(164 days)
No
The summary describes a surgical mesh system and instrumentation, with no mention of AI or ML capabilities.
Yes
The device is indicated for "tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor" in vaginal wall prolapse where surgical treatment is intended, which describes a therapeutic purpose.
No
The device is a surgical mesh system used for the repair of pelvic organ prolapse. It is intended for tissue reinforcement and stabilization, not for diagnosing a condition.
No
The device description clearly states it is made of mesh and includes instrumentation like an introducer and retrievers, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended." This describes a surgical implant used in vivo (within the body) to repair a physical condition.
- Device Description: The device is a surgical mesh system with instruments for implantation. This is consistent with a surgical device, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Coloplast Exair Anterior and Posterior Prolapse Repair Systems are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
Product codes
OTP
Device Description
The Exair Anterior Prolapse Repair System is made of NovaSilk mesh precut into a shape with an enlarged body and four appendages extending out from the main body. The Exair Posterior Prolapse Repair System is made of NovaSilk mesh precut into a shape with an elongated body and two appendages extending out from the main body. The mesh arms for both Exair Anterior and Exair Posterior Prolapse Repair Systems are sleeved in 2-mil thick polyethylene to facilitate device arm implantation and positioning; sleeves are removed after proper placement of implant is achieved. The System instrumentation includes a hollow introducer used to create a passage through the tissues and facilitate placement of the mesh arms, and four (4) anterior or two (2) posterior retrievers used to guide the mesh arms into place through the (1) and for positioning and fixating the mesh body. The System is provided sterile and for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor
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)
Substantial equivalence is supported by bench testing comparing Exair to the predicate devices and biocompatibility testing performed on the Exair device and instrumentation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.
(a)
Identification. Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.
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MAY - 8 2009
ર્. 510(K) SUMMARY
510(K) Owner's Name:
Address:
Coloplast A/S
Holtedam l 3050 Humlebaek, Denmark Establishment Registration: 9610694 Owner/Operator: 8010144
Phone/Fax/Email:
Date Prepared:
(612) 287-4211 Office: (୧୯୮) 387-1698 Mobile: (612) 287-4138 Fax: usjco@coloplast.com
Name Of Contact Person:
Regulatory Affairs Manager
November 24, 2008
Janell A. Colley
Trade Or Proprietary Name:
Exair Anterior and Exair Posterior Prolapse Repair Systems
Surgical mesh Common Or Usual Name:
Classification Name: CFR section 878.3300)
Surgical Mesh, polymeric
Legally Marketed Device To Which Your Firm Is Claiming Equivalence:
The Coloplast Exair Anterior and Exair Posterior Prolapse Repair Systems are substantially equivalent in performance, indications, design and materials to Coloplast's (formerly Mentor) NovaSilk Mesh, cleared under premarket notification number K053414 on 27 December 2005, and Ethicon Inc. Gynecare Prolift Total Pelvic Floor Repair System, cleared under Premarket notification number K071512 on 15 May 2008.
Device Description:
The Exair Anterior Prolapse Repair System is made of NovaSilk mesh precut into a shape with an enlarged body and four appendages extending out from the main body. The Exair Posterior Prolapse Repair System is made of NovaSilk mesh precut into a shape with an elongated body and two appendages extending out from the main body. The mesh arms for both Exair Anterior and Exair Posterior Prolapse Repair Systems are sleeved in 2-mil thick polyethylene to facilitate device arm implantation and positioning; sleeves are removed after proper
Exair Anterior & Posterior Prolapse Repair System
CONFIDENTIAL
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placement of implant is achieved. The System instrumentation includes a hollow introducer used to create a passage through the tissues and facilitate placement of the mesh arms, and four (4) anterior or two (2) posterior retrievers used to guide the mesh arms into place through the (1) and for positioning and fixating the mesh body. The System is provided sterile and for single use only.
Intended Use Of The Device:
The Coloplast Exair Anterior and Posterior Prolapse Repair Systems are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
Technological Characteristics Compared To Predicate Device:
The Coloplast Exair Anterior and Posterior Prolapse Repair Systems are substantially equivalent in design, materials, performance characteristics, and indications to the predicates Coloplast (formerly Mentor) NovaSilk Mesh, cleared under premarket notification number K053414 on 27 December 2005, and Gynecare Prolift Total Pelvic Floor Repair System, cleared under Premarket notification number K071512 on 15 May 2008.
Summary and Conclusions from the Nonclinical Tests Submitted:
Substantial equivalence is supported by bench testing comparing Exair to the predicate devices and biocompatibility testing performed on the Exair device and instrumentation.
CONFIDENTIAL
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three wing strokes, symbolizing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Coloplast A/S % Ms. Janell A. Colley Regulatory Affairs Manager 1499 West River Road North MINNEAPOLIS MN 55411
SEP-28 2012
Re: K083499 Trade/Device Name: Exair Anterior & Posterior Prolapse Repair Systems Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: May 1, 2009 Received: May 4, 2009
Dear Ms. Colley:
This letter corrects our substantially equivalent letter of May 8, 2009.
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 (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
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. You must
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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Benjamin R. Perkins
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the Coloplast logo. The logo consists of a circle on the left and the word "Coloplast" on the right. The circle is divided into two halves, with the top half containing horizontal lines and the bottom half containing a textured pattern. The word "Coloplast" is written in a bold, sans-serif font.
1601 Wast River Road North Minneapolis, MN 55411
(612) 588-4685
Statement of Indications for Use
510(k) Number:
Device Nanie:
Exair Anterior & Posterior Prolapse Repair Systems
Indications for Use:
The Coloplast Exair Anterior and Posterior prolapse repair systems are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
Prescription Use
Over The Counter Use
(Part 2) CIR 201 Subpart D)
AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEBDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krause for NXm
(Division Sign-Off) Division of Surgici. I. Orthopedic, and Restorative Devices
510(k) Number K083499
Exair Prolapse Repair System K083499 / A1
- CONFIDENTIAL -