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The embryo transfer catheter set is a sterile, single use device designed for in vitro fertilized (IVF) embryo transfer into the uterine cavity.

The trial transfer catheter is a sterile, single use device which is designed for ensuring a free passage through the cervix prior to the embryo transfer.

The stylet is a sterile, single-use device designed to support in initial placement of the guide catheter prior to the embryo transfer.

Embryo Transfer Catheter Set: The Swemed Embryo Transfer Catheter Set is manufactured by Swemed of medical grade polymers. The device consists of a two piece assembly comprised of an embryo transfer catheter and a detachable guide catheter (outer sheath). The overall length of the assembly ranges from 190 mm to 250 mm. The outer diameter of the transfer catheter is approximately 1.4 mm and the outer diameter of the guide catheter is approximately 2.3 mm. The catheter sets are packaged separately or assembled in an double barrier sterilisation pouch/wrapping. All devices are sterilized using e-beam irradiation.

Trial Transfer Catheter Set: The Swemed Trial Transfer Catheter Set is manufactured by Swemed and is identical to the Swemed Transfer Catheter Set except for tip design and packaging configuration. The differences are that the tip is closed, i.e. no hole, and that it is packaged in a single barrier, i.e. an outer sterilization pouch/wrapping only. All devices are sterilized using e-beam irradiation.

Stylet: The Swemed stylet is manufactured by Swemed of medical grade polymers and stainless steel. The stylet consists of a handle (polyurethane) and polymer (polytetraflourethene) covered stainless steel wire. The Swemed stylet is packaged in a single barrier, i.e. an outer sterilization pouch/wrapping only. All devices are sterilized using e-beam irradiation.

The provided document is a 510(k) summary for the Swemed ClearVision™ Embryo Transfer Catheter Set and accessories. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving that the device meets specific acceptance criteria in terms of performance metrics.

Therefore, the document does not contain the requested information regarding acceptance criteria, device performance tables, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth details for testing or training sets.

The summary of the document states:
"Swemed Lab International AB, believes that the subject devices are substantially equivalent to the predicate devices. The subject devices has the same intended use/indications for use, in principle the same dimensions, complies with the same standards/special controls. The differences are the sterilization method used and a minor difference in material composition. Based on the comparison of the Swemed Clearvision™ Embryo Transfer Catheter Set and accessories to the predicate devices the conclusion is made that no new questions of safety and effectiveness are raised. Therefore, it is concluded that the requirements for substantial equivalence for the proposed devices are met."

This indicates that the "study" proving the device meets its "acceptance criteria" (in the context of a 510(k)) is a comparative analysis of the device's technical characteristics, intended use, and indications for use against existing predicate devices. The acceptance criteria, in this case, are implicitly met by demonstrating that the new device is as safe and effective as the predicate devices, despite minor differences in sterilization method and material composition.

Without specific performance metrics being the basis for the 510(k) submission, the requested table and detailed study parameters are not applicable or extractable from this document.

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The Swemed Blastomere Biopsy Pipette is intended to conduct a blastomere biopsy, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s).

The Swemed Blastomere Biopsy Pipette is indicated to aspirate blastomeres containing genetic material for the purpose of preimplantation genetic diagnosis.

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 Swemed Blastomere Pipette is manufactured by Swemed of borosilicate glass. The pipette has an inner diameter ranging from 0.030 mm to 0.049 mm and an outer diameter of either 0.053 mm or 0.060 mm. The pipette's length ranges from 55 to 65 mm. The Blastomere Pipette has a 20-35° beveled tip. The pipette is packaged in a silicone holder together with a glass tube. The tubes are then provided in seals made of aluminum foil. The pipette is dry heat sterilized by Swemed Lab International. The pipette is intended for single use only.

The provided text is a 510(k) summary for a medical device called the Swemed Blastomere Biopsy Pipette. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a new device meets specific acceptance criteria through a clinical study.

Therefore, the document does not contain information typically found in a study proving a device meets acceptance criteria, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or details on ground truth establishment.
• Information on expert panels, adjudication methods, or MRMC studies.
• Details on standalone algorithm performance.
• Sample sizes or ground truth establishment for training sets (as this is not an AI/ML device).

The document focuses on demonstrating that the Swemed Blastomere Biopsy Pipette is "substantially equivalent" to existing predicate devices (Swemed's Assisted Hatching/Zona Drilling Pipette, Cook OB/GYN's Pre-Implantation Genetic Diagnosis Pipette, and Humagen Fertility Diagnostics, Inc.'s Blastomere Biopsy Micropipette) based on:

• Identical intended use and indications for use.
• Substantially equivalent technological characteristics, with minor variations in diameter ranges that do not raise new safety or effectiveness issues because the new device's diameter ranges are encompassed by the predicate's.

No specific acceptance criteria or a study designed to prove the device meets those criteria are described in this document. The entire submission acts as the "study" to prove substantial equivalence through comparison to predicates, rather than performance against defined metrics.

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The Swemed Follicle Aspiration Sets are intended to be used to obtain gametes from the body. The Swemed Follicle Aspiration Sets are indicated for use in flushing and/or aspiration of oocytes from ovarian follicles.

The Swemed Follicle Aspiration Sets are designed with either a single lumen which is capable for aspiration from the follicle or a double lumen which is capable of aspiration and flushing of sterile medium through the outer lumen up to the follicle. The needle has a beveled tip provided with shallow grooves to improve ultrasound image enhancement. The needle are supplied with a protective tube on the tip, which must be removed before use. The needles have inner diameters of 0.8 - 1.2 mm and outer diameters of 1.47 - 1.65 mm, which approximates a 16 and 17 gauge needle, respectively. The needle length ranges from 25 to 35 cm. The set is packed in an inner and outer wrapping, and steam sterilized.

The provided text focuses on the 510(k) summary for the Swemed Follicle Aspiration Set, demonstrating its substantial equivalence to a predicate device. This type of submission relies on comparisons to existing legally marketed devices rather than extensive new clinical studies with detailed acceptance criteria and performance metrics. Therefore, many of the requested details about acceptance criteria, specific studies, ground truth establishment, and expert involvement are not present in this document.

Here's a breakdown of the information that can be extracted and a clear indication of what is not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) submission for the Swemed Follicle Aspiration Set is based on demonstrating substantial equivalence to a predicate device (Cook OB/GYN Ovum Pick-Up Aspiration Needles). Substantial equivalence means the device is as safe and effective as a legally marketed predicate device, not that it met specific quantitative performance criteria in a de novo study with acceptance thresholds. The document states:

"The Swemed Follicle Aspiration Sets and the Cook Ovum Pick-Up Needles share the exact same intended use: to obtain oocytes from the body and the exact same indication for use: flushing and/or aspiration oocytes from ovarian follicles. Except for four minor features, the Swemed Follicle Aspiration Sets and the Cook Ovum Pick-Up Needles are nearly identical. ... These minor differences do not affect the safety or effectiveness of the device."

This implies that the "acceptance criteria" were met by demonstrating that the device's technological characteristics and intended/indications for use are sufficiently similar to a device already deemed safe and effective, and that the minor differences do not negatively impact safety or effectiveness. No specific performance metrics (e.g., aspiration efficiency, follicle retrieval rate) are provided or compared.

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

This information is not provided. The document describes the device's features and its proposed equivalence to a predicate device, but it does not detail any specific clinical testing or studies with a "test set" in the context of typical AI/diagnostic device validation. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not provided. As no specific test set or study is detailed, there's no mention of experts establishing a ground truth.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC study and, crucially, this device is a medical instrument (needles), not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

This is not applicable as the device is a medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

This information is not provided. Since the submission relies on substantial equivalence and not a de novo performance study, there's no detailed discussion of ground truth. The "ground truth" implicitly references the established safety and effectiveness of the predicate device.

8. The Sample Size for the Training Set

This information is not provided. As this is not an AI/algorithmic device, there would be no "training set."

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

This information is not provided and is not applicable for this type of device and submission.

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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.

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