(232 days)
No reference devices were used in this submission.
No
The document describes a physical medical device (a sling system) and its intended use, without mentioning any software, algorithms, or data processing that would suggest the presence of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is used for the treatment of a medical condition (stress urinary incontinence), which is a therapeutic purpose.
No
This device is an implantable surgical sling used for the treatment of stress urinary incontinence, not for diagnosing a condition. Its purpose is therapeutic.
No
The device description explicitly states it includes an "implantable, non-absorbable, single incision mid-urethral sling and disposable introducer needles," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of female stress urinary incontinence (SUI) by surgically implanting a sling. This is a therapeutic intervention performed on the patient's body.
- Device Description: The device is an implantable surgical sling and introducer needles. These are physical devices used in a surgical procedure.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any testing of samples or diagnostic purposes.
Therefore, the Altis Single Incision Sling System is a surgical device, 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 1 |
| 3050 Humlebaek, Denmark | |
| Phone/Fax/Email: | Office: (763) 607-6657 |
| Email: uslpo@coloplast.com | |
| Name of Contact Person: | Lauren Portinga, |
| Principal Regulatory Affairs Specialist | |
| Address/Contact: | 1601 West River Road North |
| Minneapolis, 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 Mesh |
| Mesh, Surgical | |
| 21 CFR 878.3300 | |
| PAH | |
| II | |
| Gastroenterology/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.