(193 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or data processing.
No.
The device facilitates the delivery and deployment of prosthetics during hernia repair, rather than directly treating a disease or condition. It is a tool for a surgical procedure.
No.
The device description clearly states its purpose is to "facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernia, by assisting surgeons with maneuvering, spreading and deploying hernia repair meshes in the abdominal cavity," which is a surgical tool function, not for diagnosis.
No
The device description clearly outlines physical components: an inflatable spreading balloon, an adaptor, and an inflation unit/pump, all of which are hardware.
Based on the provided information, this 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, tissue) to provide information about a person's health.
- Device Function: The Mesh GPS device is used during a surgical procedure (laparoscopic hernia repair) to physically manipulate and deploy a mesh within the abdominal cavity. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for "facilitat[ing] the delivery of soft tissue prosthetics during the laparoscopic repair of hernia." This is a surgical aid, not a diagnostic test.
The device's function and intended use fall under the category of surgical instruments or accessories, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Mesh GPS device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernia.
Product codes (comma separated list FDA assigned to the subject device)
OQL, GCJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
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 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 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.
K041641, K061754, K072962, K022782, K042412, K973046, K981598, K090631, K063671
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
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 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.
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
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