(46 days)
The Ceralas 1470nm Fiber-Coupled Diode Laser family (and its delivery accessories used to deliver optical energy) is 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. Endovenous Occlusion of the Saphenous Veins in Patients with Superficial Vein Reflux Associated with Varicose Veins and Varicosities. Laser Assisted Lipolysis.
The Ceralas 1470nm 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 1470nm family for Biolitec, Inc..
Here's an analysis of the provided text regarding the Ceralas 1470nm Diode Laser Family, focusing on acceptance criteria and study information:
Acceptance Criteria and Device Performance
This submission is a 510(k) for substantial equivalence, not a premarket approval (PMA) application. Therefore, it focuses on demonstrating that the device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific clinical efficacy endpoints. The "acceptance criteria" here are compliance with recognized standards and demonstrating identical characteristics to the predicate.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Compliance with Standards/Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Compliance with Voluntary Consensus Standards: | The device complies with: |
| - 21 C.F.R. §§ 1040.10 & 1040.11 (Performance Standards for Light-Emitting Products) | Not explicitly detailed, but stated as "complies." These regulations cover laser product safety. |
| - ANSI/AAMI ES1 (Medical Electrical Equipment - Part 1: General Requirements for Safety) | Not explicitly detailed, but stated as "complies." This standard addresses electrical safety. |
| - IEC 601-1 (Medical electrical equipment - Part 1: General requirements for safety) | Not explicitly detailed, but stated as "complies." This standard addresses electrical safety. |
| - IEC 601-2-22 (Medical electrical equipment - Part 2-22: Particular requirements for safety of surgical, aesthetic and therapeutic laser equipment) | Not explicitly detailed, but stated as "complies." This standard is specific to laser safety. |
| - EN 60825-1 (Safety of laser products - Part 1: Equipment classification and requirements) | Not explicitly detailed, but stated as "complies." This is an international standard for laser product safety. |
| - ANSI/AAMI/ISO 10993-7 (Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals) | Not explicitly detailed, but stated as "complies." This standard addresses biocompatibility related to sterilization. |
| Substantial Equivalence to Predicate Device: | |
| - Identical components, technology, and principles of operation | The Ceralas 1470nm 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 1470nm family for Biolitec, Inc. (K073063, K082225 and K102755). |
| - Same intended uses and indications for use | The Ceralas 1470nm family has the same intended uses, indications, technological characteristics, and principles of operation as its predicate devices. The Indications for Use Statement lists General surgical applications (incision, excision, ablation, cutting, vaporization, hemostasis, coagulation), Endovenous Occlusion of Saphenous Veins, and Laser Assisted Lipolysis. |
Study Details
This submission does not present a clinical study in the traditional sense of evaluating device performance on patients or human readers. Instead, it relies on demonstrating substantial equivalence to already cleared predicate devices. The "study" here is a comparison exercise rather than a performance trial.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. This is a substantial equivalence submission based on device characteristics, not a clinical performance study with a test set of data.
- Data Provenance: Not applicable. The "data" consists of device specifications and confirmed manufacturing processes, not patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for a clinical test set is not established in this type of submission. The "ground truth" for substantial equivalence is the established safety and effectiveness of the predicate device.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no test set or adjudication process for clinical outcomes.
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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. This device is a surgical laser, not an AI-assisted diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical laser, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth," implicitly, is the regulatory approval and a history of safe and effective use of the predicate devices (K073063, K082225, and K102755). The substantial equivalence argument states that because the new device is identical in all relevant aspects to these predicates, it shares their established safety and effectiveness.
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of an AI/machine learning model. The device's design, manufacturing, and testing (to meet standards like IEC 601-2-22) are the relevant "data" for its own performance, and these are compared to the predicate.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI model, there is no ground truth established for it. The ground truth for this submission hinges on the regulatory history and proven performance of the predicate devices.
§ 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.