(231 days)
The ORTHO® ALL-FLEX® Diaphragm, in conjunction with an appropriate spermicide, is indicated for the prevention of pregnancy in women who elect to use diaphragms as a method of contraception.
The ORTHO® ALL-FLEX® Diaphragm (arcing spring), is a molded, buff-colored, shallow silicone rubber cup with a flexible rubber covered spring rim. The ORTHO® ALL-FLEX® Diaphragm vaginal diaphragm contains a distortion-free, dual spring-within-a-spring that provides unique arcing action no matter where the rim is compressed. It is appropriate for use not only where ordinary diaphragms are indicated, but also in patients with mild cystocele, rectocele or retroversion.
The provided text is a 510(k) summary for the ORTHO® ALL-FLEX® Diaphragm. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.
Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this type of document, as they are not the primary focus of a 510(k) for a diaphragm. A 510(k) of this nature typically relies on comparisons of technological characteristics to existing legally marketed devices.
However, I can provide what information is available and indicate where the requested information is not present or not applicable in this context.
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present specific quantitative acceptance criteria or reported device performance in terms of contraceptive efficacy rates (e.g., Pearl Index) as would be demonstrated in a clinical trial. Instead, it demonstrates substantial equivalence by comparing technological characteristics and intended use.
The "acceptance criteria" here are implicitly meeting the functional and safety characteristics of the predicate devices.
| Feature / Criteria | ORTHO® ALL-FLEX® Diaphragm (New Device) | Predicate Device (Example: Milex Wide-Seal Silicone Diaphragm) |
|---|---|---|
| Intended Use | Prevention of pregnancy in conjunction with appropriate spermicide. | Prevention of pregnancy in conjunction with appropriate spermicide. |
| Mode of Action | Mechanical contraceptive barrier. | Mechanical contraceptive barrier. |
| Reusable | Yes. | Yes. |
| Material of Construction | Medical Grade Silicone. | Medical Grade Silicone. (Or Natural Latex Rubber for the other predicate) |
| Standard of Conformity | ISO 8009:2004(E) (This implies compliance with the standard for diaphragms, which would include physical and performance requirements, but specific performance metrics are not listed here). | ISO 8009:2004(E) (Implied compliance with the same standard). |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of performance evaluation (e.g., a clinical trial with a specific number of subjects). The evaluation is based on a comparison of the device's technical specifications and intended use against legally marketed predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. As no clinical "test set" with ground truth determination is described, this information is not applicable. The substantial equivalence determination is made by the FDA based on the provided technical information and comparison to predicates, not by experts establishing clinical ground truth for a test set.
4. Adjudication method for the test set
N/A. No clinical "test set" or adjudication process described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A. This device is a physical medical device (diaphragm) and not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A. This is a physical non-AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
N/A. For a 510(k) of this nature, the "ground truth" for substantial equivalence is based on established technical standards and the performance of legally marketed predicate devices. Clinical outcomes data or expert consensus for the new device's performance is not part of this 510(k) summary, as it's not a new technology requiring such a demonstration for initial market clearance under the substantial equivalence pathway.
8. The sample size for the training set
N/A. This is a physical non-AI device; therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
N/A. No training set is applicable.
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510(k) Summary
| Submitter Name: | Johnson & Johnson Produtos Profissionais Ltda. (JJPP) |
|---|---|
| Submitter Address: | Rod. Presidente Dutra km 154São José dos Campos São PauloSP-Brasil12240-908 |
| Establishment Registration Number | 3004903580 |
| Phone Number: | 011 55+12+3932.1737 |
| Fax Number: | 011 55+12+3932 1975 |
| Contact Person: | Nancy M.R.B. Lopes M.Sc. |
| Date Prepared: | 19 November 2007 |
| Device Trade Name: | ORTHO® ALL-FLEX® Diaphragm |
| Common Name | Diaphragm |
| Classification Name, | Contraceptive diaphragm and accessories |
| Number & | 884.5350 |
| Product Code: | HDW |
| Predicate Devices: | Milex Silicone Diaphragm, Cooper Surgical, Inc.ORTHO® ALL-FLEX® Diaphragm (Latex), Ortho Women's HealthGlobal Pharmaceutical Supply Group - A division of Johnson & Johnson |
| Device Descriptionand Statement ofIntended Use | Description: The ORTHO® ALL-FLEX® Diaphragm (arcing spring), is amolded, buff-colored, shallow silicone rubber cup with a flexible rubbercovered spring rim. The ORTHO® ALL-FLEX® Diaphragm vaginaldiaphragm contains a distortion-free, dual spring-within-a-spring thatprovides unique arcing action no matter where the rim is compressed. Itis appropriate for use not only where ordinary diaphragms are indicated,but also in patients with mild cystocele, rectocele or retroversion.Intended Use: The ORTHO® ALL-FLEX® Diaphragm, in conjunction withan appropriate spermicide, is indicated for the prevention of pregnancyin women who elect to use diaphragms as a method of contraception. |
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| Summary ofTechnologicalCharacteristics | When inserted into the vagina, the ORTHO® ALL-FLEX® Diaphragmfunctions as a mechanical barrier that prevents sperm from entering thecervical canal. The spring within the perimeter of the device causes thedevice to create a seal against the vaginal wall; covering the cervix andpreventing sperm from entering the cervical canal. The silicone cup alsoserves as a repository for spermicide. | |
|---|---|---|
| A table comparing the ORTHO® ALL-FLEX® Diaphragm to the predicatedevices is attached. | ||
| Conclusion | The information discussed above demonstrates that the ORTHO® ALL-FLEX® Diaphragm is substantially equivalent to the predicate devices. | |
| Declarations | This summary includes only information that is also covered in thebody of the 510(k). This summary does not contain any puffery or unsubstantiatedlabeling claims. This summary does not contain any raw data, i.e., contains onlysummary data. This summary does not contain any trade secret or confidentialcommercial information. This summary does not contain any patient identification information. |
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| Feature | ORTHO® ALL-FLEX®Diaphragm | ORTHO® ALL-FLEX®Diaphragm | Milex Wide-Seal SiliconeDiaphragm |
|---|---|---|---|
| 510(k) Number | K080040 | N/A Grandfathered | K063223 |
| Manufacturer | Johnson & JohnsonProdutos ProfissionaisLtda. -A division of Johnson &Johnson | Ortho Women's HealthGlobal PharmaceuticalSupply Group - A divisionof Johnson & Johnson | Cooper Surgical, Inc. |
| Classification # &Product Code | 884.5350 | 884.5350 | 884.5350 |
| HDW | HDW | HDW | |
| Intended Use | The ORTHO® ALL-FLEX® Diaphragm, inconjunction with anappropriate spermicide,is indicated for theprevention of pregnancyin women who elect touse diaphragms as amethod of contraception | The ORTHO® ALL-FLEX® Diaphragm, inconjunction with anappropriate spermicide, isindicated for theprevention of pregnancy inwomen who elect to usediaphragms as a methodof contraception | The Milex® Diaphragm, inconjunction with anappropriate spermicide, isindicated for the preventionof pregnancy in women whoelect to use diaphragms as amethod of contraception |
| Mode of Action | Mechanicalcontraceptive barrier | Mechanical contraceptivebarrier | Mechanical contraceptivebarrier |
| Reusable | Yes | Yes | Yes |
| Material of Construction | Medical Grade Silicone | Natural Latex Rubber | Medical Grade Silicone |
| Standard of Conformity | ISO 8009:2004(E) | ISO 8009:2004(E) | ISO 8009:2004(E) |
Summary of Technical Characteristics
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and two wavy lines below representing water. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Johnson & Johnson Produtos Profissionais Ltda. c/o Mr. William F. Greenrose President Oserve America, Inc. 220 River Road CLAREMONT NH 03743
AUG 2 5 2008
Re: K080040
Trade/Device Name: Ortho® All-Flex® Diaphragm Regulation Number: 21 CFR §884.5350 Regulation Name: Contraceptive diaphragm and accessories Regulatory Class: II Product Code: HDW Dated: August 12, 2008 Received: August 12, 2008
Dear Mr. Greenrose:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/3/Picture/10 description: The image is a circular seal with the text "FDA Centennial" in the center. Above the text is a stylized logo with the letters "FDA". The seal also contains the text "1906-2006" at the top. The seal is surrounded by a dotted border.
Protecting and Promoting Public Health
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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. 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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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4.1 Indications for Use Statement
K080040 510(k) Number (if known):
Device Name: ORTHO® ALL-FLEX® Diaphragm
Indications for Use:
The ORTHO® ALL-FLEX® Diaphragm, in conjunction with an appropriate spermicide, is indicated for the prevention of pregnancy in women who elect to use diaphragms as a method of contraception.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Prescription XXX Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
_
(Revision Sign-Off)
Division St Division of Reproductive, Abdomina and Radiological Devic 510(k) Number
Section 4.0
CONFIDENTIAL
§ 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).