(46 days)
K 991471
Not Found
No
The document describes a cryopreservation solution and its performance metrics, with no mention of AI or ML technology.
No.
The devices are solutions for freezing and thawing human blastocysts, which are for preservation purposes, not for treating a disease or condition in a patient.
No
Explanation: The device is described as being for freezing and thawing human blastocysts, and its performance is measured by survival, implantation, and abortion rates. There is no indication that it is used to diagnose a disease or condition. It is a tool for cryopreservation, not diagnosis.
No
The device description clearly states that BlastFreeze™ and BlastThaw™ are based on Earle's Balanced Salts Solution and differing concentrations of sucrose, and BlastFreeze contains glycerol as the cryoprotectant. These are chemical solutions, not software.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "For freezing of human blastocysts" and "For thawing of human blastocysts." Blastocysts are human cells/tissue.
- Device Description: The device is a solution used to preserve and revive these human cells.
- Context: The context of freezing and thawing blastocysts is directly related to assisted reproductive technologies (ART), which involve handling human gametes and embryos in vitro (outside the body).
- Performance Studies: The performance studies discuss survival rates, implantation rates, and abortion rates after using the product on human blastocysts. These are clinical outcomes related to the viability and development of the blastocysts in vitro and subsequently in vivo.
- Predicate Device: The predicate device listed (K 991471; Blastocyst Freezing Pack and Blastocyst Thawing Pack) is also likely an IVD device used for the same purpose.
While the description doesn't explicitly state "in vitro diagnostic," the nature of the product, its intended use on human cells outside the body, and the context of its application in ART strongly indicate that it falls under the definition of an IVD device. IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. In this case, the product is used to preserve and prepare human blastocysts for potential implantation, which is a critical step in ART and involves assessing the viability and potential of these in vitro specimens.
N/A
Intended Use / Indications for Use
For freezing and thawing human blastocysts.
BlastFreeze™: For freezing of human blastocysts.
BlastThaw™: For thawing of human blastocysts.
Product codes (comma separated list FDA assigned to the subject device)
85 MQL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Survival rate of around 80% and an implantation rate of 15% after freezing and thawing of human blastocysts. The abortion rate is low, being 14 % in IVF patients and 0 in ICSI patients.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K 991471
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
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
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- Sterility
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- pH
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- Endotoxin tested ≤ 0.1 EU/ml ( USP)
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- 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.
1
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
2
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.
3
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
4
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