(163 days)
Ablation and hemostasis in the treatment of gynecological and urological conditions, as well as multiple applications in gastroenterology and general surgery.
The StrateFire™ Reusable Optical Fiber is a fiberoptic laser energy delivery system intended for use with any surgical laser equipment fitted with SMA-905 compatible connectors and designed to operate at wavelengths between 532 and 1400 nm. The StrateFire™ Reusable Optical Fiber consists of a 400, 600, 800 or 1,000 micron diameter fused silica optical fiber with a proximal SMA-905 connector for attaching to a medical laser. Fibers are supplied sterile in heat-sealed Tyvek and may be reused after cleaning and sterilization as directed in the labeling.
The provided text is a 510(k) summary for the StrateFire™ Reusable Optical Fibers, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a detailed clinical study with AI components. Therefore, many of the requested sections about AI study design and endpoints will not be applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state numerical acceptance criteria for performance metrics. Instead, it relies on demonstrating comparable performance to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Comparable optical performance to predicate devices | "Optical performance testing has demonstrated comparable performance of the [StrateFire™] to the SideFire™ - Tipped Optical Fiber." |
| Safe for intended use (ablation and hemostasis) | "concluded that the StrateFire™ Reusable Optical Fibers are safe and effective for their intended use" |
| Effective for intended use (ablation and hemostasis) | "concluded that the StrateFire™ Reusable Optical Fibers are safe and effective for their intended use" |
| Performs at least as well as legally marketed predicate devices | "perform at least as well as legally marketed predicate devices" |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "optical performance testing" but does not specify the sample size for this testing. It also does not mention data provenance (e.g., country of origin, retrospective or prospective data) as it's not a clinical study involving patient data. This testing would involve laboratory-based measurements of the optical fibers themselves.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the analysis is based on physical and optical performance testing of a medical device, not on interpreting medical images or data that would require expert ground truth.
4. Adjudication Method for the Test Set
This is not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically involves human readers interpreting cases, often with and without AI assistance, to measure diagnostic performance. The StrateFire™ Reusable Optical Fiber is a physical laser delivery system, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This is not applicable. The device is an optical fiber, not an algorithm. The "optical performance testing" mentioned refers to the physical and functional characteristics of the fiber itself, not the performance of an AI algorithm.
7. Type of Ground Truth Used
The ground truth for this type of device would be established through engineering and scientific measurements of the optical fiber's properties (e.g., power transmission, output beam profile, integrity after sterilization cycles, etc.) and comparison to the specifications and performance of the predicate devices. It is not based on expert consensus, pathology, or outcomes data in the typical sense for diagnostic or prognostic devices.
8. Sample Size for the Training Set
This is not applicable as there is no AI algorithm being trained for this device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no AI algorithm being trained for this device.
Summary of the Study (as described in the 510(k) summary):
The manufacturer, MyriadLase, Inc., performed "optical performance testing" on the StrateFire™ Reusable Optical Fibers. The goal of this testing was to demonstrate that the device's optical performance was comparable to its legally marketed predicate device, the SideFire™ - Tipped Optical Fiber. The 510(k) submission states that the testing showed comparable performance, leading to the conclusion that the StrateFire™ fibers are safe and effective for their intended use and perform at least as well as the predicate devices. The specific details of this testing (e.g., methods, exact parameters measured, number of units tested) are not provided in this summary.
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K965180
510 (k) SUMMARY
ADMINISTRATIVE .
Submitter: MyriadLase, Inc. 1315 FM 1187 Mansfield, Texas 76063 817-477-2041
Contact Person: Dr. Royice Everett
Date of Preparation: April 18, 1997
DEVICE NAME ﺍﻟﻤﻌﺎﺭﺿﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
Proprietary Name: StrateFire™ Reusable Optical Fibers Common Name: Reusable Laser Fiber Classification Name: Fiberoptic Laser Delivery System
============================================================================================================================================================================== PREDICATE DEVICES
SideFire™ - Tipped Optical Fibers, MyriadLase, Inc.; K920553 SideFire™ - Tipped Reusable Optical Fibers, MyriadLase, Inc .; K952733 Laserguide Surgi Light Optical Fibers, Surgimedics; K914396
IV. DEVICE DESCRIPTION
The StrateFire™ Reusable Optical Fiber is a fiberoptic laser energy delivery system intended for use with any surgical laser equipment fitted with SMA-905 compatible connectors and designed to operate at wavelengths between 532 and 1400 nm.
The StrateFire™ Reusable Optical Fiber consists of a 400, 600, 800 or 1,000 micron diameter fused silica optical fiber with a proximal SMA-905 connector for attaching to a medical laser. Fibers are supplied sterile in heat-sealed Tyvek and may be reused after cleaning and sterilization as directed in the labeling.
V. INTENDED USE
Ablation and hemostasis in the treatment of gynecological and urological conditions, as well as multiple applications in gastroenterology and general surgery.
VI. COMPARISON TO PREDICATE DEVICES
The StrateFire™ Reusable Optical Fibers are similar in design, and identical in function and intended use, to other laser optical fibers, such as the MyriadLase SideFire™ - Tipped Optical Fibers (K920553) and SideFire™ - Tipped Reusable Optical Fibers (K952733), and Surqimedics Laserguide® Surqi Light Optical Fibers,
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(K914396). Optical performance testing has demonstrated comparable performance of the to the SideFire™ - Tipped Optical Fiber.
Accordingly, MyriadLase, Inc., concluded that the StrateFire™ Reusable Optical Fibers are safe and effective for their intended use and perform at least as well as legally marketed predicate devices, such as the SideFire™ - Tipped Optical Fibers, SideFire™ - Tipped Reusable Optical Fibers, and Surgimedics Laserguide® Surgi Light Optical Fibers.
-3. .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 5 1997
MyriadLase, Inc. c/o Mr. Richard A. Hamer Richard Hamer Associates, Inc ... PO Box 16598 Ft. Worth, Texas 76162-0958
小 Re:
K965180 Trade Name: Stratefire™ Reusable Optical Fibers Regulatory Class: II Product Code: GEX Dated: April 18, 1997 Received: April 21, 1997
Dear Mr. Hamer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Richard A. Hamer
新闻网 作者:
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
towelly
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K965180 |
|---|---|
| Device Name: | STRATEFIREStraightFire Reusable Optical Fibers |
Indications for Use:
Ablation and hemostasis in treatment of gynecological and urological 公 conditions, as well as multiple applications in gastroenterology and general surgery.
(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 General Restorative Devices
510(k) Number k9 65/80
510(k) Number
Division of General Restorative Devices
(Division Sign-Off)
Prescription Use (Per 21 CFR 801 109)
ાર
Over-the-Counter Use_
(Optional Format 1-2-96)
§ 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.