(86 days)
Not Found
No
The device description focuses on the material properties and mechanical function of a shape memory alloy clip for sternal closure. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
Yes.
The device is intended for the closure or repair of the sternum after sternotomy, fracture, or dehiscence, which are therapeutic interventions.
No
Explanation: The device description and intended use clearly state that the Flexigrip Sternal Closure System is designed for the closure or repair of the sternum. It is a surgical implant that holds the sternum together, facilitating healing, not for the purpose of making a diagnosis.
No
The device description clearly outlines a physical medical device made of Nitinol, a shape memory metal alloy, along with surgical instruments. There is no mention of software as a component or the primary function of the device.
No, the Flexigrip Sternal Closure System 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, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Flexigrip Sternal Closure System Function: The Flexigrip Sternal Closure System is a surgical implant used to physically hold the sternum together after surgery or injury. It is placed inside the body and its function is mechanical support, not diagnostic testing of bodily specimens.
The provided text clearly describes a surgical device for internal fixation, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Flexigrip Sternal Closure System is intended for use in closure or repair of the sternum after sternotomy, fracture or dehiscence.
Product codes
JDQ, HRS
Device Description
The device consists of a specially shaped clip made of shape memory metal alloy, Nitinol, which is malleable at 10°C and returns to its original shape and stiffness at 27°C. The clip is open on one side and is expanded when cold, placed around the sternum, and returns to shape when warm clamping the sternum together. It is made in a series of 9 sizes from 20 to 40 mm across and 11 to 14 mm deep. The material conforms to the ASTM F2063-05 standard for shape memory alloys and is supplied sterile. Appropriate surgical instruments are also supplied to allow for proper sizing and placement of the clip around the sternum.
The Flexigrip Sternal Closure System operates in generally the same manner as stainless steel sutures or any of the listed predicate devices in that it holds the surfaces of the surgically split sternum together after open chest surgery allowing the sternum to heal. Nitinol has a long history of successful implantation in orthopedic and cardiovascular applications dating back to the mid-1970's. The major difference between this device and the predicate devices is that this device does not completely encircle the sternum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sternum
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K974016, K050041, K030256, K983976
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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Company Name, Address and Contacts
Praesidia, S.r.l. Via del Lapidari, 19 Bologna 40129 Italy Telephone: 39 51 321238 Contact Person: Piero Malobbia
DEC 2 7 2006
1
Application Correspondent
Sternal Closure Systems Medical Products, Inc. 1083 Delaware Avenue Buffalo, NY 14209 Telephone:
Establishment Registration Number: Not applicable
Device Information
| Proprietary Name: | Flexigrip Sternal Closure System |
|---|---|
| Common Name: | Cerclage bone fixation |
| Classification Name: | Bone fixation, cerclage |
| Classification Panel: | Orthopedic |
| Classification: | 21CFR888.3010 |
| 87JDQ | |
| Class: | II |
| Substantial Equivalence: | Pioneer Surgical Technology, Cerclage cable with hex button, K974016 |
| Synthes (USA), Synthes sterile sternal fixation system, K050041 | |
| Kinamed Inc., Iso-Elastic Cerclage System, K030256 | |
| Metagen, Activelock Wire Cerclage System, K983976 | |
| Standard sternal wires, 510(k) not applicable due to preamendment status |
Device Description
The device consists of a specially shaped clip made of shape memory metal alloy, Nitinol, which is malleable at 10°C and returns to its original shape and stiffness at 27°C. The clip is open on one side and is expanded when cold, placed around the sternum, and returns to shape when warm clamping the sternum together. It is made in a series of 9 sizes from 20 to 40 mm across and 11 to 14 mm deep. The material conforms to the ASTM F2063-05 standard for shape memory alloys and is supplied sterile. Appropriate
1
surgical instruments are also supplied to allow for proper sizing and placement of the clip around the sternum.
The Flexigrip Sternal Closure System operates in generally the same manner as stainless steel sutures or any of the listed predicate devices in that it holds the surfaces of the surgically split sternum together after open chest surgery allowing the sternum to heal. Nitinol has a long history of successful implantation in orthopedic and cardiovascular applications dating back to the mid-1970's. The major difference between this device and the predicate devices is that this device does not completely encircle the sternum.
Intended Use
The Flexigrip Sternal Closure System is intended for use in closure or repair of the sternum after sternotomy, fracture or dehiscence.
| Characteristic | Flexigrip | Activelock | Iso-
Elastic | Synthes | Pioneer | Surgical
Wire |
|-------------------------|------------|-------------------------|------------------------------------------|----------------------------------|----------------------------------------------------|--------------------|
| Material(s) | Nitinol | CoCr &
Nitinol | Polymeric
with metal
clamp | Titanium
&
TiAlNb
Alloy | Stainless
Steel
(can be
silver
coated) | Stainless
steel |
| Full Cerclage | No | Yes | Yes | No | Yes | Yes |
| Special Tools | Yes | Yes | Yes | Yes | Yes | No |
| Configuration | Solid wire | Solid wire
and clamp | Polymeric
cable and
metal
clamp | Plate and
screw
system | Braided
wire
cable
with
metal
crimp | Braided
wire |
| Clamp Method | NA | Special
clamp | Special
clamp | NA | Crimp | Twisted |
| Sternal
Closure Only | Yes | No | No | Yes | Yes | No |
Summary of Technological Characteristics
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Praesidia, S.r.l. % Sternal Closure Systems Medical Products, Inc. Mr. George Haar General Manager 1083 Delaware Avenue Buffalo, New York 14209
DEC 2 7 2006
Re: K063009
Trade/Device Name: Flexigrip Sternal Closure System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ, HRS Dated: September 29, 2006 Received: October 3, 2006
Dear Mr. Haar:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Mr. George Haar
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0210 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Raubara Buehmp
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Flexigrip Sternal Closure System
Indications For Use:
The Flexigrip Sternal Closure System is intended for use in closure or repair of the sternum after strenotomy, fracture or dehiscence.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Barbara Bucknum
(Division Sign-Off) (Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
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