(71 days)
Not Found
No
The summary describes a purely mechanical implant (staple) for fracture fixation and makes no mention of any software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a humeral staple intended for fixation of proximal humerus fractures, which is a structural support device rather than a device that delivers therapy or has a therapeutic effect on a disease or condition itself. Its function is mechanical stabilization.
No
Explanation: The device, "Humeral staples," is described as being for "fixation of two-part proximal humerus fractures and three-part proximal humerus fractures." This indicates a therapeutic or corrective function (fixation), not a diagnostic one (identifying or characterizing a condition).
No
The device description clearly states it is a physical implantable staple made of metal (Stainless Steel or Titanium) for fracture fixation, which is a hardware device.
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, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the humeral staples are "designed for intramedullary implantation in the proximal humerus." This means they are surgically implanted within the body.
- Intended Use: The intended use is for "fixation of two-part proximal humerus fractures and three-part proximal humerus fractures." This is a structural and mechanical function within the body, not an analysis of bodily specimens.
The device described is a surgical implant used to stabilize bone fractures, which falls under the category of surgical devices or orthopedic implants, not IVDs.
N/A
Intended Use / Indications for Use
Humeral staples are intended for fixation of two-part proximal humerus fractures and three-part proximal humerus fractures in conjunction with limited internal fixation such as suture wire. The device is intended for single use.
Product codes
HTY
Device Description
Humeral staples are manufactured from either Stainless Steel (ASTM F 138) or Titanium (ASTM F 1472). The staple features two trocar point ends and suture holes. The staple is designed for intramedullary implantation in the proximal humerus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal 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
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)
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
JUL 3 0 2004
510(K) SUMMARY HUMERAL STAPLE
Koy/1355
page 1 of 1
SUBMITTER'S NAME: SUBMITTER'S ADDRESS: SUBMITTER'S TELEPHONE NUMBER: CONTACT PERSON: DATE SUMMARY PREPARED: TRADE OR PROPRIETARY DEVICE NAME: COMMON OR USUAL NAME: CLASSIFICATION NAME: DEVICE CLASS: PANEL CODE:
Smith & Nephew, Inc., Orthopaedic Division 1450 Brooks Road, Memphis, TN 38116 901-399-6670 John Reabe March 8, 2004 Humeral Staple Intramedullary fixation fastener Smooth or threaded metallic bone fixation fastener Class II Orthopedic/87
DEVICE INFORMATION:
INTENDED USE:
Humeral staples are intended for fixation of two-part proximal humerus fractures and three-part proximal humerus fractures in conjunction with limited internal fixation such as suture wire. The device is intended for single use.
Humeral stables are manufactured from either Stainless Steel (ASTM F 138) or Titanium (ASTM F 1472). The staple features two trocar point ends and suture holes. The staple is designed for intramedullary implantation in the proximal humerus.
DEVICE DESCRIPTION:
Humeral staples are manufactured from either Stainless Steel (ASTM F 138) or Titanium (ASTM F 1472). The staple features two trocar point ends and suture holes. The staple is designed for intramedullary implantation in the proximal humerus.
SUBSTANTIAL EQUIVALENCE INFORMATION:
The humeral staple is similar to the DePuy ACE, Inc., The Nancy Nail (K032687); Synthes, Elastic Intramedullary Nail (K971783); Smith & Nephew, Inc., Ender Nail (K811002); and Smith & Nephew. Inc., Steinman Pin (preamendment device) in that all the devices are made of stainless steel or titanium, offered in similar diameters and lengths, and have similar indications related to long bone or extremity fractures.
The humeral staple is substantially equivalent to the other predicate devices. The difference between the humeral staple and predicate devices is the humeral staple is U-shaped and the other products are not U-shaped, but are used in multiples.
SUMMARY OF TECHNOLOGICAL COMPARISON:
The humeral staple is substantially equivalent to the predicate devices listed in the previous section in terms of material, indications for use and design.
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Image /page/1/Picture/1 description: The image shows a logo with a stylized bird inside of a circle. The bird is composed of three curved lines that suggest movement or flight. The circle surrounding the bird is not a solid line but appears to be made up of smaller, possibly dashed, segments. The logo is in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2004
Mr. John Reabe Director, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116
Re: K041355
Trade/Device Name: Humeral Staple Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HTY Dated: May19, 2004 Received: May 20, 2004
Dear Mr. Reabe:
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.
2
Page 2 -- Mr. John Reabe
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter maification. The FDA finding of substantial equivalence of your device to a legally prematted 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 (301) 594-4659. 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 other Ectorers, 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. Milliken
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
Kodi 35 > 510(k) number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Humeral Staple
Indications for Use:
Humeral staples are intended for fixation of two-part proximal humerus fractures and Humoral blapios are internes in conjunction with limited internal fixation such as suture wires. The device is intended for single use.
(Please Do NoT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)
Mark N. Millerson
Sion-(Division Division of General, Restorative, and Neurological Devices
510(k) Number K041353