Who is the manufacturer of GM501 SpermAir and GM501 SpermActive?

Hamilton Thorne Incorporated filed the 510(k) submission for GM501 SpermAir and GM501 SpermActive (K192644).

What is the FDA product code for GM501 SpermAir and GM501 SpermActive?

MQL. It is classified under 21 CFR 884.6180 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for GM501 SpermAir and GM501 SpermActive?

510(k) clearance (submission type: Traditional).

What are the predicate devices for GM501 SpermAir and GM501 SpermActive?

SepaSperm® Washing Solution (K190199).

Who can help prepare an FDA 510(k) submission like GM501 SpermAir and GM501 SpermActive?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GM501 SpermAir and GM501 SpermActive

K192644 · Hamilton Thorne Incorporated · MQL · Apr 23, 2020 · Obstetrics/Gynecology

Device Facts

Record ID	K192644
Device Name	GM501 SpermAir and GM501 SpermActive
Applicant	Hamilton Thorne Incorporated
Product Code	MQL · Obstetrics/Gynecology
Decision Date	Apr 23, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.6180
Device Class	Class 2

Intended Use

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 intrauterine insemination procedures.

Device Story

GM501 SpermAir and GM501 SpermActive are ready-to-use liquid media solutions for handling and preparing sperm cells during assisted reproduction procedures. The devices are aseptically filled into sterilized bottles. They are used in clinical laboratory settings by trained personnel to maintain sperm viability during preparation steps. The media contain various salts, amino acids, human serum albumin, and gentamicin. By providing a controlled chemical environment, the media support sperm motility and survival, facilitating successful downstream assisted reproduction techniques. The healthcare provider uses the output (prepared sperm) for clinical procedures; the device benefits the patient by ensuring sperm quality is maintained during laboratory processing.

Clinical Evidence

Bench testing only. Performance data includes pH (7.2-7.5), osmolality (270-290 mOsm/kg), sterility (USP <71>), bacterial endotoxins (<0.25 EU/ml per USP <85>), and Human Sperm Survival Assay (≥80% control motility at 24h). Shelf-life and post-opening stability (7 days) were validated using these metrics. Packaging integrity was confirmed via simulated shipping and distribution testing.

Technological Characteristics

Ready-to-use liquid media containing sodium chloride, potassium chloride, glucose, potassium phosphate, magnesium sulfate, sodium lactate, sodium hydrogen carbonate, calcium chloride, sodium pyruvate, EDTA, amino acids, HEPES, human serum albumin, gentamicin, and phenol red. Aseptic filtration sterilization per ANSI/AAMI/ISO 13408-1:2008(R)2011 and ANSI/AAMI/ISO 13408-2:2003(R)2013. Osmolality 270-290 mOsm/kg; pH 7.2-7.5.

Indications for Use

Indicated for the handling and preparation of sperm for use in assisted reproduction procedures. Not indicated for intrauterine insemination procedures.

Regulatory Classification

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.).

Special Controls

*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.

Predicate Devices

SepaSperm® Washing Solution (K190199)

Related Devices

K212410 — VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium · Shenzhen Vitavitro Biotech Co., Ltd. · Feb 1, 2022
K241095 — ARTSMedia Semen Wash Medium · Artsmedia Denmark Aps · Dec 18, 2024
K962816 — SPERM PREPARATION MEDIA · Genx Intl., Inc. · Nov 26, 1996
K023717 — SPERM WASH MEDIUM WITH GENTAMICIN · Conception Technologies · Dec 13, 2002
K024290 — PROMOTOR FINAL RINSE SPERM WASH MEDIUM · Ceres Fertility, Inc. · Mar 3, 2003

Submission Summary (Full Text)

{0}------------------------------------------------ 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 and 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. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 510(k) SUMMARY K192644 GM501 SpermAir and GM501 SpermActive | 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: | 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 Supplements 21 CFR 884.6180 MQL (Media, Reproductive) Class II | | Predicate Device: | K190199 ">– Kitazato Corporation - SepaSperm® Washing Solution. The predicate device has not been subject to a design related recall. | #### 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. #### 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 {4}------------------------------------------------ intrauterine insemination procedures. | Parameter | K192644 Subject Device: GM501 SpermAir/SpermActive | K190199 Predicate Device: SepaSperm® Washing Solution | Comparison | |-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | 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. SpermActive is intended for the handling and preparation of sperm for use in assisted reproduction procedures. GM501 SpermActive is not intended for use in intrauterine insemination procedures. | SepaSperm® Washing Solution is used for preparation and washing of sperm for use in assisted reproduction procedures. SepaSperm® Washing Solution is not intended for use in intrauterine insemination procedures. | The indications for use statements are not identical. However, the subject and predicate devices have the same intended use (preparation of sperm for use in assisted reproduction procedures). | | Device Materials | Sodium chloride Potassium chloride Glucose Potassium Phosphate Magnesium Sulfate Sodium lactate Sodium hydrogen carbonate Calcium chloride Sodium pyruvate EDTA Amino acids HEPES Human serum albumin Water Gentamicin Phenol Red | Modified-Human Tubal Fluid Medium HEPES Dextran Polyvinylpyrrolidone D-glucose Water Gentamicin (is certain versions) | Different: The formulas of the subject and predicate media are not the same. Differences in media product formulations do not raise different questions of safety and effectiveness (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: GM501 SpermAir/SpermActive | Predicate Device: SepaSperm® Washing Solution | | | Human Sperm Survival Assay (HSSA) | ≥ 80% of control motility at 24h | ≥80% of control motility at 24h | Same | | Shelf-life | 6 months | 6 months (without gentamicin) 12 months (with gentamicin) | Different: The predicate device has a longer shelf life for the version including gentamicin. This difference does not raise new or different questions of | ## Substantial Equivalence Comparison: {5}------------------------------------------------ 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) {6}------------------------------------------------ - . 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.