Single Step Medium is intended for use in assisted reproductive procedures which include gamete and embryo manipulation. These procedures include the use of Single Step Medium as a culture medium from fertilization through day 5/6 of embryo development in vitro.

Device Description

Single Step Medium is a synthetic, defined medium, composed of a balance mixture of salts, amino acids, minerals and other nutrient substances designed to be used during fertilization and culture of zygote/embryo through the desired development stage (up to 5/6 days) in vitro.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Irvine Scientific Single Step Medium (K072609):

Overall Assessment:

The provided document is a 510(k) summary for a reproductive media device. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a comprehensive clinical study with detailed acceptance criteria and performance metrics typically seen for high-risk devices or AI/software. The "performance data" section primarily describes a quality control assay and makes a general statement about the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated/Inferred)	Reported Device Performance
Functional for intended use: Support of embryonic growth	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. (No specific quantitative metric or pass/fail threshold is provided in this document).
Absence of toxic components: Assured by assay	Assayed by mouse embryo assay prior to release to market. This assay assures...that no toxic components are present in the formulation. (No specific quantitative metric or pass/fail threshold is provided in this document).
Meets criteria outlined in Notice of Final Rule, 63 FR 48428	"The conclusion from performance testing, as well as a review of the historical information contained in professional literature in addition to the comparison to the predicate devices show that Single Step Medium is suitable for its intended use, and meets the criteria outlined in the Notice of Final Rule..." (This is a general statement of compliance, not a specific performance metric.)
Substantial Equivalence to Predicate Devices (K034063, K053552)	Demonstrated through comparison of intended use and technological characteristics. The FDA's 510(k) clearance implies that this criterion was met.
Mouse embryo testing (as condition of release)	"Mouse embryo testing will be performed as a condition of release for this product." (This is a future quality control action, not a performance result from a specific study for this submission).
Endotoxin testing (as condition of release)	"Endotoxin...testing will be performed as a condition of release."
Sterility testing (as condition of release)	"Sterility testing will be performed as a condition of release."

Note: For this type of device (in vitro embryo culture medium), the "acceptance criteria" are predominantly related to manufacturing quality control (sterility, endotoxin), general functionality as demonstrated by a biological assay (mouse embryo assay), and comparison to legally marketed predicate devices for substantial equivalence. The document does not provide specific numerical performance targets (e.g., embryo blastocyst rates, live birth rates) from a clinical study for K072609, but rather references a quality control test and general concordance with regulatory requirements.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified for a discrete "test set" in the context of a clinical study. The performance data section refers to a "mouse embryo assay," which is a quality control test. The number of mouse embryos used in this assay is not provided.
Data Provenance: The mouse embryo assay is an internal quality control measure. No information is given about the country of origin for any human clinical data because clinical studies, in the typical sense for a new device's primary efficacy, are not presented for K072609. The document mentions that the predicate device (MultiBlast Medium) "has been used in a variety of clinical settings." This implies real-world usage, but no specific study details are provided for K072609 itself.

3. Number of Experts and Qualifications for Ground Truth

Not Applicable. The document does not describe a study involving expert review for establishing ground truth, as it is not a diagnostic device or an AI/software product requiring human interpretation. The "ground truth" for this product is its biological efficacy in supporting embryo development, which is assessed via an in vitro mouse embryo assay, not expert consensus.

4. Adjudication Method

Not Applicable. As no expert review or human interpretation study is described, there is no need for an adjudication method like 2+1 or 3+1.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not mentioned. This type of study is typically relevant for diagnostic imaging devices or AI systems that assist human readers in making diagnoses. This device is a culture medium.

6. Standalone Performance Study (Algorithm Only)

Not Applicable. This is a physical biological medium, not an algorithm or AI product.

7. Type of Ground Truth Used

The primary "ground truth" or performance assessment method described is the mouse embryo assay. This is an in vitro biological assay designed to assess the product's ability to support embryonic growth and its lack of toxicity. It's a form of biological assay outcome data.
The overall "ground truth" for K072609's market clearance is substantial equivalence to legally marketed predicate devices, meaning it performs as expected for its intended use based on comparison rather than entirely novel clinical trial data.

8. Sample Size for the Training Set

Not Applicable. This is not an AI/ML product, so there is no concept of a "training set" in the conventional sense for algorithm development.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. (See point 8).

Summary

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K072609

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:	Single Step Medium
Common Name:	In vitro embryo culture medium
Classification Name:	Reproductive Media (21 CFR, 884.6180)

Predicate Device:

Final Rule, 63 FR 48428, Docket number 97N-0335 MultiBlast Medium (K034063) global®: fertilization, embryo culture and transfer medium (K053552)

Description:

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Intended Use:

Technological Characteristics:

After allowing the fertilized zygote to develop in vitro in Single Step Medium, the embryo is removed from the culture dish. It is placed into a fresh dish containing Single Step Medium, and protein supplementation. The dish is then returned to the incubator, and the embryo is allowed to continue develop in vitro. The media is replenished after forty-eight (48) hours with fresh media and the embryo is further incubated until the desired stage of development has been achieved (up to 5/6 days) in vitro. After the desired stage of development is obtained the embryo is implanted into the patient.

Performance Data:

Single Step 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 (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 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 in addition to the comparison to the predicate devices show that Single Step 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. References are presented in Appendix F.

Product Name	K #	FertilizationMedium	Culture ofEmbryosfromDay 3 to 5/6	Culture ofEmbryosup toDay 5/6	TransferMedium
Single StepMedium	K072609	✓		✓
MultiBlast Medium	K034063		✓
global®:fertilization,embryo cultureand transfermedium	K053552	✓		✓	✓

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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 a stylized image of an eagle with three lines representing its wings.

FEB 1 2 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wendell Lee, Pharm.D. Vice President, Regulatory Affairs/Ouality Systems Irvine Scientific Sales Co., Inc. 2511 Daimler Street SANTA ANA CA 92705-5588

Re: K072609

Trade/Device Name: Single Step Medium Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MOL Dated: January 28, 2008 Received: January 29, 2008

Dear Dr. Lee:

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 (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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Irvine Scientific

INDICATIONS FOR USE STATEMENT (page 1 of 1)

510(K) Number: KO7 2609

Device Name: Single Step Medium

Indications for Use:

Prescription Use X (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)

Janair Brigdon

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices

510(k) Number

Page 1 of

Single Step Medium

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.