NIDOIL

K012123 · Nidacon International AB · MQL · Aug 3, 2001 · Obstetrics/Gynecology

Device Facts

• Record ID: K012123
• Device Name: NIDOIL
• Applicant: Nidacon International AB
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Aug 3, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

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 Story

NidOil is a highly purified paraffin oil used as an overlay for gamete and embryo culture in incubators and during external manipulations. It serves as a protective barrier to prevent evaporation and maintain environmental stability for embryos during ART procedures. The device is used in clinical laboratory settings by embryologists or laboratory technicians. It is supplied in amber borosilicate glass bottles with silicone stoppers and tamper-proof seals. The oil is applied manually by the clinician to cover the culture medium. By preventing desiccation and maintaining optimal culture conditions, the device supports embryo viability during the sensitive stages of assisted reproduction.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on comparative bench testing and similarity in composition and intended use to the predicate device.

Technological Characteristics

Highly purified paraffin oil. Physical specifications: density 0.82-0.87 g/cm3; dynamic viscosity (20°C) 25.0-80.0 mPas; cinematic viscosity (40°C) < 33.5 mm2/s. Sterilized by filtration during aseptic filling. Packaged in amber borosilicate glass bottles with silicone stoppers.

Indications for Use

Indicated for use as an oil overlay during gamete and embryo culture for Assisted Reproduction Technology (ART) and during manipulations outside the incubator.

Regulatory Classification

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.).

Special Controls

*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.

Predicate Devices

• Ovoil™ 150 (K991351)

Submission Summary (Full Text)

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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 ℃) < 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.

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K0/2/23
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- 5. Safety and Effectiveness, comparison to predicate devices. The results of clinical trials and comparative testing against predicate product indicates that the new trials and comparative as the predicate device. The intended use of the product is the same.
- 6. Conclusion: Based on the similarity of composition, product testing results, and intended use, NidOil™ is substantially equivalent to the predicate device named above.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NidaCon International AB c/o Mr. Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015

Re: K012123 NidOil™ Dated: July 5, 2001 Received: July 6, 2001 Regulatory Class: II 21 CFR §884.6180/Procode: 85 MQL

Dear Mr. Kamm:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the We have reviewed your secuent 210(x) noursalions of muse stated in the enclosure) to legally marketed predicate devices device is substantaly of the marbators 16, the enactment date of the Medical Device Amendments, or to devices N marketed in Intelsiale commence provisions of the Federal Food, Dug, 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 therefore, market the device, subject on the general volusion proctice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval) it may be subject It your device is classince (SC above) nato vials offecting your device can be found in the Code of Federal Regulations, to such additional controls. EXisting major regulations assumes compliance with the Current Good Manufacturing ( I IIIC ZT, Patis 800 0 693. A Subsantany odir aleks asonalisation (QS) for Medical Devices: General regulation (21 CFR Partic Practice requirements, as set tour in the Quality Dystem togeneration (FDA) will verify such assumptions. Failure 820) and unal, through periodic QS mspecions, the Progulatory action. In addition, FDA may publish further announcements to comply with the Gelfr regulation in regulatory ation. " in the response to your premarket notification submission descript concerning your device in the Pockal Regiser. Trease noter and response of 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 and I fills relei will allow you to begally 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 witter II you destre specific advice tor your device of Compliance at [phone]. Additionally, for questions on the promotion diagnosic devices), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your entined, "Misolanding of the Act nother nothed it (ar C S mall Manufacturers Assistance at its toll-free number (800) 1638-2041 or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

Nancy Cbrogdon
Nancy S. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure (s)

AUG - 3 2001

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j) Indications for Use

KO12123 510(k) Number

Device Name: NidOil™

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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over the Counter Use (Per 21 CFR 801.109)

Elvin G. Jesson

OR

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 5012 510(k) Number _

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