(46 days)
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.
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.
This looks like a 510(k) summary for a medical device that does not involve AI or machine learning. The device, "DSI Pins and Wires," is described as a physical product (implant grade stainless steel pins and wires for bone fixation), not a software algorithm or diagnostic tool.
Therefore, the prompt's request for information related to AI/ML device studies (acceptance criteria table, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training sets, etc.) cannot be answered from the provided text.
The document focuses on:
- Device Description: Physical characteristics and materials.
- Intended Use: Clinical applications.
- Regulatory Classification: Class II medical device.
- Substantial Equivalence: A comparison to existing, legally marketed predicate devices, which is the standard regulatory pathway for similar physical devices.
There is no mention of any software, AI, or performance studies that would generate the kind of data requested in the prompt. The "performance" for such a device would typically relate to mechanical strength, biocompatibility, and sterilization validation, not the diagnostic accuracy of an algorithm.
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510(k) Summary
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| Submitted by: | Delta Surgical Instruments, Inc.95 Schunnemunk RoadHighland Mills, NY 10930 |
|---|---|
| Dandenia ZabatQuality Assurance / Regulatory Manager845-928-3760 | |
| Date prepared: | March 10, 2006 |
| Classification Name: | Class II, 888.3040 - Smooth or Threaded Metallic BoneFixation Fasteners |
| Common Name: | Bone Fixation Devices |
| Proprietary Name: | DSI Pins and Wires |
| Substantial Equivalence: | Comparative information presented supports substantialequivalence. |
| Description: | DSI Pins and Wires consist of various pins and wires foruse in the fixation of bone fractures, bone reconstruction, oras a guide/aid for insertion of other medical devices. AllDSI Pins and Wires included in this submission aremanufactured of implant grade stainless steel. All DSI Pinsand Wires included in this submission will be marketednon-sterile. Kirschner Wires, Steinmann Pins and CerclageWires are included in this submission. |
| Intended Use: | DSI Pins and Wires are non-sterile, single-use pins andwires intended to be used for the fixation of bone fractures,bone reconstruction, or as a guide/aid for the insertion ofother medical devices. |
| Materials: | 316 implant grade stainless steel |
:
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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
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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
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Indications for Use
<060654 510(k) Number (if known):
Device Name: D DSI Pins and Wires
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.
Prescription Use X (Part 21 CFR Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Neil
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
K660654 510(k) Number
§ 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.