(91 days)
No
The device description and performance studies focus on the physical and chemical properties of mineral oil for use in ART procedures. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The mineral oil is used as an overlay to prevent evaporation and stabilize osmolality and pH of the culture medium during ART procedures, rather than directly treating a disease or condition.
No
The device is described as an "overlay for culture of embryos, oocytes, and sperm" to prevent evaporation and maintain stable osmolality and pH. It is a consumable used in the process of assisted reproduction technology, not a tool for diagnosis or evaluation of a medical condition.
No
The device description clearly states the device is a physical substance (mineral oil) used as an overlay, not a software program.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the mineral oil is used "for culture of embryos, oocytes, and sperm in assisted reproduction technology (ART) and micromanipulation procedures." These procedures involve handling and manipulating biological samples (embryos, oocytes, sperm) in vitro (outside the living body) for diagnostic or therapeutic purposes related to fertility.
- Device Description: The description details the composition and function of the mineral oil as an overlay for culture medium, specifically to prevent evaporation and maintain stable conditions for the biological samples. This function is directly related to the in vitro handling of these samples.
- Performance Studies: The performance studies include tests like MEA (Mouse Embryo Assay), which assesses the suitability of the product for supporting embryo development in vitro. This type of testing is characteristic of products used in in vitro procedures involving biological samples.
- Predicate Device: The mention of a predicate device (K022002; Cook, Sydney IVF Culture Oil) which is also used in ART procedures further supports the classification as an IVD.
While the device itself is a chemical substance (mineral oil), its intended use and function within the context of ART procedures, which involve the in vitro handling and manipulation of human biological samples for diagnostic or therapeutic purposes, align with the definition of an In Vitro Diagnostic device. It is a reagent or material used in an in vitro procedure.
N/A
Intended Use / Indications for Use
Mineral Oil is used as an overlay for culture of embryos, oocytes, and sperm in assisted reproduction technology (ART) and micromanipulation procedures.
Product codes
MOL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-Clinical Performance Data
KITAZATO BIOPHARMA completed a number of non-clinical performance tests:
- Appearance (color): clear, particle free
- Sterility: No microbial growth from sterility testing per USP
- Endotoxin Testing: Endotoxin values conform to the value 80% of 1-cell control embryos develop at 96 hours
- Peroxide value (POV):
- 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.
Key Metrics
- MEA: ≥ 80% (96h Blastocysts)
- Endotoxin: ≤ 0.25 EU/mL (USP)
- Peroxide value (POV):
§ 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.
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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.
1
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
4
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.
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 | Significant
Differences |
|----------------------|---------------------------------------|---------------------------------------|----------------------------|
| Trade Name | Mineral Oil | Sydney IVF Culture Oil | - |
| 510(k)
Number | K160142 | K022002 | - |
| Product Code | MQL | MQL | Same |
| Regulation
Number | 884.6180 | 884.6180 | |
| Regulation
Name | Reproductive media and
supplements | Reproductive media and
supplements | Same |
| Table 1 - Comparison of Characteristics | |||
|---|---|---|---|
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| Clinical | |||
|---|---|---|---|
| Indications for | |||
| Use | Mineral Oil is used as an overlay | ||
| for culture of embryos, oocytes, | |||
| and sperm in assisted | |||
| reproduction technology (ART) | |||
| and micromanipulation | |||
| procedures. | The Sydney IVF Culture Oil is | ||
| intended for use as an oil | |||
| overlay for culture of gametes, | |||
| zygotes, or embryos in assisted | |||
| reproduction technology (ART) | |||
| and micromanupulation | |||
| procedures. | Similar | ||
| Patient | |||
| contact | This product does not contact | ||
| directly with gametes/embryos | |||
| as it is used as an overlay for | |||
| culturing in culture media. | This product does not | ||
| contact directly with | |||
| gametes/embryos as it is | |||
| used as an overlay for | |||
| culturing in culture media. | Same | ||
| Used in similar | |||
| population | The product is used for fertility | ||
| treatment of humans | The product is used for | ||
| fertility treatment of humans | Same | ||
| Technical | |||
| MEA | ≥ 80% | ||
| (96h Blastocysts) | ≥ 80% | Same | |
| Endotoxin | ≤ 0.25 EU/mL | ||
| (USP) |
- -Endotoxin Testing: Endotoxin values conform to the value 80% of 1-cell control embryos develop at 96 hours
- -Peroxide value (POV):
- -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.