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.

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.

AI/ML Overview

The provided document is a 510(k) summary for a reproductive medium called MultiBlast Medium, not a study describing a device's performance against acceptance criteria in the typical sense of a medical device with an algorithm or outcome prediction. The document describes the intended use and technological characteristics of the medium and states that it meets criteria outlined in a Notice of Final Rule (63 FR 48428, Docket number 97N-0335).

Therefore, many of the requested categories in the prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission for an in vitro embryo culture medium.

However, I can extract the information that is present and indicate where information is not available within the provided text.

Acceptance Criteria and Device Performance for MultiBlast Medium

Acceptance Criteria (Inferred from regulatory context)	Reported Device Performance
Functional for unintended use (support of embryonic growth)	MultiBlast Medium is assayed by mouse embryo assay prior to release to market to assure it is "functional for its intended use, the support of embryonic growth."
Absence of toxic components	The mouse embryo assay also assures "that no toxic components are present in the formulation."
Sterility	Sterility testing will be performed as a condition of release.
Endotoxin levels	Endotoxin testing will be performed as a condition of release.
Suitability for intended use, meeting criteria of 63 FR 48428	The conclusion from performance testing and historical information shows "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."

Study Details:

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions a "mouse embryo assay" but does not quantify the number of embryos or assays performed for pre-market release or for the historical information.
- Data Provenance: The mouse embryo assay is a routine batch release test. The document also refers to "historical information contained in professional literature" and mentions that the product "has been used in a variety of clinical settings, for its intended use, for a number of years," becoming a "standard media." This suggests the efficacy is based on established clinical use and biological principles, rather than a specific prospective clinical trial designed for this 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. The "ground truth" for a culture medium revolves around its biological performance (embryo viability and development). This is assessed via standardized biological assays (mouse embryo assay) and historical clinical use data, not through expert consensus on interpretations of complex data like images.
Adjudication method for the test set:
- Not Applicable. No adjudication method is described as the performance is based on biological assays and historical clinical use, not interpretations requiring human reader consensus.
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:
- No. This is not a device with an AI component or one that involves human-in-the-loop interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithmic device.
The type of ground truth used:
- Biological Outcome/Performance: The ground truth is the successful support of embryonic growth and development to the blastocyst stage in vitro, as assessed by a mouse embryo assay and implied by historical clinical use.
The sample size for the training set:
- Not Applicable. This device is a culture medium, not a machine learning algorithm that requires a training set. The "historical information" and "variety of clinical settings" mentioned are more akin to general clinical experience rather than a structured training set for a computational model.
How the ground truth for the training set was established:
- Not Applicable. (See #7).

Summary

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Invine Scientific

APR 2 6 2004

December 24, 2003

K034063

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:

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December 24, 2003

K034065
003
Page 2 of 3

Intended Use:

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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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

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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

Regulation Number and Section

§ 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.