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VitaVitro Single Lumen Oocyte Retrieval Needle is intended for ultrasound guided transvaginal aspiration of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.

VitaVitro Double Lumen Oocyte Retrieval Needle is intended for ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.

The Oocyte Retrieval Needle is composed of a stainless steel needle protective sleeve, needle handle, suction catheter, silicone plug, vacuum catheter and taper joint. The device includes both dual lumen (ORND) and single-lumen needles (ORNS). Three models are available: ORNS-17G, ORNS-18G and ORND-17G. The oocyte retrieval needles are available in 17 or 18 gauge sizes and two lengths: 33 and 35 cm. The needles are provided with a suction catheter of 100 cm length and a vacuum catheter with a length of 35 cm, and the ORND-17G also includes a flushing catheter of 100 cm length. Needles have an echogenic tip that enhances the visualization of the needle tip under ultrasound.

This product is a disposable, sterile medical device, sterilized by ethylene oxide.

Here's an analysis of the provided text regarding the acceptance criteria and study for the VitaVitro® Oocyte Retrieval Needle.

This document describes a 510(k) premarket notification for a medical device, which typically compares a new device to an existing legally marketed predicate device to demonstrate substantial equivalence. It is important to note that 510(k) submissions generally do not involve clinical trials to prove efficacy against specific clinical outcomes in the same way a PMA (Premarket Approval) would. The focus is on demonstrating that the new device is as safe and effective as the predicate based on technological characteristics and performance testing.

Therefore, many of the questions regarding "study that proves the device meets the acceptance criteria" in a clinical sense, particularly those related to human-in-the-loop performance, effect sizes, and detailed ground truth establishment from patient data, are not typically part of a 510(k) submission for this type of device. The acceptance criteria here are primarily based on non-clinical performance testing demonstrating the device's technical specifications and safety.

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

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Lotus Single Lumen Ovum Aspiration Needle is used for ultrasound guided transvaginal aspiration of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.

Lotus Double Lumen Ovum Aspiration Needle is used for ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.

The subject devices are single use sterile devices used for ultrasound-guided transvaginal aspiration of oocytes from ovarian follicles.

The Lotus Single Lumen Ovum Aspiration Needle consists of a stainless steel needle with a handle, which is connected to an aspiration tube with a silicone stopper at the other end. The stopper can fit onto a test tube where the oocytes are collected. The stopper is connected to a vacuum tube with a vacuum tubing connector at the other end. The vacuum tubing connector is a standard luer lock connector that enables connection to a vacuum pump to provide aspiration suction. The Lotus Single Lumen Ovum Aspiration Needle is 35 cm in length and has device variations from 21 to 16 gauge with aspiration tubing of 600 or 900 mm in length.

The Lotus Double Lumen Ovum Aspiration Needle consists of a stainless steel needle with a Y shaped handle. The Y-shaped handle has two ports: the central port through which oocytes are aspirated via the aspiration lumen, and a secondary side port to allow flushing of follicles via the flushing lumen. The central port is connected to an aspiration tube with a silicone stopper at the other end. The stopper can fit onto a test tube where the oocytes are collected. The stopper has a vacuum connector that is a standard luer lock connector that enables connection to a vacuum pump to provide aspiration suction. The side port is connected to a flushing tube with a flushing connector at the other end, which is a standard luer lock connector that can be connected to a compatible syringe for flushing of follicles. The Lotus Double Lumen Ovum Aspiration Needle is 17 gauge with an aspiration tubing length of 900 mm and with device variations of 30 or 35 mm needle length and flushing tubing of 700 or 1000 mm in length.

This document is an FDA 510(k) Premarket Notification for medical devices, specifically ovum aspiration needles. It does not describe a study involving an AI/Machine Learning device. Therefore, it is not possible to extract information about acceptance criteria or study details relevant to AI/ML device performance from this text.

The document discusses traditional medical device testing, such as:

• Biocompatibility testing: Cytotoxicity, Sensitization, Intracutaneous Irritation.
• Sterilization testing: Ethylene Oxide (EO) sterilization, residual testing.
• Simulated transportation: Adherence to ASTM D4169-22.
• Stability and Shelf Life testing: accelerated aging, package integrity, mechanical performance (appearance, dimensions, needle stiffness, breakage resistance, corrosion resistance, tip penetration force, needle bond strength, flow rate, ultrasound detectability, tubing bond strength, leak, aspiration test, component compatibility).
• Mouse Embryo Assay (MEA): This is a biological test to assess the non-toxicity of materials to embryos, not an AI performance metric. The acceptance criterion for 1-Cell MEA was ≥80% embryos developed to expanded blastocyst at 96 hours after 30 minute exposure.
• Endotoxin evaluation: Acceptance criterion was ≤ 20 EU/device.

Since the request specifically asks for details related to AI/Machine Learning device performance, and this document pertains to a traditional, non-AI medical device, I cannot fulfill the request as stated.

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Allwin Ovum Pickup Needles are used for laparoscopic or ultrasound guided transvaginal retrieval of oocytes from ovarian follicles.

Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle).

This FDA letter is a notification of substantial equivalence for a medical device (Allwin Ovum Pickup Needles). It does not contain information about acceptance criteria or specific studies that prove the device meets these criteria. The document explicitly states:

"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This means the FDA has determined the new device is as safe and effective as a legally marketed device already on the market, based on the information provided by the manufacturer in their 510(k) submission. However, the details of the studies and acceptance criteria used by the manufacturer to demonstrate this substantial equivalence are not included in this letter. The letter is the FDA's final decision, not the manufacturer's submission itself.

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The Wallace Dual Lumen Oocyte Recovery System is a sterile, single-use device for ultrasonic-guided transvaginal collection of oocytes from the ovarian follicles.

The Wallace Dual Lumen Oocyte Recovery System consists of a 33 cm dual lumen stainless steel needle with a plastic needle hub, and aspiration, flushing, and vacuum tubing. The needle hub acts as a handle and is designed for the user to hold between the thumb and index finger. It has two ports: the central port through which oocytes are aspirated via the central lumen, and a secondary side port to allow flushing of follicles via the secondary lumen that is attached to the flushing tubing. The needle aspiration tubing connects to a silicone bung that allows connection to a sample tube. The silicone bung is also connected to the vacuum tubing that allows connection to a vacuum source. The Wallace Dual Lumen Oocyte Recovery System is available in 16 or 17-gauge color-coded sizes (16G-Blue and 17G-Red). The needles are available in three aspiration tubing lengths: 500, 750, and 950 mm. The system includes flushing tubing of 700 mm length and vacuum tubing of 500 mm length. The device is provided sterile and is for single-use only.

The provided text is a 510(k) summary for a medical device (Wallace Dual Lumen Oocyte Recovery System) and does not contain information about studies related to AI or algorithm performance. The content focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing of physical attributes, such as needle size, biocompatibility, stability, shelf life, and mechanical performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies that prove a device meets criteria in the context of AI/algorithm performance, as these details are not present in the given document.

The document indicates that the device is a sterile, single-use system for ultrasonic-guided transvaginal collection of oocytes and does not mention any AI or software components.

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The Wallace Dual Lumen Oocyte Recovery System in a sterile single-use device for ultrasonic-guided transvaginal collection of oocytes from the ovarian follicles.

The Wallace Dual Lumen Oocyte Recovery System consists of a dual lumen stainless steel needle with a plastic needle hub, and aspiration, flushing, and vacuum tubing. The needle hub acts as a handle and is designed for the user to hold between the thumb and index finger. It has two ports: the central port through which oocytes are aspirated via the central lumen, and a secondary side port to allow flushing of follicles via the secondary lumen that is attached to the flushing tubing. The needle aspiration tubing connects to a silicone bung that allows connection to a sample tube. The silicone bung is also connected to the vacuum tubing that allows connection to a vacuum source.

The Wallace Dual Lumen Oocyte Recovery System consists of a 17 gauge needle that is 33 cm long, and three aspiration tubing lengths: 500, 750, and 950 mm. The system includes flushing tubing of 700 mm length and vacuum tubing of 500 mm length. The device is provided sterile and is for single-use only.

Based on the provided text, the device in question is the Wallace Dual Lumen Oocyte Recovery System, an ovulation retrieval needle. The document does not describe a study involving an AI/algorithmic device or human readers. Instead, it details the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested sections (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set ground truth establishment) are not applicable as they pertain to the evaluation of an AI or algorithm, which is not the subject of this 510(k) summary.

Here's an analysis of the available information:

Acceptance Criteria and Device Performance for the Wallace Dual Lumen Oocyte Recovery System

The device under review is an assisted reproduction needle, not an AI or algorithm. The acceptance criteria and performance data provided relate to the physical and biological characteristics of the device to demonstrate its safety and effectiveness, primarily through comparison to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes various non-clinical performance tests and their acceptance criteria (implicitly met as the conclusion states the device passed all testing).

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

• Sample Size: Not explicitly stated for each test (e.g., number of needles tested for mechanical performance, number of packages for integrity). However, the methods refer to standard test procedures (e.g., ISO, ASTM), which typically define sample sizes.
• Data Provenance: The document describes non-clinical laboratory testing of the device itself, not human clinical data or imaging data. Therefore, concepts like country of origin or retrospective/prospective are not applicable.

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

• Not Applicable. This device is a physical medical instrument, not an AI/algorithmic software. "Ground truth" in this context refers to the defined scientific and engineering standards and methods for assessing the device's physical, chemical, and biological properties, which are established by standard organizations (e.g., ISO, ASTM, USP) and verified by qualified laboratory personnel.

4. Adjudication Method for the Test Set

• Not Applicable. As this is non-clinical performance testing of a physical device, there is no "adjudication" of expert opinions in the sense of image interpretation. Test results are objective measurements against defined standards.

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

• No. This is not an AI/algorithmic device or diagnostic tool. An MRMC study would be irrelevant.

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

• Not Applicable. This is a physical medical device. "Standalone performance" in this context refers to the device's ability to meet its specifications independently, which is what the non-clinical performance testing aimed to demonstrate.

7. The Type of Ground Truth Used

• Defined Standards and Measurable Performance Metrics: The "ground truth" for this device's performance is based on established international and national standards (e.g., ISO, ASTM, ANSI/AAMI, USP) for sterility, biocompatibility, mechanical properties, and packaging integrity. Tests evaluate quantitative and qualitative measures directly against these benchmarks (e.g., specific thresholds for endotoxin, percentage of embryo development, strength limits, leak absence).

8. The Sample Size for the Training Set

• Not Applicable. This refers to an AI/algorithmic device, not a physical medical instrument. There is no concept of a "training set" for the type of evaluation described.

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

• Not Applicable. Again, this is for AI/algorithmic development. The "ground truth" for evaluating this physical device is established through adherence to recognized industrial and medical device testing standards and protocols.

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The Single Lumen Ovum Aspiration Needles are used for laparoscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.

Single Lumen Ovum Aspiration Needles consist of a stainless-steel needle with a manipulating handle which may be connected to a fluorinated ethylene-propylene (FEP) or polytetrafluorethylene (PTFE) tube, which in turn is connected to a Silicone stopper (bung). The stopper has a Luer lock fitting directly to the stopper or connected to a length of tube to allow connection to a vacuum pump which provides aspiration suction. The stopper is placed in a 14mL test tube which acts as a collection reservoir. Needles are available in 16 to 21 gauge sizes and lengths from 25 to 35 cm. Needles have an echogenic tip that enhances the visualization of the needle tip under ultrasound. The Single Lumen Ovum Aspiration Needles are sterile and single-use devices.

Here's an analysis of the provided FDA 510(k) summary, specifically addressing the acceptance criteria and the study that proves the device meets them:

The document is a 510(k) premarket notification for the "Single Lumen Ovum Aspiration Needles." This is a medical device, and the focus of the regulatory claim is substantial equivalence to a predicate device, not necessarily a demonstration of clinical superiority or a deep dive into AI performance. Therefore, many of the typical AI/ML acceptance criteria and study details you'd expect are not present.

The "acceptance criteria" here largely refer to the performance standards and modifications made to demonstrate that the new device is as safe and effective as the predicate device.

1. Table of acceptance criteria and the reported device performance

• Mechanical testing: Measurements against predefined engineering specifications for strength, leak resistance, and stiffness.

8. The sample size for the training set

This information is not applicable. The device is not an AI/ML system and therefore does not have a "training set" in the computational sense. The design verification and validation tests are performed on representative samples of the manufactured device.

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

This information is not applicable as there is no training set for an AI/ML algorithm.

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The Double Lumen Ovum Aspiration Need for laparoscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.

Double Lumen Ovum Pick-up Needles consist of a double lumen stainless steel needle with a manipulating handle. The manipulating handle has two ports: the central port through which oocytes are aspirated via the central lumen, and a secondary side port to allow flushing of follicles via a secondary lumen. The needle is intended to be used to aspirate oocytes from follicles of human ovaries via a laparoscopic or ultrasound guided transvaginal path.

The Double Lumen Ovum Aspiration Needles are sterile and single-use devices.

The Double Lumen Ovum Aspiration Needles are available in 16 or 17 gauge sizes and three lengths: 30, 33 and 35 cm. The needles are provided with an aspiration tube of 75 cm length and a vacuum tube with a length of 70 or 100 cm.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes design verification and validation activities for a medical device (Double Lumen Ovum Aspiration Needles), not a study involving human data, algorithms, or test sets in the context of medical imaging or AI.

Therefore, the concepts of "sample size used for the test set," "data provenance," "country of origin of the data," and "retrospective or prospective" are not applicable to this type of device submission. The tests were performed on the device itself or its materials.

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

This information is not applicable as the document describes physical/material testing of a medical device, not a diagnostic or AI-driven system requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above.

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 information is not applicable. This submission is for a physical medical device, not an AI-based diagnostic tool.

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

This information is not applicable. This submission is for a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on established industry standards (e.g., ISO, USP) and internal functional requirements for biocompatibility, mechanical performance, and sterility. For the Mouse Embryo Assay (MEA), the "ground truth" would be the development of a control group of embryos.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an algorithm or AI model.

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

This information is not applicable. There is no "training set" or associated ground truth establishment for an AI model.

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Intended for flushing and/or aspiration of oocytes from ovarian follicles.

The Follicle Aspiration Set. Reduced Single Lumen proposed in this submission is intended for ultrasound-guided transvaginal aspiration and flushing of oocytes from ovarian follicles. This product is comprised of the following components:

• A stainless steel needle .
• A silicone cork to be pushed into the opening of a sampling tube .
• A length of TPE-O tubing for aspiration and flushing ●
• An adapter for flushing .
  The subject device is provided sterile and is for single use only. It comes in four versions with the same design but different dimensions, as described below.

The provided text is a 510(k) summary for the Vitrolife Sweden AB Follicle Aspiration Set, Reduced Single Lumen. This document demonstrates the device's substantial equivalence to a predicate device, rather than providing a detailed study report for meeting specific performance criteria typically associated with AI/ML-enabled devices.

Therefore, many of the requested categories (such as sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, and ground truth establishment for training set) are not applicable to this type of device and submission. This is a medical device clearance based on engineering performance and material compatibility, not on diagnostic accuracy derived from AI analysis of data.

However, I can extract the acceptance criteria and reported performance for the engineering and biological tests conducted.

Acceptance Criteria and Device Performance for Vitrolife Sweden AB Follicle Aspiration Set, Reduced Single Lumen

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test set (e.g., number of devices for endotoxin testing, number of embryos for MEA). The tests are typically laboratory-based engineering and biological assessments compliant with recognized standards. Data provenance is not described in terms of geographical origin or retrospective/prospective study design as would be relevant for clinical data. These are intrinsic performance tests of the device itself.

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

Not applicable. The "ground truth" for these types of tests is generally defined by the specific test method, instrument calibration, and adherence to international standards (e.g., ISO, ASTM, USP). There are no human "experts" establishing ground truth in the context of diagnostic interpretation for these performance evaluations. Qualified laboratory personnel perform and interpret the results according to the established protocols.

4. Adjudication Method for the Test Set

Not applicable. These are quantitative and qualitative laboratory tests with defined pass/fail criteria from international standards. There is no ambiguous "case" interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is an aspiration set, primarily a mechanical and sterile instrument, not an imaging or diagnostic device that involves human interpretation of results.

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

Not applicable. This device is not an algorithm or AI-enabled system. Its performance is entirely mechanical, material-based, and biological compatibility.

7. The Type of Ground Truth Used

The ground truth is based on established international and national standards and methodologies for medical device performance, sterility, material safety, and biocompatibility. Examples include:

• Sterilization: ISO 11137-2:2013
• Endotoxin: USP
• Needle Properties: ISO 9626:2016
• Embryo Toxicity: Mouse Embryo Assay (MEA), a recognized biological test.
• Packaging Integrity: ASTM F1886/F1886M-09, ASTM F1929-12, ASTM F88/F88M-09

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning, so there is no "training set."

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

Not applicable. As there is no training set, this question is irrelevant to the device submission.

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The Kitazato OPU Needles consisting of:

• · Kitazato OPU Needle with Connection Tube (model number Type2)
• · Kitazato OPU Reduced Needle (model number Type3)
• · Kitazato OPU Two-Stage Reduced Needle (model number Type4)
  are intended to obtain oocytes from ovarian follicles.

The Kitazato OPU Needles are single-use sterile devices that are used for ultrasound-guided transvaginal collection of oocytes from ovarian follicles.
All of the Kitazato OPU Needle have a similar general design and device materials. All of the Kitazato OPU Needles are composed of a 304 stainless steel needle, acrylonitrile butadiene styrene (ABS) needle hub, PVC connection tube, and a silicone stopper that is used to connect to a collection tube and vacuum pump.

Here's a breakdown of the acceptance criteria and study information for the Kitazato OPU Needles, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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Intended for flushing and/or aspiration of oocytes from ovarian follicles.

Follicle Aspiration Sets included in this submission are intended for ultrasound-guided transvaginal aspiration and flushing of oocytes from ovarian follicles. Four types of Follicle Aspiration Sets are included in this submission, and are described in more detail below.

The Follicle Aspiration Sets are radiation sterilized and are for single use only. The materials used in these devices include: stainless steel, TPE-O tubing, silicone, medical grade adhesive, polypropylene, and methyl methacrylate acrylonitrile butadiene styrene.

Follicle Aspiration Set, Single Lumen: This device consists of a single-lumen stainless steel needle, aspiration tubing, and a silicone rubber cork for attachment to a collection tube. One version (17132) also includes vacuum tubing attached to the silicone rubber cork for attachment to the vacuum pump used for aspiration. This device also includes an adapter for flushing of ovarian follicles and removal of blockages. The needles for the majority of the versions of this device type include echogenic markings at the tip of the needle to aid in visualization during aspiration procedures.

Follicle Aspiration Set, Double Lumen: This device consists of a double lumen stainless steel needle, tubing for flushing of ovarian follicles and removal of blockages, tubing for aspiration, and a silicone rubber cork for attachment to a collection tube. One version (17129) also includes vacuum tubing attached to the silicone rubber cork for attachment to the vacuum pump used for aspiration. The needles for these versions of the device include echogenic markings at the tip of the needle to aid in visualization during aspiration procedures.

Follicle Aspiration Set, Single Lumen Luer with Tubing: This device consists of a single lumen stainless steel needle, and aspiration tubing with a luer connection at the end. The needle is provided with echogenic markings at the tip of the needle to aid in visualization during aspiration procedures.

Follicle Aspiration Set, Single Lumen, Luer: This device consists of a single lumen stainless steel needle with a luer connection at the base of the needle. The needle is provided with echogenic markings at the tip of the needle to aid in visualization during aspiration procedures.

The provided text describes the Follicle Aspiration Set, outlining its design, intended use, and comparison to a predicate device. It also includes information about performance testing to establish substantial equivalence.

Here's a breakdown of the requested information:

Acceptance Criteria and Reported Device Performance

• Sterilization Validation (ISO 11137-2:2013): International standard for radiation sterilization.
• Mechanical Testing (ISO 9626:2016, Tensile Strength): International and industry standards for needle properties and material strength.
• Biocompatibility Testing (ISO 10993-5, 10, 1): International standards for evaluating the biological effects of medical devices.
• Packaging Testing (ASTM F88/F88M, F1929, F1886/F1886M): American Society for Testing and Materials standards for package integrity.

These are objective, quantitative, and qualitative measures against defined standards or biological responses, rather than subjective ground truths established by human experts or outcomes data in a clinical trial.

8. The sample size for the training set

This information is not applicable. The device is a manufactured medical instrument, not a machine learning model, so there is no "training set."

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

This information is not applicable, as there is no "training set" for this physical device.

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