Nunc IVF 4-Well Dishes are intended for preparing, storing, manipulation or transferring human gametes or embryos for in-vitro fertilization (IVF), or other in vitro ferilization techniques and cell culture.

Nunc IVF PetriDishes are intended for preparing, storing, manipulation or transferring human gametes or embryos for in-vitro fertilization (IVF), or other in vitro fertilization techniques and cell culture.

Device Description

The Nunc IVF PetriDishes and the Nunc IVF 4-well Dish are injection molded polystyrene dishes with either a single well or 4 wells and a polystyrene lid. The single well dishes are available in diameters of 35, 60 and 90 mm. Both single well and 4-well configurations are made with a clear polystyrene lid. The polystyrene used for the dishes and lids is a virgin crystal-grade polystyrene, which has successfully passed the USP class VI test for cytotoxicity. The polystyrene is identical with the same Polystyrene use in the predicate device. For the 4-well configuration, the interface between the dish and the lid is designed with one cut off corner, hence the lid cannot be turned, and therefore cross contamination can be minimized. 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, which eases the use of the plate. The Nunc IVF tissue culture dishes are terminally sterilized by gamma irradiation to achieve SAL of 10-6. The dishes are non-pyrogenic as tested by LAL, and nonembryotoxic as tested by one cell mouse embryo assay (MEA). The Nunc IVF tissue culture dishes are disposable and intended for single use.

AI/ML Overview

This submission is for a 510(k) premarket notification for a medical device. 510(k)s demonstrate substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with formal acceptance criteria. Therefore, the information provided does not contain the typical details of a study designed to meet specific acceptance criteria as would be found in a Premarket Approval (PMA) application.

However, I can extract the information related to the device's performance claims and how they compare to a predicate device, which serves a similar purpose to acceptance criteria in the context of a 510(k).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

In a 510(k) submission, "acceptance criteria" are generally understood as demonstrating that the new device shares the same fundamental scientific technology, intended use, and similar performance characteristics (safety and effectiveness) as a legally marketed predicate device. The "reported device performance" is the evidence presented to show this similarity.

Feature / Performance Characteristic	Predicate Device (Nunc IVF Multidish 4 Well Nunclon) Performance	Applicant Device (Nunc IVF PetriDishes & 4-Well Dish) Performance Claims / Evidence	Justification for Equivalence
Intended Use	Preparing, storing, manipulating or transferring human gametes or embryos for in vitro fertilization (IVF) or other in vitro fertilization techniques, and cell culture.	Preparing, storing, manipulating or transferring human gametes or embryos for in vitro fertilization (IVF) or other in vitro fertilization techniques, and cell culture.	Identical.
Indication for Use	In vitro fertilization techniques, cell culture.	In vitro fertilization technique, cell culture.	Identical.
Contraindication	N/A	N/A	Identical.
Patient/Embryo Contact Material	Polystyrene surface treated	Polystyrene surface	The submission argues that not being surface treated does not affect safety and effectiveness.
Sterility	Sterile (SAL 10⁻⁶)	Sterile (SAL 10⁻⁶)	Identical. Both are gamma irradiated.
Non-pyrogenic	Tested non-pyrogenic by LAL	Tested non-pyrogenic by LAL	Identical.
Non-embryotoxic	Passed 1-cell mouse embryo test (MEA)	Passed 1-cell mouse embryo test (MEA)	Identical.
Product Material	Polystyrene	Polystyrene	Identical (virgin crystal-grade polystyrene, passed USP class VI).
Design Features (4-Well)	Optimized flat and optically clear bottom. Lid with cut-off corner for orientation (minimize cross-contamination). One-hand lid removal. Stackable.	Optimized flat and optically clear bottom. Lid with cut-off corner for orientation (minimize cross-contamination). One-hand lid removal. Stackable.	Identical.
Design Features (PetriDish - Single Well)	Optimized flat and optically clear bottom. Lid with cut-off corner for orientation (minimize cross-contamination). One-hand lid removal. Stackable.	Configuration not identical to predicate's single well (N/A for 4-Well in predicate).	The submission argues that "the configuration of the single well devices are not identical to the Nunc IVF Multidish 4 Well Nunclon" but that these differences "do not affect the safety and effectiveness of the device."

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

This document does not describe a "test set" in the traditional sense of a clinical study with human subjects or a defined dataset. The assessment for a 510(k) is heavily based on comparison to a predicate device and existing regulatory standards.

Cytotoxicity Test: The polystyrene materials successfully passed the USP class VI test for cytotoxicity. The sample size for this test is not specified, nor is the data provenance (e.g., country of origin, retrospective/prospective).
Sterility Test: Achieved SAL of 10⁻⁶. This is a standard measure for sterility, not a typical "dataset" or "test set" with a specified sample size of observations.
Non-pyrogenic Test (LAL): The dishes are non-pyrogenic as tested by LAL. No sample size or data provenance is specified.
Non-embryotoxic Test (MEA): The dishes are non-embryotoxic as tested by one-cell mouse embryo assay. No sample size or data provenance is specified.

These are standard laboratory tests required for devices of this type, indicating compliance with recognized methods rather than a statistically powered clinical study.

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

Not applicable. This is not a study involving expert review for ground truth establishment. The "ground truth" here is compliance with recognized standards (USP Class VI, SAL 10⁻⁶, LAL, MEA) and substantial equivalence to a legally marketed predicate device.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" or adjudication process described as typically found in clinical trials with human readers.

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 is a submission for laboratory plasticware for IVF, not an AI-powered diagnostic device. No MRMC study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" in this context is established by:

Compliance with recognized standards: USP Class VI for cytotoxicity, SAL of 10⁻⁶ for sterility, LAL for non-pyrogenicity, and 1-cell mouse embryo assay (MEA) for non-embryotoxicity.
Substantial equivalence: Comparison to the performance and characteristics of the legally marketed predicate device (Nunc IVF Multidish 4 Well Nunclon).

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device. There is no "training set."

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

Not applicable. There is no "training set" or corresponding ground truth establishment process.

Summary

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Section E - Summary

Date: March 8, 2007 Page_E |

K07 0047

COMPANY

MAY 1 8 2007

Name	Nunc A/S, Thermo Fisher Scientific
Address	Kamstrupvej 90
	DK-4000 Roskilde
	Denmark

Registration No. 3003150158

Jana S. Hellmann, QA/RA Director Contact Person

Tel No.	+45 4631 2154
Fax No.	+45 4631 2042
E-mail	janas.Hellmann@thermofisher.com

Date of Summary: December 22, 2006

DEVICE

Trade names	Nunc IVF PetriDish
	Nunc IVF 4-Well Dish
Common name	IVF tissue culture dishes
Classification name	Assisted reproduction labware, 21 CFR884.6160, Code MQK

Trade Name	Configuration	Catalogue number
Nunc IVF PetriDish	Dish 35x10 mm, with lid	150255
Nunc IVF PetriDish	Dish 60x15 mm, with lid	150270
Nunc IVF PetriDish	Dish 90x17 mm, with lid	150360
Nunc IVF 4-Well Dish	4-Well dish with lid	179830

PREDICATE DEVICE

Trade name Nunc IVF Multidish 4 Well Nunclon Common name Plastic single use labware dish Manufacturer Nunc A/S Catalogue No 144444 510(k) No. K040717

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DEVICE DESCRIPTION

The Nunc IVF PetriDishes and the Nunc IVF 4-well Dish are injection molded polystyrene dishes with either a single well or 4 wells and a polystyrene lid.

The single well dishes are available in diameters of 35, 60 and 90 mm.

Both single well and 4-well configurations are made with a clear polystyrene lid.

The polystyrene used for the dishes and lids is a virgin crystal-grade polystyrene, which has successfully passed the USP class VI test for cytotoxicity. The polystyrene is identical with the same Polystyrene use in the predicate device.

For the 4-well configuration, the interface between the dish and the lid is designed with one cut off corner, hence the lid cannot be turned, and therefore cross contamination can be minimized. 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, which eases the use of the plate.

Nunc IVF PetriDishes (Single well dishes), are packed in pouches of x units in a box for a total of Y units, as defined below:

Trade Name	Configuration	Packaging
Nunc IVF PetriDish	Dish 35x10 mm, with lid	10 units in a box for atotal of 500 plates
Nunc IVF PetriDish	Dish 60x15 mm, with lid	10 units in a box for atotal of 400 plates
Nunc IVF PetriDish	Dish 90x17 mm, with lid	10 units in a box for atotal of 150 plates

Nunc IVF 4-well Dishes, are packed in pouches of 4 units in a box for a total of 120 plates.

The Nunc IVF tissue culture dishes are terminally sterilized by gamma irradiation to achieve SAL of 106. The dishes are non-pyrogenic as tested by LAL, and nonembryotoxic as tested by one cell mouse embryo assay (MEA).

The Nunc IVF tissue culture dishes are disposable and intended for single use.

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INTENDED USE

Preparing, storing, manipulating or transferring human gametes or embryos for in vitro fertilization (IVF) or other in vitro fertilization techniques, and cell culture.

Comparison to predicate device:

Nunc IVF 4-Well DishandNunc IVF PetriDish,35x10mm, 60x15mm,90x17mm	Nunc IVF Multidish4 Well Nunclon
Intended use	Preparing, storing,manipulating ortransferring humangametes or embryos forin vitro fertilization(IVF) or other in vitrofertilization techniques,and cell culture.	Preparing, storing,manipulating ortransferring humangametes or embryos forin vitro fertilization(IVF) or other in vitrofertilization techniques,and cell culture.
Indication for use	In vitro fertilizationtechnique, cell culture	In vitro fertilizationtechniques, cell culture
Contraindication	N/A	N/A
Patient/embryo contactmaterial	Polystyrene surface	Polystyrene surfacetreated
Design features -IVF 4-Well Dish	The bottom of the plate isoptimised flat andoptically clear. The lidand the plate have a cutoff corner which requiresthat the lid always hasthe same orientation; thuscross contamination canbe minimized. The lidcan be handled by onehand while other labequipment can behandled by the otherhand. The plates can bestacked.	The bottom of the plate isoptimised flat andoptically clear. The lidand the plate have a cutoff corner which requiresthat the lid always hasthe same orientation; thuscross contamination canbe minimized. The lidcan be handled by onehand while other labequipment can behandled by the otherhand. The plates can bestacked.
Design features -IVF PetriDish	N/A	The bottom of the plate isoptimised flat andoptically clear. The lidand the plate have a cutoff corner which requiresthat the lid always hasthe same orientation; thuscross contamination canbe minimized.
		be minimized. The lidcan be handled by onehand while other labequipment can behandled by the otherhand. The plates can bestacked.
Safety features	N/A	N/A
Other relevantcharacteristics	Sterile (SAL 10-6) Tested non-pyrogenic by LAL Passed 1-cell mouse embryo test	Sterile (SAL 10-6) Tested non-pyrogenic by LAL Passed 1-cell mouse embryo test

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The Nunc IVF PetriDishes and Nunc IVF 4-Well Dish (hereinafter called Nunc IVF tissue culture dishes) and the predicate device Nunc IVF Multidish 4 Well Nunclon, have similar applications which include cell culture and IVF. Both devices are sterile with SAL of 106. They are tested non-pyrogenic by Limulus Amebocyte Lysate (LAL) and nonembryo toxic as tested by the mouse embryo assay (MEA). The plates are made of the same material (Polystyrene), and they are both gamma irradiated.

The differences between the Nunc IVF tissue culture dishes and the Nunc IVF Multidish 4 Well Nunclon is that the Nunc IVF tissue culture dishes have not been surface treated, and the configuration of the single well devices are not identical to the Nunc IVF Multidish 4 Well Nunclon. These differences do not affect the safety and effectiveness of the device.

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Image /page/4/Picture/0 description: The image shows a circular logo with the words "U.S. Department of Health & Human Services" written around the perimeter. Inside the circle is a stylized graphic of three curved lines that resemble a person with outstretched arms. The lines are thick and black, and they create a sense of movement and energy.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ms. Jana S. Hellmann OA/RA Director Nunc A/S, Thermo Fisher Scientific Kamstrupvej 90 DK-4000 Roskilde DENMARK

MAY 18 2007

Re: K070047

· Trade/Device Name: Nunc IVF Dishes and Nunc IVF 4-Well Dish Regulation Number: 21 CFR 884.6160 Regulation Name: Assisted reproduction labware Regulatory Class: II Product Code: MOK Dated: May 3, 2007 Received: May 7, 2007

Dear Ms. Hellmann:

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 (Premarket Approval), it may be subject to such 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.

Image /page/4/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. Below the text is a large "PA" with the word "Centennial" underneath. There are three stars below the word "Centennial". The text "Alliance of PA Food" is at the bottom of the logo.

Protesting and Promoting Public Health

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K070047

Device name: Nunc IVF 4-Well Dishes

Indications For Use:

Prescription Use_ X (Part 21 CFR 801 Subpart D)

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)

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Dey 510(k) Number

Page 1 of 2

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Indications for Use

510(k) Number (if known): K070047

Device name: Nunc IVF PetriDishes (35 x 10 mm, 60 x 15 mm and 90 x 17 mm)

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

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)

Nancy C. Sheldon
(Division Sign-Off)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070047

Page 2 of 2

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.