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 <88> Class VI test for in vivo cytotoxicity and USP 32 <87> 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the IVF ICSI Dish:

1. Table of Acceptance Criteria and Reported Device Performance

The submission functions as a 510(k) Premarket Notification, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with explicit numerical acceptance criteria and results. Therefore, the device performance is described in terms of meeting established standards and comparison to the predicate, rather than measured against specific quantitative acceptance metrics.

Acceptance Criteria (Inferred from 510(k) Text)	Reported Device Performance (IVF ICSI Dish)
Sterility Assurance Level (SAL): 10⁻⁶	Sterile (SAL 10⁻⁶), via gamma radiation
Non-pyrogenic: Negative LAL test	Tested non-pyrogenic by LAL
Non-embryotoxic: Supports embryonic development	Passed 1-cell mouse embryo test at ≥80% expanded blastocysts at 96 hours
Biocompatibility (in vivo): USP Class VI	Polystyrene material successfully passed USP 32 <88> Class VI test for in vivo cytotoxicity
Biocompatibility (in vitro): USP <87>	Polystyrene material successfully passed USP 32 <87> for in vitro cytotoxicity
Material Composition: Virgin crystal-grade polystyrene	Virgin crystal-grade polystyrene
Physical Design: Single well, stackable, one-hand lid removal, optically clear flat bottom	Single dish-sized well, lid can be removed with one hand, dishes can be stacked, flat and optically clear bottom.
Manufacturing Process: Injection molded	Injection molded
Disposability: Single use	Disposable and intended and labeled for single use

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not detail specific "test set" sample sizes in the context of a clinical trial or performance study with human subjects. The evaluations related to the device's material and biological safety (sterility, pyrogenicity, embryotoxicity, cytotoxicity) are laboratory-based tests.

Mouse Embryo Assay (MEA): This is a biological assay. The standard practice for MEA involves a statistically significant number of mouse embryos, typically in the range of 20-30 embryos per group (test and control) across multiple replicates, to achieve statistical power for the a ≥80% expanded blastocyst rate. The document doesn't specify the exact number of mouse embryos used.
USP Cytotoxicity Tests: These tests follow established protocols, which involve specific cell culture setups and replicates. Sample sizes are specified by the USP monographs, but not detailed here.
LAL Test: This test is performed on extracts from the device, not on a "sample set" of devices in the same way clinical data is collected.

Data Provenance: The data primarily comes from laboratory testing performed by the manufacturer (Thermo Fisher Scientific) or qualified contract laboratories. There is no mention of country of origin for the data or whether it's retrospective or prospective, as it pertains to internal product quality and safety testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is generally not applicable to the technical and biological safety tests described for this device. The "ground truth" for these tests (e.g., whether a device is sterile, non-pyrogenic, or non-embryotoxic) is established by the well-defined protocols and acceptance criteria of the respective assays (e.g., USP standards, MEA protocols). Expert interpretation is involved in executing and verifying these lab tests, but it's not a consensus-based scoring of a "test set" in the way it would be for diagnostic imaging.

4. Adjudication Method for the Test Set

Not applicable. The tests performed (sterility, LAL, MEA, cytotoxicity) have objective endpoints and established analytical methods, not subjective assessments requiring adjudication by multiple readers or experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement

Not applicable. This is a medical device (labware), not an AI/software-as-a-medical-device (SaMD) that assists human readers in making diagnostic decisions. Therefore, no MRMC study or AI-related comparative effectiveness was performed or is relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable, as this device is a piece of labware, not an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth for the various tests is established by:

Established biological assay standards: For embryotoxicity (MEA) and pyrogenicity (LAL), the ground truth is defined by the performance of control groups and the established threshold for acceptable biological response (e.g., ≥80% blastocyst development, absence of pyrogenic response).
Chemical/physical material standards: For material composition and cytotoxicity, the ground truth is based on the chemical properties of the polystyrene and the results of standardized USP tests.
Microbiological standards: For sterility, the ground truth is defined by the absence of microbial growth as detected by sterility testing, demonstrating the SAL.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning algorithm; therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary

{0}------------------------------------------------

K090429

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.

E-mail

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

www.thermofisher.com

{1}------------------------------------------------

DEVICE DESCRIPTION - IVF ICSI Dish

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 <88> Class VI test for in vivo cytotoxicity and USP 32 <87> 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 isintended for holding oocytesand sperm during fertilizationvia intracytoplasmic sperminjection (ICSI).	The NewLife™ Dish isintended to be to holdzygotes/embryos duringmicromanipulation or othertissue culture procedures inthe IVF laboratory.NewLife™ Dishes are used inthe tissue culture techniquesperformed by embryologistswhen injecting a single sperminto an egg, or assisting anembryo in hatching prior tore-implantation during theprocedure of fertilization byintracytoplasmic sperminjection. The dishes aredisposable tissue culturelabware used in proceduresthat have been developed toaid infertile couples achievepregnancy. Specifically, theICSI procedure is beneficialwhere male fertility isimpaired.
	IVF ICSI Dish	NewLife™ Dish
Indication for use	The IVF ICSI dish isintended for holding oocytesand sperm during fertilizationvia intracytoplasmic sperminjection (ICSI).	The NewLife™ Dish isintended to be to holdzygotes/embryos duringmicromanipulation or othertissue culture procedures inthe IVF laboratory.NewLife™ Dishes are used inthe tissue culture techniquesperformed by embryologistswhen injecting a single sperminto an egg, or assisting anembryo in hatching prior tore-implantation during theprocedure of fertilization byintracytoplasmic sperminjection. The dishes aredisposable tissue culturelabware used in proceduresthat have been developed toaid infertile couples achievepregnancy. Specifically, theICSI procedure is beneficialwhere male fertility isimpaired.
Contraindication	N/A	N/A
Target Population	Female	Female
Patient/embryocontact material	Polystyrene	Polystyrene
Design features	The bottom of the dishes isflat and optically clear. The lidcan be handled by one handwhile other lab equipmentcan be handled by the otherhand. The dishes can bestacked.	The bottom of the dish is flatand optically clear either withor without etched rings.
Safety features	N/A	N/A
Other relevantcharacteristics	Sterile (SAL 10-6), via gammaradiationTested non-pyrogenic by LALPassed 1-cell mouse embryotest at ≥80% expandedblastocysts at 96 hours	Sterile (SAL 10-6), viagamma radiationTested non-pyrogenic by LALPassed 2-cell mouse embryotest at ≥70%hatched/expandedblastocysts at 72 hours

75 Panorama Creek Drive

Rochester, NY 14625

Tel: 585.586.8800 Fax: 585.586.3294

' www.lharmolisher.com

. -

{3}------------------------------------------------

Thermo Fisher SCIENTIFIC

Rochester, NY
14625

Tel: 585.586.6800
Fax: 565.586.3294 し

www.lhermofisher.com

・、

{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

Regulation Number and Section

§ 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.