(275 days)
Not Found
Not Found
No
The document describes a physical medical device (vaginal pessary) and its materials, sizes, and clinical study results. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is indicated for the "conservative management of vaginal prolapse and pelvic floor muscular weakness," which describes a therapeutic purpose. The performance studies also confirm its safety and efficacy for this management.
No
The device is described as a vaginal pessary indicated for the conservative management of vaginal prolapse and pelvic floor muscular weakness, which is a treatment or management function, not a diagnostic one.
No
The device description explicitly states it is a physical object made from medical grade polycarbonate and is available in different sizes. It is a vaginal pessary, which is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- KOLPEXIN™ Sphere Function: The KOLPEXIN™ Sphere is a physical device inserted into the vagina to provide support and manage vaginal prolapse and pelvic floor weakness. It does not analyze any bodily fluids or tissues.
- Intended Use: The intended use clearly states it's for the "conservative management of vaginal prolapse and pelvic floor muscular weakness," which is a mechanical function, not a diagnostic one.
The information provided describes a physical medical device used for support and management, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
The KOLPEXIN™ Sphere is a vaginal pessary that is indicated for the conservative management of vaginal prolapse and pelvic floor muscular weakness.
Product codes (comma separated list FDA assigned to the subject device)
85 HHW
Device Description
The KOLPEXIN* Sphere is symmetrically circular shaped with an attached nylon string for device removal. The device is made from medical grade polycarbonate, LEXAN 144R-111, GE Plastics, and is available in six sizes; 44mm, 42mm, 39mm, 36mm, 32mm and 28mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina / pelvic floor
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
A multicenter study to confirm the safety, efficacy, and functionality of the KOLPEXIN* Sphere in women with vaginal prolapse was performed. The study was entitled "A Multicenter Evaluation of the COLPEXIN* Vaginal Sphere in Females with Vaginal Prolapse."
The study concluded the KOLPEXIN* Sphere is a safe and effective device for the conservative management of vaginal prolapse and pelvic floor muscular weakness.
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.
Not Found
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
MAY 2 8 2004
Page 1 of 2
510(k)-KOLPEXIN* Sphere - New Device
510(k) SUMMARY
KOLPEXIN* Sphere
(Indication for management of vaginal prolapse and pelvic floor muscular weakness)
1. DATE PREPARED
August 20, 2003
2. SUBMITTER
ADAMED Ltd. Pienkow 149, 05-152 Czosnow Poland
3. CONTACT
Norman 1. Bruckner, (972)596-4151 Study Manager, Consultant
NAME OF THE MEDICAL DEVICE 4.
| Classification name: | Vaginal Weight/Vaginal Pessary |
|---|---|
| Common/Usual Name: | Training Aid for Pelvic Floor Muscle or |
| Kegel Exercise and Pessary for Vaginal | |
| Prolapse | |
| Proprietary name: | KOLPEXIN* Sphere |
DEVICE CLASSIFICATION న.
The KOLPEXIN* Sphere has been classified by the FDA under the headings of Perineometer HIR and Vaginal Pessary HHW, both Class II devices.
STATEMENT OF SUBSTANTIAL EQUIVALENCE 6.
KOLPEXIN* Sphere with indications for conservative management of vaginal prolapse and pelvic floor muscular weakness in females is substantially equivalent in function to weighted vaginal training aids for the pelvic floor muscle or Kegel exercise and Gellhorn pessary both marketed by Milex Products, Inc. *Trademark
1
K032644
Page 2 of 2
510(k)-KOLPEXIN* Sphere - New Device
INDICATIONS FOR USE 7.
The KOLPEXIN* Sphere is indicated for the conservative management of vaginal prolapse and pelvic floor muscular weakness.
PHYSICAL DESCRIPTION 8.
The KOLPEXIN* Sphere is symmetrically circular shaped with an attached nylon string for device removal. The device is made from medical grade polycarbonate, LEXAN 144R-111, GE Plastics, and is available in six sizes; 44mm, 42mm, 39mm, 36mm, 32mm and 28mm.
BIOCOMPATIBILITY TESTING 9.
Materials manufacturer safety tests demonstrate that the KOLPEXIN* Sphere is non-sensitizing, non-irritating and suitable for its intended use.
10. CLINICAL STUDY
A multicenter study to confirm the safety, efficacy, and functionality of the KOLPEXIN* Sphere in women with vaginal prolapse was performed. The study was entitled "A Multicenter Evaluation of the COLPEXIN* Vaginal Sphere in Females with Vaginal Prolapse."
The study concluded the KOLPEXIN* Sphere is a safe and effective device for the conservative management of vaginal prolapse and pelvic floor muscular weakness.
*Trademark
2
Image /page/2/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 a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 2004
Adamed Ltd. c/o Norman I. Bruckner, Ph.D. Study Manager, Consultant Bruckner & Associates, LLC. 3432 Brookshire Drive PLANO TX 75075
Re: K032644
Trade/Device Name: KOLPEXIN™ Sphere Regulation Number: 21 CFR 884.3575 Regulation Name: Vaginal Pessary Regulatory Class: II Product Code: 85 HHW Dated: February 25, 2004 Received: March 1, 2004
Dear Dr. Bruckner:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave lovice for over your been and the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass statod in the excircular)76, the enactment date of the Medical Device Amendments, or to oonimered processified in accordance with the provisions of the Federal Food, Drug, de necs that have boon that do not require approval of a premarket approval application (PMA). and Cosmetion (i re-) the (i re-) that 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 general obtires, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it your device is easonited (old wortrols. 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 l'ederal agencies. You must or any 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) This lefter will allow you to ocgin marketing your device of your device to a legally premarket notification. The FDA miding of saction 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 on If you desire specific advice for your dones on the following numbers, based on the regulation number at the top of the 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 Additionally, for questions on the promotion in and please note the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. Also, possesses Other of Compliance at (501) 57 - 1057. Part 807.97) you may obtain. Other geteral by relected to prematically (DTSFA: in and r the Act may be obtained from the Division of Small information on your responsionalities and consumer Assistance at its toll-free mumber (800) 638-2041 or
emation of International and Consumer Assistance at its toll-ofference Manufacturers, International and Collisanter - 25-
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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Indications for Use
510(k) Number (if known): K032644
Device Name: KOLPEXIN™ Sphere
Indications For Use:
The KOLPEXIN™ Sphere is a vaginal pessary that is indicated for the conservative management of vaginal prolapse and pelvic floor muscular weakness.
Prescription Use (Part 21 CFR 801 Subpart D)
ANBYOR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Lygum
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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