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K Number
K990568
Device Name
SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MODEL 59.01
Manufacturer
SYNERGETICS, INC.
Date Cleared
1999-05-14

(80 days)

Product Code
GEX
Regulation Number
878.4810
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Synergetics Inc., Mode Scrambled LindoOto Laser Probe provides a means of delivering photocoagulation during otologic surgery. Indications include, but are not limited to treatment of stapes related disorders to be treated with stapedectorny by means of photocoagulation. This device transmits laser energy to target tissuc, thereby causing photocoagulation. Spot size can be varied by altering the distance between the tissuc and the probe tip.

Device Description

Mode Scrambled EndoOto Laser Probe

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a medical device (Mode Scrambled EndoOto Laser Probe) from 1999. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding specific acceptance criteria for device performance, nor does it describe a study proving the device meets such criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new performance studies with pre-defined acceptance criteria and statistical analyses as might be seen for novel devices or in the de novo pathway today.

Therefore, I cannot provide the requested information based on the given text.

To be explicit about the missing information:

  1. Table of acceptance criteria and reported device performance: Not present.
  2. Sample size used for the test set and data provenance: Not present. The document refers to "indications for use stated in the enclosure" and implicitly relies on the safety and effectiveness of the predicate device.
  3. Number of experts used to establish ground truth and qualifications: Not present.
  4. Adjudication method for the test set: Not present.
  5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not present. This type of study is more common for diagnostic imaging devices and AI/ML-enabled devices, which is not the case for this laser probe.
  6. Standalone performance study (algorithm only): Not applicable as this is a physical medical device, not an algorithm.
  7. Type of ground truth used: Not present.
  8. Sample size for the training set: Not applicable and not present.
  9. How ground truth for the training set was established: Not applicable and not present.

§ 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.