(391 days)
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No
The 510(k) summary describes a chemical solution for freezing and thawing blastocysts and does not mention any software, algorithms, or AI/ML components.
No.
This device is for the freezing and thawing of blastocysts, which are biological samples. It does not directly treat a disease or condition in a patient.
No
The device is described as a "Freezing Pack" and "Thawing Pack" for blastocysts, used in a two-step procedure. Its function is to preserve and rehydrate blastocysts, which is a life-support or preservation function, not a diagnostic one that identifies or characterizes a disease or condition.
No
The device description clearly indicates the product is a "Pack" containing specific chemical components (glycerol, sucrose) and a basal medium, which are physical substances, not software.
Based on the provided information, it is highly likely that this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "freezing of blastocysts" and "thawing of blastocysts." Blastocysts are human embryos, and these procedures are performed in vitro (outside the body) in a laboratory setting.
- Device Description: The device consists of "packs" containing media and cryoprotectants (glycerol and sucrose). These are chemical reagents and solutions used to manipulate biological samples in vitro.
- Context: The mention of "clinical data" and comparison to a study by "Menezo et al." suggests the device is used in a clinical context related to assisted reproductive technologies (ART), which heavily relies on in vitro procedures.
Why it fits the definition of an IVD:
An In Vitro Diagnostic (IVD) device is defined as a medical device that is intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. While this device isn't directly diagnosing a condition, it is used in a critical step of an in vitro process (ART) that ultimately leads to a clinical outcome (pregnancy). The freezing and thawing process is a crucial manipulation of human biological material performed in vitro.
In summary, the device is used to process human biological material (blastocysts) outside the body for a clinical purpose (ART), which strongly aligns with the definition and scope of In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
"Medi-Cult Blastocyst Freezing Pack" is for freezing of blastocysts in a two step procedure and the "Medi-Cult Blastocyst Thawing Pack" is for thawing of blastocysts in a two step procedure.
Product codes
85 MQL
Device Description
"Medi-Cult Blastocyst Freezing Pack" Cat.No. 1012
"Medi-Cult Blastocyst Thawing Pack" Cat.No. 1015
"Medi-Cult M3 Medium" has been used as the basal medium for both products. Furthermore Blastocyst Freezing Pack contains glycerol (vial 1) and glycerol and Sucrose (vial 2). Blastocyst Thawing pack contains sucrose (vial 1 and 2).
Product testing control contents:
- Bioburden, production-test -
- = Integrity filter testing, production-test
- Sterility, QC-test *
- pH, QC-test
- Mouse Embryo, QC-test (Two cell assay; > 80% hatched) QC Test ・
- -Endotoxin, QC-test
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
The submission references that "The first clinical data available indicates that this product has the same performance as indicated by Menezo et al." and specifically cites:
- Yves Menezo et al: In Proceedings of ASRM, Boston, USA, 1996, P006
- Yves Menezo and Anna Veiga: In proceedings of the 10th World Congress of In Vitro Fertilization and Assisted Reproduction, Vancouver (Canada), May 24-28, 1997, pp. 49-53.
The conclusion states: "Thus based on the Federal Register Notice (Final Rule, Vol. 63, No. 175, page 48429, September 10, 1998), "Obstetric and Gynecologic Devices; Reclassification and Classification of Medical Devices Used for In-Vitro Fertilization and Related Assisted Reproduction Procedures" effective on October 13, 1998 and the supportive clinical data we feel that the safety and effectiveness of the product for its intended use is shown in the present submission."
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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Page 1 of 2
510(k) Summary Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination (K991471)
The product:
- "Medi-Cult Blastocyst Freezing Pack" Cat.No. 1012
"Medi-Cult Blastocyst Thawing Pack" Cat.No. 1015
Indication for use:
"Medi-Cult Blastocyst Freezing Pack" is for freezing of blastocysts in a two step procedure and the "Medi-Cult Blastocyst Thawing Pack" is for thawing of blastocysts in a two step procedure.
Products formulation:
"Medi-Cult M3 Medium" has been used as the basal medium for both products. Furthermore Blastocyst Freezing Pack contains glycerol (vial 1) and glycerol and Sucrose (vial 2). Blastocyst Thawing pack contains sucrose (vial 1 and 2).
Product testing control contents:
- Bioburden, production-test -
- = Integrity filter testing, production-test
- Sterility, QC-test *
- pH, QC-test
- Mouse Embryo, QC-test (Two cell assay; > 80% hatched) QC Test ・
- -Endotoxin, QC-test
Medi-Cult has recently introduced a product intended for cryopreservation and thawing of human blastocyst. This product is based on the work of Yves Menezo and co workers who have developed a protocol for freezing and thawing of human blastocysts. (Yves Menezo et al: In Proceedings of ASRM, Boston, USA, 1996, P006 and Yves Menezo and Anna Veiga: In proceedings of the 10th World Congress of In Vitro Fertilization and Assisted Reproduction, Vancouver (Canada), May 24-28, 1997, pp. 49-53.)
Since our introduction of a commercially available product identical to the formulation of Menezo and co-workers, many clinics have started to use The Medi-Cult Blastocyst Freezing and Thawing pack. The first clinical data available indicates that this product has the same performance as indicated by Menezo et al.
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K991471
Page 2 of 2
Thus based on the Federal Register Notice (Final Rule, Vol. 63, No. 175, page 48429, September 10, 1998), "Obstetric and Gynecologic Devices; Reclassification and Classification of Medical Devices Used for In-Vitro Fertilization and Related Assisted Reproduction Procedures" effective on October 13, 1998 and the supportive clinical data we feel that the safety and effectiveness of the product for its intended use is shown in the present submission.
Prepared and Submitted by:
Reem Wiebry-Lernardi for
Ronald G. Leonardi, Ph. D.
Ronald G. Leonardi, Ph. D. President R & R Registrations P.O. Box 262069 San Diego CA 92196 1-619-586-0751
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 9 2000
Medi-Cult A/S c/o Ronald G. Leonardi, Ph.D. R & R Registrations P.O. Box 262069 San Diego, CA 92196-2069
Re: K991471 Medi-Cult Blastocyst Freezing and Thawing Packs Catalog #1012 and 1015 Dated: April 3, 2000 Received: April 4, 2000 Requiatory Class: II 21 CFR §884.6180/Procode: 85 MQL
Dear Dr. Leonardi:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 pror 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). 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 III (Premarket Aproval), 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 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Pracice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notfication. 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 and additionally 809.10 for in vitin diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for question 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 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
3
510(k) Number (if known) K991471
Device Name: Medi-Cult Blastocyst Freezing Pack and Medi-Cult Blastocyst Thawing Pack
Indications for Use:
Blastocyst Freezing pack is for freezing of blastocysts in a two-step procedure.
Blastocyst Thawing pack is for thawing of blastocysts in a two-step procedure.
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K991471 |
|---|---|
| --------------- | --------- |