Micro well group culture dish, 9-well; Micro well group culture dish, 16-well

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 20, 2015 HertART ApS Göran Mellbin Director of Quality and Operations Gustaf Werners gata 2 V. Frölunda, SE-421 32 Sweden Re: K150756 > Trade/Device Name: Micro well group culture dish, 9-well Micro well group culture dish, 16-well Regulation Number: 21 CFR§ 884.6160 Regulation Name: Assisted reproduction labware Regulatory Class: II Product Code: MQK Dated: May 29, 2015 Received: May 29, 2015 Dear Göran Mellbin, 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. 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. {1}------------------------------------------------ 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 Industry and Consumer Education 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" (21 CFR 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 Industry and Consumer Education 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. Sincerely yours, Herbert P. Lerner -S for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Device and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K150756 #### Device Name Micro well group culture dish, 9-well Micro well group culture dish, 16-well #### Indications for Use (Describe) For in-vitro fertilisation, handling and embryo culture. It may be used for the culturing of embryos using drop culture Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### HertART at the beginning of isse ### Chapter 5: 510(k) Summary | COMPANY | | |------------------------|-----------------------------------------------------------------------------------------| | Name: | HertART ApS | | Address: | Gustaf Werners gata 2<br>SE-421 32 V Frölunda<br>Sweden | | Registration No.: | 3008524469 | | Contact Person: | Göran Mellbin<br>HertART ApS<br>Gustaf Werners gata 2<br>SE-421 32 V Frölunda<br>Sweden | | | Phone: +46-317218069<br>Fax: +46-317218090<br>e-mail: gmellbin@vitrolife.com | | Date of Summary: | July 18, 2015 | | DEVICE<br>Trade names: | Micro well group culture dish, 9-well<br>Micro well group culture dish, 16-well | | Common name: | IVF Dishes | | Classification name: | Assisted Reproduction Labware, 21 CFR884.6160, Code MOH | ### PREDICATE DEVICE Proposed Device: Micro well group culture dish, 9-well Predicate Device: Proprietary Name: Vitrolife Micro Droplet Culture Dish Common Name: IVF Dish Manufacturer: HertART ApS 510(k) Number: K123641 Proposed Device: Micro well group culture dish, 16-well | Predicate Device: | | |-------------------|--------------------------------------| | Proprietary Name: | Vitrolife Micro Droplet Culture Dish | | Common Name: | IVF Dish | | Manufacturer: | HertART ApS | HertART ApS FDA application-Micro well group culture dish, 9-well/16-well Section 5, Version 03, July 2015 Page 1 of 6 {4}------------------------------------------------ ### HertARTst the beginning of itle ### Chapter 5: 510(k) Summary #### 510(k) Number: K123641 DESCRIPTION OF DEVICE The Micro well group culture dishes are injection molded and disposable. The dishes are round and supplied with a lid. The dishes holds 9 small wells respectively 16 small wells. The polymers used for the dishes are virgin crystal grade polystyrene, which has successfully passed 1- cell embryotoxicity test. The dishes are packed 1 unit in a sleeve, 10 sleeves in a case as defined below: | Trade Name | Configuration | Packaging | |----------------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------| | Micro well group culture dish, 9-well | Round dish with lid.<br>Diameter 40 mm x12 mm<br>9 round wells in dish.<br>Culture area 0.07 mm² per well. | 1 unit per sleeve<br>10 units per case | | Micro well group culture dish, 16-well | Round dish with lid.<br>Diameter 40 mm x12 mm<br>16 round wells in dish.<br>Culture area 0.07 mm² per well. | 1 unit per sleeve<br>10 units per case | The dishes are terminally sterilized by irradiation to achieve a SAL of 10-6. The dishes are non-pyrogenic as tested by LAL, and non-embryotoxic as tested by one cell Mouse Embryo Assay (MEA). The Dishes are single use devices. ### INTENDED USE The medical condition to be treated is infertility. The target group is couples incapable of getting fertile by normal sexual intercourse. It is the Doctor who takes the clinical decision on who should receive fertility treatment, named In Vitro Fertilization (IVF). For this procedure disposable plastic dishes are routinely used for sampling, handling, culturing and purification of gemetes for In Vitro Fertilization. ### Micro well group culture dish, 9-well: For in vitro fertilisation, handling and embryo culture. It may be used for the culturing of embryos using drop culture ### Micro well group culture dish, 16-well: For in vitro fertilisation, handling and embryo culture. It may be used for the culturing of embryos using drop culture The additional common claims are - Devices are sterile (SAL 10°9) - Devices are non-embryotoxic (Embryo safe) - Devices are non pyrogenic - Devices are single-use i - Devices are for 'Professionals' only (Rx) {5}------------------------------------------------ ## HertART in the beginning of lite # Chapter 5: 510(k) Summary Overview: Comparison between proposed devices and predicate devices | | Proposed Device<br>Micro well group<br>culture dish, 9-well | Predicate Device<br>Vitrolife<br>Micro Droplet Culture<br>Dish<br>510(k) K123641 | Differences | |--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device | Round dish with 9 round<br>wells | Square dish with 12 round<br>wells | Proposed device is<br>round with 9 round<br>wells compared to<br>square dish with 12<br>round wells in predicate<br>device | | Indication<br>for use /<br>intended<br>use | For in vitro fertilisation,<br>handling and embryo<br>culture. It may be used<br>for the culturing of<br>embryos using drop<br>culture. | Intended for IVF. It may<br>be used with sperm and<br>the culturing of embryos<br>using drop culture. | None,<br>As both predicate and<br>proposed dish may be<br>using drop culture<br>and co-culture having<br>separate wells to hold<br>the cells. Both devices<br>can be used with sperm,<br>but due to the design it<br>is unlikely that clincs<br>will use the Micro well<br>group culture dish for<br>this. | | Material | Virgin Polystyrene, | Virgin Polystyrene, | none | | Dimensions | Dish with lid: Diameter<br>40 mm x 12mm | Dish with lid: 65,96 mm x<br>65,96 mm x 13,20 mm | Proposed dish is round<br>and a bit smaller than<br>the square predicate<br>device | | Design<br>features | The basic design is a<br>round culture dish with<br>nine small wells/grooves<br>(culture area per well<br>0.07 mm²) situated in the<br>center of the dish for<br>easy microscopy /<br>imaging.<br>Each cavity has a volume<br>of approximately 0.02 µL<br>and is only intended to<br>keep each embryo in a<br>fixed place so that it can<br>be individually evaluated<br>during the culture. The<br>total volume to be used<br>will depend on how the<br>clinic uses the dish and<br>may vary in size from 50 | The basic design is a<br>square culture dish with<br>twelve small wells (volume<br>12.5 microliter, holding<br>standing drops up to 50<br>microliter).<br>The micro-wells are placed<br>with a-numerical ID in a<br>rectangular well format to<br>allow easy identification<br>during microscopy.<br>The height of a well is<br>approximately 0.95 mm at<br>the bottom with sides<br>sloping to approximately<br>4.3 mm at the top. There<br>will typically be one<br>separated media-drop in | The predicate device<br>has 12 wells (12.5 µL)<br>distributed in an array<br>across large part of the<br>base of the dish, while<br>the proposed device has<br>9 wells /grooves (0.02<br>µL) situated in an array<br>at the center of the dish<br>for easy<br>microscopy/imaging | {6}------------------------------------------------ # HertART in the beginning of litte # Chapter 5: 510(k) Summary | | µL to 150 µL depending<br>on the time and number<br>of embryos cultured.<br><br>The micro-wells are<br>placed with a-numerical<br>ID in a rectangular well<br>format to allow easy<br>identification during<br>microscopy.<br><br>The lids are designed for<br>aseptic manipulation and<br>consistent venting to<br>maintain proper<br>humidification. | each well, this is, however,<br>not linked to if the<br>customer decides to place<br>several embryos in each<br>well (co-culture) or only<br>one embryo (single<br>embryo culture). The lids<br>are designed for aseptic<br>manipulation and<br>consistent venting to<br>maintain proper<br>humidification. A patient<br>ID area not covering the<br>lid. | | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------| | Packaging | 1 dish per sleeve<br>10 dishes per case | 5 dishes per sleeve,<br>400 dishes per case | Proposed device is<br>single packed in sleeve | | Performance<br>testing | Sterile (SAL 10-6),<br>Non-pyrogenic by<br>Limulus Amebocyte<br>Lysate assay (LAL of <<br>0,25 EU/Device)<br>Non-embryotoxic tested<br>by Mouse Embryotoxicity<br>assay (MEA) 1-cell<br>method. | Sterile (SAL 10-6),<br>Non-pyrogenic by Limulus<br>Amebocyte Lysate assay<br>(LAL of < 0,25 EU/Device)<br>Non-embryotoxic tested by<br>Mouse Embryotoxicity<br>assay (MEA) 1-cell<br>method. | none | | Discussion | Predicate device is square and has 12 wells placed in an array across the base of<br>the dish. The proposed device is round and has 9 wells/grooves placed in an<br>array at the center of the dish. The design of the proposed device facilitates the<br>simultaneously imaging of the embryos in the multiple wells/grooves.<br>The differences do not impact the use of the identified predicate device to support<br>the proposed device, as they do not raise any new types of safety or<br>effectiveness questions. Therefore, the subject is substantially equivalent to the<br>predicate device. | | | {7}------------------------------------------------ # HertART is the beginning of lite Chapter 5: 510(k) Summary | | Proposed Device<br>Micro well group<br>culture dish, 16-well | Predicate Device<br>Vitrolife<br>Micro Droplet Culture<br>Dish<br>510(k) K123641 | Differences | |--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device | Round dish with 16 round<br>wells | Square dish with 12 round<br>wells | Proposed device is<br>round with 16 round<br>wells compared to<br>square dish with 12<br>round wells in predicate<br>device | | Indication<br>for use /<br>intended<br>use | For in vitro fertilisation,<br>handling and embryo<br>culture. It may be used<br>for the culturing of<br>embryos using drop<br>culture. | Intended for IVF. It may<br>be used with sperm and<br>the culturing of embryos<br>using drop culture. | None,<br>As both predicate and<br>proposed dish may be<br>using drop culture<br>and co-culture having<br>separate wells to hold<br>the cells. Both devices<br>can be used with sperm,<br>but due to the design it<br>is unlikely that clinics<br>will use the Micro well<br>group culture dish for<br>this. | | Material | Virgin Polystyrene, | Virgin Polystyrene, | none | | Dimensions | Dish with lid: Diameter<br>40 mm x 12mm | Dish with lid: 65,96 mm x<br>65,96 mm x 13,20 mm | Proposed dish is round<br>and a bit smaller than<br>the square predicate<br>device | | Design<br>features | The basic design is a<br>round culture dish with<br>nine small wells/grooves<br>(culture area per well<br>0.07 mm²) situated in the<br>center of the dish for<br>easy microscopy /<br>imaging.<br>Each cavity has a volume<br>of approximately 0.02 µL<br>and is only intended to<br>keep each embryo in a<br>fixed place so that it can<br>be individually evaluated | The basic design is a<br>square culture dish with<br>twelve small wells (volume<br>12.5 microliter, holding<br>standing drops up to 50<br>microliter).<br>The micro-wells are placed<br>with a-numerical ID in a<br>rectangular well format to<br>allow easy identification<br>during microscopy.<br>The height of a well is<br>approximately 0.95 mm at | The predicate device<br>has 16 wells (12.5 µL)<br>distributed in an array<br>across large part of the<br>base of the dish, while<br>the proposed device has<br>9 wells /grooves (0.02<br>µL) situated in an array<br>at the center of the dish<br>for easy<br>microscopy/imaging | Page 5 of 6 {8}------------------------------------------------ ### HertART in the beginning of lite . # Chapter 5: 510(k) Summary | | during the culture. The<br>total volume to be used<br>will depend on how the<br>clinic uses the dish and<br>may vary in size from 50<br>µL to 150 µL depending<br>on the time and number<br>of embryos cultured.<br>The micro-wells are<br>placed with a-numerical<br>ID in a rectangular well<br>format to allow easy<br>identification during<br>microscopy.<br>The lids are designed for<br>aseptic manipulation and<br>consistent venting to<br>maintain proper<br>humidification. | the bottom with sides<br>sloping to approximately<br>4.3 mm at the top. There<br>will typically be one<br>separated media-drop in<br>each well, this is, however,<br>not linked to if the<br>customer decides to place<br>several embryos in each<br>well (co-culture) or only<br>one embryo (single<br>embryo culture). The lids<br>are designed for aseptic<br>manipulation and<br>consistent venting to<br>maintain proper<br>humidification. A patient<br>ID area not covering the<br>lid. | | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------| | Packaging | 1 dish per sleeve<br>10 dishes per case | 5 dishes per sleeve,<br>400 dishes per case | Proposed device is<br>single packed in sleeve | | Performance<br>testing | Sterile (SAL 10-6),<br>Non-pyrogenic by<br>Limulus Amebocyte<br>Lysate assay (LAL of<br>0,25 EU/mL)<br>Non-embryotoxic tested<br>by Mouse Embryotoxicity<br>assay (MEA) 1-cell<br>method. | Sterile (SAL 10-6),<br>Non-pyrogenic by Limulus<br>Amebocyte Lysate assay<br>(LAL of < 0,25 EU/Device)<br>Non-embryotoxic tested by<br>Mouse Embryotoxicity<br>assay (MEA) 1-cell<br>method. | none | | Discussion | Predicate device is square and has 12 wells placed in an array across the base of<br>the dish. The proposed device is round and has 16 wells/grooves placed in an<br>array at the center of the dish. The design of the proposed device facilitates the<br>simultainiously imaging of the embryos in the multiple wells/grooves.<br>The differences do not impact the use of the identified predicate device to support<br>the proposed device, as they do not raise any new types of safety or<br>effectiveness questions. Therefore, the subject is substantially equivalent to the<br>predicate device. | | | G. Miller Signed Göran Mellbin, Director of Quality&Operations, Chairman of the Board 2015-07-18 (Date) HertART ApS FDA application-Micro well group culture dish, 9-well/16-well Section 5, Version 03, July 2015 Page 6 of 6