The product is intended for use in the preparation of human sperm for intrauterine insemination (IUI).
Device Story
ISolate is a sperm separation medium consisting of a colloidal suspension of silica particles modified with hydrophilic silane in a buffered physiological solution. It is used in clinical laboratory settings by trained personnel to process semen samples. The device is provided as a kit of two solutions (Upper and Lower) of differing densities or as a single stock solution. These are used to create a step-gradient in a centrifuge tube. Semen is layered onto the gradient and centrifuged; this process separates motile, viable sperm from non-viable sperm, other cell types, and soluble biochemicals/proteins. The resulting purified sperm pellet is collected for use in IUI. By isolating high-quality motile sperm, the device aims to improve the success rate of intrauterine insemination procedures compared to raw semen samples.
Clinical Evidence
Bench testing only. Semen samples (fresh and cryopreserved) were processed in parallel using ISolate, predicate devices, and Percoll. Endpoints included recovery, motility, viability, forward progression, and normal forms. Results demonstrated that ISolate-prepared samples were substantially equivalent to those prepared with predicate devices.
Technological Characteristics
Colloidal suspension of silica particles covalently modified with hydrophilic silane in a buffered physiological solution. Operates via density gradient centrifugation. Formats include a two-solution kit (Upper/Lower density) or a single stock solution. Non-automated, manual laboratory preparation.
Indications for Use
Indicated for the preparation of human sperm for intrauterine insemination (IUI) in patients undergoing fertility treatment.
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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#### K971809 Pig3 510 (k) Summary K.
Irvine Scientific Sales, Co., Inc. Submitted by: JUI = 3 1997 2511 Daimler Street Santa Ana, California 92705-5588
> Phone: 714-261-7800 Fax: 714-261-6522
Contact: Dr. Ken Lydersen
Date: May 12, 1997
Device Identification:
- · Trade Name: ISolate
- · Common Name: Sperm Separation Medium
- Classification Name: Cervical Cap (per 21CFR 884.5250)
Predicate Devices:
| • Sperm Select | (K872849) |
|-----------------------|-----------|
| • Modified Ham's F-10 | (K894432) |
# Description:
The product is a colloidal suspension of silica particles which have been covalently modified with hydrophilic silane. The colloid is formulated in a buffered physiological solution compatible with human sperm. The product is packaged in two formats. One format consists of a kit of two solutions which differ only in the concentration of the colloidal silica, and therefore in their density. The two solutions, labeled "Upper" and "Lower", are utilized to form a step-gradient in a centrifuge tube. The other product format is a single solution which can be utilized as a "stock solution" to create a different step gradient from that provided by the kit. This latter solution is identical to the "Lower" (i.e., higher density) solution.
### Intended Use:
The product is intended for use in the preparation of human sperm for intrauterine insemination (IUI).
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K971809 p273
Technological Characteristics:
Sperm separation media are used to separate motile sperm from the other constituents of semen (i.e., non-viable sperm, other cell types, soluble biochemicals and proteins). Centrifugation is the technology most commonly used to separate sperm from the soluble components of semen. Centrifugation followed by aspiration of the supernatant and resuspension of the pellet in a medium such as Modified Ham's F-10 is the most straightforward method of sperm preparation, resulting in a "washed" sperm preparation. If separation of motile sperm from other cellular constituents is desired, the pellet is incubated under a layer of medium (i.e., Modified Ham's F-10) instead of being resuspended. The motile sperm "swim-up" into the fresh medium, resulting in a sperm preparation with an increased % motility, but a decreased recovery.
The centrifugation of semen in a medium with high density is an approach which can separate motile, viable sperm from other cellular constituents without the reliance on "swim-up". This method has been used extensively with a colloidal silica product (Percoll) formulated with a variety of physiological buffers. Isolate utilizes a similar colloidal silica product to accomplish sperm separation.
Another approach is to utilize a medium with a high viscosity. If a highly viscous solution is layered over a semen sample and incubated for a sufficient length of time, motile sperm, but not other cells, will migrate into the viscous solution and allow the recovery of a fraction of the original sperm containing a high proportion of motile sperm.
Although the centrifugation of viable sperm through a high density medium is commonly used, there are no devices approved for sperm separation utilizing this technology. Modified Ham's F-10 (K894432) is a predicate device approved for sperm preparation utilizing centrifugation and washing or "swim-up". Sperm Select (K872849) is another predicate device which utilizes high viscosity medium. For the purposes of this application, ISolate has been compared to Modified Ham's F-10, as used in Washing and Swim-Up, and Sperm-Select.
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# Performance Data:
Semen samples (fresh and cryopreserved) were processed in parallel using ISolate and the predicate devices, as well as Percoll in some cases. The resulting purified sperm preparations were assayed for recovery, motility, viability, forward progression and normal forms. The results showed that sperm prepared with ISolate resulted in preparations which were substantially equivalent to those from the predicate devices.
# Conclusion:
The conclusion from the performance testing and the biocompatibility testing is that ISolate yields substantially equivalent results to the predicate devices in the preparation of human sperm for intra-uterine insemination (IUI).
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ken Lydersen, Ph.D. Vice President, Technical and Regulatory Affairs Irvine Scientific Sales, Co., Inc. 2511 Daimler Street Santa Ana, California 92705 . 川 Re: K971809
ISolate Sperm Separation Media Dated: May 12, 1997 Received: May 15, 1997 Regulatory class: unclassified Product code: 85 MQL
Dear Dr. Lydersen:
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 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). 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.
3 1997
If your device is classified (see above) into either class II (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 requirement, as set forth in the Quality System Regulation (OS) 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 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) 594-4613. 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" (21 CFR 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/odrit/dsmamain.html"
Sincerely yours
W.Liau Yin
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Satterly
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices K971809 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use . (Per 21 CFR 801.109)
ાર્વ
Over-The-Counter Use_
(Optional Format 1-2-96)
St - 36
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.
