(22 days)
The device is intended for endovascular coagulation of blood vessels. The device is indicated for the endovascular coagulation of the greater saphenous vein in the thigh in patients with superficial vein reflux.
The Ceralas D 980 nm Laser with Endo Laser Vein System Kit consists of the cleared Ceralas D 980 and the ELVeS. Twelve versions of the ELVeS kit contain various combinations of the following components: (1) 19 gauge needle; (2) 21 gauge needle; (3) 5 French (F) introducer sheath; (4) 5 F introducer sheath/dilator; (5) a 0.035" J-tip guidewire; (6) a 0.018" J-tip guidewire; (7) surgical drape; (8) surgical tape; and (9) a surgical pen.
This 510(k) summary does not contain information typically found in a study proving a device meets acceptance criteria as would be expected for a diagnostic AI/ML device. Instead, it focuses on demonstrating substantial equivalence to predicate devices for a medical laser system. Therefore, most of the requested fields cannot be filled.
Here's a breakdown based on the provided text, highlighting where information is absent:
1. A table of acceptance criteria and the reported device performance
No direct acceptance criteria or a performance table are provided in the document. The submission asserts substantial equivalence based on intended use, indications for use, and technological characteristics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission concerns a physical medical device (laser system) and its accessories, not an AI/ML diagnostic or measurement device that would typically involve a test set of 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)
Not applicable. As above, this isn't a study involving ground truth establishment for a diagnostic output.
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. No AI component is mentioned, and no MRMC study was conducted or referenced.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable.
8. The sample size for the training set
Not applicable. No training set is mentioned for this device.
9. How the ground truth for the training set was established
Not applicable.
Summary of Device Acceptance:
The device's "acceptance" is determined through the process of demonstrating substantial equivalence to legally marketed predicate devices, rather than through a performance study against predefined acceptance criteria for a novel diagnostic claim.
The provided text states:
- Predicate Devices: Ceralas D Diode Laser System (980 nm and 810 nm)
- Basis for Substantial Equivalence:
- Same intended use and indications for use as the cleared Ceralas D 980 nm Laser System and Ceralas D 810 nm Diode Laser System.
- Same technological characteristics as the cleared Ceralas D 810 and the cleared Ceralas D 980.
- The ELVeS kit, the new component with the 980nm laser, is already cleared for use with the Ceralas D 810 for the same indication.
Therefore, the study implicitly demonstrating "acceptance" is the comparison to predicate devices and the argument that the added ELVeS kit does not introduce new technological characteristics or safety/effectiveness concerns for the specified indication. The FDA's issuance of the 510(k) clearance signifies their agreement with this substantial equivalence argument.
Performance Data (as stated in the document):
The only "Performance Data" mentioned are compliance with voluntary consensus standards:
- 21 C.F.R. §§ 1040.10 & 1040.11
- ANSI/AAMI ES1
- IEC 601-1
- IEC 601-2-22
- EN 60825-1
- ANSI/AAMI/ISO 10993-7
These standards address aspects like electrical safety, laser safety, and biocompatibility, which are essential for such a device, but they do not constitute a clinical performance study in the way typically required for AI/ML diagnostic tools.
§ 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.