FALCON IVF FOUR WELL PLATE

• K Number: K991249
• Device Name: FALCON IVF FOUR WELL PLATE
• Manufacturer: BECTON DICKINSON LABWARE
• Date Cleared: 1999-05-05 ( 22 days)
• Product Code: MQK
• Regulation Number: 884.6160

Intended Use

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.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the physical characteristics and materials of a plastic plate for IVF, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

Therapeutic

No.
The device is described as plasticware intended to prepare, store, manipulate, or transfer human gametes or embryos. It does not exert any therapeutic effect on the gametes or embryos.

Diagnostic

No
This device is a plasticware plate used for preparing, storing, manipulating, or transferring human gametes or embryos. It does not perform any diagnostic function such as identifying diseases or conditions.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical plastic plate with specific dimensions, materials, and features, indicating it is a hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the FALCON® IVF Four Well Plate is not an IVD (In Vitro Diagnostic) device.

Here's why:

• Intended Use: The intended use is to "prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction techniques." This describes a device used in the process of IVF, not a device used to perform a diagnostic test on a sample taken from the body.
• Device Description: The description focuses on the physical characteristics of the plate (material, sterility, non-pyrogenic, non-embryotoxic, well size, lid design, etc.). These are features of a laboratory consumable used for handling biological materials, not a diagnostic test kit or instrument.
• Lack of Diagnostic Elements: There is no mention of reagents, assays, or any other components typically associated with performing a diagnostic test. The device itself does not analyze a sample to provide information about a patient's health status.

IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) to diagnose, monitor, or screen for diseases or conditions. The FALCON® IVF Four Well Plate is a tool used in a medical procedure (IVF), not a diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

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.

Product codes

MQK

Device Description

The FALCON® IVF Four Well Plate is sterile (SAL of 10%), non-pyrogenic by Limulus Amebocyte Lysate (LAL of

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.

Summary

0

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 Dickinson
1 Becton Drive
Franklin Lakes, NJ 07417-1880 |
|---------------|---------------------------------------------------------------------------------------------------------|
| Contact: | Cindy Morrow
Sr. Regulatory Specialist
[phone]
[phone] (FAX)
[e-mail] |
| 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 FALCON® IVF Four Well Plate is sterile (SAL of 10%), non-pyrogenic by Limulus Amebocyte Lysate (LAL of ✓ |
|------------------------|--------------------------------------------|
| (Per 21 CFR § 801.109) | |

Or

Over-the-Counter Use	✓
----------------------	--------------------------------------------

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Premarket Notification
510(k) Number	899249

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