(326 days)
Not Found
No
The device description and performance studies focus on a passive, physical separation technique based on sperm motility, with no mention of computational analysis or algorithms.
No.
The device is used to prepare sperm for assisted reproduction techniques, which is a preparatory step rather than a direct therapeutic intervention on the patient.
No
The device is designed to prepare sperm for assisted reproductive techniques by separating vigorous sperm from non-motile or abnormal sperm and ejaculate debris. This is a preparative or functional separation step, not a diagnostic one that identifies a disease or condition.
No
The device description clearly states it is a physical, disposable chamber made of medical grade polystyrene, used for a physical sperm separation technique. It is not software.
Based on the provided information, the RI MSC is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "prepare sperm by migration-sedimentation method for the assisted reproduction techniques of intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI)." These are procedures performed in vitro (outside the body) on biological specimens (sperm).
- Device Description: The device is designed to facilitate a specific laboratory technique (migration sedimentation) for processing a biological sample (sperm).
- Performance Studies: The non-clinical testing focuses on the device's compatibility with sperm and its sterility, which are relevant to its use in an in vitro setting for preparing biological samples.
- Predicate Device: The predicate device listed (K090429; IVF Center Well Dish) is also a device used in in vitro fertilization procedures, further supporting the classification of the RI MSC as an IVD.
IVD devices are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While the RI MSC isn't directly diagnosing a disease, it is a critical component in the in vitro process of preparing biological samples for assisted reproduction techniques, which fall under the scope of IVD use.
N/A
Intended Use / Indications for Use
The RI MSC is intended to prepare sperm by migration-sedimentation method for the assisted reproduction techniques of intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF), and intrauterine insemination (IUI).
Product codes
MQK
Device Description
The Research Instruments Migration Sedimentation Chamber (RI MSC) is sterile, non-pyrogenic proven by Limulus Amebocyte Lysate and non-toxic to sperm proven by Human Sperm Survival Assay (HSSA). The RI MSC is disposable and labelled for single use, individually packaged in medical pouches and sold in boxes of twenty (x20) units.
The RI MSC is manufactured from medical grade polystyrene and its surfaces are untreated. It is injection moulded as a completed unit, housing a central well with a surrounding gallery. The cylinder is 74 mm in height with a top OD of 16.5 mm and fluid capacity of 6 ml (approx) if completely filled; however, during recommended procedures it accommodates 1-2 ml of culture medium.
The RI MSC facilitates the migration sedimentation technique. The migration sedimentation technique utilizes the innate 'swimming' ability of sperm to separate vigorous, A-motile sperm from non-motile or abnormal sperm and ejaculate debris.
2 hours prior to the moment of insemination by assisted reproduction techniques (ART), the chamber is pre-loaded with culture media into which unprepared (raw) sperm is pipetted. The semen is pipetted into the gallery only section of the chamber. During a short incubation period, motile sperm migrate to the over-laying medium and fall by gravity from the gallery into the central well cavity of the chamber. The resulting sample is ready for use in ART techniques.
The RI MSC design is based on existing technology described in the published literature paper 'Selection of human spermatozoa by migration sedimentation' by Mailloux-G', Lucena-C, Tea-N-T, Jondet-M. Contraception Fertilite Sexualite, 1990, Vol.18 No.117 Pg 1037-1039.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing includes:
- sperm compatibility by HSSA to pass level: ≥ 70% motility at 24 hours
- endotoxins by LAL to a pass level:
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
0
Bickland Industrial Park, Falmouth, Cornwall, TR11 4TA, UK Tel: 01326 372753 [+44 1326 372 753] Fax: 01326 378783 [+44 1326 378 783] quality@research-instruments.com www.research-instruments.com
510(k) Summary 21CFR807.92(c)
Date prepared 21CFR807.92(a)(1)
Monday, 25 June 2012
Submitter's information 21CFR807.92(a)(1)
| Company Name: | Research Instruments Ltd. |
|---|---|
| Registration Number: | 9617095 |
| Address: | Bickland Industrial Park |
| Falmouth, | |
| Cornwall TR11 4TA | |
| United Kingdom | |
| Telephone: | +44 (0) 1326 372 753 |
| Fax: | +44 (0) 1326 378 783 |
| Contact person: | David Lansdowne |
| Contact Title: | Technical Director |
| Contact email: | david@research-instruments.com |
Device Names 21CFR807.92(a)(2)
| Device Name: | Migration Sedimentation Chamber |
|---|---|
| Trade Name: | Research Instruments Migration Sedimentation Chamber (RI MSC) |
| Common name: | IVF Tissue Dish |
| Classification Name: | Labware, Assisted Reproduction (21CFR 884.6160, 85 MQK) |
| Classification Panel: | Obstetrics/Gynecology |
| 510(k): | K112413 |
Predicate Device 21CFR807.92(a)(3)
The RI MSC claims substantial equivalence to
| Trade Name: | IVF Center Well Dish |
|---|---|
| Common name: | IVF Tissue Culture Dish |
| Manufacturer: | Thermo Fisher Scientific |
| (Nalge Nunc International) | |
| Classification Name: | Labware, Assisted Reproduction (21CFR 884.6160, 85 MQK) |
| 510(K): | K090429 |
JUL 13 2012
.
1
Image /page/1/Picture/2 description: The image shows a logo with the letters 'RI' in a bold, stylized font. The letters are connected and have a flowing, almost cursive appearance. A curved line underlines the letters, adding a sense of elegance and movement to the design. The logo is simple, yet distinctive, making it easily recognizable.
Description of the device 21CFR807.92(a)(4)
The Research Instruments Migration Sedimentation Chamber (RI MSC) is sterile, non-pyrogenic proven by Limulus Amebocyte Lysate and non-toxic to sperm proven by Human Sperm Survival Assay (HSSA). The RI MSC is disposable and labelled for single use, individually packaged in medical pouches and sold in boxes of twenty (x20) units.
The RI MSC is manufactured from medical grade polystyrene and its surfaces are untreated. It is injection moulded as a completed unit, housing a central well with a surrounding gallery. The cylinder is 74 mm in height with a top OD of 16.5 mm and fluid capacity of 6 ml (approx) if completely filled; however, during recommended procedures it accommodates 1-2 ml of culture medium.
The RI MSC facilitates the migration sedimentation technique. The migration sedimentation technique utilizes the innate 'swimming' ability of sperm to separate vigorous, A-motile sperm from non-motile or abnormal sperm and ejaculate debris.
2 hours prior to the moment of insemination by assisted reproduction techniques (ART), the chamber is pre-loaded with culture media into which unprepared (raw) sperm is pipetted. The semen is pipetted into the gallery only section of the chamber. During a short incubation period, motile sperm migrate to the over-laying medium and fall by gravity from the gallery into the central well cavity of the chamber. The resulting sample is ready for use in ART techniques.
The RI MSC design is based on existing technology described in the published literature paper 'Selection of human spermatozoa by migration sedimentation' by Mailloux-G', Lucena-C, Tea-N-T, Jondet-M. Contraception Fertilite Sexualite, 1990, Vol.18 No.117 Pg 1037-1039.
Indication for Use 21CFR807.92(a)(5)
The RI MSC is intended to prepare sperm by migration-sedimentation method for the assisted reproduction techniques of intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF), and intrauterine insemination (IUI).
Although the intended use of the predicate device differs from that of the RI MSC, both devices interact with the sample or gamete in exactly the same way, i.e. the devices are receptacles which are filled with culture media into which a sample is placed.
The essential difference between the devices is that where the IVF Center Well Dish only 'holds' the sample (gamete or embryo), the RI MSC 'holds' the sample (gamete/sperm) and 'allows it to be prepared' by it's own innate action, the interaction with the media contained within and the physical shape of the RI MSC which results in the collection of motile sperm in the central well.
These differences do not affect the safety and effectiveness of the device when used as labelled.
2
Image /page/2/Picture/1 description: The image shows a logo with the letters 'RI' in a bold, sans-serif font. The letters are black and appear to be slightly stylized. A curved line is positioned beneath the letters, adding a design element to the logo. The overall impression is simple and modern.
| Feature | RI MSC | IVF Center Well Dish |
|---|---|---|
| Indications for Use | Preparing sperm by migration- | |
| sedimentation method for the | ||
| assisted reproduction techniques of | ||
| intracytoplasmic sperm injection | ||
| (ICSI), in vitro fertilization (IVF), and | ||
| intrauterine insemination (IUI). | Preparing and culturing gametes or | |
| embryos for use in human In Vitro | ||
| Fertilization (IVF). | ||
| Contraindication | Not recommended for sperm | |
| samples with total motility rate |