(86 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical properties of a surgical sling system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a retropubic sling system intended for the treatment of adult female stress urinary incontinence, which is a medical condition.
No
This device is a retropubic sling system designed for the treatment of stress urinary incontinence, not for diagnosing it. Its description clearly outlines components for implantation (Mesh, Suture) and delivery (Handle, Needles, Sheaths, Sling Connectors), which are all tools for a surgical procedure.
No
The device description clearly outlines physical components including a Handle, delivery Needles, Sling assembly (Mesh, Suture, Sheaths, Sling Connectors), which are hardware components used for implantation.
Based on the provided information, the ArcTV Transvaginal Sling System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The ArcTV Transvaginal Sling System is a surgical implant and delivery system used to treat stress urinary incontinence by physically supporting the urethra. It is used in the body, not to test samples from the body.
The description clearly outlines a medical device intended for surgical implantation, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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).
Product codes
OTN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mid-urethral
Indicated Patient Age Range
Adult female
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (30 days) for the Mesh and Suture.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the words "FDA U.S. FOOD & DRUG" on the first line and "ADMINISTRATION" on the second line.
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
1
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)
Device Name ArcTV Transvaginal Sling System
Indications for Use (Describe)
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).
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 Stress |
| Urinary 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
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
4
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 (30 days) for the Mesh and Suture.
1.9 SUBSTANTIAL EQUIVALENCE
| Device
Characteristics | ArcTV Transvaginal Sling System | AMS RetroArc Retropubic Sling
System (K132655) |
|---------------------------|----------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Intended Use | The ArcTV Transvaginal Sling System
is intended to treat female stress urinary
incontinence. | Same |
5
| Device
Characteristics | ArcTV Transvaginal Sling System | AMS RetroArc Retropubic Sling
System (K132655) |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication 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) | The RetroArc Retropubic Sling
System is intended for the placement
of a suburethral Sling for the
treatment of female stress urinary
incontinence (SUI) resulting from
urethral hypermobility and/or
intrinsic sphincter deficiency (ISD). |
| Entry Method | Transvaginal Retropubic | Same |
| Delivery System | Handle with detachable curved Needle | Same |
| Sling | Sheathed polypropylene mesh with
adjustment bioresorbable suture | Same |
| Sterilization | EO, SAL 10⁻⁶, single-use | Same |
| Packaging | Molded tray with Tyvek lid and
separate 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.