(51 days)
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).
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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the ArcSP Suprapubic Sling System:
Device: ArcSP Suprapubic Sling System
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific quantitative thresholds. Instead, it states that "The ArcSP meets all its physical and performance specifications." The performance data is presented as a list of tests performed. Without the specific quantitative requirements for each test, a precise comparison table cannot be created from the provided text.
Here's a table based on the types of performance specifications listed:
| Acceptance Criterion (Type of Test) | Reported Device Performance |
|---|---|
| Dimensional | Meets specifications |
| Needle Functional Testing | Meets specifications |
| Sling Functional Testing | Meets specifications |
| Fatigue | Meets specifications |
| Tensile | Meets specifications |
| Packaging Testing | Meets specifications |
| Usability Testing | Meets specifications |
| Distribution Testing | Meets specifications |
| Biocompatibility | Meets specifications |
Note: The document states that for "Fatigue", "Tensile", "Packaging Testing", and "Biocompatibility", "No testing was repeated for this submission since the Sling implant assembly and packaging are identical to the predicate, ArcTV." This implies that the acceptance criteria for these aspects were met by the predicate device and are assumed to be met by the subject device due to identical components.
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set for the "Needle Functional Testing," "Usability Testing," or "Distribution Testing."
For the Sling implant assembly (including Fatigue, Tensile, Packaging, and Biocompatibility), the data provenance is by reference to the predicate device, ArcTV Transvaginal Sling System (K183134). The original sample sizes and provenance for these tests on the predicate device are not detailed in this document.
The studies mentioned are likely prospective studies, as they involve testing the device to ensure it meets specifications. However, the specific details of the study design (e.g., number of units tested per batch or simulation scenario) are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For a medical device like a surgical sling, "ground truth" establishment in terms of expert consensus would typically relate to clinical efficacy or surgical usability. The listed tests are primarily engineering and mechanical performance tests, for which "ground truth" is typically defined by engineering standards and specifications rather than expert consensus in the traditional sense of clinical imaging or diagnostic AI. Usability testing, however, would typically involve healthcare professionals, but their number and qualifications are not detailed.
4. Adjudication method for the test set
This information is not provided in the document. The tests described (dimensional, functional, fatigue, tensile, packaging, distribution, biocompatibility, usability) are typically evaluated against predefined specifications. Adjudication methods like "2+1" or "3+1" are usually applied to subjective assessments, such as those in clinical trials or image interpretation, where multiple reviewers' opinions need to be reconciled. For the engineering tests mentioned, the results are typically quantitative and objective, meaning an adjudication method is less applicable. For usability testing, if subjective feedback was collected, the adjudication method is not specified.
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
No MRMC comparative effectiveness study was done or is applicable here. This type of study is specifically relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The ArcSP Suprapubic Sling System is a surgical implantable device, not a diagnostic imaging or AI-driven diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No standalone algorithm performance study was done or is applicable here. As above, this device is a physical surgical implant, not an AI algorithm.
7. The type of ground truth used
For most of the performance tests (Dimensional, Needle Functional, Sling Functional, Fatigue, Tensile, Packaging, Distribution):
- The "ground truth" is established by predefined engineering specifications and standards. These are objective, measurable criteria that the device must meet.
For "Biocompatibility":
- The "ground truth" is established by ISO 10993-1:2009, Biological evaluation of medical devices requirements. This refers to international standards for assessing the biological compatibility of medical devices with the human body.
For "Usability Testing":
- While not explicitly stated, the "ground truth" for usability testing would typically be based on observational data, user feedback, and adherence to established usability engineering principles and task completion rates/error rates.
8. The sample size for the training set
This information is not applicable as the ArcSP Suprapubic Sling System is a physical medical device and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable as the ArcSP Suprapubic Sling System does not involve a "training set" for an AI model.
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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
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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, PhDRegulatory Consultant,Libra Medical Inc.Phone: 612-801-6782Email: 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 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 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.
| DeviceCharacteristics | Subject DeviceArcSP Suprapubic SlingSystem | Predicate DeviceArcTV TransvaginalSling System (K183134) | Reference DeviceSPARC Sling System(K081613) |
|---|---|---|---|
| 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). |
| DeviceCharacteristics | Subject DeviceArcSP Suprapubic SlingSystem | Predicate DeviceArcTV TransvaginalSling System (K183134) | Reference DeviceSPARC Sling System(K081613) |
| 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. |
| 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 | Suprapubic Retropubic |
| Delivery System | Same as technologicalreference | Handle with detachablecurved Needle | Curved 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 predicate | Molded tray with Tyveklid and separate pouch forSling | Molded tray with Tyveklid and separate pouch forSling |
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.
§ 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.