(128 days)
Blastocyst Medium is intended for use in assisted reproductive technology procedures that include gamete and embryo manipulation. Specifically, Blastoycst is intended for use as an in vitro culture medium from day three through day five of embryo development.
Blastocyst Medium is a synthetic, defined medium, composed of a balance mixture of salts, amino acids, vitamins, minerals and other nutrient substances designed to support embryonic growth and blastocyst development in vitro.
The provided text is a 510(k) summary for the Blastocyst Medium, an in vitro embryo culture medium. It describes the device, its intended use, technological characteristics, and performance data. However, it does not include the details typically found in a study proving a device meets specific acceptance criteria in the format requested.
Specifically, the document focuses on regulatory approval based on substantial equivalence to a predicate device and existing clinical use, rather than a detailed, quantitative study with acceptance criteria and measured performance outcomes as might be found for a new diagnostic or AI-driven medical device.
Therefore, many of the requested categories cannot be filled directly from the provided text because such a detailed performance study, with specific acceptance criteria, sample sizes, expert ground truth establishment, and statistical analysis, is not presented.
Here's a breakdown of what can be gleaned and what is missing, structured as per your request:
Acceptance Criteria and Study for Blastocyst Medium
Based on the provided text, the "acceptance criteria" are implied by the performance characteristics and the regulatory framework of substantial equivalence. The "study" largely refers to historical clinical use and pre-market quality control assays rather than a formal, controlled clinical trial with pre-defined statistical endpoints.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Implied from text) | Reported Device Performance (from text) |
|---|---|
| Functional for intended use: support embryonic growth | "Assures that the product is both functional for its intended use, the support of embryonic growth..." |
| Functional for intended use: support blastocyst development in vitro | "...designed to support embryonic growth and blastocyst development in vitro." |
| Non-toxic components | "...and that no toxic components are present in the formulation." |
| Support growth of human embryos from day three through day five post-fertilization, including blastocyst formation. | "Blastocyst Medium has been developed to support the growth of human embryos from day three through day five, postfertilization, including blastocyst formation." |
| Suitable for intended use, meets criteria outlined in 63 FR 48428, Docket 97N-0335 (Notice of Final Rule) | "The conclusion from performance testing, as well as a review of the historical information contained in professional literature shows that Blastocyst Medium is suitable for its intended use, and meets the criteria outlined in the Notice of Final Rule..." |
| Pass Mouse Embryo Assay (MEA) | "Blastocyst Medium is assayed by mouse embryo assay prior to release to market." |
| Pass Endotoxin and Sterility Testing | "Mouse embryo testing will be performed as a condition of release for this product, as well as endotoxin and sterility testing." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in terms of a test set for a formal study. The document mentions "Blastocyst Medium has been used in a variety of clinical settings, for its intended use, for a number of years." This implies a large, undocumented, real-world usage base. For the mouse embryo assay/endotoxin/sterility testing, the sample size is also not specified, likely referring toロット-specific testing.
- Data Provenance: Not explicitly stated beyond "historical information contained in professional literature" and usage in "a variety of clinical settings." No country of origin is specified for these historical applications, and it is entirely retrospective/uncontrolled observation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The decision of suitability is presented as a conclusion based on "performance testing" (likely internal quality control and historical use reviews) and "professional literature," not a formal expert consensus on a specific test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not described. There is no mention of a formal test set with adjudicated ground truth establishment.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an in vitro culture medium, not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC study and AI assistance are not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm. The performance is assessed by its ability to support embryo development.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance appears to be established through:
- Mouse Embryo Assay (MEA): A biological functional assay.
- Clinical Outcomes (historical): The success of IVF procedures where the medium was used, as inferred from "historical information contained in professional literature" and "variety of clinical settings."
- Regulatory Standards: Compliance with the "Notice of Final Rule, 63 FR 48428, Docket number 97N-0335."
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of Missing Information:
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence. It does not contain the detailed, quantitative efficacy data from a controlled clinical study typically associated with specific acceptance criteria and performance metrics for a novel medical device as would be required for a new diagnostic or AI product. The "performance data" section primarily refers to quality control assays (mouse embryo assay, endotoxin, sterility) and general historical clinical use, rather than a structured study with defined methodologies, sample sizes, and expert panel evaluations.
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2/18/99
Irvine Scientific
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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: Roberta L. Johnson
Date Submitted: October 9, 1998
Device Identification:
| Trade Name: | Blastocyst 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:
Blastocyst Medium is a synthetic, defined medium, composed of a balance mixture of salts, amino acids, vitamins, minerals and other nutrient substances designed to support embryonic growth and blastocyst development in vitro.
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Intended Use:
Blastocyst Medium is intended for use as the second stage of a sequential in vitro embryo culture protocol. Blastocyst 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 Blastocyst 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:
Blastocyst 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. Blastocyst 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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Conclusion:
The conclusion from performance testing, as well as a review of the historical information contained in professional literature shows that Blastocyst 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 1999
Roberta L. Johnson Manager, Regulatory Affairs Irvine Scientific 2511 Daimler Street Santa Ana, CA 92705
Re: K983580 Blastocyst Medium Dated: January 14, 1999 Received: January 19, 1999 Regulatory Class: II 21 CFR 884.6180/Procode: 85MOL
Dear Ms. Johnson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 Requlations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Capt. Daniel C. Schultz, M.D.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT (page 1 of 1)
510(K) Number: K983580
Device Name:_Blastocyst Medium
Indications for Use:
Blastocyst Medium is intended for use in assisted reproductive technology procedures that include gamete and embryo manipulation. Specifically, Blastoycst is intended for use as an in vitro culture medium from day three through day five of embryo development.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K983580/S⁰⁰¹
Blastocyst Medium
§ 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.