(19 days)
Not Found
No
The device description and performance studies indicate a manual laparoscopic surgical instrument for mesh delivery, with no mention of AI/ML terms or data processing capabilities.
No.
The device facilitates the delivery of a prosthetic during a surgical procedure, but it does not directly treat or diagnose a condition itself. The therapeutic action comes from the implanted mesh.
No
The device is described as a surgical instrument used to facilitate the delivery and placement of mesh during hernia repair. It assists the surgeon in a procedural task, rather than providing information about the patient's condition or diagnosis.
No
The device description explicitly states it is a "tray like device" and a "manual laparoscopic surgical instrument," indicating it is a physical hardware device used to manipulate mesh.
Based on the provided information, the PatchAssist™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- PatchAssist™ Function: The PatchAssist™ device is a surgical instrument used during a laparoscopic procedure to facilitate the delivery and placement of a soft tissue prosthetic (mesh) within the body. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for "facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects." This is a surgical function, not a diagnostic one.
- Device Description: The description details its use as a manual laparoscopic surgical instrument for handling and positioning mesh within the abdominal cavity.
Therefore, the PatchAssist™ device falls under the category of a surgical instrument or device used in a surgical procedure, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PatchAssist™ device 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
ORQ
Device Description
The PatchAssist™ device is used to facilitate the delivery of mesh during the laparoscopic hernia repair. The PatchAssist™ device is a hand-held "tray like" device that holds the mesh under laparoscopic view and helps the surgeon to maneuver the mesh to its proper place.
The PatchAssist™ device are manual laparoscopic surgical instrument. The surgeon connects a standard hernia mesh (not part of the device) to the device using a dedicated stapling apparatus and furls the mesh on the device deployment section (as it is outside of the abdominal cavity). Once the mesh is attached to the device it can be inserted into the abdominal cavity through a standard laparoscopic port (trocar). Once inside the abdominal cavity, the device enables the surgeon to rapidly maneuver the mesh into position over the hermiamesh, over the desired surgical location. The mesh is connected to the tissue using the same technique as currently performed by the surgeon (e.g., permanent tacks). Upon its fixation to the tissue, the surgeon releases the mesh from the device and withdraws the device from the abdominal cavity leaving the fixated mesh in its desired location. The PatchAssist™ Large is another model of the PatchAssist™ that has a slightly larger deployment frame to facilitate the insertion of large size meshes.
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)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, laparoscopic surgical instrument
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
A series of performance testing were performed to demonstrate that the PatchAssist™ Large does not raise any new questions of safety and efficacy. These tests includes:
- Mesh Rolling and Insertion using the PatchAssist™ Large Device
- Articulation and Maneuverability Test
- PatchAssist™ Large Performance Evaluation
Key Metrics
Not Found
Predicate Device(s)
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.
0
K103269
Page 1/3
510(K) SUMMARY PolyTouch Medical Ltd. PatchAssist™
NOV 2 3 2010
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PolyTouch Medical 7.1.1 Applicant's Name: Misgav Venture Accelerator M.P. Misgav 20174, Israel Tel: 972-72-260-7066 Fax: 972-72-260-7266
U.S. Regulatory Contact 7.1.2 Contact Person: Leo Basta NorthStar Biomedical Associates for PolyTouch Medical Ltd. 755 Westminster Street Unit 120 Providence, RI 02903 617.834.9866 (phone) 401.454.1733 (fax) -
November 1, 2010 7.1.3 Date Prepared:
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PatchAssist™ Large 7.1.4 Trade Name:
-
Surgical mesh deployer 7.1.5 Classification Name:
-
Class II; Product Code ORQ ; 7.1.6 Classification: Regulation No. 878.3300 Panel: General and Plastic Surgery Devices
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PolyTouch Medical Ltd. PatchAssist™ device 7.1.7 Predicate Devices: cleared under K101218.
7.1.8 Device Description:
PolyTouch PatchAssist Large 510(k) Rev. A Confidential
Confidential
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The PatchAssist™ device is used to facilitate the delivery of mesh during the The PatchAssist™ device 15 used to heatray like device that holds the mesh under laparoscopic nerma repant. Boomect the mesh to its proper place.
The PatchAssist™ device are manual laparoscopic surgical instrument. The surgeon The PatchAssist™ device are natual "lapid of the Patch Assist™ device) to the device using
connects a standard hernia mesh (not part of the davice device device device use i a dedicated stapling apparatus furls the mesh on the device deployment section (as it is a dedicated stapiling apparatus furis the mean of the abdominal cavity through a standard laparoscopic port (trocar). Once inside the abdominal cavity, the device enables the surgeon to rapidly maneuver the mesh into position over the herminesh, over the desired surgeon to rapidly maneuver the mesh is attached and placing the mesh is connected to location so that it may then be attached to the surgical location. The mesh is comected to the tissue using the same technique as currently performed by the surgeon (e.g., hermin the tissue using the same technique as occare, the surgeon releases the mesh from the fiveted tacks). " Upon thesif itsation to the tice trom the abdominal cavity leaving the fixated mesh in its desired location. The PatchAssist™ Large is another model of the PatchAssist™ that has a slightly larger deployment frame to facilitate the insertion of large size meshes.
7.1.9 Intended Use:
The PatchAssist™ device is intended to be used to facilitate the delivery of soft tissue The Tatelies during the laparoscopic repair of soft tissue defects (e.g. hernia repair).
7.1.10 Performance Standards:
No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act.
7.1.12 Performance Data & Substantial Equivalence
The PatchAssist™ Large is substantially equivalent in all aspects, e.g., technological The Tacteristics, mode of operation, performance characteristics, intended use, etc., to the characteristics, inode of operation, portormation ssist™ device cleared under K101218.
The change between the devices is in the size of the deployment frame. The slightly I he change between the devices vs aity of mesh sizes including large size meshes from 15x15cm up to 38x28cm.
A series of performance testing were performed to demonstrate that the PatchAssist™ Large does not raise any new questions of safety and efficacy. These tests includes:
PolyTouch PatchAssist Large 510(k) Rev. A Confidential
Confidential
2
K103269 page 3/3
- Mesh Rolling and Insertion using the PatchAssist™ Large Device .
- Articulation and Maneuverability Test .
- PatchAssist™ Large Performance Evaluation 보
Based on the risk analysis performed and these tests results, PolyTouch Medical Ltd. Based on the PatchAssist™ Large is substantially equivalent to the cleared believes that the PatchAssist - Earge - Is -Salety and/or effectiveness issues.
PatchAssist™ device and does not raise any new safety and/or effectiveness issues.
PolyTouch PatchAssist Large 510(k) Rev. A Confidential
Confidential
3
Image /page/3/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 abstract symbol resembling a stylized caduceus or a bird-like figure, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
PolyTouch Medical % NorthStar Biomedical Associates Mr. Leo Basta 755 Westminster Street, Unit 120 Providence, Rhode Island 02903
Re: K103269
NOV 2 3 2010
Trade/Device Name: PatchAssist™ Large Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: ORQ Dated: November 1, 2010 Received: November 4, 2010
Dear Mr. Basta:
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
4
Page 2 - Mr. Leo Basta
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 Pan 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A. Mellemson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
K 103269
510(k) Number (if known): Not known at this time
NOV 2 3 2010
Device Name:
PatchAssist™ Large
Indications for Use: The PatchAssist™ device is intended to be used to facilitate the THE Factions is a soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.g. hernia repair).
Prescription Use V (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 C.F.R. 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 Kane
Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103269
PolyTouch PatchAssist Large 510(k) Rev. A Confidential
Confidential