(232 days)
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).
The Coloplast Altis Single Incision Sling (SIS) System includes an implantable, non-absorbable, single incision mid-urethral sling and disposable introducer needles for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The Altis sling is knitted to 1.1 cm width using a 0.08mm (nominal) diameter polypropylene filament and is 7.75 cm long. The Altis sling and Altis introducers are provided sterile (ethylene oxide sterilization) and are for single-use only.
The provided text is related to a 510(k) premarket notification for the "Altis® Single Incision Sling." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data for a new or modified device. As such, the document explicitly states:
"Performance data was not necessary for the substantial equivalence determination as the subject device and the predicate device have identical intended use, target population, sterilization technique, biocompatibility features, overall device design features, and duration of use."
Therefore, I cannot extract the information required to answer your questions about acceptance criteria and the study that proves the device meets them from this document. The document primarily discusses regulatory aspects of the device, specifically its substantial equivalence to a previously cleared predicate device due to identical technical characteristics and intended use. The only change mentioned is revised labeling to include information from a completed 522 study, but details of that study are not provided here.
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February 15, 2023
Coloplast A/S Lauren Portinga Principal Regulatory Affairs Specialist 1601 West River Road North Minneapolis, MN 55411
Re: K221874
Trade/Device Name: Altis® Single Incision Sling Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: PAH Dated: January 16, 2023 Received: January 17, 2023
Dear Lauren Portinga:
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 -S
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
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Indications for Use
510(k) Number (if known) K221874
Device Name Altis® Single Incision Sling
Indications for Use (Describe)
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).
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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510(k) SUMMARY
I. SUBMITTER
| 510(K) Owner's Name: | Coloplast A/S |
|---|---|
| Address: | Holtedam 13050 Humlebaek, Denmark |
| Phone/Fax/Email: | Office: (763) 607-6657Email: uslpo@coloplast.com |
| Name of Contact Person: | Lauren Portinga,Principal Regulatory Affairs Specialist |
| Address/Contact: | 1601 West River Road NorthMinneapolis, MN 55411 |
| Date Prepared: | February 10, 2023 |
| II.DEVICE | |
| Trade or Proprietary Name: | Altis® Single Incision Sling |
| Common or Usual Name:Classification Name:Classification Number:Product Code:Regulatory Class:Review Panel: | Surgical MeshMesh, Surgical21 CFR 878.3300PAHIIGastroenterology/Urology |
III. PREDICATE DEVICE
| 510(k) Number: | K121562 |
|---|---|
| Trade Name: | Altis Single Incision Sling System |
The predicate has not been subjected to a design-related recall. No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The Coloplast Altis Single Incision Sling (SIS) System includes an implantable, non-absorbable, single incision mid-urethral sling and disposable introducer needles for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The Altis sling is knitted to 1.1 cm width using a 0.08mm (nominal) diameter polypropylene filament and is 7.75 cm long. The Altis sling and Altis introducers are provided sterile (ethylene oxide sterilization) and are for single-use only.
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V. 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).
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject device and the predicate device (K121562) have identical intended use, target population, sterilization technique, biocompatibility features, overall device design features, and duration of use. In this Special 510(k), Coloplast A/S only provided revised labeling, and there are no changes to the device itself. The labeling revisions only include added information about a completed 522 study in the instructions for use manual. This difference in device labeling does not raise different questions of safety or effectiveness, and the subject was found to be substantially equivalent with the predicate.
VII. PERFORMANCE DATA
Performance data was not necessary for the substantial equivalence determination as the subject device and the predicate device have identical intended use, target population, sterilization technique, biocompatibility features, overall device design features, and duration of use.
VIII. LABELING
In this Special 510(k), Coloplast A/S revised their instructions for use manual to include a summary of the safety and effectiveness information collected from their completed 522 study.
IX. CONCLUSION
Based on the information presented in this submission, it can be concluded that the subject device is substantially equivalent to the predicate.
§ 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.