(309 days)
No
The summary describes a mechanical implant (bone anchor) and associated instrumentation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is described as an implantable anchor used for "repairing the rotator cuff," which directly addresses and treats a medical condition.
No
Explanation: The device, the NCS Fish-Fit MD System, is described as an implantable anchor for repairing rotator cuff tendons. Its intended use is for the attachment of soft tissue to bone, and it is a medical device for treatment (surgical repair), not for diagnosis.
No
The device description clearly states it is an "implantable anchor made from Titanium grade 4" and includes an "instrumentation package," indicating it is a hardware device, not software-only.
No, this 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 for diagnosis, monitoring, or screening.
- Device Description: The NCS Fish-Fit MD System is an implantable bone anchor made of titanium, used to attach soft tissue to bone during surgery. It is a surgical implant, not a device that analyzes biological samples.
- Intended Use: The intended use is for the surgical repair of rotator cuff tendons, which is a surgical procedure, not an in vitro diagnostic test.
The information provided clearly describes a surgical implant and its associated instrumentation, which falls under the category of a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The NCS Fish-Fit MD System is intended for use for the reattachment of soft tissue (tendons) to bone in the shoulder for rotator cuff repairs. The device has the following indications for use: The NCS Fish-Fit MD System is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tendons lesions with the purpose of repairing the rotator cuff (supraspinatus, infraspinatus and subscapularis).
Product codes
MBI
Device Description
NCS Fish-Fit MD System is an implantable anchor made from Titanium grade 4. Sutures are not pre-assembled with bone anchor. The system includes an instrumentation package, Compass MD. The instrument package is intended to facilitate implantation of the anchor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder (rotator cuff tendons: supraspinatus, infraspinatus and subscapularis)
Indicated Patient Age Range
Adults
Intended User / Care Setting
Orthopedic 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 provided non-clinical testing has been performed to verify adequate fixation strength and pull-out performances of the device, demonstrating substantially equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Smith and Nephew, TwinFix Ultra Ti Suture Anchor, K100159, ConMed Linvatex, Y-Knot All-Suture Anchor, K111779
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
510(k) Summary
NCS Fish-Fit MD System
DEC 1 1 2012
000078
Submitted by:
NCS Lab Srl Via Pola Esterna 4/12 41012 Carpi (MO) Italy
Contact Person:
Matteo Mantovani Technical Director Telephone: +39 (059) 669813 Fax: +39 (059) 669813
Preparation:
November 27, 2012
- Device Name and Classification Information:
Trade/Proprietary Name:
NCS Fish-Fit MD System, which consists of the following:
-
- the Fish-Fit MD, a sterile, single use, implantable suture anchor; and,
1
- the Compass MD, a series of reusable surgical
instruments used to implant the Fish-Fit MD.
Common/Usual Name:
Anchor
Orthopedic Manual Surgical Instruments
Classification Information
NCS Fish-Fit MD System
Classification Name: Smooth or Threaded Metallic Bone Fixation Fastener
Classification Regulation: 21 CFR 888.3040
Regulatory Class: II
Product Code: MBI - Fastener, Fixation, Nondegradable, Soft Tissue
3. Predicate Devices
The NCS Fish-Fit MD System is substantially equivalent to the following predicate devices:
- Smith and Nephew, TwinFix Ultra Ti Suture Anchor, . cleared by FDA on April 19, 2010 in K100159; and
- ConMed Linvatex, Y-Knot All-Suture Anchor, cleared by . FDA on August 8, 2011 in K111779.
2
000079
2
Description of the Device 4.
NCS Fish-Fit MD System is an implantable anchor made from Titanium grade 4. Sutures are not pre-assembled with bone anchor. The system includes an instrumentation package, Compass MD. The instrument package is intended to facilitate implantation of the anchor.
5. Intended Use and Indications for Use
The NCS Fish-Fit MD System is intended for use for the reattachment of soft tissue (tendons) to bone in the shoulder for rotator cuff repairs. The device has the following indications for use:
The NCS Fish-Fit MD System is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tendons lesions with the purpose of repairing the rotator cuff (supraspinatus, infraspinatus and subscapularis).
ે. Comparison to the Predicate Devices
The NCS Fish-Fit MD System is substantially equivalent to the legally marketed predicate devices. The NCS Fish-Fit MD System
3
and its predicate devices are all smooth or threaded metallic bone fixation fastener as defined in 21 CFR 888.3040.
The NCS Fish-Fit MD System has the same intended use as both predicate devices. All three devices are intended for use during arthroscopic or open surgeries to repair rotator cuff injuries. All three devices serve the same primary function: namely, to secure the tendons to bone during healing. All three devices are used by the same health care providers (orthopedic surgeons) in the same target patient population: adults who require repair of rotator cuff injuries. All devices are implanted into a cavity drilled into the bone.
All three devices share similar design features, including materials, similar sizes and dimensions, and insertion into a pre-drilled cavity into the bone. Each device utilizes a slightly different design to fix the anchor to the bone. Data have been provided to show that the NCS Fish-Fit MD System and Bone Anchor perform as well as the predicate device with respect to fixation strength and pull-out strength. These data have been provided in accordance with the FDA guidance document entitled "Guidance Document for Testing Bone Anchor Devices" dated April 20, 1996 to show that the NCS Fish-Fit MD System.
The provided non-clinical testing has been performed to verify adequate fixation strength and pull-out performances of the device, demonstrating substantially equivalence to the predicate devices.
1
4
Conclusion 7.
:
- Sales of the same .
י
·
Based upon the similarities in performances, materials and intended uses, NCS Fish Fit MD System is substantially equivalent to the : predicate devices.
:
.
.
. .
000082
5
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-002
Letter dated: December 11, 2012
NCS Lab SRL % Mr. Matteo Mantovani Technical Director Via Pola Esterna 4/12 Carpi, Italy 41012
Re: K120356
Trade/Device Name: NCS Fish-Fit MD System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 27, 2012 Received: November 29, 2012
Dear Mr. Mantovani:
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 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
6
Page 2 – Mr. Matteo Mantovani
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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number:
Device Name:
NCS Fish-Fit MD System
Indications For Use:
The NCS Fish-Fit MD System is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tendons lesions with the purpose of repairing the rotator cuff (supraspinatus, infraspinatus and subscapularis).
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Casey Hanley
For Division of Orthopaedic Devices