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.

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.

AI/ML Overview

The provided text is a 510(k) submission for the Amielle Vaginal Dilator, seeking substantial equivalence to Young's Vaginal Dilator. This document does not describe a study with acceptance criteria and reported device performance in the way typically seen for novel or higher-risk devices requiring extensive clinical trials. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety: No adverse customer reports over 3 years in Europe.	Product has been widely accepted as an excellent product.
Effectiveness (Intended Use): Treatment of Vaginismus and Dyspareunia through gradual dilation.	"The concept is gradual dilation of the vagina until the problem is under control." Substantially equivalent to Young's Vaginal Dilator, which also targets Vaginismus and Dyspareunia.
Design/Mechanical Similarity: Visually and mechanically similar to Young's Vaginal Dilator (predicate).	Four smooth, high polished finish, hollow, penile shaped cones, graduated in size and length.
Operational Principle: Substantially equivalent to Young's Vaginal Dilator.	"The principle and design concepts and application of Amielle and Young's Vaginal Dilators are substantially equivalent."
Performance: Substantially equivalent to Young's Vaginal Dilator.	"Performance of both systems are substantially equivalent."

Explanation: The "acceptance criteria" here are implicitly linked to demonstrating substantial equivalence to the predicate device. The performance is reported in terms of its similarity to the predicate and anecdotal market acceptance, rather than quantitative metrics from a dedicated study.

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

Test Set Sample Size: Not applicable. No formal "test set" was used in a clinical study for this 510(k) submission.
Data Provenance: The submission mentions that Owen Mumford has been marketing Amielle throughout Europe for over 3 years without adverse customer reports. This suggests real-world usage data from Europe, but it's not structured as a controlled study. This would be considered retrospective market surveillance/anecdotal evidence rather than a prospective clinical trial.

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

Not applicable. There was no formal test set requiring experts to establish ground truth. The submission relies on the established safety and efficacy of the predicate device and the new device's substantial equivalence.

4. Adjudication Method for the Test Set

Not applicable. No formal test set or adjudication process was described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence, not on comparing reader performance with or without AI assistance. The device is a physical medical device (dilator), not an AI-powered diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" implicitly assumed is the established safety and efficacy of the predicate device (Young's Vaginal Dilator) for treating Vaginismus and Dyspareunia. The submission argues that because Amielle is substantially equivalent in design, intended use, and performance, it will also be safe and effective. The "no adverse customer reports" in Europe serves as supplementary evidence of safety in a real-world setting.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

Not applicable. There is no training set.

Summary

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K983045

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

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.

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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

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510(k) Number (if known): n/k

K983045

Device Name: AMIELLE.

Indications for Use:

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

Regulation Number and Section

§ 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).