(119 days)
Not Found.
No
The device description and performance studies focus on the physical properties, sterility, and non-toxicity of a culture dish, with no mention of AI or ML technologies.
No
The device is used for the culturing of embryos for in-vitro fertilization, which is a laboratory process, not a direct therapeutic intervention on a patient. It facilitates a medical procedure rather than treating a disease or condition in a living organism.
No
The device description indicates it is used for "in-vitro fertilization, handling and embryo culture" and mentions it is a "Micro well group culture dishes". This describes a tool for culturing biological samples, not for diagnosing a condition or disease. The performance studies also focus on sterility and non-toxicity, which are characteristics of lab equipment, not diagnostic tools.
No
The device description clearly states it is an injection molded, disposable dish made of polystyrene, indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For in-vitro fertilisation, handling and embryo culture." This describes a process performed outside the body, but it's not for the purpose of diagnosing a condition or disease. It's a tool used in a medical procedure (IVF).
- Device Description: The description focuses on the physical characteristics of the dishes used for culturing embryos. It doesn't mention any reagents, assays, or analytical components typically associated with IVDs.
- Lack of Diagnostic Purpose: The core function of an IVD is to provide information about a patient's health status through the examination of specimens. This device facilitates the growth of embryos, which is a step in a treatment process, not a diagnostic test.
While the process of IVF involves handling biological materials in vitro, the device itself is a tool for that process, not a diagnostic test.
N/A
Intended Use / Indications for Use
For in-vitro fertilisation, handling and embryo culture. It may be used for the culturing of embryos using drop culture.
Product codes (comma separated list FDA assigned to the subject device)
MQK
Device Description
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:
Micro well group culture dish, 9-well: Round dish with lid. Diameter 40 mm x12 mm, 9 round wells in dish. Culture area 0.07 mm² per well. 1 unit per sleeve, 10 units per case.
Micro well group culture dish, 16-well: Round dish with lid. Diameter 40 mm x12 mm, 16 round wells in dish. Culture area 0.07 mm² per well. 1 unit per sleeve, 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.
Mentions image processing
The basic design is a round culture dish with nine small wells/grooves (culture area per well 0.07 mm²) situated in the center of the dish for easy microscopy / imaging.
The design of the proposed device facilitates the simultaneously imaging of the embryos in the multiple wells/grooves.
The design of the proposed device facilitates the simultainiously imaging of the embryos in the multiple wells/grooves.
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Not Found.
Anatomical Site
Not Found.
Indicated Patient Age Range
Not Found.
Intended User / Care Setting
For 'Professionals' only (Rx)
Description of the training set, sample size, data source, and annotation protocol
Not Found.
Description of the test set, sample size, data source, and annotation protocol
Not Found.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing:
Sterile (SAL 10-6),
Non-pyrogenic by Limulus Amebocyte Lysate assay (LAL of
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
0
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 |
| SE-421 32 V Frölunda | |
| Sweden | |
| Registration No.: | 3008524469 |
| Contact Person: | Göran Mellbin |
| HertART ApS | |
| Gustaf Werners gata 2 | |
| SE-421 32 V Frölunda | |
| Sweden | |
| Phone: +46-317218069 | |
| Fax: +46-317218090 | |
| e-mail: gmellbin@vitrolife.com | |
| Date of Summary: | July 18, 2015 |
| DEVICE | |
| Trade names: | Micro well group culture dish, 9-well |
| 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. | |
| Diameter 40 mm x12 mm | ||
| 9 round wells in dish. | ||
| Culture area 0.07 mm² per well. | 1 unit per sleeve | |
| 10 units per case | ||
| Micro well group culture dish, 16-well | Round dish with lid. | |
| Diameter 40 mm x12 mm | ||
| 16 round wells in dish. | ||
| Culture area 0.07 mm² per well. | 1 unit per sleeve | |
| 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
Micro well group
culture dish, 9-well | Predicate Device
Vitrolife
Micro Droplet Culture
Dish
510(k) K123641 | Differences |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Round dish with 9 round
wells | Square dish with 12 round
wells | Proposed device is
round with 9 round
wells compared to
square dish with 12
round wells in predicate
device |
| Indication
for use /
intended
use | For in vitro fertilisation,
handling and embryo
culture. It may be used
for the culturing of
embryos using drop
culture. | Intended for IVF. It may
be used with sperm and
the culturing of embryos
using drop culture. | None,
As both predicate and
proposed dish may be
using drop culture
and co-culture having
separate wells to hold
the cells. Both devices
can be used with sperm,
but due to the design it
is unlikely that clincs
will use the Micro well
group culture dish for
this. |
| Material | Virgin Polystyrene, | Virgin Polystyrene, | none |
| Dimensions | Dish with lid: Diameter
40 mm x 12mm | Dish with lid: 65,96 mm x
65,96 mm x 13,20 mm | Proposed dish is round
and a bit smaller than
the square predicate
device |
| Design
features | The basic design is a
round culture dish with
nine small wells/grooves
(culture area per well
0.07 mm²) situated in the
center of the dish for
easy microscopy /
imaging.
Each cavity has a volume
of approximately 0.02 µL
and is only intended to
keep each embryo in a
fixed place so that it can
be individually evaluated
during the culture. The
total volume to be used
will depend on how the
clinic uses the dish and
may vary in size from 50 | 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 height of a well is
approximately 0.95 mm at
the bottom with sides
sloping to approximately
4.3 mm at the top. There
will typically be one
separated media-drop in | The predicate device
has 12 wells (12.5 µL)
distributed in an array
across large part of the
base of the dish, while
the proposed device has
9 wells /grooves (0.02
µL) situated in an array
at the center of the dish
for easy
microscopy/imaging |
6
HertART in the beginning of litte
Chapter 5: 510(k) Summary
| | µL to 150 µL depending
on the time and number
of embryos cultured.
The micro-wells are
placed with a-numerical
ID in a rectangular well
format to allow easy
identification during
microscopy.
The lids are designed for
aseptic manipulation and
consistent venting to
maintain proper
humidification. | 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 covering the
lid. | |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Packaging | 1 dish per sleeve
10 dishes per case | 5 dishes per sleeve,
400 dishes per case | Proposed device is
single packed in sleeve |
| Performance
testing | Sterile (SAL 10-6),
Non-pyrogenic by
Limulus Amebocyte
Lysate assay (LAL of