ArcTO Transobturator Sling System

K222468 · Urocure, LLC · OTN · Sep 15, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K222468
• Device Name: ArcTO Transobturator Sling System
• Applicant: Urocure, LLC
• Product Code: OTN · General, Plastic Surgery
• Decision Date: Sep 15, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

ArcTO Transobturator Sling System is a surgical implant for female stress urinary incontinence (SUI). System includes a knitted polypropylene mesh sling with integrated bioresorbable suture and plastic insertion sheaths, plus two stainless-steel helical needle delivery assemblies. Used in clinical settings by surgeons; outside-in transobturator approach. Needles facilitate placement of the sling mid-urethra; needles are removed post-placement. Integrated suture allows for sling adjustment after sheath removal. Mesh and suture remain permanently implanted to provide support. Device benefits patients by treating SUI symptoms resulting from urethral hypermobility or intrinsic sphincter deficiency.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included dimensional, needle functional, sling functional, fatigue, tensile, packaging, usability, and distribution testing. Biocompatibility testing met ISO 10993-1:2009 requirements.

Technological Characteristics

Implantable knitted polypropylene mesh with integrated bioresorbable suture. Delivery system uses stainless-steel helical needles. Sterile, single-use. Sterilization via ethylene oxide (EO) to SAL 10^-6. Biocompatibility per ISO 10993-1:2009.

Indications for Use

Indicated for female patients with stress urinary incontinence (SUI) caused by urethral hypermobility and/or intrinsic sphincter deficiency (ISD); polypropylene sling placed mid-urethra.

Regulatory Classification

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.

Predicate Devices

• ArcTV Transvaginal Sling System (K183134)

Reference Devices

• Monarc Sling System (K131229)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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).

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

| <div style="display:flex; align-items:center;"> <div style="margin-right:5px;">☑</div> <div>Research Use (Part 21 CFR 201.3 Subpart D)</div> </div> | <div style="display:flex; align-items:center;"> <div style="margin-right:5px;">□</div> <div>Basic Scientific Use (21 CFR 201.3 Subpart G)</div> </div> |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|

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: [phone] |
| | Email: [e-mail] |

#### 7.3 CONTACT INFORMATION

| Primary Submission Contact | Denise Lenz<br>Regulatory Consultant,<br>Libra Medical Inc.<br>Phone: [phone]<br>Email: [e-mail] |
|------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Secondary Submission Contact | Sew-Wah Tay, PhD<br>Regulatory Consultant,<br>Libra Medical Inc.<br>Phone: [phone] |

#### 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 Submissions<br>for 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: [e-mail]

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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

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).

### 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.

| Device<br>Characteristics | Subject Device<br>ArcTO Transobturator<br>Sling System | Predicate Device<br>ArcTV Transvaginal<br>Sling System (K183134) | Reference Device<br>Monarc Sling System<br>(K131229) |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Same as predicate<br>Implantable Sling<br>intended to treat female<br>stress urinary<br>incontinence resulting<br>from urethral<br>hypermobility and/or<br>intrinsic sphincter<br>deficiency (ISD). | Implantable Sling<br>intended to treat female<br>stress urinary<br>incontinence resulting<br>from urethral<br>hypermobility and/or<br>intrinsic sphincter<br>deficiency (ISD). | Implantable Sling<br>intended to treat female<br>stress urinary<br>incontinence resulting<br>from urethral<br>hypermobility and/or<br>intrinsic sphincter<br>deficiency (ISD). |
| Indication for<br>Use | Same as predicate<br>The polypropylene sling<br>is indicated to be placed<br>mid-urethra for the<br>treatment of female stress<br>urinary incontinence<br>(SUI) resulting from<br>urethral hypermobility<br>and/or intrinsic sphincter<br>deficiency (ISD). | The polypropylene sling<br>is indicated to be placed<br>mid-urethra for the<br>treatment of female stress<br>urinary incontinence<br>(SUI) resulting from<br>urethral hypermobility<br>and/or intrinsic sphincter<br>deficiency (ISD). | Intended for the<br>placement of pubourethral<br>sling for the treatment of<br>female stress urinary<br>incontinence (SUI)<br>resulting from urethral<br>hypermobility and/or<br>intrinsic sphincter<br>deficiency. |

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

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| Device<br>Characteristics | Subject Device<br>ArcTO Transobturator<br>Sling System | Predicate Device<br>ArcTV Transvaginal<br>Sling System (K183134) | Reference Device<br>Monarc Sling System<br>(K131229) |
|------------------------------------------|--------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Regulation<br>Number and<br>Product Code | Same as predicate | 878.3300<br>OTN | 878.3300<br>OTN |
| Regulatory<br>Classification<br>Name | Same as predicate | Surgical mesh | Surgical mesh |
| Device<br>Configuration | Same as predicate | Single use, sterile device | Single use, sterile device |
| Entry Method | Same as technological<br>reference | Transvaginal Retropubic | Outside-in Transobturator |
| Delivery System | Same as technological<br>reference | Handle with detachable<br>curved Needle | Helical needle with<br>attached handle |
| Sling | Same as predicate | Sheathed polypropylene<br>mesh with adjustment<br>bioresorbable suture | Sheathed polypropylene<br>mesh with adjustment<br>bioresorbable 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,<br>Biological evaluation of<br>medical devices<br>requirements | Meets ISO 10993-1:2009,<br>Biological evaluation of<br>medical devices<br>requirements |
| Packaging | Same as predicate<br>Molded tray shape is<br>changed | Molded tray with Tyvek<br>lid and separate pouch for<br>Sling | Molded tray with Tyvek<br>lid and separate pouch for<br>Sling |

# 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.