For Latex Sensitive Condom Users: This is a TACTYLON® condom. This is not a latex condom. You may use this TACTYLON ® condom if you or your partner are allergic to latex. You should know: - The risks of pregnancy and sexually transmitted diseases (STDs), including AIDS . (HIV infection), are not known for this condom. A study is being done. - There are laboratory tests on this TACTYLON® material. These tests show that . organisms even as small as sperm and viruses like HIV cannot pass through it. Latex condoms for men, if used correctly with every act of vaginal intercourse are highly effective at preventing pregnancy, as well as STDs, including AIDS (HIV infection).
Device Story
TACTYLON® condom; synthetic thermoplastic elastomer block copolymer (styrene-ethylene-butylenestyrene); non-latex alternative for individuals with Type I or Type IV hypersensitivity to Natural Rubber Latex (NRL). Device functions as physical barrier during vaginal intercourse; prevents transmission of sperm and viruses (e.g., HIV). Material properties (strength, elasticity, tactility) equivalent to NRL; resistant to UV, ozone, oxygen, heat, and humidity. Used by patients; over-the-counter availability. Clinical trials confirm non-irritating, non-sensitizing, and non-toxic profile; breakage and slippage rates comparable to predicate TACTYLON® models.
Clinical Evidence
Clinical trials included a modified Draize test (n=200) showing no irritation or sensitization. Use tests and skin prick tests on latex-sensitive individuals (n=20) showed no adverse reactions. Comparative clinical trial (n=not specified) evaluated breakage and slippage rates against predicate TACTYLON® condoms (K953583, K971590), demonstrating similar clinical performance.
Technological Characteristics
Material: Styrene-ethylene-butylenestyrene thermoplastic elastomer block copolymer. Meets FDA Class VI requirements for nontoxicity. Barrier properties tested via viral surrogate (φ X174) assay. Resistant to UV, ozone, oxygen, heat, and humidity. Form factor: Baggy design, high elongation (low modulus).
Indications for Use
Indicated for individuals with latex sensitivity or allergy requiring a non-latex barrier contraceptive for the prevention of pregnancy and STDs.
Regulatory Classification
Identification
A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.
Special Controls
*Classification.* (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.
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SENSICON CORPORATION 510(k) SUBMISSION 8974121 Page 1 of 2 SUMMARY OF SAFETY AND EFFECTIVENESS
## LUBRICATED BAGGY CONDOM SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is being submitted in accordance with the requirements of the SMDA of 1990.
- (A) Substantial Equivalence:
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| Submitted by: | Sensicon Corporation |
|---------------|--------------------------------------|
| Address: | 2595 Commerce Way<br>Vista, CA 92083 |
| Telephone: | (760) 734-6690 |
| Contact: | Jeff D. Grant |
- 2. Natural Rubber Latex products present a risk of anaphylaxis for individuals with Type I immediate hypersensitivity to Natural Rubber Latex (NRL) and can cause less dangerous, but uncomfortable, symptoms in individuals with Type IV delayed hypersensitivity. The synthetic TACTYLON® condom contains neither NRL protein allergens nor sensitizing chemicals. It therefore represents a suitable alternative for latex sensitive individuals. Furthermore, muscle exposure to NRL appears to be one of the primary routes of sensitization for Type I allergies.1
- 3. The TACTYLON® condom is made from styrene-ethylene-butylenestyrene thermoplastic elastomer block copolymer but has physical properties (e.g., strength, elasticity, and tactility) and general form that are substantially equivalent to a NRL condom.
- (B) The safety and efficacy of TACTYLON® involves two major issues: the potential allergenicity and toxicity of the material and the efficacy of the material's barrier.
- 1. The TACTYLON® block copolymer is a compound that meets the FDA requirements for Class VI materials, the most stringent category for nontoxicity. The plasticizer used is a USP recognized by the FDA as safe for human consumption. Toxicity is therefore not a relevant safety issue as evidenced by the following studies of the non-lubricated Standard condom (K911431). Neither primary skin irritation nor vaginal mucosal irritation was found in a rabbit model. There was no evidence of irritation or toxicity in a 3-day, 7-day, or 90-day surgical mucosal implantation study in a rabbit model. Furthermore, no delayed dermal sensitization occurred in a guinea pig model. No mutagenic changes were found in histidine dependent mutant strains of Salmonella typhimurium when exposed to
<sup>4</sup> American Academy of Allergy & Immunology: Task force on allergic reactions to latex (committee report). J. Allergy Clin Immunol 1993; 92:16-18,
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either saline or DMSO extracts of TACTYLON®. In addition, there were no positive indicators resulting from a Cytotoxicity test, by the USP elution method (MG 057), on samples which had been real-time aged for 14 Also, the lubricated condom (K953583) was tested for months. Cytotoxicity on unaged, as well as aged (oven conditioned), sample at 70°C for seven (7) days with no positive indicators. The lubricated condom was tested for systemic toxicity using Saline and Cottonseed Oil as well as for vaginal irritation in rabbits using saline extract. These tests both meet the USP requirements.
The barrier properties of TACTYLON® are substantially equivalent to NRL as demonstrated by an in vitro challenge with a viral surrogate (φ X174) to simulate the HIV (AIDS) measured by an extremely sensitive assay. As with NRL products, however, petroleum-based lubricants should be avoided. Because the chemical structure of the copolymer has no unsaturated bond, TACTYLON® is resistant to conditions such as ultraviolet radiation, ozone, oxygen, heat and humidity, that can accelerate aging and adversely affect barrier properties.
- Clinical trials conducted on the non-lubricated TACTYLON® material 2. indicated it is nontoxic, nonirritating, and nonsensitizing. In the modified Draize test conducted in 200 human subjects, TACTYLON® was nonirritating and nonsensitizing in all 200 subjects. When a group of 20 latex-sensitive individuals was subjected to use tests and skin prick tests, TACTYLON® caused no adverse reactions.2
- In a clinical trial of TACTYLON® lubricated condoms, the clinical 3. breakage and slippage rates as well as the subjective perceptions were These trials showed that the clinical breakage of the Baggy studied. TACTYLON® condoms were similar to the Standard TACTYLON® condom cleared by 510(k) K953583 and the High Elongation condom cleared by 510(k) K971590 3
- The results of both the nonclinical and the clinical studies suggest that 4. TACTYLON® material is nonallergenic, nonirritating, and nontoxic when in contact with either the intact dermis or mucosal tissue for clinically relevant periods. Furthermore, the barrier was as impermeable to a viral surrogate as NRL in nonclinical studies and tolerated the stresses associated with use as well as NRL in a large clinical trial. The copolymer's chemistry confers a distinct advantage over NRL in terms of potential shelf-life.
<sup>2</sup>Labti A, Camarasa JG, Ducombs G, et al: Patch tests with TACTYLON™ in patients with contact allergy to rubber. Contact Dermatitis 1992; 27:188.
<sup>3</sup> Contraceptive Research and Development Program Final Report, April 18, 1997. Comparative Evaluation of Three Tactylon® Condoms with a Latex Condom During Vaginal Intercourse: Breakage and Slippage - Table 17.
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Image /page/2/Picture/2 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the logo is a stylized representation of an eagle, with its wings forming a series of curved lines.
20196
Jeff D. Grant Vice President Sensicon Corporation 2595 Commerce Way Vista, CA 92083
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K974121 Tactylon® Condom - Lubricated, high elongation (i.e., low modulus) (baggy design) Dated: October 28, 1997 Received: October 31, 1997 Regulatory Class: II 21 CFR 884.5300/Procode: 85 MOL
Dear Mr. Grant:
We have reviewed your Section 510(k) notification of intent to market the device 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.
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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 marketd 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/dsmamain.html".
Sincerely yours,
Sincerely yours,
N) Kiau hi
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
Enclosure
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510 (k) Number: K974121 Page 1 of 1
Sensicon Corporation Company Name:
Device Name: Male Condom
Indications For Use:
For Latex Sensitive Condom Users:
This is a TACTYLON® condom. This is not a latex condom.
You may use this TACTYLON ® condom if you or your partner are allergic to latex.
You should know:
- The risks of pregnancy and sexually transmitted diseases (STDs), including AIDS . (HIV infection), are not known for this condom. A study is being done.
- There are laboratory tests on this TACTYLON® material. These tests show that . organisms even as small as sperm and viruses like HIV cannot pass through it.
Latex condoms for men, if used correctly with every act of vaginal intercourse are highly effective at preventing pregnancy, as well as STDs, including AIDS (HIV infection).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Datent D (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1974121 510(k) Number _
Prescription Use · (Per 21 CFR 801.109) OR
Over-The-Counter Use\$\checkmark\$
(Optional Format 1-2-96)
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.
