(16 days)
Not Found
No
The device description and performance studies focus on the mechanical aspects of the device and its compatibility with existing mesh products and laparoscopic equipment. There is no mention of AI, ML, image processing, or data-driven decision making.
No.
The device is intended to facilitate the delivery and placement of soft tissue prosthetics (hernia mesh) during laparoscopic repair, not to treat or diagnose a disease itself.
No
Explanation: The AccuMesh Positioning System is described as a "manual laparoscopic device intended to facilitate hernia mesh delivery and placement." Its intended use is to deliver soft tissue prosthetics, not to diagnose medical conditions or provide diagnostic information.
No
The device description explicitly states it is a "manual laparoscopic device" with physical components like an "operation handle," "deployment section," and "furling sleeve." This indicates it is a hardware device, not software-only.
Based on the provided information, the AccuMesh Positioning System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to "facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.g. hernia repair)." This describes a surgical tool used in vivo (within the body) during a procedure.
- Device Description: The description details a "manual laparoscopic device" for "hernia mesh delivery and placement." This further reinforces its use as a surgical instrument.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The AccuMesh Positioning System does not perform any such analysis of biological samples.
- Anatomical Site: The device is used on "Soft tissue defects (e.g. hernia repair)," which is an anatomical site within the body.
Therefore, the AccuMesh Positioning System is a surgical device, not an In Vitro Diagnostic device.
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 the laparoscopic repair of soft tissue defects (e.g. hernia repair).
Product codes (comma separated list FDA assigned to the subject device)
ORQ
Device Description
The AccuMesh Positioning System is a manual laparoscopic device. Intended to facilitate hernia mesh delivery and placement in laparoscopic ventral hernia repair. The AccuMesh Positioning System comprises 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 fur! 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
soft tissue defects (e.g. hernia repair)
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 conducted using sterilized samples of the proposed design of the AccuMesh Positioning System with the furling sleeve. The furling sleeve interface and compatibility with laparoscopic ports and components of the AccuMesh Positioning System were evaluated with various commercially available mesh products.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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Covidien
AccuiMesh Positioning System
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: 9615742
Name of contact person:
James McMahon Senior Manager, Regulatory Affairs Covidien 15 Crosby drive Bedford, MA 01730 USA Phone: (781) 839 1787
April 12, 2012 Date prepared:
AccuMesh™ Positioning System Trade or proprietary name:
Mesh Deployer Common or usual name: Mesh, Surgical, Deployer Classification name: General and Plastic Surgery (79) Classification panel:
21 CFR 878.3300 Requiation:
ORQ Product Code:
Legally marketed devices to which equivalence is claimed:
Accumesh Positioning System (510k cleared as the PatchAssist device - K101218 Accumesh Positioning System PatchAssist Large (510k cleared as the PatchAssist device - K103269
Reason for 510(k) submission:
To obtain market clearance on the Accumesh Positioning System with furling sleeve.
Device description:
The AccuMesh Positioning System is a manual laparoscopic The nobalities. Intended to facilitate hernia mesh delivery and placement in laparoscopic ventral hernia repair. The
CONFIDENTIAL
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K12.1139
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Covidien
AccuMesh Positioning System
AccuMesh Positioning System comprises 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 fur! the mesh tightly and rapidly over the AccuMesh positioning system.
Intended use of the device: Intended to be used 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 addition of the AccuMesh Furling Sleeve maintains the same fundamental design as the previously cleared AccuMesh (PatchAssist) device (K101218 and K103269). Both designs are intended to be used to facilitate the delivery of soft tissue prosthetics during laparoscopic repair of soft tissue defects (e.g. hernia repair).
Performance data:
Performance testing was conducted using sterilized samples of the proposed design of the AccuMesh Positioning System with the furling sleeve. The furling sleeve interface and compatibility with laparoscopic ports and components of the AccuMesh Positioning System were evaluated with various commercially available mesh products.
CONFIDENTIAL
9
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Covidien % Mr. James McMahon Senior Manager, Regulatory Affairs 15 Crosby Drive Bedford, Massachusetts 01730
Re: K121139
Trade/Device Name: AccuMesh™ Positioning System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: ORQ Dated: April 13, 2012 Received: April 16, 2012
Dear Mr. McMahon:
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
MAY - 2 2012
3
Page 2 - Mr. James McMahon
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/CDRH0ffices/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/ReportalProblem/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,
for Peter
Mark N. Molkerson
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): K 12.1139
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 the laparoscopic repair of soft tissue defects (e.g. hernia repair).
AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)
510(k) Number
Over-The-Counter Use (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)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
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