(119 days)
For in-vitro fertilisation, handling and embryo culture. It may be used for the culturing of embryos using drop culture
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. 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.
This document describes a 510(k) premarket notification for a new medical device, not a study evaluating a device's performance against detailed acceptance criteria for an AI algorithm. Therefore, many of the requested fields are not applicable to the provided text.
The document discusses two new devices: a "Micro well group culture dish, 9-well" and a "Micro well group culture dish, 16-well," for use in in-vitro fertilization (IVF). The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Vitrolife Micro Droplet Culture Dish, K123641) rather than presenting a performance study of a novel AI system.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are based on the characteristics of the predicate device and established standards for IVF labware. The performance is reported as meeting these standards.
| Acceptance Criteria (from Predicate Device/Standards) | Reported Device Performance (Micro well group culture dish, 9-well & 16-well) |
|---|---|
| Sterility: SAL 10⁻⁶ | Sterile (SAL 10⁻⁶) |
| Non-pyrogenic: LAL of < 0.25 EU/Device | Non-pyrogenic by Limulus Amebocyte Lysate assay (LAL of < 0.25 EU/mL) |
| Non-embryotoxic: Tested by Mouse Embryotoxicity assay (MEA) 1-cell method | Non-embryotoxic tested by Mouse Embryotoxicity assay (MEA) 1-cell method |
| Material: Virgin Polystyrene | Virgin Polystyrene |
| Intended Use: For in-vitro fertilisation, handling and embryo culture; may be used with sperm and for culturing embryos using drop culture. | For in-vitro fertilisation, handling and embryo culture. It may be used for the culturing of embryos using drop culture. |
| Single Use: Yes | Single use devices |
2. Sample size used for the test set and the data provenance:
- Not applicable. This document describes a medical device (culture dish) and its regulatory approval process, not an AI algorithm's performance study with a test set of data. The "tests" mentioned are for biological safety (sterility, pyrogenicity, embryotoxicity) of the physical product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in the context of an AI algorithm's performance is not relevant here. The ground truth for the physical device characteristics (e.g., sterility) is established by standard laboratory testing protocols and validated methods (e.g., LAL assay, MEA).
4. Adjudication method for the test set:
- Not applicable. There is no "test set" of AI algorithm outputs requiring adjudication by experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This document is not about AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document does not describe an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the performance testing of the physical device, the "ground truth" is based on standardized laboratory assays and biological indicators:
- Sterility: Achieves a Sterility Assurance Level (SAL) of 10⁻⁶, meaning the probability of a single viable microorganism occurring on a product unit after sterilization is no more than one in a million.
- Non-pyrogenic: Demonstrated by Limulus Amebocyte Lysate (LAL) assay, with results of < 0.25 EU/mL.
- Non-embryotoxic: Demonstrated by a 1-cell Mouse Embryo Assay (MEA). This is a biological assay where mouse embryos are cultured in the device's environment to assess any toxic effects.
8. The sample size for the training set:
- Not applicable. There is no AI algorithm being trained.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI algorithm being trained.
Summary of Device and Regulatory Context:
The document is an FDA 510(k) clearance letter for IVF culture dishes. The primary "study" referred to is the submission of data demonstrating that the new devices are substantially equivalent to a previously cleared predicate device. This equivalence is based on:
- Materials: Both devices use virgin crystal grade polystyrene.
- Intended Use: Both are for in-vitro fertilization, handling, and embryo culture, potentially using drop culture.
- Performance Testing: Both meet the same standards for sterility (SAL 10⁻⁶), non-pyrogenicity (LAL < 0.25 EU/mL), and non-embryotoxicity (1-cell MEA).
The document specifically highlights the differences in physical dimensions, number of wells (9 or 16 in the proposed vs. 12 in the predicate), and well design (round, central array vs. square, distributed array). However, the submission argues that these 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." This is the core argument for substantial equivalence, which is a regulatory pathway, not a clinical efficacy study for an AI device.
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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.
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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
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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)
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HertART at the beginning of isse
Chapter 5: 510(k) Summary
| COMPANY | |
|---|---|
| Name: | HertART ApS |
| Address: | Gustaf Werners gata 2SE-421 32 V FrölundaSweden |
| Registration No.: | 3008524469 |
| Contact Person: | Göran MellbinHertART ApSGustaf Werners gata 2SE-421 32 V FrölundaSweden |
| Phone: +46-317218069Fax: +46-317218090e-mail: gmellbin@vitrolife.com | |
| Date of Summary: | July 18, 2015 |
| DEVICETrade names: | Micro well group culture dish, 9-wellMicro 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
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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.Diameter 40 mm x12 mm9 round wells in dish.Culture area 0.07 mm² per well. | 1 unit per sleeve10 units per case |
| Micro well group culture dish, 16-well | Round dish with lid.Diameter 40 mm x12 mm16 round wells in dish.Culture area 0.07 mm² per well. | 1 unit per sleeve10 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)
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HertART in the beginning of lite
Chapter 5: 510(k) Summary
Overview: Comparison between proposed devices and predicate devices
| Proposed DeviceMicro well groupculture dish, 9-well | Predicate DeviceVitrolifeMicro Droplet CultureDish510(k) K123641 | Differences | |
|---|---|---|---|
| Device | Round dish with 9 roundwells | Square dish with 12 roundwells | Proposed device isround with 9 roundwells compared tosquare dish with 12round wells in predicatedevice |
| Indicationfor use /intendeduse | For in vitro fertilisation,handling and embryoculture. It may be usedfor the culturing ofembryos using dropculture. | Intended for IVF. It maybe used with sperm andthe culturing of embryosusing drop culture. | None,As both predicate andproposed dish may beusing drop cultureand co-culture havingseparate wells to holdthe cells. Both devicescan be used with sperm,but due to the design itis unlikely that clincswill use the Micro wellgroup culture dish forthis. |
| Material | Virgin Polystyrene, | Virgin Polystyrene, | none |
| Dimensions | Dish with lid: Diameter40 mm x 12mm | Dish with lid: 65,96 mm x65,96 mm x 13,20 mm | Proposed dish is roundand a bit smaller thanthe square predicatedevice |
| Designfeatures | The basic design is around culture dish withnine small wells/grooves(culture area per well0.07 mm²) situated in thecenter of the dish foreasy microscopy /imaging.Each cavity has a volumeof approximately 0.02 µLand is only intended tokeep each embryo in afixed place so that it canbe individually evaluatedduring the culture. Thetotal volume to be usedwill depend on how theclinic uses the dish andmay vary in size from 50 | The basic design is asquare culture dish withtwelve small wells (volume12.5 microliter, holdingstanding drops up to 50microliter).The micro-wells are placedwith a-numerical ID in arectangular well format toallow easy identificationduring microscopy.The height of a well isapproximately 0.95 mm atthe bottom with sidessloping to approximately4.3 mm at the top. Therewill typically be oneseparated media-drop in | The predicate devicehas 12 wells (12.5 µL)distributed in an arrayacross large part of thebase of the dish, whilethe proposed device has9 wells /grooves (0.02µL) situated in an arrayat the center of the dishfor easymicroscopy/imaging |
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HertART in the beginning of litte
Chapter 5: 510(k) Summary
| µL to 150 µL dependingon the time and numberof embryos cultured.The micro-wells areplaced with a-numericalID in a rectangular wellformat to allow easyidentification duringmicroscopy.The lids are designed foraseptic manipulation andconsistent venting tomaintain properhumidification. | each well, this is, however,not linked to if thecustomer decides to placeseveral embryos in eachwell (co-culture) or onlyone embryo (singleembryo culture). The lidsare designed for asepticmanipulation andconsistent venting tomaintain properhumidification. A patientID area not covering thelid. | ||
|---|---|---|---|
| Packaging | 1 dish per sleeve10 dishes per case | 5 dishes per sleeve,400 dishes per case | Proposed device issingle packed in sleeve |
| Performancetesting | Sterile (SAL 10-6),Non-pyrogenic byLimulus AmebocyteLysate assay (LAL of <0,25 EU/Device)Non-embryotoxic testedby Mouse Embryotoxicityassay (MEA) 1-cellmethod. | Sterile (SAL 10-6),Non-pyrogenic by LimulusAmebocyte Lysate assay(LAL of < 0,25 EU/Device)Non-embryotoxic tested byMouse Embryotoxicityassay (MEA) 1-cellmethod. | none |
| Discussion | Predicate device is square and has 12 wells placed in an array across the base ofthe dish. The proposed device is round and has 9 wells/grooves placed in anarray at the center of the dish. The design of the proposed device facilitates thesimultaneously imaging of the embryos in the multiple wells/grooves.The differences do not impact the use of the identified predicate device to supportthe proposed device, as they do not raise any new types of safety oreffectiveness questions. Therefore, the subject is substantially equivalent to thepredicate device. |
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HertART is the beginning of lite
Chapter 5: 510(k) Summary
| Proposed DeviceMicro well groupculture dish, 16-well | Predicate DeviceVitrolifeMicro Droplet CultureDish510(k) K123641 | Differences | |
|---|---|---|---|
| Device | Round dish with 16 roundwells | Square dish with 12 roundwells | Proposed device isround with 16 roundwells compared tosquare dish with 12round wells in predicatedevice |
| Indicationfor use /intendeduse | For in vitro fertilisation,handling and embryoculture. It may be usedfor the culturing ofembryos using dropculture. | Intended for IVF. It maybe used with sperm andthe culturing of embryosusing drop culture. | None,As both predicate andproposed dish may beusing drop cultureand co-culture havingseparate wells to holdthe cells. Both devicescan be used with sperm,but due to the design itis unlikely that clinicswill use the Micro wellgroup culture dish forthis. |
| Material | Virgin Polystyrene, | Virgin Polystyrene, | none |
| Dimensions | Dish with lid: Diameter40 mm x 12mm | Dish with lid: 65,96 mm x65,96 mm x 13,20 mm | Proposed dish is roundand a bit smaller thanthe square predicatedevice |
| Designfeatures | The basic design is around culture dish withnine small wells/grooves(culture area per well0.07 mm²) situated in thecenter of the dish foreasy microscopy /imaging.Each cavity has a volumeof approximately 0.02 µLand is only intended tokeep each embryo in afixed place so that it canbe individually evaluated | The basic design is asquare culture dish withtwelve small wells (volume12.5 microliter, holdingstanding drops up to 50microliter).The micro-wells are placedwith a-numerical ID in arectangular well format toallow easy identificationduring microscopy.The height of a well isapproximately 0.95 mm at | The predicate devicehas 16 wells (12.5 µL)distributed in an arrayacross large part of thebase of the dish, whilethe proposed device has9 wells /grooves (0.02µL) situated in an arrayat the center of the dishfor easymicroscopy/imaging |
Page 5 of 6
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HertART in the beginning of lite .
Chapter 5: 510(k) Summary
| during the culture. Thetotal volume to be usedwill depend on how theclinic uses the dish andmay vary in size from 50µL to 150 µL dependingon the time and numberof embryos cultured.The micro-wells areplaced with a-numericalID in a rectangular wellformat to allow easyidentification duringmicroscopy.The lids are designed foraseptic manipulation andconsistent venting tomaintain properhumidification. | the bottom with sidessloping to approximately4.3 mm at the top. Therewill typically be oneseparated media-drop ineach well, this is, however,not linked to if thecustomer decides to placeseveral embryos in eachwell (co-culture) or onlyone embryo (singleembryo culture). The lidsare designed for asepticmanipulation andconsistent venting tomaintain properhumidification. A patientID area not covering thelid. | ||
|---|---|---|---|
| Packaging | 1 dish per sleeve10 dishes per case | 5 dishes per sleeve,400 dishes per case | Proposed device issingle packed in sleeve |
| Performancetesting | Sterile (SAL 10-6),Non-pyrogenic byLimulus AmebocyteLysate assay (LAL of0,25 EU/mL)Non-embryotoxic testedby Mouse Embryotoxicityassay (MEA) 1-cellmethod. | Sterile (SAL 10-6),Non-pyrogenic by LimulusAmebocyte Lysate assay(LAL of < 0,25 EU/Device)Non-embryotoxic tested byMouse Embryotoxicityassay (MEA) 1-cellmethod. | none |
| Discussion | Predicate device is square and has 12 wells placed in an array across the base ofthe dish. The proposed device is round and has 16 wells/grooves placed in anarray at the center of the dish. The design of the proposed device facilitates thesimultainiously imaging of the embryos in the multiple wells/grooves.The differences do not impact the use of the identified predicate device to supportthe proposed device, as they do not raise any new types of safety oreffectiveness questions. Therefore, the subject is substantially equivalent to thepredicate 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
§ 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.