SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM
Applicant
Irvine Scientific Sales Co., Inc.
Product Code
MQL · Obstetrics/Gynecology
Decision Date
Apr 26, 1999
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 884.6180
Device Class
Class 2
Indications for Use
Sperm Washing Medium and Modified Sperm Washing Medium are intended for sperm processing procedures prior to intrauterine or in vitro fertilization procedures.
Device Story
Sperm Washing Medium and Modified Sperm Washing Medium are synthetic, defined media used to purify and concentrate human sperm. The device facilitates the separation of viable sperm from non-sperm constituents of seminal fluid, simulating the filtering effect of cervical mucus. In clinical practice, semen is suspended in the medium and centrifuged; the supernatant containing seminal debris is removed, and the sperm pellet is resuspended in fresh medium. This process concentrates viable sperm for use in intrauterine or in vitro fertilization procedures. The media differ only in protein supplementation: Sperm Washing Medium contains human serum albumin, while Modified Sperm Washing Medium contains bovine serum albumin. The device is used in clinical settings by laboratory personnel.
Clinical Evidence
No clinical data. Performance is supported by bench testing, specifically mouse embryo assay to ensure absence of toxic components, as well as endotoxin and sterility testing. The device has a history of satisfactory use as standard media for human sperm processing.
Technological Characteristics
Synthetic, defined media composed of salts and physiologically compatible substances. Sperm Washing Medium contains 5 mg/mL human serum albumin; Modified Sperm Washing Medium contains 5 mg/mL bovine serum albumin. Liquid form factor. Quality control includes mouse embryo assay, endotoxin testing, and sterility testing.
Indications for Use
Indicated for assisted reproduction procedures requiring processing or manipulation of human sperm prior to insemination or in vitro fertilization.
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.
Predicate Devices
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
Submission Summary (Full Text)
{0}------------------------------------------------
K9835F8
4/26/99
Irvine Scientific
October 9, 1998
Image /page/0/Picture/4 description: The image is a black and white graphic of a logo. The logo is a stylized design with a combination of straight lines and geometric shapes. The logo is enclosed within a square border. The letters 'TM' are visible in the lower right corner of the image.
IRVINE SCIENTIFIC
## 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
> Telephone: (800) 437-5706 Facsimile: (949) 261-6522
Contact: Roberta L. Johnson
Date Submitted: October 9, 1998
#### Device Identification:
| Trade Name: | Sperm Washing Medium<br>Modified Sperm Washing Medium |
|----------------------|-------------------------------------------------------|
| Common Name: | Sperm processing media |
| Classification Name: | Reproductive Media (21 CFR, 886.6180) |
#### Predicate Device:
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
#### Description:
Sperm Washing Medium and Modified Sperm Washing Medium are synthetic, defined media composed of a mixture of salts and other physiologically compatible substances. The two products differ only in their protein supplementation. Sperm Washing Medium contains 5 mg/mL of human serum albumin, while Modified Sperm Washing Medium contains the same concentration of bovine serum albumin.
Sperm Washing Medium
{1}------------------------------------------------
October 9, 1998
### Intended Use:
Sperm Washing Medium and Modified Sperm Washing Medium are intended for sperm processing procedures prior to intrauterine or in vitro fertilization procedures.
## Technological Characteristics:
Sperm Washing Medium and Modified Sperm Washing Medium are used to purify and concentrate sperm prior to use in assisted reproductive procedures. The goal of such sperm "washing" procedures is to concentrate and purify viable sperm, and separate them from the non-sperm constituents of seminal fluid, simulating the filtering effect of cervical mucous. A higher concentration of viable sperm increases the chance of successful insemination, either in vitro, or intrauterine. When performed with a culture medium such as Sperm Washing Medium, semen is suspended in the medium, centrifuged to concentrate the viable sperm, and the supernatant, containing seminal debris, is removed. The sperm pellet is then resuspended in fresh medium, and recentrifuged. During this process, viable sperm are concentrated in the medium, and are then aspirated and used for the fertilization procedure.
## Performance Data:
Sperm Wash and Modified Sperm Wash are assayed by mouse embryo assay prior to their release to market. This assay assures that the product contains no toxic components. Both Sperm Wash and Modified Sperm Wash have been used in a variety of clinical settings, for their original, intended use, for a number of years. In that time, the products have become the standard media used for the processing of human sperm prior to assisted reproductive procedures.
{2}------------------------------------------------
#### Additional Information:
Mouse embryo testing will be performed as a condition of release for these products, as well as endotoxin and sterility testing. Results of all release assays performed will be reported on a lot-specific certificate of analysis, and will be indicated on the labeling.
# Conclusion:
The conclusion from performance testing, as well as a history of satisfactory use for sperm processing prior to intrauterine insemination, shows that Sperm Washing Medium and Modified Sperm Washing Medium are suitable for their intended use, and meet the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.
{3}------------------------------------------------
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles an eagle or bird in flight, composed of three curved lines. The text is arranged around the top and left side of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 1999
Ms. Roberta L. Johnson Manager, Regulatory Affairs Irvine Scientific 2511 Daimler Street Santa Ana, CA 92705-5588 Re: K983588
Sperm Washing Medium, Modified Sperm Washing Medium Dated: February 12, 1999 Received: February 16, 1999 Regulatory Class: II 21 CFR 884.6180/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, 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 requlation (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) 594-4613. 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
{4}------------------------------------------------
#### INDICATIONS FOR USE STATEMENT (page 1 of 1)
510(K) Number:_K983588
Device Name: Sperm Washing Medium, Modified Sperm Washing Medium
Indications for Use:
Sperm Washing Medium and Modified Sperm Washing Medium are intended for assisted reproduction procedures that require the processing or manipulation of human sperm prior to insemination or in vitro fertilization.
# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription
David A. Segner
Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological De 510(k) Number
Sperm Washing Medium
Modified Sperm Washing Medium
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.
