(51 days)
No
The 510(k) summary describes a surgical implant and delivery system with no mention of software, data processing, or any technology that would typically incorporate AI/ML. The performance studies focus on physical and functional characteristics of the device.
Yes
The device is a sling system indicated for the treatment of stress urinary incontinence, which is a medical condition. It is permanently implanted to achieve its therapeutic effect.
No
The device is a surgical sling system designed for the treatment of stress urinary incontinence by physically supporting the urethra, not for diagnosing conditions.
No
The device description explicitly details physical components like a sling, needles, handles, and sheaths, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat female stress urinary incontinence by surgically implanting a sling. This is a therapeutic procedure performed on a patient's body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device consists of a sling, needles, and handles used for surgical implantation. These are surgical tools and implants, not reagents, instruments, or software used to analyze biological samples.
- No mention of in vitro testing: The description focuses on the surgical placement of the device and its physical and functional properties. There is no mention of analyzing blood, urine, tissue, or any other biological sample outside of the body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ArcSP Suprapubic Sling System does not fit this description.
N/A
Intended Use / Indications for Use
The ArcSP Suprapubic Sling System 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).
Product codes (comma separated list FDA assigned to the subject device)
OTN
Device Description
The ArcSP Suprapubic Sling System consists of the following:
- 1 ArcSP Sling with bio-resorbable Suture with plastic sheath
- 2 ArcSP Handle and Needle Delivery Assemblies
The Handle and Needle delivery assembly is a sterile, single-use system, consisting of a two curved, stainless-steel Needles with attached Handles. The conical tip 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 ArcSP 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mid-urethra
Indicated Patient Age Range
Not Found
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 ArcSP Suprapubic Sling System has been tested to meet the device's intended use and to ensure conformance to the product specifications.
The ArcSP meets all its physical and performance specifications including:
- Dimensional
- Needle Functional Testing
- Sling Functional Testing
- Fatigue
- Tensile
- Packaging Testing
- Usability Testing
- Distribution Testing
- Biocompatibility
No testing was repeated for this submission since the Sling implant assembly and packaging are identical to the predicate, ArcTV.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows 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 letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
September 21, 2022
UroCure LLC % Denise Lenz Regulatory Consultant Libra Medial, Inc. 8401 73rd Ave N. Suite 63 Brooklyn Park, MN 55428
K222293 Re:
Trade/Device Name: ArcSP Suprapubic Sling System Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: OTN Dated: August 31, 2022 Received: September 6, 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 (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 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,
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
2
Indications for Use
510(k) Number (if known) K22293
Device Name ArcSP Suprapubic Sling System
Indications for Use (Describe)
The ArcSP Suprapubic Sling System is indicated to be placed at 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)
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: July 29, 2022
7.2 SUBMITTER INFORMATION
John Nealon Submitter 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 Lenz |
|---|---|
| Regulatory Consultant, | |
| Libra Medical Inc. | |
| Phone: 763-232-3701 | |
| Email: dlenz@libramed.com | |
| Secondary Submission Contact | Sew-Wah Tay, PhD |
| Secondary Submission Contact | Sew-Wah Tay, PhD
Regulatory Consultant,
Libra Medical Inc.
Phone: 612-801-6782
Email: swtay@libramed.com |
| ------------------------------ | ---------------------------------------------------------------------------------------------------------------------- |
|---|
DEVICE INFORMATION 7.4
| Trade Name | ArcSP Suprapubic 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 | |
| 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 ArcSP Suprapubic Sling System, a modification to the delivery device for the predicate ArcTV
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Transyaginal 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).
DEVICE DESCRIPTION 7.7
The ArcSP Suprapubic Sling System consists of the following:
- 1 ArcSP Sling with bio-resorbable Suture with plastic sheath ●
- 2 ArcSP Handle and Needle Delivery Assemblies .
The Handle and Needle delivery assembly is a sterile, single-use system, consisting of a two curved, stainless-steel Needles with attached Handles. The conical tip 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 ArcSP 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 ArcSP Suprapubic Sling System 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 ArcSP Suprapubic Sling System has been tested to meet the device's intended use and to ensure conformance to the product specifications.
The ArcSP 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 and packaging are identical to the predicate, ArcTV.
7.11 DEVICE COMPARISON
The ArcSP Suprapubic Sling System consists of the following:
- 1 ArcSP Sling with bio-resorbable Suture and plastic sheath
- 2 ArcSP Handle and Needle Delivery Assemblies .
The ArcSP Suprapubic Sling is identical to the predicate sling, ArcTV. The delivery approach of the sling is suprapubic for the subject device (ArcSP) versus transvaginal for the predicate device (ArcTV); therefore, the shape of the needle has changed to facilitate a suprapubic delivery. The final placement of the sling is the same for both. The two different Needles are to accommodate physician's preference of approach to implant.
The following table compares the subject device, ArcSP to the predicate device, ArcTV and the reference device, SPARC.
| Device
Characteristics | Subject Device
ArcSP Suprapubic Sling
System | Predicate Device
ArcTV Transvaginal
Sling System (K183134) | Reference Device
SPARC Sling System
(K081613) |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Same as predicate
Implantable Sling
intended to treat female
stress urinary
incontinence resulting
from urethral
hypermobility and/or
intrinsic sphincter
deficiency (ISD). | Implantable Sling
intended to treat female
stress urinary
incontinence resulting
from urethral
hypermobility and/or
intrinsic sphincter
deficiency (ISD). | Implantable Sling
intended to treat female
stress urinary
incontinence resulting
from urethral
hypermobility and/or
intrinsic sphincter
deficiency (ISD). |
| Device
Characteristics | Subject Device
ArcSP Suprapubic Sling
System | Predicate Device
ArcTV Transvaginal
Sling System (K183134) | Reference Device
SPARC Sling System
(K081613) |
| Indication for
Use | Same as predicate
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). | 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). | Intended for the
placement of pubourethral
sling for the treatment of
female stress urinary
incontinence (SUI)
resulting from urethral
hypermobility and/or
intrinsic sphincter
deficiency. |
| Regulation
Number and
Product Code | Same as predicate | 878.3300
OTN | 878.3300
OTN |
| Regulatory
Classification
Name | Same as predicate | Surgical mesh | Surgical mesh |
| Device
Configuration | Same as predicate | Single use, sterile device | Single use, sterile device |
| Entry Method | Same as technological
reference | Transvaginal Retropubic | Suprapubic Retropubic |
| Delivery System | Same as technological
reference | Handle with detachable
curved Needle | Curved needle with
attached handle |
| Sling | Same as predicate | Sheathed polypropylene
mesh with adjustment
bioresorbable suture | Sheathed polypropylene
mesh with adjustment
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,
Biological evaluation of
medical devices
requirements | Meets ISO 10993-1:2009,
Biological evaluation of
medical devices
requirements |
| Packaging | Same as predicate | Molded tray with Tyvek
lid and separate pouch for
Sling | Molded tray with Tyvek
lid and separate pouch for
Sling |
Table 7-1: Comparison of Device Characteristics to Marketed Predicate Device
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7.12 SUBSTANTIAL EQUIVALENCE
The ArcSP Suprapubic Sling System covered by this 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 ArcSP's top-down 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 ArcSP is substantially equivalent to its predicate. The minor difference in the shape, size and stiffness of the needle does not raise any new questions of safety or efficacy.