(196 days)
Not Found
No
The device description and intended use focus on culture media for oocytes and embryos, with no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device components are media used for washing, maturation, and maintenance of oocytes and embryos in vitro, which are steps in an assisted reproductive technology procedure, not directly treating a patient's disease or condition by themselves.
No
The device is described as a system for maturing oocytes and maintaining embryos for in vitro fertilization, as well as various media used in these processes. It does not mention analyzing or interpreting medical data to diagnose a condition.
No
The device description clearly outlines various culture media (Oocyte Washing Medium, Oocyte Maturation Medium, Embryo Maintenance Medium) which are physical substances, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "maturing immature oocytes of infertile women undergoing in vitro fertilization." This process involves handling and manipulating human biological material (oocytes) outside of the body for a medical purpose (infertility treatment).
- Device Description: The description details various media (Oocyte Washing Medium, Oocyte Maturation Medium, Embryo Maintenance Medium) that are used to support and facilitate biological processes (washing, maturation, maintenance of oocytes and embryos) in a laboratory setting.
- Predicate Devices: The listed predicate devices (K041284 MediCult IVM System and K002836 Media For Gamete Preparation And Embryo Culture) are also IVD devices used in assisted reproductive technology (ART) procedures. This further supports the classification of this device as an IVD.
IVD devices are defined as 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 strictly for diagnosis, it is used in a laboratory setting to facilitate a medical procedure (IVF) involving human biological material, which falls under the scope of IVD regulation.
N/A
Intended Use / Indications for Use
System for maturing immature oocytes of infertile women undergoing in vitro fertilization who for medical reasons cannot or choose not to undergo conventional ovarian stimulation using drugs.
Oocyte Washing Medium: This medium is used for washing immature oocytes contained within cumulus-oocyte complexes (COCs), collected from the follicles before maturation in culture.
Oocyte Maturation Medium: This medium is used for maturation in culture of immature oocytes in an incubator.
Embryo Maintenance: This medium is used for embryonic culture following insemination by intracytoplasmic sperm injection (ICSI).
Product codes
MQL
Device Description
Oocyte Washing Medium is a balanced salt solution containing nutrients, amino acids and vitamins to maintain immature oocytes during their collection and washing.
Oocyte Maturation Medium is a balanced salt solution containing nutrients, amino acids and vitamins for the in vitro culture of immature oocytes.
Embryo Maintenance Medium is a balanced salt solution containing nutrients and amino acids for maintaining embryos in culture.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The predicates and these devices were compared in the following areas and found to have equivalent technological characteristics and therefore are equivalent.
Formula
Indications for Use
Performance Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
5. 510(k) Summary
Image /page/0/Picture/2 description: The image shows the word "SAGE" inside of a circle. The circle is not fully complete, as there is a break in the lower right-hand side. The word "SAGE" is written in all capital letters and is centered inside of the circle. The font is a simple sans-serif font.
Assisted Reproduction Products™
SAGE In-Vitro Fertilization, Inc. a CooperSurgical Company CA. Vanniato Don a mispa (2) fine a (2015) 6:11-6 11. 2490 100 11.4 30
KOS 36 46
Submitter's name: Address:
Phone: Fax number: SAGE In-Vitro Fertilization 95 Corporate Drive Trumbull, CT 09911 203-601-5200 203-601-4737
JUL 1 4 2006
Name of contact person:
Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 Fax: 949-552-2821 Email: grace@regulatoryspecialists.com
Date the summary was prepared: December 26, 2005
Name of the device: Trade or proprietary name: Common or usual name: Classification name:
Name of the device: Trade or proprietary name: Common or usual name: Classification name:
Oocyte Washing Medium Oocyte Washing Medium Oocyte Washing Medium Reproductive media
Oocyte Maturation Medium Oocyte Maturation Medium Oocyte Maturation Medium Reproductive media
Name of the device: Trade or proprietary name: Common or usual name: Classification name:
Embryo Maintenance Medium Embryo Maintenance Medium Embryo Maintenance Medium Reproductive media
1
The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:
| Device | Ref# | Decided |
|---|---|---|
| MediCult IVM System | K041284 | 11/22/2004 |
| Media For Gamete Preparation And | ||
| Embryo Culture (Blastocyst Medium) | K002836 | 10/03/2000 |
Description of the devices:
Qocyte Washing Medium is a balanced salt solution containing nutrients, amino acids and vitamins to maintain immature oocytes during their collection and washing.
Oocyte Maturation Medium is a balanced salt solution containing nutrients, amino acids and vitamins for the in vitro culture of immature oocytes.
Embryo Maintenance Medium is a balanced salt solution containing nutrients and amino acids for maintaining embryos in culture.
Indications:
Oocyte Washing Medium: This medium is used for washing immature oocytes contained within cumulus-oocyte complexes (COCs), collected from the follicles before maturation in culture.
Oocyte Maturation Medium: This medium is used for maturation in culture of immature oocytes in an incubator.
Embryo Maintenance Medium: This medium is used for embryonic culture following insemination by intracytoplasmic sperm injection (ICSI).
Summary of the technological characteristics of our device compared to the predicate device:
The predicates and these devices were compared in the following areas and found to have equivalent technological characteristics and therefore are equivalent.
2
Formula Indications for Use Performance Testing
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a representation of human services, featuring three curved lines that suggest movement or flow.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL 1 4 2006
SAGE In-Vitro Fertilization, Inc. % Ms. Grace Holland Regulatory Specialist Regulatory Specialists, Inc. 3722 Ave. Sausalito IRVINE CA 92606
Re: K053646
Trade/Device Name: IVM System Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: June 15, 2006 Received: June 20, 2006
Dear Ms. Holland:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/3/Picture/10 description: The image shows a logo with the text "1906-2006" at the top. Below that is the text "FDA Centennial" in a stylized font. There are three stars below the word "Centennial". The logo is surrounded by a circular border with text.
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Page 2 –
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
4. Indications for Use Statement Indications for Use
510(k) Number (if known): Ko5 36466
Device Name: _ IVM System_____________________________________________________________________________________________________________________________________________________ Indications for Use:
System for maturing immature oocytes of infertile women undergoing in vitro fertilization who for medical reasons cannot or choose not to undergo conventional ovarian stimulation using drugs.
Oocyte Washing Medium: This medium is used for washing immature oocytes contained within cumulus-oocyte complexes (COCs), collected from the follicles before maturation in culture.
Oocyte Maturation Medium: This medium is used for maturation in culture of immature oocytes in an incubator.
Embryo Maintenance: This medium is used for embryonic culture following insemination by intracytoplasmic sperm injection (ICSI).
AND/OR
x Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ---------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device
Page 1 of 1
REGULATORY SPECIALISTS, INC.
510(k) Number