COLONRING

K093661 · Niti Surgical Solutions, Ltd. · FZP · Feb 10, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K093661
• Device Name: COLONRING
• Applicant: Niti Surgical Solutions, Ltd.
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Feb 10, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NiTi ColonRing™ device is intended for use throughout the alimentary tract for end-to-end, end-to-side and side-to-side anastomoses, in both open and laparoscopic surgeries. Once wound strength is sufficient to maintain the anastomosis, the NiTi ColonRing™ is passed from the body.

Device Story

ColonRing™ is a sterile, single-use implantable device for creating circular compression anastomoses in the alimentary tract. During surgery, the device compresses tissue sides; over 7-10 days, compression-induced necrosis occurs at the anastomosis site. The device and necrosed tissue detach and are naturally expelled via stool once wound strength is sufficient. Used by surgeons in open or laparoscopic procedures.

Clinical Evidence

Performance data includes bench testing and animal data demonstrating safety and effectiveness equivalent to the predicate device.

Technological Characteristics

Sterile, single-use implantable device. Operates via compression-induced tissue necrosis. No electronic components, software, or external energy sources.

Indications for Use

Indicated for patients undergoing alimentary tract surgery (end-to-end, end-to-side, or side-to-side anastomoses) via open or laparoscopic approach.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Compression Anastomosis Ring (CAR™) (K062008)
• Compression Anastomosis Ring (CAR™) (K050356)

Submission Summary (Full Text)

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# K093661 10f2

#### 510(k) SUMMARY

# FEB 1 0 2011

## NiTi Surgical Solution' ColonRing™ Device

## Submitter's Name:

NiTi Surgical Solutions Ltd. Seeim Industrial Park, Building 9E Netanya, 425006 Israel Phone: [phone] Facsimile: [phone]

#### Contact Person:

Jonathan Kahan, Esq. Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109 Phone: [phone] Facsimile: [phone]

#### And:

Dorit Winitz, Ph.D. NiTi Surgical Solutions Ltd. Seeim Industrial Park, Building 9E Netanya, 425006 Israel Phone: [phone] Facsimile: [phone]

#### Date Prepared:

November 19, 2009

## Trade Name:

ColonRing™ Device

#### Classification Name:

Implantable Clip, FZP

#### Predicate Devices

Compression Anastomosis Ring (CAR™) (NiTi Surgical Solutions Ltd.), cleared under K062008 and K050356

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K093661

20f2

#### Intended Use

The NiTi ColonRing™ device is intended for use throughout the alimentary tract for endto-end, end-to-side and side-to-side anastomoses, in both open and laparoscopic surgeries. Once wound strength is sufficient to maintain the anastomosis, the NiTi ColonRing™ is passed from the body.

#### Technological Characteristics

The ColonRing™ device is a sterile single use device. The ColonRing™ provides a simple method for the creation circular compression anastomosis of the alimentary tract. After a period of 7-10 days, a compression-induced necrosis of the tissue sides underneath the ring occurs and the whole device, together with the necrosed tissue that was compressed by the rings, detaches and is naturally expelled with the stool.

#### Substantial Equivalence and Performance Data

The ColonRing™ has the same intended use and similar indications, principles of operation, and technological characteristics as the predicate device. The minor differences in the ColonRing™ technological characteristics do not raise any new questions of safety or effectiveness. Performance data including bench tests and animal data demonstrates that the ColonRing™ is as safe and effective as its predicate device. Based on the design verification and validation processes, performed as a result of risk analysis, NiTi Surgical Solutions Ltd. believes that the ColonRing™ is substantially equivalent to its predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room – WO66-G609 Silver Spring, MD 20993-0002

NiTi Surgical Solutions. Ltd. % Hogan and Hartson, L.L.P. Jonathan Kahan, Esq. 555 Thirteenth Street, NW Washington, District of Columbia 20004-1109

Re: K093661

Trade/Device Name: ColonRing™ Device Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: FZP Dated: January 31, 2011 Received: January 31, 2011

#### Dear Mr. Kahan:

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

# FEB 1 0 201

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Page 2 - Jonathan Kahan, Esq.

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 forth in the quality systems (OS) 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 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Sincerely yours,

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

1093661 510(k) Number (if known):_

Device Name:

Indications for Use:

The NiTi ColonRing™ device is intended for use throughout the alimentary tract for end-to-end, end-to-side and side-to-side anastomoses, in both open and laparoscopic surgeries. Once wound strength is sufficient to maintain the anastomosis, the NiTi ColonRing™ is passed from the body.

Prescription Use
(Per 21 C.F.R. 801.109)

AND/OR

Over-The-Counter Use (Per 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

Daniel Kranefur MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093661