The product is intended for use in the preparation, concentration and purification of human sperm prior to assisted reproductive technology procedures, included in vitro fertilization.
Device Story
ISolate products are colloidal suspensions of silica particles modified with hydrophilic silane in a buffered physiological solution. Used in clinical laboratories to separate motile sperm from seminal fluid constituents (non-viable sperm, debris, proteins). Seminal fluid is layered over the density gradient and centrifuged; motile sperm penetrate the gradient to form a pellet, while contaminants remain in the upper layer. The pellet is extracted, washed, and resuspended for use in assisted reproductive technology (ART) procedures, including in vitro fertilization. The device enables clinicians to obtain a concentrated, purified sample of viable sperm, potentially improving outcomes for insemination procedures.
Clinical Evidence
Clinical comparison of ISolate Concentrate against the predicate ISolate 2-layer kit (K971809). Metrics evaluated included sperm survival, forward progression, and percent recovery of motile sperm. Results demonstrated comparable performance between the subject and predicate devices.
Technological Characteristics
Colloidal suspension of silica particles covalently modified with hydrophilic silane in a buffered physiological solution. Density gradient separation principle. Provided as a concentrate for user dilution or as a stock solution for single or two-layer gradient procedures. Non-electronic, chemical-based separation medium.
Indications for Use
Indicated for use as a human sperm separation medium to concentrate and purify viable motile sperm from seminal fluid, removing cellular contaminants like dead sperm, white blood cells, and debris, prior to in vitro fertilization and assisted reproductive technology 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.
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Image /page/0/Picture/2 description: The image shows the logo for Irvine Scientific. The logo consists of a stylized letter "I" and "S" inside of a square. The words "IRVINE SCIENTIFIC" are printed below the square.
# 510(k) SUMMARY AS REQUIRED BY SECTION 807.92(c)
Irvine Scientific Sales Co., Inc. Submitted by: 2511 Daimler Street Santa Ana, CA 92705-5588
1991341
Telephone: (800) 437-5706 Facsimile: (949) 261-6522
Contact: Roberta L. Johnson
Date Submitted: April 13, 1999
# Device Identification:
ISolate® Trade Name: ISolate® Concentrate ISolate® Stock Solution Sperm Separation Medium Common Name: Cervical Cap (21 CFR, 844.5250) Classification Name:
# Predicate Device:
ISolate® 2-layer kit K971809
# Description:
The products are a colloidal suspension of silica particles that have been covalently modified with hydrophilic silane. The colloid is formulated in a buffered physiological solution, compatible with human sperm. They are identical to the predicate device, in formulation and differ only in the intended use ..
ISolate® ISolate® Concentrate ISolate® Stock Solution Page 36 of 44
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Irvine Scientific
April 13, 1999
#### Intended Use:
The product is intended for use in the preparation, concentration and purification of human sperm prior to assisted reproductive technology procedures, included in vitro fertilization.
## Technological Characteristics:
Sperm separation media are commonly used to separate motile sperm from the other constituents of semen (such as non-viable sperm, other cell types, soluble biochemicals and proteins). The resulting concentrated and purified sperm contains more active, viable cells which may then be used in a variety of insemination procedures.
The predicate device, ISolate 2-layer kits, is a two density gradient system designed to assist in the separation of human sperm from seminal fluid. Seminal fluid is layered over the step gradient, briefly centrifuged, and the suspended pellet extracted. Due to the higher density of the motile sperm, they penetrate the density gradient to form the pellet under centrifugation, while cellular debris, and other constituents of semen, are trapped in the upper layer of the gradient. The supernatant is then remove, the pellet resuspended in an appropriate medium, and the pellet washed twice by additional centrifugation.
ISolate Concentrate and ISolate Stock Solution differ only from each other, and from the predicate, in the concentration of the colloidal silica in the formulation. ISolate Stock Solution, is, in fact, identical to the "lower layer" component of the two layer kits. They are provided for those laboratories that wish to use either a two-layer gradient with densities of their own choice, or a single gradient procedure. ISolate Concentrate is designed for further dilution by the user, into an appropriate density gradient. ISolate Stock Solution may be used as supplied, for those laboratories who choose to use a single density procedure, or may be diluted to densities of the laboratory's choice.
The intent of this submission is to expand the intended use of these devices to include sperm processing procedures prior to in vitro fertilization.
ISolate® ISolate® Concentrate ISolate® Stock Solution
Page 37 of 44
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## Performance Data:
ISolate Concentrate has been compared clinically to ISolate 2-layer kits, and has been found to perform comparably in sperm survival, forward progression and percent recovery of motile sperm. ISolate 2-layer kits were cleared for marketing under K971809. ISolate Stock Solution is identical to the "Lower Layer" component of the 2-layer kits.
## Additional Information:
The shelf-life and biocompatibility of both ISolate Concentrate and ISolate Stock Solution are identical to the predicate device, ISolate 2-layer kits. Mouse embryo testing will not be performed on the device, but sperm survival tests are performed as a condition of release. Endotoxin and sterility tests are also performed and documented on the labeling and certificate of analysis.
## Conclusion:
The conclusion from performance testing, as well as an examination of the formulations of ISolate Concentrate and ISolate Stock Solution, when compared to the predicate, ISolate 2-layer kits, shows that the devices are substantially equivalent for the preparation and concentration of human sperm prior to use in insemination procedures in assisted reproductive technology, including in vitro fertilization.
Solate® ISolate® Concentrate ISolate® Stock Solution Page 38 of 44
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that resembles an abstract bird with three curved lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 8 1999
Ms. Roberta L. Johnson Manager, Requiatory Affairs Irvine Scientific, Inc. 2511 Daimler Street Santa Ana, CA 92705
Re: K991341
Solated: ISolated Concentrate; ISolated Stock Solution Dated: April 16, 1999 Received: April 19, 1999 Regulatory Class: II 21 CFR 5884.6180/Procode: 85 MQL
Dear Ms. Johnson:
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 (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, itsting of devices, good manufacturing practice, labeling, and prohibilions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or dass 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 requirement 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 predication 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/cdrh/dsma/dsmamain.html".
Sincerely yours.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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#### INDICATIONS FOR USE STATEMENT (page 1 of 1)
991341 510(K) Number:
Device Name: ISolate®; ISolate® Concentrate; ISolate® Stock Solution
Indications for Use:
ISolate® is a density gradient medium designed to separate the motile fraction of sperm from seminal fluid. As a two-layer gradient system, it effectively reduces cellular contaminants such as dead sperm, white blood cells and miscellaneous debris. The resulting sample contains predominantly motile sperm. It is intended for use as a human sperm separation medium, to concentrate and purify viable sperm, prior to in vitro fertilization, and related assisted reproductive technology, procedures.
## (PLEASE DO NOT 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)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K991341
ISolate® ISolate® Concentrate ISolate® Stock Solution Page 2 of 42
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.
