(265 days)
No
The device description and performance studies focus on the mechanical properties and components of a surgical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to treat peritrochanteric fractures of the hip, using implant components to provide structural support for healing. This direct intervention for a medical condition classifies it as a therapeutic device.
No
The device description clearly states that the SIGN Hip Construct (SHC) is composed of various implantable components (e.g., intramedullary nail, screws) made from stainless steel, designed for the surgical treatment of peritrochanteric fractures of the hip. It is a medical implant used for fixation and stabilization, not for diagnosing disease or conditions.
No
The device description explicitly states that the device is composed of physical implant components made from stainless steel and a set of surgical instruments. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating peritrochanteric fractures of the hip. This is a surgical procedure involving the implantation of a medical device to stabilize a bone fracture.
- Device Description: The device is a collection of implants (nails, plates, screws) made of stainless steel, designed to be surgically inserted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Indications for the SIGN Hip Construct (SHC) include all peritrochanteric fractures of the hip with proper soft tissue management. This does not include femoral neck fractures and may include subtrochanteric fractures.
Product codes
KTT, HSB, HRS
Device Description
The SIGN Hip Construct (SHC) is composed of a Fin Nail Flat (Intramedullary Nail, a Rod Plate, a Rod Connector, an Interlocking Screw, two Compression Screws, a Unicortical Screw and a set of surgical instruments. Each implant component is made from stainless steel, per requirements in ASTM F138.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip (peritrochanteric fractures, femoral neck fractures, subtrochanteric fractures)
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
Mechanical testing was performed on the SHC implant and the results demonstrated sufficient strength for static and dynamic compressive and torsional loading modes and resistance to subsidence and expulsion. The results did not raise any issues on the safety or effectiveness of the device.
Key Metrics
Not Found
Predicate Device(s)
SIGN Fin Nail (K043200), Holland Femoral Nail System (K983641), Synthes Locking Stabilization Plate (K052677), Howmedica Omega 3 Trochanteric Stabilization Plate (K081278), Howmedica T2 Recon Nail (K051624), Synthes CerviFix (K030377)
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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AUG 2 6 2009
510(k) Summary of Safety and Effectiveness SIGN Hip Construct (SHC)
| Contact Information | Classification Name: | Appliance, Fixation, Nail/Plate
Combination, Multiple Components |
|---------------------------|----------------------|---------------------------------------------------------------------|
| Doug Donnelly | Common Name: | Hip Fixation System |
| 451 Hills Street, Suite B | Proprietary Name: | SIGN Fin Nail |
| Richland, WA 99354 | Regulatory Class: | Class II, OR, 21 CFR §888.3030 |
| Phone: (509) 371-1107 | Product Codes: | KTT, HSB, HRS |
| Fax: (509) 371-1316 | | |
| signcom@sign-post.org | | |
Substantial Equivalence Information
The SIGN Hip Construct (SHC) is similar to the following predicate devices:
- SIGN Fin Nail (K043200) .
- Holland Femoral Nail System (K983641) .
- Synthes Locking Stabilization Plate (K052677) �
- Howmedica Omega 3 Trochanteric Stabilization Plate (K081278) ●
- Howmedica T2 Recon Nail (K051624) ●
- Synthes CerviFix (K030377) ●
All of the devices listed above are similar in both their intended use and the basic concept by which they are used. The safety and effectiveness of the SHC is also based on a long history of use of this type of device in the marketplace.
Device Description
The SIGN Hip Construct (SHC) is composed of a Fin Nail Flat (Intramedullary Nail, a Rod Plate, a Rod Connector, an Interlocking Screw, two Compression Screws, a Unicortical Screw and a set of surgical instruments. Each implant component is made from stainless steel, per requirements in ASTM F138.
Indications for Use
Indications for the SIGN Hip Construct (SHC) include all peritrochanteric fractures of the hip with proper soft tissue management. This does not include femoral neck fractures and may include subtrochanteric fractures.
Performance Data
Mechanical testing was performed on the SHC implant and the results demonstrated sufficient strength for static and dynamic compressive and torsional loading modes and resistance to subsidence and expulsion. The results did not raise any issues on the safety or effectiveness of the device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Surgical Implant Generation Network (SIGN), Inc. % Mr. Doug Donnelly Manager, Regulatory Affairs 451 Hills Street, Suite B Richland, WA 99354
AUG 2 6 2009
Re: K083582
Trade/Device Name: SIGN Hip Construct (SHC) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, HSB, HRS Dated: July 29, 2009 Received: August 4, 2009
Dear Mr. Donnelly:
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 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
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Page 2 – Mr. Doug Donnelly
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/CDRH0ffices/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.
Sincerely, yours,
Boban Buchm
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K083582
Device Name: SIGN Hip Construct (SHC)
Indications For Use: .
Indications for the SIGN Hip Construct (SHC) include all peritrochanteric fractures of the hip with proper soft tissue This does not include femoral neck fractures and may management . include subtrochanteric fractures.
X Prescription Use (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)
Sanita Lo mxm
(Division Sign Off)
(Division Sign-Of Division of Surgical, Orthope and Restorative Devices
510(k) Number K083582
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