(28 days)
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.
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.
This document describes a 510(k) submission for a medical device called NidOil™. It's a reproductive media product. Crucially, this document is a 510(k) summary, not a detailed study report. Therefore, much of the information you've requested regarding specific study details, sample sizes, expert qualifications, and detailed performance metrics is not present in the provided text.
The primary method for demonstrating safety and effectiveness in a 510(k) submission is to show substantial equivalence to a predicate device, not necessarily to perform extensive de novo clinical trials with detailed performance acceptance criteria as might be expected for novel AI/diagnostic devices.
Here's an analysis based on the provided text, highlighting what is and isn't available:
Acceptance Criteria and Device Performance
The concept of "acceptance criteria" in a typical quantitative sense (e.g., sensitivity, specificity thresholds) is not explicitly detailed in the provided K012123 document. The acceptance criteria for a 510(k) submission like this, seeking substantial equivalence, generally revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from 510(k) Submission) | Reported Device Performance (NidOil™) |
|---|---|
| I. Intended Use and Indications are the Same | Met: "The intended use of the product is the same." (Section 5) The stated Indications for Use for NidOil™ are "as an oil overlay during gamete and embryo culture for ART, (Assisted Reproduction Technology) and during manipulations outside the incubator." (Section 3 and Indications for Use statement) |
| II. Composition and Physical Properties Similar to Predicate | Met (by comparison): "NidOil™ is a light, highly purified, paraffin oil product..." (Section 4) Specific properties provided: - Shelf life: two years from production date in unopened bottle - Spec. density: 0.82 - 0.87 g/cm³ - Dynamic viscosity (20 ℃): 25.0 - 80.0 mPas - Cinematic viscosity (40 ℃): < 33.5 mm²/s (The document implies these properties are "similar" to the predicate, but specific values for the predicate are not given to make a direct comparison here.) |
| III. Sterility and Biocompatibility (MEA tested) | Met: "Sterilized by filtration during aseptic filling" and "MEA tested" (Section 4). (MEA - Mouse Embryo Assay - is a standard test for reproductive media biocompatibility. The specific pass/fail criteria for MEA are not given in this document, but its mention implies it passed acceptable standards for reproductive media.) |
| IV. Equivalence in Safety and Effectiveness | Met: "The results of clinical trials and comparative testing against predicate product indicates that the new trials and comparative as the predicate device." and "Based on the similarity of composition, product testing results, and intended use, NidOil™ is substantially equivalent to the predicate device named above." (Section 5 & 6) |
Study Details (Based on available information):
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified in this document. The document mentions "clinical trials and comparative testing" but does not provide any details on the sample size, type of study (e.g., retrospective vs. prospective), or data provenance. This level of detail is typically found in the full 510(k) submission, not the summary exhibit.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not specified. This device is a reproductive media product, not an imaging diagnostic device that would require expert adjudication of "ground truth" in the way an AI diagnostic tool would. The "ground truth" for this device would likely be related to embryo development rates, fertilization rates, etc., which are observable biological outcomes, rather than expert interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not specified. See point 2.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI-assisted diagnostic device; it is an oil overlay for embryo culture. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical product (oil overlay), not an algorithm or AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this type of device, the "ground truth" for its effectiveness would typically be outcomes data such as:
- Fertilization rates in vitro.
- Embryo cleavage rates and quality (morphology).
- Development to blastocyst stage.
- Possibly live birth rates, though this may not be required for 510(k) of an ancillary product like an oil overlay.
- The document states "results of clinical trials and comparative testing," implying these biological outcomes were measured, but specific details are not provided.
- For this type of device, the "ground truth" for its effectiveness would typically be outcomes data such as:
-
The sample size for the training set
- Not applicable / Not specified. This is not an AI/machine learning device that uses a "training set."
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How the ground truth for the training set was established
- Not applicable. See point 7.
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K012123
Page 1 of 2
EXHIBIT 2 NidaCon International AB Mölndalsvägen 22 S-412 63, Göteborg, Sweden Tel +46-31-405440 Fax +46 31-405415
Contact: Paul V. Holmes MSc, PhD, DrMedSc., General Manager July 5, 2001
510(k) Summary of Safety and Effectiveness
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- 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
-
- 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
Page 2 of 2
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- 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.
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- 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 (301) 594-4639. Additionally, for questions on the promotion diagnosic devices), please contact the Office of Compliance at (301) 594-4639. 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 (301) 443-6597 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 _
Page 7
§ 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.