(130 days)
Lyophilized Early Cleavage Medium Kit is for use in assisted reproduction technology (ART) that involved the manipulation of gametes or embryos. Specifically, Lyophilized Early Cleavage Medium Kit is intended for use as a culture medium from fertilization through day three (3) of embryo development.
Lyophilized Early Cleavage Medium Kit is a synthetic, defined medium composed of a balanced mixture of salts and other nutrient substances designed to support early stages of embryonic growth (up to three days post-fertilization).
Here's a breakdown of the acceptance criteria and the study information for the Lyophilized Early Cleavage Medium (ECM) Kit, based on the provided document:
Acceptance Criteria and Device Performance
The document describes the performance of the Lyophilized Early Cleavage Medium Kit and its comparison to predicate devices, Early Cleavage Medium (K033462) and P-1 (K983589). The acceptance criteria are implicitly defined by the successful performance in the mouse embryo assay, demonstrating functionality and absence of toxicity comparable to the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (Lyophilized ECM Kit) |
|---|---|
| Supports embryonic growth | Demonstrated functionality in mouse embryo assay |
| Non-toxic | Demonstrated absence of toxic components in mouse embryo assay |
| Performance equivalent to predicate devices (Early Cleavage Medium K033462 and P-1 K983589) | Parallel mouse embryo studies showed equivalent performance to predicate devices |
Study Details
This submission describes a non-clinical study involving mouse embryo assays.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the numerical sample size (e.g., number of mouse embryos or assays) used for the test set. It mentions "parallel mouse embryo studies."
- Data Provenance: The studies were conducted by Irvine Scientific Sales Co., Inc., likely in their own facilities, to assess their product's performance prior to release to market. The data is prospective in relation to the submission date, as it was generated to support the 510(k) application. The country of origin is not explicitly stated but can be inferred as the USA, where Irvine Scientific is located and where the submission was made to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- This is a non-clinical study involving a mouse embryo assay, not human expert interpretation of data. Therefore, the concept of human experts establishing ground truth for the test set is not applicable in the same way as it would be for, for example, an imaging device. The "ground truth" is based on the biological outcome of embryonic growth in the mouse models.
4. Adjudication Method for the Test Set:
- Not applicable. As a non-clinical, objective biological assay, human adjudication of results is not described. The outcome of the mouse embryo assay (e.g., successful embryonic development, absence of toxicity) is a direct biological observation.
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:
- No. This is a non-clinical study evaluating an in vitro culture medium, not an AI-assisted diagnostic or interpretative device that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The mouse embryo assay is a standalone test of the culture medium's biological performance. It evaluates the medium itself without human intervention in the interpretative process (though human observation and execution of the assay are required). There is no "algorithm" involved in the sense of a digital diagnostic tool.
7. The Type of Ground Truth Used:
- Biological Outcome (Mouse Embryo Development): The ground truth is the observable biological effect of the culture medium on mouse embryos – specifically, their ability to support embryonic growth and the absence of toxic effects, as determined by the mouse embryo assay. This is a direct measure of the product's intended function.
8. The Sample Size for the Training Set:
- This document refers to performance testing for market release and comparison to predicate devices, not a 'training set' in the machine learning context. The studies described are for validation and verification of the product's performance. The previous studies on the predicate devices (K033462 and K983589) could be considered historical data that informed the design and expected performance of the new device, but they are not a training set for an algorithm. The sample size for those historical studies is not detailed here.
9. How the Ground Truth for the Training Set was Established:
- Not applicable as there is no "training set" in the machine learning sense. The ground truth for the performance testing (as described in point 7) was established through the direct biological observation of mouse embryo development in the assay.
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Irvine Scientific
September 14, 2007
K072607
pq. 102
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
JAN 25
Contact: Wendell Lee
Date Submitted: September 14, 2007
Device Identification:
| Trade Name: | Lyophilized Early Cleavage Medium (ECM) Kit |
|---|---|
| Common Name: | In vitro embryo culture medium |
| Product Code: | MLQ |
| Classification Name: | Reproductive Media (21 CFR, 884.6180) |
Predicate Device:
Early Cleavage Medium (K033462)
Description:
Lyophilized Early Cleavage Medium Kit is a synthetic, defined medium composed of a balanced mixture of salts and other nutrient substances designed to support early stages of embryonic growth (up to three days post-fertilization).
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K072607
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Intended Use:
Lyophilized Early Cleavage Medium Kit is intended for assisted reproductive technology (ART) that involves the manipulation of gametes and embryos. Specifically Lyophilized Early Cleavage Medium Kit is intended for use as a culture medium through day three (3) of embryo development.
Technological Characteristics:
After retrieval of oocytes from the patient, the oocytes are placed in a culture dish containing the reconstituted Lyophilized Early Cleavage Medium and the desired type and amount of protein supplementation. Fertilization is allowed to take place, and the zygote is removed to a fresh dish containing fresh Lyophilized Early Cleavage Medium and protein. This culture dish is placed into a carbon dioxide incubator, and the embryo is allowed to develop, in vitro, until the desired stage of development has been achieved, usually up to three days post fertilization. At that time, the embryo may be transferred to the patient, or to a second, more complex medium for continued growth.
Performance Data:
The Lyophilized Early Cleavage 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. Parallel mouse embryo studies have been performed on Early Cleavage Medium (K033462) and P-1 (K983589) to assure the performance of the Lyophilized Early Cleavage Medium Kit. These studies are similar to those previously performed, and submitted for the 510(k) of Early Cleavage Medium (K033462) and P-1 (K983589).
Additional Information:
Mouse embryo testing will be performed as a condition of release for these products, as well as endotoxin and sterility testing. Results of all release
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Irvine Scientific
K072607
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assays performed will be reported on a lot-specific certificate of analysis, and wil 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 the Lyophilized Early Cleavage Medium Kit is suitable for its intended use, and meet the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335. References are presented in Appendix F of this submission.
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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 curved lines representing its wings.
JAN 25 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wendell Lee, Pharm.D. Vice President Regulatory Affairs/Quality Systems Irvine Scientific Sales Company, Inc. 2511 Daimler Street SANTA ANA CA 92705
Re: K072607
Trade Name: Lyophilized Early Cleavage Medium (ECM) Kit Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: January 3, 2008 Received: January 4, 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, 1796, 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/cdrh/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)
072607 510(K) Number:_
Device Name: Lyophilized Early Cleavage Medium Kit
Indications for Use:
Lyophilized Early Cleavage Medium Kit is for use in assisted reproduction technology (ART) that involved the manipulation of gametes or embryos. Specifically, Lyophilized Early Cleavage Medium Kit is intended for use as a culture medium from fertilization through day three (3) of embryo development.
Prescription Use X
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)
Helentewner
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Page 1 of 1
Lyophilized Early Cleavage 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.