(19 days)
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).
The PatchAssist™ device is used to facilitate the delivery of mesh during the laparoscopic hernia repair. It is a tray like device that holds the mesh under tension and enables the surgeon to connect 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, furls the mesh on the device deployment section (as it is a dedicated stapling apparatus), and inserts the device 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 hernia, over the desired surgical location. The mesh is attached and placing the mesh is connected to the tissue using the same technique as currently performed by the surgeon (e.g., suturing or using fixated tacks). Upon the mesh fixation to the tissue, the surgeon releases the mesh from the device and removes 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.
Acceptance Criteria and Device Performance Study for PolyTouch Medical Ltd. PatchAssist™ Large
This document summarizes the acceptance criteria and the study conducted to demonstrate that the PolyTouch Medical Ltd. PatchAssist™ Large device meets these criteria, as described in K103269.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this 510(k) summary is for a device asserting substantial equivalence to an already cleared predicate device (K101218) and the primary change is a larger deployment frame, the acceptance criteria are implicitly tied to demonstrating that the change does not introduce new safety or efficacy issues. The performance tests conducted are designed to confirm this.
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Safety and Efficacy (Overall) | The PatchAssist™ Large does not raise any new safety and/or effectiveness issues compared to the predicate device. | This is the overarching claim. The performance tests below support this. |
| Mesh Rolling and Insertion Capability | Successfully performed using the PatchAssist™ Large Device. | Confirms the device's ability to roll and insert larger meshes, a key functional aspect related to the increased frame size. |
| Articulation and Maneuverability | Demonstrated adequate articulation and maneuverability. | Confirms that the larger size does not negatively impact the surgeon's ability to manipulate the device within the abdominal cavity. |
| Overall Performance Evaluation | Satisfactory performance. | A general assessment of the device's functional integrity and ability to perform its intended use with the larger frame. |
2. Sample Size and Data Provenance
The 510(k) summary does not explicitly state specific sample sizes for the performance tests conducted for the PatchAssist™ Large. It mentions "A series of performance testing," implying multiple tests.
- Test Set Sample Size: Not explicitly stated. The tests appear to be conducted on the device itself (engineering tests) rather than on patient data.
- Data Provenance: The tests were performed by PolyTouch Medical Ltd. (the manufacturer). The report does not specify the country of origin for the data beyond the manufacturer's location in Israel. The studies are prospective in the sense that they were conducted specifically for this 510(k) submission to demonstrate the performance of the new, larger device.
3. Number of Experts and Their Qualifications for Ground Truth
This 510(k) is for a surgical mesh deployer, and the performance evaluation largely pertains to the mechanical and functional aspects of the device in facilitating mesh delivery during laparoscopic surgery. Ground truth in this context is likely established through engineering and simulated use testing, potentially involving surgical experts for ergonomic and usability assessments.
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. However, for a "Performance Evaluation," it is highly probable that qualified engineers and potentially surgeons (or individuals with surgical expertise) were involved in assessing the device's functionality, ease of use, and overall performance in a simulated surgical environment.
4. Adjudication Method for the Test Set
Given the nature of the performance tests (Mesh Rolling and Insertion, Articulation and Maneuverability, Performance Evaluation), an formal adjudication method like "2+1" or "3+1" is not applicable. These tests likely involved:
- Direct observation and measurement: For mechanical properties and functional execution.
- Expert assessment/feedback: For subjective aspects like maneuverability and overall performance in a simulated surgical setting.
The results would likely be documented and reviewed by the development team and internal quality control, rather than through a multi-reader adjudication process typically seen in diagnostic imaging studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and the AI's impact on their performance (e.g., accuracy, efficiency) is evaluated. The PatchAssist™ Large is a surgical instrument, not a diagnostic AI device. Therefore, the concept of improving human reader performance with AI assistance is not applicable.
6. Standalone Performance Study
Yes, standalone performance studies were done. The "Mesh Rolling and Insertion using the PatchAssist™ Large Device," "Articulation and Maneuverability Test," and "PatchAssist™ Large Performance Evaluation" are all examples of standalone performance studies. These tests evaluate the device's own functional capabilities and performance characteristics directly, without involving human-in-the-loop performance measurement on diagnostic tasks. The device itself (algorithm) is not performing any independent diagnostic or therapeutic decision-making tasks here; it is a tool.
7. Type of Ground Truth Used
The ground truth for the performance tests would be based on:
- Engineering specifications and objective measurements: For parameters like rolling capability, articulation range, and physical dimensions.
- Simulated use performance: Successful completion of simulated surgical tasks (e.g., deploying large meshes) as assessed by engineers and potentially surgical experts.
- Comparison to predicate device: Implicitly, the ground truth for "no new safety or efficacy issues" is that the PatchAssist™ Large performs comparably to the predicate device K101218, especially concerning the larger mesh capabilities, without introducing adverse effects.
It is not based on pathology, outcomes data, or expert consensus on patient diagnoses, as these are not relevant to the evaluation of a surgical instrument's mechanical and functional performance in this context.
8. Sample Size for the Training Set
This question is not applicable. The PatchAssist™ Large is a mechanical surgical instrument, not an AI or machine learning algorithm that requires a "training set" of data in the computational sense. The device's design is based on engineering principles and iterative development, not on learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" for a mechanical device like the PatchAssist™ Large.
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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:
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Surgical mesh deployer 7.1.5 Classification Name:
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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
56
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K 103269 page 2/3
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
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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
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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
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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
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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
§ 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.