Medi-Cult Freezing Pack is for freezing of 1-4 cell stage embryos. Medi-Cult Thawing Pack is for thawing of embryos.
Device Story
Medi-Cult Freezing and Thawing Packs are chemical media kits used in IVF laboratories for embryo cryopreservation. The Freezing Pack utilizes a 3-step procedure involving Embryo Freezing Medium (EFM), propanediol, and sucrose to prepare embryos for freezing. The Thawing Pack uses a multi-vial system containing EFM, propanediol, and sucrose to rehydrate and prepare embryos for transfer. These products are used by embryologists in clinical IVF settings. By providing standardized, validated media for cryopreservation, the device enables the storage of embryos for future replacement, potentially increasing the cumulative pregnancy rate per IVF cycle by allowing multiple attempts from a single oocyte retrieval.
Clinical Evidence
Clinical data provided from multiple IVF clinics in Norway, Sweden, and the UK. Data includes live birth rates and pregnancy rates per embryo replacement. For example, the University of Trondheim reported a 17.0% pregnancy rate (n=966) and the UK national average for clinics using Medi-Cult products showed performance metrics consistent with or exceeding the national average of 12.1%. No serious adverse events reported in 1.5 years of use.
Technological Characteristics
Chemical media formulation based on Embryo Freezing Medium (EFM), propanediol, and sucrose. Multi-vial system for step-wise cryopreservation and thawing. Quality control testing includes bioburden, filter integrity, sterility, pH, osmolarity, and endotoxin levels.
Indications for Use
Indicated for the cryopreservation and thawing of human embryos (1-4 cell stage) in patients undergoing assisted reproductive technology (ART) procedures.
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.
Submission Summary (Full Text)
{0}------------------------------------------------
## - == 28 ZURI
## 510(k) Summary Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination (K991335)
The products:
.
:" ,
- "Medi-Cult Freezing Pack with EFM" Cat.No. 1026 -
- "Medi-Cult Thawing Pack with EFM and IVF" Cat.No 1063 -
- "Medi-Cult Thawing Pack with EFM" Cat.No 1098 -
## Indication for use:
Medi-Cult Freezing Pack" is for freezing of 1-4 cell stage embryos, & Medi-Cult Thawing Pack" is for thawing of embryos.
Products formulation: All products are based on Embryo Freezing Medium (EFM)
The Freezing Packs contains 3 different solutions reflecting a 3-step procedure and 4 vials:
- 1 x Vial 1: Embryo Freezing Medium (EFM) .
- 1 x Vial 2: EFM and propanediol .
- 2 x Vial 3; EFM, propanediol and Sucrose. ●
For thawing the Thawing Packs are used. They are composed as follows:
- Vial 1: Embryo Freezing Medium (EFM), propanediol and sucrose. ◆
- Vial 2: EFM, propanediol and Sucrose. .
- . Vial 3: EFM and Sucrose.
- Vial 4: EFM (Cat.No. 1098) or Universal IVF Medium (Cat.No. 1063) .
Product testing control contents:
- Bioburden, production-test -
- -Integrity filter testing, production-test
- -Sterility, OC-test
- pH, QC-test -
- Osmolarity, OC-test -
- Endotoxin, QC-test ﮯ
The culture media from Medi-Cult have been used by many European IVF-units since the end of the 1980's. (Produced and distributed by GEA-Biotech 1987 to 1989 and by Medi-Cult als from 1989). The Medi-Cult media were at that time introduced as a replacement for in-house prepared culture media. The Medi-Cult products for cryopreservation is in general formulated according to data published in peer reviewed international journals by internationally recognised scientists in the field.
The clinical date shown below comes from clinics using one or several of these products for cryopreservation of zygotes and embryos: The Medi-Cult Embryo freezing medium; The Medi-Cult Embryo freezing pack; The Medi-Cult Embryo thawing pack with EFM and IVF-medium.
We have collected clinical data from clinics that use only products from Medi-Cult. The data from cycles with replacement of cryopreserved embryos are in general not reported as the data from replacement of fresh IVF/ICSI embryos. Consequently, national data can be difficult to obtain.
A comparison of the clinical performance of clinics using only Medi-Cult media with other IVF-clinics using similar clinical and laboratory routines can give an indicate on the performance of the Medi-Cult culture media. In countries were we have access to both national data from individual clinics, clinics using Medi-Cult media generally performs well.
The IVF-units in the Nordic countries use similar clinical and laboratory protocols and their patient populations are comparable. The largest IVF clinics in Norway have been using only Medi-Cult media since the end of the 1980's.
Table1. The outcome after replacement of frozen/thawed IVF-embryos at the IVF-Unit, Dept of Ob. & Gyn. University of Trondheim, Norway in the period 1988-1998.
| Number of embryo replacements | Clinical pregnancies | Pregnancy rate per embryo replacement |
|-------------------------------|----------------------|---------------------------------------|
| 966 | 164 | 17.0 |
{1}------------------------------------------------
| rant<br>Table 2. The outcome after replacement of frozen/thawed The National Hospital, Oslo, Norway 1994-1996. ' | | | | |
|------------------------------------------------------------------------------------------------------------------|--|---------------------------|--|--|
| Number of embryo replacements Clinical pregnancies | | Pregnancy rate per embryo | | |
| | | ren acement | | |
18.3
કર્ The national average for Norway is not meaningful since the two other clinics cryopreserving embryos only performed a few cycles (1994 -1996: 37 cycles/ 3 pregnancies 8.1% pregnancy rate)
In Sweden, the Carl von Linne Clinic uses only products from Medi-Cult for culture of gametes and embryos. For the year 1997 their birth rate per frozen embryo replacement was 22% (National data not available),
The Human Fertilisation and Embryology Authority (HFEA) of the UK, collects clinical data from all centres licensed to offer treatment for infertility by assisted reproduction. HFEA publishes these and on the web. The clinical data are presented both unadjusted for the demographics of the clinics patient population. In the Table below the clinical data from some UK-clinics that use only Medi-Cult products is shown. These clinics have all given their consent to be presented as clinics using only Medi-Cult products.
Table 3. Live birth rates per embryo replacement in IVF units in the UK April 1, 1996 to March 31, 1997.
| Name of clinic | Number of FER*-cycles | Live birth rate per embryo replacement % |
|----------------------------------------------|-----------------------|------------------------------------------|
| Chelsea and Westminster Hospital | 24 | 20.8 |
| CARE at Park Hospital | 95 | 20.0 |
| The Woking Nuffield Hospital | 38 | 15.8 |
| Leeds General Infirmary | 333 | 14.1 |
| Nurture | 104 | 7.8 |
| Holly House Fertility and IVF | 115 | 17.4 |
| Guy's and St Thomas Assisted Conception Unit | 651 | 27.1 |
| UK national average | 4646 | 12.1 |
*FER: Frozen embrvo replacement
465
The Medi-Cult Blastocyst Freezing and Thawing pack has recently been introduced for cryopreservation and thawing of human blastocyst. This product is based on the work of Yves Menezo and co workers who has developed a protocol for freezing and thawing of human blastocysts. (Y.Menezo et al., In Proceedings of ASRM, Boston, 1996 & Y.Menezo & A.Veiga. In Proc. of 10th World Congress of IVF & Assisted Reproduction, Vancouver (Canada), May 1997). Since 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. Clinical data available indicates that our product has the same performance as indicated by Menezo.
There have been no registered complaints on the product and thus no evidence in the last 1.5 years that the product has been the cause of any serious adverse events in connection with its intended use.
Thus based on the Federal Register Notice (Final Rule, Vol. 63, No. 175, page 48429, September 10, 1998), "Obstetric and Gynecologic Devices; Reclassification 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.
Date
Prepared and Submitted by:
Keen Wüher-Lousada for February 18, 2000
Ronald G. Leonardi, Ph. D. President R & R Registrations P.O. Box 262069 San Diego CA 92196 1-858-586-0751
{2}------------------------------------------------
Public Health Service
DEPARTMENT
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2000
Medi-Cult A/S c/o Ronald G. Leonardi, Ph.D. President R & R Registrations P.O. Box 262069 San Diego, CA 92196
Re: K991335
Medi-Cult Freezing and Thawing Packs Dated: December 14, 1999 Received: December 15, 1999 Regulatory Class: Il 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 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). 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 (Premarket Approval), 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 equivalent determination assumes compliance with the Current Good Manufacturing Practice 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 the Electronic Product 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. 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 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/dsma/dsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D.
Daniel G. Schultz, M.D Captain, USPHS Acting 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) K991335
Device Name: Medi-Cult Freezing Pack and Thawing Pack Indications for Use:
Freezing Pack is for freezing of 1-4 cell stage embryos.
Thawing Pack is for thawing of embryos.
(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 K991335
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
