(219 days)
Not Found
No
The device description focuses on the physical characteristics, materials, and sterilization of culture dishes, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as a culture dish for preparing, storing, manipulating, or transferring human gametes or embryos in IVF procedures, which are assistive and not therapeutic in nature.
No
The device description indicates these dishes are for preparing, storing, manipulating, or transferring gametes or embryos, not for diagnosing a condition or disease.
No
The device description clearly details physical, injection-molded plastic dishes used for IVF procedures. It describes their materials, dimensions, sterilization method, and packaging, indicating a hardware-based medical device.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states that these dishes are for "preparing, storing, manipulating, or transferring human gametes or embryos" for IVF and other reproduction procedures. This involves handling biological materials outside the body for therapeutic or reproductive purposes, not for diagnostic testing on a sample taken from the body to determine a medical condition.
- Device Description: The description focuses on the physical characteristics of the dishes, the materials used, sterilization, and testing for non-pyrogenicity and non-embryotoxicity. This aligns with devices used for handling and culturing biological samples, not for performing diagnostic tests.
- Lack of Diagnostic Elements: There is no mention of reagents, assays, or any components that would be used to detect or measure specific substances or characteristics within a biological sample for diagnostic purposes.
- Predicate Devices: The listed predicate devices are also culture dishes used in IVF procedures, further supporting the classification as devices for handling and manipulating biological materials rather than diagnostic tests.
In summary, these Vitrolife culture dishes are tools used in the process of in vitro fertilization, which is a reproductive procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Vitrolife Culture Dish 60 mm, Vitrolife Culture Dish 40 mm and Vitrolife Centre Well Dish are intended for IVF, suitable for use in preparing, storing, manipulating, or transferring human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other reproduction procedures.
The Vitrolife 5 Well Culture Dish is intended for preparing, storing, manipulating or transferring human gametes or embryos for in vitro fertilization (IVF), or other in vitro fertilization techniques.
The Vitrolife ICSI Dish is intended for IVF, suitable for holding oocytes and sperm during fertilization via intracytoplasmic sperm injection (ICSI).
The Vitrolife Micro Droplet Culture Dish is intended for IVF. It may be used with sperm and for the culturing of embryos using drop culture.
Product codes (comma separated list FDA assigned to the subject device)
MQK
Device Description
The HertART disposable dishes are injection molded. The dishes are supplied with a lid. The polymers used for the dishes are virqin crystal grade polystyrene, which has successfully passed the USP class VI test for cytotoxicity, as well as 1-cell embryotoxicity test. The HertART dishes are packed in sleeves of x units in a box for a total of y units, as defined below:
Vitrolife Culture Dish 60 mm: Round dish with lid: ø63 x 15,15 mm One round well 60 mm in diameter Well Volume: 24,00 mL. Packaging: 10 units per sleeve, 540 units per case.
Vitrolife Culture Dish 40 mm: Square dish with lid; 65,96 mm x 65,96 mm x 13,20 mm One round well: 40 mm in diameter, Well volume of 12,56 mL. Packaging: 5 units per sleeve, 400 units per case.
Vitrolife 5-well Culture Dish: Square dish with lid: 65,96 mm x 65,96 mm x. 13,20 mm 5 round wells, Well Volume: 1,7 mL. Packaging: 5 units per sleeve, 400 units per case.
Vitrolife Centre Well Dish: Square dish with lid: 65,96 mm x 65,96 mm x 13,20 mm 1 well, round bottom, oval opening. Packaging: 5 units per sleeve, 400 units per case.
Vitrolife ICSI Dish: Square dish with lid: 65,96 mm x 65,96 mm x 11,70 mm 1 square well with rounded corners. Packaging: 5 units per sleeve, 400 units per case.
Vitrolife Micro-droplet Culture Dish: Square dish with lid: 65,96 mm x 65,96 mm x 13,20 mm 12 round wells holds drops up to 50 µL Well Volume: 12.5 µL. Packaging: 5 units per sleeve, 400 units per case.
The dishes are terminally sterilized by gamma irradiation to achieve a SAL of 10 °. The dishes are non-pyrogenic as tested by LAL, and non-embryotoxic as tested by 1-cell Mouse Embryo Assay (MEA). The dishes are disposable and intended for single use.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K991253, K040717, K090429, K991251, K993881
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
HertAR 510(k) Summary
COMPANY
| Name:
Address: | HertART ApS
Korskildelund 6
DK-2670 Greve
Denmark |
|-------------------------------|-----------------------------------------------------------------|
| Registration No.: | 3008524469 |
| Contact Person: | Mr. Henrik Dörge
Korskildelund 6
DK 2670 Greve
Denmark |
| Office:
Mobile:
E-mail: | +45 3651 9170
+45 2214 3822
hdo@hertart.com |
| Date of Summary: | July 02, 2013 |
K123641 pg 1 of 8
JUL 0 3 2013
DEVICE NAME
| Trade names: | Vitrolife Culture Dish 40 mm
Vitrolife Culture Dish 60 mm
Vitrolife Micro-droplet Culture Dish
Vitrolife 5-well Culture Dish
Vitrolife Centre Well Dish
Vitrolife ICSI Dish |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name: | IVF Dishes |
| Classification name: | Assisted Reproduction Labware |
| Classification regulation: | 21 CFR884.6160 |
| Product code: | MQK |
| Classification panel: | Obstetrics/Gynecology |
| Device class: | II |
PREDICATE DEVICES
Falcon IVF Round Dish (K991253) for Vitrolife Culture Dish 60 mm & Vitrolife Culture Dish 40 mm Nunc IVF Multidish 4 Wells Nunclon (K040717) for Vitrolife 5 Well Culture Dish
Nunc IVF ICSI Dish (K090429) for Vitrolife ICSI Dish
Falcon IVF One Well Dish (K991251) for Vitrolife Centre Well Dish
Genx Culture Dish (now marketed as Sun IVF Embryo Corral Dish) (K993881) for Vitrolife Micro Droplet Culture Dish
HertART ApS IVF Dishes
Page 1 of 8
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HertART. at the transmines at se
510(k) Summary
DESCRIPTION OF DEVICE
The HertART disposable dishes are injection molded. The dishes are supplied with a lid. The polymers used for the dishes are virqin crystal grade polystyrene, which has successfully passed the USP class VI test for cytotoxicity, as well as 1-cell embryotoxicity test. The HertART dishes are packed in sleeves of x units in a box for a total of y units, as defined below:
| Trade Name | Configuration | Packaging |
|---|---|---|
| Vitrolife Culture Dish 60 mm | Round dish with lid: ø63 x 15,15 mm | |
| One round well 60 mm in diameter | ||
| Well Volume: 24,00 mL | 10 units per sleeve | |
| 540 units per case | ||
| Vitrolife Culture Dish 40 mm | Square dish with lid; | |
| 65,96 mm x 65,96 mm x 13,20 mm | ||
| One round well: 40 mm in diameter, Well | ||
| volume of 12,56 mL | 5 units per sleeve | |
| 400 units per case | ||
| Vitrolife 5-well Culture Dish | Square dish with lid: | |
| 65,96 mm x 65,96 mm x. 13,20 mm | ||
| 5 round wells, Well Volume: 1,7 mL | 5 units per sleeve | |
| 400 units per case | ||
| Vitrolife Centre Well Dish | Square dish with lid: | |
| 65,96 mm x 65,96 mm x 13,20 mm | ||
| 1 well, round bottom, oval opening. | 5 units per sleeve | |
| 400 units per case | ||
| Vitrolife ICSI Dish | Square dish with lid: | |
| 65,96 mm x 65,96 mm x 11,70 mm | ||
| 1 square well with rounded corners | 5 units per sleeve | |
| 400 units per case | ||
| Vitrolife Micro-droplet Culture | ||
| Dish | Square dish with lid: | |
| 65,96 mm x 65,96 mm x 13,20 mm | ||
| 12 round wells holds drops up to 50 µL | ||
| Well Volume: 12.5 µL | 5 units per sleeve | |
| 400 units per case |
The dishes are terminally sterilized by gamma irradiation to achieve a SAL of 10 °. The dishes are non-pyrogenic as tested by LAL, and non-embryotoxic as tested by 1-cell Mouse Embryo Assay (MEA). The dishes are disposable and intended for single use.
INDICATIONS FOR USE
The Vitrolife Culture Dish 60 mm, Vitrolife Culture Dish 40 mm and Vitrolife Centre Well Dish are intended for IVF, suitable for use in preparing, storing, manipulating, or transferring human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other reproduction procedures.
The Vitrolife 5 Well Culture Dish is intended for preparing, storing, manipulating or transferring human gametes or embryos for in vitro fertilization (IVF), or other in vitro fertilization techniques.
The Vitrolife ICSI Dish is intended for IVF, suitable for holding oocytes and sperm during fertilization via intracytoplasmic sperm injection (ICSI).
The Vitrolife Micro Droplet Culture Dish is intended for IVF. It may be used with sperm and for the culturing of embryos using drop culture.
HertART ApS IVF Dishes
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HertART.ne : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
K123641
:
510(k) Summary
PREDICATE DEVICE COMPARISON
| Parameter | Subject Device -- Vitrolife
Culture Dish 60 mm | Predicate Device - Falcon
IVF Round Dish (K991253) | Differences |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Device | Round petri dish with diameter
60 mm | Round petri dish with diameter
60 mm | none |
| Indication for
Use | Intended for IVF, suitable for
use in preparing, storing,
manipulating, or transferring
human gametes or embryos for
in vitro fertilization (IVF),
gamete intrafallopian transfer
(GIFT), or other reproduction
procedures | Intended for use in preparing,
storing, manipulating, or
transferring human gametes or
embryos for in vitro fertilization
(IVF), gamete intrafallopian
transfer (GIFT), or other
reproduction procedures | none |
| Material | Virgin Polystyrene, tested for
USP Class VI cytotoxicity | Virgin Polystyrene, tested for
USP Class VI cytotoxicity | none |
| Dimensions | Diameter 60 mm | Diameter 60 mm | none |
| Design
features | Round dishes with vented lid.
Flat bottom, optically clear
surfaces.
Surfaces are non-treated | Round dishes with vented lid.
Flat bottom, optically clear
surfaces. Surfaces are treated
for improved wettability | Predicate device is
surface treated for
increased wettability |
| Well shape | Well area of 24,07 cm² | Well area of 24,07 cm² | none |
| Well volume | 23,00 mL | 23,00 mL | none |
| Discussion | Predicate device uses surface treatment, which is traditionally used for cell culture labware
for better cell adhesion. As gametes and embryos do not adhere to surfaces, and since most
culture within IVF nowadays is done in drops of media, improved wettability is not a desired
product feature for modern IVF procedures. The proposed device uses a more sensitive 1-
cell MEA assay compared to the predicate device using a 2-cell MEA in order to improve/
ensure consistency of product performance
The differences do not impact the use of the identified predicate device to support the
proposed device, as they do not raise any new types of safety or effectiveness questions.
Therefore, the subject is substantially equivalent to the predicate device. | | |
| Parameter | Subject Device - Vitrolife
Culture Dish 40 mm | Predicate Device – Falcon
IVF Round Dish (K991253) | Differences |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Device | Square dish with round inner
diameter of 40 mm | Round petri dish with diameter
60 mm | Proposed device has
square outer geometry
and smaller round well |
| Indication for
use | Intended for IVF, suitable for
use in preparing, storing,
manipulating, or transferring
human gametes or embryos for
in vitro fertilization (IVF),
gamete intrafallopian transfer
(GIFT), or other reproduction
procedures. | Intended for use in preparing,
storing, manipulating, or
transferring human gametes or
embryos for in vitro fertilization
(IVF), gamete intrafallopian
transfer (GIFT), or other
reproduction procedures | None |
| Material | Virgin Polystyrene, tested for
USP Class VI cytotoxicity | Virgin Polystyrene, tested for
USP Class VI cytotoxicity | none |
HertART ApS
IVF Dishes
Page 3 of 8
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HertART and someons of the
K123641
pg 4 of 8
510(k) Summary Dimensions Dish Size without lid: 65,96 Diameter 60 mm round dish Proposed device has smaller round diameter mm x 65,96 mm x 10,50 mm Dish Size with lid: 65.96 mm x 65,96 mm x 13,20 mm Well diameter: 40 mm Square dish with round well. Round dishes with vented lid Proposed device has an Design features with vented lid. A patient ID coving all of the dish. Flat outer square geometry area not covered by the lid. bottom, optically clear surfaces. with ID area. Predicate Flat bottom, optically clear Surfaces are treated for device is surface treated for increased improved wettability surfaces. wettability. Surfaces are non-treated Well shape Round well area of 12,56 cm2 Well area of 24,07 cm2 Proposed device has smaller well area and Well volume 12.56 mL 23,00 ml less mL Proposed device has a square outer geometry and a patient ID area. The square outer Discussion geometry facilitates the handling and stacking of dishes, while the patient ID area for writing or barcode increases the safety in relation to mix-ups. Predicate device uses surface treatment, which is traditionally used for cell culture labware for better cell adhesion. As gametes and embryos do not adhere to surfaces, and since most culture within IVF nowadays is done in drops of media, improved wettability is not a desired product feature for modern IVF procedures. The proposed device uses a more sensitive 1-cell MEA assay compared to the predicate device using a 2-cell MEA in order to improve/ensure consistency of product performance
The differences do not impact the use of the identified predicate device to support the proposed device, as they do not raise any new types of safety or effectiveness questions. Therefore, the subject is substantially equivalent to the predicate device.
| Parameter | Subject Device - Vitrolife 5
well Culture Dish | Predicate Device - Nunc IVF
Multidish 4 Wells (K040717) | Differences |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Device | Square dish with 5 round wells | Square dish with 4 round wells | Proposed device has 5
wells while predicate
device has 4 wells. |
| Indications for
Use | Intended for IVF, suitable for
preparing, storing,
manipulating or transferring
human gametes or embryos for
in vitro fertilization (IVF), or
other in vitro fertilization
techniques | Intended for preparing, storing,
manipulating or transferring
human gametes or embryos for
in vitro fertilization (IVF.), or
other in vitro fertilization
techniques, and cell culture | none |
| Material | Virgin Polystyrene, tested for
USP Class VI cytotoxicity | Virgin Polystyrene, tested for
USP Class VI cytotoxicity | none |
| Dimensions | Base: 65,96 mm x 65,96 mm
Dish size with lid: 65,96 mm x
65,96 mm x 13,20 mm | Base: 65,96 mm x 65,96 mm | none |
| Design
features | Square dish with vented lid. A
patient ID area not covered by
the lid.
Flat bottom, optically clear
surfaces.
Surfaces are non-treated | Square dish with vented lid
coving all of the dish. Flat
bottom, optically clear surfaces.
Product comes both with or
without surface treatment for
improved wettability | Proposed dish has a
patient ID area.
Predicate device can
come as surface
treated for increased
wettability |
HertART ApS IVF Dishes
Page 4 of 8
4
HertART ====================================================================================================================================================================== 510(k) Summary
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| Well shape | Well area of 1.9 cm²
Well Volume of 1,7 mL
Wells having a ramp along the
edge
The well diameter is
approximately 10.7 mm at the
bottom of the well and then
quickly expands to a 15,3 mm
diameter cylinder. The height is
approximately 9.4 mm from
the bottom of the well to the
rim | Well area of 1.9 cm² | Proposed device has a
ramp along the inner
edge of the wells |
|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|--------------------------------------------------------------------|
| Discussion | Proposed device has a patient ID area. The square outer geometry facilitates the handling
and stacking of dishes, while the patient ID area for writing or barcode increases the safety
in relation to mix-ups.
Proposed device has a ramp along the inner edge of the wells preventing the embryos from
getting stuck in the corners and thereby facilitates the use of the product.
Predicate device uses surface treatment, which is traditionally used for cell culture labware
for better cell adhesion. As gametes and embryos do not adhere to surfaces, and since most
culture within IVF nowadays is done in drops of media, improved wettability is not
considered a desired product feature for modern IVF procedures.
The differences do not impact the use of the identified predicate device to support the
proposed device, as they do not raise any new types of safety or effectiveness questions.
Therefore, the subject is substantially equivalent to the predicate device. | | |
.
| Parameter | Subject Device - Vitrolife
ICSI Dish | Predicate Device - Nunc IVF
ICSI Dish (K090429) | Differences |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Square dish with 1 well with
rounded corners | Round dish with 1 round well | Proposed device has
square outer geometry
and 1 well with rounded
corners, while predicate
device has round outer
geometry and round
well |
| Indication for
Use | Intended for IVF, suitable for
holding oocytes and sperm
during fertilization via
intracytoplasmic sperm
injection (ICSI). | Intended for holding oocytes
and sperm during fertilization
via intracytoplasmic sperm
injection (ICSI). | none |
| Material | Virgin Polystyrene, tested for
USP Class VI cytotoxicity | Virgin Polystyrene, tested for
USP Class VI cytotoxicity | none |
| Dimensions | Dish Size without lid: 65,96 mm
x 65,96 mm x 9,00 mm
Dish Size with lid: 65,96 mm x
65,96 mm x 11,70 mm
The ICSI dish has one large
continuous surface with the
length (at the bottom of the
well) of 50.5 mm and a width
of 34.8 mm. The corners are
rounded and the total volume is
approximately 14.5 mL. | Diameter: 55.77 mm
Height without lid: 8.64 mm
Height with lid: 9.75 mm | Proposed device is
square and wider.
Height is comparable. |
:
. :
:
5
HertART.......................................................................................................................................................................
510(k) Summary
K123641 pg 6 of 8
| Design
features | The bottom of the dishes is
clear and optimal clear.
The lid can be handled with one
hand while other lab equipment
can be handled with the other
hand. The dishes can be
stacked.
A patient ID area not covered
by the lid. | The bottom of the dishes is
clear and optimal clear.
The lid can be handled with one
hand while other lab equipment
can be handled with the other
hand. The dishes can be
stacked. | Proposed device has a
patient ID area. |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Discussion | Proposed device has a patient ID area. The square outer geometry facilitates the handling
and stacking of dishes, while the patient ID area for writing or barcode increases the safety
in relation to mix-ups.
The differences do not impact the use of the identified predicate device to support the
proposed device, as they do not raise any new types of safety or effectiveness questions.
Therefore, the subject is substantially equivalent to the predicate device. | | |
:
| Parameter | Subject Device - Vitrolife
Centre Well Dish | Predicate Device - Falcon
IVF One Well Dish
(K991251) | Differences |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Square dish with 1 oval well | Round dish with 1 round well | Proposed device has
square outer geometry
and oval well. Predicate
device has round outer
geometry and round well |
| Indication for
Use | Intended for IVF, suitable for
use in preparing, storing,
manipulating, or transferring
human gametes or embryos for
in vitro fertilization (IVF),
gamete intrafallopian transfer
(GIFT), or other reproduction
procedures. | Intended for use in preparing,
storing, manipulating, or
transferring human gametes or
embryos for in vitro fertilization
(IVF), gamete intrafallopian
transfer (GIFT), or other
reproduction procedures | None |
| Material | Virgin Polystyrene, tested for
USP Class VI cytotoxicity | Virgin Polystyrene, tested for
USP Class VI cytotoxicity | none |
| Dimensions | Dish with lid: 65,96 mm x
65,96 mm x 13,20 mm
Height without lid: 10,50 mm | Diameter: 55.77 mm
Height without lid: 8.64 mm
Height with lid: 9.75 mm | Height is comparable |
| Design
features | The dishes have perfectly flat,
optically clear surfaces for
optimum manipulation and
observation of the ova and
embryos. The oval well
facilitates the handling of the
ova and embryos by equipment
during microscopy.
The lids are designed for
aseptic manipulation and
consistent venting to maintain
proper humidification. The
dishes can be stacked.
A patient ID area not covered
by the lid | The dishes have perfectly flat,
optically clear surfaces for
optimum manipulation and
observation of the ova and
embryos. Surfaces are treated
for improved wettability.
The lids are designed for
aseptic manipulation and
consistent venting to maintain
proper humidification | Proposed device has an
oval well while predicate
device has a round well.
Predicate device is surface
treated for increased
wettability.
Proposed device has a
patient ID area |
HertART ApS IVF Dishes
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6
HertART ... " .
K123641 pg 7 of 8
:
510(k) Summary
| Well shape. | Round bottom with diameter
approx. 15.5 mm and a larger
oval opening | Round | |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|--|
| Well volume | Well Volume > 2.5 mL | Well volume of 2.5 mL | |
| Discussion | Proposed device has a patient ID area. The square outer geometry facilitates the handling and
stacking of dishes, while the patient ID area for writing or barcode increases the safety in
relation to mix-ups.
The oval well in proposed device facilitates the handling of the ova and embryos by equipment
during microscopy.
Predicate device uses surface treatment, which is traditionally used for cell culture labware for
better cell adhesion. As gametes and embryos do not adhere to surfaces, and since most
culture within IVF nowadays is done in drops of media, improved wettability is not a desired
product feature for modern IVF procedures.
Proposed device used 1-cell method for MEA testing while predicate device used 2-cell method.
There is to day no established standard discriminating between 1-cell or 2-cell method.
The differences do not impact the use of the identified predicate device to support the
proposed device, as they do not raise any new types of safety or effectiveness questions.
Therefore, the subject is substantially equivalent to the predicate device. | | |
| Parameter | Subject Device - Vitrolife
Micro Droplet Culture Dish | Predicate Device – Genx
Culture Dish (Sun IVF
Embryo Corral) (K993881) | Differences |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Square dish with 12 round wells | Round dish with 11 round wells | Proposed device has
square outer geometry
and round walls, while
predicate device has
round outer geometry and
picket-fenced walls |
| Indication for
use /
intended use | Intended for IVF. It may be
used with sperm and for the
culturing of embryos using drop
culture. | Intended to be used when
culturing tissues and cells. It
may be used with sperm and
for the culturing of embryos. | Predicate device allows
media to flow freely
among culturing
cells/embryos, however
Proposed device allow
individual cells/embryos
to be cultures in
separated drop cultures. |
| Material | Virgin Polystyrene, tested for
USP Class VI cytotoxicity | Polystyrene | Proposed device uses USP
Class tested polystyrene |
| Dimensions | Dish with lid: 65,96 mm x
65,96 mm x 13,20 mm | Outer Diameter: 60 mm | Proposed device has
square outer geometry
while predicate device has
round |
| Design
features | The basic design is a square
culture dish with twelve small
wells (volume 12.5 microliter,
holding standing drops up to 50
microliter). The micro-wells are
placed with a-numerical ID in a
rectangular well format to allow
easy identification during
microscopy. | The basic design is that of a
traditional culture dish. Approx
60 mm round with areas of $1/2$
inch side walls. This dish does
not have defined areas for the
cell to be confined within.
These areas are squares of
picket-fenced walls. | Proposed device has a
square outer geometry
and well areas defined by
small solid walls, while
predicate device has a
round outer geometry and
well areas defined by
small picket-fenced walls.
Proposed device has
micro-wells with a- |
: 上
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HertART ApS IVF Dishes
:
Page 7 of 8
7
HertART.neimmers at # .
510(k) Summary
| approximately 0.95 mm and
the diameter is 3.3 mm at the
bottom with sides sloping to
approximately 4.3 mm at the
top. There will typically be one
separated media-drop in each
well, this is however not linked
to if the customer decides to
place several embryos in each
well (co-culture) or only one
embryo (single embryo culture
The lids are designed for
aseptic manipulation and
consistent venting to maintain
proper humidification.
A patient ID area not covered
by the lid. | numerical ID to allow easy
identification during
microscopy, as well as a
separate patient ID area. |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Discussion | The square outer geometry of the proposed device facilitates the handling and stacking of dishes, while the patient ID area for writing or barcode increases the safety in relation to mix- ups.
Predicate device allows media to flow freely among culturing cells/embryos, while
Proposed device allow individual cells/embryos to be cultured in separated drop cultures, which is a routine procedure in many IVF clinics.
The alphanumerical ID at each microwell allows easy drop identification during microscopy.
The differences do not impact the use of the identified predicate device to support the proposed device, as they do not raise any new types of safety or effectiveness questions. Therefore, the subject is substantially equivalent to the predicate device. |
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Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and a wavy line representing its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 3, 2013
HertART ApS % Mr. Henrik Dörge VP Business Development Korskildelund 6 Greve 2670 DENMARK
Re: K123641
Trade/Device Name: Vitrolife Culture Dish 40 mm, Vitrolife Culture Dish 60 mm, Vitrolife Centre Well Dish, Vitrolife 5 Well Culture Dish, Vitrolife ICSI Dish, and Vitrolife Micro Droplet Culture Dish Regulation Number: 21 CFR 884.6160 Regulation Name: External uterine contraction monitor and accessories Regulatory Class: Class II
Product Code: MQK Dated: May 6, 2013 Received: May 23, 2013
Dear Mr. Dörge:
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 marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean ' that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin Fisher-S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K123641
Device Name:
Vitrolife Culture Dish 40 mm Vitrolife Culture Dish 60 mm Vitrolife Centre Well Dish
Indications for Use:
The Vitrolife Culture Dishes are intended for IVF, suitable for use in preparing, storing, manipulating, or transferring human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other reproduction procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) . .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Benjamin R. Fisher -S 2013.07.03 12:45:19 -04'00'
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K123641 510(k) Number _
Page 1 of 4
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510(k) Number: K123641
Vitrolife 5 Well Culture Dish Device Name:
Indications for Use:
The Vitrolife 5 Well Culture Dish is intended for IVF, suitable for preparing, storing, manipulating or transferring human gametes or embryos for in vitro fertilization (IVF), or other in vitro fertilization techniques.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Benjamin R. Fisher -S 2013.07.03 12:46:47 -04'00'
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K123641 510(k) Number
Page 2 of 4
.
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510(k) Number: K123641
Vitrolife ICSI Dish Device Name:
Indications for Use:
The Vitrolife ICSI Dish is intended for IVF, suitable for holding oocytes and sperm during fertilization via intracytoplasmic sperm injection (ICSI).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Benjamin R. Fisher -S 2013.07.03 12:47:27 -04'00'
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K123641 510(k) Number
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510(k) Number: K123641
Vitrolife Micro Droplet Culture Dish Device Name:
Indications for Use:
The Vitrolife Micro Droplet Culture Dish is intended for IVF. It may be used with sperm and for the culturing of embryos using drop culture.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Benjamin 2013.07.03
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K123641 510(k) Number
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