The Caya® contoured diaphragm is indicated for the prevention of pregnancy in women who elect to use diaphragms as a method of contraception. It is recommended for use with a contraceptive gel.

Device Description

The Caya® contoured diaphragm is a contoured, flexible, single-sized, silicone elastomer cup for covering the cervix that is circumscribed by a rim encapsulating a nylon spring. The Caya contoured diaphragm has an anatomically shaped spring that has been designed to fit women representing a range of traditional diaphragm sizes.

AI/ML Overview

The document describes the Caya® contoured diaphragm and its clinical study to demonstrate substantial equivalence to a predicate device, the ORTHO® ALL-FLEX® Diaphragm.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" but rather describes a non-inferiority finding compared to a historical control group using the predicate device. The primary performance metric is the 6-month Kaplan-Meier cumulative typical-use pregnancy probability.

Acceptance Criterion (Implicit)	Reported Device Performance (Caya® contoured diaphragm)
Non-inferiority in 6-month typical-use cumulative pregnancy probability compared to the ORTHO® ALL-FLEX® Diaphragm (historical control).	The 6-month Kaplan-Meier cumulative typical-use pregnancy probability for all Caya users was 10.4 per 100 women (95% CI: 6.9, 14.0). The document explicitly states: "The rate for all SILCS users was non-inferior to the rate for all users of the ORTHO® ALL-FLEX® Diaphragm, using data from the historical control groups."
Clinical safety profile similar to the predicate device.	The document states: "The single-sized Caya diaphragm has a similar clinical safety profile as the predicate device." (No specific quantitative metrics provided in this summary, but this was an outcome of the study.)
Acceptability and ease of use (no specific quantitative acceptance criteria mentioned, but these were study outcomes).	These were study outcomes, but specific acceptance criteria or performance metrics are not detailed in this summary.
Biocompatibility testing in accordance with ISO 10993 (passed).	Device passed.
Performance testing in accordance with ISO 8009 (passed).	Device passed.
Cleaning validation (passed).	Device passed.
Barrier effectiveness (pre-pivotal study finding).	Reduced average number of progressively motile sperm per high powered field from 12.5 to 0 in a Phase I post-coital study.

2. Sample Size Used for the Test Set and Data Provenance

Test Set (Pivotal Study): 450 couples recruited.
- 300 couples randomized to Caya® contoured diaphragm (referred to as SILCS diaphragm) with BufferGel.
- 150 couples randomized to Caya® contoured diaphragm with N-9 spermicide gel.
Data Provenance: The pivotal study for the Caya® contoured diaphragm was conducted at six sites in the United States. It was a prospective study. The historical control data for the predicate device was from a multi-center contraceptive study conducted by the National Institute for Child Health and Human Development (NICHD), likely also from the US.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. For a contraceptive device's effectiveness study, the "ground truth" of pregnancy is typically established by medical diagnosis (e.g., urine/blood tests in a clinical setting by trained medical staff), not typically by "experts" in the way an imaging study would use radiologists. The document mentions "Study outcomes included pregnancy probability, safety, acceptability, diaphragm fit, and ease of use." Medical professionals at the study sites would have been responsible for diagnosing pregnancy and assessing other outcomes.

4. Adjudication Method for the Test Set

This information is not provided beyond the general design of a randomized controlled trial. For pregnancy, the outcome is relatively clear. For safety or device fit/ease of use, the document doesn't detail any specific adjudication committee or method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and 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 contraceptive diaphragm, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The primary ground truth for the pivotal study was pregnancy outcomes. This would have been established through clinical diagnosis by medical professionals at the study sites. Other outcomes included safety (e.g., adverse events diagnosed by medical staff), acceptability, diaphragm fit, and ease of use (likely assessed via patient questionnaires and clinician evaluations).

8. The Sample Size for the Training Set

This information is not applicable as the Caya® contoured diaphragm is a physical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The device underwent design, development, and evaluation, which involved iterative testing, but not a "training set" of data for an algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as #8. Design and development involved various engineering, biocompatibility, and preliminary clinical tests (like the Phase I post-coital study), but these are part of product development and validation, not "training an algorithm."

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other.

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

August 26, 2014

Kessel medintin GmbH Martin Kessel CEO Kelsterbacher Str. 28. 64546 Moerfelden-Walldorf, Frankfurt Germany

Re: K140305

Trade/Device Name: Caya® contoured diaphragm Regulation Number: 21 CFR§ 884.5350 Regulation Name: Contraceptive diaphragm and accessories Regulatory Class: II Product Code: HDW Dated: July 24, 2014 Received: July 28, 2014

Dear Martin Kessel,

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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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/CDRH/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Herbert P. Lerner -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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4. Indications for Use Statement

510(k) Number (if known):

Device Name: Caya® contoured diaphragm

Indications for Use:

The Caya® contoured diaphragm is indicated for the prevention of pregnancy in women who elect to use diaphragms as a method of contraception. It is recommended for use with a contraceptive gel.

Prescription Use XXX Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary-Revised

Submitter Name

Kessel medintim GmbH

Submitter Address

Kelsterbacher Str. 28, 64546, Moerfelden-Walldorf, Frankfurt, Germany

Establishment Registration Number

Kessel medintim GmbH will register its establishment and list the Caya " contoured diaphragm prior to initial importation of any devices intended for commercial distribution within the United States.

Phone Number +49 6105 203 728

Fax Number +49 6105 455 901

Contact Person Martin Kessel

Date Prepared February 5, 2014 (revised July 23, 2014)

Device Trade Name Caya® contoured diaphragm

Common Name Diaphragm

Classification Name, Number, and Product Code

Classification Name: Contraceptive diaphragm and accessories (Class II)

Classification Number: 21 CFR §884.5350

Product Code: HDW

Predicate Devices ORTHO® ALL-FLEX® Diaphragm (silicone), Johnson & Johnson Produtos Profissionais Ltda. – A division of Johnson & Johnson, 510(k) number K080040.

Device Description and Statement of Intended Use

Description: The Caya® contoured diaphragm is a contoured, flexible, single-sized, silicone elastomer cup for covering the cervix that is circumscribed by a rim encapsulating a nylon spring. The Caya contoured diaphragm has an anatomically shaped spring that has been designed to fit women representing a range of traditional diaphragm sizes.

1 Caya is a registered trademark of Kessel medintim GmbH of Frankfurt, Germany.

2 The Caya contoured diaphragm was known as the SILCS diaphragm throughout design, development, and evaluation.

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As with the predicate device, the Caya contoured diaphragm is inserted by squeezing the rim at the sides to fold the diaphragm into a narrow profile. The Caya® contoured diaphragm has grip dimples along the sides of the rim that provide a tactile cue as to where to squeeze the diaphragm during insertion. The single-size diaphragm was developed and tested as the SILCS diaphragm.

Statement of Intended Use: The Caya® contoured diaphragm is indicated for the prevention of pregnancy in women who elect to use diaphragms as a method of contraception. It is recommended for use with a contraceptive gel.

Summary of Technological Characteristics

When inserted into the vagina, the Caya® contoured diaphragm functions as a mechanical barrier that prevents sperm from entering the cervical canal. The spring within the perimeter of the device causes the device to create a seal against the vaginal wall, covering the cervix and preventing sperm from entering the cervical canal. The silicone cup also serves as a repository for contraceptive gel. See Table 5.1 (below) for a comparison of the Caya" contoured diaphragm to its predicate device, the ORTHO® ALL-FLEX® Diaphragm.

Performance Data

The subject device has passed biocompatibility testing in accordance with ISO 10993, performance testing in accordance with ISO 8009, and cleaning validation. Specifically the device has been subjected to and passed the following biocompatibility and performance tests:

Biocompatability testing

. Cytotoxicity Growth Inhibition Test
. Vaginal Irritation Study
Delayed Type Hypersensitivity
Genotoxicity, bacterial reverse mutation study ●
Inductively Coupled Plasma Investigations ●
Gas Chromato-graphic and FTIR Fingerprint Investigations ●
ISO intracutaneous study ●
Mouse peripheral blood microcutaneous study ●
Genotoxicity, mouse lymphoma ●
12-week muscle implant ●
Subchronic Systemic Toxicity

Performance testing

Visual inspection
Weight ●
Kneel-down bending ●
Membrane tensile strength and elongation ●
Shore A hardness
Membrane thickness
Chemical resistance ●
Compression Test ●
Twist Test ●

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Clinical Testing

In a Phase I post coital study of barrier effectiveness, the SILCS diaphragm3 used with Nonoynol-9 (N-9) spermicide reduced the average number of progressively motile sperm per high powered field from a baseline of 12.5 to 0, confirming that the SILCS diaphragm would likely perform well in an effectiveness study.

The Phase II/II contraceptive effectiveness study-conducted at six sites in the United States-recruited 450 couples to participate in the study. Couples were randomized to two groups: 300 to SILCS diaphragm used with BufferGel (BG-an investigational lactic-acid based contraceptive gel) and 150 to SILCS diaphragm with N-9 spermicide gel. Healthy, sexually active female volunteers 18–40 years old, at risk for pregnancy, and desiring contraception but at low risk for HIV/STIs, were considered for enrollment. Eligible volunteers were not pregnant, had normal menstrual cycles, were not actively desiring pregnancy and were willing to accept an unknown risk of pregnancy and engage in at least 4 acts of vaginal intercourse per cycle. Participants were followed for at least 190 days and 6 menstrual cycles, and were seen at enrollment and after menstrual cycles 1. 3. and 6. Study outcomes included pregnancy probability. safety, acceptability, diaphragm fit, and ease of use. Results on effectiveness and safety were compared to an historical control group who used the ORTHO® ALL-FLEX® Diaphragm with these gels.

The historical control for the SILCS diaphragm pivotal study was a multi-center contraceptive study conducted by the National Institute for Child Health and Human Development (NICHD). That study demonstrated that BG used with an ORTHO® ALL-FLEX® Diaphragm worked about as well as N-9 with that diaphragm (6-month typical-use cumulative probability of pregnancy rates of 10.1 per 100 women (95% CI 7.1-13.1) and 12.3 (95% CI 7.7-16.9), respectively. * The SILCS pivotal study was based on that previous study which was then used in the SILCS historical control analysis to compare the single-size SILCS diaphragm with the ORTHO® ALL-FLEX® Diaphragm on contraceptive effectiveness and safety.

In the SILCS pivotal study, 35 study pregnancies were reported which yielded 6-month Kaplan-Meier cumulative typical-use pregnancy probabilities per 100 women (with 95% confidence intervals) of 10.4 (6.9, 14.0), 9.6 (5.5, 13.6) and 12.5 (5.4, 19.5) for all SILCS with BG and SILCS with N-9, respectively. The rate for all SILCS users was non-inferior to the rate for all users of the ORTHO® ALL-FLEX® Diaphragm, using data from the historical control groups. The observed 6-month cumulative typical-use pregnancy probability was 10.4 per 100 women (95% CI: 6.9, 14.0). The observed 6-cycle cumulative perfect-use probability was 7.9 per 100 women (95% CI: 1.7. 14.0). Extrapolated to 12 months these estimates are for typical use: 17.8 per 100 women (95% CI: 12, 23.6) and for perfect use: 14.0 per 100 women (95% CI: 3.0, 23.6) (See Table 1 (below)).

3 The Caya® contoured diaphragm was known as the SILCS diaphragm throughout design, development, and evaluation.

4 Barnhart KT, Rosenberg MJ, MacKay HT, et al. Contraceptive efficacy of a novel spermicidal microbicide used with a diaphragm: a randomized controlled trial. Obstet Gynecol. 2007;110(3):577-586.

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	Estimated number ofpregnancies per 100 womenduring time period	95% confidence interval
6 months
Typical use	10.4	6.9, 14.0
Perfect use*	7.9	1.7, 14.0

12 months
Typical use	17.8	12.0, 23.6
Perfect use	14.0	3.0, 23.6

Table. 5.1. Typical and Perfect Use Pregnancy Probabilities at 6- and 12-months

*6-cycle

Conclusion

Differences in technological characteristics between the Caya® contoured diaphragm and the predicate device raise no new safety concerns, and the devices have intended use. Results from the pivotal study show that the single-sized Caya diaphragm used with a contraceptive gel provided similar use effectiveness as results from a previously implemented study that evaluated the predicate device (ORTHO® ALL-FLEX® Diaphragm) used with the same contraceptive gels. The single-sized Caya diaphragm has a similar clinical safety profile as the predicate device. The above information demonstrates that the single-sized Caya diaphragm is substantially equivalent to the predicate device.

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Attribute	Subject device	Predicate device
Device information
Trade/Device name	Caya® contoured diaphragm	ORTHO® ALL-FLEX®Diaphragm
510(k) number	K140305	K080040
Manufacturer	Kessel medintim GmbH	Johnson & Johnson ProdutosProfissionais Ltda. – A divisionof Johnson & Johnson
Classification/Product code	21 CFR §884.5350 / HDW	21 CFR §884.5350 / HDW
Similarities
Indication for use	The Caya® contoured diaphragm isindicated for the prevention ofpregnancy in women who elect touse diaphragms as a method ofcontraception. It is recommendedfor use with a contraceptive gel.	The ORTHO® ALL-FLEX®Diaphragm, in conjunction withan appropriate spermicide, isindicated for the prevention ofpregnancy in women who electto use diaphragms as a methodof contraception.
Mode of action	Mechanical contraceptive barrier	Same
Reusable	Yes	Same
Material (barrier)	Medical-grade silicone	Same
Standard of conformity	ISO 8009:2004(E)	Same
Differences
Rim shape	Anatomically contoured (arcingspring) in one size (60 to 85 mm)	Circular (arcing spring) in foursizes (65, 70, 75, and 80 mm)
Spring stiffness (relative)	Soft	Stiff
Grip dimples	Present	Not present
Finger removal dome	Present	Not present
Material: spring	Nylon	Metal
Material: color (of silicone)	Violet	Buff

Table 5.2. Summary comparison of technological characteristics between the single-sized Caya contoured diaphragm and its predicate.

Regulation Number and Section

§ 884.5350 Contraceptive diaphragm and accessories.

(a)
Identification. A contraceptive diaphragm is a closely fitting membrane placed between the posterior aspect of the pubic bone and the posterior vaginal fornix. The device covers the cervix completely and is used with a spermicide to prevent pregnancy. This generic type of device may include an introducer.(b)
Classification. Class II (performance standards).