(434 days)
No
The device is a ready-to-use solution for washing and micromanipulation of oocytes and embryos, and the description focuses on its chemical composition and stability, with no mention of AI or ML.
No
This product is a solution used for handling and manipulating human oocytes and embryos in vitro, not for diagnosis, treatment, or prevention of disease in a patient.
No
The device is a solution used for handling and micromanipulation of human oocytes and embryos during in vitro Assisted Reproduction Technology (ART) procedures. It provides supporting conditions for these biological materials, rather than diagnosing a condition or disease in a patient.
No
The device description clearly indicates it is a ready-to-use solution, which is a physical substance, not software.
Based on the provided text, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is intended for "in vitro procedures involving handling and micromanipulation of human oocytes and embryos outside of a CO2 incubator." The term "in vitro" is a key indicator of an IVD.
- Device Description: The description further clarifies that it's a "ready-to-use solution providing supporting conditions for human oocytes and embryos during in vitro Assisted Reproduction Technology (ART) procedures." Again, the "in vitro" aspect is highlighted.
- Nature of the Device: The device is a solution used to support biological materials (oocytes and embryos) outside of the body for diagnostic or therapeutic purposes (in this case, ART procedures). This aligns with the definition of an IVD, which are 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 specific device isn't directly diagnosing a disease, it's a critical component in a process (ART) that can be considered a treatment for infertility, and the handling and manipulation of the biological samples are performed in vitro.
Therefore, the intended use and the nature of the device strongly indicate that GM501 Wash with Phenol Red and Gentamicin is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MQL
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).
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
Prescription Use (Part 21 CFR 801 Subpart D)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Summary of non-clinical performance testing detailed the following metrics:
- Endotoxins:
§ 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 & 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.
1
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)
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.
| 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 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).
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
4
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 Device
GM501 Wash with Phenol
Red and Gentamicin
K192503 | Predicate Device
GM501 Wash
K190383 | Comparison |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | 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. 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. | 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. | Same |
| Formulation | Sodium chloride
Potassium chloride
Glucose
Potassium Phosphate
Magnesium Sulfate
Sodium lactate
Sodium hydrogen carbonate
Calcium chloride
Sodium pyruvate
EDTA
Amino acids
HEPES
HSA
Water
Gentamicin sulfate
Phenol red | Sodium chloride
Potassium chloride
Glucose
Potassium Phosphate
Magnesium Sulfate
Sodium lactate
Sodium hydrogen carbonate
Calcium chloride
Sodium pyruvate
EDTA
Amino acids
HEPES
HSA
Water | Different - the
subject device
includes
phenol red and
gentamicin that
are not present
in the predicate
device
formulation.
These
formulation
differences do
not raise
different
questions of
safety and
effectiveness. |
| Sterilization | Sterilized by sterile filtration | Sterilized by sterile filtration | Same |
| Endotoxins |