SpermSlow™ is used to slow down the movement of sperm to allow for the selection of the most mature, viable sperm for Intracytoplasmic sperm injection (ICSI).
Device Story
SpermSlow™ is a defined medium used in assisted reproduction clinics by embryologists or reproductive specialists. It functions by slowing sperm motility to assist in the selection of mature, viable sperm for ICSI procedures. The medium is composed of a sodium bicarbonate buffered solution containing hyaluronate (HA), human serum albumin (HSA), pyruvate, glucose, amino acids, nucleotides, vitamins, and antibiotics. Hyaluronate, the primary active component, mimics the extracellular matrix found between cumulus cells of matured oocytes. The device is supplied in 0.5 mL polypropylene vials. By slowing sperm movement, the medium enables the clinician to visually identify and isolate the most viable sperm, potentially improving the success rate of the ICSI procedure.
Clinical Evidence
Clinical evidence includes a human study demonstrating the product is effective for its intended use. Additionally, the device has been marketed in Europe since May 2004 with no reported serious adverse events. Bench testing includes batch-specific testing for sterility, endotoxin, viscosity, and sperm survival per Ph.Eur and USP standards.
Technological Characteristics
Physiological salt solution containing hyaluronate, HSA, pyruvate, glucose, amino acids, nucleotides, vitamins, and antibiotics. Supplied in 0.5 mL polypropylene vials. Batch testing performed for sterility and endotoxin per Ph.Eur and USP standards.
Indications for Use
Indicated for use by professionals in assisted reproduction to slow sperm movement, facilitating the selection of mature, viable sperm for Intracytoplasmic sperm injection (ICSI).
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.
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Kx61145
# 510(k) Summary
OCT - 2 2006
| Submitted by: | MediCult a/s |
|-----------------|-----------------------------|
| | Møllehaven 12 |
| | 4040 Jyllinge |
| | Denmark |
| | Telephone: + 45 46 79 02 00 |
| | Fax: + 45 46 79 03 00 |
| Contact person: | Ronald G. Leonardi, Ph.D. |
| | R&R Registrations |
| | 991 Cam. Chirimolla |
| | San Diego CA 92131 |
Date Submitted: September 6, 2006
### Device Identification:
Trade name: SpermSlow™ Common name: SpermSlowTM Classification name: Reproductive media and supplements (21 CFR 884.6180, Product Code MQL)
#### Predicated device:
MediCult PVP Medium (K991329).
## Description
SpermSlow™ is a defined medium used by professionals within assisted reproduction designed to slow down the movement and to select the most mature, viable sperm as required for Intracytoplasmatic sperm injection (ICSI). SpermSlow wis principally composed of hyaluronate (HA), the main component of the extracellular matrix, which appears in large amounts between the cumulus cells of the matured oocyte-cumulus complex.
SpermSlow™ is based on a sodium bicarbonate buffered solution containing hyaluronate, HSA (US licensed source), pyruvate, glucose, amino acids, nucleotides, vitamins and antibiotics.
SpermSlow™ is supplied in polypropylene plastic vials with screw top closures in a volume of 0.5ML. Each unit is labelled and the product is presented in four pack containers which also include a package insert.
### Intended use
SpermSlow™ is used to slow down the movement of sperm to allow for the selection of the most mature, viable sperm for Intracytoplasmic sperm injection (ICSI).
## Technological Characteristics
The technological characteristics of SpermSlow™ are essentially similar to those of the predicate device; it has the same intended use and is based on a physiological salt solution. However, SpermSlow™ differs in the composition in also containing vitamins, amino acids, nucleotides and hyaluronate instead of polyvinylpyrrolidone.
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## Performance data
SpermSlow™ has been tested in a human study. The results show that the product is effective for its intended use.
It has been marketed in Europe since May 2004 and there has been no evidence of any serious adverse events in connection with the intended use.
## Product Testing Controls
Frouter Testing Controls
Each batch of SpermSlow™ is tested according to Ph.Eur and USP for sterility and endotoxin and each batch is also tested for viscosity and sperm survival. The results are reported on a certificate of analysis. Stability studies have been performed.
#### Conclusion
Thus based on the performance testing presented and our experience with the SpermSlow product, we feel that the safety and the effectiveness of the product for its intended use are shown in the present submission and that the product is substantial equivalent to the predicated device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
# OCT - 2 2006
MediCult a/s c/o Ronald G. Leonardi, Ph.D. President R&R Registrations 9915 Cam. Chirimolla SAN DIEGO CA 92131
Re: K061145
Trade/Device Name: SpermSlow™ Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MOL Dated: September 27, 2006 Received: September 28, 2006
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image is a circular logo for the FDA Centennial, celebrating 100 years from 1906 to 2006. The logo features the letters "FDA" in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. The logo is surrounded by a dotted circle.
Promoting Public Health
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## Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA \$ Issualic of a substance or only other requirements of the Act
that FDA has made a determination that your device and one anaios. You must that FDA has made a delerimiation that your are records agencies. You must or any Federal statules and regulations administered of registration and listing (21)
comply with all the Act's requirements, including, but not many as set comply with all the Act Stequirements, moreans, conviacturing practice requirements as sets CFR Part 807); labeling (21 CFR Part 801); good manara 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 100); 11 CFR 1000 (050 forth in the quality systems (Q5) regalation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing of substantial equivalence of your device to a legally premarket notification. The PDA midning of satoration of 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 If you desire specific advice for your de rice on our has may be any of 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" Also, please note the regulation chittled, "Phisotanation on your responsibilities under (21CFR Part 607.97). Tournal other generational 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.
Nancy C. Hogdon
Nancv C. Brogdon 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):
Device Name:
SpermSlow™
Indications For Use:
SpermSlow™ is used to slow down the movement of sperm to allow for the selection of the most mature, viable sperm for Intracytoplasmic sperm injection (ICSI).
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
David A. Luyben
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number
K061145
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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.
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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?
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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.
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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.
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Reading rule for every project: how many summaries do you read in full?
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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.
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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.
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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.
