CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH

Q: Who is the manufacturer of CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH?

Hertart filed the 510(k) submission for CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH (K123641).

Q: What is the FDA product code for CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH?

MQK. It is classified under 21 CFR 884.6160 as a Class 2 device in the Obstetrics/Gynecology panel.

Q: What is the regulatory pathway for CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH?

Falcon IVF Round Dish (K991253); Nunc IVF Multidish 4 Wells Nunclon (K040717); Nunc IVF ICSI Dish (K090429); Falcon IVF One Well Dish (K991251); Genx Culture Dish (now marketed as Sun IVF Embryo Corral Dish) (K993881).

Q: Who can help prepare an FDA 510(k) submission like CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K123641 · Hertart · MQK · Jul 3, 2013 · Obstetrics/Gynecology

Device Facts

Record ID	K123641
Device Name	CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH
Applicant	Hertart
Product Code	MQK · Obstetrics/Gynecology
Decision Date	Jul 3, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.6160
Device Class	Class 2

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.

Device Story

Disposable injection-molded polystyrene dishes; used in IVF clinics by embryologists/technicians for handling, culturing, and storing human gametes and embryos. Dishes feature various well configurations (single, multi-well, micro-droplet) and square or round geometries to facilitate stacking and handling. Some models include patient ID areas to prevent mix-ups; specific well shapes (e.g., ramps) prevent embryo entrapment. Devices are non-pyrogenic, non-embryotoxic, and terminally sterilized via gamma irradiation. Used as passive containers; output is the physical environment for gamete/embryo maintenance during IVF procedures. Benefits include improved handling efficiency, reduced risk of sample mix-ups, and optimized conditions for embryo development.

Clinical Evidence

Bench testing only. Evidence includes USP Class VI cytotoxicity testing, LAL testing for non-pyrogenicity, and 1-cell Mouse Embryo Assay (MEA) for non-embryotoxicity. No clinical data presented.

Technological Characteristics

Materials: Virgin crystal grade polystyrene (USP Class VI). Design: Injection-molded, disposable, single-use dishes with lids. Sterilization: Gamma irradiation (SAL 10^-6). Features: Optically clear, non-treated surfaces, vented lids, various well configurations (1, 5, 12 wells), square or round outer geometry, patient ID areas.

Indications for Use

Indicated for IVF procedures including preparation, storage, manipulation, or transfer of human gametes or embryos; includes GIFT, ICSI, and drop culture techniques. For professional use in clinical IVF settings.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Falcon IVF Round Dish (K991253)
Nunc IVF Multidish 4 Wells Nunclon (K040717)
Nunc IVF ICSI Dish (K090429)
Falcon IVF One Well Dish (K991251)
Genx Culture Dish (now marketed as Sun IVF Embryo Corral Dish) (K993881)

Submission Summary (Full Text)

{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 {1}------------------------------------------------ ### 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 Page 2 of 8 {2}------------------------------------------------ # 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 : . . . {3}------------------------------------------------ ## 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 : . · | 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 Page 6 of 8 · : · {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 · 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. | . . : . . {8}------------------------------------------------ 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. {9}------------------------------------------------ #### Page 2 - Mr. Henrik Dörge 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 {10}------------------------------------------------ #### 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 {11}------------------------------------------------ 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 . {12}------------------------------------------------ 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 Page 3 of 4 {13}------------------------------------------------ 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 Page 4 of 4

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CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH

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Predicate Devices

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