(89 days)
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.
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.
The document provided is a 510(k) summary for a medical device called the "In2Bones® Kirschner wire." It does not present a study with acceptance criteria and device performance results in the context of an AI/algorithm-driven device.
Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, indications for use, and a statement about conformity to an international standard. There is no mention of an AI/algorithm component in this device.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable for this type of device and submission.
- Sample size used for the test set and the data provenance: No test set in the context of an AI/algorithm study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of what the document does provide regarding "performance":
The document states:
- "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."
This indicates that the "performance" verification relies on:
- Substantial equivalence: The device is similar in design, materials, and intended use to already legally marketed devices (NEWDEAL K WIRE (K022599) and Syntec-Taichung Non-sterile Kirschner Wires and Steinmann Pins (K983121)).
- Conformity to international standards: The device conforms to ISO 5838-1 (2013), which is a standard for implantable devices for surgery - metallic materials.
In essence, for this specific K-wire device, the "acceptance criteria" and "proof" presented are based on its similarity to existing devices and adherence to relevant material standards, not on a study with performance metrics in the way one would describe for an AI or diagnostic device.
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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
| Sponsoridentification | In2Bones SAS28 chemin du Petit Bois69130 Ecully – FrancePhone: +33.4.72.29.26.26Fax: +33.4.72.29.26.29 |
|---|---|
| Establishmentregistration number | 3010470577 |
| Date of preparation | October 28, 2015 |
| Contact person | Norman F. Estrin, Ph.D.Estrin Consulting Group LLC9109 Copenhaver DrivePotomac, MD 20854Phone: (301) 279-2899Cell: 240-994-9999Email: estrin@yourFDAconsultant.com |
| Authorized Agentin the United States | Norman F. Estrin, Ph.D.Estrin Consulting Group LLC9109 Copenhaver DrivePotomac, MD 20854Phone: (301) 279-2899Cell: 240-994-9999Email: estrin@yourFDAconsultant.com |
| Proprietary Name | In2Bones® Kirschner wire |
| Common name | Osteosynthesis wire |
| Deviceclassificationregulation | 21 CFR 888.3040: Smooth or threaded metallic bone fixationfastenerClass II |
| Device ProductCode and Panel | HTY: Pin, Fixation, SmoothJDW: Pin, Fixation, Threaded87 orthopedics |
| Device Description | The In2Bones® Kirschner wire is a metallic wire available in fourpoint styles: sharp, partially threaded, lanceolate, both ends sharp.One part is fixed on standard surgical power tool equipment forinsertion. |
| Sizes: The In2Bones® Kirschner wire is available in variousdiameters (0.8mm to 2.5mm) and length (70mm to 300mm). | |
| Material: The In2Bones® Kirschner wire is manufactured fromstainless steel 316LVM, according to ISO 5832-1 and ASTMF138-13. It does not have any coating. | |
| Single use: The In2Bones® Kirschner wire is designed for singleuse only. | |
| Sterilization: The In2Bones® Kirschner wire is supplied sterile andnon-sterile. The sterile In2Bones® Kirschner wire is sterilizedusing gamma radiation. The non-sterile In2Bones® Kirschner wiremust be steam sterilized before use. | |
| Place of use: The In2Bones® Kirschner wire is indicated for use ina hospital, or outpatient surgery center, where sterile field may becreated 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 bonefractures, bone reconstruction, and as guide pins for insertion ofother implants. The size of the In2Bones® Kirschner wire chosenshould be adapted to the specific indication. |
| Comparison of theindications for usewith the predicatedevices: | The indications for use for the In2Bones® Kirschner wire aresimilar to the predicate devices Syntec Taichung Non-sterileKirschner Wires and Steinmann Pins (K983121) and NEWDEALK WIRE (K983121). |
| Comparison ofTechnologicalcharacteristics withthe predicatedevices: | The In2Bones® Kirschner wire is similar to the predicate devicesin regards to insertion, design, size ranges, and materials:- They all are intended for surgical implantation into bone forlonger than 30 days.- The In2Bones® Kirschner wire has identical design as theSyntec-Taichung Non-sterile Kirschner Wires and Steinmann Pins(K983121) predicate, except for the partially threaded self-drillingtip. The In2Bones® Kirschner wire has the identical design as theNEWDEAL K WIRE (K022599) predicate, except for thelanceolate self-drilling tip- The In2Bones® Kirschner has similar size range when comparedto the predicate devices.- The In2Bones® Kirschner wire has similar raw material, whencompared 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 stainlesssteel and meet appropriate ASTM standards. |
| SubstantialEquivalenceSummary: | The In2Bones® Kirschner wire has similar technologicalcharacteristics when compared to the predicate devicesThe indications for use, design and sizes available are similar andany differences do not impact safety and effectiveness. |
| SummaryPerformance Data | The In2Bones® Kirschner wires are stainless steel wires withdiameters and lengths comparable to those featured in thepredicate device systems. The design and indications of theIn2Bones® Kirschner wires are substantially equivalent to thepredicate devices identified in the 510(k) submission. No newmaterials or processes are used in the development of this implant.Moreover, the In2Bones® Kirschner wires conform to theinternational standard ISO 5838-1 (2013). Testing, therefore, is notneeded to demonstrate that the subject devices are substantiallyequivalent to other legally marketed Kirschner wires. |
| CONCLUSION | Based on the evaluations performed, the design and indications ofthe In2Bones® Kirschner wires are substantially equivalent to thepredicate devices identified in the 510(k) submission. No newmaterials or processes are used in the development of this implant.The In2Bones® Kirschner wires are acceptable for the applicationsrequested. |
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§ 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.