(219 days)
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.
The HertART disposable dishes are injection molded. The dishes are supplied with a lid. The polymers used for the dishes are virgin 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
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
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
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.
Vitrolife ICSI Dish: Square dish with lid: 65,96 mm x 65,96 mm x 11,70 mm 1 square well with rounded corners
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
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.
The provided text describes a 510(k) summary for various IVF dishes and primarily focuses on demonstrating substantial equivalence to predicate devices. It does not contain information related to acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), study designs (e.g., MRMC, standalone), sample sizes for test/training sets, data provenance, ground truth establishment, or expert involvement typically associated with AI/software medical device studies.
The document details the physical characteristics, intended use, and material composition of the Vitrolife Culture Dishes and compares them feature-by-feature to existing predicate devices. The "Discussion" sections within each comparison consistently state that the differences do not impact safety or effectiveness and therefore support substantial equivalence.
Specifically, the studies mentioned are not performance studies in the AI/software sense, but rather tests to assure material compatibility and safety:
- USP class VI test for cytotoxicity: This is a standard biocompatibility test for materials that will come into contact with the body.
- 1-cell embryotoxicity test (MEA): This is a biological assay used to assess the potential toxicity of materials to embryos. The document notes that the subject device uses a "more sensitive 1-cell MEA assay" compared to the predicate's 2-cell MEA, but this is a test of the material's safety, not a measure of the device's diagnostic or predictive performance.
- LAL test (Limulus Amebocyte Lysate): This is a test for bacterial endotoxins (pyrogens).
Therefore, I cannot fulfill the request as the provided text does not contain the necessary information to describe acceptance criteria, device performance, or study details relevant to AI/software medical devices. The document is a regulatory submission for physical medical devices used in IVF, focusing on substantial equivalence based on material and design characteristics, not on the performance of a diagnostic or assistive AI algorithm.
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HertAR 510(k) Summary
COMPANY
| Name:Address: | HertART ApSKorskildelund 6DK-2670 GreveDenmark |
|---|---|
| Registration No.: | 3008524469 |
| Contact Person: | Mr. Henrik DörgeKorskildelund 6DK 2670 GreveDenmark |
| Office:Mobile:E-mail: | +45 3651 9170+45 2214 3822hdo@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 mmVitrolife Culture Dish 60 mmVitrolife Micro-droplet Culture DishVitrolife 5-well Culture DishVitrolife Centre Well DishVitrolife 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 mmOne round well 60 mm in diameterWell Volume: 24,00 mL | 10 units per sleeve540 units per case |
| Vitrolife Culture Dish 40 mm | Square dish with lid;65,96 mm x 65,96 mm x 13,20 mmOne round well: 40 mm in diameter, Wellvolume of 12,56 mL | 5 units per sleeve400 units per case |
| Vitrolife 5-well Culture Dish | Square dish with lid:65,96 mm x 65,96 mm x. 13,20 mm5 round wells, Well Volume: 1,7 mL | 5 units per sleeve400 units per case |
| Vitrolife Centre Well Dish | Square dish with lid:65,96 mm x 65,96 mm x 13,20 mm1 well, round bottom, oval opening. | 5 units per sleeve400 units per case |
| Vitrolife ICSI Dish | Square dish with lid:65,96 mm x 65,96 mm x 11,70 mm1 square well with rounded corners | 5 units per sleeve400 units per case |
| Vitrolife Micro-droplet CultureDish | Square dish with lid:65,96 mm x 65,96 mm x 13,20 mm12 round wells holds drops up to 50 µLWell Volume: 12.5 µL | 5 units per sleeve400 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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K123641
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510(k) Summary
PREDICATE DEVICE COMPARISON
| Parameter | Subject Device -- VitrolifeCulture Dish 60 mm | Predicate Device - FalconIVF Round Dish (K991253) | Differences |
|---|---|---|---|
| Device | Round petri dish with diameter60 mm | Round petri dish with diameter60 mm | none |
| Indication forUse | Intended for IVF, suitable foruse in preparing, storing,manipulating, or transferringhuman gametes or embryos forin vitro fertilization (IVF),gamete intrafallopian transfer(GIFT), or other reproductionprocedures | Intended for use in preparing,storing, manipulating, ortransferring human gametes orembryos for in vitro fertilization(IVF), gamete intrafallopiantransfer (GIFT), or otherreproduction procedures | none |
| Material | Virgin Polystyrene, tested forUSP Class VI cytotoxicity | Virgin Polystyrene, tested forUSP Class VI cytotoxicity | none |
| Dimensions | Diameter 60 mm | Diameter 60 mm | none |
| Designfeatures | Round dishes with vented lid.Flat bottom, optically clearsurfaces.Surfaces are non-treated | Round dishes with vented lid.Flat bottom, optically clearsurfaces. Surfaces are treatedfor improved wettability | Predicate device issurface treated forincreased 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 labwarefor better cell adhesion. As gametes and embryos do not adhere to surfaces, and since mostculture within IVF nowadays is done in drops of media, improved wettability is not a desiredproduct 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 performanceThe differences do not impact the use of the identified predicate device to support theproposed 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 - VitrolifeCulture Dish 40 mm | Predicate Device – FalconIVF Round Dish (K991253) | Differences |
|---|---|---|---|
| Device | Square dish with round innerdiameter of 40 mm | Round petri dish with diameter60 mm | Proposed device hassquare outer geometryand smaller round well |
| Indication foruse | Intended for IVF, suitable foruse in preparing, storing,manipulating, or transferringhuman gametes or embryos forin vitro fertilization (IVF),gamete intrafallopian transfer(GIFT), or other reproductionprocedures. | Intended for use in preparing,storing, manipulating, ortransferring human gametes orembryos for in vitro fertilization(IVF), gamete intrafallopiantransfer (GIFT), or otherreproduction procedures | None |
| Material | Virgin Polystyrene, tested forUSP Class VI cytotoxicity | Virgin Polystyrene, tested forUSP Class VI cytotoxicity | none |
HertART ApS
IVF Dishes
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K123641
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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 5well Culture Dish | Predicate Device - Nunc IVFMultidish 4 Wells (K040717) | Differences |
|---|---|---|---|
| Device | Square dish with 5 round wells | Square dish with 4 round wells | Proposed device has 5wells while predicatedevice has 4 wells. |
| Indications forUse | Intended for IVF, suitable forpreparing, storing,manipulating or transferringhuman gametes or embryos forin vitro fertilization (IVF), orother in vitro fertilizationtechniques | Intended for preparing, storing,manipulating or transferringhuman gametes or embryos forin vitro fertilization (IVF.), orother in vitro fertilizationtechniques, and cell culture | none |
| Material | Virgin Polystyrene, tested forUSP Class VI cytotoxicity | Virgin Polystyrene, tested forUSP Class VI cytotoxicity | none |
| Dimensions | Base: 65,96 mm x 65,96 mmDish size with lid: 65,96 mm x65,96 mm x 13,20 mm | Base: 65,96 mm x 65,96 mm | none |
| Designfeatures | Square dish with vented lid. Apatient ID area not covered bythe lid.Flat bottom, optically clearsurfaces.Surfaces are non-treated | Square dish with vented lidcoving all of the dish. Flatbottom, optically clear surfaces.Product comes both with orwithout surface treatment forimproved wettability | Proposed dish has apatient ID area.Predicate device cancome as surfacetreated for increasedwettability |
HertART ApS IVF Dishes
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HertART ====================================================================================================================================================================== 510(k) Summary
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| Well shape | Well area of 1.9 cm²Well Volume of 1,7 mLWells having a ramp along theedgeThe well diameter isapproximately 10.7 mm at thebottom of the well and thenquickly expands to a 15,3 mmdiameter cylinder. The height isapproximately 9.4 mm fromthe bottom of the well to therim | Well area of 1.9 cm² | Proposed device has aramp along the inneredge of the wells |
|---|---|---|---|
| Discussion | Proposed device has a patient ID area. The square outer geometry facilitates the handlingand stacking of dishes, while the patient ID area for writing or barcode increases the safetyin relation to mix-ups.Proposed device has a ramp along the inner edge of the wells preventing the embryos fromgetting stuck in the corners and thereby facilitates the use of the product.Predicate device uses surface treatment, which is traditionally used for cell culture labwarefor better cell adhesion. As gametes and embryos do not adhere to surfaces, and since mostculture within IVF nowadays is done in drops of media, improved wettability is notconsidered a desired product feature for modern IVF procedures.The differences do not impact the use of the identified predicate device to support theproposed 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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| Parameter | Subject Device - VitrolifeICSI Dish | Predicate Device - Nunc IVFICSI Dish (K090429) | Differences |
|---|---|---|---|
| Device | Square dish with 1 well withrounded corners | Round dish with 1 round well | Proposed device hassquare outer geometryand 1 well with roundedcorners, while predicatedevice has round outergeometry and roundwell |
| Indication forUse | Intended for IVF, suitable forholding oocytes and spermduring fertilization viaintracytoplasmic sperminjection (ICSI). | Intended for holding oocytesand sperm during fertilizationvia intracytoplasmic sperminjection (ICSI). | none |
| Material | Virgin Polystyrene, tested forUSP Class VI cytotoxicity | Virgin Polystyrene, tested forUSP Class VI cytotoxicity | none |
| Dimensions | Dish Size without lid: 65,96 mmx 65,96 mm x 9,00 mmDish Size with lid: 65,96 mm x65,96 mm x 11,70 mmThe ICSI dish has one largecontinuous surface with thelength (at the bottom of thewell) of 50.5 mm and a widthof 34.8 mm. The corners arerounded and the total volume isapproximately 14.5 mL. | Diameter: 55.77 mmHeight without lid: 8.64 mmHeight with lid: 9.75 mm | Proposed device issquare and wider.Height is comparable. |
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HertART.......................................................................................................................................................................
510(k) Summary
K123641 pg 6 of 8
| Designfeatures | The bottom of the dishes isclear and optimal clear.The lid can be handled with onehand while other lab equipmentcan be handled with the otherhand. The dishes can bestacked.A patient ID area not coveredby the lid. | The bottom of the dishes isclear and optimal clear.The lid can be handled with onehand while other lab equipmentcan be handled with the otherhand. The dishes can bestacked. | Proposed device has apatient ID area. |
|---|---|---|---|
| Discussion | Proposed device has a patient ID area. The square outer geometry facilitates the handlingand stacking of dishes, while the patient ID area for writing or barcode increases the safetyin relation to mix-ups.The differences do not impact the use of the identified predicate device to support theproposed 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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| Parameter | Subject Device - VitrolifeCentre Well Dish | Predicate Device - FalconIVF One Well Dish(K991251) | Differences |
|---|---|---|---|
| Device | Square dish with 1 oval well | Round dish with 1 round well | Proposed device hassquare outer geometryand oval well. Predicatedevice has round outergeometry and round well |
| Indication forUse | Intended for IVF, suitable foruse in preparing, storing,manipulating, or transferringhuman gametes or embryos forin vitro fertilization (IVF),gamete intrafallopian transfer(GIFT), or other reproductionprocedures. | Intended for use in preparing,storing, manipulating, ortransferring human gametes orembryos for in vitro fertilization(IVF), gamete intrafallopiantransfer (GIFT), or otherreproduction procedures | None |
| Material | Virgin Polystyrene, tested forUSP Class VI cytotoxicity | Virgin Polystyrene, tested forUSP Class VI cytotoxicity | none |
| Dimensions | Dish with lid: 65,96 mm x65,96 mm x 13,20 mmHeight without lid: 10,50 mm | Diameter: 55.77 mmHeight without lid: 8.64 mmHeight with lid: 9.75 mm | Height is comparable |
| Designfeatures | The dishes have perfectly flat,optically clear surfaces foroptimum manipulation andobservation of the ova andembryos. The oval wellfacilitates the handling of theova and embryos by equipmentduring microscopy.The lids are designed foraseptic manipulation andconsistent venting to maintainproper humidification. Thedishes can be stacked.A patient ID area not coveredby the lid | The dishes have perfectly flat,optically clear surfaces foroptimum manipulation andobservation of the ova andembryos. Surfaces are treatedfor improved wettability.The lids are designed foraseptic manipulation andconsistent venting to maintainproper humidification | Proposed device has anoval well while predicatedevice has a round well.Predicate device is surfacetreated for increasedwettability.Proposed device has apatient ID area |
HertART ApS IVF Dishes
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HertART ... " .
K123641 pg 7 of 8
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510(k) Summary
| Well shape. | Round bottom with diameterapprox. 15.5 mm and a largeroval 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 andstacking of dishes, while the patient ID area for writing or barcode increases the safety inrelation to mix-ups.The oval well in proposed device facilitates the handling of the ova and embryos by equipmentduring microscopy.Predicate device uses surface treatment, which is traditionally used for cell culture labware forbetter cell adhesion. As gametes and embryos do not adhere to surfaces, and since mostculture within IVF nowadays is done in drops of media, improved wettability is not a desiredproduct 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 theproposed 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 - VitrolifeMicro Droplet Culture Dish | Predicate Device – GenxCulture Dish (Sun IVFEmbryo Corral) (K993881) | Differences |
|---|---|---|---|
| Device | Square dish with 12 round wells | Round dish with 11 round wells | Proposed device hassquare outer geometryand round walls, whilepredicate device hasround outer geometry andpicket-fenced walls |
| Indication foruse /intended use | Intended for IVF. It may beused with sperm and for theculturing of embryos using dropculture. | Intended to be used whenculturing tissues and cells. Itmay be used with sperm andfor the culturing of embryos. | Predicate device allowsmedia to flow freelyamong culturingcells/embryos, howeverProposed device allowindividual cells/embryosto be cultures inseparated drop cultures. |
| Material | Virgin Polystyrene, tested forUSP Class VI cytotoxicity | Polystyrene | Proposed device uses USPClass tested polystyrene |
| Dimensions | Dish with lid: 65,96 mm x65,96 mm x 13,20 mm | Outer Diameter: 60 mm | Proposed device hassquare outer geometrywhile predicate device hasround |
| Designfeatures | The basic design is a squareculture dish with twelve smallwells (volume 12.5 microliter,holding standing drops up to 50microliter). The micro-wells areplaced with a-numerical ID in arectangular well format to alloweasy identification duringmicroscopy. | The basic design is that of atraditional culture dish. Approx60 mm round with areas of $1/2$inch side walls. This dish doesnot have defined areas for thecell to be confined within.These areas are squares ofpicket-fenced walls. | Proposed device has asquare outer geometryand well areas defined bysmall solid walls, whilepredicate device has around outer geometry andwell areas defined bysmall picket-fenced walls.Proposed device hasmicro-wells with a- |
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HertART ApS IVF Dishes
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HertART.neimmers at # .
510(k) Summary
| approximately 0.95 mm andthe diameter is 3.3 mm at thebottom with sides sloping toapproximately 4.3 mm at thetop. There will typically be oneseparated media-drop in eachwell, this is however not linkedto if the customer decides toplace several embryos in eachwell (co-culture) or only oneembryo (single embryo cultureThe lids are designed foraseptic manipulation andconsistent venting to maintainproper humidification.A patient ID area not coveredby the lid. | numerical ID to allow easyidentification duringmicroscopy, as well as aseparate 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, whileProposed 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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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
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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
Page 3 of 4
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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
Page 4 of 4
§ 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.