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K Number
K991251
Device Name
FALCON IVF ONE WELL DISH
Manufacturer
BECTON DICKINSON LABWARE
Date Cleared
1999-05-05

(22 days)

Product Code
MQK
Regulation Number
884.6160
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

Not Found

Not Found

No
The device description focuses on the physical characteristics and materials of a plastic dish for IVF procedures, with no mention of software, algorithms, or data processing.

No
The device is described as plasticware for preparing, storing, manipulating, or transferring gametes or embryos, not for treating a disease or condition itself.

No

Explanation: The device is described as plasticware for preparing, storing, manipulating, or transferring human gametes or embryos in assisted reproduction procedures; it does not perform any diagnostic function.

No

The device description clearly states it is a single-use plastic dish, which is a physical hardware component, not software.

Based on the provided information, the FALCON® IVF Round Dish and FALCON® IVF One Well Dish are not In Vitro Diagnostic (IVD) devices.

Here's why:

  • IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
  • Device Intended Use: The intended use of these dishes is for the preparation, storage, manipulation, or transfer of human gametes or embryos for IVF and other assisted reproduction procedures. They are containers and tools used in the process, not devices that analyze biological samples to provide diagnostic information.
  • Device Description: The description focuses on the physical characteristics of the dishes (material, sterility, non-pyrogenic, non-embryotoxic) and their suitability for handling gametes and embryos. It does not describe any analytical or diagnostic function.

These devices are considered medical devices used in assisted reproductive technology procedures, but they do not fit the definition of an IVD.

N/A

Intended Use / Indications for Use

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.

Product codes

85 MQK

Device Description

The FALCON® IVF One Well Dish is sterile (SAL of 10-9, non-pyrogenic by Limulus Amebocyte Lysate (LAL of

§ 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.

0

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 Dickinson
1 Becton Drive
Franklin Lakes, NJ 07417-1880 |
|---------------|---------------------------------------------------------------------------------------------------------|
| Contact: | Cindy Morrow
Sr. 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))

The FALCON® IVF One Well Dish is sterile (SAL of 10-9, non-pyrogenic by Limulus Amebocyte Lysate (LAL of