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510(k) Data Aggregation
(167 days)
MYELOTEC, INC.
when used with a fiberoptic endoscope, this device can be used in the lumbar and sacral spine for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications.
The MYELOTEC VIDEO GUIDED CATHETER (VGC) consists of a flexible double lumen catheter, steering handle and associated ports for access to the lumens. The catheter has a built in steering mechanism that allows for guiding the soft tip through the epidural space and soft tissues for optimal access to the source of distress. Each lumen is one (1) mm in diameter. The design allows the use of a flexible fiber optic endoscope for visual examination of the area and surrounding tissues at the distal end of the catheter. This visual examination then allows the physician to diagnose the potential causes of neural distress and pain.
The port on the second lumen allows the injection of saline to expand the space and expose the source of distress for viewing and treatment. The port also facilitates the connection of syringes to deliver physician selected therapeutic agents as appropriate to their diagnosis.
The provided text is a 510(k) notification summary for the MYELOTEC VIDEO GUIDED CATHETER II. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications for the device.
Therefore, I cannot provide the requested information from the given text.
The document mainly includes:
- Contact information and submission date
- Device name, classification, and predicate device
- Description and intended uses of the device
- New indications for use
- A comparison table between the MYELOTEC VGC and the RACZ Tun-L-Kath, highlighting differences in attributes like length, lumen diameter, number of lumens, endoscope capability, and steerability.
- An FDA letter confirming the review and substantial equivalence determination.
- An enclosure reiterating the intended use/indications.
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(232 days)
MYELOTEC, INC.
The Myeloscope is intended to be used by physicians for the illumination and The Mydlescope is intenthe epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease.
The Myelotec Myeloscope is a flexible fiberoptic system that includes a video guided catheter that allows steering of the fiberoptic scope. The fiberoptic scope is a reusable device that is supplied non-sterile with instructions for cleaning, sterilization and re-use. The video guided catheter is a sterile, disposable device.
The provided document is a 510(k) premarket notification letter from the FDA for a device called Myeloscope. It does not contain acceptance criteria or a detailed study proving the device meets acceptance criteria.
The 510(k) summary only briefly mentions some performance and safety testing. Therefore, I cannot complete the table or answer most of the questions as the information is not present in the provided text.
Here's what can be extracted from the text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Catheter is capable of flexing the Myeloscope optics 30 degrees to the right and left for 250 cycles without damage to the tip bonds or steering mechanism. |
| Not specified in document | Biocompatibility for patient contacting materials demonstrated. |
| Not specified in document | Optical and mechanical performance and materials are similar to predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the test set or the data provenance. It only mentions "performance testing of the video guided catheter."
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)
Not mentioned in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not mentioned in the document.
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
No MRMC study was mentioned. The device described is a physical scope, not an AI system for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not specified. The performance testing appears to be functional and safety testing of the device itself (e.g., flexibility, biocompatibility), not related to diagnostic accuracy against a ground truth for disease.
8. The sample size for the training set
Not applicable. No training set is mentioned as this is a physical device subject to performance and safety testing, not an AI/ML model that requires training.
9. How the ground truth for the training set was established
Not applicable (see point 8).
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