(91 days)
Not Found
No
The 510(k) summary describes a laser fiber for surgical procedures and does not mention any AI or ML components or functionalities.
Yes.
The device is used for surgical procedures like cutting, vaporizing, or coagulating soft tissue, which are therapeutic actions.
No
The device is described as a laser for surgical procedures used for cutting, vaporizing, or coagulating soft tissue, which indicates a therapeutic rather than diagnostic function.
No
The device description explicitly states "Laser Fiber" and "Laser", indicating a hardware component that delivers laser energy, not solely 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 surgical laser fiber used for cutting, vaporizing, or coagulating soft tissue during surgical procedures. This is a therapeutic and surgical application, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as a "Straight Firing Laser Fiber," which is consistent with a surgical tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's function is directly related to surgical intervention on the body.
N/A
Intended Use / Indications for Use
The Clarus Model 1150 Straight Firing Laser Fiber may be used both intraoperatively and percutaneously through regulatory cleared delivery systems.
The Clarus Model 1150 Straight Firing Laser is for use in general, urological, OB-GYN, orthopedic (including lumbar and cervical), 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 (comma separated list FDA assigned to the subject device)
GEX
Device Description
Not Found
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)
Not Found
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.
K922881, K011207, K973172, K992083, K972272
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
K022610 510(k) Summary
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 | October 29, 2002 | |
| Device Name: | Model 1150 Clarus Straight 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 Laser Fiber may be used both intraoperatively and percutaneously through regulatory cleared delivery systems.
1
ood and Drug Administration Cornorate Boulevaro kville MD 20850
5 2002
Mr. Tom Barthel President Clarus Medical, LLC 1000 Boone Avenue North Minneapolis, MN 55427
Re: K022610
Trade/Device Name: Model 1150 Clarus Straight Firing Laser Fiber Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: August 5, 2002 Received: August 6, 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 vour 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 applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
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 vou 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,
Moram C. Parvat
中「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
3
510(k) Number (if known):
Clarus Model 1150 Straight Firing Laser Fiber Device Name:_
Indications For Use:
.
The Clarus Model 1150 Straight Firing Laser is for use in general, urological, OB-GYN, orthopedic (including lumbar and cervical), and ENT laser surgical procedures for cutting, vaporizing, or coagulating in any soft tissue application for which 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)
Marian C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K022610
Prescription Use √
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)