(77 days)
Not Found
Not Found
No
The device description details a physical probe guide for laser fibers and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
No
The device is a probe guide used to stabilize tissue and guide a laser fiber for contact, but it does not directly treat or diagnose a disease itself.
No
Explanation: The device description indicates that it is a guide to facilitate contact between a laser fiber probe and tissue. Its purpose is to stabilize tissue and guide the probe, not to collect or analyze data for diagnostic purposes.
No
The device description clearly outlines physical components made of PVC tubing and silicone, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections.
- Device Description: The description clearly states the device is a "Probe Guide" designed to "slide onto tissue and stabilize this tissue" and facilitate "contact of the probe to tissue" with a laser fiber. This indicates the device is used directly on or with tissue within the body during a procedure, not for testing samples outside the body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or any other activities typically associated with in vitro diagnostics.
Therefore, the SLT Fumich Probe Guide is a surgical accessory used in conjunction with a laser system for direct tissue manipulation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The SLT Fumich Probe Guide geometry consists of PVC tubing with an adjustable sleeve being a 2-pronged fork on the distal end and a silicone connector on the proximal end of this tubing. Total length of this is approximately 4 inches. The distal end configuration is designed to slide onto tissue and stabilize this tissue. Laser fiber is threaded through the lumen of this guide with a probe at the end of the fiber for direct contact with tissue. Therefore, this configuration allows the user to know where the tissue and the probe are making contact and facilitates contact of the probe to tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
MAY 1 6 1996
SLT FUMICH PROBE GUIDE 510K SUMMARY
Device Description:
The SLT Fumich Probe Guide geometry consists of PVC tubing with an adjustable sleeve being a 2-pronged fork on the distal end and a silicone connector on the proximal end of this tubing. Total length of this is approximately 4 inches. The distal end configuration is designed to slide onto tissue and stabilize this tissue. Laser fiber is threaded through the lumen of this guide with a probe at the end of the fiber for direct contact with tissue. Therefore, this configuration allows the user to know where the tissue and the probe are making contact and facilitates contact of the probe to tissue.
Equivalency:
The SLT Fumich Probe Guide is designed to be used with the distal end of the SSRH8 handpiece. This hand-piece is inserted through the proximal end of the Fumich Probe Guide; prior to use, a probe can be threaded onto that hand-piece and then withdrawn through the guide so that the guide can be first placed on tissue locating the tissue for contact with the probe. This accessory to the SLT Laser Multidimensional Fiber Delivery System is similar to the CO2 laser arm distal end that incorporates the tissue stabilizer or backstop such as that for the Sharplan 1100 CO2 surgical laser system. CO2 lasers have this guide to facilitate the tissue fiber location for assuring the location of the coagulation and vaporization of tissue.
Conclusion:
The SLT Fumich Probe Guide will be provided as a sterile single use only accessory to the SLT Multidimensional Fiber Delivery System.