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Punctal Occluders (plugs) are indicated for the treatment of "dry eye" syndrome.

This device, made of medical grade silicone, titanium dioxide as a colorant and utilizing a proprietary surface treatment made under current good manufacturing practices, is a small, generally "plug" shaped design. Punctal Occluders are intended for the treatment of "dry eve" conditions through partial occlusion of individual punctual openings.

This 510(k) summary (K090938) describes a Micro Flow Punctal Occluder, a medical device intended for the treatment of "dry eye" conditions. The submission makes a case for substantial equivalence to a predicate device (Odyssey Punctal Occluder, K970631) rather than directly presenting a study to prove new acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study to prove the device meets them is not explicitly available in the provided text. The document focuses on demonstrating that the new device is substantially equivalent to a previously cleared device.

Here's an explanation based on the provided text:

• Acceptance Criteria and Reported Device Performance: This information is not explicitly stated in the form of measurable acceptance criteria or performance metrics derived from a study. The submission asserts substantial equivalence based on material, design, and intended use.
• Study Details: There is no description of a study conducted to demonstrate the device's performance against specific acceptance criteria.

Key points from the 510(k) summary regarding the device and its comparison to the predicate:

• Device Description: The Micro Flow Punctal Occluder is made of medical grade silicone with titanium dioxide as a colorant and a proprietary surface treatment. It's a small, "plug" shaped design.
• Intended Use: Treatment of "dry eye" conditions through partial occlusion of individual punctal openings.
• Predicate Device: Odyssey Punctal Occluder (K970631).
• Differences from Predicate (Micro-Flow vs. Original Odyssey Plug):
  • Original: Larger angle nose, no through hole, shorter length.
  • Micro-Flow (New):
    • Has a through hole for partial occlusion.
    • A 0.002 ridge on the nose to support the through hole.
    • Smaller angle on the nose (tip).
• Safety and Reversibility: The document highlights that the submitted method is functionally safe and fully reversible, unlike some alternative methods that are permanent or difficult to reverse, or risk damaging intact tissue.

In summary, the provided document does not contain the details of a study with acceptance criteria, sample sizes, expert qualifications, or adjudication methods as requested. It is a 510(k) submission relying on substantial equivalence to a predicate device.

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The LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets are intended for use in controlling the infusion rate of I.V. fluids from a container to a patient's vascular system. The indications for use of the LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets include intravenous infusion where a manual flow control is desired.

The LifeShield® Latex-Free GraviTech™ Flow Controller !.V. Set will consist of variations of the following components: non-DEHP plasticized polyvinyl tubing, piercing pins, fluid shut off devices, integral CLAVE® ports or prepierced injection sites, backcheck valves, semi-rigid adapters, male adapter and air filter assembly. The GraviTech™ device provides a manual flow control with head height compensation to the LifeShield® product line.

The provided document for the Hospira, Inc. LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets (K063239) is a 510(k) summary and FDA clearance letter, which describes the device and its intended use, and states that it is substantially equivalent to predicate devices.

However, this document does not contain the specific acceptance criteria or the study that proves the device meets those criteria.

510(k) summaries typically focus on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed performance study results with specific acceptance criteria in the public summary. While the summary states that "The LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Set will meet the functional described in the product labeling, and is as safe and effective in terms of substantial equivalence as the predicates," it does not explicitly list the acceptance criteria or the specific data from a study that demonstrates this.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This information would typically be found in a more detailed technical report or in the full 510(k) submission, which is not publicly available in this format. The provided document is a high-level summary for regulatory clearance purposes.

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GraviTech™ is a single use, disposable gravity-driven flow regulator used in conjunction with I.V. administration sets and extension sets for controlling the flow rate of I.V. solutions into the human body.

GraviTech™ Primary Sets are for use in controlling the infusion rate of I.V. fluids from the solution bag to a patient catheter, which is inserted into a human vein.

GraviTech™ Extension Sets are intended for use in conjunction with commonly used I.V. primary sets for controlling the infusion rate of I.V. fluids into the human body.

GraviTech™ is a single use, disposable gravity-driven flow regulator used in conjunction with I.V. administration sets and extension sets for controlling the flow rate of I.V. solutions into the human body.

The provided text is a 510(k) premarket notification letter from the FDA to IV Medical, Incorporated regarding their GraviTech™ Flow Controller Primary Set/GraviTech™ Flow Controller Extension Set. This document does not contain information about acceptance criteria or a study proving the device meets those criteria.

The 510(k) clearance process primarily establishes substantial equivalence to a legally marketed predicate device, rather than requiring the submission of detailed performance studies against specific acceptance criteria in the same way a PMA (Premarket Approval) would.

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

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The ACTIS® (Venous Flow Controller) device is an erection enhancement device that is designed to slow venous outflow from the penis and thus aid in the normal erection process.

It is a linear elastic tube with an O ring and ball locking unit that allows ease of adjustment to increase or decrease tension. Placement is around the base of the penis.

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and study details as per your request. The document is a 510(k) summary for a medical device (ACTIS® Venous Flow Controller) and primarily focuses on its description, intended use, and substantial equivalence to a predicate device. It does not include performance data, study design details, or acceptance criteria in the format you've specified.

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