Search Results

Biopsy pipettes are used in assisted reproduction techniques (ART) for the removal of blastomere(s) from embryos or polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis (PGD) on the genetic materials in the biopsied cell(s).

The Biopsy pipette is part of the RI Pipettes range. Other pipettes available in this range include ICSI Injection, ICSI Holding, and Assisted Hatching pipettes.

Biopsy pipettes are offered in a range

• ID sizes - 14μm, 20μm, 25μm, 30μm, 40μm .
• bend angles 0°, 15°, 20°, 25°, 30°, 35°, 40°, 45° .
• . tip profiles - flat , non-spiked (bevelled), spiked

All pipettes in this range are manufactured from very fine borosilicate glass, packed individually into a Twista-Pak (primary packaging) and sealed in a medical pouch. They are then batch sterilised by gamma irradiation.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: RI Pipettes - Biopsy

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

Blastomere Biopsy Pipettes: The intended use of the Blastomere Biopsy Pipettes is for removal of blastomere(s) from embryos, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s).

Polar Body Biopsy Pipettes: The intended use of the Polar Body Biopsy Pipettes is for removal of polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s).

The Blastomere Biopsy Pipettes are very fine glass pipettes used in IVF/Assisted Reproduction Technology (ART) laboratories for the aspiration of blastomere(s) from embryos for the purpose of preimplantation genetic diagnosis. These pipettes have an inner diameters varying from 18-42 um based customer's preferences and the stage of the embryos being biopsied. The tip may be flat or beveled at 45 degrees, then fire polished, and bended to 10 - 45 degrees or straight.

The Polar Body Biopsy Pipettes are very fine glass pipettes tools used in IVF/Assisted Reproduction Technology (ART) laboratories for the aspiration of polar bodies from oocytes and embryos for the purpose of preimplantation genetic diagnosis. These pipettes have an inner diameters varying from 13-15 um. The tip may be flat or beveled at 45 degrees, then fire polished, and bended to 10-45 degrees or straight. Some of the tip may be pulled to form a sharp spike after polishing based customer's preferences.

These devices are intended for one-time use and will be marked sterile.

These devices are manufactured entirely from borosilicate glass. They are manufactured to specific sizes or the size may be modified to meet customer specifications, following procedures of the Sunlight Quality System. The final products are batch tested as part of a quality assurance program using Mouse Embryo Toxicity testing and endotoxin testing. The acceptance specifications of these tests are ≥80% of 2-cell mouse embryos to blastocysts and endotoxin ≤ 0.5 EU/device.

The Sunlight Medical, Inc. Biopsy Pipettes (Blastomere Biopsy Pipettes and Polar Body Biopsy Pipettes) underwent a 510(k) submission (K092554) to demonstrate substantial equivalence to predicate devices rather than a direct clinical performance study with acceptance criteria in the traditional sense. The equivalence was established based on similarities in indications for use, materials, physical construction, manufacturing processes, and quality controls.

Here's an analysis based on the provided document:

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

The submission does not specify "acceptance criteria" for clinical performance as would be seen in a diagnostic accuracy study. Instead, the "acceptance specifications" refer to quality control tests performed on the manufactured devices. The primary "performance" reported is related to the equivalence to the predicate device and the results of these quality control tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

There is no test set of clinical images or cases described for evaluating device performance in a clinical setting. The "test set" for the quality control criteria would be a sample of manufactured pipettes, but the number of devices tested is not specified. The provenance of the data for these quality control tests (Mouse Embryo Toxicity and Endotoxin) is from the manufacturer's internal "Quality Assurance Program".

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as there was no test set requiring expert ground truth for clinical performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there was no test set requiring adjudication for clinical performance evaluation.

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

This is not applicable. The device is a surgical tool (pipette) and not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This is not applicable. The device is a physical tool, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the quality control tests is based on established biological and chemical assays:

• Mouse Embryo Toxicity: The ability of 2-cell mouse embryos to develop to the blastocyst stage in the presence of the device's leachables. This is an accepted biological indicator for cytotoxicity in reproductive medical devices.
• Endotoxin Test: Quantification of bacterial endotoxins, which is a standard safety measure for medical devices that may come into contact with biological systems.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of device performance in a clinical scenario or AI training, as this is a physical medical device. The "training" for the device would pertain to the manufacturing process and quality system setup, for which sample sizes are not specified in the document.

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

This is not applicable as there is no training set of clinical data. The "ground truth" for manufacturing consistency and quality is established through standard operating procedures, material specifications, and quality control methodologies (like the mouse embryo and endotoxin tests).

Ask a specific question about this device

The Pre-Implantation Genetic Diagnosis Pipettes are used for the aspiration of Blastomeres for pre-implantation genetic diagnosis.

The Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) are used for the aspiration of The Tre Implantation genetic diagnosis. These devices are intended for one-time use and will be marketed sterile. These devices are manufactured entirely from borosilicate glass. Mouse Embryo Toxicity testing and Endotoxin testing have been performed on the borosilicate glass. Results show the material meets the requirements of these tests.

The provided text is a 510(k) Summary of Safety and Effectiveness for the Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes), along with the FDA's clearance letter. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed studies with specific acceptance criteria, performance metrics, and human reader studies as would be seen for complex AI/ML-driven or diagnostic devices.

Therefore, the information requested in your prompt related to specific performance criteria, statistical study details (sample sizes for test/training sets, ground truth establishment, expert adjudication), and AI-specific elements (MRMC studies, standalone performance with AI) is not present in this document. This is because the device is a simple medical tool (pipettes) and the 510(k) pathway primarily requires demonstrating equivalence, not extensive clinical performance studies in the same vein as more complex devices.

However, I can extract the information that is available:

Acceptance Criteria and Device Performance (Limited Information)

The document states equivalence to predicate devices based on materials, design, and function, rather than specific numerical performance metrics.

Study Details (Limited; focus on material safety)

Given the nature of the device (borosilicate glass pipettes), the "studies" performed were primarily material testing.

2. Sample size used for the test set and the data provenance: Not specified for "Mouse Embryo Toxicity testing" and "Endotoxin testing." The provenance would be Cook OB/GYN labs or a contracted testing facility. This would be a prospective test of newly manufactured materials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material testing typically follows standardized protocols, and results are interpreted according to pre-defined thresholds, not through expert consensus on a "ground truth" derived from cases.
4. Adjudication method for the test set: Not applicable for material testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is relevant for diagnostic imaging or AI devices, not for basic medical tools like pipettes.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is not an AI/algorithm-driven device.
7. The type of ground truth used: For the material testing, the "ground truth" is adherence to established biological safety standards, as determined by the results of the Mouse Embryo Toxicity and Endotoxin tests against their respective benchmarks.
8. The sample size for the training set: Not applicable. This device is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of Device and Regulatory Context:

The Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) by Cook OB/GYN are simple borosilicate glass tools intended for aspirating blastomeres for pre-implantation genetic diagnosis. The 510(k) submission focused on demonstrating substantial equivalence to existing pipettes, specifically noting Cook Australia devices as predicates. The key evidence provided for safety and effectiveness related to the materials used: Mouse Embryo Toxicity testing and Endotoxin testing were performed on the borosilicate glass, and the results indicated the material met the required standards. No clinical performance data, AI algorithm performance, or human reader studies were presented or required for this type of device and regulatory pathway.

Ask a specific question about this device

The Pre-Implantation Genetic Diagnosis Pipettes are used for the aspiration of blastomeres for pre-implantation genetic diagnosis. These devices are intended for one-time use and will be marketed sterile.

"This tool is indicated for embryo or blastomere biopsy, which may be done in order to perform preimplantation genetic diagnosis (PIGD) on the genetic material in the biopsied cell(s). Tests for PGD are currently developed and their performance characteristics are determined by the individual laboratories for their own use. The performance of these tests may vary depending on the particular assay and disease evaluated. Currently these tests have not been cleared or approved by the Food and Drug Administration.

The Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) are used for the aspiration of blastomeres for Pre-Implantation genetic diagnosis. These devices are intended for one-time use and will be marketed sterile.

These devices are manufactured entirely from borosilicate glass. Mouse Embryo Toxicity testing and Endotoxin testing have been performed on the borosilicate glass. Results show the material meets the requirements of these tests.

The provided document is a 510(k) summary for a medical device called Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes). This document asserts substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria or a comprehensive study demonstrating performance against specific criteria in the way one would expect for a more complex diagnostic or therapeutic device.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) does not explicitly state quantitative acceptance criteria in a dedicated table format. Instead, it relies on demonstrating substantial equivalence to a predicate device.

The reported "performance" is primarily related to material safety and manufacturing quality rather than diagnostic accuracy or clinical efficacy.

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

Not applicable. This 510(k) submission primarily focuses on substantial equivalence based on design, materials, and intended use to existing devices, and biocompatibility testing. There isn't a "test set" of clinical cases or data in the context of diagnostic accuracy for this type of basic microtool. The data provenance for the biocompatibility tests (Mouse Embryo Toxicity and Endotoxin testing) is not specified (e.g., country of origin, retrospective/prospective).

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

Not applicable. As this device is a microtool for cell manipulation rather than a diagnostic algorithm, there is no "ground truth" derived from expert consensus on clinical cases. The "ground truth" would be the verified safety of the materials and the functional design for its intended purpose.

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 device is not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

Not applicable. This device is a physical microtool, not an algorithm or software.

7. The Type of Ground Truth Used

For the biocompatibility claims:

• Mouse Embryo Toxicity and Endotoxin Testing Results: These tests in laboratories define the "ground truth" for material safety as per established biological evaluation standards. The "results show the material meets the requirements of these tests," indicating a pass/fail ground truth based on the specific test's criteria.

For the substantial equivalence claim:

• Comparison to Predicate Device: The "ground truth" for substantial equivalence is the existing, legally marketed predicate device (Cook Australia's pipettes) in terms of its indications for use, design, construction, and materials.

8. The Sample Size for the Training Set

Not applicable. There is no machine learning or AI component requiring a training set.

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

Not applicable.

Ask a specific question about this device