(231 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities, let alone AI/ML.
No.
This device is a contraceptive device, preventing pregnancy, and is not used for treating a disease or condition.
No
The device is indicated for contraception, not for diagnosing a medical condition.
No
The device description clearly states it is a "molded, buff-colored, shallow silicone rubber cup with a flexible rubber covered spring rim," indicating it is a physical medical device, not software.
Based on the provided information, the ORTHO® ALL-FLEX® Diaphragm is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the prevention of pregnancy by acting as a physical barrier within the body. This is a contraceptive device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a physical device (a silicone cup with a spring rim) designed to be inserted into the vagina. It does not describe reagents, instruments, or systems used for testing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using chemical reactions or analytical methods
- Reporting test results
Therefore, the ORTHO® ALL-FLEX® Diaphragm falls under the category of a medical device, specifically a contraceptive device, and not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
HDW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina, cervical canal, cervix
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Milex Silicone Diaphragm, ORTHO® ALL-FLEX® Diaphragm (Latex)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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).
0
510(k) Summary
| Submitter Name: | Johnson & Johnson Produtos Profissionais Ltda. (JJPP) |
|---|---|
| Submitter Address: | Rod. Presidente Dutra km 154 |
| São José dos Campos São Paulo | |
| SP-Brasil | |
| 12240-908 | |
| 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 Health | |
| Global Pharmaceutical Supply Group - A division of Johnson & Johnson | |
| Device Description | |
| and Statement of | |
| Intended Use | Description: 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. | |
| Intended 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. |
1
| Summary of
Technological
Characteristics | When inserted into the vagina, the ORTHO® ALL-FLEX® 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 spermicide. | |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | A table comparing the ORTHO® ALL-FLEX® Diaphragm to the predicate
devices 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 the
body of the 510(k). This summary does not contain any puffery or unsubstantiated
labeling claims. This summary does not contain any raw data, i.e., contains only
summary data. This summary does not contain any trade secret or confidential
commercial information. This summary does not contain any patient identification information. | |
2
| Feature | ORTHO® ALL-FLEX®
Diaphragm | ORTHO® ALL-FLEX®
Diaphragm | Milex Wide-Seal Silicone
Diaphragm |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K080040 | N/A Grandfathered | K063223 |
| Manufacturer | Johnson & Johnson
Produtos Profissionais
Ltda. -
A division of Johnson &
Johnson | Ortho Women's Health
Global Pharmaceutical
Supply Group - A division
of Johnson & Johnson | Cooper Surgical, Inc. |
| Classification # &
Product Code | 884.5350 | 884.5350 | 884.5350 |
| | HDW | HDW | HDW |
| Intended 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 | 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 Milex® 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 |
| Mode of Action | Mechanical
contraceptive barrier | Mechanical contraceptive
barrier | Mechanical contraceptive
barrier |
| 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
3
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
4
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
5
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