(198 days)
None
No
The device is a ready-to-use solution for washing and micromanipulation of oocytes and embryos, and the performance studies focus on chemical, biological, and sterility parameters of the solution itself, with no mention of AI/ML technology.
No.
The device is a solution used for handling and micromanipulation of human oocytes and embryos outside of a CO2 incubator in in vitro procedures, not for direct therapeutic treatment of a patient.
No
Explanation: The device is a "Wash" solution intended for supporting oocytes and embryos during in vitro ART procedures, such as washing and micromanipulation. It does not perform any diagnostic function (e.g., identifying a disease or condition).
No
The device description clearly states that GM501 Wash is a "ready-to-use solution" which is a liquid medium, not software. The performance studies also focus on chemical and biological properties of the solution.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "intended for in vitro procedures involving handling and micromanipulation of human occytes and embryos outside of a CO> incubator." This clearly indicates that the device is used outside of the human body for diagnostic or therapeutic purposes related to human biological material (oocytes and embryos).
- Device Description: The description reinforces this by stating it's a "ready-to-use solution providing supporting conditions for human oocytes and embryos during in vitro Assisted Reproduction Technology (ART) procedures."
- Performance Studies: The performance studies include tests like pH, osmolality, sterility, bacterial endotoxins, and a Mouse Embryo Assay (MEA). These are all tests performed on the device itself to ensure its suitability for use with biological samples in vitro.
- Predicate Device: The mention of a predicate device (K142991; LifeGlobal Group, LLC - Global Total w/HEPES w/HSA) which is also likely an IVD in the ART field further supports this classification.
The definition of an In Vitro Diagnostic (IVD) device generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While this device isn't directly diagnosing a disease, it is a critical component used in vitro as part of a medical procedure (ART) that addresses a medical condition (infertility). The handling and manipulation of oocytes and embryos outside the body falls squarely within the scope of in vitro procedures.
N/A
Intended Use / Indications for Use
GM501 Wash is intended for in vitro procedures involving handling and micromanipulation of human occytes and embryos outside of a CO> 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 is not intended for use in transferring embryos into the uterine cavity.
Product codes
MQL
Device Description
GM501 Wash 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, 50 and 500 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.
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)
- Aseptic filling validation per ANSI/AAMI/ISO 13408-1:2008(R)2011, ANSI/AAMI/ISO 13408-. 2:2003(R)2013, and the FDA's "Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice."
- . Sterility testing per USP (acceptance criterion: no growth)
- Bacterial endotoxins testing per USP (acceptance criterion: 80% blastocysts at 96h following a 1h exposure to GM501 Wash."
- Shelf-life testing was conducted to ensure that device specifications for the following parameters are met at time zero and at the end of shelf-life (6 months): pH, osmolality, sterility, 1-cell MEA, and endotoxin
- Stability testing after bottle opening was conducted to ensure that device specifications for the following parameters are met seven days after opening of bottles: pH, osmolality, sterility, 1-cell MEA, and endotoxin.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
September 5, 2019
Hamilton Thorne, Inc. Donald Fournier Director, Regulatory Affairs & QA 100 Cummings Center, Suite 465E Beverly, MA 01915
Re: K190383 Trade/Device Name: GM501 Wash Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: July 26, 2019 Received: August 1, 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 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.
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 Ouality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K190383
Device Name GM501 Wash
Indications for Use (Describe)
GM501 Wash is intended for in vitro procedures involving handling and micromanipulation of human occytes and embryos outside of a CO> 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 is not intended for use in transferring embryos into the uterine cavity.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
K190383 - GM501 Wash
| 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: | August 29, 2019 |
| Trade Name: | GM501 Wash |
| Common 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: | LifeGlobal Group, LLC - Global Total w/HEPES w/HSA (K142991). The
predicate device has not been subject to a design-related recall. |
Device Description:
GM501 Wash 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, 50 and 500 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.
Indications for Use:
GM501 Wash 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 is not intended for use in transferring embryos into the uterine cavity.
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Substantial Equivalence Comparison:
| Parameter | K181004
Subject Device | K142991
Predicate Device
LifeGlobal Global Total
w/HEPES w/HSA | Comments |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | GM501 Wash is intended for in
vitro procedures involving
handling and
micromanipulation of human
oocytes and embryos outside of
a 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 is not intended
for use in transferring embryos
into the uterine cavity. | Oocyte and embryo washing,
manipulation, fertilization by
intracytoplasmic sperm
injection (ICSI), embryo
transfer. | Different: Both
devices are indicated
for washing, handling,
and manipulation of
oocytes and embryos.
The predicate device
has additional uses
beyond the subject
device including
sperm washing, ICSI,
and embryo transfer.
These differences do
not represent a
different intended use,
but rather a more
limited use for the
subject device. |
| Device
Materials | Sodium chloride
Potassium chloride
Glucose
Potassium Phosphate
Magnesium Sulfate
Sodium lactate
Sodium hydrogen carbonate
Calcium chloride
Sodium pyruvate
EDTA
Amino acids
HEPES
HSA
Water | Sodium chloride
Potassium chloride
Glucose
Potassium Phosphate
Magnesium Sulfate
Sodium bicarbonate
Sodium lactate
Calcium chloride
Sodium pyruvate
EDTA
Amino acids
HEPES
HSA
Phenol red
Gentamicin sulfate
Water | 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
MEA | Aseptic filtration, no growth
1-Cell: ≥80% blastocysts at
96h following a 1h exposure to
GM501 Wash | Aseptic filtration
1-Cell: ≥80% blastocysts at
96h | Same
Different - Mouse
embryos are exposed
to the subject medium
for one hour as
compared to 96 hours
for the predicate.
Differences in
exposure times do not |
| | | | raise different
questions of S&E. |
| Endotoxin | (acceptance criterion: no growth)
- Bacterial endotoxins testing per USP (acceptance criterion: 80% blastocysts at 96h following a 1h exposure to GM501 Wash."
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- Shelf-life testing was conducted to ensure that device specifications for the following parameters are met at time zero and at the end of shelf-life (6 months): pH, osmolality, sterility, 1-cell MEA, and endotoxin
- Stability testing after bottle opening was conducted to ensure that device specifications for the following parameters are met seven days after opening of bottles: pH, osmolality, sterility, 1-cell MEA, and endotoxin.
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.