NIDOIL

• K Number: K012123
• Device Name: NIDOIL
• Manufacturer: NIDACON INTERNATIONAL AB
• Date Cleared: 2001-08-03 ( 28 days)
• Product Code: MQL REP
• Regulation Number: 884.6180

Intended Use

The product is intended for use as an oil overlay during gamete and embryo culture for ART, (Assisted Reproduction Technology) and during manipulations outside the incubator.

Device Description

NidOil™ is a light, highly purified, paraffin oil product to be used as an overlay for gamete and embryo culture in the incubator, and for manipulations outside the incubator. Shelf life of two years from production date in unopened bottle Spec. density of 0.82 - 0.87 glcm; Dynamic viscosity (20 ℃) 25.0 - 80.0 mPas Cinematic viscosity (40 ℃) < 33.5 mm 2/s MEA tested Sterilized by filtration during aseptic filling Packaged in amber borosilicate glass bottles with silicone stoppers and Tamper-proof seals Storage of unopened bottles at ambient temperature Opened bottles can also be stored at ambient temperature, if opened only under sterile conditions. NidOil™ is CE marked in countries of the European Union. It is supplied in 100 and 250 ml bottles.

Predicate Devices

K991351

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use are for a paraffin oil product used in assisted reproduction technology, with no mention of AI or ML capabilities.

Therapeutic

No
The product is an oil overlay for cell culture, not a device used to treat or diagnose a disease or condition in a patient.

Diagnostic

No
The device, NidOil, is described as a paraffin oil product used as an overlay for gamete and embryo culture, not for diagnosing a condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is a physical product (paraffin oil) supplied in bottles, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for "use as an oil overlay during gamete and embryo culture for ART, (Assisted Reproduction Technology) and during manipulations outside the incubator." This describes a product used in the process of assisted reproduction, not a product used to diagnose a condition or disease based on in vitro examination of specimens.
• Device Description: The description focuses on the physical properties and packaging of the oil. There is no mention of analyzing biological samples or providing diagnostic information.
• Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological specimens (blood, urine, tissue, etc.)
  • Detecting or measuring specific analytes
  • Providing diagnostic information about a patient's health status
  • Calibration or quality control procedures related to diagnostic testing

The device is a reagent or material used in a laboratory procedure (ART), but it is not performing a diagnostic test itself.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The product is intended for use as an oil overlay during gamete and embryo culture for ART, (Assisted Reproduction Technology) and during manipulations outside the incubator.

Product codes

85 MQL

Device Description

NidOil™ is a light, highly purified, paraffin oil product to be used as an overlay for gamete and embryo culture in the incubator, and for manipulations outside the incubator. Shelf life of two years from production date in unopened bottle Spec. density of 0.82 - 0.87 glcm; Dynamic viscosity (20 ℃) 25.0 - 80.0 mPas Cinematic viscosity (40 ℃)

Regulation Number and Section

§ 884.6180 Reproductive media and supplements.

(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Summary

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K012123
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EXHIBIT 2 NidaCon International AB Mölndalsvägen 22 S-412 63, Göteborg, Sweden Tel [phone] Fax [phone]

Contact: Paul V. Holmes MSc, PhD, DrMedSc., General Manager July 5, 2001

510(k) Summary of Safety and Effectiveness

• 1. Identification of the Device: Proprietary-Trade Name: NidOil TM Classification Name/Product Code: Reproductive Media and Supplements (21 CFR 884.6180) Procode: 85 MQL Common/Usual Name: Assisted Reproduction Media
• 2. Equivalent legally marketed devices: Ovoil™ 150, K991351
• Indications for Use (intended use) The product is intended for use as an oil 3. overlay during gamete and embryo culture for ART, (Assisted Reproduction Technology) and during manipulations outside the incubator.

Description of the Device: NidOil™ is a light, highly purified, paraffin oil 4. product to be used as an overlay for gamete and embryo culture in the incubator, and for manipulations outside the incubator. Shelf life of two years from production date in unopened bottle Spec. density of 0.82 - 0.87 glcm; Dynamic viscosity (20 ℃) 25.0 - 80.0 mPas Cinematic viscosity (40 ℃)