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 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.

AI/ML Overview

This document is a 510(k) summary for the Meridian Vaginal Positioning System (VPS), a medical device. It describes the device, its intended use, and the non-clinical performance testing conducted to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and study information based on the provided text:

No acceptance criteria and device performance table can be generated from the provided text. The document lists the types of non-clinical performance tests performed (e.g., biocompatibility, sterilization validation, mechanical testing) but does not provide specific quantitative acceptance criteria values or the reported performance data for these tests. It only states that "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."

This document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results with acceptance criteria as one might find in a clinical trial report for an AI/ML diagnostic device.

Here's what can be extracted regarding the study, with explanations for what is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

As stated above, this information is not present in the provided 510(k) summary. The document lists the types of tests performed (e.g., Cytotoxicity, Sensitization, Irritation, Functional testing, Maximum force for head, etc.) but does not provide numerical acceptance criteria or the specific results obtained for each test. The summary only states that the performance testing results "demonstrate that the Meridian Vaginal Positioning System is as safe and effective."

2. Sample Sizes Used for the Test Set and Data Provenance:

The document describes non-clinical performance testing (e.g., biocompatibility, mechanical testing, sterilization validation). It does not involve a "test set" in the context of patient data or clinical images. Therefore:

Sample size for the test set: Not applicable, as this was non-clinical testing of the device itself, not a clinical study involving patient data. The document would typically refer to the number of devices or test units used for each test (e.g., n=5 for bend testing), but these specific numbers are not provided.
Data provenance (country of origin, retrospective/prospective): Not applicable for non-clinical device testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This was non-clinical performance testing of a physical medical device (Vaginal Positioning System), not a study involving the interpretation of data where expert ground truth would be established (e.g., image annotation for an AI algorithm).

4. Adjudication Method for the Test Set:

Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This document describes the non-clinical performance testing of a physical surgical instrument. An MRMC study is typically performed for diagnostic devices (especially AI/ML-driven ones) to assess the impact of the device on human reader performance.

6. Standalone (Algorithm Only) Performance:

No. This device is a physical surgical instrument, not an algorithm. Standalone performance is relevant to AI/ML algorithms that provide an output without human intervention.

7. Type of Ground Truth Used:

Not applicable. For physical device testing, "ground truth" refers to established material properties, mechanical specifications, and biological safety limits, as defined by standards like ISO 10993-1. The "ground truth" for these tests would be the established limits and specifications against which the device's performance is measured. The document states that tests were performed "per the special controls listed in 21 CFR 884.4910" and according to standards like ISO 10993-1.

8. Sample Size for the Training Set:

Not applicable. This document is not describing an AI/ML device that requires a training set. The "device" is a physical instrument.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. See point 8.

In summary:

The provided document is a 510(k) summary for a physical medical device, the Meridian Vaginal Positioning System (VPS). It details non-clinical performance testing to establish substantial equivalence. It does not contain information about acceptance criteria values, reported performance data, clinical study sample sizes, expert adjudication, or AI/ML-specific testing methodologies (like MRMC studies or training set details). The "proof" of meeting safety and effectiveness criteria relies on demonstrating compliance with recognized standards and pre-defined specifications through the listed non-clinical tests, which include biocompatibility, sterilization validation, package integrity, dimensional analysis, and various mechanical tests.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

Prescription Use (Part 21 CFR 801 Subpart D)	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 13050 Humlebaek, Denmark
Contact Person:	Diane BrinzaSr. Strategic Regulatory Affairs ManagerOffice: 612.979.8983Email: usdlb@coloplast.com
Address/Contact:	1601 West River Road NorthMinneapolis, 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 withurogynecologic 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:

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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(K173501)	Predicate Device(K140116)
Indications for Use	The Meridian VPS is asingle-use deviceintended to assist in theposition and manipulationof the vagina duringgynecologic surgicalprocedures such assacrocolpopexy.	Restorelle Y Contourpolypropylene meshdevice is indicated for useas bridging material forsacrocolposuspension /sacrocolpopexy(laparotomy,laparoscopic, or roboticapproach) where surgicaltreatment for vaginalvault prolapse iswarranted.
Operating Principle	Aid in the position andmanipulation of thevagina during	Transabdominal tissuereinforcement in womenwith pelvic organprolapse.

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	gynecologic surgicalprocedures
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,Tyvek lid (sterile barrier)and chipboardretail box	PETG Retainer tray,Tyvek lid (sterile barrier)and chipboardretail 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.

Regulation Number and Section

§ 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.