The polypropylene sling is indicated to be placed mid-urethra for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

Device Description

The ArcTO Transobturator Sling System consists of the following:

1 ArcTO Sling with bio-resorbable Suture and plastic sheath .
2 ArcTO Handle and Needle Delivery Assemblies .
The Handle and Needle delivery assembly is a sterile, single-use system, consisting of two helical, stainless-steel Needles with attached Handles. The tip portion of each delivery Needle is designed to allow for passage through tissue. The Needles are a tool and together with the Sling Connectors and Sheaths, facilitate placement of the Sling and are not implanted.
The ArcTO Sling assembly is identical to the predicate, ArcTV Sling assembly and includes one knitted polypropylene 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 integrated Suture helps to minimize deformation of the mesh during sling insertion and placement and allows for adjustment of the Sling after removal of the Sheaths. The two plastic Sheaths cover and facilitate placement of the Sling. The Mesh and the bioresorbable Suture are permanently implanted.

AI/ML Overview

The provided text describes a medical device, the "ArcTO Transobturator Sling System," and its submission for FDA clearance. However, it does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of clinical performance or diagnostic accuracy.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device based on physical and performance specifications of the device components, rather than clinical efficacy studies with human subjects that would typically involve acceptance criteria for a diagnostic or AI-assisted device.

Here's a breakdown of the specific points you requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The document lists "performance data" as:

Dimensional
Needle Functional Testing
Sling Functional Testing
Fatigue
Tensile
Packaging Testing
Usability Testing
Distribution Testing
Biocompatibility

It states, "The ArcTO meets all its physical and performance specifications." However, it does not specify what those specifications (acceptance criteria) are or provide numerical results of the testing. For example, it doesn't state "Tensile strength must be >X Newtons; device achieved Y Newtons."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided as there is no clinical study described in the document. The "testing" mentioned refers to engineering and material characterization, not patient data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as there is no clinical study described that would require expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as there is no clinical study described that would involve adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. This device is a surgical mesh, not a diagnostic or AI-assisted device, so an MRMC study is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided. This device is a surgical mesh; it does not have an algorithm component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided as there is no clinical study described that would require ground truth. The "ground truth" for the engineering performance tests would be the established engineering standards and specifications for the materials and components, but these specific standards are not detailed.

8. The sample size for the training set

This information is not provided. There is no training set mentioned as this is not an AI/ML device.

9. How the ground truth for the training set was established

This information is not provided. There is no training set mentioned.

In summary, the provided document focuses on the mechanical and material properties of the device components and its substantial equivalence to a predicate device for FDA clearance. It does not contain information related to clinical performance, diagnostic accuracy, or AI model validation, which are typically associated with the type of acceptance criteria and study details you've requested.

Summary

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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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 15, 2022

UroCure LLC Denise Lenz Regulatory Consultant Libra Medical, Inc. 8401 73rd Avenue North, Suite 63 Brooklyn Park, MN 55428

Re: K222468

Trade/Device Name: ArcTO Transobturator Sling System Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: OTN Dated: August 15, 2022 Received: August 16, 2022

Dear Denise Lenz:

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 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Jessica K. Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222468

Device Name ArcTO Transobturator Sling System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Research Use (Part 21 CFR 201.3 Subpart D)	□ Basic Scientific Use (21 CFR 201.3 Subpart G)
-----------------------------------------------------------------------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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7 510(K) SUMMARY

7.1 ADMINISTRATIVE INFORMATION

Date of Summary Preparation: Aug 15, 2022

7.2 SUBMITTER INFORMATION

Submitter	John Nealon
	UroCure, LLC
	701 North 3rd Street, Suite 110,
	Minneapolis, MN 55401
	Phone: 612-850-6814
	Email: john.nealon@urocure.com

7.3 CONTACT INFORMATION

Primary Submission Contact	Denise LenzRegulatory Consultant,Libra Medical Inc.Phone: 612-965-3445Email: dlenz@libramed.com
Secondary Submission Contact	Sew-Wah Tay, PhDRegulatory Consultant,Libra Medical Inc.Phone: 612-801-6782

7.4 DEVICE INFORMATION

Trade Name	ArcTO Transobturator Sling System
Common Name	Urinary sling
Classification Name	Surgical Mesh
Classification Regulation	878.3300
Class	II
Panel	Gastroenterology/Urology
Product Code	OTN
Prior Regulatory Submissionsfor Device	None

7.5 510(K) TYPE AND REASON FOR SUBMISSION

This 510(k) is a Special 510(k) and is submitted to obtain marketing clearance for the ArcTO Transobturator Sling System, a modification to the delivery device for the predicate ArcTV

Email: swtay@libramed.com

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Transvaginal Sling. The implantable portion of the device is identical to the predicate (ArcTV), with the delivery tool being the only difference from the predicate, ArcTV.

7.6 PREDICATE DEVICE

The predicate is ArcTV Transvaginal Sling System (K183134).

7.7 DEVICE DESCRIPTION

The ArcTO Transobturator Sling System consists of the following:

1 ArcTO Sling with bio-resorbable Suture and plastic sheath .
2 ArcTO Handle and Needle Delivery Assemblies .

The Handle and Needle delivery assembly is a sterile, single-use system, consisting of two helical, stainless-steel Needles with attached Handles. The tip portion of each delivery Needle is designed to allow for passage through tissue. The Needles are a tool and together with the Sling Connectors and Sheaths, facilitate placement of the Sling and are not implanted.

The ArcTO Sling assembly is identical to the predicate, ArcTV Sling assembly and includes one knitted polypropylene 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 integrated Suture helps to minimize deformation of the mesh during sling insertion and placement and allows for adjustment of the Sling after removal of the Sheaths. The two plastic Sheaths cover and facilitate placement of the Sling. The Mesh and the bioresorbable Suture are permanently implanted.

7.8 INTENDED USE

Implantable Sling intended to treat female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

7.9 INDICATIONS FOR USE

7.10 PERFORMANCE DATA

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

The ArcTO meets all its physical and performance specifications including:

Dimensional .
Needle Functional Testing .
*Sling Functional Testing ●
. *Fatigue
*Tensile .
. Packaging Testing

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. Usability Testing
Distribution Testing .
*Biocompatibility .

No testing was repeated for this submission since the Sling implant assembly is identical to the predicate, ArcTV.

7.11 DEVICE COMPARISON

The ArcTO Transobturator Sling System consists of the following:

1 ArcTO Sling with bio-resorbable Suture and plastic sheath .
2 ArcTO Handle and Needle Delivery Assemblies .

The ArcTO Transobturator Sling is identical to the predicate sling, ArcTV. The delivery of the sling is the outside-in transobturator approach for the subject device (ArcTO) versus transvaginal for the predicate device (ArcTV); therefore, the shape of the needle has changed to facilitate an outside-in transobturator delivery. The mid-urethral placement of the sling is the same for both. The different Needle designs specific patient considerations and physician surgical preferences.

The following table compares the subject device. ArcTO to the predicate device. ArcTV and the reference device, Monarc.

DeviceCharacteristics	Subject DeviceArcTO TransobturatorSling System	Predicate DeviceArcTV TransvaginalSling System (K183134)	Reference DeviceMonarc Sling System(K131229)
Intended Use	Same as predicateImplantable Slingintended to treat femalestress urinaryincontinence resultingfrom urethralhypermobility and/orintrinsic sphincterdeficiency (ISD).	Implantable Slingintended to treat femalestress urinaryincontinence resultingfrom urethralhypermobility and/orintrinsic sphincterdeficiency (ISD).	Implantable Slingintended to treat femalestress urinaryincontinence resultingfrom urethralhypermobility and/orintrinsic sphincterdeficiency (ISD).
Indication forUse	Same as predicateThe polypropylene slingis indicated to be placedmid-urethra for thetreatment of female stressurinary incontinence(SUI) resulting fromurethral hypermobilityand/or intrinsic sphincterdeficiency (ISD).	The polypropylene slingis indicated to be placedmid-urethra for thetreatment of female stressurinary incontinence(SUI) resulting fromurethral hypermobilityand/or intrinsic sphincterdeficiency (ISD).	Intended for theplacement of pubourethralsling for the treatment offemale stress urinaryincontinence (SUI)resulting from urethralhypermobility and/orintrinsic sphincterdeficiency.

Table 7-1: Comparison of Device Characteristics to Marketed Predicate Device

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DeviceCharacteristics	Subject DeviceArcTO TransobturatorSling System	Predicate DeviceArcTV TransvaginalSling System (K183134)	Reference DeviceMonarc Sling System(K131229)
RegulationNumber andProduct Code	Same as predicate	878.3300OTN	878.3300OTN
RegulatoryClassificationName	Same as predicate	Surgical mesh	Surgical mesh
DeviceConfiguration	Same as predicate	Single use, sterile device	Single use, sterile device
Entry Method	Same as technologicalreference	Transvaginal Retropubic	Outside-in Transobturator
Delivery System	Same as technologicalreference	Handle with detachablecurved Needle	Helical needle withattached handle
Sling	Same as predicate	Sheathed polypropylenemesh with adjustmentbioresorbable suture	Sheathed polypropylenemesh with adjustmentbioresorbable suture
Sterilization	Same as predicate	EO, SAL 10-6, single use	EO, SAL 10-6, single use
Biocompatibility	Same as predicate	Meets ISO 10993-1:2009,Biological evaluation ofmedical devicesrequirements	Meets ISO 10993-1:2009,Biological evaluation ofmedical devicesrequirements
Packaging	Same as predicateMolded tray shape ischanged	Molded tray with Tyveklid and separate pouch forSling	Molded tray with Tyveklid and separate pouch forSling

7.12 SUBSTANTIAL EQUIVALENCE

The ArcTO Transobturator Sling System covered by this submission is substantially equivalent to the predicate ArcTV Transvaginal Sling System device (K183134). The minor difference in the shape and size of the needle to optimize the ArcTO's outside-in transobturator needle passage and technique do not raise new safety and efficacy as the shape, size and stiffness of the needle is the same as the technological reference.

7.13 CONCLUSION

Since the implantable sling assembly system is identical to the predicate, ArcTV, and the intended use is the same, the ArcTO is substantially equivalent to its predicate. The minor difference in the shape and size of the needle does 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.