(98 days)
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.
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.
The provided text appears to be an FDA 510(k) summary for a medical device called "GM501 Mineral Oil." It does not describe an AI medical device or a study involving human readers or AI.
Therefore, I cannot provide the information requested for acceptance criteria and a study proving a device meets these criteria, especially concerning AI, human readers, or expert evaluations. The document focuses on demonstrating substantial equivalence of a mineral oil product to a predicate device, based on similar indications for use, materials, specifications, and shelf-life, rather than providing performance data from a clinical or AI-specific study.
The closest information provided to "acceptance criteria" are the "Specification" values in the table on page 4, which are chemical and biological characteristics of the mineral oil product rather than performance metrics for an AI algorithm.
Table of Acceptance Criteria and Reported Device Performance (based on provided text):
| Parameter | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Density | 0.83-0.86 g/ml | Not explicitly reported as a measured value for the subject device, but implied to meet specification by "Performance testing to support the subject device... supports the device specifications." |
| Viscosity | < 30 cP at 30°C | Not explicitly reported as a measured value for the subject device, but implied to meet specification. |
| Sterility (USP<71>) | No growth | Not explicitly reported as a measured value for the subject device, but implied to meet specification. |
| Endotoxins (LAL, USP<85>) | < 0.10 EU/ml | Not explicitly reported as a measured value for the subject device, but implied to meet specification. |
| 1-Cell MEA | ≥ 80% blastocysts after 120h exposure | Not explicitly reported as a measured value for the subject device, but implied to meet specification. |
| Peroxide Value (POV) | < 0.1 mEq/kg | Not explicitly reported as a measured value for the subject device, but implied to meet specification. |
Regarding the other requested information, the document does not contain any of the following, as it is not a study on an AI device:
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study, nor effect size of human readers improving with/without AI assistance.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
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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 465EBeverly, MA 01915Tel: (978) 921-2050Fax: (978) 921-0250 |
|---|---|
| Contact Person: | Donald FournierDirector, Regulatory Affairs & Quality Assurance100 Cummings Center, Suite 465EBeverly MA 01915Tel: (978) 921-2050 Ext. 1726Fax: (978) 921-0250dfournier@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 Supplements21 CFR 884.6180MQL (Media, Reproductive)Class II |
| Predicate Device: | FertiPro Oil for Tissue Culture (K053494). The predicate device has not beensubject 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.
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| Parameter | Specification |
|---|---|
| Density | 0.83-0.86 g/ml |
| Viscosity | < 30 cP at 30°C |
| Sterility (USP<71>) | No growth |
| Endotoxins (LAL, USP<85>) | < 0.10 EU/ml |
| 1-Cell MEA | ≥ 80% blastocysts after 120h exposure |
| Peroxide Value (POV) | < 0.1 mEq/kg |
The table below lists the key specifications of the device:
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.
Substantial Equivalence Comparison:
The indications for use statements for the subject and predicate devices are shown in the table below:
| K191552 | K053494 |
|---|---|
| Subject Device | Predicate Device |
| GM501 Mineral Oil | Oil for Tissue Culture |
| GM501 Mineral Oil is intended for use as an overlay forculture of gametes, zygotes, or embryos in AssistedReproduction Technology (ART) and micro-manipulationprocedures. | Oil for Tissue Culture is used in covering tissue culture in in-vitro fertilization, embryo culture and micromanipulativeprocedures such as ICSI and assisted hatching. |
The subject and predicate devices have similar indications for use statements, and the same intended use, i.e., overlay of media used in ART procedures.
The technological features of the subject and predicate device are identical (i.e., materials, specifications, and shelf-life). Therefore, there are no technological differences between the subject and predicate devices that raise different questions of safety and effectiveness.
Summary on Non-Clinical Performance Testing:
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,
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device shelf-life, and validation of the sterilization methods.
Conclusion:
The subject and predicate devices have the same intended use and technological characteristics. Therefore, the subject device is substantially equivalent to the predicate device.
§ 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.