTrac™ 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: II Product Code: GEX Dated: March 24, 2011 Received: March 25, 2011
Dear Ms. Anderson:
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 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
3
Page 2 - Ms. Lauren B. Anderson
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 liast 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 (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-100.
If you desire specific advice for your device on our labeling regulation (21 CFR Pan 801), please go to http://www.fda.gov/AboutFDA/Centers0ffices/CDRH/CDRHOffices/ucm115809.html 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.ida.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 tolli inc (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Aling B. n h
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k) Premarket Notification AccuTrac Laser Fiber
Indications for Use Statement
510(k) Number To be determined.
Device Name
AccuTracTM Laser Fiber
Indications For Use
The AccuTrac Laser Fibers are intended for use in laser-based surgical applications, including, but not limited to, endoscopic, laparoscopic 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 AccuTrac Laser Fibers are designed for use with 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)
Nifel Coder for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number