(88 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No
The device is intended to assist in the position and manipulation of the vagina during gynecologic surgical procedures, not to treat or cure a disease or condition. It is a surgical tool, not a therapeutic device.
No
Explanation: The device is intended for positioning and manipulation of the vagina during surgical procedures, not for diagnosing a medical condition. Its function is described as stabilizing and aiding in the identification of vaginal structures, which are actions related to surgical assistance rather than diagnosis.
No
The device description explicitly states it is comprised of multiple polymers with an ergonomic handle and adjustable head, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in the position and manipulation of the vagina during gynecologic surgical procedures." This is a surgical tool used in vivo (within the body) to physically manipulate tissue.
- Device Description: The description details a physical device with an ergonomic handle and adjustable head for positioning. It's a mechanical tool, not a device designed to analyze biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Meridian VPS is a single-use device intended to assist in the position and manipulation of the vagina during gynecologic surgical procedures such as sacrocolpopexy.
Product codes (comma separated list FDA assigned to the subject device)
PWK, LKF
Device Description
The Meridian® Vaginal Positioning System (VPS) is a single-use vaginal positioning device comprised of multiple polymers with an ergonomic handle and adjustable head for positioning. The head of the device consists of four main parts: a support body, a kick-out door, an adjustable cervical pin and an adjustable rib feature. The handle of the device consists of three main parts: two handle halves and an actuator knob. The Meridian Vaginal Positioning System is placed in the vagina to stabilize and aid in the identification of vaginal structures including anterior, posterior, apex, fornices and sulci during surgical procedures such as sacrocolpopexy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina
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)
The following non-clinical performance tests were performed on the subject device, per the special controls listed in 21 CFR 884.4910:
- Biocompatibility testing per ISO 10993-1 and FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1:Evaluation and testing within a risk management process."
- Cytotoxicity
- Sensitization
- Irritation
- Sterilization validation
- Package integrity testing
- Simulated shipping and handling
- Bubble leak testing
- Seal strength testing
- Dimensional analysis
- Mechanical testing
- Functional testing
- Maximum force for head, rib, and kick out door
- Compression
- Bending force
- Torque
- Pull force
- Side load
- Separation force
- Shelf life Testing
The results of the performance testing described above demonstrate that the Meridian Vaginal Positioning System is as safe and effective as the predicate device and supports a determination of substantial equivalence.
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.
Restorelle Y Contour Mesh, K140116.
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
§ 884.4910 Specialized surgical instrumentation for use with urogynecologic surgical mesh.
(a)
Identification. Specialized surgical instrumentation for use with urogynecologic surgical mesh is a prescription device specifically intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures. These procedures include transvaginal pelvic organ prolapse repair, sacrocolpopexy (transabdominal pelvic organ prolapse repair), and treatment of female stress urinary incontinence. Examples of specialized surgical instrumentation include needle passers and trocars, needle guides, fixation tools, and tissue anchors. This device is not a manual gastroenterology-urology surgical instrument and accessories (§ 876.4730) or a manual surgical instrument for general use (§ 878.4800).(b)
Classification. Class II (special controls). The special controls for specialized surgical instrumentation for use with urogynecologic surgical mesh are:(1) The device must be demonstrated to be biocompatible;
(2) The device must be demonstrated to be sterile and, if reusable, it must be demonstrated that the device can be adequately reprocessed;
(3) Performance data must support the shelf life of the device by demonstrating package integrity and device functionality over the requested shelf life;
(4) Non-clinical performance testing must demonstrate that the device meets all design specifications and performance requirements, and that the device performs as intended under anticipated conditions of use; and
(5) Labeling must include:
(i) Information regarding the mesh design that may be used with the device;
(ii) Detailed summary of the clinical evaluations pertinent to use of the device;
(iii) Expiration date; and
(iv) Where components are intended to be sterilized by the user prior to initial use and/or are reusable, validated methods and instructions for sterilization and/or reprocessing of any reusable components.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 9, 2018
Coloplast A/S Diane Brinza Sr. Strategic Regulatory Affairs Manager 1601 West River Road North Minneapolis, MN 55411
Re: K173501
Trade/Device Name: Meridian Vaginal Positioning System (VPS) Regulation Number: 21 CFR 884.4910 Regulation Name: Specialized Surgical Instrumentation for use with Urogynecologic Surgical Mesh Regulatory Class: II Product Code: PWK, LKF Dated: November 10, 2017 Received: November 13, 2017
Dear Diane Brinza:
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.
1
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); medical device reporting of medical device-related 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the name "Joyce M. Whang -S" in a large, bold font. The text is black and is set against a white background. The name appears to be a title or heading, possibly indicating the name of a person.
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
510(k) Number (if known)
Device Name Meridian Vaginal Positioning System (VPS)
Indications for Use (Describe)
The Meridian VPS is a single-use device intended to assist in the position and manipulation of the vagina during gynecologic surgical procedures such as sacrocolpopexy.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY - K173501
| 510(K) Owner's Name: | Coloplast A/S |
|---|---|
| Legal Manufacturer Address: | Holtedam 1 |
| 3050 Humlebaek, Denmark | |
| Contact Person: | Diane Brinza |
| Sr. Strategic Regulatory Affairs Manager | |
| Office: 612.979.8983 | |
| Email: usdlb@coloplast.com | |
| Address/Contact: | 1601 West River Road North |
| Minneapolis, MN 55411 | |
| Date Prepared: | 9 February 2018 |
| Trade or Proprietary Name: | Meridian Vaginal Positioning System (VPS) |
| Common or Usual Name: | Instrumentation for use with urogynecologic surgical mesh |
| Classification Name: | Specialized surgical instrumentation for use with |
| urogynecologic surgical mesh | |
| Classification Number: | 884.4910 |
| Product Codes: | PWK (instrumentation, surgical mesh, urogynecologic, |
| transabdominal repair of pelvic organ prolapse) | |
| LKF (cannula, manipulator/injector, uterine) | |
| Device Class: | II |
| Classification Panel: | Obstetrics/Gynecology |
| Predicate Device: | Restorelle Y Contour Mesh, K140116. |
| The predicate device has not been subject to a design- | |
| related recall. |
Device Description:
The Meridian® Vaginal Positioning System (VPS) is a single-use vaginal positioning device comprised of multiple polymers with an ergonomic handle and adjustable head for positioning. The head of the device consists of four main parts: a support body, a kick-out door, an adjustable cervical pin and an adjustable rib feature. The handle of the device consists of three main parts: two handle halves and an actuator knob. The Meridian Vaginal Positioning System is placed in
4
the vagina to stabilize and aid in the identification of vaginal structures including anterior, posterior, apex, fornices and sulci during surgical procedures such as sacrocolpopexy.
The device dimensions are listed in the table below:
| Part | Dimension |
|---|---|
| Head width | 45 mm |
| Head length | 80 mm |
| Head thickness | 30 mm |
| Cervical pin length | 20 mm |
| Overall VPS length | 43 cm |
| Kick-out door length (from tip of head to end of door) | 8 cm |
| Kick-out door angle | 40° |
| Rib height | 5 mm |
Indications for Use:
The Meridian VPS is a single-use device intended to assist in the position and manipulation of the vagina during gynecologic surgical procedures such as sacrocolpopexy.
Predicate Device Comparison:
Per the final rule published on January 6, 2017 (82 FR 1598), urogynecologic surgical mesh instrumentation has been upclassified from Class I to Class II. Because this device type has been recently upclassified, there are no cleared urogynecologic surgical mesh instrumentation devices that can serve as a predicate device. Therefore, the surgical mesh that is intended to be used with the instrumentation may serve as a predicate device.
The indications for use and technological features of the subject and predicate device are listed in the table below:
| Device Characteristic | Subject device
(K173501) | Predicate Device
(K140116) |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Meridian VPS is a
single-use device
intended to assist in the
position and manipulation
of the vagina during
gynecologic surgical
procedures such as
sacrocolpopexy. | Restorelle Y Contour
polypropylene mesh
device is indicated for use
as bridging material for
sacrocolposuspension /
sacrocolpopexy
(laparotomy,
laparoscopic, or robotic
approach) where surgical
treatment for vaginal
vault prolapse is
warranted. |
| Operating Principle | Aid in the position and
manipulation of the
vagina during | Transabdominal tissue
reinforcement in women
with pelvic organ
prolapse. |
5
| | gynecologic surgical
procedures | |
|-----------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Patient Contact |