(25 days)
The Ceralas Fiber Coupled 980nm Diode Laser family (and their delivery accessories used to deliver optical energy) are indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated. Indications include: General Surgery, Urology, Gynecology, Gastroenterology, Otolaryngology, Plastic Surgery, Dermatology, Podiatry, Neurosurgery/ Peripheral. Pulmonary Surgery, Arthroscopy, Cardiothoracic Surgery, Laser Assisted Lipolysis. Ophthalmology, Dental Applications, Endovenous Occlusion of the Greater Saphenous Vein.
The Ceralas 980nm family for Biolitec Medical Devices, Inc. is identical (contains the same components, technology and principles of operation and assembled by the same manufacturer) as the cleared Ceralas 980nm family for Biolitec. Inc..
The provided submission is for a Ceralas 980nm Diode Laser Family for general surgical applications. This is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies to prove effectiveness or safety. Therefore, the information requested about acceptance criteria and a study proving device performance in the context of, for example, AI/ML device evaluations, is not directly applicable here.
Here's an analysis based on the provided text, addressing the points where information is available or noting its absence:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence in intended uses, indications, technological characteristics, and principles of operation to predicate devices. | The device is identical (contains the same components, technology, and principles of operation, and assembled by the same manufacturer) to the cleared Ceralas 980nm family for Biolitec. Inc. It shares the same intended uses, indications, technological characteristics, and principles of operation as its predicate devices. |
| Compliance with specific voluntary consensus standards. | The device complies with: 21 C.F.R. §§ 1040.10 & 1040.11; ANSI/AAMI ES1; IEC 601-2-22; EN 60825-1, and ANSI/AAMI/ISO 10993-7. |
| Substantial equivalence to predicate device. | The FDA determined the device is substantially equivalent to legally marketed predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided. This submission is for substantial equivalence of a physical medical device (laser) to a predicate device, not for a data-driven AI/ML model that would use a test set from patient data. The "test" here refers to demonstrating compliance with standards and equivalence, not evaluating performance on a clinical dataset.
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 applicable and not provided. Ground truth in the context of clinical data interpretation by experts is not relevant to this type of device submission. The "ground truth" here is the established safety and efficacy of the predicate device, and the current device's compliance with established engineering and performance standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are used in studies involving expert interpretation of data, which is not the nature of this submission.
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
This information is not applicable and not provided. This type of study is for evaluating observer performance with or without AI assistance, which is not relevant to a laser device submission focused on substantial equivalence.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This refers to AI algorithm performance studies, which are not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the established regulatory compliance, safety, and efficacy of the predicate device, as well as compliance with recognized voluntary consensus standards for electrical safety, electromagnetic compatibility, and biocompatibility. There is no clinical "ground truth" derived from patient data or pathology in this type of submission.
8. The sample size for the training set
This information is not applicable and not provided. There is no "training set" in the context of an AI/ML algorithm for this physical device submission.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As there is no training set mentioned, the establishment of its ground truth is irrelevant.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" proving the device meets the acceptance criteria is primarily a substantial equivalence comparison and compliance demonstration against recognized standards.
- Substantial Equivalence Study: The core of the submission relies on demonstrating that the Ceralas 980nm Diode Laser Family is "as safe and effective as" its predicate device (the Ceralas 980nm family by Biolitec, Inc.). The proof is based on the assertion that the devices are "identical in all aspects except labeling relating to the manufacturer/distributor." Specifically, it's stated they contain "the same components, technology and principles of operation and assembled by the same manufacturer." This direct identity is the primary evidence for substantial equivalence in this context.
- Compliance with Voluntary Consensus Standards: The device's performance is shown to meet acceptance criteria through compliance with a list of voluntary consensus standards:
- 21 C.F.R. §§ 1040.10 & 1040.11 (likely related to radiation control for laser products).
- ANSI/AAMI ES1 (likely electrical safety).
- IEC 601-2-22 (likely specific safety requirements for surgical lasers).
- EN 60825-1 (likely laser safety classification and requirements).
- ANSI/AAMI/ISO 10993-7 (likely biocompatibility evaluation relevant to medical devices).
The FDA's review and subsequent "substantial equivalence" determination (K112324) confirms that the evidence provided was sufficient to meet the regulatory requirements for this 510(k) submission. This is a regulatory review process, not a clinical trial or AI performance study.
§ 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.