The Mesh GPS facilitates the delivery of soft tissue prosthetics during the laparoscopic ventral hernia repair, by assisting surgeons with maneuvering, spreading and deploying hernia repair meshes in the abdominal cavity, resulting in easier final fixation to the abdominal wall and shortening of OR time. The device is comprised of three main components: an inflatable spreading balloon; an adaptor and an inflation unit/pump. The device's three components are sterile, single use and packed within a double pouch. The Spreading Inflatable Balloon is composed of biocompatible Thermoplastic Polyurethane (TPU). The balloon is the main component of the device which supports and facilitates the navigation and deployment of a mesh within the abdominal cavity. It is reversibly attached to the mesh using the mesh connectors, before its insertion into the body, then rolled together. Once located in the abdominal cavity it is easily spread at the desired location by inflating it using the external Inflation Pump. The balloon comes in several sizes/configurations to enable its use with a wide variety of meshes available on the market. The Inflation Tube is composed of biocompatible Thermoplastic Polyurethane (TPU). Its purpose is to transport the air from the external Inflation Pump into the Spreading balloon and inflate it and to externally grab the balloon by the suture passer and position it at the proper location within the abdominal cavity.

AI/ML Overview

The provided text describes the "Mesh GPS device" by Surgical Structure Ltd., intended to facilitate the delivery of soft tissue prosthetics during laparoscopic hernia repair. The document details the device's description, intended use, and the performance data submitted for its 510(k) premarket notification.

Here's the breakdown of the acceptance criteria and study information as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Implied)	Reported Device Performance and Evidence
Biocompatibility	Compliance with ISO 10993-1 and Blue Book Memo G95-1 requirements.	"The Mesh GPS components that contact the body were tested for biocompatibility according to ISO 10993-1 standard and Blue Book Memo G95-1 requirements." (Implies compliance was met, as no issues were raised).
Safe and Effective Performance (Overall)	The device should safely and effectively deliver, spread/deploy, facilitate attachment of mesh, and be withdrawn from the abdominal cavity without raising new safety or effectiveness issues.	"The Mesh GPS device underwent a full battery of bench tests and animal studies to demonstrate its safe and effective performance in delivering, spreading/deployment, facilitating the attachment of the mesh to the abdominal wall and withdrawing from the abdominal cavity." "All tests met the acceptance criteria demonstrating that the device is safe, effective, performs as intended, and is substantially equivalent to its predicates." "Animal studies conducted on pigs... revealed that mesh delivery and deployment using the Mesh GPS device is safe and effective. The procedure is simple, the delivery and deployment are effective without needing any additional activities by the surgeons."
Mechanical Integrity/Design Features	Device components connection strength/integrity, burst/over inflation resistance, withdrawal capability.	"Studies included performance testing as well as various mechanical testing for design features that are different from the predicate devices, e.g. device components connection strength/integrity, burst/over inflation testing, withdrawal test, performance & usability tests, etc." "All tests met the acceptance criteria..."
Usability/Efficiency (Implied)	The device should assist surgeons with maneuvering, spreading, and deploying hernia repair meshes, potentially shortening OR time and simplifying the procedure.	"The Mesh GPS facilitates the delivery of soft tissue prosthetics... by assisting surgeons with maneuvering, spreading and deploying hernia repair meshes in the abdominal cavity, resulting in easier final fixation to the abdominal wall and shortening of OR time." "The procedure is simple, the delivery and deployment are effective without needing any additional activities by the surgeons."
Compatibility with Marketed Meshes	Ability to be used with a wide variety of market-cleared mesh types and sizes.	"Tests were performed with various market-cleared mesh types and sizes using all Mesh GPS device models." "Animal studies conducted on pigs, using a wide variety of market-cleared meshes..."
Substantial Equivalence	Demonstrating that the device is substantially equivalent to predicate devices without raising new safety or effectiveness concerns.	The entire submission and the FDA's final decision imply this criterion was met. "Surgical Structure Ltd. believes that, based on the information provided in this submission, the Mesh GPS device is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness concerns." (This indicates the manufacturer's belief that their data supported this criterion).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated in terms of a specific number of devices or animals for each test. The text uses general terms like "a full battery of bench tests and animal studies" and "various market-cleared mesh types and sizes."
Data Provenance:
- Bench tests: Conducted by the manufacturer or a contracted lab. The document does not specify a country of origin beyond the manufacturer (Israel).
- Animal Studies: Conducted on "pigs." The country of origin for these animal studies is not specified, but the manufacturer is based in Israel.
- Retrospective or Prospective: These studies appear to be prospective as they were conducted specifically for the 510(k) submission to demonstrate the device's performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The studies described are bench tests and animal studies, not human clinical trials or evaluations where expert assessment of "ground truth" in the diagnostic sense would typically be required. The "ground truth" here is the observable mechanical function and biological response (in animals).

4. Adjudication Method for the Test Set

This information is not applicable as the studies are bench and animal tests, not human assessments requiring adjudication (e.g., comparing multiple expert reads of medical images). The "acceptance criteria" and "performance" were based on measurable outcomes from the tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices involving human readers and AI. The Mesh GPS is a surgical assist device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not fully applicable in the context of this device. The Mesh GPS is a physical medical device intended to assist a human surgeon. Its performance is intrinsically tied to human-in-the-loop operation. The "performance data" described (bench and animal tests) evaluates the device itself and its interaction with the surgeon and mesh, not an autonomous algorithm.

7. The Type of Ground Truth Used

The ground truth used for these studies can be generalized as:

Bench Test Standards/Specifications: For mechanical and biocompatibility tests, the "ground truth" is compliance with predefined engineering specifications, burst pressures, material properties, and regulatory standards (e.g., ISO 10993-1).
Observable Outcomes in Animal Models: For animal studies, the "ground truth" is the direct observation of successful mesh delivery, deployment, ease of use, lack of adverse events, and effective functionality within the living tissue model. This might include surgical observations, post-procedure assessment of mesh placement, and tissue response.

8. The Sample Size for the Training Set

This information is not applicable. The Mesh GPS is a mechanical surgical device, not an AI or machine learning algorithm that requires a "training set" in the traditional sense of data-driven model development.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" for this type of device.

Summary

{0}------------------------------------------------

092726
pg 1 of 3

Surgical Structure ath Mesh Circ. Techniq Techups of

Mesh GPS **

Pre Market Notification Submission - 510(k)

510(K) SUMMARY
Mesh GPS TM Device
510(k) Number K

MAR 1 5 2010

Company Name

Surgical Structure Ltd. HaShita Street. Moshav Herev Le'Et, Israel, 38860 Tel: +972-77-5161900 Fax: +972-77-5161901

Contact Person

Shoshana (Shosh) Friedman 1914 J.N. Pease Place Charlotte, NC 28262, USA Tel: (704) 430-8695; (704) 899-0092 Fax: (704) 899-0098 Email: shosh(@pushmed.com

Trade/Proprietary Name

Mesh GPS device

Classification Name

laparoscope, general & plastic surgery

Classification:

FDA has classified this type of device as class II, product code OQL for a "mesh deployment balloon" under 21 CFR §878.3300, and they are reviewed by the Plastic and Reconstructive Surgery Branch.

Predicate Devices

Davol Delivery System (currently marketed as PrecisionPass Laparoscopic Delivery . Device), K041641 (Davol Inc.).
Bard Composix® L/P Mesh, K061754 (Davol, Inc.). .
Biomesh CA.B.S.'Air, K072962 (Cousin Biotech S.A.S). .
DualMesh EMERGE Biomaterial and DualMesh EMERGE PLUS Biomaterial, . K022782 (W.L. Gore and Associates, Inc).
Modified SPACEMAKER System, K042412 (United States Surgical). This is a . special 510k on the SPACEMAKER* Dissection Balloon, K973046.
Hernia Mesh Stabilizer, K981598 (Medivices Inc.). .
PAJUNKs Balloons and Balloon systems, K090631 (Pajunk Medical Systems). .
Rebound HRD, K063671 (Minnesota Medical Development, Inc. (MMDI)). .

{1}------------------------------------------------

1092726

Pre Market Notification Submission - 510(k)

Intended Use

The Mesh GPS device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernia.

Device Description

The device is comprised of three main components: an inflatable spreading balloon; an adaptor and an inflation unit/pump. The device's three components are sterile, single use and packed within a double pouch.

The Spreading Inflatable Balloon is composed of biocompatible Thermoplastic Polyurethane (TPU). The balloon is the main component of the device which supports and facilitates the navigation and deployment of a mesh within the abdominal cavity. It is reversibly attached to the mesh using the mesh connectors, before its insertion into the body, then rolled together. Once located in the abdominal cavity it is easily spread at the desired location by inflating it using the external Inflation Pump. The balloon comes in several sizes/configurations to enable its use with a wide variety of meshes available on the market. The Inflation Tube is composed of biocompatible Thermoplastic Polyurethane (TPU). Its purpose is to transport the air from the external Inflation Pump into the Spreading balloon and inflate it and to externally grab the balloon by the suture passer and position it at the proper location within the abdominal cavity.

Performance Data

The Mesh GPS components that contact the body were tested for biocompatibility according to ISO 10993-1 standard and Blue Book Memo G95-1 requirements.

The Mesh GPS device underwent a full battery of bench tests and animal studies to demonstrate its safe and effective performance in delivering, spreading/deployment, facilitating the attachment of the mesh to the abdominal wall and withdrawing from the abdominal cavity. Tests were performed with various market-cleared mesh types and sizes using all Mesh GPS device models.

In general the studies included performance testing as well as various mechanical testing for design features that are different from the predicate devices, e.g. device components connection strength/integrity, burst/over inflation testing, withdrawal test, performance & usability tests, etc. All tests met the acceptance criteria demonstrating that the device is safe, effective, performs as intended, and is substantially equivalent to its predicates.

Animal studies conducted on pigs, using a wide variety of market-cleared meshes, revealed that mesh delivery and deployment using the Mesh GPS device is safe and effective. The procedure is simple, the delivery and deployment are effective without needing any additional activities by the surgeons.

All these tests demonstrate that the Mesh GPS is a safe and effective device for facilitating the delivery of soft tissue prosthetics during the laparoscopic repair of

{2}------------------------------------------------

092726

Pre Market Notification Submission - 510(k)

hernia without raising any new safety or effectiveness issues.

Conclusion:

Surgical Structure Ltd. believes that, based on the information provided in this submission, the Mesh GPS device is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness concerns.

{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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird with outstretched wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MAR 1 5 2010

Surgical Structure, Ltd. % Push-Med LLC Ms. Shoshana Friedman 1914 J.N. Pease Place Charlotte, North Carolina 28262

Re: K092726

Trade/Device Name: Mesh GPS™ Device Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OQL, GCJ Dated: February 24, 2010 Received: February 25, 2010

Dear Ms. Friedman:

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 - Ms. Shoshana Friedman

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/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,

ely yours,

For

N. Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Surgical Structure 人心得上一篇: 上一篇:

MES 1 1 - 15 9 0

K092726

Pre Market Notification Submission - 510(k)

Indications for Use Statement

510(k) Number (if known):_

Mesh GPS Device Name:

The Mesh GPS device is intended to be used to facilitate Indications For Use: the delivery of soft tissue prosthetics during the laparoscopic repair of hernia.

Over-The-Counter Use _ AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(Please do not write Below this Line-Continue on another Page IF Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone for LXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K992726

Regulation Number and Section

§ 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.