(275 days)
The KOLPEXIN™ Sphere is a vaginal pessary that is indicated for the conservative management of vaginal prolapse and pelvic floor muscular weakness.
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.
Here's an analysis of the provided text regarding the KOLPEXIN* Sphere, focusing on the acceptance criteria and the study conducted.
It's important to note that the provided documents are a 510(k) summary and a 510(k) clearance letter. These documents typically provide high-level summaries of studies, but not the detailed study protocols, full results, or comprehensive acceptance criteria that would be found in a complete clinical study report or a peer-reviewed publication. Therefore, some of the requested information may not be explicitly present in these specific documents.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicit or Implied from Indications) | Reported Device Performance (from "Clinical Study" section) |
|---|---|
| Safety: Device is non-sensitizing, non-irritating, and suitable for intended use. | "materials manufacturer safety tests demonstrate that the KOLPEXIN* Sphere is non-sensitizing, non-irritating and suitable for its intended use." (Biocompatibility Testing) "The study concluded the KOLPEXIN* Sphere is a safe and effective device..." (Clinical Study) |
| Efficacy: Effective for conservative management of vaginal prolapse. | "The study concluded the KOLPEXIN* Sphere is a safe and effective device for the conservative management of vaginal prolapse..." (Clinical Study) |
| Efficacy: Effective for management of pelvic floor muscular weakness. | "The study concluded the KOLPEXIN* Sphere is a safe and effective device... for pelvic floor muscular weakness." (Clinical Study) |
| Functionality: Operates as intended (symmetrically circular shaped, attached nylon string for removal, available in six sizes). | No explicit performance metric is given for functionality from the clinical study, but the physical description details these aspects. The study states "A multicenter study to confirm the safety, efficacy, and functionality... was performed." implying functionality was confirmed. |
Missing Information:
- Specific quantitative acceptance criteria (e.g., minimum percentage reduction in prolapse grade, minimum strength increase, specific thresholds for adverse events).
- Detailed quantitative performance data from the clinical study. The provided text only states that the device was found "safe and effective."
2. Sample Size Used for the Test Set and Data Provenance
- Sample size: Not explicitly stated in the provided text for the clinical study. It is referred to as "A multicenter study," implying multiple sites and likely more than a handful of participants, but no specific number is given.
- Data provenance (country of origin, retrospective/prospective): Not explicitly stated. The submitter is ADAMED Ltd. from Poland, and the contact is in the USA. The study is described as "A multicenter study," suggesting a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the 510(k) summary. Given the nature of a medical device for vaginal prolapse and pelvic floor weakness, the "ground truth" (i.e., diagnosis, assessment of change, etc.) would typically be established by physicians specializing in gynecology or urogynecology. However, the document doesn't detail this.
4. Adjudication Method for the Test Set
- This information is not provided in the 510(k) summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The device in question is a physical medical device (a pessary/training aid), not an AI algorithm that assists human readers in interpreting medical images or data. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, this is not applicable. The KOLPEXIN* Sphere is a physical device, not an algorithm. Its performance is directly observed in patients, not through standalone algorithmic processing.
7. Type of Ground Truth Used
- Based on the indication "conservative management of vaginal prolapse and pelvic floor muscular weakness," the ground truth would likely be based on:
- Clinical Assessments: Physical examinations by medical professionals (e.g., POP-Q staging for prolapse, palpation for muscle strength).
- Patient-Reported Outcomes (PROs): Questionnaires related to symptoms, quality of life, and satisfaction.
- The document does not detail the specific ground truth methods or metrics used in the clinical study.
8. Sample Size for the Training Set
- This concept is not applicable here. The KOLPEXIN* Sphere is a physical medical device, not a machine learning algorithm that requires a "training set" in the computational sense. The "clinical study" evaluates its performance in actual patients.
9. How the Ground Truth for the Training Set Was Established
- This concept is not applicable, as there is no "training set" in the context of this device. The clinical study for this device is the primary evaluation of its safety and efficacy.
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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 orKegel Exercise and Pessary for VaginalProlapse |
| 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
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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
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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.
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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
Page 1 of
§ 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).