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K Number
K991253
Device Name
FALCON IVF ROUND 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 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.
More Information

Not Found

Not Found

No
The device description is for a plastic dish used in IVF procedures and does not mention any software, algorithms, or data processing capabilities.

No.
Explanation: The device is a plastic dish used for preparing, storing, manipulating, or transferring human gametes or embryos; it does not directly treat a disease or condition.

No

Explanation: The device description states it is a dish used for preparing, storing, manipulating, or transferring human gametes or embryos. It does not mention any function related to diagnosing a condition or disease.

No

The device description clearly indicates it is a physical plastic dish, not software.

Based on the provided text, the FALCON® IVF Round Dish is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use clearly states that the device is for "preparing, storing, manipulating, or transferring human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other reproduction procedures." This describes a device used in the process of assisted reproduction, not a device used to diagnose a condition or disease.
  • Device Description: The description focuses on the physical characteristics of the dish (material, size, sterility, non-pyrogenicity, non-embryotoxicity) and its suitability for handling biological materials in a laboratory setting. It does not mention any diagnostic function or the analysis of biological samples to provide diagnostic information.
  • Lack of Diagnostic Elements: The text does not mention any features related to analyzing samples, detecting biomarkers, or providing diagnostic results.

IVD devices are typically 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. The FALCON® IVF Round Dish is a tool used in a procedure, not a diagnostic test.

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 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.

Product codes (comma separated list FDA assigned to the subject device)

85 MQK

Device Description

The FALCON® IVF Round Dish is sterile (SAL of 10.9), non-pyrogenic by Limulus Amebocyte Lysate (LAL) assay (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 _ K 9912533

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 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))

The FALCON® IVF Round Dish is sterile (SAL of 10.9), non-pyrogenic by Limulus Amebocyte Lysate (LAL) assay (LAL of