GM501 Wash with Phenol Red and Gentamicin is intended for in vitro procedures involving handling and micromanipulation of human oocytes and embryos outside of a CO2 incubator. Include oocyte and embryo washing (e.g. after oocyte aspiration, after hyaluronidase treatment to remove cumulus cells, before and after cryopreservation, and before embryo transfer) and micromanipulation procedures (e.g. assisted hatching). GM501 Wash with Phenol Red and Gentamicin is not intended for use in transferring embryos into the uterine cavity.

Device Description

GM501 Wash with Phenol Red and Gentamicin is a ready-to-use solution providing supporting conditions for human oocytes and embryos during in vitro Assisted Reproduction Technology (ART) procedures taking place outside of a CO2 incubator, including washing and micromanipulation procedures. GM501 Wash is aseptically filled into sterilized bottles (20 and 50 ml) and has a six-month shelf-life when stored as recommended. This product can also be used for up to seven days after bottle opening.

GM501 Wash with Phenol Red and Gentamicin is identical to the predicate GM501 Wash with the exception of the addition of gentamicin sulfate (10 mg/liter) and phenol red (3 mg/liter).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, structured to address your specific points:

1. A table of acceptance criteria and the reported device performance

Parameter	Acceptance Criteria (Subject Device - GM501 Wash with Phenol Red and Gentamicin)	Reported Device Performance (Subject Device)	Comparison to Predicate Device
Endotoxins	< 0.25 LAL, EU/ml	< 0.25 LAL, EU/ml	Same
Osmolality (mOsm/Kg)	270-290	270-290	Same
pH	7.2-7.5	7.2-7.5	Same
1-Cell MEA (Mouse Embryo Assay)	≥ 80% blastocyst at 96h after 1h exposure to GM501 Wash with Phenol Red and Gentamicin	≥ 80% blastocyst at 96h after 1h exposure to GM501 Wash with Phenol Red and Gentamicin	Same
Shelf-life	6 months	6 months (supported by testing of MEA, sterility, pH, osmolality, and endotoxins)	Same
Use-life after bottle opening	7 days (supported by stability testing at the end of the shelf-life period with MEA, sterility, pH, osmolality, and endotoxins)	7 days (supported by stability testing at the end of the shelf-life period with MEA, sterility, pH, osmolality, and endotoxins)	N/A (this specific testing addresses a formulation change in the subject device)
Sterilization	Sterilized by sterile filtration	Sterilized by sterile filtration	Same

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 explicitly state the sample sizes used for the "test set" in terms of human subjects or embryos. The primary performance data presented is the 1-Cell MEA (Mouse Embryo Assay) which uses mouse embryos. The specific number of mouse embryos used in this assay is not provided.

The data provenance (country of origin, retrospective/prospective) is also not explicitly stated in the provided text.

3. 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)

This information is not applicable and not present in the document. The device is a reproductive media for in vitro procedures. Its performance is assessed through laboratory assays (like MEA) and chemical/physical property measurements, not through expert interpretation of images or clinical diagnoses.

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

This information is not applicable and not present in the document. The device's performance is determined by objective laboratory measurements (MEA, pH, osmolality, endotoxins, sterility) rather than subjective human interpretation.

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

This information is not applicable and not present in the document. The device is a reproductive media, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and "human reader improvement with AI" are not relevant to this submission.

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

This information is not applicable and not present in the document. The device is a biological/chemical media, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for assessing the performance of GM501 Wash with Phenol Red and Gentamicin is based on:

Laboratory Assay Results: Primarily the Mouse Embryo Assay (MEA), which assesses the ability of the media to support blastocyst development from 1-cell mouse embryos.
Chemical/Physical Specifications: Adherence to defined ranges for pH, osmolality, and endotoxin levels.
Sterility Testing: Confirmation of absence of microbial contamination.
Stability Testing: Demonstrating that the media maintains its specifications over its shelf-life and use-life.

8. The sample size for the training set

This information is not applicable and not present in the document. The device is a reproductive media, not an AI model that requires a training set.

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

This information is not applicable and not present in the document. The device is a reproductive media, not an AI model.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 19, 2020

Hamilton Thorne, Inc. Donald J. Fournier Director, Regulatory Affairs & OA 100 Cummings Center, Suite 465E Beverly, MA 01915

Re: K192503

Trade/Device Name: GM501 Wash with Phenol Red and Gentamicin Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: October 22, 2020 Received: October 23, 2020

Dear Donald J. 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.

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing 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 (QS) 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 Monica D. Garcia, Ph.D. 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) K192503

Device Name

GM501 Wash with Phenol Red and Gentamicin

Indications for Use (Describe)

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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510(k) SUMMARY - K192503

GM501 Wash with Phenol Red and Gentamicin

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:	November 18, 2020
Trade Name:	GM501 Wash with Phenol Red and Gentamicin
Common Name:	Assisted Reproduction Medium
Regulation Name:	Reproductive Media and Supplements
Regulation Number:	21 CFR 884.6180
Product Code:	MQL (Media, Reproductive)
Regulatory Class:	Class II
Predicate Device:	K190383 - GM501 Wash

The predicate device has not been subject to a design-related recall.

Device Description:

GM501 Wash with Phenol Red and Gentamicin is identical to the predicate GM501 Wash with the exception of the addition of gentamicin sulfate (10 mg/liter) and phenol red (3 mg/liter).

Indications for Use Statement:

GM501 Wash with Phenol Red and Gentamicin is intended for in vitro procedures involving handling and micromanipulation of human oocytes and embryos outside of a

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CO2 incubator. Indications include oocyte and embryo washing (e.g. after oocyte aspiration, after hyaluronidase treatment to remove cumulus cells, before and after cryopreservation, and before embryo transfer) and micromanipulation procedures (e.g. assisted hatching). GM501 Wash with Phenol Red and Gentamicin is not intended for use in transferring embryos into the uterine cavity.

Comparison to Predicate:

A comparison of the subject and predicate devices intended use and technological characteristics are shown in the table below:

Parameter	Subject DeviceGM501 Wash with PhenolRed and GentamicinK192503	Predicate DeviceGM501 WashK190383	Comparison
Indications forUse	GM501 Wash with Phenol Redand Gentamicin is intended forin vitro procedures involvinghandling andmicromanipulation of humanoocytes and embryos outside ofa CO2 incubator. Indicationsinclude oocyte and embryowashing (e.g. after oocyteaspiration, after hyaluronidasetreatment to remove cumuluscells, before and aftercryopreservation, and beforeembryo transfer) andmicromanipulation procedures(e.g. assisted hatching). GM501Wash with Phenol Red andGentamicin is not intended foruse in transferring embryos intothe uterine cavity.	GM501 Wash is intended for invitro procedures involvinghandling and micromanipulationof human oocytes and embryosoutside of a CO2 incubator.Indications include oocyte andembryo washing (e.g. afteroocyte aspiration, afterhyaluronidase treatment toremove cumulus cells, beforeand after cryopreservation, andbefore embryo transfer) andmicromanipulation procedures(e.g. assisted hatching). GM501Wash is not intended for use intransferring embryos into theuterine cavity.	Same
Formulation	Sodium chloridePotassium chlorideGlucosePotassium PhosphateMagnesium SulfateSodium lactateSodium hydrogen carbonateCalcium chlorideSodium pyruvateEDTAAmino acidsHEPESHSAWaterGentamicin sulfatePhenol red	Sodium chloridePotassium chlorideGlucosePotassium PhosphateMagnesium SulfateSodium lactateSodium hydrogen carbonateCalcium chlorideSodium pyruvateEDTAAmino acidsHEPESHSAWater	Different - thesubject deviceincludesphenol red andgentamicin thatare not presentin the predicatedeviceformulation.Theseformulationdifferences donot raisedifferentquestions ofsafety andeffectiveness.
Sterilization	Sterilized by sterile filtration	Sterilized by sterile filtration	Same
Endotoxins	< 0.25 LAL, EU/ml	< 0.25 LAL, EU/ml	Same
Osmolality(mOsm/Kg)	270-290	270-290	Same
pH	7.2-7.5	7.2-7.5	Same
1-Cell MEA	≥ 80% blastocyst at 96h after1h exposure to GM501 Washwith Phenol Red andGentamicin	≥ 80% blastocyst at 96h after 1hexposure to GM501 Wash	Same
Shelf-life	6 months	6 months	Same

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The subject media product is modification to the predicate device. The two media products have the same specifications (endotoxin. MEA. pH. and osmolality), shelf-life, and sterilization methods. However, differences exist in media formulation. As discussed in the table above, these differences do not raise different questions of safety and effectiveness as compared to the predicate device and can be assessed through performance data.

Summary of Non-Clinical Performance Testing:

The subject device is identical to the predicate device, with the exception that gentamicin sulfate and phenol red have been added to the subject device. Based on the risk analysis, shelf-life and use-life after bottle opening of the subject device was conducted to support the change in formulation. All other testing to support this device relies on testing included in the predicate submission (K190383) and in K192644 for GM501 SpermActive which is identical in formulation to the subject device, but has a different indications for use for handling and preparation of sperm. A summary of the shelf-life and use-life testing conducted to support this change is shown below:

. Shelf-life testing was conducted to support the six-month shelf-life (MEA, sterility, pH, osmolality, and endotoxins)
. Stability testing after bottle opening at the end of the shelf-life period was conducted to ensure that device specifications are met seven days after opening and simulated use of bottles (MEA, sterility, pH, osmolality, and endotoxins)

Conclusion:

The subject and predicate devices have the same intended use and comparable technological characteristics. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device.

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.