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The Ivalon® Eye Drain 80cc, Eye Drain 400cc, Surgical Spears, and Eye Wick 8-inch are used to absorb fluids from the operative field in ophthalmic surgery.

The Eye Drain 80cc, Eye Drain 400cc, Eye Wick 8-inch, and Surgical Spears are packaged individually as a sterile, dried and compressed sponge. They are used to absorb fluids from the operative field in ophthalmic surgery. M-PACT Eye Drain 80cc, Eye Drain 400cc, Eye Wick 8-inch, and Surgical Spears are made from formalized PVA sponge, which is a condensation product of polyvinyl alcohol and formaldehyde.

This is a 510(k) premarket notification for a medical device, not a study evaluating a device's performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in the provided text.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device that was on the market prior to May 28, 1976, or has been reclassified. This pathway focuses on equivalence rather than clinical performance studies demonstrating meeting specific acceptance criteria as you might find in a clinical trial for a novel device.

Here's what can be extracted based on the provided text, and where information is missing:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly defined or reported in the document. The basis for clearance is "substantial equivalence" to predicate devices.
• Reported Device Performance: Not reported in terms of specific metrics (e.g., accuracy, sensitivity, specificity). The claim is that the devices are "identical in size, shape, material composition and intended use" to the predicate devices.

2. Sample size used for the test set and the data provenance

• Sample size: Not applicable/not provided. This document is a premarket notification for substantial equivalence, not a clinical study report with a test set.
• Data provenance: Not applicable.

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

• Not applicable. Ground truth establishment for a test set is not part of a 510(k) substantial equivalence submission for this type of device.

4. Adjudication method for the test set

• Not applicable.

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

• Not applicable. This is not an AI-based device, and no MRMC study is mentioned.

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

• Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

• Not applicable. For a 510(k) based on substantial equivalence for this type of device, the "ground truth" is essentially the established safety and effectiveness profile of the predicate device(s).

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established

• Not applicable.

Summary of Device and 510(k) Basis from the Text:

• Device Name: Ivalon® Eye Drain 80cc, Eye Drain 400cc, Surgical Spears, and Eye Wick 8-inch.
• Intended Use: To absorb fluids from the operative field in ophthalmic surgery.
• Material: Formalized PVA sponge.
• Regulatory Basis: Substantial equivalence (510(k)) to predicate devices (Merocel Eye Drain 80cc, Eye Drain 400cc, Eye Wick 8-inch, and Surgical Spears).
• Reason for Substantial Equivalence Claim: The M-PACT devices are "identical in size, shape, material composition and intended use" to the Merocel predicate devices. The only differences mentioned are in labeling and packaging.

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The Ivalon® Instrument Wipe and PVA Knife Cleaning Block are used to clean surgical instruments and knives.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the Ivalon Instrument Wipe and Ivalon Knife Cleaning Block. It does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria.

The document is a notification of an administrative change related to a previous substantial equivalence (SE) determination, and the initial SE letter itself. These documents confirm that the devices are substantially equivalent to devices marketed prior to May 28, 1976, or reclassified devices, and therefore can be marketed. They discuss regulatory compliance such as annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Therefore, I cannot provide the requested information as it is not present in the given text.

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Nasal and sinus packings are used to absorb excess body fluids after septal, turbinate, or rhinoplastic surgery or endoscopic sinus surgery, and for the control of epistaxis (i.e., nose bleeds). Thev are packaged individually as a sterile, dried and compressed sponge that is inserted into the nasal or sinus cavity. When expanded via absorption of blood after insertion, the nasal packing is intended to fill the necessary space to prevent lateral motion of the turbinate and provide gentle pressure on the mucosa. The sinus packing is intended to selectively pack only the ostiomeatal complex leaving the nasal cavity clear for breathing.

M-PACT nasal and sinus packings are made from formalized PVA sponge, which is a condensation product of polyvinyl alcohol and formaldehyde. Once the chemical reaction has taken place and the foam sponge has cured, the material is washed clean of any residual chemicals.

M-PACT's nasal and sinus products will be sold in different configurations with drawstrings and with and without airway tubes. The products will be provided sterile via gamma radiation in industry standard Tyvek/film and metalized polyester peelable pouches.

This document is a premarket notification (510(k)) and does not contain the detailed information needed to answer your questions about acceptance criteria and a study proving device performance. The summary statement outlines the device, its intended use, and claims substantial equivalence to existing devices.

Here's why the requested information cannot be extracted from the provided text:

• Acceptance Criteria & Reported Performance: The document states, "The device is currently in the validation process and will not be marketed until the validation is complete." This indicates that the performance criteria and the results of a study demonstrating compliance with those criteria are not yet available or are not included in this summary statement.
• Study Details (Sample Size, Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone, Training Set): Since the validation study is still in progress or not yet detailed, none of these specifics related to a performance study can be found.

In summary, the provided text describes the device and its intended use but does not present the results of a performance study against acceptance criteria.

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