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illumination of the operating field and/or the use of a manipulating tool during ophthalmic surgery

The device is a hand held surgical instrument that combines a fiberoptic illuminator with a manipulating tool. It consists of a 20 ga. stainless steel tube enclosing a plastic fiberoptic filament. The distal end of the tube is fashioned into a surgical instrument that extends past the fiberoptic element. The device is intended to be used during ophthalmic surgery to provide light to the operating field and/or to manipulate elements in the surgical field.

The provided document is a 510(k) summary for the "MBI Illuminated Retinal Pick." It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and quantitative results. Therefore, much of the requested information cannot be directly extracted from this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present quantitative acceptance criteria or detailed performance metrics in the way a clinical study would for a diagnostic device. The basis for acceptance is stated as substantial equivalence to predicate devices. The performance is deemed identical due to this equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is not a study that involves a "test set" in the context of clinical data or algorithm evaluation. The "test" for this device is a comparison to predicate devices, focusing on design, materials, and intended use. No human or patient data is used in this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No ground truth was established by experts for a performance study. The "ground truth" here is the established safety and effectiveness of the predicate devices based on their prior 510(k) clearances.

4. Adjudication Method

Not applicable. No adjudication method was used, as there was no clinical or observational data to adjudicate.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document does not mention or present any MRMC study. The device is a surgical instrument, not an AI or diagnostic imaging device that would typically undergo such a study.

6. Standalone Performance Study (Algorithm Only)

No. This device is a physical surgical instrument, not an algorithm. Therefore, a standalone algorithm performance study is not relevant or applicable.

7. Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the predicate devices (MBI Fiberoptic Endo-illuminator K961036 and Trek 9801 Light Pipe Pick K875195) based on their prior FDA clearances. The applicant is leveraging the regulatory history of similar devices to demonstrate substantial equivalence for this new device.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set was used.

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Lighting posterior segment of eye and/or tool for manipulation of elements in eye or aspiration and irrigation within the eye.

The device is a Coaxial Illuminated Retinal Pick. It is a hand held surgical instrument that combines a fiberoptic illuminator with a manipulating tool and has a lumen for aspiration or irrigation. It consists of a stainless steel tube enclosing six smaller fiberoptic filaments made of polymethyl methacrylate with polytetra fluoroethylene sheathing. The distal end has a small amount of "Helioseal" to position and prevent leakage between the fibers and the tool. The device will be marketed as non-sterile not non-pyrogenic.

This document is a 510(k) summary for a medical device called the "MBI Coaxial Illuminated Retinal Pick." It aims to demonstrate substantial equivalence to predicate devices, not to present a study proving the device meets specific performance criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness is not available in this document.

The document primarily focuses on:

• Device Description: Comparing the submitted device's features and materials to predicate devices.
• Intended Use: Showing that the intended use is the same as predicate devices.
• Technological Characteristics: Highlighting similarities and minor modifications.

There is no mention of a performance study with defined acceptance criteria or detailed methodologies for evaluating the device's clinical performance. The statement "Performance is identical to that of the predicate devices" is a claim of equivalence, not a result from a specific performance study outlined in the provided text.

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illumination of the operating field during ophthalmic surgery

The trade name of the device for which the determination of substantial equivalence is being sought is "MBI Fiberoptic Endo-Illuminator". The classification name of the device is Illuminator, Fiberoptic, Surgical Field. It is classified as Illuminator, Fiberoptic, Surgical Field - HBI Reg 878.4580. There are no standards applying to it.

The device is identical to the Storz, MVS Disposable Fiberoptic Lightpipe marketed as a class II postamendment device by Storz Ophthalmics, Inc. under 510(k) marketing clearance issued by FDA as document control number K854587. The MBI device has the same intended use (illumination of the operating field during ophthalmic surgery) and the same technological characteristics (materials used and methods of manufacture). The applicant has been functioning as a capive manufacturing site producing. the predicate device for Storz and now intends to produce and sell to other customers the same device it has been manufacturing for Storz.

Performance is identical to that of the predicate device. When in use during ophthalmic surgery, part of the device will come into contact with the eye of the patient. The distal end that will contact the patient is a 20 ga. stainless steel tube enclosing a plastic fiber-optic filament whose flat end surface will give off the light needed by the surgeon. All materials are identical to those used in the predicate device. Just as in the predicate device, except for three plastic constituents white color added, all components are natural with no colorants added. Those constituents having white color added are the proximal end plug. that is insected into the light source device which is away from the patient, the sheathing for the fiber-optic filament, and the surgeon's grasping point that holds the distal tube that is inserted into the patient's eye during surgery. The colorant is in the plastic material of which the components are made. No constituent to which colorant is added will come into contact with the patient. There are no changes from the color additives used in the predicate device.

The device will be marketed as a single-use, sterile device. As with the prodicate device, sterility will be obtained by packaging the device in a clean, sealed envelope having a clear plastic window as one side and gas-permeable non-woven plastic (Tyvek) as the other side. In a process identical to that used for the predicate device, sealed envelopes containing the device will be sterilized by ethylene oxide gas which will penetrate the gas-permeable non-woven plastic fabric killing all pathogens on the device. Maximum residual levels of ethylene oxide, ethylene chlorohydrin, and ethylene glycol on the device are 250 PPM, 250 PPM, and 5000 PPM respectively. Successful sterilization will be confirmed by culturing spoor strips embedded in the lot to be sterilized. The device will meet sterility assurance level 10°. The constituents of the envelope are impenetrable by pathogens ensuring that sterility is maintained as long as package integrity is not compromised. The device is not considered non-pyrogenic.

The provided document is a 510(k) summary for the "MBI Fiberoptic Endo-Illuminator." It is a submission to the FDA seeking clearance for a medical device. As such, it describes the device as being substantially equivalent to a predicate device, rather than providing a detailed study proving its performance against acceptance criteria in the way a clinical trial might.

Therefore, many of the requested elements (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment for a study) are not applicable to this type of regulatory submission. The document focuses on demonstrating equivalence to an already-cleared device.

However, I can extract the relevant information regarding acceptance criteria and reported performance as presented within the context of substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Not applicable. This document is a 510(k) submission based on substantial equivalence to a predicate device, not a performance study in the typical sense with a "test set" of patient data. The "test" here is demonstrating identical characteristics and processes to the predicate device.
• Data Provenance: The "data" primarily comes from the manufacturing specifications and processes established for the predicate device, which MBI Inc. was already producing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not applicable. No expert ground truth establishment for a diagnostic test set is described. The "ground truth" for this submission is the performance and safety profile of the predicate device, which has already been cleared by the FDA.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring expert adjudication is described in this regulatory submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This is not an MRMC study. It's a submission for substantial equivalence based on manufacturing an identical product to a previously cleared device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This is a physical medical device (an illuminator), not an algorithm or AI.

7. The Type of Ground Truth Used

• The "ground truth" implicitly used for this 510(k) submission is the established safety and effectiveness profile of the predicate device (Storz, MVS Disposable Fiberoptic Lightpipe, K854587) as determined by its prior FDA clearance. The entire submission hinges on demonstrating that the MBI device is identical in all material aspects.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/ML device or a diagnostic performance study. The "experience" or "basis" comes from MBI's historical manufacturing of the predicate device.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. See point 8. The manufacturing history and established specifications for the predicate device serve as the foundational "knowledge" for the submission. The sterility assurance is confirmed by "culturing spoor strips embedded in the lot to be sterilized," which is a quality control measure rather than establishing a "ground truth" for a training set.

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