The ArcTV Transvaginal Sling System is a retropubic sling indicated for a transvaginal (TV) placement of a midurethral sling for the treatment of adult female stress urinary inconting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

Device Description

The ArcTV Transvaginal Sling System is a sterile, single-use system, consisting of a Handle, two delivery Needles and a Sling assembly. The tip portion of each delivery Needle is configured to allow for passage through tissue. The opposite end of the Needle is configured to connect with the Handle. The Handle is detachable and is used to direct both delivery Needles through tissue. The Sling assembly includes one piece of loosely knitted polymeric Mesh with an integrated bioresorbable Suture, two removable plastic insertion Sheaths, and two Sling Connectors. The Suture is an integral feature of the Mesh. The Suture and Mesh allow for adjustment of the Sling after initial placement in the patient without the use of additional tools. The two plastic Sheaths facilitate the placement of the Sling. The Sling Connectors, Sheaths, Needles, and Handle are used to facilitate placement of the Sling assembly, and are not implanted. The Mesh and the bioresorbable Suture are permanently implanted.

AI/ML Overview

The provided document is a 510(k) summary for the ArcTV Transvaginal Sling System. This document details the device, its intended use, and its substantial equivalence to a predicate device. However, it does NOT contain detailed information about acceptance criteria for a "device" in the context of an AI/ML algorithm or a study proving that the device meets those criteria.

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as this document is for a physical medical device (a surgical mesh system) and not an AI/ML powered device.

Summary

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February 7, 2019

UroCure LLC % Ming-Cheng Chew Regulatory Consultant Libra Medical, Inc. 8401 73rd Ave No., Suite 63 Brooklyn Park, MN 55428

Re: K183134

Trade/Device Name: ArcTV Transvaginal Sling System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OTN Dated: January 9, 2019 Received: January 11, 2019

Dear Ming-Cheng Chew:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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statutes and regulations administered by other Federal agencies. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,

Glenn B. Bell -S

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)

K183134

Device Name ArcTV Transvaginal Sling System

Indications for Use (Describe)

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 1

1.1 ADMINISTRATIVE INFORMATION

Date of Summary Preparation: 1/9/2018

CONTACT INFORMATION 1.2

Primary Submission Contact	Ming-Cheng Chew
	Regulatory Consultant,
	Libra Medical Inc.
	Phone: 763-232-3701
	Email: mcchew@libramed.com
Secondary Submission Contact	Sew-Wah Tay, PhD
	Regulatory Consultant,

DEVICE INFORMATION 1.3

Trade Name	ArcTV Transvaginal Sling System
Common Name	Urinary sling
Classification Name	Surgical Mesh
Classification Regulation	878.3300
Class	II
Panel	Gastroenterology/Urology
Product Code	OTN
Product Code Name	Mesh, Surgical, Synthetic, Urogynecologic, For StressUrinary Incontinence, Retropubic Or Transobturator

Libra Medical Inc. Phone: 612-801-6782

Email: swtay@libramed.com

1.4 510(K) TYPE AND REASON FOR SUBMISSION

This 510(k) is a traditional 510(k) and is submitted to obtain marketing clearance for a new device - the ArcTV Transvaginal Sling System.

PREDICATE DEVICE 1.5

RetroArc Repubic Sling System (K132655)

DEVICE DESCRIPTION 1.6

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the Handle. The Handle is detachable and is used to direct both delivery Needles through tissue. The Sling assembly includes one piece of loosely knitted polymeric Mesh with an integrated bioresorbable Suture, two removable plastic insertion Sheaths, and two Sling Connectors. The Suture is an integral feature of the Mesh. The Suture and Mesh allow for adjustment of the Sling after initial placement in the patient without the use of additional tools. The two plastic Sheaths facilitate the placement of the Sling.

The Sling Connectors, Sheaths, Needles, and Handle are used to facilitate placement of the Sling assembly, and are not implanted. The Mesh and the bioresorbable Suture are permanently implanted.

1.7 INDICATIONS FOR USE

The ArcTV Transvaginal Sling System is a retropubic Sling indicated for a transvaginal (TV) placement of a mid-urethral Sling for the treatment of adult female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD)

1.8 PERFORMANCE DATA

The ArcTV Transvaginal Sling System has been tested to meet the device's intended use and to ensure conformance to the product specifications.

The ArcTV meets all its physical and performance specifications including:

Dimensional ●
Fatigue
Tensile
Packaging Testing
Usability Testing ●
Distribution Testing

In addition, the ArcTV was tested for biocompatibility per ISO 10993-1:2009 for external communicating device with tissue for limited duration contact with (<24 hours) for the Needle and Handle, and for permanent implant in tissue (>30 days) for the Mesh and Suture.

1.9 SUBSTANTIAL EQUIVALENCE

DeviceCharacteristics	ArcTV Transvaginal Sling System	AMS RetroArc Retropubic SlingSystem (K132655)
Intended Use	The ArcTV Transvaginal Sling Systemis intended to treat female stress urinaryincontinence.	Same

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DeviceCharacteristics	ArcTV Transvaginal Sling System	AMS RetroArc Retropubic SlingSystem (K132655)
Indication for Use	The ArcTV Transvaginal Sling Systemis a retropubic Sling indicated for atransvaginal (TV) placement of a mid-urethral Sling for the treatment of adultfemale stress urinary incontinence(SUI) resulting from urethralhypermobility and/or intrinsic sphincterdeficiency (ISD)	The RetroArc Retropubic SlingSystem is intended for the placementof a suburethral Sling for thetreatment of female stress urinaryincontinence (SUI) resulting fromurethral hypermobility and/orintrinsic sphincter deficiency (ISD).
Entry Method	Transvaginal Retropubic	Same
Delivery System	Handle with detachable curved Needle	Same
Sling	Sheathed polypropylene mesh withadjustment bioresorbable suture	Same
Sterilization	EO, SAL 10⁻⁶, single-use	Same
Packaging	Molded tray with Tyvek lid andseparate pouch for Sling	Same

1.10 CONCLUSION

Based on the test data and the same intended use, the ArcTV is substantially equivalent to its predicate. The minor differences do not raise any new questions of safety or efficacy.

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.