(15 days)
No
The summary describes a mechanical laparoscopic surgical instrument for mesh delivery and placement, with no mention of AI, ML, image processing, or data-driven functionalities.
No.
The device description indicates it is a surgical instrument used to facilitate the delivery of soft tissue prosthetics, not to directly treat or cure a disease or condition.
No
The device is described as a surgical instrument intended to facilitate the delivery and placement of soft tissue prosthetics (like hernia mesh), not to diagnose a condition. Its function is to assist in a surgical procedure, not to identify a disease or condition.
No
The device description explicitly states it is a laparoscopic surgical instrument comprised of physical components (operation handle, deployment section, tube, furling sleeve). This indicates it is a hardware device, not software-only.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The AccuMesh Positioning System is a surgical instrument used during a laparoscopic procedure to physically manipulate and position a soft tissue prosthetic (mesh). It does not analyze any biological samples or provide diagnostic information.
- Intended Use: The intended use clearly states it is for "facilitate the delivery of soft tissue prosthetics during laparoscopic repair of soft tissue defects." This is a surgical function, not a diagnostic one.
The device is a surgical tool used in a surgical procedure, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The AccuMesh Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during laparoscopic repair of soft tissue defects (e.g. hernia repair).
Product codes
ORQ
Device Description
The AccuMesh Positioning System is laparoscopic surgical instrument intended to facilitate hernia mesh delivery and placement in laparoscopic ventral hernia repair. It is comprised of two main sections: operation handle and deployment section which are connected via a tube. Included in the packaging configuration is a furling sleeve intended to assist the surgeons to furl the mesh tightly and rapidly over the AccuMesh positioning system.
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
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)
Performance testing was performed on the colorant and consisted of opening, closing and articulating with visual inspection following aging at all hinge joints, all testing passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Accumesh Positioning System (510k cleared as the PatchAssist device - K101218, Accumesh Positioning System PatchAssist Large (510k cleared as the PatchAssist device - K103269, AccuMesh Position System- K121139
Reference Device(s)
Not Found
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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AccuMesh Positioning System
Covidien
OCT 1 6 2012
4.0 510(K) SUMMARY
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.98.
Submitter Information
Name:
Address:
Covidien 15 Crosby Drive Bedford, MA 01730
Establishment Registration:
Name of contact person:
Date prepared:
Trade or proprietary name:
Common or usual name: Classification name: Classification panel:
Regulation:
Product Code:
Legally marketed devices to which equivalence is claimed:
ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
9615742
Elizabeth McMeniman Senior Regulatory Affairs Product Specialist Covidien 15 Crosby drive Bedford, MA 01730 USA Phone: (781) 839 1785
September 28, 2012
AccuMesh™ Positioning System
Mesh Deployer Mesh, Surgical, Deployer General and Plastic Surgery (79)
21 CFR 878.3300
ORQ
- Accumesh Positioning System (510k cleared as the ಂ PatchAssist device - K101218
- Accumesh Positioning System PatchAssist Large (510k 0 cleared as the PatchAssist device - K103269
- AccuMesh Position System- K121139 O
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AccuMesh·Positioning System
Reason for 510(k) submission:
:
To obtain market clearance on the Accumesh Positioning System with a component color change from natural to blue.
Device description:
Covidien
The a AccuMesh Positioning System is laparoscopic surgical instrument intended to facilitate hernia mesh delivery and placement in laparoscopic ventral hernia repair. It is comprised of two main sections: operation handle and deployment section which are connected via a tube. Included in the packaging configuration is a furling sleeve intended to assist the surgeons to furl the mesh tightly and rapidly over the AccuMesh positioning system.
Intended use of the device:
Intended to facilitate the delivery of soft tissue prosthetics during laparoscopic repair of soft tissue defects (e.g. hernia repair).
Indications for use:
Indicated to facilitate the delivery of soft tissue prosthetics during laparoscopic repair of soft tissue defects (e.g. hernia repair).
Summary comparing the technological characteristics of the subject and predicate devices:
The proposed colorant change is on the deployment section frame. The frame design has not changed and is previously cleared in the AccuMesh (PatchAssist) device (K101218, K103269, and K121139) 510k's. Accumesh is intended to be used to facilitate the delivery of soft tissue prosthetics during laparoscopic repair of soft tissue defects (e.g. hernia repair). There are no changes to the technological characteristics as a result of the proposed colorant change.
Performance data:
Performance testing was performed on the colorant and consisted of opening, closing and articulating with visual inspection following aging at all hinge joints, all testing passed.
There were no changes to the technological characteristics of the frame, sterilization method, shelf life of the product, or design control
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2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 16 2012
Covidien, LLC % Ms. Elizabeth McMeniman Senior Regulatory Affairs Specialist 15 Crosby Drive Bedford, Massachusetts 01730
Re: K123066
Trade/Device Name: AccuMesh" Positioning System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: ORQ Dated: September 28, 2012 Received: October 1, 2012
Dear Ms. McMeniman:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Elizabeth McMeniman
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" (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 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,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K123066
Device Name: AccuMesh™ Positioning System
Indications For Use:
The AccuMesh Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during laparoscopic repair of soft tissue defects (e.g. hernia repair).
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Kromefur MM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K123066