(22 days)
No
The 510(k) summary describes simple bone wires made of standard materials for fracture fixation and guiding implants. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is used for fixation of bone fractures and / or to guide other implants, which is a structural or supportive function, not a therapeutic one that treats or cures a disease.
No
Explanation: The intended use of the device is the fixation of bone fractures and/or to guide other implants, which are therapeutic and guidance functions, not diagnostic.
No
The device description clearly identifies the device as "Bone Wires" made of physical materials (Stainless Steel or Titanium Alloy) and intended for physical implantation and fixation of bone fractures. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "fixation of bone fractures and / or to guide other implants during insertion to the skeletal system." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as "Bone Wire" and includes terms like "Kirschner Wire (K wire), Steinmann Wire, Bonell Wire (Pin), Cerclage Wire." These are all types of surgical implants used in orthopedic procedures.
- Anatomical Site: The anatomical site is the "Skeletal system," which is part of the patient's body.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not involve testing samples from the body.
The information provided clearly indicates that this device is a surgical implant used for treating bone fractures, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The intended use of Störk Instrumente GmbH's Bone Wires is the fixation of bone fractures and / or to guide other implants during insertion to the skeletal system.
Due to their design and used materials, which is either Stainless Steel acc. ASTM F 138 / 139 (316 L) or Titanium Alloy acc. to ASTM F 136, Grade 5, these devices can be used as implants.
Product codes (comma separated list FDA assigned to the subject device)
87 HTY, 87 JDW
Device Description
Trade Name: Bone Wire Common Name: Kirschner Wire (K wire), Steinmann Wire, Bonell Wire (Pin), Cerclage Wire
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system
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): 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.
K983121, K971862, K960385, 961522
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.
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
§ 888.3040 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.
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K...030665.....
510(K) Summary of Safety and EFFECTIVENESS IN Accordance with SMDA of 1990
DATE OF APPLICATION: 2003-02-21
Störk Instrumente GmbH Submitted by:: Engener Straße 29 D-78576 Emmingen/Liptingen Germany Tel.: +49 (7465) 825 Fax: +49 (7465) 2216
1. DEVICE DESCRIPTION
Trade Name: Bone Wire Common Name: Kirschner Wire (K wire), Steinmann Wire, Bonell Wire (Pin), Cerclage Wire
2. Classification
| Device: | Pin, Fixation Smooth | Pin, Fixation, Threaded |
|---|---|---|
| Medical Specialty: | Part 888, Orthopedic | Part 888, Orthopedic |
| Product Code: | 87 HTY | 87 JDW |
| Device Class: | 2 | 2 |
| Regulation Number: | 888.3040 | 888.3040 |
3. INTENDED USE
The intended use of Störk Instrumente GmbH's Bone Wires is the fixation of bone fractures and / or to guide other implants during insertion to the skeletal system.
Due to their design and used materials, which is either Stainless Steel acc. ASTM F 138 / 139 (316 L) or Titanium Alloy acc. to ASTM F 136, Grade 5, these devices can be used as implants.
Störk Instrumente GmbH is offering their Bone Wires only in an Non-Sterile condition.
| Created on: | Updated on: | Index: | File: | Validated by: | |
|---|---|---|---|---|---|
| 2003-02-20 | 0000-00-00 | 01 | 510(k) bone wires_annexl_Summary.doc | Klaus Störk | Page 1 of 2 |
| © MEDACENT GmbH & Co KG 2003 |
C MF-DAGENT GmbH & Co. KG. 2003
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030665 page 2 of st
4. SUBSTANTIAL EQUIVALENCE
Störk Instrumente GmbH's Bone Wires are substantially equivalent to other Bone Wires e.g. Kirschner Wires or Steinmann Pins legally marketed by many companies including
- Syntec-Taichung Co., Ltd., #K983121 트
- Osteonics Corporation, #K971862 .
- . DePuy Inc., #K960385
- . Synvasive Technology Inc., #961522
5. BIOCOMPATIBILITY
The biocompatibility is guaranteed by the composition of the used materials as mentioned in chapter 6. These materials are also used for most other surgical implants as bone screws, bone plates or neuro surgical implants as Aneurysm Clips as mentioned in following 510(k)'s:
- K983758, Aesculap AG, Aesculap Yasargil Titanium Aneurysm Clips; 를
- K000080, Howmedica Osteonics Corp., Asnis III Cannulated Screw System; 트
- I K003500, Rebstock Instruments GmbH, Rebstock Yasargil Aneurysm Clips.
Störk Instrumente GmbH's Bone Wires are only made out of the in chapter 6 mentioned Raw Materials.
Compared with competitors Störk Instrumente GmbH's Bone Wires are made out of similar materials.
6. Sterilization by User
Störk Instrumente GmbH delivers all Bone Wires in Non-Sterile conditions. The user may sterilize these devices by using a validated and applicable sterilization process.
Störk Instrumente GmbH recommends to use a steam-sterilizer that uses a validated sterilization cycle of 134°C / 270°F, 3 bar, for 10 minutes.
| Created on: | Updated on: | Index: | File: | Validated by: | |
|---|---|---|---|---|---|
| 2003-02-20 | 0000-00-00 | 01 | 510(k) bone wires_annexl_Summary.doc | Klaus Störk | Page 2 of 2 |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 2003
Störk Instrumente GmbH c/o Ms. Lori Advids Independent Import Agent Service LLC Subsidiary of the Hirdes Group 7046 Bentley Drive Gurnee, IL 60031
Re: K030665
Trade/Device Name: Bone Wire Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: February 21, 2003 Received: March 3, 2003
Dear Ms. Advids:
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
3
Page 2 - Ms. Lori Advids
forth in the quality systems (OS) 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 (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 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 vours.
Sincerely, yours,
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
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к ... Коздова 5 ...
IFU-STATEMENT
INDICATION FOR USE
The intended use of Stork Instrumente GmbH's Bone Wires is the fixation of bone fractures and I or to guide other implants during insertion to the skeletal system.
Due to their design and used materials, which is either Stainless Steel acc. ASTM F 138 / 139 (316 L) or Titanium Alloy acc. to ASTM F 136, Grade 5, these devices can be used as implants.
Störk Instrumente GmbH delivers all Bone Wires in Non-Sterile conditions. The user may sterilize these devices by using a validated and applicable sterilization process.
Störk Instrumente GmbH recommends to use a steam-sterilizer that uses a validated sterilization cycle of 134°C / 270°F, 3 bar, for 10 minutes.
Mach N. Melkersen
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number.
| Created on: | Updated on: | Index: | File: | Validated by: | |
|---|---|---|---|---|---|
| 2003-02-20 | 0000-00-00 | 01 | 510(k) bone | ||
| wires_annexII_IFU_Statement.doc | Klaus Störk | Page 1 of 1 |