GM501 SpermAir is intended for the handling and preparation of sperm for use in assisted reproduction procedures. GM501 SpermAir is not intended for use in intrauterine insemination procedures.

GM501 SpermActive is intended for the handling and preparation of sperm for use in assisted reprocedures. GM501 SpermActive is not intended for use in intrauterine insemination procedures.

Device Description

GM501 SpermAir and GM501 SpermActive are ready-to-use solutions for handling and preparation of sperm cells during assisted reproduction procedures. Both devices are aseptically filled into sterilized bottles and sealed. GM501 SpermAir comes in three volumes: 2 ml, 20 ml, and 50 ml. GM501 SpermActive comes in two volumes: 20 ml and 50 ml. Both media have a six-month shelf-life when stored as recommended and can be used for up to seven days after opening.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the GM501 SpermAir and GM501 SpermActive devices, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
pH	7.2-7.5 (GM501 SpermAir/SpermActive)
Osmolality (mOsm/kg)	270-290 (GM501 SpermAir/SpermActive)
Sterility (per USP <71>)	No growth (demonstrated through testing)
Bacterial Endotoxins (per USP <85>)	< 0.25 EU/ml (demonstrated through testing)
Human Sperm Survival Assay (HSSA)	≥ 80% of control motility at 24h (demonstrated through testing)
Shelf-life	6 months (demonstrated through testing for HSSA, sterility, pH, osmolality, and endotoxins)
Stability after bottle opening	Device specifications met for seven days after opening (HSSA, sterility, pH, osmolality, and endotoxins)
Aseptic filling information	Compliant with ANSI/AAMI/ISO 13408-1:2008(R)2011, ANSI/AAMI/ISO 13408-2:2003(R)2013
Simulated shipping and distribution testing	Demonstrated (details of outcome not provided, but implies successful testing)

Additional Study Information:

Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes for the individual performance tests (pH, osmolality, sterility, endotoxins, HSSA, shelf-life, stability after opening, aseptic filling, shipping).
- The data provenance is not specified (e.g., country of origin, retrospective/prospective). These were non-clinical performance tests, usually conducted in a controlled laboratory environment.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as the tests are for objective analytical performance rather than subjective interpretation by experts. For example, pH is measured by a meter, not by expert consensus.
Adjudication method for the test set:
- Not applicable, as the tests are objective analytical measurements against predefined criteria.
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:
- No MRMC study was conducted. This device is a reproductive media for sperm handling, not an AI or imaging device involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a chemical medium, not an algorithm. The performance tests are measurements of its chemical and biological properties.
The type of ground truth used:
- For most parameters (pH, osmolality, endotoxins, sterility), the ground truth is established by objective analytical measurements using validated laboratory methods and instruments, comparing them to established scientific or regulatory limits (e.g., USP standards).
- For the Human Sperm Survival Assay (HSSA), the ground truth is based on biological outcomes (sperm motility compared to a control) measured quantitatively.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set. The performance studies are conducted to characterize the product's properties.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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April 23, 2020

Hamilton Thorne Incorporated Donald Fournier Director, Regulatory Affairs & QA 100 Cummings Center, Suite 465E Beverly, MA 01915

Re: K192644

Trade/Device Name: GM501 SpermAir and GM501 SpermActive Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MOL Dated: March 18, 2020 Received: March 24, 2020

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.

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

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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 postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 medical devices and radiation-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,

Monica D. Garcia, Ph.D. Acting 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) K192644

Device Name GM501 SpermAir and GM501 SpermActive

Indications for Use (Describe)

GM501 SpermAir is intended for the handling and preparation of sperm for use in assisted reproduction procedures. GM501 SpermAir is not intended for use in intrauterine insemination procedures.

GM501 SpermActive is intended for the handling and preparation of sperm for use in assisted reprocedures. GM501 SpermActive is not intended for use in intrauterine insemination 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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510(k) SUMMARY K192644 GM501 SpermAir and GM501 SpermActive

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:	April 22, 2020
Name of Device:	GM501 SpermAir and GM501 SpermActive
Common/Usual Name:	Reproductive Media
Regulation Name:Regulation Number:Product Code:Regulatory Class:	Reproductive Media and Supplements21 CFR 884.6180MQL (Media, Reproductive)Class II
Predicate Device:	K190199 ">– Kitazato Corporation - SepaSperm® WashingSolution. The predicate device has not been subject to a designrelated recall.

Device Description:

Indications for Use Statements:

GM501 SpermAir is intended for the handling and preparation of sperm for use in assisted reproduction procedures. GM501 SpermAir is not intended for use in intrauterine insemination procedures.

GM501 SpermActive is intended for the handling and preparation of sperm for use in assisted reproduction procedures. GM501 SpermActive is not intended for use in

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intrauterine insemination procedures.

Parameter	K192644Subject Device:GM501SpermAir/SpermActive	K190199Predicate Device:SepaSperm® Washing Solution	Comparison
Indicationsfor Use	GM501 SpermAir isintended for the handlingand preparation of spermfor use in assistedreproduction procedures.GM501 SpermAir is notintended for use inintrauterine inseminationprocedures.SpermActive is intended forthe handling andpreparation of sperm for usein assisted reproductionprocedures. GM501SpermActive is not intendedfor use in intrauterineinsemination procedures.	SepaSperm® WashingSolution is used forpreparation andwashing of sperm foruse in assistedreproductionprocedures.SepaSperm® WashingSolution is notintended for use inintrauterineinseminationprocedures.	The indicationsfor usestatements arenot identical.However, thesubject andpredicatedevices have thesame intendeduse (preparationof sperm for usein assistedreproductionprocedures).
DeviceMaterials	Sodium chloridePotassium chlorideGlucosePotassium PhosphateMagnesium SulfateSodium lactateSodium hydrogen carbonateCalcium chlorideSodium pyruvateEDTAAmino acidsHEPESHuman serum albuminWaterGentamicinPhenol Red	Modified-HumanTubal Fluid MediumHEPESDextranPolyvinylpyrrolidoneD-glucoseWaterGentamicin (is certainversions)	Different: Theformulas of thesubject andpredicate mediaare not thesame.Differences inmedia productformulations donot raisedifferentquestions ofsafety andeffectiveness(S&E).
Sterilization	Aseptic filtration	Aseptic filtration	Same
Endotoxins	< 0.25 LAL, EU/ml	< 0.25 LAL, EU/ml	Same
Osmolality(mOsm/kg)	270-290	270-300	Similar
pH	7.2-7.5	7.2-7.6	Similar
Parameter	K192644	K190199	Comparison
	Subject Device:GM501SpermAir/SpermActive	Predicate Device:SepaSperm®Washing Solution
HumanSpermSurvivalAssay(HSSA)	≥ 80% of control motilityat 24h	≥80% of controlmotility at 24h	Same
Shelf-life	6 months	6 months (withoutgentamicin)12 months (withgentamicin)	Different: Thepredicate devicehas a longershelf life for theversionincludinggentamicin.This differencedoes not raisenew or differentquestions of

Substantial Equivalence Comparison:

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As noted in the table above, the subject and predicate devices have the same intended use for preparation of sperm for use in assisted reproduction procedures.

In addition, the subject and predicate devices have similarities in specifications (pH, osmolality, endotoxin, and HSSA) and sterilization methods. However, differences exist in media formulation and shelf-life duration for the different media products. 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 on Non-Clinical Performance Testing:

The following studies have been performed to support substantial equivalence to the predicate device:

pH testing (acceptance criterion: 7.2-7.5) ●
Osmolality testing (acceptance criterion: 270-290 mOsm/kg) ●
Sterility testing per USP <71> (acceptance criterion: no growth)
Bacterial endotoxins testing per USP <85> (acceptance criterion: <0.25 . EU/ml)
. Human Sperm Survival Assay (acceptance criterion: ≥ 80% of control motility at 24h)
Shelf-life testing was conducted to support the six-month shelf-life . (HSSA, sterility, pH, osmolality, and endotoxins)

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. Stability testing after bottle opening was conducted to ensure that device specifications are met seven days after opening of bottles (HSSA, sterility, pH, osmolality, and endotoxins)
Aseptic filling information per ANSI/AAMI/ISO 13408-1:2008(R)2011, . ANSI/AAMI/ISO 13408-2:2003(R)2013
. Simulated shipping and distribution testing on device packaging.

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.