MediCult Biopsy Medium is a defined sterile media used by professionals within assisted reproduction and designed for blastomere biopsy of cleavage stage embryos for pre-implantation genetic diagnosis (PGD). The formulation is based on a HEPES-buffered HTF solution added SSR (Synthetic Serum Replacement: ART supplement), human serum albumin (HSA) and amino acid but without calcium and magnesium ions to facilitate the process of biopsy. The absence of calcium and magnesium ions reversibly reduces the cellular connection between the blastomeres making it easy to excise a blastomere from the embryo without fatal trauma.
Biopsy Medium is supplied in 10 ml polyethylene plastic vials with screw top closures.

AI/ML Overview

The provided text describes a 510(k) submission for the MediCult Biopsy Medium. It includes details about the device's intended use, technological characteristics, and performance data. However, the document is a regulatory submission and approval letter, not a detailed study report. Therefore, it lacks specific information typically found in a scientific study.

Based on the provided information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the device as meeting its intended use but does not present a table with explicit acceptance criteria or quantitative performance metrics that would typically be found in a study for medical devices requiring specific performance measurements.

Acceptance Criteria	Reported Device Performance
Implied Acceptance Criteria
Effective for intended use (blastomere biopsy)	"The results showed that the product is effective for its intended use."
No serious adverse events	"no evidence of any serious adverse events in connection with the intended use."
No registered complaints	"no registered complaints"
Cytotoxicity	"Biopsy Medium has been cytotoxicity tested." (Implicitly passed, as it was deemed effective and safe)
Stability	"Stability studies have been performed." (Implicitly passed, as it was deemed effective and safe)
Sterility (Ph. Eur. and USP)	"Each batch is tested according to Ph. Eur. and USP for sterility..." (Implicitly passed for each batch)
Osmolality	"...osmolality..." (Implicitly passed for each batch)
pH	"...pH..." (Implicitly passed for each batch)
Endotoxin	"...endotoxin..." (Implicitly passed for each batch)
MEA (Mouse Embryo Assay, implied for ART products)	"...and MEA." (Implicitly passed for each batch)

Note: The acceptance criteria are largely implied by the statements that the product is "effective," "safe," and has "no serious adverse events" or "registered complaints." Specific numerical thresholds or pass/fail criteria are not detailed in this document.

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

Sample Size for Test Set: Not explicitly stated. The document mentions a "human study" but does not provide the number of participants or embryos involved in this study.
Data Provenance: The human study was conducted in a European context, as it states the device "has been marketed in Europe since 2002." It is implied to be retrospective reporting of clinical experience rather than a prospective trial designed to specifically test the device's performance in a controlled manner, though the exact study design is not detailed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

N/A. This information is not provided in the document. For a product like a biopsy medium, "ground truth" would likely relate to embryo viability, successful biopsy, or genetic diagnosis outcomes, which would be assessed by embryologists, geneticists, or other ART professionals. However, the document does not specify how these outcomes were assessed or by whom.

4. Adjudication Method for the Test Set

N/A. The document does not describe any specific adjudication method.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study is typically relevant for diagnostic imaging devices where human readers interpret results with and without AI assistance. This device is a culture medium used in a laboratory procedure, not an imaging device with human interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

N/A. This question is not applicable as the device is a biopsy medium, not an AI algorithm. Its performance is intrinsically tied to its use by human embryologists/technicians in a laboratory setting.

7. The Type of Ground Truth Used

The "ground truth" for evaluating the efficacy of the biopsy medium would indirectly relate to:

Successful blastomere excision without fatal trauma to the embryo.
Viability and further development of the biopsied embryo.
Accuracy of subsequent PGD results (though the medium itself doesn't directly perform diagnosis, it facilitates the sample collection).

The document states, "The results showed that the product is effective for its intended use." This implies that the human study observed positive outcomes related to these aspects, but the specific metrics and how ground truth was established (e.g., through embryo development rates, successful genetic diagnosis, etc.) are not detailed.

8. The Sample Size for the Training Set

N/A. The concept of a "training set" is typically associated with machine learning or AI models. This device is a chemical medium, not a software algorithm that would require a training set.

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

N/A. As there's no training set for this type of device, this question is not applicable.

Summary

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510(k) summary

Submitted by:	MediCult a/sMøllehaven 124040 JyllingeDenmarkTelephone: + 45 46 79 02 00Fax: + 45 46 79 03 00	K060983
Contact person:	Ronald G. Leonardi, Ph.D.Date Submitted: June 15, 2006	JUL 28 2006

Device Identification

Trade name: Biopsy Medium Common name: Biopsy Medium Classification name: Reproductive media and supplements (21 CFR 884.6180, Product Code MQL)

Predicate device:

Embryo Biopsy Medium from Irvine Scientific (K021358) and the Sydney IVF Embryo Biopsy Medium from Cook (K023850).

Description

Biopsy Medium is supplied in 10 ml polyethylene plastic vials with screw top closures.

Intended use

Biopsy Medium is intended for blastomere biopsy of cleavage stage embryos for PGD (preimplantation genetic diagnosis)

Technological Characteristics

The technological characteristics of Biopsy Medium are essentially similar to those of the predicate devices they have the same intended use and are based on a physiological salt solution with amino acids and like the predicate devices without calcium and magnesium. However, Biopsy Medium differs in the composition in containing SSR. This change does not affect the safety or effectiveness of the device.

Performance data

Biopsy Medium has been tested in a human study. The results showed that the product is effective for its intended use.

If has been marketed in Europe since 2002 and there has been no registered complaints and no evidence of any serious adverse events in connection with the intended use.

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Product Testing Controls

Biopsy Medium has been cytotoxicity tested. Each batch is tested according to Ph. Eur. and USP for sterility, osmolality, pH, endotoxin and MEA. The results are reported on a certificate of analysis. Stability studies have been performed.

Conclusion

Thus based on the performance testing presented and our experience with the Biopsy Medium product, we feel that the safety and the effectiveness of the product for its intended use is shown in the present submission and that the product is substantial equivalence to the predicated device.

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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol, composed of three curved lines that suggest the wings and body of a bird. The seal appears to be a logo or emblem, likely representing the U.S. Department of Health and Human Services.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 2 8 2006

MediCult a/s % Ronald G. Leonardi, Ph.D. President R & R Registrations 9915 Cam. Chirimolla SAN DIEGO CA 92131

Re: K060983

Trade/Device Name: Biopsy Medium Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: July 10, 2006 Received: July 11, 2006

Dear Dr. Leonardi:

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 (Premarket Approval), 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.

Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, followed by the letters "DA" in a bold, blocky font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial". The logo appears to be a commemorative emblem for a centennial celebration.

oting Public

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Page 2 -

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 $10(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 this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

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 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 vours,

Nancy C. Hogdon

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

KO60983 510(k) Number (if known)

Biopsy Medium Device Name:

Indications for Use:

Biopsy Medium is indicated for blastomere biopsy of cleavage stage embryos for PGD (pre-implantation genetic diagnosis)

(PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Dennis Harrison

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_

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.