(211 days)
Not Found
No
The device description is for a simple, disposable plastic dish used in IVF procedures and contains no mention of software, algorithms, or any technology that would incorporate AI or ML.
No
The device is a polystyrene dish for holding biological samples, not a device that treats or diagnoses a condition.
No
The device is a laboratory dish used for holding oocytes and sperm during fertilization procedures (ICSI). It is not designed to diagnose any condition or disease.
No
The device description clearly details a physical, injection-molded polystyrene dish with a lid, indicating it is a 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 "holding oocytes and sperm during fertilization via intracytoplasmic sperm injection (ICSI)." This describes a container used in a laboratory procedure, not a device that performs a diagnostic test on a sample from the human body.
- Device Description: The description details a plastic dish designed for holding biological materials. It doesn't mention any components or functionalities related to analyzing or testing a sample to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device performing any kind of test, measurement, or analysis on the biological materials it holds to provide information about a patient's health or condition.
- Performance Studies: The performance studies mentioned (LAL for non-pyrogenicity and mouse embryo assay for non-embryo toxicity) are related to the safety and suitability of the dish for its intended purpose of holding sensitive biological materials, not its ability to perform a diagnostic test.
IVD devices are specifically designed to examine specimens derived from the human body (such as blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This dish serves as a container for a procedure, not a diagnostic tool itself.
N/A
Intended Use / Indications for Use
The IVF ICSI Dish is intended for holding oocytes and sperm during fertilization via intracytoplasmic sperm injection (ICSI).
The IVF Center Well Dish is intended for preparing and culturing gametes or embryos for use in human In Vitro Fertilization (IVF)
Product codes (comma separated list FDA assigned to the subject device)
MQK
Device Description
The IVF ICSI Dish is an injection molded polystyrene dish with a single dish-sized well. The dish has overall outside dimensions of 1.999" (50.77 mm) diameter and 0.340" (8.64 mm) height without the lid. Addition of the lid increases overall height to 0.384" (9.75 mm).
The dish has a fluid capacity of 12.5 ml, if filled to the top of the sidewall; however, individual IVF clinics typically use a small fraction of that potential volume.
The polystyrene used for the dish and lid are virgin crystal-grade polystyrene, which has successfully passed the USP 32 Class VI test for in vivo cytotoxicity and USP 32 for in vitro cytotoxicity.
The dish is designed in such a way that when the lid is mounted on the dish, dishes can be stacked. The lid can be removed with one hand.
The IVF ICSI Dish is packed in strips of 3 dishes with lids and 40 strips in a box for a total of 120 units
The IVF ICSI Dish is terminally sterilized by gamma irradiation to achieve an SAL of 10 °. The dish is non-pyrogenic as tested by LAL, and non-embryo toxic as tested by one-cell mouse embryo assay (MEA),
The IVF ICSI dish is disposable and intended and labeled for single use.
Mentions image processing
Not Found
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
Not Found
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)
The IVF ICSI Dish and the predicate device NewLife™ Dish, have similar applications which include the ICSI technique. Both devices are sterile with SAL of 10°. They are tested non-pyrogenic by Limulus Amebocyte Lysate (LAL) and non-embryotoxic as tested by the mouse embryo assay (MEA). The dishes are made of the same material polymer (Polystyrene) and they are gamma irradiated.
The differences between the IVF ICS! Dish and the NewLife™ Dish (predicate device) are that the IVF ICSI Dish is not offered in a configuration with etched circles on the bottom. And the predicate device is tested with the 2-cell mouse embryo assay. There is no consensus among IVF clinics as to a preference for the 1-cell or 2-cell test. These differences do not affect the safety and effectiveness of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Passed 1-cell mouse embryo test at ≥80% expanded blastocysts at 96 hours
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
SEP 1 8 2009
ThermoFisher
SCIENTIFIC
510(k) Summary - IVF ICSI Dish
COMPANY
Name
Address
Thermo Fisher Scientific Labware & Specialty Plastics Business Unit [Nalge Nunc International] 75 Panorama Creek Drive Rochester, NY 14625-2385 USA
Registration No. Contact Person
Robert Prescott, Manager, Regulatory Affairs and Quality Assurance 1-585-586-8800 ext. 7610 1-585-899-7405 robert.prescott@thermofisher.com
Date of Summary February 11, 2009
DEVICE
Tel No.
Fax No.
| Trade name | IVF ICSI Dish |
|---|---|
| Common name | IVF tissue culture dish |
| Classification name | Assisted Reproduction Labware |
| 21 CFR | 884.6160 |
| Code | MQK |
| K Number | K090429 |
| Trade Name | IVF ICSI Dish |
|---|---|
| Configuration | 1-Well dish with lid |
| Catalog Number | 150265 |
PREDICATE DEVICE
Trade name Common name Manufacturer
Catalog No.
510(k) No.
NewLife™ Dish IVF tissue culture dish Humagen Fertility Diagnostics, Inc 2400 Hunter's Way Charlottesville, VA 22911 14-52L K990941
Rochester, NY 14625
Tel. 585.586 8800 Fax: 585 586 329
1
DEVICE DESCRIPTION - IVF ICSI Dish
The IVF ICSI Dish is an injection molded polystyrene dish with a single dish-sized well. The dish has overall outside dimensions of 1.999" (50.77 mm) diameter and 0.340" (8.64 mm) height without the lid. Addition of the lid increases overall height to 0.384" (9.75 mm).
The dish has a fluid capacity of 12.5 ml, if filled to the top of the sidewall; however, individual IVF clinics typically use a small fraction of that potential volume.
The polystyrene used for the dish and lid are virgin crystal-grade polystyrene, which has successfully passed the USP 32 Class VI test for in vivo cytotoxicity and USP 32 for in vitro cytotoxicity.
The dish is designed in such a way that when the lid is mounted on the dish, dishes can be stacked. The lid can be removed with one hand.
The IVF ICSI Dish is packed in strips of 3 dishes with lids and 40 strips in a box for a total of 120 units
The IVF ICSI Dish is terminally sterilized by gamma irradiation to achieve an SAL of 10 °. The dish is non-pyrogenic as tested by LAL, and non-embryo toxic as tested by one-cell mouse embryo assay (MEA),
The IVF ICSI dish is disposable and intended and labeled for single use.
INTENDED USE
The dish is intended for holding oocytes and sperm during fertilization via intracytoplasmic sperm injection (ICSI).
Rochester, NY 44625
Tel: 585,586,8800 Fax: 585,586.3294
.thermofisher.com
2
SCIENTIFIC
.
COMPARISON TO PREDICATE DEVICE
| IVF ICSI Dish | NewLife™ Dish | |
|---|---|---|
| Intended use | The IVF ICSI dish is | |
| intended for holding oocytes | ||
| and sperm during fertilization | ||
| via intracytoplasmic sperm | ||
| injection (ICSI). | The NewLife™ Dish is | |
| intended to be to hold | ||
| zygotes/embryos during | ||
| micromanipulation or other | ||
| tissue culture procedures in | ||
| the IVF laboratory. | ||
| NewLife™ Dishes are used in | ||
| the tissue culture techniques | ||
| performed by embryologists | ||
| when injecting a single sperm | ||
| into an egg, or assisting an | ||
| embryo in hatching prior to | ||
| re-implantation during the | ||
| procedure of fertilization by | ||
| intracytoplasmic sperm | ||
| injection. The dishes are | ||
| disposable tissue culture | ||
| labware used in procedures | ||
| that have been developed to | ||
| aid infertile couples achieve | ||
| pregnancy. Specifically, the | ||
| ICSI procedure is beneficial | ||
| where male fertility is | ||
| impaired. | ||
| IVF ICSI Dish | NewLife™ Dish | |
| Indication for use | The IVF ICSI dish is | |
| intended for holding oocytes | ||
| and sperm during fertilization | ||
| via intracytoplasmic sperm | ||
| injection (ICSI). | The NewLife™ Dish is | |
| intended to be to hold | ||
| zygotes/embryos during | ||
| micromanipulation or other | ||
| tissue culture procedures in | ||
| the IVF laboratory. | ||
| NewLife™ Dishes are used in | ||
| the tissue culture techniques | ||
| performed by embryologists | ||
| when injecting a single sperm | ||
| into an egg, or assisting an | ||
| embryo in hatching prior to | ||
| re-implantation during the | ||
| procedure of fertilization by | ||
| intracytoplasmic sperm | ||
| injection. The dishes are | ||
| disposable tissue culture | ||
| labware used in procedures | ||
| that have been developed to | ||
| aid infertile couples achieve | ||
| pregnancy. Specifically, the | ||
| ICSI procedure is beneficial | ||
| where male fertility is | ||
| impaired. | ||
| Contraindication | N/A | N/A |
| Target Population | Female | Female |
| Patient/embryo | ||
| contact material | Polystyrene | Polystyrene |
| Design features | The bottom of the dishes is | |
| flat and optically clear. The lid | ||
| can be handled by one hand | ||
| while other lab equipment | ||
| can be handled by the other | ||
| hand. The dishes can be | ||
| stacked. | The bottom of the dish is flat | |
| and optically clear either with | ||
| or without etched rings. | ||
| Safety features | N/A | N/A |
| Other relevant | ||
| characteristics | Sterile (SAL 10-6), via gamma | |
| radiation | ||
| Tested non-pyrogenic by LAL | ||
| Passed 1-cell mouse embryo | ||
| test at ≥80% expanded | ||
| blastocysts at 96 hours | Sterile (SAL 10-6), via | |
| gamma radiation | ||
| Tested non-pyrogenic by LAL | ||
| Passed 2-cell mouse embryo | ||
| test at ≥70% | ||
| hatched/expanded | ||
| blastocysts at 72 hours |
75 Panorama Creek Drive
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Rochester, NY 14625
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Tel: 585.586.8800 Fax: 585.586.3294
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Thermo Fisher SCIENTIFIC
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Rochester, NY
14625
Tel: 585.586.6800
Fax: 565.586.3294 し
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・ 、
4
Image /page/4/Picture/0 description: The image shows the logo for Thermo Fisher Scientific. The logo is in black and consists of the company name in a bold, sans-serif font. The word "ThermoFisher" is on the top line, and the word "SCIENTIFIC" is on the second line in a smaller font size.
The IVF ICSI Dish and the predicate device NewLife™ Dish, have similar applications which include the ICSI technique. Both devices are sterile with SAL of 10°. They are tested non-pyrogenic by Limulus Amebocyte Lysate (LAL) and non-embryotoxic as tested by the mouse embryo assay (MEA). The dishes are made of the same material polymer (Polystyrene) and they are gamma irradiated.
The differences between the IVF ICS! Dish and the NewLife™ Dish (predicate device) are that the IVF ICSI Dish is not offered in a configuration with etched circles on the bottom. And the predicate device is tested with the 2-cell mouse embryo assay. There is no consensus among IVF clinics as to a preference for the 1-cell or 2-cell test. These differences do not affect the safety and effectiveness of the device.
75 Panorama Creek Drive
Rochester, NY 14625
Tel: 585.586.8800 Fax; 585.586.3294 www.liermofisher.com
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
SEP 1 8 2009
Mr. Robert Prescott Manager Regulatory Affairs and Quality Assurance ThermoFisher Scientific 75 Panorama Creek Drive ROCHESTER NY 14625
K090429 Re:
Trade/Device Name: IVF ICSI Dish and IVF Center Well Dish Regulation Number: 21 CFR §884.6160 Regulation Name: Assisted reproduction labware Regulatory Class: II Product Code: MOK Dated: August 28, 2009
Received: August 31, 2009
Dear Mr. Prescott:
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.
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. 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
6
Page 2 -
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Section 4 - Indication for Use Summary Page: D 1
Date: June 19, 2009
Indications for Use
510(k) Number (if known): K090429 Device Name: IVF Center Well Dish
Indications for Use:
"The IVF Center Well Dish is intended for preparing and culturing gametes or embryos for use in human In Vitro Fertilization (IVF)"
Prescription Use × (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulut Aseun
(Division Sign-Off) (Division of Reproductive, Abdominal, Division of Reprocal
and Radiological Devices 479 510(k) Number ـ
510(k) application
Thermo Fisher Scientific, 75 Panorama Creek Drive, Rochester, NY 14625