(48 days)
Not Found
Not Found
No
The summary does not mention any AI or ML terms, image processing, or data sets typically associated with AI/ML development and validation. The device description and performance studies focus on mechanical delivery and deployment of a prosthetic.
Yes
The device is intended to facilitate the delivery of soft tissue prosthetics during laparoscopic repair of soft tissue defects, which is a therapeutic intervention.
No
The device description states its purpose is to "facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects," which is an interventional or assistive function, not a diagnostic one. There is no mention of identifying, detecting, or monitoring any medical condition.
No
The device description explicitly states it is a "single use device that will be provided sterile," indicating it is a physical, hardware-based medical device, not software only.
Based on the provided information, the PatchAssist device is not an IVD (In Vitro Diagnostic).
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.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples, diagnostic purposes, or any of the typical components or functions of an IVD.
Therefore, the PatchAssist device is a surgical instrument, 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 (comma separated list FDA assigned to the subject device)
ORO
Device Description
The PatchAssist device is a single use device that will be provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal wall
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)
The PatchAssist device underwent a full battery of bench tests and animal studies to demonstrate its safe and effective performance in delivering, deploying and placing, the hernia mesh. In addition, usability testing was conducted. It was concluded that the device facilitates the attachment of the mesh to the abdominal wall and is easily withdrawn from the abdominal cavity.
The testing demonstrated that the PatchAssist device is a safe and effective device for facilitating the delivery of soft tissue prosthetics during the laparoscopic repair of hernia without raising any new safety or effectiveness issues.
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.
Not Found
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
K101218
JUN 1 7 201
Pre Market Notification Submission – 510(k)
510(K) SUMMARY PatchAssist Device 510(k) Number K
Company Name
PolyTouch Medical Ltd. Misgav Venture Accelerator M.P. Misgav 20174, Israel Tel: 972-72-260-7066 Fax: 972-72-260-7266
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
And/or
Orly Maor 25 A Sirkin Street Kfar-Saba 44421, Israel Tel: 972-7453607 Fax: 972-153-9-7453607
Trade/Proprietary Name
PatchAssist device
Classification Name
..............................................................................................................................................................................
Laparoscope, General & Plastic Surgery
1
The PatchAssist device is a single use device that will be provided sterile.
Performance Data
The PatchAssist device underwent a full battery of bench tests and animal studies to demonstrate its safe and effective performance in delivering, deploying and placing, the hernia mesh. In addition, usability testing was conducted. It was concluded that the device facilitates the attachment of the mesh to the abdominal wall and is easily withdrawn from the abdominal cavity.
The testing demonstrated that the PatchAssist device is a safe and effective device for facilitating the delivery of soft tissue prosthetics during the laparoscopic repair of hernia without raising any new safety or effectiveness issues.
Conclusion:
PolyTouch Ltd. believes that, based on the information provided in this submission, the PatchAssist device is substantially equivalent to its predicate devices.
024
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three arms or branches extending upwards.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
PolyTouch Medical Ltd. % NorthStar Biomedical Associates Mr. Leo Basta 755 Westminster Street, Unit 120
Providence, Rhode Island 02903
Re: K101218
Trade/Device Name: PatchAssist device Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: ORO Dated: April 29, 2010 Received: April 30, 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 reclacsified 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
!JUN 1 7 2010
3
Page 2 - Mr. Leo Basta
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/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 tollofreene (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 D Rummell mo msk
Mark N. Merkerson
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):
Device Name: PatchAssist device
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).
Prescription Use X (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)
Daniel Keane for MXM
Division Sign-Off) (Division Sign of Surgical, Orthopedic, and Restorative Devices
Page 1 of
510(k) Number K101218