(85 days)
Not Found
Not Found
No
The summary describes a physical medical device (vaginal dilators) with no mention of software, algorithms, or any technology that would suggest AI/ML. The comparison to a predicate device also focuses on physical characteristics and performance equivalence.
Yes
The device is intended to treat vaginismus and dyspareunia by dilating the vagina in controlled stages, which is a therapeutic intervention.
No
The device is described as a tool to dilate the vagina, used for treatment (vaginismus and dyspareunia), not for diagnosing a condition.
No
The device description explicitly states it consists of "Four smooth, high polished finish, hollow, penile shaped cones which are graduated in size and length," indicating it is a physical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat vaginismus and dyspareunia by physically dilating the vagina. This is a therapeutic intervention, not a diagnostic one.
- Device Description: The device is a set of physical dilators. It does not involve any reagents, test kits, or analysis of biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's condition.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's purpose is purely therapeutic.
N/A
Intended Use / Indications for Use
The device is intended to treat women suffering from vaginismus and dyspareunia. VAGINISMUS is the involuntary spasm of the muscles in the vaginal wall which then inhibits sexual intercourse by making it painful or impossible. DYSPAREUNIA is the pain experienced during sexual intercourse caused by physical and/or emotional problems.
The device comes in varying sizes, the most appropriate is then selected by the physician for use by the patient and the patient's partner as an assistant if appropriate. It is used as a tool to DILATE the vagina in controlled stages.
Product codes
85 KXP
Device Description
Four smooth, high polished finish, hollow, penile shaped cones which are graduated in size and length. Owen Mumfords Amielle is visually and mechanically similar to that of Young's Vaginal Dilator to which substantially equivalence is claimed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician for use by the patient and the patient's partner as an assistant if appropriate.
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)
Performance of both systems are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Young's Vaginal Dilator
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 884.3900 Vaginal stent.
(a)
Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery.(b)
Classification. Class II (performance standards).
0
510k SUBMISSION
AMIELLE VAGINAL DILATOR
SUMMARY
Submitted by:
Mr. S D Miles Head of Regulatory Affairs Owen Mumford Limited Brook Hill Woodstock Oxfordshire OX7 1TÜ
| Device Name: | Amielle |
|---|---|
| Substantial Equivalence: | Young's Vaginal Dilator |
| Classification Name: | Vaginal Stent |
Owen Mumford have been marketing Amielle throughout Europe for over 3 years without any adverse customer reports. The product has been widely accepted as an excellent product for treatment of Vaginismus and Dyspareunia.
DESCRIPTION
Four smooth, high polished finish, hollow, penile shaped cones which are graduated in size and length. Owen Mumfords Amielle is visually and mechanically similar to that of Young's Vaginal Dilator to which substantially equivalence is claimed.
INTENDED USE
Both Amielle and Young's Dilators are intended for the treatment of Vaginismus and Dyspareunia. The concept is gradual dilation of the vagina until the problem is under control.
OPERATIONAL
The principle and design concepts and application of Amielle and Young's Vaginal Dilators are substantially equivalent.
PERFORMANCE
Performance of both systems are substantially equivalent.
1
Image /page/1/Picture/2 description: The image shows a partial logo of the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN" is partially visible, arranged in a circular fashion around the emblem.
NOV 2 5 1998
Robert E. Shaw Vice President Owen Mumford, Inc. 849 Pickens Idustrial Drive, Suite 14 Marietta, Georgia 30062-3165
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K983045 Vaginal Dilator Dated: August 31, 1998 Received: September 1, 1998 Regulatory Class: II 21 CFR 884.3900/Procode: 85 KXP
Dear Mr. Robert E. Shaw:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmam.html".
Sincerely yours
Lillian Yin, Ph.D.
Director. Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): n/k
Device Name: AMIELLE.
Indications for Use:
The device is intended to treat women suffering from vaginismus and dyspareunia. VAGINISMUS is the involuntary spasm of the muscles in the vaginal wall which then inhibits sexual intercourse by making it painful or impossible. DYSPAREUNIA is the pain experienced during sexual intercourse caused by physical and/or emotional problems.
The device comes in varying sizes, the most appropriate is then selected by the physician for use by the patient and the patient's partner as an assistant if appropriate. It is used as a tool to DILATE the vagina in controlled stages.
The device can be autoclaved or sterilised by normal methods.
Concurrence of CDRH, Office of Device Evaluation (ODE).
Prescription Use
OR Over-The-Counter Use
(Per 21CFR 801.109)
(Optional Format 1-2-96)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Di 510(k) Number
c:\stcw\winword\amicllc\S10stat1_doc