(160 days)
No
The device description details a mechanical sling system and surgical tools, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for the treatment of a medical condition (stress urinary incontinence), which is a common characteristic of therapeutic devices.
No
This device is a surgical implant designed to treat stress urinary incontinence, not to diagnose it. Its purpose is therapeutic, providing physical support to the urethra.
No
The device description clearly details a physical implant (sling, anchors, suture) and surgical introducers, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Altis Single Incision Sling System is a surgical implant used to treat stress urinary incontinence. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use is the treatment of a medical condition through surgical intervention, not the diagnosis of a condition through laboratory testing.
Therefore, the Altis Single Incision Sling System falls under the category of a surgical device or implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Altis Single Incision Sling System is indicated for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
Product codes
PAH
Device Description
The Altis System is a single-incision mini-sling.. The sling material is manufactured using the commercialized Aris polypropylene mesh (K050148). Altis sling is made of a 0.08mm (nominal) diameter monofilament polypropylene mesh, knitted into a sling 1.1 cm wide by 7.75 cm long. One end of the sling assembly connects to a short length of USP size 1 monofilament polypropylene suture and to a polypropylene static (non-tensioning) anchor. The second side of the sling assembly terminates to a longer section of USP size 1 monofilament polypropylene suture. This suture is then positioned through the second anchor that is dynamic with an integrated tensioning system. The tensioning capability is accomplished by threading the suture through a polyurethane tensioning collar which is assembled onto the anchor. The anchor/suture assembly wraps around the anchor, resulting in a gap between the anchor and the collar providing constant pressure on the suture, preventing it from moving on its own, or during a pelvic stress event. Tensioning is achieved by pulling on the suture loop, thus applying increased tension of the sling to the urethra until desired support is achieved. The Altis anchors perform an acute mechaning the desired position and tension through the acute post-operative tissue healing and in-growth phase, The Altis sling assembly is packaged with two (2) helical type introducers (one right, one left) that are used to place the sub-urethral sling. The Altis introducers are designed with the appropriate curvature and length to reach the obturator foramen through a single vaginal incision. The tip of the needle is designed to fit into the anchors to facilitate placement into the obturator foramen during the surgical implant procedure. The sling assembly pouch and introducers are placed in a tray sealed with a Tyvek lid. The Altis system (implant plus introducers) is provided sterile (ethylene oxide) and is for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethral
Indicated Patient Age Range
The median age for the women enrolled in the study was 54.5 years (range = 25.3 - 89.3).
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 clinical study of the Altis Sling System was a prospective, single arm, non-randomized, multi-center trial conducted at 17 sites in the US and Canada.
A total of 113 women were implanted with the Altis Sling.
The study's primary effectiveness objective was improvement in subject continence status measured by reduction in 24-hour pad weight. At 6 months, 88 of 103 evaluable subjects showed >50% reduction in pad weight compared to baseline.
Secondary effectiveness endpoints included cough stress test (CST) at 6 months, assessment of subject Quality of Life (QOL) through validated questionnaires at 6 months, and voiding diaries were evaluated using performance goals. All results were statistically significant.
Cough Stress Test: 92.2% (95/103) successful (negative cough stress test) with a lower 95.81% CL of 86.1% and p-value = 50% reduction in UDI Score) with a lower 95.81% CL of 81.8% and p-value = 50% reduction in IIQ Score) with a lower 95.81% CL of 87.4% and p-value = 50% reduction in number of incontinence episodes) with a lower 95.81% CL of 80.6% and p-value
§ 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.
0
Image /page/0/Picture/0 description: The image shows the Coloplast logo, which includes a circle with horizontal lines on the left and the word "Coloplast" in bold black letters on the right. Above the logo, there is the text "K121562" and "Page 1 of 3". The text is handwritten and appears to be part of a document or report.
510(K) SUMMARY
510(k) Owner's Name: | Coloplast A/S | NOV | 5 | 2012 |
---|---|---|---|---|
Address: | Holtedam 1 | |||
3050 Humlebaek, Denmark | ||||
Establishment Registration: 9610694 | ||||
Owner/Operator: 8010144 | ||||
Phone/Fax/Email: | Office: (612) 302-4922 | |||
Mobile: (612) 703-6180 | ||||
Fax: (612) 287-4138 | ||||
Name of Contact Person: | Janell Colley | |||
Regulatory Affairs Manager | ||||
Date Prepared: | November 2, 2012 | |||
Trade or Proprietary Name: | Altis® Single Incision Sling System | |||
Common or Usual Name: | Surgical mesh | |||
Classification Name/ | ||||
Number/Product code: | Mesh, surgical, gynecologic, for stress urinary | |||
incontinence, female, single-incision mini-sling/ | ||||
21 CFR 878.3300/PAH |
Legally Marketed Device To Which Your Firm Is Claiming Equivalence:
The Coloplast Altis Single Incision Sling System (hereafter referred to as the Altis System) is substantially equivalent in performance, indications, design and materials to Coloplast's Aris System (previously Mentor's), cleared under premarket notification K050148 on March 9, 2005, American Medical System's MiniArc System, cleared under premarket notification K073703 on January 30, 2008 and C.R. Bard Ajust Adjustable Single Incision Sling, cleared under premarket notification K092607 on November 20, 2009.
Device Description:
The Altis System is a single-incision mini-sling.. The sling material is manufactured using the commercialized Aris polypropylene mesh (K050148). Altis sling is made of a 0.08mm (nominal) diameter monofilament polypropylene mesh, knitted into a sling 1.1 cm wide by 7.75 cm long. One end of the sling assembly connects to a short length of USP size 1 monofilament polypropylene suture and to a polypropylene static (non-tensioning) anchor. The second side of the sling assembly terminates to a longer section of USP size 1 monofilament polypropylene suture. This suture is then positioned through the second anchor that is dynamic with an integrated tensioning system. The tensioning capability is accomplished by threading the suture through a polyurethane tensioning collar which is assembled onto the anchor. The anchor/suture assembly wraps around the anchor, resulting in a gap between the anchor and the collar providing constant pressure on the suture, preventing it from moving on its own, or during a pelvic stress event. Tensioning is achieved by pulling on the suture loop, thus applying increased tension of the sling to the urethra until desired support is achieved. The Altis anchors perform an acute mechaning the desired position and tension through the acute post-operative tissue healing and in-growth phase, The Altis sling assembly is packaged with two (2) helical type introducers (one right, one left) that are used to place the sub-urethral sling. The Altis introducers are designed with the appropriate curvature and length to reach
1
the obturator foramen through a single vaginal incision. The tip of the needle is designed to fit into the anchors to facilitate placement into the obturator foramen during the surgical implant procedure. The sling assembly pouch and introducers are placed in a tray sealed with a Tyvek lid. The Altis system (implant plus introducers) is provided sterile (ethylene oxide) and is for single use only.
Page 2 of 3
Intended Use Of The Device:
The Altis Single Incision Sling System is indicated for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
Technological Characteristics Compared To Predicate Device:
The Altis System is substantially equivalent in design, materials, performance characteristics, and indications to the predicates; Coloplast (formerly Mentor) Aris Mesh, cleared under premarket notification K050148 on 9 March 2005, American Medical System's MiniArc System, cleared under premarket notification K073703 on 30 January 2008 and C.R. Bard Ajust Adjustable Single Incision Sling, cleared under premarket notification K092607 on November 20, 2009.
The Altis, Aris, Ajust, and MiniArc Systems have the same intended use, mesh material (i.e., knitted polypropylene monofilament), introducer instrument for implantation provided with implant, sterilization method (i.e., ethylene oxide), and transobturator surgical approach. The Altis and Aris Systems use identical and introducer materials. The Altis, Ajust, and MiniArc Systems utilize polypropylene anchors and a single incision technique. The Altis and Ajust Systems have the following similarities: Altis and Ajust may be tensioned intraoperatively via a tensioning system connected to a tissue anchor; Altis and Ajust utilize helical type introducers which control positioning and placement of tissue anchors in the obturator space while avoiding the vascular and nerve bundles.
While the predicate Aris sling utilizes multiple incisions, the Altis, Ajust, and MiniArc systems use a single-incision surgical technique. The Altis and Ajust introducer radii are smaller than the Aris introducer radius, consistent with the difference in surgical approach. In terms of tensioning, the predicates have the following differences:
- Aris is a full length sling that is placed using a relatively tension-free method I
- . MiniArc is tensioned by pushing the anchors deeper into tissue; no further increase in tensioning is possible after introducers needles are removed and tension on the sling cannot be loosened if anchors are placed too deeply
- . Ajust utilizes a tubular piece of mesh (attached to the sling) moving through its anchor to position the mesh beneath the urethra. When the physician has positioned the Ajust sling, a plug pre-positioned in the mesh tube is advanced using a stylet that is inserted to push the plug up the tube to limit the anchor mobilization.
- . Altis utilizes suture attached to the sling that moves through the anchor in order to position the mesh beneath the urethra. When the physician has positioned the Altis sling, the tensioning system relies on compression force applied by the anchor/suture assembly to allow for precise positioning
Summary from the Nonclinical Tests Submitted:
Design verification (bench) testing was conduct on the Altis mesh and introducers and included the all recommended evaluations detailed in FDA's Guidance for Preparation of a Premarket Notification for a Surgical Mesh, including mesh thickness, mesh weave characteristics, pore size, mesh density, tensile strength, device stiffness, suture pullout strength, burst strength, tear resistance, device thickness, pore size, and burst strength. In addition, introducers were tested for pull out forces of needle from handle, torsion resistance of needle from handle, and handle diameter.
All testing results demonstrated acceptable results based on the established specifications.
Biocompatibility testing per ISO 10993 and per FDA 's Guidance for Preparation of a Premarket Notification Application for a Surgical Mesh was conducted on the Altis mesh and introducers, including cytotoxicity. sensitization, irritation, systemic toxicity (acute), genotoxicity, implantation (with histology of the surrounding tissue, hemolysis, pyrogenicity, heavy metals residuals, pyrogen levels
2
Page 3 of 3
All biocompatibility testing results demonstrated acceptable results based on the established specifications.
Simulated use evaluations were conducted in animals and human cadaveric laboratory testing per FDA Design Control requirements. All testing results demonstrated acceptable results based on the established specifications.
Summary from the Clinical Tests Submitted:
The clinical study of the Altis Sling System was a prospective, single arm, non-randomized, multi-center trial conducted at 17 sites in the US and Canada. The objective of the study was to assess safety and efficacy of the Altis single incision sling system for females with SUI. A total of 113 women were implanted with the Altis Sling. The median age for the women enrolled in the study was 54.5 years (range = 25.3 - 89.3). The median body mass index (BMI) was 29.9 (range = 20.0-55.8).
The study's primary effectiveness objective was improvement in subject continence status measured by reduction in 24-hour pad weight. At 6 months, 88 of 103 evaluable subjects showed >50% reduction in pad weight compared to baseline.
Secondary effectiveness endpoints included cough stress test (CST) at 6 months, assessment of subject Quality of Life (QOL) through validated questionnaires at 6 months, and voiding diaries were evaluated using performance goals. All results were statistically significant.
Endpoint | Success | Lower 95.81% CL | p-value | ||
---|---|---|---|---|---|
Cough Stress Test1 | 92.2% (95/103) | 86.1% |