(163 days)
Not Found
No
The device description and performance studies focus on the optical fiber's physical properties and performance in delivering laser energy, with no mention of AI or ML.
Yes
The device is described as a "fiberoptic laser energy delivery system" used for "ablation and hemostasis in the treatment of gynecological and urological conditions, as well as multiple applications in gastroenterology and general surgery," which clearly indicates a therapeutic purpose.
No
The device is described as an "energy delivery system" used for "ablation and hemostasis," which are therapeutic functions, not diagnostic ones. It delivers laser energy rather than collecting data for diagnosis.
No
The device description explicitly states it is a "fiberoptic laser energy delivery system" consisting of a physical optical fiber with connectors, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The StrateFire™ Reusable Optical Fiber is a surgical tool used to deliver laser energy directly to tissues within the body for ablation and hemostasis. It is used in vivo (within the living body), not in vitro (in glass/outside the body).
The intended use and device description clearly indicate its function as a surgical instrument for direct tissue treatment, which is not the purpose of an IVD.
N/A
Intended Use / Indications for Use
Ablation and hemostasis in the treatment of gynecological and urological conditions, as well as multiple applications in gastroenterology and general surgery.
Product codes
GEX
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.
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)
Optical performance testing has demonstrated comparable performance of the to the SideFire™ - Tipped Optical Fiber.
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
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,
10
1
(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. .
11
2
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
4
of 1 Page 1
| 510(k) Number (if known): | K965180 |
|---|---|
| Device Name: | STRATEFIRE |
| StraightFire 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)