Mineral Oil is used as an overlay for culture of embryos, oocytes, and sperm in assisted reproduction technology (ART) and micromanipulation procedures.

Device Description

Mineral Oil is used to cover medium during embryo, oocyte, and sperm culture in assisted reproduction technology (ART) and micro-manipulation procedures. Mineral Oil is recommended for use as an overlay for a small volume of medium to prevent evaporation stable osmolality and pH.

The material composition:

High Purity Paraffin Oil comes in two density types:

Light type has a ratio between 0.8200 to 0.8400 g/mL (15°C) and a viscosity which is between 8.850 to 11.70mm²/s (37.78°C)
Heavy type has a ratio between 0.8500 to 0.8700 g/mL (15°C) and a viscosity which is between 41.90 to 44.10mm²/s (37.78°C).

There are two types of products, Mineral Oil - Light and Mineral Oil - Heavy. Two different unit sizes (100mL and 50mL) are available for each type. Mineral oils are colorless, tasteless, clear oil fluids which do not produce fluorescence.

Both Mineral Oils (Heavy and Light) do not contact the ova or embryo during culture. Mineral Oil is filter sterilized and dispensed into sterile light-resistant glass bottles.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Mineral Oil" used in assisted reproductive technology. This is not the type of document that typically includes information about acceptance criteria and a study proving the device meets those criteria, as one would find for a software-based AI/ML medical device.

The document is a US FDA 510(k) clearance letter and summary for a physical product (Mineral Oil) which functions as a reproductive media supplement. It aims to demonstrate "substantial equivalence" to a predicate device rather than independently proving safety and efficacy through extensive clinical studies and AI performance metrics.

Therefore, many of the requested categories for acceptance criteria and study details for an AI/ML device are not applicable or cannot be extracted from this document. However, I can extract the "non-clinical performance data" which serves as the "acceptance criteria" and "device performance" for this specific product, as well as some details about its testing.

Here's a breakdown of the information that can be extracted, and where the requested AI/ML specific information is not available:

1. Table of Acceptance Criteria and Reported Device Performance & 7. The type of ground truth used:

The acceptance criteria for this non-AI/ML device are based on non-clinical performance tests designed to establish substantial equivalence concerning safety and effectiveness. The "ground truth" here is essentially the compliance with these established biological and chemical specifications.

Acceptance Criteria (Non-Clinical Performance Tests)	Reported Device Performance (Mineral Oil)	Ground Truth Type
Appearance (color): clear, particle free	Clear, particle free	Predefined chemical/physical specification
Sterility: No microbial growth from sterility testing per USP <71>	No microbial growth	USP <71> Standard
Endotoxin Testing: < 0.25 EU/mL	< 0.25 EU/mL	Predefined chemical specification
MEA (Mouse Embryo Assay): >80% of 1-cell control embryos develop at 96 hours	>80% of 1-cell control embryos develop at 96 hours	Biological assay (embryo development)
Peroxide Value (POV): < 0.1 meq/kg	< 0.1 meq/kg	Predefined chemical specification
Readily carbonizable substance test: no discoloration, color of sulfuric acid layer paler than control per USP <271>	No discoloration, color of sulfuric acid layer paler than control	USP <271> Standard
Shelf-life testing	Demonstrated 12 months shelf-life	Stability testing

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not specify exact sample sizes for each non-clinical performance test. It only states that tests were completed. Data provenance is not detailed beyond the manufacturer being "KITAZATO BioPharma Co., Ltd." in Japan. The tests are non-clinical (laboratory-based), not human data, so "retrospective or prospective" does not apply in the typical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the "ground truth" for these non-clinical tests is based on established laboratory standards (e.g., USP <71>, <271>), chemical specifications, and biological assay outcomes, rather than expert interpretation of medical images or patient data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable for non-clinical laboratory tests.

5. 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 for a physical medical device (mineral oil), not an AI/ML device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical product, not an algorithm.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set. The "device" itself is the mineral oil which is manufactured according to specifications.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/ML device.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of a bird-like figure, possibly representing an eagle or other national symbol. The image is in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 21, 2016

KITAZATO BioPharma Co., Ltd. % Diane Sudduth RA Consultant Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, TX 78701

Re: K160142 Trade/Device Name: Mineral Oil Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MOL Dated: January 20, 2016 Received: January 21, 2016

Dear Diane Sudduth,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Herbert P. Lerner -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160142

Device Name Mineral Oil

Indications for Use (Describe)

Mineral Oil is used as an overlay for culture of embryos, oocytes, and sperm in assisted reproduction technology (ART) and micromanipulation procedures.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

MINERAL OIL

K160142

1. Submission Sponsor

KITAZATO Biopharma Co., Ltd. 81 Nakajima Fuji Shizuoka, 416-0907 Japan Phone number: +81-545-66-2202 Contact: Kyoko Izumi Title: Quality Assurance Manager

2. Submission Correspondent

Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (561) 305.5075 Office Phone: (512) 327.9997 Contact: Diana Sudduth, Senior Consultant, RA Email: project.management@emergogroup.com

3. Date Prepared

April 12, 2016

4. Device Identification

Trade/Proprietary Name:	Mineral Oil
Common/Usual Name:	Mineral Oil
Classification Name:	Reproductive media and supplements
Regulation Number:	21 CFR 884.6180
Product Code:	MQL, Reproductive media and supplements
Device Class:	Class II
Classification Panel:	Obstetrics/Gynecology

5. Legally Marketed Predicate Device(s)

Cook, Sydney IVF Culture Oil, K022002

6. Device Description

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The material composition:

High Purity Paraffin Oil comes in two density types:

Light type has a ratio between 0.8200 to 0.8400 g/mL (15°C) and a viscosity which is between 8.850 to 11.70mm²/s (37.78°C)
Heavy type has a ratio between 0.8500 to 0.8700 g/mL (15°C) and a viscosity which is between 41.90 to 44.10mm²/s (37.78°C).

Both Mineral Oils (Heavy and Light) do not contact the ova or embryo during culture. Mineral Oil is filter sterilized and dispensed into sterile light-resistant glass bottles.

7. Indication for Use Statement

Mineral Oil is used as an overlay for culture of embryos, oocytes, and sperm in assisted reproduction technology (ART) and micromanipulation procedures.

8. Substantial Equivalence Discussion

The following Table 1 compares the Mineral Oil to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence.

Manufacturer	Kitazato BioPharma Co., Ltd.	Cook	SignificantDifferences
Trade Name	Mineral Oil	Sydney IVF Culture Oil	-
510(k)Number	K160142	K022002	-
Product Code	MQL	MQL	Same
RegulationNumber	884.6180	884.6180
RegulationName	Reproductive media andsupplements	Reproductive media andsupplements	Same

			Table 1 - Comparison of Characteristics

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Clinical
Indications forUse	Mineral Oil is used as an overlayfor culture of embryos, oocytes,and sperm in assistedreproduction technology (ART)and micromanipulationprocedures.	The Sydney IVF Culture Oil isintended for use as an oiloverlay for culture of gametes,zygotes, or embryos in assistedreproduction technology (ART)and micromanupulationprocedures.	Similar
Patientcontact	This product does not contactdirectly with gametes/embryosas it is used as an overlay forculturing in culture media.	This product does notcontact directly withgametes/embryos as it isused as an overlay forculturing in culture media.	Same
Used in similarpopulation	The product is used for fertilitytreatment of humans	The product is used forfertility treatment of humans	Same
Technical
MEA	≥ 80%(96h Blastocysts)	≥ 80%	Same
Endotoxin	≤ 0.25 EU/mL(USP)	< 0.4 EU/mL	Similar
Sterilizationmethod	Aseptic filtration sterilization	Aseptic filtration sterilization	Same
Storagemethod	8-30 °CDark storageDo not freeze	2-8 °CDo not freeze	Similar
Shelf life	12 months	8 weeks	Similar
Content	100 mL50 mL	200 mL50 mL	Similar
Composition	Mineral Oil	Mineral Oil	Same

The technological characteristics of Mineral Oil are comparable to the predicate device. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of Mineral Oil and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, KITAZATO BIOPHARMA completed a number of non-clinical performance tests as described below:

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Appearance (color): clear, particle free -
-Sterility: No microbial growth from sterility testing per USP <71>
-Endotoxin Testing: Endotoxin values conform to the value < 0.25 EU/mL
-MEA: >80% of 1-cell control embryos develop at 96 hours
-Peroxide value (POV): < 0.1 meq/kg
-Readily carbonizable substance test: no discoloration, color of sulfuric acid layer paler than control per USP <271>
-Shelf-life testing

The Mineral Oil meets all the requirements for overall design, and sterilization results confirming that the design output meets the design inputs and specifications for the device.

10. Statement of Substantial Equivalence

The results of the testing described above provide a reasonable assurance that Mineral Oil is as safe and effective as the predicate device and supports a determination of substantial equivalence.

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.