(43 days)
Not Found
No
The summary describes a diode laser for surgical applications and does not mention any AI or ML capabilities.
Yes
The device is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue, which are all therapeutic actions.
No
The device is described as a surgical laser indicated for ablation, vaporization, excision, incision, and coagulation of soft tissue, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a diode laser emitting radiation, which is a hardware component. The intended use also describes surgical applications requiring physical interaction with tissue.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The PhoTex15 Diode Laser Series is described as a surgical laser used for the ablation, vaporization, excision, incision, and coagulation of soft tissue in vivo (within the living body). It directly interacts with tissue during surgical procedures.
- Lack of Sample Analysis: The description does not mention any analysis of samples taken from the body. The device's function is to perform surgical actions on tissue directly.
Therefore, the PhoTex15 Diode Laser Series is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PhoTex15 Diode Laser Series is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including; gastroenterology, general surgery, plastic surgery, genitourinary (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT) head and neck, orthopedics, ophthalmology, pulmonology, and thoracic surgery.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The PhoTexys Diode Laser Series are diode lasers emitting radiation in either a continuous-wave (CW) or pulsed-mode in the infrared range at one of the following wavelengths: 980nm, 810nm, and 940nm. The PhoTexis Diode Laser Series provides a means for cutting, coagulation, and vaporization of tissue using a compatible fiber optic delivery accessory. The laser is compatible with any fiber optic delivery accessory terminated with a standard SMA905 connector whose core fiber diameter is 400 micron or larger with a numerical aperture of at least .37.
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)
Engineering studies have demonstrated the substantial equivalence of the PhoTex 13 Diode Laser Series to the SLT Thermalite Diode Laser Series (K 952661).
The studies concluded that the lasers are in compliance with FDA standards 21CFR1040,10 and 21CFR1040.11. In all instances, the lasers functioned and performed in a manner similar to the predicate device when used in accordance with the labeled directions for use and specified indications.
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.
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
MAR 2 1 2006
510(k) Summary
In accordance with the Safe Medical Devices Act of 1990 and in compliance with 21CFR 807, the following serves as the 510(k) Summary information upon which the substantlal equivalence determination is based.
Contact Information
| Submitter: | BioTex, Inc.
8058 El Rio St.
Houston, TX 77054 |
|-----------------|------------------------------------------------------|
| Phone: | 713.741.0111 |
| Contact Person: | Matthew Fox |
| Date Prepared: | 03/14/2006 |
Device Names
| Trade/Proprietary Name: | PhoTex₁₅ Diode Laser Series: 980, 810, 940 |
|---|---|
| Common Name: | Diode Laser Series |
| Classification Name: | Powered surgical laser instrument |
| Product Code: | GEX |
| Reg.Class: | II |
| Rea Number: | 878.4810 |
Predicate Device
SLT Thermalite Diode Laser Series: 980, 810, 940 (K952661)
Description of Device
The PhoTexys Diode Laser Series are diode lasers emitting radiation in either a continuous-wave (CW) or pulsed-mode in the infrared range at one of the following wavelengths: 980nm, 810nm, and 940nm. The PhoTexis Diode Laser Series provides a means for cutting, coagulation, and vaporization of tissue using a compatible fiber optic delivery accessory. The laser is compatible with any fiber optic delivery accessory terminated with a standard SMA905 connector whose core fiber diameter is 400 micron or larger with a numerical aperture of at least .37.
Indications for Use
The PhoTex15 Diode Laser Series is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including; gastroenterology, general surgery, plastic surgery, genitourinary (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT) head and neck, orthopedics, ophthalmology, pulmonology, and thoracic surgery.
1
Comparison to Predicate Device
The PhoTexts Diode Laser Series has been shown to be substantially equivalent to the predicate devices, the SLT Thermalite Diode Laser Series and PhotoMedex LaserPro Diode Laser Systems. Based on the technological features, device performance, and indications for use, BioTex, Inc. believes that no significant differences exist between the PhoTexts Diode Laser Series and the predicate device. Differences were determined to be minor and are each within the specifications listed by the predicate device and does not raise any concerns regarding the overall safety and effectiveness of the device.
Non-clinical Performance Tests:
Engineering studies have demonstrated the substantial equivalence of the PhoTex 13 Diode Laser Series to the SLT Thermalite Diode Laser Series (K 952661).
The studies concluded that the lasers are in compliance with FDA standards 21CFR1040,10 and 21CFR1040.11. In all instances, the lasers functioned and performed in a manner similar to the predicate device when used in accordance with the labeled directions for use and specified indications,
Conclusion
BioTex has demonstrated the PhoTex. Diode Laser Series is substantially equivalent to the predicate device based on design, test results, and indications for use.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing the three branches of government.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1 2006
BioTex, Incorporated c/o Mr. Matthew Fox Development Engineer 8058 El Rio Street Houston, Texas 77054
Re: K060304
Trade/Device Name: PhoTex15 Diode Laser Series: 980, 810, 940 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 6, 2006 Received: February 8, 2006
Dear Mr. Fox:
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. ↑ 10 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, FI)A may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs 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
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Page 2 – Mr. Matthew Fox
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. product friendly 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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. Melkerson
Active Director
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K060304
Device Name: PhoTex15 Diode Laser Series: 980, 810, 940
Indications For Use:
The PhoTex15 Diode Laser Series is indicated for use in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in areas of surfigery including: gastroenterology, general surgery, plastic surgery, genitourinary (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT) head and neck, orthopedics, ophthalmology, pulmonology, and thoracic surgery.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of ffice of Device Evaluation (ODE)
elmoe.
Division of General, Restorative。 and Neurological Devices
K060304 Response Lett r Page 3 of 6