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 Round Dish is sterile, nonpyrogenic, embryotoxicity tested, single-use 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 Round Dish is sterile (SAL of 10.9), non-pyrogenic by Limulus Amebocyte Lysate (LAL) assay (LAL of < 20 EU/device), and nonembryotoxic as tested by the mouse embryotoxicity assay (MEA) 2-cell method. The single-use plastic dishes have a diameter of 60-mm, well area of 24.07 cm², and well volume of 23.0 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 document is a 510(k) summary for the FALCON® IVF Round Dish, a medical device for use in assisted reproduction. The information provided outlines the device description, intended use, and substantial equivalence to a predicate device. However, it does not contain any data from a clinical or performance study to prove the device meets specific acceptance criteria.

The document primarily focuses on:

Device Identification: Name, classification, and contact information.
Substantial Equivalence: Claiming equivalence to existing devices based on regulatory reclassification.
Device Characteristics: Describing it as sterile, non-pyrogenic, non-embryotoxic, made from specific materials, and with certain physical dimensions and features.
Intended Use: For preparing, storing, manipulating, or transferring human gametes or embryos in IVF and other assisted reproduction procedures.
FDA Clearance: The letter from the FDA confirming clearance based on substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria with reported device performance or details about a study that proves the device meets those criteria, as this information is not present in the provided text.

Based on the nature of this 510(k) submission (which focuses on substantial equivalence for a labware device), a formal clinical trial with human subjects or a comparative effectiveness study with AI is highly unlikely to have been performed or required for this type of product clearance in 1999. The "studies" mentioned are laboratory tests to demonstrate sterility, non-pyrogenicity, and non-embryotoxicity, which are standard for this class of device.

Below is an outline of the types of information requested, with an explanation of why it cannot be provided from the given text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided from the text. The document lists characteristics like "sterile (SAL of 10.9)," "non-pyrogenic by Limulus Amebocyte Lysate (LAL) assay (LAL of < 20 EU/device)," and "nonembryotoxic as tested by the mouse embryotoxicity assay (MEA) 2-cell method." These are performance claims based on standard lab tests, but the specific "acceptance criteria" (e.g., SAL must be 10^-6 or better) are not explicitly stated in a table format with corresponding reported values. No performance data related to clinical outcomes (e.g., IVF success rates) is presented using this device vs. others.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided from the text. The document describes laboratory tests (sterility, pyrogenicity, embryotoxicity) but does not provide details about the sample sizes used for these tests or the data provenance. These are typically internal quality control tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Cannot be provided from the text. This device is labware, not an AI or diagnostic device that requires expert ground truth for interpretation of images or other complex data. The "ground truth" for its performance would be derived from objective laboratory assays (e.g., microbial culture for sterility, LAL assay for pyrogenicity, MEA for embryotoxicity).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Cannot be provided from the text. As this device's performance relies on objective laboratory assays, adjudication methods related to human interpretation of outcomes are not relevant.

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 piece of labware for assisted reproduction, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related comparative effectiveness study would not be relevant or expected.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical labware device, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Laboratory Assay Results. For sterility, non-pyrogenicity, and non-embryotoxicity, the "ground truth" would be established by the results of validated laboratory assays (e.g., the absence of microbial growth for sterility, LAL results within specification for non-pyrogenicity, and successful embryo development in the MEA for non-embryotoxicity). These are objective tests with predefined acceptance criteria, rather than subjective expert consensus or pathology.

8. The sample size for the training set

Not applicable. This is a physical labware device and does not involve AI or machine learning models that require a "training set."

9. How the ground truth for the training set was established

Not applicable. This is a physical labware device and does not involve AI or machine learning models that require a "training set" or its associated ground truth establishment.

Summary

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5/5/99

Attachment D 510(k) Summary

The assigned 510(k) number is _ K 9912533

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 Round 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))

David L. Ball

4/12/99

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

MAY 5 1099

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

Re: K991253

FALCON® IVF Round Dish Dated: April 12, 1999 Received: April 13, 1999 Requiatory Class: II 21 CFR 884.6160/Procode: 85 MQK

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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

Indications for Use

510(k) Number:_K991253

Device Name: FALCON® IVF Round 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
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Premarket Notification
510(k) Number	K991253

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.