(402 days)
Not Found
No
The device description and performance studies focus on the mechanical and biological properties of the device components (cervical cap, sheath, applicator) and their ability to collect and deliver semen. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
It is indicated for assisted insemination in cases of low sperm count, sperm immobility, or hostile vaginal environments, which are conditions that impair biological function.
No
The device is an assisted insemination system designed for conception, not for diagnosing medical conditions. It is used after a diagnosis of low sperm count, sperm immobility, or hostile vaginal environment has been made.
No
The device description clearly outlines physical components (Conceptacle, applicator, cervical cap, condom-like sheath, retainer, removal cord) and performance studies related to these physical components (biocompatibility, sperm survival, bench testing for burst pressure and pull strength). There is no mention of any software component.
Based on the provided information, the Focus Touch Conception System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Focus Touch Function: The Focus Touch Conception System is a device used in vivo (within the body) to collect and deliver semen to the cervix as an aid to conception. It does not analyze biological specimens to provide diagnostic information.
- Intended Use: The intended use is for assisted insemination, not for diagnosing a condition. While it's indicated for use in instances where certain conditions (low sperm count, etc.) have been diagnosed, the device itself is not performing the diagnosis.
- Device Description: The description details a physical system for semen collection and delivery, not a system for analyzing biological samples.
- Performance Studies: The performance studies focus on biocompatibility, sperm survival within the device, bench testing of physical properties, shelf life, and usability. These are not studies typically associated with validating the performance of a diagnostic test.
Therefore, the Focus Touch Conception System is a medical device intended for assisted reproduction, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
OBB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervix, vaginal tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used by couples at home following physician instruction.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Biocompatibility Testing: Demonstrated non-cytotoxic, non-irritant, and no sensitization response.
Human Sperm Survival Assay (HSSA) testing: Performed on the silicone Conceptacle to show no deleterious effects on human semen.
Bench testing: Verified that the condom-like sheath exceeded minimum burst pressure and volume requirements for commercially available condoms. Demonstrated pull strength of the withdrawal cord (Cervical Cap/Collet Separation Force) was met.
Shelf life study: Verified all components functioned as designed after 6 months of real-time storage or equivalent accelerated aging.
Clinical human factors/usability testing:
Study 1: Performed with cervical cap and applicator to demonstrate end-user understanding of Instructions for Use, and ability to manipulate, insert, and remove the cap correctly without direct supervision. A physical examination verified safety to the vaginal tract. All success criteria were met.
Study 2: Performed to demonstrate appropriate ease of use, comfort, acceptability, and safety when used during sexual intercourse as a collection device.
Key Metrics
Human Sperm Survival Assay (HSSA) testing: To pass the HSSA test, the 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.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
K | | 2200
510(k) Summary
[Refer to 21 CFR 807.92]
SEP 6 2012
| Owner: | Intimate Bridge 2 Conception, Inc
2425 Sidney Street,
Pittsburgh, PA 15203 | | |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|--------------------------|
| Applicant: | Stephen Bollinger
Chief Executive Officer
412.770.1641 Office | | |
| Application
Correspondent: | Niki Caporali Spaniel
Senior, Regulatory & Quality Specialist
Regulatory & Quality Solutions, LLC
Phone: (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: | Manufacturer
Conceivex, Inc | Device Name
Conception Kit | 510(k) Number
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
1
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.
Conception Kit | Proposed - Focus Touch
Conception System | Conclusio
n |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Indication
for Use | The Conceivex Conception
Kit is indicated for assisted
insemination in situations in
which low sperm count, sperm
immobility, or hostile vaginal
environment have been
diagnosed. The kit is used for
semen collection and
placement into the bowl of a
cervical cap as an aid to
conception. It is to be used at
home following physician
instruction. The Cap should
not be left in place for longer
than 6 hours. | 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. | Same |
| Usage | Prescription Use. For use at | Prescription Use. For use at | Same |
Device Similarities:
2
| | home following physician
instruction. | home following physician
instruction. | |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| User Group | Couples who are trying to
conceive and have been
diagnosed with low sperm
count, sperm immobility, or
hostile vaginal environment. | Couples who are trying to
conceive and have been
diagnosed with low sperm count,
sperm immobility, or hostile
vaginal environment. | Same |
| Material
Composition of
Cervical Cap | Silicone Cervical Cap | Silicone Cervical Cap | Same |
| Insemination
Technology | Cervical Cap Insemination | Cervical Cap Insemination | Same |
| Biocompatibility | Materials tested and shown to
be biocompatible. | Materials tested and shown to be
biocompatible. | Same |
| Sperm
Compatibility | Human Sperm Survival Assay
Tested to demonstrate that
device materials have no
deleterious effects on human
sperm. | Conceptacle Human Sperm
Survival Assay (HSSA) Tested.
To pass the HSSA test, the
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. | Same |
| Sterility | Nonsterile | Nonsterile | Same |
| Single use | Yes | Yes | Same |
Device Differences:
・・・ #
ﮮ ﮧ۔
| Device | Predicate - Conceivex Inc.
Conception Kit | Proposed - Focus Touch Conception
System |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Semen
Collection
Method | A collection condom is used during
intercourse to collect semen. | The Focus Touch™ Conception System
does not contain a separate collection
condom, rather the collection cervical
cap 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. | | |
| Collection
Condom
Material | Polyurethane | The condom-like sheath component of the
Conceptacle is made from silicone. |
| Discussion: | | |
| Silicone has been used historically for medical devices used in the vaginal tract. | | |
·
3
| | The Condom-like Sheath of the Conceptacle is very similar in malleability to
standard 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 semen
collection device with regard to comfort (slip, breakage, ability to ejaculate) and
adequacy (ability to collect and contain semen) in validation testing. Therefore,
the material used for the condom-like sheath of the proposed device is
substantially equivalent to the material used for the condom for the predicate
device. | |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Placement
and
Delivery
Method | The device is placed into the
vagina and in front of the cervical
os by hand. | The Focus Touch™ Conception System
uses an applicator for placement and
delivery of the cervical cap to the cervical
os. |
| | Discussion: | |
| | The applicator component, for which biocompatibility and usability have been
demonstrated during testing, allows the user to insert the cervical cap into the
vaginal tract without the use of the user's hand. It is performed in a similar
manner as inserting a tampon with a plastic applicator. It has smoothness
requirements for comfort and safety and allows for insertion and placement.
Therefore, the placement and delivery method of the proposed device is
substantially equivalent to that of the predicate device. | |
| Removal
Method | The proposed device contains a
loop that is molded with the
cervical cap. The user reaches
into the vagina and grasps the
loop to remove the device. | The Focus Touch™ Conception System
applicator features a mechanism which
applies 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 is
the same for the predicate and proposed device. The difference is that the remove
cord on the proposed device remains outside of the vagina and provides for
removal of the device without insertion of the hands into the vaginal opening, as
was demonstrated during Usability testing. Testing was also performed to verify
that the pull strength of the collet/string attached to the cervical cap is sufficient
to ensure that the cap will not be separated from the collet. Therefore the
removal cord method of the proposed device is substantially equivalent to that of
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
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
5
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
6
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
7
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