(75 days)
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology. The device description is not available, and the predicate device is a dosimeter, which typically does not incorporate AI/ML.
No
The device is a surgical laser intended for soft tissue applications, not a therapeutic device.
No
The device is described as being for "soft tissue surgical applications," indicating a therapeutic rather than diagnostic purpose. The predicate device also appears to be a dosimeter, which is used for measuring dose, again not directly diagnostic.
Unknown
The provided 510(k) summary lacks a device description, which is crucial for determining if the device is software-only. The intended use refers to a surgical application, but without knowing the device's components and how it interacts with the surgical process, it's impossible to definitively classify it as software-only.
Based on the provided information, the CyberScan Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "soft tissue surgical applications." This indicates a device used on a patient during a surgical procedure, not a device used to test samples from a patient in a lab setting.
- Anatomical Site: The anatomical site is "soft tissue," which is a part of the human body, not a biological sample.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), performing tests in a laboratory, or providing diagnostic information based on such tests.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The CyberScan Device's intended use and anatomical site point towards a surgical tool used directly on the patient.
N/A
Intended Use / Indications for Use
The CyberScan Device is intended for use for all cleared Heraeus LaserSonics CO2 soft tissue surgical applications.(K955734)
Product codes
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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SUMMARY OF SAFETY AND EFFECTIVENESS
CYBERSCAN DEVICE SYSTEM
REGULAROY AUTHORITY:
Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT:
Nidek Incorporated 47651 Westinghouse Drive Fremont, CA. 94539-7474 Phone: (510)226-5700 (800) 223-9044 (510) 2265750 Fax:
DEVICE TRADE NAME
CyberScan Device
DEVICE COMMON NAME
Scanning Laser Delivery System
DEVICE CLASSIFICATION:
CO2 laser systems have been classified as Class II (79 GEX) medical devices by the OB/GYN, General, Plastic Surgery and ENT Device Advisory Panels. To the best of our knowledge, scanning laser delivery systems have not been classified.
PERFORMANCE STANDARDS:
The ParaScan Dosimeter Device complies with 21 CFR 1040.10 and 1040.11. FDA regulations for medical laser products, as applicable.
INDICATIONS FOR USE STATEMENT
The CyberScan Device is intended for use for all cleared Heraeus LaserSonics CO2 soft tissue surgical applications.(K955734)
트
1
COMPARISON WITH PREDICATE DEVICE:
The CyberScan Device is substantially equivalent to the ParaScan Dosimeter Device manufactured by Heraeus Surgical.(K955734)
The risks and benefits of the CyberScan are comparable to the predicate device when used for similar clinical applications.
Since the CyberScan Device is substantially equivalent with respect to indication for use, materials, method of operation and physical construction to the predicate device, we believe it clearly meets the requirements for substantial equivalence according to Section 510 (k) guidelines. Safety and effectiveness are reasonable assured, therefore justifying 510 (k) clearance.