(47 days)
No
The device description and intended use are solely focused on a mechanical intramedullary nail system for fracture fixation, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device, an Intramedullary (IM) Nail, is used for internal fixation of fractures and corrective osteotomies, which are therapeutic interventions aimed at treating and healing anatomical issues.
No
The device is described as an Intramedullary nail for internal fixation of fractures, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states that the device is a system including physical components like intramedullary nails, interlocking screws, and instruments made of stainless steel.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided information clearly describes the SIGN IM Nail as an implantable device used for the internal fixation of bone fractures. It is a physical device inserted into the body to stabilize bones.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples, nor does it provide diagnostic information about a patient's condition beyond the mechanical stabilization of a fracture.
Therefore, based on the provided information, the SIGN IM Nail is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SIGN IM Nail is indicated for internal fixation of diaphyseal tibial fractures and distal femur fractures including transverse fractures, oblique and spiral fractures, comminuted fractures, fractures with bone loss, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions and fractures in the proximal femur.
The SIGN IM Nail may be removed upon fracture healing.
Product codes
HSB
Device Description
The SIGN IM Nail system includes Intramedullary nails, Interlocking Screws and Instruments. The SIGN IM Nail is manufactured from Solid Bar Stainless Steel, Type 316 as per ASTM F138. This device is available with diameters of 9mm, 11mm, 11mm, 12mm, 13mm and 14mm in the following lengths: 280mm, 300mm, 320mm, 340mm, 360mm, 380mm, 400mm. Each nail has holes and/or slots at both the distal and proximal ends to accept solid 4.5mm diameter cortical bone screws. Screws in a range from 25mm to 75mm in 5mm increments are supplied with the nails. Each nail uses distal and proximal bends to accommodate the shape of the femur.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
diaphyseal tibial, distal femur, proximal femur
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)
Not Found
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
SEP 2 3 2002
K022632
Page 1 of 2
2950 George '
510(k) Summary of Safety and Effectiveness
SIGN IM Nail
Contact Information Doug Donnelly Manager, Regulatory Affairs SIGN (Surgical Implant Generation Network) 2950 George Washington Way Richland, WA 99352 Phone: (509) 371-1107, Fax: (509) 371-1316, e-mail: doug@sign-post.org Date Prepared: August 1, 2002
| Classification Name: | Rod, Fixation, Intramedullary and Accessories |
|---|---|
| Common Name: | Intramedullary Rod |
| Proprietary Name: | SIGN IM Nail |
| Proposed Regulatory Class: | Class II, Intramedullary Fixation Rod, |
| 21 CFR §888.3020, OR | |
| Device Product Code: | HSB |
Substantial Equivalence Information
The SIGN IM Nail is substantially equivalent to the below listed legally marketed predicate femoral nailing devices:
-
- Howmedica T2™ Femoral Nail #K010801
-
- Howmedica S2™ Femoral Nail #K021026
-
- Howmedica Alta® Femoral IM Rod #K972108
All of the devices listed above are similar in design, material, intended use and method of application to the SIGN IM Nail system. The safety and effectiveness of the SIGN IM Nail is also based on a long history of use of this type of device in the market place. This 510(k) serves to extend the SIGN IM Nail line, which is currently distributed under various 510(k) notifications, by adding to the indications for use and providing a greater size range.
1
Device Description
The SIGN IM Nail system includes Intramedullary nails, Interlocking Screws and Instruments. The SIGN IM Nail is manufactured from Solid Bar Stainless Steel, Type 316 as per ASTM F138. This device is available with diameters of 9mm, 11mm, 11mm, 12mm, 13mm and 14mm in the following lengths: 280mm, 300mm, 320mm, 340mm, 360mm, 380mm, 400mm. Each nail has holes and/or slots at both the distal and proximal ends to accept solid 4.5mm diameter cortical bone screws. Screws in a range from 25mm to 75mm in 5mm increments are supplied with the nails. Each nail uses distal and proximal bends to accommodate the shape of the femur.
Indications for use
The SIGN IM Nail is indicated for internal fixation of diaphyseal tibial fractures and distal femur fractures including transverse fractures, oblique and spiral fractures, comminuted fractures, fractures with bone loss, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions and fractures in the proximal femur.
The SIGN IM Nail may be removed upon fracture healing.
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 circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 2002
Surgical Implant Generation Network Douglas J. Donnelly Manager, Regulatory Affairs 2950 George Washington Way Richland, Washington 99352-1615
Re: K022632
Trade/Device Name: SIGN IM Nail Regulation Number: 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: August 1, 2002 Received: August 7, 2002
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 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.
3
Page 2 – Mr. Douglas J. Donnelly
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N Millkenan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section VI, Indications For Use
Page 1 of 1
510(k) Number (if known): K020632
Device Name:
Indications for Use:
The SIGN IM Nail is indicated for internal fixation of diaphyseal tibial fractures and distal femur fractures including transverse fractures, oblique and spiral fractures, comminuted fractures, fractures with bone loss, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions and fractures in the proximal femur.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Mullen
Division Sign-Off) Division of General, Restorative and Neurological Devices ()22632
510(k) Number _
(Optional Format 3-10-98)