Meridian Vaginal Positioning System (VPS)

K173501 · Coloplast · PWK · Feb 9, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K173501
• Device Name: Meridian Vaginal Positioning System (VPS)
• Applicant: Coloplast
• Product Code: PWK · Obstetrics/Gynecology
• Decision Date: Feb 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4910
• Device Class: Class 2

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.

Device Story

Meridian Vaginal Positioning System (VPS) is a single-use, polymer-based surgical instrument; used during gynecologic procedures like sacrocolpopexy. Device features ergonomic handle with actuator knob and adjustable head containing support body, kick-out door, cervical pin, and rib feature. Surgeon places device in vagina to stabilize and identify vaginal structures (anterior, posterior, apex, fornices, sulci). Device aids in positioning/manipulation of vaginal tissue to facilitate surgical mesh placement. Benefits include improved visualization and stabilization of anatomy during surgery. Operated by surgeons in clinical/OR settings.

Clinical Evidence

No clinical data. Bench testing only. Testing included biocompatibility (ISO 10993-1), sterilization validation (SAL 10^-6), package integrity (shipping, bubble leak, seal strength), dimensional analysis, and mechanical testing (force, compression, bending, torque, pull, side load, separation).

Technological Characteristics

Single-use instrument constructed of multiple polymers. Features include 45mm wide head, 43cm overall length, adjustable cervical pin, and kick-out door. Sterilized via Ethylene Oxide (EtO) to SAL 10^-6. Packaging includes PETG retainer tray and Tyvek lid. Mechanical design includes manual actuator knob for head adjustment.

Indications for Use

Indicated for use in women undergoing gynecologic surgical procedures, such as sacrocolpopexy, to assist in the positioning and manipulation of the vagina.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Restorelle Y Contour Mesh (K140116)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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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

510(k) Number (if known)

K173501

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)

| <span style="font-size:100%;"><b></b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:100%;"><b></b></span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|

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# 510(k) SUMMARY - K173501

| 510(K) Owner's Name: | Coloplast A/S |
|-----------------------------|------------------------------------------------------------------------------------------------------------------|
| Legal Manufacturer Address: | Holtedam 1<br>3050 Humlebaek, Denmark |
| Contact Person: | Diane Brinza<br>Sr. Strategic Regulatory Affairs Manager<br>Office: 612.979.8983<br>Email: [e-mail] |
| Address/Contact: | 1601 West River Road North<br>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<br>urogynecologic surgical mesh |
| Classification Number: | 884.4910 |
| Product Codes: | PWK (instrumentation, surgical mesh, urogynecologic,<br>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.<br>The predicate device has not been subject to a design-<br>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

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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<br>(K173501) | Predicate Device<br>(K140116) |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Meridian VPS is a<br>single-use device<br>intended to assist in the<br>position and manipulation<br>of the vagina during<br>gynecologic surgical<br>procedures such as<br>sacrocolpopexy. | Restorelle Y Contour<br>polypropylene mesh<br>device is indicated for use<br>as bridging material for<br>sacrocolposuspension /<br>sacrocolpopexy<br>(laparotomy,<br>laparoscopic, or robotic<br>approach) where surgical<br>treatment for vaginal<br>vault prolapse is<br>warranted. |
| Operating Principle | Aid in the position and<br>manipulation of the<br>vagina during | Transabdominal tissue<br>reinforcement in women<br>with pelvic organ<br>prolapse. |

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| | gynecologic surgical<br>procedures | |
|-----------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Patient Contact | < 24 hours (tissue/bone) | Permanent (tissue/bone) |
| Meridian VPS Material | Multiple polymers | n/a |
| Mesh Material | n/a | Polypropylene |
| Shelf life | 3 years | 3 years |
| Sterility | Sterile, EtO | Sterile, EtO |
| Sterilization level | SAL 10-6 | SAL 10-6 |
| Packaging | PETG Retainer tray,<br>Tyvek lid (sterile barrier)<br>and chipboard<br>retail box | PETG Retainer tray,<br>Tyvek lid (sterile barrier)<br>and chipboard<br>retail box |

The subject device has a different intended use than the predicate device, as the predicate device is a surgical mesh device indicated for the transabdominal repair of pelvic organ prolapse. The subject and predicate devices are intended to be used together, as the subject device is an accessory to a surgical mesh.

The operating principle, patient contact, and materials used are different in the subject and predicate device. The predicate device is surgical mesh whereas the subject device is used for the positioning and manipulation of the vagina during placement of the surgical mesh. The differences between the subject and predicate device raise different questions or safety and effectiveness, as we are comparing two different device types with two different intended uses. However, the subject device is an accessory to the predicate device. The differences in technological characteristics and safety and efficacy were evaluated through completion of the special controls published in the final order, as described in the performance testing section below.

## Non-clinical performance testing:

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."
- o Cytotoxicity
- Sensitization O
- o Irritation
- Sterilization validation ●
- Package integrity testing ●
- O Simulated shipping and handling
- Bubble leak testing O
- Seal strength testing o
- Dimensional analysis ●
- Mechanical testing
- Functional testing O
- Maximum force for head, rib, and kick out door O
- Compression O

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K173501 Page 4 of 4

- Bending force O
- Torque O
- Pull force O
- Side load O
- Separation force O
- Shelf life Testing ●

## Summary

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.