(117 days)
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
Not Found
No
The document describes a culture medium and its performance based on biological assays and clinical use, with no mention of AI or ML technologies.
No
The device is a culture medium designed to support the in vitro growth of human embryos, not to treat a disease or condition in a patient.
No
The device is a medium used for culturing human embryos (MultiBlast Medium), not for diagnosing a condition or disease. Its purpose is to support embryo growth, not to provide diagnostic information.
No
The device description clearly states that MultiBlast Medium is a "synthetic, defined medium, composed of a balance mixture of salts, amino acids, minerals and other nutrient substances," indicating it 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 MultiBlast Medium is intended for use as the second stage of a sequential in vitro embryo culture protocol. The term "in vitro" is a key indicator of an IVD.
- Device Description: The description further clarifies that it's a "synthetic, defined medium" designed to "support embryonic growth and blastocyst development in vitro." Again, the "in vitro" aspect is central.
- Performance Studies: The "Summary of Performance Studies" mentions a "mouse embryo assay" and its use in "clinical settings, for its intended use." While not a diagnostic test in the traditional sense of diagnosing a disease, the medium is used in vitro to support a biological process (embryo development) that is part of a clinical procedure (IVF).
While the device itself isn't performing a diagnostic test on a patient sample to diagnose a condition, it is a reagent used in vitro as part of a process that is integral to assisted reproductive technology (ART), which falls under the purview of IVD regulation. The "Notice of Final Rule, 63 FR 48428, Docket number 97N-0335" mentioned in the Predicate Device section likely refers to regulations related to assisted reproductive technology and the media used in these procedures, further supporting its classification as an IVD.
N/A
Intended Use / Indications for Use
MultiBlast Medium is intended for use as the second stage of a sequential in vitro embryo culture protocol. MultiBlast Medium has been developed to support the growth of human embryos from day three through day five, postfertilization, including blastocyst formation.
MultiBlast Medium is intended for use in the culture of human embryos to the blastocyst stage of development.
Product codes (comma separated list FDA assigned to the subject device)
85 MQL
Device Description
MultiBlast Medium is a synthetic, defined medium, composed of a balance mixture of salts, amino acids, minerals and other nutrient substances designed to support embryonic growth and blastocyst development in vitro.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
MultiBlast Medium is assayed by mouse embryo assay prior to release to market. This assay assures that the product is both functional for its intended use, the support of embryonic growth, and that no toxic components are present in the formulation. MultiBlast Medium has been used in a variety of clinical settings, for its intended use, for a number of years. In that time, the product has become the one of the standard media used as the second, more complex stage of a sequential media protocol.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Invine Scientific
APR 2 6 2004
December 24, 2003
Page 1 of 3
510(k) SUMMARY AS REQUIRED BY SECTION 807.92(c)
Submitted by:
Irvine Scientific Sales Co., Inc. 2511 Daimler Street Santa Ana, CA 92705-5588
Telephone: (800) 437-5706 Facsimile: (949) 261-6522
Contact: Wendell Lee
Date Submitted: November 21, 2003
Device Identification:
| Trade Name: | MultiBlast Medium |
|---|---|
| Common Name: | In vitro embryo culture medium |
| Classification Name: | Reproductive Media (21 CFR, 886.6180) |
Predicate Device:
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
Description:
MultiBlast Medium is a synthetic, defined medium, composed of a balance mixture of salts, amino acids, minerals and other nutrient substances designed to support embryonic growth and blastocyst development in vitro.
1
December 24, 2003
K034065
003
Page 2 of 3
Intended Use:
MultiBlast Medium is intended for use as the second stage of a sequential in vitro embryo culture protocol. MultiBlast Medium has been developed to support the growth of human embryos from day three through day five, postfertilization, including blastocyst formation.
Technological Characteristics:
After allowing the fertilized zygote to develop in vitro in a less complex, glucose- and phosphate-free culture medium (usually through day three, postfertilization), the embryo is removed from the culture dish. It is placed into a fresh dish containing MultiBlast Medium, and protein supplementation. The dish is then returned to the incubator, and allowed to continue development, in vitro, until the desired stage of development has been achieved (usually day five postfertilization). At that time, the embryo is removed from the medium, placed into a HEPES-buffered transport medium, and implanted into the patient.
Performance Data:
MultiBlast Medium is assayed by mouse embryo assay prior to release to market. This assay assures that the product is both functional for its intended use, the support of embryonic growth, and that no toxic components are present in the formulation. MultiBlast Medium has been used in a variety of clinical settings, for its intended use, for a number of years. In that time, the product has become the one of the standard media used as the second, more complex stage of a sequential media protocol.
Additional Information:
Mouse embryo testing will be performed as a condition of release for this product, as well as endotoxin and sterility testing. Results of all release assays performed will be reported on a lot-specific certificate of analysis, and will be indicated on the labeling.
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K034063
December 24, 2003 Page 3 of 3
Conclusion:
The conclusion from performance testing, as well as a review of the historical information contained in professional literature shows that MultiBlast Medium is suitable for its intended use, and meets the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.
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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 stylized eagle with three wavy lines representing the department's mission to promote health, well-being, and human services. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 2004
Wendell Lee, Pharm. D. Vice President Regulatory Affairs/Quality Systems Irvine Scientific Sales Co., Inc. 2511 Daimler Street SANTA ANA CA 92705-5588
Re: K034063
Trade/Device Name: MultiBlast Medium Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL Dated: April 5, 2004 Received: April 9, 2004
Dear Dr. Lec:
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 Devicc 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 (sec above) into cither 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. 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 sct 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.
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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 the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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
Indications for Use
510(k) Number (if known): K034063
MultiBlast Medium Device Name:
Indications For Use: MultiBlast Medium is intended for use in the culture of human embryos to the blastocyst stage of development.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Segerson
Page 1 of 1
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K034063