(21 days)
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Not Found
No
The summary describes a laser surgical fiber and does not mention any AI or ML capabilities.
Yes
The device is described as a fiber intended for use in "laser surgical procedures for cutting, vaporizing or coagulating in any soft tissue application." These actions are directly aimed at treating or alleviating a disease, injury, or medical condition, which aligns with the definition of a therapeutic device.
No
The device is described as a fiber for laser surgical procedures for cutting, vaporizing, or coagulating soft tissue, which indicates a therapeutic rather than a diagnostic function.
No
The device description explicitly states "Lateral Emitting Fiber," which is a physical hardware component used in laser surgical procedures. The intended use also describes surgical procedures involving cutting, vaporizing, or coagulating, which are physical actions performed by a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for surgical procedures involving cutting, vaporizing, or coagulating soft tissue using lasers. This is an in vivo application (within a living organism).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This device does not perform such tests.
- Device Description: The description is of a surgical fiber, not a diagnostic test kit or instrument.
The information provided focuses on a surgical tool used directly on a patient, not on analyzing biological samples outside the body.
N/A
Intended Use / Indications for Use
The ScatterFree™ Lateral Emitting Fiber is intended for use in General, Urological, OB-GYN, Orthopedic and ENT laser surgical procedures for cutting, vaporizing or coagulating in any soft tissue application for which compatible Nd:YAG, KTP and Ho:YAG lasers have been cleared.
Product codes
GEX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
soft tissue
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/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. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird, with a smaller curved line representing the head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1.2 1999
Ms. Nancy L. Arnold President Laser Peripherals, Inc. 5484 Feltl Road Minnetonka, Minnesota 55343
Re: K992083
Trade Name: ScatterFree™ Lateral Emitting Fiber Regulatory Class: II Product Code: GEX Dated: June 18, 1999 Received: June 21, 1999
Dear Ms. Arnold:
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 current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 - Ms. Nancy L. Arnold
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,
Celia B. Fisher, Ph.D.
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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ATTACHMENT B
Indications for Use Statement
992083
510(k) Number
ScatterFree™ Lateral Emitting Fiber Device Name
The ScatterFree™ Lateral Emitting Fiber is intended for use in Indications General, Urological, OB-GYN, Orthopedic and ENT laser surgical For Use procedures for cutting, vaporizing or coagulating in any soft tissue application for which compatible Nd:YAG, KTP and Ho:YAG lasers have been cleared.
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| OR | |
| Over-The-Counter Use |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K992083 |
|---|---|
| --------------- | --------- |