BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216

K080172 · Medicult A/S · MQL · Dec 18, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K080172
• Device Name: BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216
• Applicant: Medicult A/S
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Dec 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

BlastAssist® and BlastAssist® with Phenol Red are used for culture of embryos from the 4-8 cell stage through to blastocyst stage. Can also be used for transfer,

Device Story

BlastAssist® and BlastAssist® with Phenol Red are sterile culture media used by assisted reproduction professionals in clinical settings. The media supports embryo development from the 4-8 cell stage to the blastocyst stage and facilitates embryo transfer. The formulation consists of a physiological salt solution supplemented with Synthetic Serum Replacement (SSR), human serum albumin (HSA), ethanolamine, amino acids, vitamins, and a stable form of L-glutamine. The device is supplied in 10 ml polyethylene vials. It is used as a chemical environment for ex vivo embryo maintenance, allowing clinicians to monitor and support development before implantation. The product is intended to provide a stable, nutrient-rich environment to improve embryo viability, potentially increasing the success rate of assisted reproductive procedures.

Clinical Evidence

Human study conducted to evaluate safety and effectiveness. No complaints or adverse events reported during the study. Product testing controls include batch testing for sterility, osmolality, pH, endotoxin, and Mouse Embryo Assay (MEA) per Ph. Eur. and USP standards.

Technological Characteristics

Physiological salt solution base; contains SSR, HSA, ethanolamine, amino acids, stable L-glutamine, vitamins, and antibiotics. Supplied in 10 ml polyethylene vials with screw top closures. Batch testing per Ph. Eur. and USP standards for sterility, osmolality, pH, endotoxin, and MEA.

Indications for Use

Indicated for culture of embryos from 4-8 cell stage to blastocyst stage and for embryo transfer in patients undergoing assisted reproduction.

Regulatory Classification

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.).

Special Controls

*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.

Predicate Devices

• BlastAssist System (K003156)

Submission Summary (Full Text)

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K080172
pg. 1 of 2

DEC 1 8 2008

## 510(K) SUMMARY Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

| Submitted by: | MediCult a/s<br>Møllehaven 12<br>4040 Jyllinge<br>Denmark<br>Telephone: + 45 46 79 02 00<br>Fax: + 45 46 79 03 00 |
|-----------------|-------------------------------------------------------------------------------------------------------------------|
| Contact person: | Ronald G. Leonardi, Ph.D. |

#### Device Identification

Trade name: BlastAssist® and BlastAssist® with Phenol Red Common name: BlastAssist® and BlastAsist® with Phenol Red Classification name: Reproductive media and supplements (21 CFR 884.6180, Product Code MQL)

Date Submitted: January 23, 2008

### Predicate device:

BlastAssist System (K003156) from MediCult.

## Description

BlastAssist® and BlastAssist® with Phenol Red are defined sterile media, used by assisted reproduction professionals and intended for culture of embryos from the 4-8 cell stage to blastocyst stage and for embryo transfer.

The design of BlastAssist® and BlastAssist® with Phenol Red is based on BlastAssist® System Medium 2 ( K003156). The BlastAssist® medium is a salt solution added SSR (Synthetic Serum Replacement), HSA, ethanolamine, amino acids, a stable form of L-glutamine, vitamins and antibiotics.

BlastAssist® is supplied in 10 ml polyethylene plastic vials with screw top closures

## Intended use

BlastAssist® and BlastAssist® with Phenol Red are used for culture of embryos from the 4-8 cell stage through to blastocyst stage. Can also be used for transfer,

## Technological Characteristics

The technological characteristics of BlastAssist® are essentially similar to those of the predicate device as they have the same intended use and are based on a physiological salt solution with SSR and amino acids. However, BlastAssist® differs in the composition in containing vitamins and ethanolamine. This change does not affect the safety or effectiveness of the device. To prolong the stability of the product a stable form of glutamine has been added.

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### Performance data

BlastAssist® has been tested in a human study. The results showed that the product is effective and safe for its intended use. During our study no complaints and no adverse events has been registered in connection with the intended use.

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#### Product Testing Controls

Each batch of BlastAssist® is tested according to Ph. Eur. and USP for sterility, osmolality, pH, endotoxin and Mouse embryo Assay (MEA). Stability studies have been performed.

#### Conclusion

It is concluded 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 MediCult's BlastAssist® System (K003156).

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 1 8 2008

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

Re: K080172

> Trade/Device Name: BlastAssist® Regulation Number: 21 CFR §884.6180 Regulation Name: Assisted Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: December 1, 2008 Received: December 2, 2008

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 (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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## 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 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 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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

logu M. Whang

Joyce M. Whang, Ph.D. Acting 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):

K080/72

Device Name:

BlastAssist®

Indications For Use:

BlastAssist® is for culture from the 4-8 cell stage through to blastocyst stage. Can also be used for embryo transfer.

Prescription Use x AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Helen Thomas

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

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# Indications for Use

510(k) Number (if known):

(KNOWN).

Device Name:

BlastAssist® with Phenol Red

Indications For Use:

BlastAssist® with Phenol Red is for culture from the 4-8 cell stage through to blastocyst stage. Can also be used for embryo transfer.

1080172

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use_ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

Herbert Reimer

(Division Sign-Off) (Division Sign-On)
Division of Reproductive, Abdominal, Division of Radiological Devices 510(k) Number.