(98 days)
Not Found
No
The device description and intended use clearly state that the device is mineral oil used as an overlay for cell culture media in ART/IVF procedures. There is no mention of any computational or analytical functions, let alone AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
This device is an oil overlay used to protect cell culture medium in ART, not to treat a disease or condition in a patient.
No
The device, GM501 Mineral Oil, is used as an overlay for cell culture media in Assisted Reproductive Technology procedures to protect the medium, not to diagnose a condition or disease.
No
The device is a mineral oil product, which is a physical substance used in ART procedures, not a software application.
Based on the provided information, yes, this device is likely an IVD (In Vitro Diagnostic) or a device used in an IVD procedure.
Here's why:
- Intended Use: The intended use explicitly states "for use as an overlay for culture of gametes, zygotes, or embryos in Assisted Reproduction Technology (ART) and micro-manipulation procedures." ART and micro-manipulation procedures involving gametes, zygotes, and embryos are inherently in vitro processes.
- Device Description: The description further clarifies its use in "Assisted Reproductive Technology (ART) or In Vitro Fertilization (IVF) procedures." IVF is a classic example of an in vitro diagnostic or related procedure.
- Predicate Device: The predicate device listed, "FertiPro Oil for Tissue Culture," also strongly suggests a connection to in vitro procedures, as tissue culture is a common technique in IVD and related fields.
While the device itself (mineral oil) isn't directly performing a diagnostic test on a sample, it is an essential component used in vitro to support the viability and integrity of biological samples (gametes, zygotes, embryos) during procedures that are part of the diagnostic or therapeutic process of ART/IVF.
Therefore, it falls under the scope of devices used in in vitro diagnostic procedures, even if it's not a diagnostic reagent or instrument itself. Regulatory bodies often classify such supporting materials used in IVD workflows as IVD devices or devices used in IVD procedures.
N/A
Intended Use / Indications for Use
GM501 Mineral Oil is intended for use as an overlay for culture of gametes, zygotes, or embryos in Assisted Reproduction Technology (ART) and micro-manipulation procedures.
Product codes
MOL
Device Description
GM501 Mineral Oil is light, mineral oil (paraffin oil) which is used to overlay cell culture media during Assisted Reproductive Technology (ART) or In Vitro Fertilization (IVF) procedures. The oil overlay is intended to protect the culture medium from evaporation in the incubator, limiting potential temperature, osmolality and pH changes in the medium.
GM501 Mineral Oil is aseptically filtered and provided in bottles of 100 ml and 500 ml. This product has an 18-month shelf-life when stored as recommended.
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
Performance testing to support the subject device is identical to that provided in support of the predicate device and supports the device specifications shown in the Device Description section of this summary, device shelf-life, and validation of the sterilization methods.
Key Metrics
Density: 0.83-0.86 g/ml
Viscosity: ): No growth
Endotoxins (LAL, USP):
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 18, 2019
Hamilton Thorne Inc. Donald Fournier Director, Regulatory Affairs & QA 100 Cummings Center, Suite 465E Beverly, MA 01915
Re: K191552
Trade/Device Name: GM501 Mineral Oil Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MOL Dated: August 22, 2019 Received: August 23, 2019
Dear Donald Fournier:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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.
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 of medical device-related adverse events) (21 CFR 803) for devices or post marketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Sharon M. Andrews Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191552
Device Name GM501 Mineral Oil
Indications for Use (Describe)
GM501 Mineral Oil is intended for use as an overlay for culture of gametes, zygotes, or embryos in Assisted Reproduction Technology (ART) and micro-manipulation procedures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K191552 Page 1 of 3
510(k) SUMMARY
K191552 - GM501 Mineral Oil
| Submitter: | Hamilton Thorne, Inc.
100 Cummings Center, Suite 465E
Beverly, MA 01915
Tel: (978) 921-2050
Fax: (978) 921-0250 |
|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Donald Fournier
Director, Regulatory Affairs & Quality Assurance
100 Cummings Center, Suite 465E
Beverly MA 01915
Tel: (978) 921-2050 Ext. 1726
Fax: (978) 921-0250
dfournier@hamiltonthorne.com |
| Date Prepared: | September 12, 2019 |
| Trade Name: | GM501 Mineral Oil |
| Common Name: | Reproductive Media |
| Regulation Name:
Regulation Number:
Product Code:
Regulatory Class: | Reproductive Media and Supplements
21 CFR 884.6180
MQL (Media, Reproductive)
Class II |
| Predicate Device: | FertiPro Oil for Tissue Culture (K053494). The predicate device has not been
subject to a design-related recall. |
Device Description:
GM501 Mineral Oil is light, mineral oil (paraffin oil) which is used to overlay cell culture media during Assisted Reproductive Technology (ART) or In Vitro Fertilization (IVF) procedures. The oil overlay is intended to protect the culture medium from evaporation in the incubator, limiting potential temperature, osmolality and pH changes in the medium.
GM501 Mineral Oil is aseptically filtered and provided in bottles of 100 ml and 500 ml. This product has an 18-month shelf-life when stored as recommended.
4
| Parameter | Specification |
|---|---|
| Density | 0.83-0.86 g/ml |
| Viscosity | ) |
| Endotoxins (LAL, USP) |