(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.
§ 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.