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The Pronto Pump Tube Set is a part of the Pronto Pump System. This tube set provides peristaltic pump driven fluid transfer that facilities repeatable drug dosage distribution in healthcare environments. The Pronto Pump Tube set provides the fluid path way and pumping mechanism for the pump system.

The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Sets are sold sterile.

The ProntoPump Sterile Tube Sets are fluid transfer tube sets used in conjunction with the ProntoPump pharmacy pump in hospital and compounding pharmacies to provide a pathway through which fluid is transferred from one source container into another suitable container.

The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Sets are sold sterile.

The ProntoPump sterile tube set is a single channel tube set for use with the ProntoPump pharmacy pump. It consists of clear plastic tubing connected to a silicone tube that functions as a peristaltic pumping chamber. Peristaltic pumps function by a roller compressing the pump tubing and rolling along the length of the tube, squeezing the fluid inside the tube from one end to the other. It has a plastic cassette that holds the pumping chamber in place for insertion into the ProntoPump, which provides the rollers that the force the fluid to move. The proximal and distal ends of the PVC tubing have connectors for various devices and containers. Using the ProntoPump, the tube set is used to deliver specified volumes of liquid into a final dosing container in hospital pharmacies or compounding pharmacies. The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Sets are sold sterile.

The cassette is non-fluid-contact and helps hold the tubing in place for loading. It has a machine-readable barcode that can be read by the pharmacy pump. The barcode includes information about the particular tube set item number, lot number, and expiration date, which is used by pharmacy pump to facilitate set up of the tubing.

The tube set is intended to be used by trained healthcare personnel, and is not intended to be used for direct patient contact. Tube sets are packaged individually in a peel pouch and sterilized by radiation.

The provided text describes the regulatory clearance for the "ProntoPump Sterile Tube Set" (K200893) and its substantial equivalence to a predicate device (K062909). However, it does not explicitly state "acceptance criteria" for performance in a table format with specific quantitative goals and reported device performance against those goals for the K200893 device. Instead, it compares the technological characteristics and performance of the subject device to the predicate in a qualitative manner and mentions general ISO and ASTM standards to which the device was tested.

The closest information relating to performance criteria and reported performance is about Volume Accuracy and Minimum Flow Rate, which are compared to the predicate device.

Here's an attempt to create the requested table based on the limited quantitative performance data provided, and then address the other points.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, explicit "acceptance criteria" with pass/fail thresholds are not clearly stated for the K200893 device. Instead, the document compares its performance characteristics to the predicate device. The information below is extracted from the "Comparison of Technological Characteristics with The Predicate Device" table and the "Differences Compared to Predicate Device / Substantial Equivalence Discussion" section.

Note: The document states "Although the accuracy of the ProntoPump tube sets is not as precise as the predicate device, in the context of doses prepared in Hospital and Compounding Pharmacies the accuracy of the volume delivered to the final container is substantially equivalent in terms of safety and effectiveness." This indicates that the "reported device performance" for volume accuracy, while different, was deemed acceptable for substantial equivalence.

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

The document refers to "Bench Testing" against various ISO and ASTM standards. However, it does not provide any specific sample sizes for these tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for the performance testing results, as these are laboratory/bench tests, not clinical studies involving patient data.

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

N/A - This submission is for a medical device (sterile tube set) and relies on bench testing against established engineering and safety standards (ISO, ASTM, USP). There are no human experts involved in establishing a "ground truth" in the context of clinical interpretation or diagnostic accuracy for this type of device. The ground truth is defined by the objective metrics and criteria outlined in the referenced standards.

4. Adjudication Method for the Test Set

N/A - As this is bench testing against objective engineering and safety standards, no adjudication method (like 2+1, 3+1 consensus) is applicable or mentioned. The results are typically measured against the specified tolerances within the standards.

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

N/A - This document describes a syringe pump accessory (sterile tube set), not an AI-powered diagnostic or interpretive device. Therefore, no MRMC comparative effectiveness study was conducted or is relevant.

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

N/A - This device is a physical medical device (tube set) used in conjunction with a pump, not an algorithm. Therefore, no standalone algorithm performance study was conducted.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by the requirements and specifications within recognized international standards for medical devices, particularly those related to infusion equipment, sterilization, packaging, and biocompatibility. These include:

• ISO 8536-4:2019 (Infusion equipment)
• ASTM D4169-16 (Shipping Containers)
• ISO 80369-7:2016 (Small-bore connectors)
• ISO 10993-1:2018 (Biocompatibility)
• USP 788 (Particulate Matter)
• ISO 11607-1:2019 & ISO 11607-2:2019 (Packaging)
• ISO 11137-1:2006 & ISO 11137-2:2013 (Radiation Sterilization)
• The established performance characteristics of the legally marketed predicate device (K062909) also serve as a comparative ground truth for evaluating substantial equivalence.

8. The Sample Size for the Training Set

N/A - This is a physical medical device, not a machine learning or AI algorithm. Therefore, there is no concept of a "training set" for this submission.

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

N/A - As there is no training set for a physical device, this question is not applicable.

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Blink Gold Eyelid Weight Implants, surgically implanted in the upper eyelid, work by gravity to restore a functional blink mechanism in the patient with lagophthalmos resulting from temporary or permanent facial paralysis, specifically the orbicularis oculi muscle. This paralysis may be the result of Bell's palsy or from surgical trauma to the facial nerve.

Functional defects which may be corrected or avoided with the use of Blink Gold Eyelid Weight Implants include inadequate eyelid closure, corneal exposure, serious keratopathy such as ocular irritation, keratitis, corneal abrasion or ulceration. These conditions may result in decreased vision.

The patient with lagophthalmos is unable to close the eyelid completely because of partial or complete paralysis to the facial nerve. This paralysis may be the result of Bell's palsy or from surgical trauma to the facial nerve. The condition of paralysis can be either permanent or transient.

The Blink Gold Eyelid Weight Implants are spherically radiused strips of pure gold, constructed in twelve sizes ranging from 0.6 grams to 2.8 grams in 0.2 gram increments. All product specifications are identical to the predicate device, the Series 3000 Gold Eyelid Implant, produced by MedDev Corporation.

The Blink Gold Eyelid Weight Implant is implanted into the evelid following the surgical technique described in the product brochure. This technique is identical to the technique used to implant the predicate device, the Series 3000 Gold Eyelid Implant.

Blink Gold Eyelid Weight Implants are constructed of pure gold (99.99%). The weights are designed in a rectangular shape with a spherical radius of curvature of 12.7 mm which conforms to the shape of the eye. All edges are smoothly rounded. Suture holes are placed in the implant to allow the surgeon to secure it to the tarsus or orbital septum.

In the engineering specifications, dimensions are stated in the plano view. In the product literature, dimensions are stated in the radiused view.

The provided document is a 510(k) Summary for the Blink Gold Eyelid Weight Implants. This summary focuses on demonstrating substantial equivalence to a predicate device, the Series 3000 Gold Eyelid Implants, rather than presenting a performance study against specific acceptance criteria.

Therefore, the document does not contain information on:

• Acceptance criteria: No specific performance metrics or thresholds are defined.
• Device performance: No quantitative results from a study are reported for the Blink Gold device.
• Sample size: No test set or training set sample sizes are mentioned.
• Data provenance: No information about country of origin or retrospective/prospective nature of data.
• Number and qualifications of experts: Not applicable as no ground truth establishment is described.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: No such study is mentioned.
• Standalone algorithm performance: This device is a physical implant, not an algorithm.
• Type of ground truth: Not applicable.
• Training set size and ground truth establishment: Not applicable.

Instead, the document asserts that the Blink Gold Eyelid Weight Implants are "substantially equivalent" to the predicate device, the Series 3000 Gold Eyelid Implant, across various characteristics.

Here's a breakdown of the comparison presented, which serves as the "study" and "acceptance criteria" in the context of a 510(k) substantial equivalence submission:

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" in this context are a demonstration of sameness or substantial equivalence across key attributes to a legally marketed predicate device. The reported "device performance" is the assertion of this sameness.

The Study that Proves the Device Meets Acceptance Criteria:

The "study" in this submission is a comparison to a predicate device (Series 3000 Gold Eyelid Implants, a preamendment device). The manufacturer, Ipax, Inc., asserts that their Blink Gold Eyelid Weight Implants are identical or substantially equivalent to the predicate device in all critical aspects.

The document explicitly states:

• "All product specifications are identical to the predicate device, the Series 3000 Gold Eyelid Implant, produced by MedDev Corporation."
• "The Blink Gold Eyelid Weight Implant is implanted into the evelid following the surgical technique described in the product brochure. This technique is identical to the technique used to implant the predicate device, the Series 3000 Gold Eyelid Implant."
• "The intended use of the Blink Gold Eyelid Weight Implant is identical to the intended use of the predicate device, the Series 3000 Gold Eyelid Implant."
• "All technological characteristics of the Blink Gold Eyelid Weight Implants are identical to the technological characteristics of the predicate device, the Series 3000 Gold Eyelid Implant."

The FDA's review letter (K971242) concludes: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This FDA determination confirms that the comparison presented by Ipax, Inc. was sufficient to establish substantial equivalence based on the provided information.

The remaining numbered points (2-9) are not applicable to this document as it describes a 510(k) submission based on substantial equivalence to a predicate device, not a performance study of a novel device or an AI algorithm.

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Blink External Eyelid Weights, attached to the outer skin of the upper eyelid with an adhesive, work by gravity to restore a functional blink mechanism to the patient who suffers from lagophthalmos resulting from temporary or permanent facial paralysis, specifically the orbicularis oculi muscle. This paralysis may be the result of Bell's palsy or from surgical trauma to the facial nerve. Functional defects which may be corrected or avoided with the use of Blink External Eyelid Weights include inadequate evelid closure, corneal exposure, serious keratopathy such as ocular irritation, keratitis, corneal abrasion or ulceration. These conditions may result in decreased vision.

The Blink External Evelid Weights are spherically radiused strips of pure tantalum, constructed in twelve sizes ranging from 0.6 grams to 2.8 grams in 0.2 gram increments. The Blink External Weight is attached to the outer skin of the upper eyelid with a double coated adhesive tape strip or with mastisol. Blink External Eyelid Weights are offered in four flesh tone colors: White. Tan. Medium Brown and Dark Brown Only the top surface of the weight is painted. The underneath surface is bare tantalum metal. The physical specifications and materials used in the construction of the Blink External Eyelid Weights are identical to the EyeClose External Eyelid Weights. Blink External Eyelid Weights are produced to the same specifications as the EyeClose External Weights. Blink External Eyelid Weights are constructed of pure tantalum. The weights are designed in a rectangular shape with a spherical radius of curvature of 12.7 mm which conforms to the shape of the eye. All edges are smoothly rounded. The top surface is painted with a Polane 2.8 T Plus polyurethane enamel paint.

This document is a 510(k) summary for the Blink™ External Eyelid Weights, which was submitted to the FDA in 1997. It describes the device and its intended use, and claims substantial equivalence to a predicate device, the Series 1000 External Eyelid Weight (MedDev).

Based on the provided text, the device's acceptance criteria and the study that proves it meets those criteria are not explicitly defined as a traditional performance study with specific quantifiable acceptance criteria and results against them. Instead, the basis for approval is a claim of substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text, with "N/A" where the information is not available or not applicable to this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" here is implicitly that the Blink device must demonstrate that it is "the same" as the predicate device in all critical aspects. The "reported device performance" is the direct assertion from the manufacturer that it is the same.

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

• Sample Size: N/A (No separate "test set" or clinical trial data for the Blink device itself is presented in this 510(k) summary for performance evaluation against acceptance criteria. The claim is based on equivalence to the predicate.)
• Data Provenance: N/A (The submission relies on a comparison table asserting "sameness" with a predicate device, rather than new performance data from the Blink device itself.)

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

• Number of Experts: N/A
• Qualifications of Experts: N/A
  (This type of expert review to establish ground truth is typically associated with clinical studies involving human subject data or image analysis, which isn't described in this 510(k) summary.)

4. Adjudication Method for the Test Set

• Adjudication Method: N/A (No test set or adjudication process described.)

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size

• MRMC Study: No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. This type of study is more common for diagnostic devices where human reader performance is a key metric.
• Effect Size of AI assistance: N/A (Not relevant, as this is a physical medical device, not an AI software.)

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

• Standalone Performance: N/A (This is a physical medical device, not an algorithm. Standalone performance for an algorithm would not be applicable.)

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this context is the established performance and safety profile of the predicate device (Series 1000 External Eyelid Weight by MedDev). The submission effectively states that the Blink device's "sameness" to this predicate device constitutes its "truth" of fitness for market. No new, independent ground truth for the Blink device itself (e.g., from pathology or patient outcomes) is provided.

8. The Sample Size for the Training Set

• Sample Size for Training Set: N/A (No "training set" in the context of an algorithm or statistical model is applicable here. The device is a physical product based on an existing design.)

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

• Ground Truth for Training Set: N/A (As there's no training set, this is not applicable.)

Summary of the 510(k) Submission Approach:

The K971245 submission for the Blink™ External Eyelid Weights is a classic example of a "substantial equivalence" pathway to FDA clearance. Instead of conducting new clinical trials or extensive performance studies, the manufacturer (Ipax, Inc.) asserted that its device is exactly the same as a predicate device (Series 1000 External Eyelid Weight by MedDev) across all critical characteristics, including indications for use, design, materials, and performance. The FDA's letter of clearance confirms that they accepted this claim of substantial equivalence. This means the acceptance criteria were met by demonstrating identical characteristics to a legally marketed device rather than proving performance against specific pre-defined metrics through new studies.

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