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.

Device Description

The Focus Touch™ Conception System includes detailed Instructions for Use, one Conceptacle and one plastic applicator. The system can be purchased packaged in a quantity of one (1) or three (3) individually packaged systems.

Once the couple has decided to attempt to become pregnant, the Focus Touch™ 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 cao 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 cervical cap is loaded onto the applicator (while it is still outside of the Retainer locks onto the Cervical Cap and is delivered with the Cervical Cap intravaginally. 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 Focus Touch™ Conception System and its substantial equivalence to a predicate device. It details various aspects of the device and the testing performed, but it does not provide acceptance criteria in a quantitative format or a comprehensive study report with detailed performance metrics. The information is primarily focused on demonstrating equivalence through comparison and summary of tests.

Here's an attempt to extract and synthesize the requested information based on the provided text, acknowledging where specific details are missing:

Acceptance Criteria and Device Performance for Focus Touch™ Conception System

The provided documentation focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with explicit quantitative acceptance criteria and detailed performance results. The "performance" is largely reported as successful completion of specific tests, indicating the device met the implicit requirements for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the submission, precise numerical acceptance criteria and corresponding reported device performance for clinical effectiveness are not provided. Instead, the document outlines types of tests performed and their successful completion for demonstrating safety and functionality.

Test Category	Implied Acceptance Criterion	Reported Device Performance
Biocompatibility	Device materials should be non-cytotoxic, non-irritating, and not elicit a sensitization response.	Demonstrated that the device is non-cytotoxic, not an irritant, and did not elicit a sensitization response. ("considered non-cytotoxic, is not an irritant and did not elicit a sensitization response.")
Sperm Compatibility (HSSA)	Device materials (Conceptacle) should have no deleterious effects on human sperm. For HSSA, human sperm must demonstrate forward progressive motility rate of ≥80% of the initial forward progressive motility sperm swim up after 6 hours of sample preparation.	Human Sperm Survival Assay (HSSA) testing performed on the silicone Conceptacle demonstrated "no deleterious effects on human semen." ("Conceptacle, material has no deleterious effects on human semen.") (The 80% criterion is stated for the predicate device's test, and "Same" is indicated for the proposed device, suggesting this criterion was met.)
Semen Collection	The Conceptacle should be comfortable (no slip, breakage, ability to ejaculate) and adequate (able to collect and contain semen) during use.	Usability and acceptability testing successfully validated that "the use of the Conceptacle for semen collection was comfortable (slip, breakage, ability to ejaculate) and adequate (able to collect and contain semen)."
Condom-like Sheath Material	Silicone material should be biocompatible, acceptable as a semen collection device (comfort, adequacy), and similar in malleability to standard polyurethane condoms.	Silicone material was shown to be biocompatible and acceptable with regard to comfort and adequacy in validation testing. Malleability was noted as "very similar... with a durometer of 30-40 on the Shore A scale." ("The device has been shown to be biocompatible and acceptable as a semen collection device with regard to comfort (slip, breakage, ability to ejaculate) and adequacy (ability to collect and contain semen) in validation testing.")
Burst Pressure & Volume	Exceed minimum requirements for commercially available condoms.	Bench testing "exceeded the minimum requirements for burst pressure and volume for commercially available condoms."
Pull Strength (Withdrawal Cord)	Sufficient pull strength of the collet/string attached to the cervical cap to prevent separation from the collet.	Bench testing "demonstrated that the pull strength of the withdrawal cord, specifically Cervical Cap/Collet Separation Force for the Focus Touch System, was met for all systems tested."
Shelf Life	All components should function correctly and according to their design intent after a specified real-time storage or accelerated aging period.	A shelf life study verified that "all components of the Focus Touch System were shown to function correctly and according to their design intent following a minimum real-time storage during and or accelerated aging period equivalent to six (6) months."
Usability (Study 1)	End-users should understand Instructions for Use, and manipulate, insert, and remove the cap correctly without direct supervision. Safety to the vaginal tract verified by physical examination.	"Study 1 testing was performed with the cervical cap and applicator to demonstrate that the end user can understand the Instructions for Use, and manipulate, insert and remove the cap correctly without direct supervision. ... a physical examination occurred to verify safety of the device to the vaginal tract and all success criteria were met."
Usability (Study 2)	Appropriate ease of use, comfort, acceptability, and safety when used during sexual intercourse as a collection device.	"Study 2 testing was performed to demonstrate appropriate ease of use, comfort and acceptability and safety when used during sexual intercourse as a collection device." The text implies success but does not explicitly state "all success criteria were met" for Study 2 as it does for Study 1. However, the subsequent conclusion of substantial equivalence implies satisfactory results.

2. Sample Sizes and Data Provenance

Test Set Sample Sizes:
- No specific numerical sample sizes are provided for the usability studies or bench testing, except that "all systems tested" met the pull strength requirement.
- For the HSSA, the description "human sperm must demonstrate..." refers to the criterion for the test rather than the number of samples or subjects used in the actual test itself.
Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective as they involved active testing (bench, HSSA, usability studies).

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The "ground truth" for these tests relates to measurable physical or biological properties (biocompatibility, sperm motility, burst strength) or observable user behavior/feedback (usability studies), rather than expert interpretation of medical images or patient records. The "experts" would likely be laboratory technicians for bench tests or study coordinators/medical professionals for usability, but their specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable. The tests described are primarily objective (e.g., measuring burst pressure, checking for cytotoxicity) or involve direct observation/user feedback that doesn't typically require an adjudication method like 2+1 or 3+1.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a physical medical device (conception assistance kit), not a diagnostic algorithm that would typically undergo an MRMC study. The study focuses on the device's physical and functional properties, biocompatibility, and usability.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This is not an algorithm, but a physical device.

7. Type of Ground Truth Used

The "ground truth" for the tests mentioned includes:

Laboratory-measured properties: Biocompatibility (cytotoxicity, irritation, sensitization), HSSA (sperm motility), mechanical properties (burst pressure, pull strength).
User feedback/observation: For usability (comfort, ease of use, ability to manipulate and remove).
Physical examination: To verify safety to the vaginal tract in Usability Study 1.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm requiring a "training set."

9. How Ground Truth for Training Set Was Established

Not applicable. As above, this is not an AI/ML device.

Summary

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K | | 2200

510(k) Summary

[Refer to 21 CFR 807.92]

SEP 6 2012

Owner:	Intimate Bridge 2 Conception, Inc2425 Sidney Street,Pittsburgh, PA 15203
Applicant:	Stephen BollingerChief Executive Officer412.770.1641 Office
ApplicationCorrespondent:	Niki Caporali SpanielSenior, Regulatory & Quality SpecialistRegulatory & Quality Solutions, LLCPhone: (724) 327-0230 x207
Date Prepared:	August 24, 2012
Proprietary Name:	Focus TouchTM Conception System
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
Predicate Devices:	ManufacturerConceivex, Inc	Device NameConception Kit	510(k) NumberK063227
Reason for Submission	New Device
510(k) Number:	K112200

Description of Device

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from the penis by rolling it down and separating it from the penis. After removal, the rim of the cervical cao 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 cervical cap is loaded onto the applicator (while it is still outside of the Retainer locks onto the Cervical Cap and is delivered with the Cervical Cap intravaginally. 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.

Indication For Use

Comparison between predicate and proposed device

The tables below compare the two devices:

Device	Predicate - Conceivex Inc.Conception Kit	Proposed - Focus TouchConception System	Conclusion
Indicationfor Use	The Conceivex ConceptionKit is indicated for assistedinsemination in situations inwhich low sperm count, spermimmobility, or hostile vaginalenvironment have beendiagnosed. The kit is used forsemen collection andplacement into the bowl of acervical cap as an aid toconception. It is to be used athome following physicianinstruction. The Cap shouldnot be left in place for longerthan 6 hours.	The Focus Touch ConceptionSystem is indicated for assistedinsemination in instances wherelow sperm count, spermimmobility, or hostile vaginalenvironment has beendiagnosed. The system (cervicalcap in a condom-like siliconesheath) is used to collect semeninto a cervical cap, and thendeliver the cap to the outside ofthe cervix as an aid toconception. It is to be used athome following physicianinstruction. The Focus TouchConception System should notbe left in place for longer than 6hours.	Same
Usage	Prescription Use. For use at	Prescription Use. For use at	Same

Device Similarities:

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	home following physicianinstruction.	home following physicianinstruction.
User Group	Couples who are trying toconceive and have beendiagnosed with low spermcount, sperm immobility, orhostile vaginal environment.	Couples who are trying toconceive and have beendiagnosed with low sperm count,sperm immobility, or hostilevaginal environment.	Same
MaterialComposition ofCervical Cap	Silicone Cervical Cap	Silicone Cervical Cap	Same
InseminationTechnology	Cervical Cap Insemination	Cervical Cap Insemination	Same
Biocompatibility	Materials tested and shown tobe biocompatible.	Materials tested and shown to bebiocompatible.	Same
SpermCompatibility	Human Sperm Survival AssayTested to demonstrate thatdevice materials have nodeleterious effects on humansperm.	Conceptacle Human SpermSurvival Assay (HSSA) Tested.To pass the HSSA test, thehuman sperm must demonstrateforward progressive motility rateof ≥80% of the initial forwardprogressive motility sperm swimup after 6 hours of samplepreparation.	Same
Sterility	Nonsterile	Nonsterile	Same
Single use	Yes	Yes	Same

Device Differences:

・・・ #

ﮮ ﮧ۔

Device	Predicate - Conceivex Inc.Conception Kit	Proposed - Focus Touch ConceptionSystem
SemenCollectionMethod	A collection condom is used duringintercourse to collect semen.	The Focus Touch™ Conception Systemdoes not contain a separate collectioncondom, rather the collection cervicalcap and condom-like sheath are pre-assembled into one unit.
Discussion:
Collection is still performed in the same manner as it is with the predicate device.
Usability and acceptability testing was successfully performed to validate that the
use of the Conceptacle for semen collection was comfortable (slip, breakage,
ability to ejaculate) and adequate (able to collect and contain semen). Therefore,
the semen collection method utilizing the Conceptacle (cervical cap and condom-like sheath assembly) is substantially equivalent to and the collection method of
the predicate device.
CollectionCondomMaterial	Polyurethane	The condom-like sheath component of theConceptacle is made from silicone.
Discussion:
Silicone has been used historically for medical devices used in the vaginal tract.

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	The Condom-like Sheath of the Conceptacle is very similar in malleability tostandard polyurethane condoms with a durometer of 30-40 on the Shore A scale.The device has been shown to be biocompatible and acceptable as a semencollection device with regard to comfort (slip, breakage, ability to ejaculate) andadequacy (ability to collect and contain semen) in validation testing. Therefore,the material used for the condom-like sheath of the proposed device issubstantially equivalent to the material used for the condom for the predicatedevice.
PlacementandDeliveryMethod	The device is placed into thevagina and in front of the cervicalos by hand.	The Focus Touch™ Conception Systemuses an applicator for placement anddelivery of the cervical cap to the cervicalos.
	Discussion:
	The applicator component, for which biocompatibility and usability have beendemonstrated during testing, allows the user to insert the cervical cap into thevaginal tract without the use of the user's hand. It is performed in a similarmanner as inserting a tampon with a plastic applicator. It has smoothnessrequirements for comfort and safety and allows for insertion and placement.Therefore, the placement and delivery method of the proposed device issubstantially equivalent to that of the predicate device.
RemovalMethod	The proposed device contains aloop that is molded with thecervical cap. The user reachesinto the vagina and grasps theloop to remove the device.	The Focus Touch™ Conception Systemapplicator features a mechanism whichapplies a removal cord to the cervical cap(during the process of loading the applicator)to aid in removal of the device.
	Discussion:
	The removal means of the looped removal device to grip and pull to withdraw isthe same for the predicate and proposed device. The difference is that the removecord on the proposed device remains outside of the vagina and provides forremoval of the device without insertion of the hands into the vaginal opening, aswas demonstrated during Usability testing. Testing was also performed to verifythat the pull strength of the collet/string attached to the cervical cap is sufficientto ensure that the cap will not be separated from the collet. Therefore theremoval cord method of the proposed device is substantially equivalent to that ofthe predicate device.

Testing Summary

Biocompatibility Testing performed on the device demonstrated that like the predicate device, the Focus Touch Conception System is considered non-cytotoxic, is not an irritant and did not elicit a sensitization response. Human Sperm Survival Assay (HSSA) testing was performed on the silicone Conceptacle (Cervical cap inserted into condom-like sheath) to demonstrate that like the predicate device, the Focus Touch collection device and cervical cap, Conceptacle, material has no deleterious effects on human semen. Bench testing was performed to verify that the condom-like sheath of the Focus Touch Conceptacle exceeded the minimum requirements for

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

burst pressure and volume for commercially available condoms. Bench testing demonstrated that the pull strength of the withdrawal cord, specifically Cervical Cap/Collet Separation Force for the Focus Touch System, was met for all systems tested. A shelf life study was performed to verify that all components of the Focus Touch System were shown to function procently and according to their design intent following a minimum real-time storage during of and or accelerated aging period equivalent to six (6) months. Clinical human factors/usability testing was performed to validate the usability of the device. Specifically, Study 1 testing was performed with the cervical cap and applicator to demonstrate that the end user can understand the Instructions for Use, and manipulate, insert and remove the cap cherectly without direct supervision. Study 2 testing was performed to demonstrate appropriate ease of yoe, confort and acceptability and safety when used during sexual intercourse as a collection device. During Study 1, a physical examination occurred to verify safety of the device to the vaginal tract and all success criteria were met.

Conclusion

The differences between the predicate device and the Focus Touch™ Conception System have been evaluated through testing to show that they are not critical to the intended therapeutic effect of the device, nor do they affect the safety or effectiveness of the device when used as labeled. Therefore, the Focus Touch Conception System is substantially equivalent to the Conceivex Conception Kit

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

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

Intimate Bridge 2 Conception, Inc. % Ms. Niki Caporali Spaniel Senior Regulatory & Quality Specialist Regulatory and Quality Solutions, Inc. 3919 William Penn Highway, Suite 200 MURRYSVILLE PA 15668

Re: K112200

Trade/Device Name: Focus Touch™ Conception System Regulation Number: 21 CFR$ 884.5250 Regulation Name: Cervical cap Regulatory Class: II Product Code: OBB Dated: April 18, 2012 Received: August 29, 2012

Dear Ms. Caporali Spaniel:

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 that 1 Drival 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 (reporting of medical

SEP 6 2012

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Page 2 -

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de rice-relation adverse or ones (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 11 you uchte spoolite active to: your le ntersOffices/CDRH/CDRHOffices/ucm115809.htm for go to mtp.//www.tdai.gov/rtoodable/s/cal Health's (CDRH's) Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance the Concertion be recording by reference to premarket notification" (21CFR Part note the regulation online and 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 Tou may 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,

Benjamin R. Ecker

Beniamin 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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Indications for Use

510(k) Number (if known): FBB K HZ2 DO

Device Name: Device Name: Focus Touch™ Conception System

Indications for Use:

The Focus Touch Conception System is indicated for assisted insemination in instances The Focus I ouch Conception by stom in mobility, or hostile vaginal environment has been where low spenn (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 cervisa. The conception. It is to be used at home following physician instruction. The and all to conception. The is to be assume as work in place for longer than 6 hours.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Norm

Division Sign-Off vision of Reproductive, Gastro-Renal, and frological Devices 510(k) Number

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).