(207 days)
Not Found
No
The summary describes a physical medical device (a pessary) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as providing vaginal support to prevent the uterus from descending and designed to ease uterine prolapse, which are therapeutic actions.
No
Explanation: The device is a pessary, a physical support device used to treat uterine prolapse and stress incontinence. Its function is to provide support and correct physical displacements, not to diagnose a condition.
No
The device description clearly states it is a physical ring pessary made from PVC or Polythene, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide physical support within the vagina to prevent uterine descent and correct uterine displacements. This is a mechanical function performed directly on the patient's body.
- Device Description: The device is a physical ring made from PVC or Polythene, designed for insertion into the vagina.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information about a patient's health status through in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Portex Ring Pessaries provide vaginal support to prevent the uterus from descending. Designed to ease uterine prolapse. Ring Pessaries are also used to correct other uterine displacements and to alleviate stress incontinence by pressure through the anterior vaginal wall onto the urethra.
Product codes (comma separated list FDA assigned to the subject device)
85 HHW
Device Description
A ring pessary made from PVC or Polythene, available in various sizes, designed to ease uterine prolapse, and provide vaginal support to prevent the uterus from descending.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina, uterus, urethra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
competent trained personnel
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)
The biological safety assessment of the Wallace Endometrial has been performed in accordance with the International Standard ISO 10993, Part 1:1994, "Biological Evaluation of medical Devices: Evaluation and Testing." In addition to ISO 10993 the selection of tests, taking into consideration the particular application of the product.
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.
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
§ 884.3575 Vaginal pessary.
(a)
Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.(b)
Classification. Class II (performance standards).
0
ייד בגווע א
FEB 1 1 2002
510(k) SUMMARY
The Summary of Safety and Effectiveness on the Portex Ring Pessary reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.
| Applicant | Claire Mullins
SIMS Registration Manager
SIMS Portex Ltd
Hythe
Kent CT21 6JL
UK |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone | 44 1303 260551 |
| Facsimile | 44 1303 266761 |
| Date | 12th July 2001 |
| Name | Portex Ring Pessary |
| Classification | Class II device with Product Code 85 HHW |
| Predicate | PelvXGellhorn Vaginal Pessary
K002329 |
| Description | A ring pessary made from PVC or Polythene, available in various sizes, designed to ease uterine prolapse, and provide vaginal support to prevent the uterus from descending. |
| Intended Use | Portex Ring Pessaries provide vaginal support to prevent the uterus from descending.
Designed to ease uterine prolapse.
Ring Pessaries are also used to correct other uterine displacements and to alleviate stress incontinence by pressure through the anterior vaginal wall onto the urethra. |
| Contraindications | (PRECAUTIONS)
Inspection of the vagina using a speculum is recommended prior to insertion or
replacement of a ring pessary.
Ring Pessaries should be removed and reinserted as prescribed by the attending clinician.
The Portex ring Pessaries are supplied non-sterile and are reusable for single patient use.
Re-use of this device in another patient may result in cross infection. |
| Caution | (WARNINGS)
Insertion and removal of Ring Pessaries should only be performed by competent trained
personnel.
After removal of Ring Pessary an inspection of the vagina should be performed to check
for ulceration, bleeding, infection.
Ring Pessaries should be removed and checked as prescribed by competent trained
personnel to prevent embedding in the vaginal tissue or fisula formation. |
| Technological
Characteristics | There are no published standards for these particular types of products, and as such tests have been developed which are considered sufficient to ensure the efficacy and safety of the device(s) for its intended use. Such tests include – Visual and Dimensional |
| Data Submitted | The biological safety assessment of the Wallace Endometrial has been performed in
accordance with the International Standard ISO 10993, Part 1:1994, "Biological
Evaluation of medical Devices: Evaluation and Testing." In addition to ISO 10993 the
selection of tests, taking into consideration the particular application of the product. |
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized symbol resembling an abstract caduceus or a series of flowing lines, possibly representing health and well-being.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB | | 2002
Mr. Steven Ogilvie Director, Regulatory Affairs and Scientific Affairs Sims Portex Limited Hythe, Kent CT21 6JL UNITED KINGDOM
Re: K012277
Trade/Device Name: Sim's Portex Vaginal Ring Pessary Regulation Number: 21 CFR 884.3575 Regulation Name: Vaginal pessary Regulatory Class: II Product Code: 85 HHW Dated: November 7, 2001 Received: November 13, 2001
Dear Mr. Ogilvie:
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 (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. 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.
2
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page Page Ca of
510(k) Number (if known): K (1 גבר 77
Device Name: Sim's Pocter Ring Pessa
Indications For Use:
Portex Ring Pessaries provide vaginal support to prevent the uterus from descending. Designed to ease uterine prolapse. Ring Pessaries are also used to correct other uterine displacements and to alleviate stress incontinence by pressure through the anterior vaginal wall onto the urethra.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Nancy C. Snazkon
(Division Sia 510(k) Numb (Optional Format 3-10-98)