(464 days)
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No
The description focuses on a physical system for sperm separation based on the swim-up technique and a heating device. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is intended for preparing and separating motile sperm for use in assisted reproductive procedures, not for treating a disease or condition in a patient.
No
The device is intended for separating motile sperm from a semen sample for use in assisted reproductive procedures, not for diagnosing a condition or disease.
No
The device description explicitly lists hardware components: a disposable kit with containers and labware accessories, and a heating device.
Based on the provided information, the Seaforia™ Sperm Separation Assistance System is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The system is intended for "preparing motile sperm using the swim-up (SU) separation method and holding sperm for use in assisted reproductive procedures such as intrauterine insemination (IUI), intracervical insemination (ICI) and in-vitro fertilization (IVF)." While the system itself doesn't directly diagnose a condition, the preparation of sperm is a crucial step in in vitro fertilization (IVF) and other assisted reproductive procedures, which are considered in vitro diagnostic procedures. The sperm preparation is performed in vitro (outside the body) and is a necessary step before the actual fertilization or insemination.
- Device Description: The description explicitly states that the system "separates motile/progressively motile sperm cells from debris and non-motile sperm cells from the original semen sample for further use in assisted reproductive procedures." This process of preparing a biological sample for use in an in vitro procedure aligns with the definition of an IVD.
- Predicate Devices: The predicate devices listed (K112413 RI Migration Sedimentation Chamber (MSC) and K002971 MTG- Minitüb Heated Stage System) are also devices used in assisted reproductive technology labs for handling and preparing sperm, which are typically classified as IVDs or accessories to IVDs.
While the system doesn't perform a diagnostic test itself, its function is to prepare a biological sample (semen) for use in an in vitro diagnostic procedure (IVF, IUI, ICI). This makes it an accessory to or a component used in an IVD process.
N/A
Intended Use / Indications for Use
The Seaforia™ Sperm Separation Assistance System consists of the following components:
The Seaforia™ Sperm Separation Assistance System Disposable Kit (Versions 0.5-2 ml, 2.5-3.0 ml, 3.5-4.0 ml, 4.5-5.0 ml, and 5.5-6.0 ml)
The Seaforia™ Sperm Separation Assistance System Disposable Kit is intended for preparing motile sperm using the swim-up (SU) separation method and holding sperm for use in assisted reproductive procedures such as intrauterine insemination (IUI), intracervical insemination (ICI) and in-vitro fertilization (IVF). The Seaforia™ Sperm Separation Assistance System Disposable Kit is indicated for incubation periods not exceeding one (1) hour.
The Seaforia™ Sperm Separation Assistance System Heating Device
The Seaforia™ Sperm Separation Assistance System Heating Device is indicated for use only with the Seaforia™ Sperm Separation Assistance System Disposable Kit to maintain the temperature (37°C ±0.5) of sperm during the swim-up (SU) separation procedure.
Product codes (comma separated list FDA assigned to the subject device)
MQK, MQG
Device Description
The Seaforia™ Sperm Separation Assistance System separates motile/progressively motile sperm cells from debris and non-motile sperm cells from the original semen sample for further use in assisted reproductive procedures, including intrauterine insemination (IUI), intra-cervical insemination (ICI) and in-vitro fertilization (IVF). The system provides conditions such as temperature 37°C ±0.5 and effective surface area for the separation of motile human sperm cells. Note: The separation media is not included with the Seaforia™ Sperm Separation Assistance System. LOTUS BIO® requires that the media used with the Seaforia™ Sperm Separation Assistance System be a media cleared for use in the United States that is indicated for sperm handling, washing, or swim-up procedures with a formulation compatible with use outside of a CO2 environment.
The system is composed of the following units:
- Seaforia™ Sperm Separation Assistance System Disposable Kit - includes designated containers (separators) for the separation media available in various volumes and labware accessories such as syringes, polypropylene tips, pipette and vials. Five versions of the kit will be available to accommodate sperm samples ranging from 0.5-6 ml (Versions 0.5-2 ml. 2.5-3.0 ml. 3.5-4.0 ml, 4.5-5.0 ml, and 5.5-6.0 ml).
- Seaforia™ Sperm Separation Assistance System Heating Device capable. of maintaining the sperm sample at the required temperature (37℃ ±0.5).
The sperm separation procedure takes place within the separator and is based on the original swim-up technique. Media is layered over the liquefied semen sample and during a subsequent incubation period of 30 minutes in the Seaforia™ Sperm Separation Assistance System Heating Device, the motile sperm cells migrate from the semen layer into the media.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing on the Seaforia™ Sperm Separation Assistance System was completed to assure that the device performed as intended in accordance with design and functional specifications. The following performance testing was conducted:
-
Efficacy testing of sperm preparation using the Seaforia™ Sperm Separation Assistance System
The test was designed to confirm that by using the Seaforia™ Sperm Separation Assistance System, the separation process yields an end product with improved characteristics relative to the original semen sample. Results showed that media overlaving semen in the separators was enriched with motile sperm cells characterized by progressive motility and improved percentage of normal morphology, leaving most round non-sperm cells and immotile sperm cells behind. Therefore, testing confirmed that separation using the Seaforia™ Sperm Separation Assistance System resulted in an end product with improved characteristics as compared to the original semen sample. -
Thermal verification test for the Seaforia™ Sperm Separation Assistance System Heating Device
Thermal verification testing was conducted to validate the thermal performance of the Seaforia Sperm Separation Assistance System Heating Device. Testing showed that devices met the acceptance criteria (temperature maintenance at 37 ± 0.5°C).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
HSSA ≥ 70% motility following 1 hour
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
DEC 1 9 2012
510(k) Summary
510(k) Number:
510(K) Owner:
Submitter (US Agent):
Contact:
Manufacturer:
Date Prepared:
Trade name:
Common name:
Classification name:
Product Code(s):
Lotus Bio® (NYMPHAEA) Ltd. Jabotinsky 135a Ramat Gan 52563, Israel
Lori Kahler The RC Insight Group 461 Main Street, Suite 200 Pawtucket, RI 02860 Telephone: 401-722-1811 / 202-715-6242 Fax: 202-686-2877 Email: Ikahler@rcinsightgroup.com
Dr. Vered Shany, DMD, MBA CEO Telephone: +972 - 777-00-1669 Fax: +972 - 777-00-1670 Email: Vered@LotusBio.com
Lotus Bio® (NYMPHAEA) Ltd. Jabotinsky 135a Ramat-Gan 52563, Israel
17 December 2012
Seaforia™ Sperm Separation Assistance System
Assisted Reproduction Labware. Assisted Reproduction Accessories
21 C.F.R. §884.6160 , 21 C.F.R. § 884.6120
MQK (labware, assisted reproduction), MQG (accessories, assisted reproduction)
Classification:
Class II
1
Legally Marketed Device - Claiming Equivalence:
RI Migration Sedimentation Chamber (MSC) Research Instruments Ltd K112413
MTG- Minitüb Heated Stage System Zander Medical Supplies, Inc. K002971
Summary Description of the Device:
The SeaforiaTM Sperm Separation Assistance System separates motile/progressively motile sperm cells from debris and non-motile sperm cells from the original semen sample for further use in assisted reproductive procedures, including intrauterine insemination (IUI), intra-cervical insemination (ICI) and in-vitro fertilization (IVF). The system provides conditions such as temperature 37°C ±0.5 and effective surface area for the separation of motile human sperm cells. Note: The separation media is not included with the Seaforia" Sperm Separation Assistance System. LOTUS BIO® requires that the media used with the Seaforia'™ Sperm Separation Assistance System be a media cleared for use in the United States that is indicated for sperm handling, washing, or swim-up procedures with a formulation compatible with use outside of a CO2 environment.
The system is composed of the following units:
- . Seaforia™ Sperm Separation Assistance System Disposable Kit - includes designated containers (separators) for the separation media available in various volumes and labware accessories such as syringes, polypropylene tips, pipette and vials. Five versions of the kit will be available to accommodate sperm samples ranging from 0.5-6 ml (Versions 0.5-2 ml. 2.5-3.0 ml. 3.5-4.0 ml, 4.5-5.0 ml, and 5.5-6.0 ml).
- Seaforia™ Sperm Separation Assistance System Heating Device capable . of maintaining the sperm sample at the required temperature (37℃ ±0.5).
The sperm separation procedure takes place within the separator and is based on the original swim-up technique. Media is layered over the liquefied semen sample and during a subsequent incubation period of 30 minutes in the Seaforia™ Sperm Separation Assistance System Heating Device, the motile sperm cells migrate from the semen layer into the media.
Indications for Use/Intended Use:
The Seaforia™ Sperm Separation Assistance System consists of the following components:
2
The Seaforia™ Sperm Separation Assistance System Disposable Kit (Versions 0.5-2 ml, 2.5-3.0 ml. 3.5-4.0 ml. 4.5-5.0 ml. and 5.5-6.0 ml)
The Seaforia TM Sperm Separation Assistance System Disposable Kit is intended for preparing motile sperm using the swim-up (SU) separation method and holding sperm for use in assisted reproductive procedures such as intrauterine insemination (IUI), intracervical insemination (ICI) and in-vitro fertilization (IVF). The Seaforia™ Sperm Separation Assistance System Disposable Kit is indicated for incubation periods not exceeding one (1) hour.
The Seaforia TM Sperm Separation Assistance System Heating Device
The Seaforia TM Sperm Separation Assistance System Heating Device is indicated for use only with the Seaforia TM Sperm Separation Assistance System Disposable Kit to maintain the temperature (37°C ±0.5) of sperm during the swim-up (SU) separation procedure.
Substantial Equivalence Summary:
The SeaforiaTM Sperm Separation Assistance System is substantially equivalent to the Research Instruments Ltd Migration Sedimentation Chamber (K112413) and to the MTG-Minitüb Heated Stage System (K002971).
The SeaforiaTM Sperm Separation Assistance System Disposable Kit and the Research Instruments Ltd Migration Sedimentation Chamber (K112413) have equivalent intended use and indications for use as assisted reproduction labware to aid in the separation of motile sperm from liquefied semen for use in assisted reproductive medicine applications. The SeaforiaTM Sperm Separation Assistance System Disposable Kit and the RI Migration Sedimentation Chamber (MSC) are both disposable devices and are made of materials commonly used in assisted reproduction labware. All components of the Seaforia™ Sperm Separation Assistance System Disposable Kit are made of polypropylene except for the pipettes which are made from a low density polyethylene, while the RI MSC is made from polystyrene. The main difference between the SeaforiaTM Sperm Separation Assistance System Disposable Kit and the RI MSC is that the disposable kit contains designated containers for different semen volume and accessories (such as syringes, polypropylene tips, pipette, and vials) whereas the RI MSC device is a single device rather than a kit. Both the Seaforia™ Sperm Separation Assistance System Disposable Kit and the RI MSC are indicated for use in preparing sperm in assisted reproduction procedures. Both the Seaforia™ Sperm Separation Assistance System Disposable Kit and the RI MSC use a comparable swim-up procedure and collection principal. The only minor difference in the design between the predicate device and the proposed device is the Seaforia™ System method of loading and collecting that requires the use of designated containers and accessories to aid in sperm separation procedure (such as syringes, polypropylene tips, pipette, and vials). The differences in the design do not impact the swim-up procedure and collection method. Regarding the Seaforia™ Sperm Separation Assistance System Disposable Kit HSSA specification: as the Seaforia™ Sperm Separation Assistance System Disposable Kit is
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indicated for incubation periods of 30 minutes (should not exceed one (1) hour); the HSSA assessment was completed at 1 hour. The predicate's assessment was completed at 24 hours; however, the predicate device is also indicated for sample storage and the sperm is pre-loaded with culture media two hours prior to the moment of insemination. The proposed device has a short incubation period and is not indicated for sample storage. The HSSA assessment completed at 1 hour is appropriate for the use of the proposed device.
In addition, the Seaforia™ Sperm Separation Assistance System is also for use in assisted reproductive procedures such as intra-cervical insemination (ICI) whereas the RI MSC is not indicated for use with ICI. This difference would not represent a new intended use as intra-cervical insemination (ICI) is a common method of assisted reproduction.
The SeaforiaTM Sperm Separation Assistance System Heating Device and the MTG-Minitüb Heated Stage System (K002971) are equivalent with respect to intended use, indications for use and technological characteristics as a heating device used to warm biological material. The MTG-Minitüb Heated Stage System (K002971) has a wider variation of temperature range (ambient temperature through 55°C with a control accuracy +/- 0.2°C) while the Seaforia™ Heating Device maintains a temperature of 37°C ±0.5. The differences do not affect the safety and effectiveness of the device and does not impact the use of the identified predicate to support an equivalence decision.
The following detailed substantial equivalence table compares the Seaforia"M Sperm Separation Assistance System with the predicate devices.
| New Device | Predicate Device | Predicate Device | ||
|---|---|---|---|---|
| 510(k) # | K002971 | K112413 | ||
| Company | Lotus Bio® | |||
| (NYMPHAEA) Ltd. | Zander Medical Supplies, Inc. | Research Instruments Ltd. | ||
| Name | Seaforia™ | MTG-Minitüb Heated Stage System | RI MSC | |
| Classification/ | ||||
| Regulation | Class II / 884.6160, | |||
| 884.6120 | Class II / 884.6120 | Class II / 884.6160 | ||
| Product Code | ||||
| Indications for | ||||
| Use - Disposable | ||||
| Kit | Disposable Kit: MQK | |||
| (labware, assisted | ||||
| reproduction Heating | ||||
| Device: MQG (accessories, | ||||
| assisted reproduction);) | ||||
| The Seaforia™ Sperm | ||||
| Separation Assistance | ||||
| System Disposable Kit | ||||
| The Seaforia ™ Sperm | ||||
| Separation Assistance | ||||
| System Disposable Kit is | ||||
| intended for preparing | ||||
| motile sperm using the | ||||
| swim-up (SU) separation | ||||
| method and holding sperm | ||||
| for use in assisted | ||||
| reproductive procedures | ||||
| such as intrauterine | ||||
| insemination (IUI), intra- | ||||
| cervical insemination (ICI) | ||||
| and in-vitro fertilization | MQG (accessories. assisted | |||
| reproduction) | ||||
| n/a | MQK (labware, assisted | |||
| reproduction) | ||||
| 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). | ||||
| New Device | Predicate Device | Predicate Device | ||
| (IVF). The Seaforia™ | ||||
| Sperm Separation | ||||
| Assistance System | ||||
| Disposable Kit is indicated | ||||
| for incubation periods not | ||||
| exceeding one (1) hour. | ||||
| Indications for | ||||
| Use - Heating | ||||
| Device | The Seaforia™ Sperm | |||
| Separation Assistance | ||||
| System Heating Device | ||||
| The Seaforia ™ Sperm | ||||
| Separation Assistance | ||||
| System Heating Device is | ||||
| indicated for use only with | ||||
| the Seaforia ™ Sperm | ||||
| Separation Assistance | ||||
| System Disposable Kit to | ||||
| maintain the temperature | ||||
| (37°C ±0.5) of sperm | ||||
| during the swim-up (SU) | ||||
| separation procedure. | Maintaining the temperature | |||
| of biological material like | ||||
| gametes and embryos at a | ||||
| certain temperature is | ||||
| essential to cover multiple | ||||
| applications in reproductive | ||||
| medicine, biology and other | ||||
| areas. | n/a | |||
| Disposable | ||||
| Materials | Polypropylene; low | |||
| density polyethylene | ||||
| (pipette only) | n/a | Medical grade | ||
| polystyrene - non treated | ||||
| Design Features - | ||||
| Disposable Kit | The Disposable Kit | |||
| contains designated | ||||
| containers (for different | ||||
| semen volume) and | ||||
| accessories (such as | ||||
| syringes, polypropylene | ||||
| tips, pipette, and vials). | ||||
| The kits are suitable for | ||||
| variable semen volume 0.5- | ||||
| 6ml. The containers are | ||||
| made of polypropylene. | n/a | Cylindrical container with | ||
| internal gallery and well. | ||||
| Optically clear, with flat | ||||
| base. | ||||
| Design Features - | ||||
| Heating Device | Switch on/off toggle: | |||
| PC+ABS GE C2950 plastic | ||||
| protective case. | ||||
| Temperature range 37°C | ||||
| ±0.5. Output 5.0 VDC ± | ||||
| 5%, 1000mA | Control Units: metal casing | |||
| protects electronic control | ||||
| unit - Digital displays and | ||||
| touch pads control and | ||||
| monitor the temperature. | ||||
| Temperature range: ambient | ||||
| temperature through 55℃. | ||||
| Control accuracy +/- 0.2℃. | ||||
| All control units can be | ||||
| switched between 200- | ||||
| 240V/50Hz or 100- | ||||
| 120V/60Hz. | n/a | |||
| Sterile | Disposable Kit: Yes, Sterile | |||
| (SAL 10-6), via gamma | ||||
| irradiation | ||||
| Heating Device: n/a | n/a | Yes, Sterile (SAL 10-6), | ||
| via gamma irradiation | ||||
| HSSA | HSSA ≥ 70% motility | |||
| following 1 hour | n/a | HSSA ≥ 70% motility at | ||
| 24hr | ||||
| Cytotoxicity | Cytotoxicity tested per ISO | |||
| 10993-5:2009. | n/a | Not known | ||
| Endotoxin (LAL) | Disposable Kit: Tested | |||
| non-pyrogenic by LAL | ||||
| Acceptance Criteria: |