(119 days)
The Visualase Cooled Laser Applicator System (VCLAS) is comprised of a Laser Diffusing Fiber (LDF), a Cooling Catheter System (CCS), and a Bare Tip Fiber (BTF),
The Laser Diffusing Fiber (LDF) and Cooling Catheter System (CCS) are indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology for the wavelength range of 800nm through 1064nm.
The Bare Tip Fiber (BTF) is intended for use in vaporization, cutting, ablation and coagulation of soft tissues with or without scopes or handpieces, for contact or noncontact surgery in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology for the wavelength range of 800nm through 1064nm.
The VCLAS family consists of three components, the LDF, CCS, and BTF. The LDF and BTF transmit laser energy to the tissue situated at their distal regions. The LDF is comprised of a standard silica fiber optic cable affixed with a diffusing tip assembly. The diffusing tip assembly is comprised of a plastic tube that is filled with a transparent matrix in which light dispersing particles are embedded. The distal end of the tube is sealed with a higher concentration of scattering particles in a conical structure to prevent significant forward transmission of energy.
The LDF may be used with a cooling catheter, in particular the compatible CCS, but such a catheter is not required. The CCS can be employed with or without coolant flow. The use of coolant provides cooling for the surfaces of the CCS in contact with both the tissue and the LDF.
The BTF is comprised of a standard silica fiber optic cable identical to fiber optic used in the LDF. The distal end of the BTF is terminated in a flat, polished face and is designed for use in both contact and non-contact applications.
The provided 510(k) summary describes the Visualase Cooled Laser Application System (VCLAS), which includes the Laser Diffusing Fiber (LDF), Cooling Catheter System (CCS), and Bare Tip Fiber (BTF). This submission focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness through extensive clinical trials with acceptance criteria.
Therefore, the document does not contain information on acceptance criteria in the typical sense of performance metrics for a diagnostic or AI-driven device (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implicitly met by demonstrating that the device performs similarly to predicate devices and is safe for its intended use.
Here's an analysis based on the provided text, aligning with your request as much as possible, interpreting "acceptance criteria" through the lens of substantial equivalence:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (like sensitivity or specificity) for new clinical claims. Instead, the "acceptance criteria" are met by demonstrating:
- Functional Equivalence: The device performs its intended function (e.g., tissue coagulation/necrosis for LDF/CCS, vaporization/cutting/ablation/coagulation for BTF) in a manner similar to predicate devices.
- Biocompatibility: Materials used are safe for human contact.
- Safety: No new safety concerns are raised compared to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance and Evidence |
|---|---|
| Functional Equivalence - LDF to Predicate SLT Diffuser™ Fiber | "Engineering studies have demonstrated the substantial equivalence of the Laser Diffusing Fiber (LDF) to the SLT Diffuser Fiber Delivery Systems (K 010041). The studies concluded that the treated tissue displayed an ellipsoidal coagulation area surrounding the diffusing region of the laser diffusing fiber. In all instances, the fiber and lasers functioned as intended and performed in a manner similar to the predicate device..." (Page 2) |
| Functional Equivalence - BTF to Predicate Indigo Bare-Tip™ Fiberoptic | "The Bare Tip Fiber (BTF) has been shown to be substantially equivalent to the bare tip fiber marketed with the Indigo Diffuser Fiberoptic (K963081)." (Page 1) This is supported by the overall conclusion of substantial equivalence. |
| Biocompatibility | "The materials used in the Visualase Laser Diffusing Fiber (LDF). Cooling Catheter System (CCS), and Bare Tip Fiber (BTF) were determined to be biocompatible according to appropriate international test standards." (Page 2) |
| Safety and Effectiveness (Overall) | "Differences were determined to be minor and are each within the specifications listed by the predicate devices and does not raise any concerns regarding the overall safety and effectiveness of the device." (Page 1) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "engineering studies" and "non-clinical performance tests." It does not specify:
- Sample size: The number of fibers, catheteters, or tissues tested.
- Data provenance: The country of origin or whether the data was retrospective or prospective. Given these are engineering studies, they are likely controlled laboratory experiments rather than human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. Given the nature of the studies as "engineering studies" for a physical device, expert review (e.g., by radiologists or pathologists) for ground truth as would be common for diagnostic AI/imaging devices is not described. The assessment likely relied on physical measurements and observations of coagulation effects from the engineering studies themselves.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are typically relevant for human-interpreted data (e.g., medical images), which is not the primary focus of the described "engineering studies."
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
No MRMC comparative effectiveness study was done or mentioned. This type of study is relevant for diagnostic or AI-assisted interpretation devices, not for a laser fiber and catheter system. The submission is for a physical medical device (laser accessories), not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a physical medical instrument (laser fiber and catheter system), not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the "engineering studies" that concluded "the treated tissue displayed an ellipsoidal coagulation area," the "ground truth" would be the observed physical effect on the tissue (e.g., lesion size, shape, and characteristics), likely measured directly or via histological analysis in a laboratory setting. The document does not specify how this "ground truth" (i.e., the observed tissue effects) was established or by whom.
8. The sample size for the training set
Not applicable. This device is a physical instrument, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this device is a physical instrument, not an AI algorithm requiring a training set and associated ground truth.
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MAR 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 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, PhD |
| Date Prepared: | 11/01/2005 |
Device Names
| Trade Name: | Laser Diffusing Fiber (LDF)Cooling Catheter System (CCS)Bare Tip Fiber (BTF) |
|---|---|
| Proprietary Name: | Visualase Cooled Laser Application System (VCLAS) |
| Common Name: | Diffusing laser fiber or probeCooling catheter or sheathBare tip laser fiber or probe |
| Classification: | Accessory to powered surgical laser instrument |
Predicate Device
SLT Diffuser™ Fiber (K010041) Indigo Bare-Tip™ Fiberoptic (K963081)
Description of Device
The VCLAS family consists of three components, the LDF, CCS, and BTF. The LDF and BTF transmit laser energy to the tissue situated at their distal regions. The LDF is comprised of a standard silica fiber optic cable affixed with a diffusing tip assembly. The diffusing tip assembly is comprised of a plastic tube that is filled with a transparent matrix in which light dispersing particles are embedded. The distal end of the tube is sealed with a higher concentration of scattering
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particles in a conical structure to prevent significant forward transmission of energy.
The LDF may be used with a cooling catheter, in particular the compatible CCS, but such a catheter is not required. The CCS can be employed with or without coolant flow. The use of coolant provides cooling for the surfaces of the CCS in contact with both the tissue and the LDF.
The BTF is comprised of a standard silica fiber optic cable identical to fiber optic used in the LDF. The distal end of the BTF is terminated in a flat, polished face and is designed for use in both contact and non-contact applications.
Indications for Use
The LDF and CCS are indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology, and urology, for wavelengths 800nm through 1064nm,
The Bare Tip Fiber (BTF) is intended for use in vaporization, cutting, ablation and coagulation of soft tissues with or without scopes or handpieces, for contact or non-contact surgery in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, earnose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology for the wavelength range of 800nm through 1064nm.
Comparison to Predicate Device
The Laser Diffusing Fiber (LDF) and Cooling Catheter System (CCS) have been shown to be substantially equivalent to the SLT Diffuser™ fiber (K010041). The Bare Tip Fiber (BTF) has been shown to be substantially equivalent to the bare tip fiber marketed with the Indigo Diffuser Fiberoptic (K963081). Differences were determined to be minor and are each within the specifications listed by the predicate devices 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 Laser Diffusing Fiber (LDF) to the SLT Diffuser Fiber Delivery Systems (K 010041).
The studies concluded that the treated tissue displayed an ellipsoidal coagulation area surrounding the diffusing region of the laser diffusing fiber. In all instances,
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the fiber and 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.
The materials used in the Visualase Laser Diffusing Fiber (LDF). Cooling Catheter System (CCS), and Bare Tip Fiber (BTF) were determined to be biocompatible according to appropriate international test standards.
Conclusion
BioTex has demonstrated the Visualase Laser Diffusing Fiber (LDF), Cooling Catheter System (CCS), and Bare Tip Fiber (BTF) are substantially equivalent to the predicate devices based on design, test results, and indications for use.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 MAR I
BioTex, Inc. c/o Ashok Gowda, Ph.D. President 8058 El Rio Street Houston, Texas 77054
Re: K053087
Trade/Device Name: Visualase Cooled Laser Application System 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 5, 2006 Received: January 20, 2006
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 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, FIDA 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.
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Page 2 - Dr. Gowda
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). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation chiritled. "Misbranding by reference to premarket notification" (21 CFR 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/industry/support/index.html.
Sincerely yours,
el.mde
Mark N. Melkerson, M.S. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
Device Name:
Visualase Cooled Laser Application System (VCLAS) Laser Diffusing Fiber (LDF) Cooling Catheter System (CCS) Bare Tip Fiber (BTF)
Indications for Use:
The Visualase Cooled Laser Applicator System (VCLAS) is comprised of a Laser Diffusing Fiber (LDF), a Cooling Catheter System (CCS), and a Bare Tip Fiber (BTF),
The Laser Diffusing Fiber (LDF) and Cooling Catheter System (CCS) are indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology for the wavelength range of 800nm through 1064nm.
The Bare Tip Fiber (BTF) is intended for use in vaporization, cutting, ablation and coagulation of soft tissues with or without scopes or handpieces, for contact or noncontact surgery in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology for the wavelength range of 800nm through 1064nm.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (O Division Sign-Off 600 Division of General, Restorative. and Neurological Devices
KOS 3087 510(k) Number_ K053087 Response Letter Page 5 of 60
§ 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.