(135 days)
Lyophilized MultiBlast Medium Kit is intended for use in the culture of human embryos from day three (3) to the blastocyst stage of development.
Lyophilized MultiBlast Medium Kit 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.
The provided document is a 510(k) summary for a medical device called the "Lyophilized MultiBlast Medium Kit," which is an in vitro embryo culture medium. This type of device is a consumable product used in assisted reproductive technology and not an AI/ML powered diagnostic device. Therefore, many of the requested fields regarding acceptance criteria and study parameters for AI/ML devices are not applicable.
Here's an analysis based on the information provided, specifically addressing the aspects that are relevant to this type of device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functionality for intended use (support of embryonic growth and blastocyst development in vitro) | Assured by mouse embryo assay prior to market release. The predicate device (MultiBlast Medium) has a history of successful clinical use, suggesting the new device, being substantially equivalent, will also be functional. |
| Absence of toxic components | Assured by mouse embryo assay prior to market release. |
| Endotoxin testing | Performed as a condition of release. |
| Sterility testing | Performed as a condition of release. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The primary "testing" for this biological medium is through mouse embryo assay. The document doesn't specify a sample size for these assays, but states they are performed "prior to release to market" and "as a condition of release for this product." The data provenance is internal to Irvine Scientific (manufacturer). The nature of this testing is prospective, as it occurs for each lot of product before it is released.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The ground truth for a cell culture medium is its functional performance (supporting embryo development and being non-toxic), which is assessed by biological assays (mouse embryo assay) rather than expert interpretation of images or other data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML diagnostic device requiring adjudication of human-interpreted results.
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 is not an AI/ML diagnostic device, and therefore, no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth used is biological performance as demonstrated by mouse embryo assays, specifically the ability to support embryonic growth and blastocyst development, and the absence of toxic components. Additionally, historical clinical use data from the predicate device (MultiBlast Medium) contributes to the understanding of the intended use and expected outcomes.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
Summary of the study that proves the device meets the acceptance criteria:
The primary study proving that the Lyophilized MultiBlast Medium Kit meets its acceptance criteria is a mouse embryo assay. This assay is performed on each lot of the product prior to market release. The purpose of this assay is to ensure that the medium is:
- Functional for its intended use: capable of supporting embryonic growth and blastocyst development in vitro.
- Non-toxic: free from components that could harm embryos.
Additionally, the submission relies heavily on the substantial equivalence to the predicate device, MultiBlast Medium (K034063). The predicate device has a long history of successful clinical use, being a "standard media used as the second, more complex stage of a sequential media protocol." This historical clinical performance of the predicate device provides strong supportive evidence for the new device's suitability for its intended use, assuming the new device performs equivalently in the mouse embryo assays and other specified release tests (endotoxin and sterility testing).
No large-scale human clinical trial data is presented for this specific device, as the biological assay and substantial equivalence to a clinically established predicate device are deemed sufficient for this product class.
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Irvine Scientific
September 14, 2007
JAN 30
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: September 14, 2007
Device Identification:
| Trade Name: | Lyophilized MultiBlast Medium Kit |
|---|---|
| Common Name: | In vitro embryo culture medium |
| Classification Name: | Reproductive Media (21 CFR, 884.6180) |
Predicate Device:
K034063: MultiBlast Medium
Description:
Lyophilized MultiBlast Medium Kit 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.
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September 14, 2007
Intended Use:
Lyophilized MultiBlast Medium Kit is intended for use in the culture of human embryos from day three (3) to the blastocyst stage of development.
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 Lyophilized MultiBlast Medium Kit, 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 post-fertilization). At that time, the embryo is removed from the medium, placed into a HEPES-buffered transport medium, and implanted into the patient.
Performance Data:
Lyophilized MultiBlast Medium Kit 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 (K034063) 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
Lyophilized MultiBlast Medium Kit
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Irvine Scientific
performed will be reported on a lot-specific certificate of analysis, and will be indicated on the labeling.
Conclusion:
The conclusion from performance testing, as well as a review of the historical information contained in professional literature shows that Lyophilized MultiBlast Medium Kit 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The image is in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 30 2008
Wendell Lee, Pharm.D. Vice President, Regulatory Affairs/Quality Systems Irvine Scientific 2511 Daimler Street SANTA ANA CA 92705-5588
K072608 Re:
Trade/Device Name: Lyophilized MultiBlast Medium Kit Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: January 8, 2008 Received: January 17, 2008
Dear Dr. Lee:
We have reviewed vour 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 (PMA), 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.
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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); 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/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
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INDICATIONS FOR USE STATEMENT (page 1 of 1)
510(K) Number:__ ҚоフŽСОВ
Device Name: Lyophilized MultiBlast Medium Kit
Indications for Use:
Lyophilized MultiBlast Medium Kit is intended for use in the culture of human embryos from day three to the blastocyst stage of development.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Lyophilized MultiBlast Medium Kit
§ 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.