The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Device Description

The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

It is a straight walled textured condom with a nipple end and made of natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. It has a nominal length of 190 ± 10 mm, nominal width of 54 ± 2 mm and nominal thickness of 0.06 ± 0.01 mm.

Lelo Hex Lubricated Natural Rubber Latex Condom is packaged in individually sealed flexible laminate foils which is then packaged into an outer consumer cardboard carton. The Lelo Hex Lubricated Natural Rubber Latex Condom is intended for over-the-counter (OTC) use. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the Lelo Hex Lubricated Natural Rubber Latex Condom, and references its performance testing. However, it does not explicitly define acceptance criteria in a structured table or detail a specific study proving the device meets these criteria in the way typically required for AI/ML-based diagnostic devices.

The document focuses on demonstrating substantial equivalence to a predicate device for FDA clearance. The "acceptance criteria" can be inferred from the standards the device claims to meet and the types of tests performed.

Here's an interpretation based on the provided text, structured as requested, but with caveats about the specificity of the "acceptance criteria" as defined in this context:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria (Inferred from standards and tests)	Reported Device Performance
Biocompatibility	Non-cytotoxic (ISO 10993-5:2009/R 2014)	Met criteria: Device is non-cytotoxic.
	Non-sensitizing (ISO 10993-10:2021)	Met criteria: Device is non-sensitizing.
	Non-irritating (Vaginal Irritation, ISO 10993-10:2021)	Met criteria: Device is non-irritating.
	Non-acutely systemically toxic (Acute Systemic Toxicity, ISO 10993-11:2017)	Met criteria: Device is non-acutely systemically toxic.
Physical Performance	Conformance to ISO 4074:2015 "Natural rubber latex male condom – Requirement and test methods" for:	All samples met predefined acceptance criteria.
	- Dimensional requirements	(Implied: Met dimensional requirements)
	- Tensile strength	(Implied: Met tensile strength requirements)
	- Force at break	(Implied: Met force at break requirements)
	- Lubricant quantity	(Implied: Met lubricant quantity requirements)
	- Visible defects	(Implied: Met visible defect requirements)
	- Elongation	(Implied: Met elongation requirements)
	- Air burst volume (>18.0 L)	(Implied: Met air burst volume >18.0 L)
	- Air burst pressure (>1.0 kPa)	(Implied: Met air burst pressure >1.0 kPa)
Physical Performance	Conformance to ASTM D3492-16 "Standard Specification for Rubber Contraceptives (Male Condoms)" for:	(Same as above, reported that device met all requirements of this standard for corresponding parameters)
Shelf Life	Three-year shelf-life (based on accelerated stability evaluation conducted as required in 21 CFR 801.435, with predefined acceptance criteria for all samples)	Met criteria: Has a three-year shelf-life. All samples met predefined acceptance criteria during accelerated stability evaluation.

Note: The details of the specific quantitative acceptance criteria (e.g., exact tensile strength values, specific acceptable defect rates) from ISO 4074 or ASTM D3492 are not provided in this document, only that the device met these standards.

Regarding the study proving the device meets the acceptance criteria:

The document summarizes the performance testing conducted, which serves as the "study" proving the device meets the inferred acceptance criteria.

The following information is largely not applicable (N/A) or not available (N/A – not provided) because this is a submission for a physical medical device (condom) and not an AI/ML-based diagnostic device. The questions about test sets, experts, adjudication, MRMC studies, standalone algorithm performance, and training sets are directly relevant to AI/ML device evaluations.

2. Sample size used for the test set and the data provenance:

Sample size: Not explicitly stated for each test, but implied to be sufficient to meet the statistical requirements of the referenced ISO and ASTM standards.
Data provenance: Not explicitly stated, tests were presumably performed by laboratories in a controlled environment to standard specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A. This question is for AI/ML diagnostics. For a physical device like a condom, "ground truth" refers to the objective measurement against established physical standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

N/A. This question is for AI/ML diagnostics.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

N/A. This question is for AI/ML diagnostics.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

N/A. This question is for AI/ML diagnostics. The device is a physical product.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Objective measurement against recognized international and national standards. For biocompatibility, it's the results from standardized biological tests. For physical performance, it's direct measurements (e.g., dimensions, burst pressure, tensile strength) compared to numerical thresholds defined in ISO 4074:2015 and ASTM D3492-16.

8. The sample size for the training set:

N/A. This question is for AI/ML diagnostics. There is no "training set" for a physical device like this in the context of this submission. The device is developed through manufacturing processes and then tested against standards.

9. How the ground truth for the training set was established:

N/A. This question is for AI/ML diagnostics.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 7, 2025

Lelo Inc. % Kevin Walls Principal Consultant Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton. CO 80127

Re: K243421

Trade/Device Name: Lelo Hex Lubricated Natural Rubber Latex Condom Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: November 2, 2024 Received: January 29, 2025

Dear Kevin Walls:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

{1}------------------------------------------------

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

{2}------------------------------------------------

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Monica D. Garcia -S

Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K243421

Device Name

Lelo Hex Lubricated Natural Rubber Latex Condom

Indications for Use (Describe)

The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510(k) Summary K243421 Lelo Hex Lubricated Latex Condom

1. Submitter Information

Applicant: Lelo Inc. Address: 5799 Fontanoso Way San Jose, CA 95138, Phone: (877) 872-5356

2. Correspondent Information

Company: Regulatory Insight Contact: Kevin Walls Address: 33 Golden Eagle Lane Littleton, CO 80127 Phone: (720) 962-5412 Email: kevin@reginsight.com

3. Date Prepared: March 7, 2025

4. Device Information

Device Name: Lelo Hex Lubricated Natural Rubber Latex Condom Common Name: Male Natural Rubber Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Product Code: HIS (Condom) Regulatory Class: Class II

5. Predicate Device Information

Device Name: One Touch Spiral Condom 510(k) Number: K210294 Sponsor: Thai Nippon Rubber Industry Public Company Limited

The predicate device has not been subject to a design-related recall.

6. Device Description

The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

{5}------------------------------------------------

K243421 Page 2 of 3

7. Indications for Use Statement

The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

1. Comparison of Intended Use and Technological Characteristics with the Predicate Device The table below includes a comparison of the intended use and technological characteristics of the subject and predicate devices.

	Subject Device	Predicate Device
Device & Predicate Device	Lelo Hex Lubricated LatexCondom	One Touch Spiral Condom
510(K) Number	K240679	K210294
Product Code	HIS	HIS
Regulation Number	21 CFR 884.5300	21 CFR 884.5300
Regulation Name	Condom	Condom
Indications for Use	The Lelo Hex Lubricated LatexCondom is used forcontraception and forprophylactic purposes (to helpprevent pregnancy and thetransmission of sexuallytransmitted infections).	The One Touch Spiral Condomis used for contraception andfor prophylactic purposes (tohelp prevent pregnancy andthe transmission of sexuallytransmitted infections).
Prescription or Over-The-Counter Use	Over-The-Counter	Over-The-Counter
Condom Material	Natural Rubber Latex	Natural Rubber Latex
Nominal Width	54 ± 2 mm	52 ± 2mm54 ± 2mm
Nominal Length	190 ± 10 mm	190 ± 10 mm
Nominal Thickness	0.060 ± 0.010 mm	0.080 ± 0.010 mm
Lubricant	L Arginine Lubricant	Silicone Oil
Lubricant Quantity	550 ± 150 mg	Not publicly available
Air Burst Pressure	>1.0 kPa	Not publicly available; metthe criteria specified in ISO4074:2015, Natural latexrubber condoms -Requirements and testmethods
Air Burst Volume	>18.0 L	the criteria specified in ISO4074:2015, Natural latexrubber condoms -Requirements and testmethods
Sterilization	Non-sterile	Non-sterile
Shape	Straight walled, nipple end	Straight wall, spiral head withnipple end (Single and doublespiral)
Texture	Hexagonal Textured	Smooth
Shelf life	3 years	5 years

{6}------------------------------------------------

The subject and predicate device have identical indications for use statements, with the exception of device name, and the same intended use - for contraception and for prophylactic purposes. The technological characteristics of the subject device and predicate device are similar in that they are natural rubber latex-based and lubricated. The subject and predicate device have different technological characteristics, including different dimensions, shelf-life, lubricant formulation, and texture. These differences do not raise different questions of safety and effectiveness.

9. Summary of Non-Clinical Performance Testing

Biocompatibility:

Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation, Cytotoxicity, and Sensitization testing, were performed in accordance with the 2023 FDA Guidance Document, Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process" and ISO 10993-1:2009 as follows:

Cytotoxicity (ISO 10993-5:2009/R 2014)
Sensitization (ISO 10993-10:2021)
Vaginal Irritation (ISO 10993-10:2021)
. Acute Systemic Toxicity (ISO 10993-11:2017)

The result of testing demonstrates that the subject device is non-cytotoxic, non-irritating, nonsensitizing, and non-acutely, systemically toxic.

Physical Performance Testing:

The Lelo Hex Lubricated Natural Rubber Latex Condom was tested and met all the requirements of ISO 4074:2015 " Natural rubber latex male condom – Requirement and test methods" and ASTM D3492-16 "Standard Specification for Rubber Contraceptives (Male Condoms)" for dimensional, tensile strength, force at break, lubricant quantity, visible defects, elongation, air burst volume and air burst pressure requirements.

Shelf Life:

The Lelo Hex Lubricated Natural Rubber Latex Condom has a three-year shelf-life based on the results of accelerated stability evaluation conducted as required in 21 CFR 801.435. All samples met predefined acceptance criteria.

10. Conclusion

The results of the performance testing described above demonstrate that the Lelo Hex Lubricated Natural Rubber Latex Condom is as safe and effective as the predicate device and supports a determination of substantial equivalence.

Regulation Number and Section

§ 884.5300 Condom.

(a)
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.(b)
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.