(77 days)
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Not Found
No
The device description and intended use are purely mechanical, describing a physical implant for fracture fixation. There is no mention of software, data processing, or any capabilities that would suggest AI/ML.
Yes
Explanation: The device is an intramedullary nail indicated for internal fixation of stable fractures, which is a therapeutic intervention. It directly participates in the treatment and healing process of the fracture.
No
The device is described as an "internal fixation" device for bone fractures, indicating its therapeutic rather than diagnostic function. Its description focuses on its physical characteristics and use in stabilization, not in identifying or diagnosing medical conditions.
No
The device description explicitly details physical components made of stainless steel (intramedullary nails, interlocking screws, and instruments), indicating it is a hardware medical 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 about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The SIGN Fin Nail is an implantable device used for internal fixation of bone fractures. It is a physical object inserted into the body to stabilize bones.
- Intended Use: The intended use is to fix stable fractures in the femur and humerus, which is a surgical procedure, not a diagnostic test performed on a specimen.
The description clearly indicates a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The SIGN Fin nail is indicated for internal fixation of stable fractures in the femur and humerus.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The SIGN Fin Nail system includes intramedullary nails, Interlocking Screws and Instruments. All components are manufactured from stainless steel. The SIGN Fin Nail is available with diameters of 7mm, 8mm, 9mm, 11mm, 11mm, and 12mm in the following lengths: 160mm, 190mm, 240mm and 280mm. Each nail is made from a solid type 316, ASTM F138, solid stainless steel bar with distal and proximal bends. Each nail has a hole and a slot at the proximal end to accept solid 4.5mm diameter cortical bone screws for fixation and uses rigid distal fins for rotational stability. The SIGN Fin Nail may be removed upon fracture healing.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
femur and humerus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image is a logo for SIGN Fracture Care International. The logo features the word "SIGN" in bold, black letters, with the tagline "Creating Equality of Fracture Care Throughout the World" underneath. To the left of the word "SIGN" is an image of a medical device, possibly an intramedullary nail, with a globe at the top. The globe has some text on it, but it is too small to read.
510(k) Summary of Safety and Effectiveness
SIGN Fin Nail
Contact Information
Doug Donnelly 2950 George Washington Way Richland WA 99352 Phone: (509) 371-1107 Fax: (509) 371-1316 signcom@sign-post.org
| Classification Name: | Rod, Fixation, Intramedullary and Accessories |
|---|---|
| Common Name: | Intramedullary Rod |
| Proprietary Name: | SIGN Fin Nail |
| Proposed Regulatory Class: | Class II, Intramedullary Fixation Rod, |
| 21 CFR §888.3020, OR | |
| Device Product Code: | HSB |
Substantial Equivalence Information
The SIGN Fin Nail is similar to the following Devices: SIGN IM Nail System Howmedica Alta IM Rod System Biomet Brooker Femoral nail Encore True/Flex Upper Extremity Nail
All of the devices listed above are similar in design to the SIGN Fin Nail system. The safety and effectiveness of the SIGN Fin Nail is also based on a long history of use of this type of device in the market place.
Device Description
The SIGN Fin Nail system includes intramedullary nails, Interlocking Screws and Instruments. All components are manufactured from stainless steel. The SIGN Fin Nail is available with diameters of 7mm, 8mm, 9mm, 11mm, 11mm, and 12mm in the following lengths: 160mm, 190mm, 240mm and 280mm. Each nail is made from a solid type 316, ASTM F138, solid stainless steel bar with distal and proximal bends. Each nail has a hole and a slot at the proximal end to accept solid 4.5mm diameter cortical bone screws for fixation and uses rigid distal fins for rotational stability. The SIGN Fin Nail may be removed upon fracture healing.
Indications for use
The SIGN Fin nail is indicated for internal fixation of stable fractures in the femur and humerus.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB = 3 2005
Mr. Douglas J. Donnelly Manager, Regulatory Affairs SIGN, Inc. 2950 George Washington Way Richland, Washington 99352
Re: K043200
Trade/Device Name: SIGN Fin Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: November 15, 2004 Received: November 18, 2004
Dear Mr. Donnelly:
We have reviewed your Section 510(k) premarket notification of intent to market the are died we nave reviewed your becaon - 10(t) personalially equivalent (for the indications felerenced above and nave decemblicate devices marketed predicate devices marketed in interstate for use stated in the enclosure) to regars actment date of the Medical Device Amendments, or 10 commence provide to thay 20, 1978, the encordance with the provisions of the Federal Food. Drug. devices mat have been receissmed in assee approval of a premarket approval application (PMA). and Cosmetic Act (1101) that do not require to the general controls provisions of the Act. The I ou may, dicrerore, market the act include requirements for annual registration, listing of general controls provisions of tactice, 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 If your device is classined (over as controls. Existing major regulations affecting your device can thay be subject to sach additions, 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 i lease oc actived that I Driver and in that your device complies with other requirements of the Act that I Dr Has intatutes and regulations administered by other Federal agencies. You must or any I oderal banks and seeg.
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 CI IT rate 677, adoning (21 CFR Part 820); and if applicable, the electronic forth in the qualis) by our provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
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), please contact the Office of Compliance at (240) 276-0115. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Mikkelson
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
3
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
SIGN Fin Nail Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use: The SIGN Fin nail is indicated for internal fixation of stable fractures in the femur and humerus.
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 OF NEEDED)
Concurrence of CI Device Evaluation (ODE) ign=4 i (Division of General, Restorative, and Neurological Devices K04 3200 510(k) Number-
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Section VI