(77 days)
The PhoTex30 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.
The PhoTex30 Diode Laser Series are diode lasers emitting radiation in either a continuous-wave (CVV), pulsed or external modulation modes in the initialians and series provides a means. wavelengths: 980nm, 810nm, and 940nm. The PhoTexy Diode Laser Series dollygry wavelengths. 960mm, and vaporization of tissue using a compatible fiber optic delivery for cutting, coagulation, and vaporization of tiber optic delivery accessory terminated with a numerical accessory. The laser is compatible with uny hist "bptro" and one of larger with a numerical aperture of at least .37.
The provided document is a 510(k) summary for the PhoTex30 Diode Laser Series. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through clinical or analytical testing with quantitative performance metrics.
Instead, the document states generally that "Engineering studies have demonstrated the substantial equivalence of the PhoTex30 Diode Laser Series" to predicate devices. The conclusion is that "the lasers functioned as intended and performed in a manner similar to the predicate device when used in accordance with the labeled directions for use and specified indications."
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.
The information that can be extracted relates to the comparison to predicate devices and general compliance:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The document implies the acceptance criterion is "substantial equivalence" to the predicate devices (PhoTex15 Diode Laser Series (K060304) and SLT Thermalite Diode Laser Series (K952661)) in terms of "technological features, device performance, and indications for use." It also states compliance with "FDA standards 21CFR1040.10 and 21CFR1040.11."
- Reported Device Performance: "The studies concluded that the lasers functioned as intended and performed in a manner similar to the predicate device when used in accordance with the labeled directions for use and specified indications." However, no specific quantitative performance metrics (e.g., accuracy, precision, wavelength stability, power output consistency, etc.) are provided in the summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (K060304, K952661) in technological features, device performance, and indications for use. | The PhoTex30 Diode Laser Series has been shown to be substantially equivalent to the predicate devices. Differences were determined to be minor and are each within the overall safety and effectiveness of the device. |
| Compliance with FDA standards 21CFR1040.10 and 21CFR1040.11. | Engineering studies concluded that the lasers are in compliance with FDA standards 21CFR1040.10 and 21CFR1040.11. The studies concluded that the lasers functioned as intended and performed in a manner similar to the predicate device when used in accordance with the labeled directions for use and specified indications. |
2. Sample size used for the test set and the data provenance: Not applicable. The document refers to "engineering studies" rather than a test set with data collected from human subjects or retrospective/prospective medical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The studies mentioned are "engineering studies," not clinical or diagnostic studies requiring expert review for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical laser, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes "Engineering studies" of the device itself, implying standalone performance evaluation, but without specific quantitative metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic performance. The "ground truth" for an engineering study would be the device's adherence to design specifications and regulatory standards, evaluated through physical measurements and tests.
8. The sample size for the training set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.
In summary: The provided 510(k) summary focuses on demonstrating "substantial equivalence" through engineering studies, rather than providing detailed performance metrics from clinical or analytical studies as one might expect for a diagnostic or AI-powered device.
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CT - 6 2009
510(k) Summary
In accordance with the Safe Medical Devices Act of 1990 and in compliance with 21CFR 807, the In accordance with the Oale Medion Donoof of in the substantial equivalence determination is based.
Contact Information
| Submitter: | BioTex, Inc.8058 El Rio St. .Houston, TX 77054 |
|---|---|
| Phone: | 713.741.0111 |
| Contact Person: | Ashok Gowda |
| Date Prepared: | 6/18/2009 |
Device Names
| Trade/Proprietary Name: | PhoTex30 Diode Laser Series: 980, 810, 940 |
|---|---|
| Common Name: | Diode Laser Series |
| Classification Name: | Powered surgical laser instrument |
| Product Code: | GEX |
| Reg.Class: | II |
| Reg. Number: | 878.4810 |
Predicate Device
PhoTex15 Diode Laser Series: 980, 810, 940 (K060304) SLT Thermalite Diode Laser Series: 980, 810, 940 (K952661)
Description of Device
The PhoTexാ Diode Laser Series are diode lasers emitting radiation in either a continuous-wave The ProTexsi Diode Laser Senes are dious facile that manye at one of the following (CVV), pulsed or external modulation modes in the initalians and series provides a means.
wavelengths: 980nm, 810nm, and 940nm. The PhoTexy Diode Laser Series dollygry wavelengths. 960mm, and vaporization of tissue using a compatible fiber optic delivery for cutting, coagulation, and vaporization of tiber optic delivery accessory terminated with a numerical accessory. The laser is compatible with uny hist "bptro" and one of larger with a numerical aperture of at least .37.
Indications for Use
The PhoTex30 Diode Laser Series is indicated for use in surgications requiring The PhoTex.50 Diode Easer Ochoo is inalisation of soft tissue in areas of
the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of the ablation, vaponzution, oxolon, meneral surgery, plastic surgery, genitourinary
surgery including: gastroenterology, general surgery, plastic surgery, genitourings surgery including. gastroomorology, genery, otolaryngology (ENT) head and neck, (urchogy), g) . synoothalmology, pulmonology, and thoracic surgery.
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Comparison to Predicate Device
Comparison to Predicate Device
The PhoTexy Diode Laser Series has been shown to be substantially equivalent to the predicate The PhoTex.g Diode Laser Series nas been shown to be subscaninder stars. Based on the devices, the PhoTex., Diode Laser Series and SET Theimalic Liber States that no
technological features, device performance, and indications for use, BioTex, Inc. belices that technological features, device performance, and the productions of the producate devices.
significant differences exist between the PhoTexa Diode Laser Series and the significant differences exist between the Prior example the spectively and the listed by the Differences were determined to be minor and are each within the operall safety and effectiveness of the device.
Non-clinical Performance Tests:
Engineering studies have demonstrated the substantial equivalence of the PhoTexa Diode Laser Series Engineering studies have demonstrated (ne subscribe bir The mail of The mail on the mainten of the maint Series to the PhoText Diode Laser Seles (Kooooors and in compliano with FDA standards
(K952661). The Studies concluded that the lasers are in compliance with FDA standards (K952661). The studies concluded that the lasers finctioned as intonded and 21CFR1040.10 and 21CFR1040.11. In an Tirances, the facebook and and and and and and and one with the labeled
performed in a manner similar to the predicate device when used i directions for use and specified indications.
Conclusion
BioTex has demonstrated the PhoTexto Diode Laser Series is substantially equivalent to the BloTex fras demonstrated the The PhoToxy Disable and indications for use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three wing-like extensions.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
BioTex, Inc. % Ashok Gowda, Ph.D. President 8058 El Rio Street Houston, Texas 77054
OCT - 6 2009
Re: K092197
Trade/Device Name: PhoTex30 Diode Laser Series, Model 980nm, 810nm, 940nm 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: July 16, 2009 Received: July 21, 2009
Dear Dr. Gowda:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ashok Gowda, Ph.D.
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,
Sincerely yours,
Mark N. Melkerson
Director
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
PhoTex30 Diode Laser Series, Model 980nm, 810nm, 940nm
Indications for Use:
The PhoTex30 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.
Prescription Use × (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 CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page of
510(k) Number K092197
§ 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.