FOCUS TOUCH CONCEPTION SYSTEM

K112200 · Intimate Bridge 2 Conception, Inc. · OBB · Sep 6, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K112200
• Device Name: FOCUS TOUCH CONCEPTION SYSTEM
• Applicant: Intimate Bridge 2 Conception, Inc.
• Product Code: OBB · Obstetrics/Gynecology
• Decision Date: Sep 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5250
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Focus Touch Conception System assists conception via cervical cap insemination. System includes Conceptacle (cervical cap pre-assembled in silicone condom-like sheath) and plastic applicator. During intercourse, semen is collected in Conceptacle; male removes sheath. User loads cap onto applicator; applicator delivers cap to cervix. Applicator features removal cord mechanism for withdrawal. Device remains in place up to 6 hours. Used at home by couples under physician instruction. Output is physical placement of semen at cervical os. Benefits include aid to conception for patients with low sperm count, sperm immobility, or hostile vaginal environment.

Clinical Evidence

No clinical trials; evidence based on bench testing and human factors/usability studies. Bench testing: biocompatibility (non-cytotoxic, non-irritant, non-sensitizing), Human Sperm Survival Assay (HSSA) (≥80% forward progressive motility after 6 hours), burst pressure, and pull strength. Usability studies (Study 1 and 2): validated user ability to understand instructions, manipulate, insert, and remove device without supervision; confirmed comfort, acceptability, and safety during intercourse.

Technological Characteristics

Silicone cervical cap and condom-like sheath; plastic applicator. Non-sterile, single-use. Mechanical delivery and retention. Biocompatible materials. No energy source. No software.

Indications for Use

Indicated for assisted insemination in patients diagnosed with low sperm count, sperm immobility, or hostile vaginal environment. Used at home per physician instruction. Contraindicated for use longer than 6 hours.

Regulatory Classification

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.

Predicate Devices

• Conception Kit (K063227)

Submission Summary (Full Text)

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# K | | 2200

#### 510(k) Summary

[Refer to 21 CFR 807.92]

SEP 6 2012

| Owner: | Intimate Bridge 2 Conception, Inc<br>2425 Sidney Street,<br>Pittsburgh, PA 15203 | | |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|--------------------------|
| Applicant: | Stephen Bollinger<br>Chief Executive Officer<br>412.770.1641 Office | | |
| Application<br>Correspondent: | Niki Caporali Spaniel<br>Senior, Regulatory & Quality Specialist<br>Regulatory & Quality Solutions, LLC<br>Phone: [phone] 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: | Manufacturer<br>Conceivex, Inc | Device Name<br>Conception Kit | 510(k) Number<br>K063227 |
| Reason for Submission | New Device | | |
| 510(k) Number: | K112200 | | |

### Description of Device

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

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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

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.

#### Comparison between predicate and proposed device

The tables below compare the two devices:

| Device | Predicate - Conceivex Inc.<br>Conception Kit | Proposed - Focus Touch<br>Conception System | Conclusio<br>n |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Indication<br>for Use | The Conceivex Conception<br>Kit is indicated for assisted<br>insemination in situations in<br>which low sperm count, sperm<br>immobility, or hostile vaginal<br>environment have been<br>diagnosed. The kit is used for<br>semen collection and<br>placement into the bowl of a<br>cervical cap as an aid to<br>conception. It is to be used at<br>home following physician<br>instruction. The Cap should<br>not be left in place for longer<br>than 6 hours. | The Focus Touch Conception<br>System is indicated for assisted<br>insemination in instances where<br>low sperm count, sperm<br>immobility, or hostile vaginal<br>environment has been<br>diagnosed. The system (cervical<br>cap in a condom-like silicone<br>sheath) is used to collect semen<br>into a cervical cap, and then<br>deliver the cap to the outside of<br>the cervix as an aid to<br>conception. It is to be used at<br>home following physician<br>instruction. The Focus Touch<br>Conception System should not<br>be left in place for longer than 6<br>hours. | Same |
| Usage | Prescription Use. For use at | Prescription Use. For use at | Same |

#### Device Similarities:

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| | home following physician<br>instruction. | home following physician<br>instruction. | |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| User Group | Couples who are trying to<br>conceive and have been<br>diagnosed with low sperm<br>count, sperm immobility, or<br>hostile vaginal environment. | Couples who are trying to<br>conceive and have been<br>diagnosed with low sperm count,<br>sperm immobility, or hostile<br>vaginal environment. | Same |
| Material<br>Composition of<br>Cervical Cap | Silicone Cervical Cap | Silicone Cervical Cap | Same |
| Insemination<br>Technology | Cervical Cap Insemination | Cervical Cap Insemination | Same |
| Biocompatibility | Materials tested and shown to<br>be biocompatible. | Materials tested and shown to be<br>biocompatible. | Same |
| Sperm<br>Compatibility | Human Sperm Survival Assay<br>Tested to demonstrate that<br>device materials have no<br>deleterious effects on human<br>sperm. | Conceptacle Human Sperm<br>Survival Assay (HSSA) Tested.<br>To pass the HSSA test, the<br>human sperm must demonstrate<br>forward progressive motility rate<br>of ≥80% of the initial forward<br>progressive motility sperm swim<br>up after 6 hours of sample<br>preparation. | Same |
| Sterility | Nonsterile | Nonsterile | Same |
| Single use | Yes | Yes | Same |

### Device Differences:

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| Device | Predicate - Conceivex Inc.<br>Conception Kit | Proposed - Focus Touch Conception<br>System |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Semen<br>Collection<br>Method | A collection condom is used during<br>intercourse to collect semen. | The Focus Touch™ Conception System<br>does not contain a separate collection<br>condom, rather the collection cervical<br>cap and condom-like sheath are pre-<br>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 <i>Conceptacle</i> 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 <i>Conceptacle</i> (cervical cap and condom-<br>like sheath assembly) is substantially equivalent to and the collection method of | | |
| the predicate device. | | |
| Collection<br>Condom<br>Material | Polyurethane | The condom-like sheath component of the<br><i>Conceptacle</i> 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 to<br>standard polyurethane condoms with a durometer of 30-40 on the Shore A scale.<br>The device has been shown to be biocompatible and acceptable as a semen<br>collection device with regard to comfort (slip, breakage, ability to ejaculate) and<br>adequacy (ability to collect and contain semen) in validation testing. Therefore,<br>the material used for the condom-like sheath of the proposed device is<br>substantially equivalent to the material used for the condom for the predicate<br>device. | |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Placement<br>and<br>Delivery<br>Method | The device is placed into the<br>vagina and in front of the cervical<br>os by hand. | The Focus Touch™ Conception System<br>uses an applicator for placement and<br>delivery of the cervical cap to the cervical<br>os. |
| | Discussion: | |
| | The applicator component, for which biocompatibility and usability have been<br>demonstrated during testing, allows the user to insert the cervical cap into the<br>vaginal tract without the use of the user's hand. It is performed in a similar<br>manner as inserting a tampon with a plastic applicator. It has smoothness<br>requirements for comfort and safety and allows for insertion and placement.<br>Therefore, the placement and delivery method of the proposed device is<br>substantially equivalent to that of the predicate device. | |
| Removal<br>Method | The proposed device contains a<br>loop that is molded with the<br>cervical cap. The user reaches<br>into the vagina and grasps the<br>loop to remove the device. | The Focus Touch™ Conception System<br>applicator features a mechanism which<br>applies a removal cord to the cervical cap<br>(during the process of loading the applicator)<br>to aid in removal of the device. |
| | Discussion: | |
| | The removal means of the looped removal device to grip and pull to withdraw is<br>the same for the predicate and proposed device. The difference is that the remove<br>cord on the proposed device remains outside of the vagina and provides for<br>removal of the device without insertion of the hands into the vaginal opening, as<br>was demonstrated during Usability testing. Testing was also performed to verify<br>that the pull strength of the collet/string attached to the cervical cap is sufficient<br>to ensure that the cap will not be separated from the collet. Therefore the<br>removal cord method of the proposed device is substantially equivalent to that of<br>the 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

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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 [phone] or [phone] 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