(89 days)
Not Found
No
The device description and performance studies focus on the physical properties and equivalence to predicate devices, with no mention of software, algorithms, or AI/ML capabilities.
No
The device aids in fixing bone fractures and reconstruction, which are surgical procedures, but it does not provide therapy itself.
No
The device is a Kirschner wire, explicitly stated as being "indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants." These are therapeutic or interventional functions, not diagnostic ones. There is no mention of it being used to detect, identify, or monitor a medical condition.
No
The device description clearly states it is a metallic wire and details its physical characteristics, material, and sterilization methods, indicating it is a hardware device.
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 physical fixation of bone fractures, bone reconstruction, and as guide pins for surgical procedures. This is a direct surgical intervention on the body.
- Device Description: The device is a metallic wire designed to be physically inserted into bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples to provide diagnostic information. This device is used in vivo (inside the body) for a structural and procedural purpose.
N/A
Intended Use / Indications for Use
The In2Bones® Kirschner wires are indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants. The size of the In2Bones® Kirschner wire chosen should be adapted to the specific indication.
Product codes
HTY, JDW
Device Description
The In2Bones® Kirschner wire is a metallic wire available in four point styles: sharp, partially threaded, lanceolate, both ends sharp. One part is fixed on standard surgical power tool equipment for insertion.
Sizes: The In2Bones® Kirschner wire is available in various diameters (0.8mm to 2.5mm) and length (70mm to 300mm).
Material: The In2Bones® Kirschner wire is manufactured from stainless steel 316LVM, according to ISO 5832-1 and ASTM F138-13. It does not have any coating.
Single use: The In2Bones® Kirschner wire is designed for single use only.
Sterilization: The In2Bones® Kirschner wire is supplied sterile and non-sterile. The sterile In2Bones® Kirschner wire is sterilized using gamma radiation. The non-sterile In2Bones® Kirschner wire must be steam sterilized before use.
Place of use: The In2Bones® Kirschner wire is indicated for use in a hospital, or outpatient surgery center, where sterile field may be created and maintained.
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
hospital, or outpatient surgery center
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)
The In2Bones® Kirschner wires are stainless steel wires with diameters and lengths comparable to those featured in the predicate device systems. The design and indications of the In2Bones® Kirschner wires are substantially equivalent to the predicate devices identified in the 510(k) submission. No new materials or processes are used in the development of this implant. Moreover, the In2Bones® Kirschner wires conform to the international standard ISO 5838-1 (2013). Testing, therefore, is not needed to demonstrate that the subject devices are substantially equivalent to other legally marketed Kirschner wires.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 1, 2016
In2Bones SAS % Norman F. Estrin, Ph.D. Managing Partner Estrin Consulting Group LLC 9109 Copenhaver Drive Potomac, Maryland 20854
Re: K153204
Trade/Device Name: In2Bones® Kirschner Wire Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY, JDW Dated: November 1, 2015 Received: November 4, 2015
Dear Dr. Estrin:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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005_Indications for Use.pdf
Indications for Use
| 510(k) Number (if known): | Not yet assigned K153204 |
|---|---|
| Device Name: | In2Bones® Kirschner wire |
| Indications For Use: | The In2Bones® Kirschner wires are indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants. The size of the In2Bones® Kirschner wire chosen should be adapted to the specific indication. |
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/1 description: The image shows the logo for IN2BONES. The logo is set on a gray oval background. The text "IN2BONES" is in white, with the "2" in orange.
510(k) SUMMARY For In2Bones® Kirschner wire
| Sponsor
identification | In2Bones SAS
28 chemin du Petit Bois
69130 Ecully – France
Phone: +33.4.72.29.26.26
Fax: +33.4.72.29.26.29 |
|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
registration number | 3010470577 |
| Date of preparation | October 28, 2015 |
| Contact person | Norman F. Estrin, Ph.D.
Estrin Consulting Group LLC
9109 Copenhaver Drive
Potomac, MD 20854
Phone: (301) 279-2899
Cell: 240-994-9999
Email: estrin@yourFDAconsultant.com |
| Authorized Agent
in the United States | Norman F. Estrin, Ph.D.
Estrin Consulting Group LLC
9109 Copenhaver Drive
Potomac, MD 20854
Phone: (301) 279-2899
Cell: 240-994-9999
Email: estrin@yourFDAconsultant.com |
| Proprietary Name | In2Bones® Kirschner wire |
| Common name | Osteosynthesis wire |
| Device
classification
regulation | 21 CFR 888.3040: Smooth or threaded metallic bone fixation
fastener
Class II |
| Device Product
Code and Panel | HTY: Pin, Fixation, Smooth
JDW: Pin, Fixation, Threaded
87 orthopedics |
| Device Description | The In2Bones® Kirschner wire is a metallic wire available in four
point styles: sharp, partially threaded, lanceolate, both ends sharp.
One part is fixed on standard surgical power tool equipment for
insertion. |
| | Sizes: The In2Bones® Kirschner wire is available in various
diameters (0.8mm to 2.5mm) and length (70mm to 300mm). |
| | Material: The In2Bones® Kirschner wire is manufactured from
stainless steel 316LVM, according to ISO 5832-1 and ASTM
F138-13. It does not have any coating. |
| | Single use: The In2Bones® Kirschner wire is designed for single
use only. |
| | Sterilization: The In2Bones® Kirschner wire is supplied sterile and
non-sterile. The sterile In2Bones® Kirschner wire is sterilized
using gamma radiation. The non-sterile In2Bones® Kirschner wire
must be steam sterilized before use. |
| | Place of use: The In2Bones® Kirschner wire is indicated for use in
a hospital, or outpatient surgery center, where sterile field may be
created and maintained. |
| Predicate Devices | NEWDEAL K WIRE (K022599)
Syntec-Taichung Non-sterile Kirschner Wires and Steinmann Pins
(K983121) |
| Indications for use: | The In2Bones® Kirschner wires are indicated for fixation of bone
fractures, bone reconstruction, and as guide pins for insertion of
other implants. The size of the In2Bones® Kirschner wire chosen
should be adapted to the specific indication. |
| Comparison of the
indications for use
with the predicate
devices: | The indications for use for the In2Bones® Kirschner wire are
similar to the predicate devices Syntec Taichung Non-sterile
Kirschner Wires and Steinmann Pins (K983121) and NEWDEAL
K WIRE (K983121). |
| Comparison of
Technological
characteristics with
the predicate
devices: | The In2Bones® Kirschner wire is similar to the predicate devices
in regards to insertion, design, size ranges, and materials:
- They all are intended for surgical implantation into bone for
longer than 30 days. - The In2Bones® Kirschner wire has identical design as the
Syntec-Taichung Non-sterile Kirschner Wires and Steinmann Pins
(K983121) predicate, except for the partially threaded self-drilling
tip. The In2Bones® Kirschner wire has the identical design as the
NEWDEAL K WIRE (K022599) predicate, except for the
lanceolate self-drilling tip - The In2Bones® Kirschner has similar size range when compared
to the predicate devices. - The In2Bones® Kirschner wire has similar raw material, when
compared to the NEWDEAL K WIRE (K022599) and Syntec-
Taichung Non-sterile Kirschner Wires and Steinmann Pins
(K983121): all are manufactured from the same type of stainless
steel and meet appropriate ASTM standards. |
| Substantial
Equivalence
Summary: | The In2Bones® Kirschner wire has similar technological
characteristics when compared to the predicate devices
The indications for use, design and sizes available are similar and
any differences do not impact safety and effectiveness. |
| Summary
Performance Data | The In2Bones® Kirschner wires are stainless steel wires with
diameters and lengths comparable to those featured in the
predicate device systems. The design and indications of the
In2Bones® Kirschner wires are substantially equivalent to the
predicate devices identified in the 510(k) submission. No new
materials or processes are used in the development of this implant.
Moreover, the In2Bones® Kirschner wires conform to the
international standard ISO 5838-1 (2013). Testing, therefore, is not
needed to demonstrate that the subject devices are substantially
equivalent to other legally marketed Kirschner wires. |
| CONCLUSION | Based on the evaluations performed, the design and indications of
the In2Bones® Kirschner wires are substantially equivalent to the
predicate devices identified in the 510(k) submission. No new
materials or processes are used in the development of this implant.
The In2Bones® Kirschner wires are acceptable for the applications
requested. |
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