K Number
K060983
Device Name
BIOPSY MEDIUM, MODEL REF 1062
Manufacturer
Date Cleared
2006-07-28

(109 days)

Product Code
Regulation Number
884.6180
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Biopsy Medium is intended for blastomere biopsy of cleavage stage embryos for PGD (preimplantation genetic diagnosis)
Device Description
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.
More Information

Not Found

No
The device description and intended use clearly define it as a sterile media solution for embryo biopsy, with no mention of software, algorithms, or data processing that would indicate AI/ML.

No.
The device facilitates the process of excising a blastomere from an embryo for pre-implantation genetic diagnosis, which is a diagnostic procedure, not a therapeutic one.

Yes

This device is a Biopsy Medium used for preimplantation genetic diagnosis (PGD), which is a diagnostic procedure to identify genetic defects in embryos before implantation. While the medium itself isn't performing the diagnosis, it's an essential component in the diagnostic process.

No

The device is a sterile media supplied in plastic vials, indicating it is a physical substance and container, not software.

Based on the provided information, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "for blastomere biopsy of cleavage stage embryos for PGD (preimplantation genetic diagnosis)". PGD is a diagnostic procedure performed on embryos in vitro (outside the body) to test for genetic abnormalities.
  • Device Description: The device 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)". This further reinforces its use in an in vitro diagnostic context.
  • Nature of the Device: The device is a medium used to facilitate a diagnostic procedure (biopsy for genetic testing) performed on biological material (embryos) in vitro.

While the device itself is a medium and not a test kit that directly measures a substance, it is an essential component used in vitro to enable a diagnostic procedure. This aligns with the definition of an IVD, which includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. In this case, the "condition" being diagnosed is the presence of genetic abnormalities in the embryo.

The predicate devices listed (K021358 Embryo Biopsy Medium from Irvine Scientific; K023850 Sydney IVF Embryo Biopsy Medium from Cook) also strongly suggest that this type of product is regulated as an IVD.

N/A

Intended Use / Indications for Use

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

Product codes

MQL

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Professionals within assisted reproduction

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K021358, K023850

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

510(k) summary

| Submitted by: | MediCult a/s
Møllehaven 12
4040 Jyllinge
Denmark
Telephone: + 45 46 79 02 00
Fax: + 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

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.

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.

1

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.

2

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

3

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
Other240-276-0100

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

4

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)

OR

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_