(207 days)
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.
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.
The provided text describes the 510(k) summary for the Portex Ring Pessary, which is a medical device. However, it does not contain any information about acceptance criteria, device performance metrics, or study details such as sample size, data provenance, expert adjudication, or MRMC comparative effectiveness studies.
The document primarily focuses on:
- Device Identification: Applicant, name, classification, predicate device.
- Device Description and Intended Use: What it is, what it's for, contraindications, and warnings.
- Technical Characteristics: Mentions that "tests have been developed which are considered sufficient to ensure the efficacy and safety of the device(s) for its intended use" and lists "Visual and Dimensional" tests.
- Data Submitted (Safety): States that a biological safety assessment was performed in accordance with ISO 10993, Part 1:1994.
Therefore, I cannot provide the requested table and study details as the information is not present in the given text.
Summary of what can be extracted (and what cannot):
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated. The document mentions "tests have been developed which are considered sufficient to ensure the efficacy and safety of the device" including "Visual and Dimensional" tests, and biological safety per ISO 10993. No specific quantifiable criteria or pass/fail thresholds are given.
- Reported Device Performance: No specific performance metrics or results (e.g., success rate in preventing prolapse, reduction in stress incontinence) are provided.
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not mentioned for any performance or efficacy testing.
- Data Provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not mentioned. The document relies on pre-clinical testing and comparison to a predicate device, not clinical studies with expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned, as there is no described test set requiring adjudication in the context of clinical performance or diagnostic accuracy.
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:
- Not applicable. This device is a pessary, not an AI-assisted diagnostic tool, so MRMC studies involving human readers and AI are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical pessary, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biological safety, the ground truth would be established by the ISO 10993 standards and associated laboratory tests.
- For physical characteristics (visual and dimensional), the ground truth would be engineering specifications and quality control measurements.
- No "ground truth" equivalent to what would be used for a diagnostic device (e.g., pathology for cancer detection) is described for this product.
8. The sample size for the training set:
- Not applicable/Not mentioned. There is no "training set" as this is a physical device, not a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable.
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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 MullinsSIMS Registration ManagerSIMS Portex LtdHytheKent CT21 6JLUK |
|---|---|
| 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 PessaryK002329 |
| 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 orreplacement 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 trainedpersonnel.After removal of Ring Pessary an inspection of the vagina should be performed to checkfor ulceration, bleeding, infection.Ring Pessaries should be removed and checked as prescribed by competent trainedpersonnel to prevent embedding in the vaginal tissue or fisula formation. |
| TechnologicalCharacteristics | 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 inaccordance with the International Standard ISO 10993, Part 1:1994, "BiologicalEvaluation of medical Devices: Evaluation and Testing." In addition to ISO 10993 theselection of tests, taking into consideration the particular application of the product. |
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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.
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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
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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)
§ 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).