HYLASINE

• K Number: K993362
• Device Name: HYLASINE
• Manufacturer: BIOMATRIX, INC.
• Date Cleared: 2000-03-13 ( 159 days)
• Product Code: EMX , 77E
• Regulation Number: 874.4100
• Type: Traditional
• Panel: EN
• Reference & Predicate Devices: K982732 , K984069 , K920394

Intended Use

The intended use of Hylasine™ is for use in nasal/sinus cavity as a space-occupying gel stent, to separate mucosal surface and to help control minimal bleeding following surgery or nasal trauma.

Device Description

Hylasine™ is a sterile, transparent, viscoelastic gel composed of cross-linked polymers of hyaluronan. Due to its physical properties, Hylasine may be used to reduce synechiae and middle meatal stenosis. Its tamponade effect may also contribute to controlling bleeding. Hylasine leaves the site of placement by natural elimination, or it may be aspirated from the cavity earlier at the discretion of the physician.

AI/ML Overview

Here's an analysis of the provided text regarding the Hylasine™ device's acceptance criteria and studies:

Acceptance Criteria and Device Performance (Based on Clinical Safety and Efficacy Study Summary):

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Reduction of Synechiae/Adhesions	Significant reduction compared to no treatment.	Clearly shows support for superiority over no treatment in controlling synechiae/adhesions.
Improvement of Middle Meatal Stenosis	Significant improvement compared to no treatment.	Clearly shows support for superiority over no treatment in controlling middle meatal stenosis.
Mucosal Status and Regeneration	Favorable effect compared to no treatment at certain time points.	Showed a favorable effect over no treatment in mucosal status and regeneration as compared to the contralateral side at certain time points. Suggests a better, unimpeded healing process.
Control of Operative Bleeding	Effective in stilling operative bleeding.	Judged as somewhat or very effective in the stilling of operative bleeding in 19 of 20 patients where it was measured.
Safety and Tolerability	Well-tolerated.	Safety profile showed the product was well-tolerated.

Study Details:

1. Sample Size used for the test set and the data provenance:

   • Sample Size: 30 patients.
   • Data Provenance: The study was a clinical evaluation conducted at three centers. It involved comparing treatment in one sinus with no treatment in the contralateral sinus of the same patient. This indicates prospective, multi-center clinical data. The country of origin is not explicitly stated, but the submission is to the US FDA, implying data may be from the US or internationally recognized clinical trials.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not explicitly state the number or qualifications of experts used to establish ground truth for the clinical study's endpoints (synechiae/adhesions, middle meatal stenosis, mucosal status, bleeding control). It only mentions that the product was judged as effective for bleeding, implying clinical assessment by the physicians involved in the study.

3. Adjudication method for the test set:

   • The document does not specify an adjudication method like 2+1 or 3+1. The results are presented as direct comparisons within each patient (treated vs. untreated contralateral sinus).

4. 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, an MRMC study was NOT done. This device is a medical product (gel stent), not an AI diagnostic or assistance system that would involve human readers interpreting images.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a medical device (gel) and not an algorithm or AI system.

6. The type of ground truth used:

   • Clinical observation and assessment. The ground truth for the clinical study outcomes (synechiae, stenosis, mucosal status, bleeding) would have been established through direct clinical examination and assessment by the treating surgeons/clinicians during the follow-up period.

7. The sample size for the training set:

   • Not applicable. This device is a physical product (gel), not a machine learning model, so there is no concept of a "training set" in the context of data used for algorithm development. The safety and performance data came from preclinical animal studies and a human clinical trial.

8. How the ground truth for the training set was established:

   • Not applicable. As a physical device, there is no "training set" or "ground truth" established for algorithm training. The preclinical and clinical studies provided evidence for safety and effectiveness. For the preclinical studies, ground truth for endpoints like irritation, toxicity, and implantation was established through standard laboratory and histological analyses. For the clinical study, it was clinical observation.

Regulation Number and Section

§ 874.4100 Epistaxis balloon.

(a)
Identification. An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.