The Stork® OTC is indicated for over-the-counter home use by couples who have been unable to conceive naturally and who have received a diagnosis of low sperm count, sperm immobility or unfavorable vaginal environment. The Stork® OTC contains a cervical cap inside a condom-like silicone sheath. It is used to collect semen into a cervical cap then deliver it to the outside of the cervix as an aid to conception. The Stork® OTC should be used during the ovulatory phase of the menstrual cycle. The Stork® OTC Cervical Cap should not be left in place for longer than six hours.

Device Description

The Stork® OTC package includes: one Instructions for Use, one Conceptacle® and one plastic applicator. Once the couple has decided to attempt to become pregnant, the Stork® OTC Conception System Instruction for Use recommends using the device during female's most fertile days in a given month. During sexual intercourse, semen will be collected using the Conceptacle®, a cervical cap that is pre-inserted into a condom-like sheath. The male removes the Conceptacle® from the penis by rolling it down and separating it from the penis. After removal, the rim of the cervical cap is lightly pinched so that the Condom-like Sheath can be separated. (The Cervical Cap and Condom-like Sheath are separated in two separate parts). The semen is contained in the cervical cap and its reservoir. The second component, the Applicator, is used for ease of transition of the Cervical Cap to the cervix. The applicator seals the Cervical Cap and contains the semen for transition through the vaginal tract, assisting the female in guiding the cap to the cervix and releasing the semen and the cap in front of the cervix. When the cervical cap is loaded onto the applicator (while it is still outside of the body), the Retainer locks onto the Cervical Cap and is delivered with the Cervical Cap intra-vaginally. The Retainer also has a removal cord that is attached for withdrawal. The Cervical Cap and Retainer then remain in place for up to 6 hours.

AI/ML Overview

The provided text describes "The Stork® OTC," a conception assistance kit, and studies conducted to support its over-the-counter (OTC) use.

Here's a breakdown of the acceptance criteria and the studies that prove the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criterion	Reported Device Performance
User Understanding (Self-Selection & Labeling Comprehension)	Understanding the Indications for Use	All primary endpoints for self-selection and labeling comprehension were achieved. The device description explicitly states these were met.
	Understanding the Selection of the Device	All primary endpoints for self-selection and labeling comprehension were achieved. The device description explicitly states these were met.
	Understanding the Contraindications for Use	All primary endpoints for self-selection and labeling comprehension were achieved. The device description explicitly states these were met.
	Understanding Warnings	All primary endpoints for self-selection and labeling comprehension were achieved. The device description explicitly states these were met.
	Understanding When to Use the Device	All primary endpoints for self-selection and labeling comprehension were achieved. The device description explicitly states these were met.
	Understanding Activity Limitations While Wearing the Cervical Cap	All primary endpoints for self-selection and labeling comprehension were achieved. The device description explicitly states these were met.
	Understanding that the Device Does Not Guarantee Pregnancy	All primary endpoints for self-selection and labeling comprehension were achieved. The device description explicitly states these were met.
	Understanding How Long To Use the Device Without Successful Results Before Contacting a Physician	All primary endpoints for self-selection and labeling comprehension were achieved. The device description explicitly states these were met.
Physical Usability (Simulated Use)	Male Endpoints:	Male Performance:
	Correctly Place the Conceptacle on a Penis	Successfully completed ("All primary endpoints were achieved" for simulated use, and later confirmed "All subjects were able to use the device to collect semen").
	Correctly Remove the Conceptacle from a Penis	Successfully completed ("All primary endpoints were achieved" for simulated use, and later confirmed "All subjects were able to use the device to collect semen").
	Correctly Separate the Condom from the Cervical Cap	Successfully completed ("All primary endpoints were achieved" for simulated use, and later confirmed "All subjects were able to use the device to collect semen").
	Collect and Contain Semen Using the Conceptacle (Usability only)	Successfully completed ("All primary endpoints were achieved" for simulated use, and later confirmed "All subjects were able to use the device to collect semen").
	Female Endpoints:	Female Performance:
	Correctly Place the Cervical Cap in the Applicator	Successfully completed ("All primary endpoints were achieved" for simulated use, and confirmed "All subjects were able to...effectively position and place the Conceptacle® in the vaginal tract using the applicator, and remove the cervical cap from the vaginal tract").
	Correctly Close the Applicator	Successfully completed.
	Correctly Insert the Applicator into a Vaginal Tract	Successfully completed.
	Correctly Position the Applicator Near the Cervical Os	Successfully completed.
	Correctly Open the Cervical Cap with the Applicator	Successfully completed.
	Correctly Engage the Trigger Button to Release the Cervical Cap	Successfully completed.
	Leave the Cap in Place as Directed (Usability only)	Successfully completed.
	Correctly Avoid Sexual Activity While the Cervical Cap is in Place (Usability only)	Successfully completed.
	Correctly Withdraw Device from the Vaginal Tract	Successfully completed.
	Correctly Treat the Device as Single Use	Successfully completed.
Safety (Clinical Human Factors/Usability & Physical Examination)	No evidence of trauma or injury to the vaginal tract or cervical os during use and removal.	"These steps [collection, placement, removal] were successfully completed without any evidence of trauma or injury to the vaginal tract or cervical os." This was verified by visual inspection and physical examination by the primary investigator.
Biocompatibility	Materials are non-cytotoxic, non-irritating, and non-sensitizing.	Testing demonstrated that the Stork® OTC materials are considered non-cytotoxic, non-irritating, and non-sensitizing. Colorant safety also deemed acceptable through Colorant Leachables Testing and Toxicological Risk Assessment.
Material/Mechanical Properties	Pull strength of the withdrawal cord is met.	Bench testing demonstrated that the pull strength of the withdrawal cord was met for all systems tested.
Shelf-Life	All components function properly and according to design intent after a specified shelf life.	A 6-month shelf-life study was performed, and all components were shown to function properly and according to design intent. (Note: Data from the predicate device was used for Condom Mechanical Testing and Shelf-life for the Conceptacle itself).
Human Sperm Survival Assay (HSSA)	(Implicitly, the device should not adversely affect sperm viability).	Data from the predicate device (Focus Touch® Conception System) was used for Human Sperm Survival Assay (HSSA), implying the Stork® OTC also meets this.
Condom Mechanical Testing	(Implicitly, the condom-like sheath should meet mechanical standards).	Data from the predicate device (Focus Touch® Conception System) was used for Condom Mechanical Testing, implying the Stork® OTC also meets this.

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

The document does not specify the exact sample size for the self-selection, labeling comprehension, simulated use, or clinical human factors/usability studies. It states "All primary endpoints were achieved in all three sections of the study" and "All subjects were able to use the device." Without specific numbers, the sample size remains unknown from the provided text.
Data Provenance: The studies were described as "Performance Testing - Clinical" and "Performance Testing - Bench." These were conducted prospectively to demonstrate the device's suitability for over-the-counter use and safe application by lay users. The country of origin for the studies is not explicitly stated, but given the context of a 510(k) submission to the FDA, it's highly likely they were conducted in the United States.

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

For the clinical human factors/usability testing where safety was assessed, it states: "These endpoints were verified by visual inspection and physical examination by the primary investigator." This indicates at least one expert (the primary investigator) was involved in establishing safety ground truth.
Qualifications of the expert(s): The qualifications of the primary investigator are not explicitly detailed beyond being a "primary investigator" for a clinical study involving physical examination. It can be inferred they are a medical professional, likely a physician or gynecologist, qualified to conduct such examinations and verify safety endpoints related to the vaginal tract and cervical os.

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

The document does not detail any specific adjudication method like 2+1 or 3+1 for the user studies or the primary investigator's findings. The verification appears to have been carried out by the "primary investigator" directly. Therefore, it implicitly suggests a "none" or "single expert review" adjudication for the clinical safety aspects. For user performance, the "correctness" of actions was likely directly observed and recorded.

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:

No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (conception kit), not an AI-powered diagnostic tool requiring human reader interpretation of images or data. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

Not applicable. As stated above, this is a physical medical device and does not involve an algorithm. The testing focused on the standalone performance of users correctly applying the device without professional medical supervision.

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

For Usability and Safety: The ground truth was primarily established through direct observation of user performance (for correct steps) and physical examination by a primary investigator (for safety endpoints like trauma/injury). This constitutes a form of expert assessment of physical outcomes.
For Biocompatibility and Mechanical Testing: The ground truth was established through laboratory testing against established ISO standards and internal specifications (e.g., ISO 10993-1: 2009 for biocompatibility, specific pull strength measurements).

8. The sample size for the training set:

The document does not mention a training set for the device's studies. The studies described are performance testing (self-selection, comprehension, simulated use, clinical human factors/usability, bench testing), which are typically considered validation or verification tests rather than training data for a device or algorithm.

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

Not applicable, as no training set for the device's studies is mentioned in the provided text.

Summary

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Traditional 510(K) K140186 Pg. 1of 8 and the country of the states

TAB 2

The Stork® OTC

JUL 1 1 2014

510(K) SUMMARY - K140186 THE STORK® OTC

Sponsor:

Rinovum Women's Health, Inc. 300 Oxford Drive Suite 330 Monroeville, PA 15146

Applicant:

Andrew Zeltwanger Rinovum Women's Health, Inc. 300 Oxford Drive Suite 330 Monroeville, PA 15146

724-241-8934 Phone: Facsimile: 724-204-8141

Date Prepared: June 5, 2014

Proprietary Name: The Stork® OTC

Common Name: Conception Assistance Kit

Classification Name: Kit, Conception-Assist, Home Use (Product Code: OBB)

Classification Panel: Obstetrical/Gynecological

Regulation: 21 CFR § 884.5250, Cervical Cap

Manufacturer Device Name Predicate Devices: Rinovum Women's The Focus Touch® Health, Inc Conception System

510(k) Number K112200

Reason for Submission:

Description of Device

The Stork® OTC package includes: one Instructions for Use, one Conceptacle® and one plastic applicator.

New Indication for Over-The-Counter Use

Once the couple has decided to attempt to become pregnant, the Stork® OTC Conception System Instruction for Use recommends using the device during female's most fertile days in a given month. During sexual intercourse, semen will be collected using the Conceptacle®, a cervical cap that is

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Traditional 510(K) K140186 Pg. 2 of 8

pre-inserted into a condom-like sheath. The male removes the Conceptacle® from the penis by rolling it down and separating it from the penis. After removal, the rim of the cervical cap is lightly pinched so that the Condom-like Sheath can be separated. (The Cervical Cap and Condom-like Sheath are separated in two separate parts). The semen is contained in the cervical cap and its reservoir. The second component, the Applicator, is used for ease of transition of the Cervical Cap to the cervix. The applicator seals the Cervical Cap and contains the semen for transition through the vaginal tract, assisting the female in guiding the cap to the cervix and releasing the semen and the cap in front of the cervix. When the cervical cap is loaded onto the applicator (while it is still outside of the body), the Retainer locks onto the Cervical Cap and is delivered with the Cervical Cap intra-vaginally. The Retainer also has a removal cord that is attached for withdrawal. The Cervical Cap and Retainer then remain in place for up to 6 hours.

Indications for Use

The Stork® OTC is indicated for over-the-counter home use by couples who have been unable to conceive naturally and who have received a diagnosis of low sperm count. sperm immobility or unfavorable vaginal environment. The Stork® OTC contains a cervical cap inside a condom-like silicone sheath. It is used to collect semen into a cervical cap then deliver it to the outside of the cervix as an aid to conception. The Stork® OTC should be used during the ovulatory phase of the menstrual cycle. The Stork® OTC Cervical Cap should not be left in place for longer than six hours.

Comparison between predicate and proposed device

The tables below compare the two devices:

	PREDICATE DEVICE:	PROPOSED DEVICE:
	Focus Touch® Conception System	The Stork® OTC
MANUFACTURER	Rinovum Women's Health(formerly Intimate bridge 2Conception, Inc.)	Same as K112200
510(k) NUMBER	K112200	K140186
REGULATION NUMBER	884.5250 Cervical Cap:	Same as K112200
FDA PRODUCT CODE	OBB	Same as K112200
CLASSIFICATION	II	Same as K112200
	PREDICATE DEVICE:	PROPOSED DEVICE:
	Focus Touch® Conception System	The Stork® OTC
INDICATIONS FOR USE	The Focus Touch™ Conception System is indicated for assisted insemination in instances where low sperm count, sperm immobility, or hostile vaginal environment has been diagnosed. The system (cervical cap in a condom-like silicone sheath) is used to collect semen into a cervical cap, and then deliver the cap to the outside of the cervix as an aid to conception. It is to be used at home following physician instruction. The Focus Touch Conception System should not be left in place for longer than 6 hours.	The Stork® OTC is indicated for over-the-counter home use by couples who have been unable to conceive naturally and who have received a diagnosis of low sperm count, sperm immobility or unfavorable vaginal environment. The Stork® OTC contains a cervical cap inside a condom-like silicone sheath. It is used to collect semen into a cervical cap then deliver it to the outside of the cervix as an aid to conception. The Stork® OTC should be used during the ovulatory phase of the menstrual cycle. The Stork® OTC Cervical Cap should not be left in place for longer than six hours.
CONTRAINDICATIONS FOR USE	This product is not for use by those for which it is medically unsafe to have sexual intercourse or to become pregnant.	Same as K112200
INTENDED ENVIRONMENT FOR USE	Prescription Home Use Device	Over the Counter (OTC) Home Use Device
PATIENT POPULATION	Adult	Same as K112200

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・

	PREDICATE DEVICE:	PROPOSED DEVICE:
	Focus Touch® ConceptionSystem	The Stork® OTC
TECHNOLOGY	Cervical Cap Inseminationwith an applicator for deliveryand placement. A removalstring for cervical capwithdrawal.	Same as K112200
MATERIAL
Cervical Cap	Liquid Silicone Rubber (LSR)10:1, Implant Grade, Cured	Same as K112200
Condom Sheath	Liquid Silicone Rubber (LSR)10:1, Implant Grade, Cured	Same as K112200
Retainer	Acetal Copolymer	Same as K112200
Applicator	Acetal Copolymer	Same as K112200
Removal Cord Tether	Polyester USP SutureMaterial	Same as K112200
BIOCOMPATIBILITY	Devices met requirements ofISO 10993-1: 2009 forSensitization, Cytotoxicityand Irritation	Same as K112200
STERILITY	Non-sterile	Same as K112200
PACKAGING	The system can bepurchased packaged in aquantity of one (1) or three(3) systems per package.	The system can bepurchased packaged in aquantity of one (1)
SINGLE USE	Yes	Same as K112200
CONDOM/CONCEPTACLE(SEMEN COLLECTION)SHEATH OUTSIDEDIAMETER	$1.378" +/-.046"$	Same as K112200

・

. 1

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Traditional 510(K) K140186 Pg. 5 of 8

	PREDICATE DEVICE:	PROPOSED DEVICE:
	Focus Touch® ConceptionSystem	The Stork® OTC
OVERALL LENGTH OFCONDOM/CONCEPTACLE	7.429" +/-.120" (estimatedtolerance - overall length iscomprised of 3 separatelytoleranced dimensions"	Same as K112200
OVERALL CAP LENGTH(WHEN CONCEPTACLEIS SEPARATED FROMCONDOM)	1.67"±.010"	Same as K112200
SEMEN RESERVOIRDIMENSIONS	.500±.010" diameter X.800±.010" deep	Same as K112200
REMOVAL CORDLENGTH	Loop positioned at 6.50" fromthe Cap Rim	Same as K112200
DELIVERY DEVICELENGTH	9.05"—9.45"	Same as K112200
DELIVERY DEVICEMAXIMUM INSERTABLEOUTER DIAMETER	0.984"	Same as K112200

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Technological Characteristics

Please refer to the comparison table above to see a listing of technological features between the new and predicate device. No new technologies were introduced; therefore, no new questions of safety or efficacy are raised.

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Figure 1: The Stork® OTC Component Diagram

Image /page/5/Figure/3 description: The image shows two diagrams, one labeled "the Applicator" and the other "the Conceptacle." The applicator diagram shows a long, slender device with several labeled parts, including "Petals (open)," "Cap Holder," "Stem," "Cap Release," "Plunger Release," and "Plunger Tab." The conceptacle diagram shows a funnel-shaped object with labels pointing to the "Cervical Cap (Inside)" and "Condom (outside)." The diagrams appear to be illustrating the components of a medical or contraceptive device.

Indication for Use Comparison

The indications for use between the predicate and proposed device differ in that the proposed device is indicated for over-the-counter use of the device rather than prescription use. The indication for use includes the same user group as the predicate, having the diagnoses of low sperm count, sperm immobility or unfavorable vaginal environment. It also includes further specification for users that have not been able to successfully conceive naturally. Further, the device labeling includes the same warnings and precautions. Studies were completed to demonstrate that the over-the-counter user population could sufficiently self-select and comprehend the labeling. The usability and safety clinical trial demonstrated that users could effectively and safely use the device without physician instruction, overview or intervention, and in accordance with the instructions for use. Therefore, the differences between the indications for use do not represent a new Intended Use. Nor do these differences present new concerns of safety and efficacy.

Performance Testing - Clinical

A self-selection study and labeling comprehension study were performed to demonstrate that users could determine the uses of the device, the target population for device use, and if the labeling was clear and understandable. Additionally, a simulated use study was performed to verify that users could follow instructions under simulated-use conditions. All primary endpoints were achieved in all three sections of the study: Self-selection, labeling comprehension, and simulated use.

Following successful completion of the self-selection, labeling comprehension, and simulated use study and the finalization of labeling, clinical human factors and usability testing was performed to validate the instructions for use and demonstrate the proper use placement of

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Traditional 510(K) K140186 Pg. 7 of 8

and the safety of the device for users. All subjects were able to use the device to collect semen, effectively position and place the Conceptacle® in the vaginal tract using the applicator, and remove the cervical cap from the vaginal tract. These steps were successfully completed without any evidence of trauma or injury to the vaginal tract or cervical os. These endpoints were verified by visual inspection and physical examination by the primary investigator.

Primary Self-Selection and Labeling Comprehension Endpoints:

Understanding the Indications for Use .
Understanding the Selection of the Device
Understanding the Contraindications for Use
Understanding Warnings �
. Understanding When to Use the Device
Understanding Activity Limitations While Wearing the Cervical Cap ●
Understanding that the Device Does Not Guarantee Pregnancy .
Understanding How Long To Use the Device Without Successful Results Before Contacting a Physician

Primary Simulated Use / Usability Endpoints (Male):

Correctly Place the Conceptacle on a Penis .
Correctly Remove the Conceptacle from a Penis
Correctly Separate the Condom from the Cervical Cap .
Collect and Contain Semen Using the Conceptacle (Usability only)

Primary Simulated Use / Usability Endpoints (Female):

Correctly Place the Cervical Cap in the Applicator .
Correctly Close the Applicator ●
Correctly Insert the Applicator into a Vaqinal Tract .
Correctly Position the Applicator Near the Cervical Os .
Correctly Open the Cervical Cap with the Applicator .
Correctly Engage the Trigger Button to Release the Cervical Cap .
Leave the Cap in Place as Directed (Usability only) ●
Correctly Avoid Sexual Activity While the Cervical Cap is in Place (Usability only) .
Correctly Withdraw Device from the Vaginal Tract .
Correctly Treat the Device as Single Use .

Performance Testing - Bench

Biocompatibility Testing was performed on the device to support the applicator color changes from the predicate device. Testing demonstrated that the Stork® OTC materials are considered non-cytotoxic, non-irritating, and non-sensitizing. Colorant safety was deemed acceptable through additional Colorant Leachables Testing and a resulting Toxicological Risk Assessment of Extractable Chemicals. Bench testing demonstrated that the pull strength of the withdrawal cord was met for all systems tested

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The Stork® OTC

Traditional 510(K) K140186 Pg. 8 of 8

and a shelf life study was performed to verify that all components of the Stork® OTC were shown to function properly and according to their design intent following a 6 month shelf life test. The Stork® OTC Conceptacle is identical to the predicate and data from the predicate device was used for the following aspects:

. Human Sperm Survival Assay (HSSA)
Condom Mechanical Testing .
Shelf-life ◆

Conclusions

The Stork® OTC is substantially equivalent to the Focus Touch® Conception System. The Stork® OTC has the same intended uses, technological characteristics, and principles of operation as its predicate device. The differences between The Stork® OTC and the Focus Touch® Conception System raise no new issues of safety or effectiveness. Usability and Clinical data demonstrate that The Stork® OTC is as safe and effective as the Focus Touch®. Thus, The Stork® OTC is substantially equivalent.

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Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 11, 2014

Rinovum Women's Health, Inc. Andrew Zeltwanger Director of Regulatory & Quality 300 Oxford Drive, Suite 330 Monroeville, PA 15146

Re: K140186

Trade/Device Name: The Stork® OTC Regulation Number: 21 CFR§ 884.5250 Regulation Name: Cervical Cap Regulatory Class: II Product Code: OBB Dated: June 10, 2014 Received: June 11, 2014

Dear Andrew Zeltwanger,

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 (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. 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.

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.

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Page 2 - Andrew Zeltwanger

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

GlenBell-S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K140186

Device Name The Stork® OTC

Indications for Use (Describe)

The Stork® OTC is indicated for over-the-counter home been unable to conceive naturally and who have received a diagnosis of low sperm immobility or unfavorable vaginal environment. The Stork® OTC contains a cervical cap inside a condom-like silicone sheath. It is used to collect semen into a cervical cap the cervix as an aid to conception. The Stork® OTC should be used during the ovulatory phase of the Stork® OTC Cervical Cap should not be left in place for longer than six hours.

Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D) ☑Over-The-Counter Use (21 CFR 801 Subpart C)	Prescription Use (Part 21 CFR 801 Subpart D)	☑ Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)	for Ben R Fisher
------------------------------------------------------------------------------	------------------

Glenn B. Bell -S

FORM FDA 3881 (1/14)	Page 1 of 2
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Regulation Number and Section

§ 884.5250 Cervical cap.

(a)
Identification. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.(b)
Classification. Class II (performance standards).