(498 days)
EIS Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women
The subject device is a silicone vaqinal pessary. The submission includes the following designs: cube, dish, donut, marland, oval, gellhorn, gellhorn short, shaatz, and ring.
The provided document is a 510(k) premarket notification decision letter from the FDA for a device named "Pessary" manufactured by EIS Corporation. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.
The essential nature of a 510(k) submission, particularly for a device like a vaginal pessary, means that the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically related to demonstrating substantial equivalence to a predicate device, rather than proving novel clinical efficacy or diagnostic performance. Therefore, the "acceptance criteria" in this context refer to showing that the new device shares fundamental technological characteristics and intended use with the predicate, and does not raise new questions of safety or effectiveness. The "study" refers to non-clinical performance testing confirming that these characteristics are maintained.
Based on the provided text, here's the information broken down:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) for a physical medical device like a pessary, the acceptance criteria are not typically expressed in terms of diagnostic metrics like accuracy or sensitivity. Instead, they relate to material properties, safety assessments, and functional comparison to a predicate.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from 510(k) process and provided text) | Reported Device Performance (from K132313 Summary) |
|---|---|---|
| Intended Use Equivalence | New device's intended use is substantially equivalent to the predicate. | "EIS Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women." This is identical to the predator device's intended use as stated in the comparison table. |
| Material Equivalence | New device material is the same as or equivalent to the predicate and biocompatible. | "silicone" (same as predicate). Biocompatibility tests performed and "completed" per ISO 10993-1. |
| Technological Characteristics Equivalence | New device's fundamental technological characteristics (shape, size, class) are substantially equivalent to the predicate. | "Various and similar" shapes and sizes to the predicate. Classified as Class 2 (same as predicate). |
| Biocompatibility | Device material must be biocompatible according to recognized standards. | Biocompatibility tests completed per ISO 10993-1, including Cytotoxicity, Intracutaneous (intradermal) reactivity, Skin sensitization, and Acute systemic toxicity. |
| Shelf Life | Device maintains integrity and functionality over its claimed shelf life. | Shelf life testing was performed and included in the performance testing. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a 510(k) for a physical device, not an AI/ML diagnostic or prognostic device. The "test set" in this context would refer to samples used for non-clinical performance testing (e.g., material testing, biocompatibility).
- Sample size: Not specified. Standard practice for biocompatibility and shelf-life testing involves a sufficient number of samples to achieve statistical confidence or meet regulatory requirements, but the exact number isn't in this summary.
- Data provenance: Not explicitly stated regarding country of origin for the non-clinical tests. The manufacturer is based in Korea. The studies are "non-clinical study performance," meaning laboratory-based rather than human clinical trials. Thus, the data is prospective within the lab setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For a physical device 510(k), experts are typically involved in designing and interpreting the non-clinical tests (e.g., toxicologists for biocompatibility, engineers for material properties), but their "ground truth establishment" is not in the same vein as expert consensus for diagnostic interpretation. The "ground truth" for these tests would be objective measurements against established scientific standards.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1) are relevant for reconciling differing expert opinions in diagnostic studies. For non-clinical material and performance testing, results are typically objective measurements or observations against predetermined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical studies (biocompatibility, shelf life) would be:
- Established scientific standards and regulatory guidelines: For biocompatibility, this refers to the criteria outlined in ISO 10993-1, where specific chemical, biological, and physical parameters are measured and compared against acceptable thresholds.
- Material specifications: For physical properties, performance is compared against predefined engineering specifications for the silicone material.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no training set in the machine learning sense. The "training" for such a device is in its manufacturing and material selection process.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See #8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5, 2014
EIS Corporation % Ho Dong, Yang CEO Onbix Corporation #821 Samil Plaza 837-26 Yeuksam-dong, Gangnam-gu (135-768), Seoul Korea
Re: K132313 Trade/Device Name: Pessary Regulation Number: 21 CFR 884.3575 Regulation Name: Vaginal Pessary Regulatory Class: Class II Product Code: HHW Dated: October 31, 2014 Received: November 6, 2014
Dear Ho Dong, Yang
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known):
Device Name: Pessary
Indications for Use:
EIS Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________ (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off Office of Device Evaluation
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510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
| Submitter Information: | EIS CorporationSuite #603, #610 Woori Venture Town II, 82-29Mullae-Dong 3ga, YoungDungPo-Ku, Seoul, 150-700, KoreaTel: +82-2-2671-4296Fax: +82-2-2671-4298 |
|---|---|
| Contact Person: | Ho Dong, YangOnbix Corporation#821 Samil Plaza, 837-26 Yeuksam-dongGangnam-gu, Seoul, KoreaTel: *82-2-566-3360 / Fax: *82-2-6280-3360Email: onbix@naver.com |
Date Summary Prepared: Nov 24, 2014
Device Name:
| Trade Name(s): | Pessary |
|---|---|
| Classification Name: | Vaginal pessary |
| Panel: | Obstetrics/Gynecology |
| Product code: | HHW |
| Regulation: | 21 CFR 884.3575 |
Predicate Device Information:
K092981 / PANPAC VAGINAL PESSARY (Panpac Medical Corporation)
Device Description:
The subject device is a silicone vaqinal pessary. The submission includes the following designs: cube, dish, donut, marland, oval, gellhorn, gellhorn short, shaatz, and ring.
Intended Use:
EIS Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele, as well as stress urinary incontinence in women.
Comparison to Predicate Device(s):
This subject device is equivalent to the predicate device in its intended use and technological characteristics. The following table compares the technological characteristics of the subject and predicate device.
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| No | Item | Pessary(new device, K132313) | PANPAC VAGINALPESSARY (K092981) |
|---|---|---|---|
| 1 | Manufacturer | EIS Corporation | Panpac Medical Corporation |
| 2 | Material | silicone | Silicone |
| 3 | Shape | Various and similar | Various and similar |
| 4 | Size | Various and similar | Various and similar |
| 5 | Class | Class 2 | Class 2 |
| 6 | Indications for use | Effective support forcystocele, rectocele, uterineprolapsed or procidentia,urinary incontinence | Effective support forcystocele, rectocele, uterineprolapsed or procidentia,urinary incontinence |
Non-Clinical Study performance
The performance testing provided included shelf life and biocompatibility testing per ISO 10993-1. The completed biocompatibility tests included the following:
Cytotoxicity Intracutaneous (intradermal) reactivity Skin sensitization Acute systemic toxicity
Conclusion
Based on the information provided in this summary we conclude that pessary is substantially equivalent to the predicate device K092981 (PANPAC VAGINAL PESSARY - Panpac Medical Corporation).
§ 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).