(442 days)
Not Found
No
The summary describes a mechanical device for creating surgical anastomoses and does not mention any computational or data-driven components indicative of AI/ML.
No
The device facilitates anastomosis by compressing tissue which is then expelled, but it does not directly treat a disease or condition itself. It's a surgical tool, not a therapeutic agent.
No
The provided text describes a device used for creating surgical anastomoses (connecting two ends of a tubular structure) in the alimentary tract. Its function is surgical, not diagnostic.
No
The device description clearly states it is a "sterile single use device" and describes a physical ring that is implanted and later expelled, indicating it is a hardware device, not software-only.
Based on the provided information, the NiTi ColonRing™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- ColonRing™ Function: The ColonRing™ is a surgical device used within the body (in vivo) to create surgical connections (anastomoses) in the alimentary tract. It facilitates healing and is then expelled. It does not perform any testing or analysis of bodily specimens.
Therefore, the NiTi ColonRing™ falls under the category of a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
FZP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance data including bench tests and animal data demonstrates that the ColonRing™ is as safe and effective as its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
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: +972 9 860 3000 Facsimile: +972 9 861 2828
Contact Person:
Jonathan Kahan, Esq. Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109 Phone: (202)637-5794 Facsimile: (202)637-5910
And:
Dorit Winitz, Ph.D. NiTi Surgical Solutions Ltd. Seeim Industrial Park, Building 9E Netanya, 425006 Israel Phone: +972 9 860 3000 Facsimile: +972 9 861 2828
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
1
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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird.
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
3
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 (800) 638-2041 or (301) 796-7100 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
4
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