(90 days)
ProLite Mesh and ProLite Ultra Mesh are intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds, and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.
ProLoop Mesh Plug is intended for use in soft tissue deficiencies including hernia repair and traumatic or surgical wounds requiring reinforcement with a non-absorbable supportive material.
ProLite™ and ProLite Ultra™ Mesh are sterile, non-absorbable, knitted polypropylene monofilament mesh material. The ProLoop™ Mesh Plug is a non-absorbable, lightweight, pre-formed, three-dimensional plug constructed of knitted rows of monofilament polypropylene with multiple protruding monofilament loops. The devices are available in various configurations with sizes up to 12" X 18". The devices are terminally sterilized using Ethylene Oxide and intended as a single use device.
I am sorry, but based on the provided document, I cannot adequately answer your request. The document is a 510(k) summary for surgical mesh devices (ProLite Mesh, ProLite Ultra Mesh, and ProLoop Mesh Plug) and focuses on establishing substantial equivalence to previously cleared predicate devices.
Here's why I cannot provide the requested information:
- No Acceptance Criteria or Performance Study: The document explicitly states, "This submission does not contain technological changes for subject devices. ProLite, ProLite Ultra and ProLoop have the same technological characteristics as previously cleared ProLite Family devices (K930669 and K002093). The subject devices differ only from the predicate devices in the indications for use and contraindications in the labeling." This means no new performance studies were conducted or acceptance criteria defined for these specific devices in this submission because their core technology and performance are considered identical to their predicate devices. The submission focused on labeling changes.
- No Clinical Study Data: Consequently, there is no information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or training sets.
- Data provenance (country of origin, retrospective/prospective).
- Number or qualifications of experts.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used or how it was established.
This 510(k) is essentially seeking approval for updated labeling for existing devices, leveraging the prior approvals of the predicate devices. Therefore, the detailed study information you're asking for would likely be found in the original 510(k) submissions for the predicate devices (K930669 and K002093), not in this document.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 27, 2015
Atrium Medical Corporation Mr. Timothy J. Talcott Senior Director of Regulatory Affairs 5 Wentworth Drive Hudson, New Hampshire 03051
Re: K151437
Trade/Device Name: ProLite™ Mesh, ProLite Ultra™ Mesh, and ProLoop™ Mesh Plug Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: May 28, 2015 Received: May 29, 2015
Dear Mr. Talcott:
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. 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. 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 (reporting of medical
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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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use Statement 2
| 510(k) Number (if known): | K151437 |
|---|---|
| Device Name: | ProLite™ Mesh, ProLite Ultra™ Mesh, and ProLoop™ Mesh Plug |
| Indications for Use: | ProLite Mesh and ProLite Ultra Mesh are intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds, and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.ProLoop Mesh Plug is intended for use in soft tissue deficiencies including hernia repair and traumatic or surgical wounds requiring reinforcement with a non-absorbable supportive material. |
Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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1 510(K) Summary
May 28, 2105 Submission Date:
1.1 Submitter Information:
| Submitted by: | Atrium Medical Corporation5 Wentworth DriveHudson, NH 03051 |
|---|---|
| Contact Person: | Timothy J. TalcottSenior Director of Regulatory AffairsPhone: (443) 283-2768Email: timothy.talcott@maquet.comPhone: (603) 880-1433 x 5342Fax: (603) 821-1420 |
1.2 Device Information
| Trade/ProprietaryName | ProLite and ProLite Ultra Mesh, and ProLoop Mesh Plug |
|---|---|
| Common/Usual Name: | Mesh, Surgical, Polymeric |
| Regulation Name: | Surgical Mesh |
| Device Class: | 21 CFR 878.3300, Class II |
| Product Code: | FTL |
| Reviewing Panel: | General & Plastic Surgery |
| Predicate Devices: | K930669 Atrium ProLiteTM MeshK002093 Atrium ProLite UltraTM MeshK930669 Atrium ProLoopTM Mesh Plug |
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| Device Description: | ProLite™ and ProLite Ultra™ Mesh are sterile, non-absorbable, knitted polypropylene monofilament mesh material. The ProLoop™ Mesh Plug is a non-absorbable, lightweight, pre-formed, three-dimensional plug constructed of knitted rows of monofilament polypropylene with multiple protruding monofilament loops. The devices are available in various configurations with sizes up to 12" X 18". The devices are terminally sterilized using Ethylene Oxide and intended as a single use device. |
|---|---|
| --------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
ProLite Mesh and ProLite Ultra Mesh are intended for use in Indications for Use: soft tissue deficiencies including hernia repair, traumatic or surgical wounds, and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.
ProLoop Mesh Plug is intended for use in soft tissue deficiencies including hernia repair and traumatic or surgical wounds requiring reinforcement with a non-absorbable supportive material.
This submission does not contain technological changes for Technological subject devices. ProLite, ProLite Ultra and ProLoop have the Characteristics same technological characteristics as previously cleared ProLite Family devices (K930669 and K002093). The subject devices differ only from the predicate devices in the indications for use and contraindications in the labeling.
There are no new types of questions of safety and effectiveness raised by these differences, thereby supporting substantial equivalence to predicates.
The mesh materials used to construct the Atrium ProLite, Performance ProLite Ultra and ProLoop Mesh have not been modified and Characteristics remain the same as those described in predicate polypropylene mesh devices.
This notification contains all information required by 21 CFR Conclusion: 807.87. Atrium believes the labeling changes allow the devices to be remain substantially equivalent to each other and do not raise any new types of safety or effectiveness questions.
Q.e.d.
§ 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.