Search Results

The manufactured microtools are to be used for Assisted Reproductive Technology (ART) and Reproductive Medicine (RM), and the specific pipette indication is as follows:

Injection Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for intracytoplasmic sperm injection (ICSI)

Holding Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for holding oocyte or embryo during ICSI or biopsy

Biopsy Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories 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 Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of polar bodies from occytes, which may be done in order to perform pre implantation genetic diagnosis on the genetic material in the biopsied cell(s)

Assisted Hatching Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories to create a defect in the zona pellucida chemically using Tyrode's acid solution in order to perform assisted hatching of embryos

Denuding Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories to denuding cumulus cells from oocytes by delivering enzymes to aid separation

Partial Zona Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories to cut zona pellucida to create a defect in the zona pellucida mechanically in order to perform assisted hatching of embryos mechanically

The following Jieying Microtools are made of glass capillary tubing. They range in sizes and have various degrees of beveled angles as necessary for each individual application. They are gamma radiated and tested for endotoxin and mouse embryo. These devices are assisted reproduction microtools/pipettes that are used in the laboratory to denude, micromanipulate, or hold human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.

• a. Injection pipette;
• b. Holding pipette;
• c. Biopsy pipette;
• d. Polar body biopsy pipette;
• e. Denuding pipette;
• f. Partial zona dissection (PZD) pipette;
• g. Assisted hatching (AH) pipette.

The provided document describes Jieying Laboratory Inc.'s micro-manipulation pipettes and their equivalence to predicate devices, focusing on the safety and performance characteristics for regulatory approval.

Acceptance Criteria and Device Performance:

Ask a specific question about this device

The Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of oocytes. The Holding Pipettes are used to hold the oocyte in position with the application of vacuum. The Denuding Pipettes are used to remove the cumulus cell layers. The Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable blastomere removal or embryo assisted hatching.

The Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of oocytes, the Holding Pipettes are used to hold the occyte in position with the application of vacuum during single sperm injection with the micro-injection pipette, the Denuding Pipettes are used to remove cumulus cell layers, and the Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable embryo assisted hatching. These devices are manufactured entirely from borosilicate glass. Mouse Embryo Toxicity testing has been performed on the borosilicate glass. Results show the material meets the requirements of these tests.

The provided text describes a 510(k) summary for Cook OB/GYN's Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes. However, it does not include detailed information about specific acceptance criteria or a study that clearly defines and proves the device meets those criteria in a format typically seen for medical device performance studies involving AI or complex algorithm evaluations.

The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria through a dedicated study.

Here's an analysis based on the provided text, addressing the requested points where information is available, and indicating when it is not:

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

  This information is not explicitly stated in the provided document in the context of quantitative performance metrics for the pipettes' function (e.g., success rate of ICSI, embryo viability, etc.). The 510(k) submission relies on demonstrating substantial equivalence.

  The "acceptance criteria" for this type of device, as per the submission, appear to be met by:

  • Equivalence in indications for use, design, construction, and materials to predicate devices.
  • Satisfactory Mouse Embryo Toxicity testing for the borosilicate glass material.
  • Adherence to specified process controls and a Quality Assurance Program.

  Acceptance Criterion (Inferred from Substantial Equivalence)	Reported Device Performance (Inferred from Submission)
  Equivalence in indications for use	"similar to the ... predicate devices"
  Equivalence in design	"similar to the ... predicate devices"
  Equivalence in construction	"similar to the ... predicate devices"
  Equivalence in materials	"similar to the ... predicate devices"
  Satisfactory Mouse Embryo Toxicity (MET) testing of material	"Results show the material meets the requirements of these tests."
  Adherence to process controls and Quality Assurance	"This device will be manufactured according to specified process controls and a Quality Assurance Program."

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

  The document does not describe a clinical "test set" in the sense of a dataset for evaluating device performance in human or animal subjects. The "test" mentioned is Mouse Embryo Toxicity testing.

  • Sample Size: Not specified for MET testing (e.g., number of embryos, batches tested).
  • Data Provenance: Not specified for MET testing.
  • Retrospective or Prospective: Not applicable, as it's a materials test, not a clinical study.

• 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)

  Not applicable. The evaluation is for substantial equivalence and material safety (Mouse Embryo Toxicity), not for diagnostic or clinical performance requiring "ground truth" established by human experts in the context of complex image or data interpretation.

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

  Not applicable. No clinical test set requiring expert adjudication is described.

• 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 a micro-tool (pipette), not an AI/software-as-a-medical-device (SaMD) or diagnostic imaging system. No human reading or AI assistance is involved in its direct function.

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

  Not applicable. This is a physical medical device, not an algorithm.

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

  For the Mouse Embryo Toxicity testing, the "ground truth" would be the observed viability/health of mouse embryos after exposure to the device material, assessed against established biological safety standards for such materials. For substantial equivalence, the "ground truth" is the established regulatory compliance and performance of the predicate devices.

• 8. The sample size for the training set

  Not applicable. No training set for an algorithm is mentioned as this is a physical device.

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

  Not applicable. No training set for an algorithm.

Summary of the Regulatory Strategy:

The manufacturer, Cook OB/GYN, pursued a 510(k) pathway by demonstrating substantial equivalence of their Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes to legally marketed predicate devices. This approach meant they did not need to conduct in-depth clinical performance studies as would be required for novel devices or AI solutions. Instead, they focused on showing that their devices are "similar with respect to indications for use, materials and physical construction" to existing devices and that the materials used are biologically safe (via Mouse Embryo Toxicity testing). The FDA agreed with this assessment, granting 510(k) clearance.

Ask a specific question about this device

Ask a specific question about this device

The Swemed Pipettes are intended to be used to denude, micromanipulate, hold or transfer human gametes or embryos for assisted hatching, ISCI, or other assisted reproduction methods.

The Swemed Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of occytes; the Swemed Holding Pipettes are used to hold the occyte in position with the application of vacuum during single sperm injection with the micro-injection pipette; the Swemed Denuding Pipettes are used to remove the cumulus cell layers; and the Swemed Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable embryo assisted hatching.

The Swemed Pipettes are manufactured by Swemed of borosilicate glass. The pipettes have inner diameters ranging from .0048 - . 190 mm and outer diameters ranging from . 0068 - . 280 mm. The pipette length ranges from 50 to 90 mm. The Denuding Pipette does not have a beveled tip. The ICSI, the holding, and the Assisted Hatching/Zona Drilling Pipettes have a 30-35° beveled tip. The pipettes are packaged in a rubber holder together with a glass tube. The tube is then provided in a seal made of aluminum foil. The pipette is dry heat sterilized by Swemed Lab International. The pipette is intended for single use only.

The provided document is a 510(k) Summary for Swemed Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes.

Crucially, this document focuses on establishing substantial equivalence to a predicate device (Cook OB/GYN Pipettes) rather than presenting a performance study with defined acceptance criteria and detailed study results as would be found in a clinical trial report or a comprehensive validation study.

Therefore, most of the requested information regarding acceptance criteria, device performance metrics, sample sizes for test/training sets, expert qualifications, and adjudication methods is not available in the provided text. The document is primarily a regulatory submission demonstrating a lack of significant differences from a legally marketed device.

Here's a breakdown of what can be extracted and what is missing:

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

1. Dimensions: "inside and outside diameters, pipette lengths, and bevel angles are slightly different"
2. Aspiration Method for Denuding Pipettes: "Cook Denuding Pipettes can be ordered with a mouth aspiration tubing line, whereas the Swemed Denuding Pipettes are intended for use with a vacuum device." |

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

• Sample Size for Test Set: Not applicable. No dedicated performance test set (as in a clinical study) is described. The comparison is based on device specifications and intended use against a predicate device.
• Data Provenance: Not applicable. No clinical data or performance study data is presented to analyze.

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)

• Number of Experts: Not applicable. No "ground truth" establishment from experts is described for a performance study.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. No performance study requiring adjudication is presented.

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

• MRMC Study: No. This device is a micro-tool pipette, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this type of device.
• Effect Size of AI Improvement: Not applicable.

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

• Standalone Performance: Not applicable. This is not an algorithm or an AI device.

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

• Type of Ground Truth: Not applicable. The "ground truth" for this 510(k) submission is the existence and performance of the legally marketed predicate device (Cook Pipettes) and the manufacturer's assertion that the Swemed Pipettes perform equivalently for their intended use.

8. The sample size for the training set

• Sample Size for 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

• Ground Truth Establishment for Training Set: Not applicable.

Ask a specific question about this device

The Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of oocytes. The Holding Pipettes are used to hold the oocyte in position with the application of vacuum. The Denuding Pipettes are used to remove the cumulus cell layers. The Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable blastomere removal or embryo assisted hatching.

The Intractoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of oocytes, the Holding Pipettes are used to hold the oocyte in position with the application of vacuum during single sperm injection with the micro-injection pipette, the Denuding Pipettes are used to remove cumulus cell layers, and the Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable blastomere removal or embryo assisted hatching. These devices are manufactured entirely from borosilicate glass. Mouse Embryo Toxicity testing has been performed on the borosilicate glass. Results show the material meets the requirements of these tests.

The provided text describes a 510(k) Premarket Notification for various micro-injection pipettes used in assisted reproduction. However, it does not contain information about specific acceptance criteria or a study proving the device meets particular performance metrics.

Instead, the submission relies on demonstrating substantial equivalence to existing predicate devices based on indications for use, design, construction, and materials. The "study" mentioned is Mouse Embryo Toxicity testing, but this is a material compatibility test and not a performance study in the context of clinical effectiveness or accuracy.

Here's a breakdown of the requested information based on the provided text, highlighting what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable/Not provided. There is no mention of a "test set" in the context of a performance study for the pipettes' intended use.
• Data Provenance: Not applicable/Not provided. The Mouse Embryo Toxicity testing is implicitly laboratory-based, but no details on the origin or type of data are given for any performance evaluation.

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

• Number of Experts: Not applicable/Not provided. No performance study requiring expert ground truth is described.
• Qualifications of Experts: Not applicable/Not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not provided. No performance study requiring adjudication is described.

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

• MRMC Study Done: No. There is no mention of an MRMC study or any study comparing human readers (or users of the device) with or without AI assistance. The devices are tools, not AI algorithms.
• Effect Size of Human Readers with vs. without AI: Not applicable/Not provided.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Standalone Study Done: No. The devices are physical tools (pipettes), not algorithms. Performance is related to their physical properties and material safety, not an algorithm's standalone capability.

7. Type of Ground Truth Used

• Type of Ground Truth: For the material safety (Mouse Embryo Toxicity test), the "ground truth" would be established by the defined pass/fail criteria of the toxicity test itself, likely based on viability or developmental benchmarks of mouse embryos exposed to the material. No clinical or diagnostic "ground truth" is established for the pipettes' functional performance.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not provided. The submission describes medical devices (pipettes), not an AI algorithm requiring a training set.

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

• How Ground Truth Was Established: Not applicable/Not provided. As above, these are physical devices, not an AI algorithm with a training set.

Summary of the K983596 Submission's Approach:

The K983596 submission primarily establishes substantial equivalence by demonstrating that the Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes are similar in indications for use, design, construction, and materials to previously marketed predicate devices (Humagen Fertility Diagnostics Inc., SWEMED LAB International AB, and Cook Australia products available in Europe).

The only specific testing mentioned is Mouse Embryo Toxicity testing performed on the borosilicate glass material from which the pipettes are made. The submission states, "Results show the material meets the requirements of these tests," which serves as evidence of biocompatibility and material safety, rather than functional performance or clinical efficacy against specific acceptance criteria.

The FDA's successful clearance (K983596) indicates acceptance of this substantial equivalence argument, rather than a direct demonstration of meeting explicit performance criteria through a dedicated clinical or comparative study as might be expected for novel or higher-risk devices or AI algorithms.

Ask a specific question about this device