The FALCON® IVF Four Well Plate 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 Four Well Plate is sterile (SAL of 10%), 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 plate has four wells, each well area is 1.39 cm2 and each well volume is 1.8 mL. The plate has a unique lid which provides access to two wells at a time, while two remain covered. The wells are numbered and a large writing patch allows clear sample identification. Plates are packaged in individual peel-open trays for sterile presentation and are shipped in cases of 100 plates per case.

The plates 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 plates 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) summary for the FALCON® IVF Four Well Plate, a medical device used in assisted reproduction. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria. The provided text focuses on the device description, intended use, and substantial equivalence to a predicate device, as required for a 510(k) submission.

Based on the available information, here's what can be extracted and what cannot:

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

The document mentions several characteristics that serve as performance criteria for the device. These are inherent properties of the plate that ensure its suitability for IVF procedures.

Acceptance Criteria	Reported Device Performance
Sterility	Sterile (SAL of 10%)
Non-pyrogenicity	Non-pyrogenic by Limulus Amebocyte Lysate (LAL of < 20 EU/device)
Non-embryotoxicity	Non-embryotoxic as tested by the mouse embryotoxicity assay (MEA) 2-cell method
Material-USP Class Compliance	Manufactured from virgin crystalline polystyrene tested for USP Class IV, V, and VI cytotoxicity
Surface Wettability/Hydrophilicity	Surfaces are treated to provide a more wettable or hydrophilic surface for tissue culture
Optimal Manipulation and Observation	Perfectly flat, optically clear surfaces
Aseptic Manipulation and Humidification	Lids designed for aseptic manipulation and consistent venting to maintain proper humidification
Well Area	1.39 cm² per well
Well Volume	1.8 mL per well

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

The document does not specify the sample sizes used for testing each of the performance criteria (e.g., how many plates were tested for sterility, pyrogenicity, or embryotoxicity). It also does not provide details on data provenance (country of origin, retrospective/prospective).

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)

This information is not provided in the document. The tests performed (sterility, pyrogenicity, embryotoxicity) are typically laboratory-based assays with defined pass/fail criteria, rather than those requiring expert consensus for "ground truth" in the way clinical diagnostic devices might.

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

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for human interpretation, not for validating the intrinsic properties of a labware device.

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

This is not applicable to the FALCON® IVF Four Well Plate. This device is labware, not an AI-assisted diagnostic tool.

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

This is not applicable to the FALCON® IVF Four Well Plate. It is not an algorithm-based device.

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

The "ground truth" for the performance criteria mentioned are established through validated laboratory assays and standards:

Sterility: Measured by a Sterility Assurance Level (SAL) of 10⁻⁶, a standard microbiological test.
Non-pyrogenicity: Measured by the Limulus Amebocyte Lysate (LAL) assay, a standard test for bacterial endotoxins.
Non-embryotoxicity: Measured by the mouse embryotoxicity assay (MEA) 2-cell method, a standard biological assay using mouse embryos.
Material properties: Compliance with USP Class IV, V, and VI cytotoxicity standards involves specific material testing protocols.

8. The sample size for the training set

This is not applicable. The device is labware, not a machine learning model requiring a training set.

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

This is not applicable.

Summary

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5/5/99

Attachment D

510(k) Summary

The assigned 510(k) number is _ K 99/249

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 Four Well Plate
Classification:	Assisted reproduction labware, Class II, 884.6160, Code: 85 MQI-

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))

The plates have perfectly flat, optically clear surfaces for optimum manipulation and observation of the ova and embryos. The lids are designed for aseptic manipulation and

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K 991249

consistent venting to maintain proper humidification. The plates 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.

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

The FALCON® IVF Four Well Plate 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.

David L. Ball

4/12/99

Date

David Ball Director of Quality Assurance/ Regulatory Affairs Becton Dickinson

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 5 1999

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

Re: K991249

FALCON® IVF Four Well Plate Dated: April 12, 1999 Received: April 13, 1999 Regulatory 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 regult 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: _K 991249 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Device Name: FALCON® IVF Four Well Plate

(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) Premarket Notification
510(k) Number	899249

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.