(212 days)
Not Found
No
The 510(k) summary describes ready-to-use solutions for sperm handling and preparation, with performance studies focused on chemical, biological, and physical properties of the media. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of such technologies.
No
The device is described as "ready-to-use solutions for handling and preparation of sperm cells during assisted reproduction procedures" and is intended for sperm preparation, not for direct treatment of a disease or condition in a patient.
No
This device is described as a solution for "handling and preparation of sperm" in assisted reproduction procedures. It focuses on maintaining sperm viability and properties (pH, osmolality, sterility) for further use, rather than diagnosing a condition or providing information about a disease state.
No
The device description clearly states that the devices are "ready-to-use solutions" and are "aseptically filled into sterilized bottles and sealed," indicating they are physical substances (liquids) and not software. The performance studies also focus on physical and biological properties of the solutions.
Based on the provided information, it is unlikely that this device is an IVD (In Vitro Diagnostic). Here's why:
- Intended Use: The intended use is for "handling and preparation of sperm for use in assisted reproduction procedures." This describes a process performed outside the body to prepare biological material for a medical procedure. IVDs are typically used to examine specimens from the body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device is described as "ready-to-use solutions for handling and preparation of sperm cells." This aligns with a reagent or media used in a laboratory or clinical setting for processing biological samples, not a diagnostic test itself.
- Performance Studies: The performance studies focus on the quality and suitability of the media for maintaining sperm viability and motility (Human Sperm Survival Assay), as well as sterility, pH, osmolality, and endotoxin levels. These are tests to ensure the media is safe and effective for its intended purpose of sperm preparation, not tests to diagnose a condition or provide diagnostic information about a patient.
- Lack of Diagnostic Language: There is no mention of analyzing a specimen to provide diagnostic information, detecting a disease, or monitoring a condition.
While the device is used in a clinical setting and involves biological material, its function is to facilitate a medical procedure (assisted reproduction) by preparing the sperm, rather than providing diagnostic information about the patient or the sperm itself.
Therefore, based on the provided text, GM501 SpermAir and GM501 SpermActive are most likely classified as medical devices used in assisted reproduction procedures, but not as In Vitro Diagnostic devices.
N/A
Intended Use / 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.
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.
Product codes
MOL
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.
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
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 (acceptance criterion: no growth)
- Bacterial endotoxins testing per USP (acceptance criterion:
§ 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 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 | (acceptance criterion: no growth)
- Bacterial endotoxins testing per USP (acceptance criterion: