(498 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a silicone vaginal pessary, with no mention of AI or ML.
Yes
The device is a vaginal pessary used to treat uterine prolapse and stress urinary incontinence, which are medical conditions, thus qualifying it as a therapeutic device.
No
The device, a vaginal pessary, is indicated for treating conditions like uterine prolapse and stress urinary incontinence. It is a supportive or therapeutic device, not one used to identify or diagnose a disease or condition.
No
The device description explicitly states it is a "silicone vaginal pessary," which is a physical, hardware medical 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 clearly states that the device is a "removable structure placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women." This describes a device that is used in vivo (within the body) for a therapeutic purpose (treating conditions).
- IVD Definition: In vitro diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used in vitro (outside the body).
- Device Description: The description of the device as a "silicone vaginal pessary" further supports its use as a physical device placed within the body.
- Performance Studies: The performance studies mentioned (shelf life and biocompatibility) are typical for medical devices used in contact with the body, not for IVDs which focus on analytical and clinical performance of tests.
Therefore, the EIS Vaginal Pessaries are a medical device used for treatment in vivo, not an in vitro diagnostic device.
N/A
Here's the extracted information from the FDA summary:
Intended Use / Indications for 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.
Product codes
HHW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina
Indicated Patient Age Range
women
Intended User / Care Setting
Prescription Use
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
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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
1
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
2
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
page 1 of 1
Vol_003 (3)
3
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 Corporation
Suite #603, #610 Woori Venture Town II, 82-29
Mullae-Dong 3ga, YoungDungPo-Ku, Seoul, 150-700, Korea
Tel: +82-2-2671-4296
Fax: +82-2-2671-4298 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ho Dong, Yang
Onbix Corporation
#821 Samil Plaza, 837-26 Yeuksam-dong
Gangnam-gu, Seoul, Korea
Tel: *82-2-566-3360 / Fax: *82-2-6280-3360
Email: 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.
4
| No | Item | Pessary
(new device, K132313) | PANPAC VAGINAL
PESSARY (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 for
cystocele, rectocele, uterine
prolapsed or procidentia,
urinary incontinence | Effective support for
cystocele, rectocele, uterine
prolapsed 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).