(46 days)
Not Found
Not Found
No
The device description and intended use clearly define the device as physical pins and wires made of stainless steel for bone fixation. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is intended for the fixation of bone fractures and bone reconstruction, which are therapeutic interventions.
No
The device description and intended use state that DSI Pins and Wires are for the fixation of bone fractures, bone reconstruction, or as a guide/aid for the insertion of other medical devices. This describes a therapeutic or surgical tool, not a device used to identify or determine the nature of a disease or condition.
No
The device description explicitly states that the device consists of physical pins and wires made of stainless steel, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of bone fractures, bone reconstruction, or as a guide/aid for the insertion of other medical devices." This describes a surgical or procedural use within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device consists of "pins and wires" made of "implant grade stainless steel." These are physical devices intended for implantation or use during surgery, not reagents, instruments, or systems used to examine specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on sample analysis.
- Using reagents or analytical methods.
Therefore, the DSI Pins and Wires are medical devices intended for surgical or procedural use, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
DSI Pins and Wires are non-sterile, single-use pins and wires intended to be used for the fixation of bone fractures, bone reconstruction, or as a guide/aid for the insertion of other medical devices.
Product codes
HTY, JDW
Device Description
DSI Pins and Wires consist of various pins and wires for use in the fixation of bone fractures, bone reconstruction, or as a guide/aid for insertion of other medical devices. All DSI Pins and Wires included in this submission are manufactured of implant grade stainless steel. All DSI Pins and Wires included in this submission will be marketed non-sterile. Kirschner Wires, Steinmann Pins and Cerclage Wires are included in this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
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)
Not Found
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
510(k) Summary
Page 1 of 1
| Submitted by: | Delta Surgical Instruments, Inc.
95 Schunnemunk Road
Highland Mills, NY 10930 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Dandenia Zabat
Quality Assurance / Regulatory Manager
845-928-3760 |
| Date prepared: | March 10, 2006 |
| Classification Name: | Class II, 888.3040 - Smooth or Threaded Metallic Bone
Fixation Fasteners |
| Common Name: | Bone Fixation Devices |
| Proprietary Name: | DSI Pins and Wires |
| Substantial Equivalence: | Comparative information presented supports substantial
equivalence. |
| Description: | DSI Pins and Wires consist of various pins and wires for
use in the fixation of bone fractures, bone reconstruction, or
as a guide/aid for insertion of other medical devices. All
DSI Pins and Wires included in this submission are
manufactured of implant grade stainless steel. All DSI Pins
and Wires included in this submission will be marketed
non-sterile. Kirschner Wires, Steinmann Pins and Cerclage
Wires are included in this submission. |
| Intended Use: | DSI Pins and Wires are non-sterile, single-use pins and
wires intended to be used for the fixation of bone fractures,
bone reconstruction, or as a guide/aid for the insertion of
other medical devices. |
| Materials: | 316 implant grade stainless steel |
:
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA", indicating the department's name and national affiliation. The seal is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
200 2 8 2005
Delta Surgical Instruments, Inc. c/o Ms. Dandenia Zabat Quality Assurance/Regulatory Manager 95 Schunnemunk Road Highland Mills, New York 10930
Re: K060654
Trade/Device Name: DSI Pins and Wires Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY, JDW Dated: March 10, 2006 Received: March 16, 2006
Dear Ms. Zabat:
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
2
Page 2 - Ms. Dandenia Zabat
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. 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) 276-0120. 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/dsma/dsmamain.html
Sincerely yours.
Neil R.P. Ogden
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3