(90 days)
No
The device description focuses on the physical characteristics and intended use of laser fibers for surgical procedures, with no mention of AI or ML technologies.
Yes
The device is used for cutting, vaporizing, or coagulating in any soft tissue application, which are therapeutic medical procedures.
No
The device description clearly states its purpose is for "cutting, vaporizing, or coagulating in any soft tissue application," which are therapeutic functions, not diagnostic ones.
No
The device description clearly describes physical components such as optical fibers, catheter tubes, cannulas, needles, handpieces, and handles, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "laser surgical procedures for cutting, vaporizing, or coagulating in any soft tissue application." This describes a surgical tool used directly on the patient's tissue.
- Device Description: The description details a "laser fiber" that transmits laser energy for surgical purposes. It mentions being used "intraoperatively and percutaneously."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for surgical intervention.
N/A
Intended Use / Indications for Use
The Clarus Model 1150 Straight Firing and the Clarus Model 1160 Side Firing Laser Fibers may be used both intraoperatively and percutaneously through regulatory cleared delivery systems.
The Clarus Straight Firing Laser Fiber and the Clarus Side Firing Lasers Fiber are 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 Ho:YAG lasers have been cleared.
Product codes
GEX
Device Description
This 510(k) submission is a modification of the existing Clarus Model 1150 Lascr Fiber previously filed as K922881 and found to be substantially equivalent by the FDA on November 16, 1992. The original 510(k) device was a single-use, straight firing laser fiber with a fiber indicated for laser disc decompression where the laser is used to remove inner disc material. The laser fiber core ranges from 380 -- 600 microns. The modifications represented by this submission are the addition of a reusable fiber, a side firing version (Model 1160), increased indications for any soft tissue application for which Ho:YAG lasers have been cleared, and an increased laser fiber core size range from 200 – 1000 microns.
The Model 1150 Clarus Straight Firing Fiber is identical in materials, methods of manufacture, sterilization, and dimensions to the currently marketed Clarus Model 1150 Laser Fiber (K922881) with the following exceptions. These exceptions are: making the fiber assembly reusable, increasing the range of the laser fiber core size from 380 - 600 microns to 200 - 1000 microns, and the indications for use. The distal end is polished flat and the laser energy is transmitted in a forward direction. The low OH fiber is terminated on the proximal end with a standard compatible laser connector. These devices consist of an optical fiber, which may be contained in a catheter tube, cannula. needle, handpiece or handle.
The Model 1160 Clarus Side Firing Laser Fiber is built identical to the Model 1150 Clarus Straight Firing Fiber listed above with the following exceptions. The exceptions being that the entire working length of the fiber is in a protective sheath and the distal end is polished at an angle, and then terminated in a quartz. cap. The distal tip includes an exit beam indicator that is easily visible to the operator when the fiber is placed through an endoscope. On the proximal end, the low OH fiber is terminated with a standard compatible laser connector.
The Clarus Model 1150 Straight Firing and the Clarus Model 1160 Side Firing Laser Fibers are supplied sterile (ETO) and are intended for reuse.
The Clarus Straight Firing and the Clarus Side Firing Laser Fibers may be used both intraoperatively and percutaneously through regulatory cleared delivery systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
K922881, K011207, K973172, K992083, K972272
Reference Device(s)
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
Section 4
لقرب المنتجات المنتجات المنتجات المنتجات المتحدة المنتخب المنتجات المنتجات المنتخب المنتجات المنتجات المنتجات المنتجات المنتجات المنتجات المنتجات المنتجات المنتجات المنتجات
510(k) Summary
General Information:
| General Information: | ||
|---|---|---|
| Submitted by: | Clarus Medical, LLC | |
| 1000 Boone Avenue North | ||
| Minneapolis, MN 55427 | ||
| Contact: | Tom Barthel, President | |
| Telephone | 763-525-8401 | |
| Facsimile | 763-525-8656 | |
| Summary Date | May 8, 2002 | |
| Device Name: | Model 1150 Clarus Straight Firing Laser Fiber | |
| Model 1160 Clarus Side Firing Laser Fiber | ||
| Common Name: | Low OH Laser Fiber | |
| Classification Name: | Laser surgical instrument for use in general and plastic | |
| surgery and in dermatology. |
Predicate Devices:
| 510(k) Number | Description | Manufacturer |
|---|---|---|
| K922881 | Model 1150 Laser Fiber | Clarus Medical, LLC |
| K011207 | Reusable Holmium Fiber | Laser Peripherals |
| K973172 | Resposable Holmium Bare Fibers | Trimedyne, Inc. |
| K992083 | Scatter Free Lateral Emitting Fiber | Laser Peripherals |
| K972272 | Laser Peripherals Holmium Bare Fibers | Laser Peripherals |
Intended Use:
.
The Clarus Model 1150 Straight Firing and the Clarus Model 1160 Side Firing Laser Fibers may be used both intraoperatively and percutaneously through regulatory cleared delivery systems.
Page 4.1
1
Device Description:
General
This 510(k) submission is a modification of the existing Clarus Model 1150 Lascr Fiber previously filed as K922881 and found to be substantially equivalent by the FDA on November 16, 1992. The original 510(k) device was a single-use, straight firing laser fiber with a fiber indicated for laser disc decompression where the laser is used to remove inner disc material. The laser fiber core ranges from 380 -- 600 microns. The modifications represented by this submission are the addition of a reusable fiber, a side firing version (Model 1160), increased indications for any soft tissue application for which Ho:YAG lasers have been cleared, and an increased laser fiber core size range from 200 – 1000 microns.
Construction
The Model 1150 Clarus Straight Firing Fiber is identical in materials, methods of manufacture, sterilization, and dimensions to the currently marketed Clarus Model 1150 Laser Fiber (K922881) with the following exceptions. These exceptions are: making the fiber assembly reusable, increasing the range of the laser fiber core size from 380 - 600 microns to 200 - 1000 microns, and the indications for use. The distal end is polished flat and the laser energy is transmitted in a forward direction. The low OH fiber is terminated on the proximal end with a standard compatible laser connector. These devices consist of an optical fiber, which may be contained in a catheter tube, cannula. needle, handpiece or handle.
The Model 1160 Clarus Side Firing Laser Fiber is built identical to the Model 1150 Clarus Straight Firing Fiber listed above with the following exceptions. The exceptions being that the entire working length of the fiber is in a protective sheath and the distal end is polished at an angle, and then terminated in a quartz. cap. The distal tip includes an exit beam indicator that is easily visible to the operator when the fiber is placed through an endoscope. On the proximal end, the low OH fiber is terminated with a standard compatible laser connector.
The Clarus Model 1150 Straight Firing and the Clarus Model 1160 Side Firing Laser Fibers are supplied sterile (ETO) and are intended for reuse.
Use Of Laser Fiber with Delivery system
The Clarus Straight Firing and the Clarus Side Firing Laser Fibers may be used both intraoperatively and percutaneously through regulatory cleared delivery systems.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 2002 SEP
Mr. Tom Barthel President Glarus Medical, LLC 1000 Boone Avenue, North Minneapolis, Minnesota 55427
Re: K021848
Trade/Device Name: Model 1150 Clarus Straight Firing Laser Fiber Model 1160 Clarus Side Firing 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: Class II Product Code: GEX Dated: June 4, 2002 Received: June 5, 2002
Dear Mr. Barthel:
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 to 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 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 listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicáble, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Tom Barthel
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Milburn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
5219
Statement of Indications for Use
The Clarus Straight Firing Laser Fiber and the Clarus Side Firing Lasers Fiber are 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 Ho:YAG lasers have been cleared.
Mark N. Millison
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number _K021848