(329 days)
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.
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
The provided document (K080172) is a 510(k) Summary for a reproductive media device (BlastAssist®), not an AI/ML medical device. Therefore, many of the requested details regarding AI/ML device acceptance criteria and performance studies (such as MRMC studies, effect size of human reader improvement with AI, ground truth establishment for training sets, etc.) are not applicable to this submission.
However, I can extract the relevant information regarding the performance data and product testing controls mentioned for this specific device.
Here's the information based on the provided text, tailored to what is applicable for a medical device like BlastAssist®:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (BlastAssist®) |
|---|---|
| Clinical Performance | Effective for its intended use (culture of embryos from 4-8 cell stage to blastocyst stage, and embryo transfer). No complaints and no adverse events registered during the study. |
| Safety | Safe for its intended use. No complaints and no adverse events registered during the study. |
| Sterility | Tested according to Ph. Eur. and USP. |
| Osmolality | Tested according to Ph. Eur. and USP. |
| pH | Tested according to Ph. Eur. and USP. |
| Endotoxin | Tested according to Ph. Eur. and USP. |
| Mouse embryo Assay (MEA) | Performed for each batch. |
| Stability | Stability studies have been performed. |
| Substantial Equivalence | Concluded to be substantially equivalent to the predicate device (MediCult's BlastAssist® System K003156). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document states "BlastAssist® has been tested in a human study." However, the specific sample size (number of embryos, patients, or study participants) for this human study is not provided in the summary.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study was a "human study," implying prospective clinical assessment, but further details are not given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. The performance assessment was based on the effectiveness and safety of the media in embryo culture, likely evaluated by assisted reproduction professionals (e.g., embryologists), but no details on expert panels for 'ground truth' in the AI sense are relevant here.
4. Adjudication method for the test set
- Not applicable and not provided. This is relevant for AI/ML studies where multiple human readers might disagree; for a media product, effectiveness is typically measured by biological outcomes.
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. An MRMC study is not relevant for this type of medical device (embryo culture media) and was not performed. This is an AI/ML-specific study design.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is an embryo culture media, not an algorithm.
7. The type of ground truth used
- The "ground truth" for the device's performance was its demonstrated effectiveness in supporting embryo development to the blastocyst stage and safety (absence of complaints/adverse events) in a human study, and its ability to pass various biochemical and biological quality control tests (sterility, osmolality, pH, endotoxin, MEA, stability).
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set. The "design" (formulation) was based on the predicate device and modified with new ingredients (vitamins, ethanolamine, stable L-glutamine).
9. How the ground truth for the training set was established
- Not applicable. As above, there is no 'training set' in the AI/ML sense for this product. The development of the media was based on scientific formulation and empirical testing (performance data, product testing controls).
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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/sMøllehaven 124040 JyllingeDenmarkTelephone: + 45 46 79 02 00Fax: + 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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Image /page/1/Picture/0 description: The image shows handwritten text that appears to be a combination of letters and numbers. The first line reads 'KOXO172', and the second line reads 'pg. 2 of 2'. The handwriting is somewhat stylized, with distinct strokes and varying line thickness.
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.
raz
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 (800) 638-2041 or (240) 276-3150 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.
§ 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.