The FALCON® IVF Round Dish is intended for use in preparing, storing, manipulating, or transferring human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other reproduction procedures.

The FALCON® IVF One Well Dish is sterile, nonpyrogenic, embryotoxicity tested, singleuse plasticware intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction techniques.

Device Description

The FALCON® IVF One Well Dish is sterile (SAL of 10-9, non-pyrogenic by Limulus Amebocyte Lysate (LAL of < 20 EU/device), and nonembryotoxic as tested by the mouse embryotoxicity assay (MEA) 2-cell method. The single-use plastic dish diameter is 60-mm, the well area is 2.45 cm2, the well volume is 2.5 mL, and the total volume is 20 mL. The dish is sold in units of 20 dishes per bag, and 500 dishes per case.

The dishes have perfectly flat, optically clear surfaces for optimum manipulation and observation of the ova and embryos. The lids are designed for aseptic manipulation and consistent venting to maintain proper humidification. The dishes are manufactured from virgin crystalline polystyrene tested for USP Class IV, V, and VI cytotoxicity. and the surfaces are treated to provide a more wetable or hydrophilic surface for tissue culture.

AI/ML Overview

The provided text describes a 510(k) submission for the FALCON® IVF One Well Dish. This document, however, focuses on regulatory approval and substantial equivalence to a predicate device, rather than a clinical study evaluating the device's performance against specific acceptance criteria in the manner typically associated with medical imaging or diagnostic AI devices.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, training set, ground truth methods) are not applicable to the information provided.

Based on the provided text, here's what can be extracted and what cannot:

Acceptance Criteria and Device Performance:

The "acceptance criteria" for this device are primarily related to its manufacturing quality and safety for its intended use, rather than a quantifiable performance metric for accuracy or effectiveness in a clinical diagnostic sense. The text highlights the following characteristics:

Acceptance Criteria	Reported Device Performance
Sterility (SAL)	10⁻⁹
Non-pyrogenic (LAL)	< 20 EU/device
Non-embryotoxic	Tested by mouse embryotoxicity assay (MEA) 2-cell method
Material (Virgin crystalline polystyrene)	Tested for USP Class IV, V, and VI cytotoxicity
Material Surface (for tissue culture)	Treated to provide a more wettable or hydrophilic surface
Design (for manipulation/observation)	Perfectly flat, optically clear surfaces
Design (for aseptic manipulation/venting)	Lids designed for aseptic manipulation and consistent venting to maintain proper humidification
Single-use plasticware	Yes

Points that Cannot be extracted from the provided text:

Sample sized used for the test set and the data provenance: Not applicable. This device is labware, not a diagnostic tool that relies on a test set of data. The "testing" refers to manufacturing quality control.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI device or a diagnostic device that human readers would use in conjunction with.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device is established through standard laboratory testing for sterility, pyrogenicity, embryotoxicity, and material biocompatibility. For example, embryotoxicity is determined by the mouse embryotoxicity assay (MEA) 2-cell method.
The sample size for the training set: Not applicable. This device does not use a training set as it's not based on machine learning or AI.
How the ground truth for the training set was established: Not applicable.

Summary

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5/5/99

Attachment D

510(k) Summary

The assigned 510(k) number is _ 9912 51

Submitter Information (21 CFR 807.92(a)(1))

Submitter:	Becton Dickinson1 Becton DriveFranklin Lakes, NJ 07417-1880
Contact:	Cindy MorrowSr. Regulatory Specialist(408) 954-2694(408) 954-2495 (FAX)cmorrow@bdis.com
Summary date:	April 12, 1999

Device Name/Classification (21 CFR 807.92(a)(2))

Name:	FALCON® IVF One Well Dish
Classification:	Assisted reproduction labware, Class II, 884.6160, Code: 85 MQK

Substantially Equivalent/Predicate Device (21 CFR 807.92(a)(3))

This product is being submitted according to the Federal Register notice located on page 48428 of Vol.63, No. 175 on September 10, 1998 under the title Obstetric and Gynecologic Devices; Reclassification and Classification of Medical Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures.

Device Description (21 CFR 807.92(a)(4))

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virgin crystalline polystyrene tested for USP Class IV, V, and VI cytotoxicity. and the surfaces are treated to provide a more wetable or hydrophilic surface for tissue culture.

Intended Use (21 CFR 807.92(a)(5))

Daniel Ball

4/2/99

Date

David Ball Director of Quality Assurance/ Regulatory Affairs Becton Dickinson

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 1099 MAY

Mr. David Ball Director of Quality Assurance /Requlatory Affairs Becton Dickinson & Company 1 Becton Drive Franklin Lakes, NJ 07417-1884

Re: K991251 FALCON®IVF One Well Dish Dated: April 12, 1999 Received: April 13, 1999 Requlatory Class: II 21 CFR 884. 6160/Procode: 85MQK

Dear Mr. Ball:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic cevices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment C

K991251

Indications for Use

510(k) Number: K 991251

Device Name: FALCON® IVF One Well Dish

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR § 801.109)

Over-the-Counter Use
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(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K991251

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.