(46 days)
For freezing and thawing human blastocysts.
BlastFreeze™: For freezing of human blastocysts.
BlastThaw™: For thawing of human blastocysts.
BlastFreeze™ and BlastThawTM, Cat.No. 10532010 and 10542010. BlastFreeze and BlastThaw are based on Earle's Balanced Salts Solution and differing concentrations of sucrose. BlastFreeze contains glycerol as the cryprotectant.
Here's a breakdown of the acceptance criteria and study information for the BlastFreeze™ and BlastThaw™ devices, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterility | Product testing controls are reported, and a Certificate of Analysis is available for each batch. (Specific results not given) |
| pH | Product testing controls are reported, and a Certificate of Analysis is available for each batch. (Specific results not given) |
| Endotoxin | Endotoxin tested ≤ 0.1 EU/ml (USP). A Certificate of Analysis confirms this for each batch. |
| Mouse Embryo Assay (2-cell) | Blastocyst rate µ 80 %. A Certificate of Analysis confirms this for each batch. |
| Survival Rate (clinical) | Around 80% after freezing and thawing of human blastocysts. |
| Implantation Rate | 15% after freezing and thawing of human blastocysts. |
| Abortion Rate | 14% in IVF patients and 0% in ICSI patients. (Lowered compared to other methods). |
| Adverse Events | No registered complaints and no evidence of serious adverse events since commercialization in Europe (April 2002). |
Study Details
The provided document describes a clinical documentation approach supported by a substantially equivalent argument to a predicate device (K991471). It does not outline a formal, prospective clinical trial in the traditional sense with specific statistical endpoints to meet acceptance criteria. Instead, it relies on accumulated clinical experience and comparison to existing products.
Here's what can be inferred and what is not explicitly stated:
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "clinical documentation" and "daily clinical practice" but does not give a specific number of cases or patients included in the reported survival, implantation, and abortion rates.
- Data Provenance: The document states, "BlastFreeze and BlastThaw were marketed in Europe in April 2002. There has been no registered complaints and no evidence that the product has been the cause of any serious adverse events in connection with its intended use." This suggests the clinical data is retrospective and derived from real-world usage in Europe.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. Given that the data is presented as aggregated clinical outcomes from "daily clinical practice," it's highly unlikely that a formal ground truth establishment process with a defined number of experts was conducted for this submission. The outcomes (survival, implantation, abortion) are typically documented by treating clinicians in a standard IVF clinic setting.
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Adjudication method for the test set:
- Not applicable/Not mentioned. There is no indication of an adjudication method as would be used in a blinded, prospective study. The clinical outcomes are likely recorded as part of routine patient care.
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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 medical device for freezing/thawing blastocysts, not an AI-powered diagnostic device. Therefore, an MRMC study and AI-related effectiveness are not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a cryopreservation solution used by human embryologists/clinicians with human intervention. It is not an algorithm that performs tasks independently.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the clinical performance metrics (survival rate, implantation rate, abortion rate) is based on patient outcomes data collected during routine clinical practice (IVF/ICSI cycles).
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The sample size for the training set:
- Not applicable. The "study" here is not an algorithm a's training. It's a submission for a medical device (cryopreservation media) that relies on clinical performance data and substantial equivalence to a predicate device.
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How the ground truth for the training set was established:
- Not applicable. As stated above, there is no "training set" in the context of an algorithm. The clinical data supports the observed performance of the product in human embryology procedures. The document does reference "Ménézo. Y and Veiga.A. 1997" for similar results, suggesting a comparison to published literature or internal data used to inform the observed performance.
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KO31486
510(k) Summary Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
The Products
BlastFreeze™ and BlastThawTM, Cat.No. 10532010 and 10542010
Indications for use:
For freezing and thawing human blastocysts.
Composition:
BlastFreeze and BlastThaw are based on Earle's Balanced Salts Solution and differing concentrations of sucrose. BlastFreeze contains glycerol as the cryprotectant.
Stability and biocompatibility testing
BlastFreeze and BlastThaw have been stability tested. When following the procedure described in our package inserts BlastFreeze and BlastThaw will not be patient contacting that is why biocompatibility testing has not been performed.
Product testing controls
-
- Sterility
-
- pH
-
- Endotoxin tested ≤ 0.1 EU/ml ( USP)
-
- Mouse Embryo Assay, (two-cell assay, blastocyst rate µ 80 %)
For each batch a Certificate of Analysis with the results of the above tests is available.
Clinical Documentation:
The clinical documention show a survival rate of around 80% and an implantation rate of 15% after freezing and thawing of human blastocysts. No difference in results between IVF and ICSI. The abortion rate is low, being 14 % in IVF patients and 0 in ICSI patients.
BlastFreeze and BlastThaw products have demonstrated their suitability in daily clinical practice for freezing and thawing of blastocysts giving survival and implantation rates similar to the results obtained by using other products available for freezing and thawing blastocysts ( Ménézo. Y and Veiga.A. 1997 ). In addition, by using BlastFreeze and BlastThaw the abortion rate can be lowered.
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BlastFreeze and BlastThaw were marketed in Europe in April 2002. There has been no registered complaints and no evidence that the product has been the cause of any serious adverse events in connection with its intended use.
Based on the clinical data presented and our experience with the BlastFreeze and BlastThaw products we feel that the safety and effectiveness of the product for its intended use is shown in the present submission and the products are substantially equivalent to the predicated devices, our Blastocyst Freezing Pack and Blastocyst Thawing Pack ( K 991471)
Prepared and Submitted by:
Date
Ronald G. Leonardi, Ph.D. President R & R REGISTRATIONS P.O. Box 262069 San Diego, Ca 92131 858-586-0751
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its head, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2003
Medi-Cult a/s % Ronald G. Leonardi, Ph.D. President R & R Registrations P.O. Box 262069 SAN DIEGO CA 92196-2069 Re: K031486
Trade/Device Name: BlastFreeze™ and BlastThawTM Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL Dated: May 9, 2003 Received: May 14, 2003
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 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.
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.
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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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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
Page 2
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510(k) Number (if known)
k 031486
Device Name:
BlastFreeze™ and BlastThaw™
INDICATIONS FOR USE: BlastFreeze™: For freezing of human blastocysts.
BlastThaw™: For thawing of human blastocysts.
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use 1 (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
David A. Ayres
productive, Abdominal, a De . 10(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.