PATCHASSIST LARGE

K103269 · Polytouch Medical, Ltd. · ORQ · Nov 23, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K103269
• Device Name: PATCHASSIST LARGE
• Applicant: Polytouch Medical, Ltd.
• Product Code: ORQ · General, Plastic Surgery
• Decision Date: Nov 23, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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).

Device Story

Manual laparoscopic surgical instrument; facilitates delivery/positioning of hernia mesh during laparoscopic repair. Surgeon attaches standard hernia mesh to device deployment frame; inserts device through standard trocar into abdominal cavity. Device enables rapid maneuvering of mesh to desired surgical location. Once positioned, surgeon attaches mesh to tissue using standard techniques (e.g., tacks); releases mesh from device; removes device from cavity. PatchAssist™ Large features larger deployment frame to accommodate larger mesh sizes (15x15cm to 38x28cm). Benefits include improved handling and placement of mesh during minimally invasive procedures.

Clinical Evidence

Bench testing only. Testing included mesh rolling and insertion, articulation and maneuverability, and performance evaluation of the larger deployment frame.

Technological Characteristics

Manual laparoscopic surgical instrument. Features a deployment frame for mesh delivery. No energy source. Non-powered. Dimensions modified to accommodate mesh sizes from 15x15cm up to 38x28cm.

Indications for Use

Indicated for patients undergoing laparoscopic repair of soft tissue defects, such as hernia repair, requiring the delivery of soft tissue prosthetics.

Regulatory Classification

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.

Predicate Devices

• PatchAssist™ device (K101218)

Submission Summary (Full Text)

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

K103269
Page 1/3

## 510(K) SUMMARY PolyTouch Medical Ltd. PatchAssist™

NOV 2 3 2010

- PolyTouch Medical 7.1.1 Applicant's Name: Misgav Venture Accelerator M.P. Misgav 20174, Israel Tel: [phone] Fax: [phone]
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:
- 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
- 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

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

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

{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 [phone] or [phone] 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