(144 days)
K2M CoCr Wires are intended for:
. Bone fracture fixation
. Osteotomy
Arthrodesis .
Correction of deformity .
Revision procedures when other treatments or devices have been unsuccessful, and, .
Bone reconstruction procedures .
K2M CoCr Wires are single stranded implants, with a diameter of 1.0mm (18 gauge).
Materials: The wires are manufactured from Cobalt Chrome per ASTM standards.
Function: K2M CoCr Wires are single use devices intended for the stabilization of bony segments.
The provided 510(k) summary for the K2M CoCr Wire is for a medical device (orthopedic wire) that is seeking clearance based on substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than on new performance studies with specific acceptance criteria like those often seen for novel AI/software as a medical device (SaMD) products.
Therefore, the document does not contain the information required to populate most of the requested fields regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment. This is because the K2M CoCr Wire is a hardware device, not an AI/SaMD device, and its clearance process does not involve performance studies in the same way.
Here's an explanation of why the requested information is absent and what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance
- Absent. The document does not define specific performance acceptance criteria or report performance metrics in the context of a clinical or analytical study. For hardware devices like this wire, "performance" is often assessed through bench testing (e.g., mechanical strength, corrosion resistance, fatigue life) against established ASTM or ISO standards, and comparison to the predicate device's specifications. While the document states "The K2M CoCr Wires are manufactured in compliance with ASTM F1091," it doesn't list specific acceptance criteria from this standard or detailed test results.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Absent. No test set sample size or clinical data provenance is mentioned because this type of 510(k) clearance does not typically involve clinical data collection for establishing effectiveness, but rather focuses on substantial equivalence based on design, materials, function, and intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Absent. Ground truth establishment by experts is not applicable here as there is no clinical "test set" in the context of diagnostic or predictive performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Absent. Not applicable.
5. 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
- Absent. Not applicable, as this is not an AI/SaMD device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Absent. Not applicable, as this is not an AI/SaMD device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Absent. Not applicable.
8. The sample size for the training set
- Absent. Not applicable, as this is not an AI/SaMD device.
9. How the ground truth for the training set was established
- Absent. Not applicable, as this is not an AI/SaMD device.
What can be extracted from the document regarding "acceptance criteria" and "study":
The "study" in this context is the comparison to a predicate device and demonstration of adherence to recognized standards.
Acceptance Criteria (Implied by Substantial Equivalence):
The primary "acceptance criterion" for this 510(k) submission is to demonstrate substantial equivalence to the predicate device(s). This is achieved by showing that the K2M CoCr Wire is as safe and effective as the predicate based on:
- Identical Intended Use: The intended uses must be the same or highly similar.
- Similar Technological Characteristics: The design, function, materials, and overall technological characteristics must be sufficiently similar to the predicate that any differences do not raise new questions of safety or effectiveness.
- Compliance with Standards: Adherence to recognized consensus standards demonstrates safety and performance.
The "Study" (Demonstration of Substantial Equivalence):
The document itself is the summary of the "study" that proves the device meets the acceptance criteria of substantial equivalence.
-
A table of acceptance criteria and the reported device performance
- Acceptance Criteria:
- Intended Use Equivalence: K2M CoCr Wire's intended uses must match those of the predicate device (Howmedica Orthopedic Wire, K031127).
- Material Equivalence: Must be made from Cobalt Chrome per ASTM standards, similar to predicate.
- Design/Functional Equivalence: Single stranded, 1.0mm (18 gauge) diameter, intended for stabilization of bony segments, with no significant differences from predicate.
- Compliance with Standards: Manufactured in compliance with ASTM F1091.
- Reported Device Performance (as presented for 510(k) purposes):
- Intended Use: Matches predicate (Bone fracture fixation, osteotomy, arthrodesis, correction of deformity, revision procedures, bone reconstruction procedures).
- Material: Cobalt Chrome per ASTM standards.
- Design/Function: Single stranded, 1.0mm (18 gauge) diameter, functions for stabilization.
- Compliance: "The K2M CoCr Wires are manufactured in compliance with ASTM F1091." "There are no significant differences between the K2M wire and other wires currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use."
- Acceptance Criteria:
-
Sample size used for the test set and the data provenance: Not applicable; no clinical test set mentioned.
-
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: No, not applicable.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable.
-
The type of ground truth used: For this device type, "ground truth" is established through engineering specifications, material standards (ASTM F1091), and verified manufacturing processes that ensure the device meets its design requirements and is equivalent to the predicate.
-
The sample size for the training set: Not applicable.
-
How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
K103797 (pg 1/1)
MAY 2 0 2011
510(k) Summary for the K2M CoCr Wire
This 510(k) summary for the K2M CoCr Wire is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.
-
- Submitter :
K2M, Inc. 751 Miller Drive SE, Suite F1 Leesburg, VA 20175 Contact Person : Nancy Giezen K2M, Inc. Telephone: 703-777-3155
- Submitter :
Date Prepared: 12/23/10
- Tradename:
Common Name: Classification Name: Device Product Code: Regulatory Class:
K2M CoCr Wire Orthopedic Wire Bone Fixation Cerclage (21CFR 888.3010) 87 JDQ Class II
-
- Predicate or legally marketed devices which are substantially equivalent :
- Howmedica Orthopedic Wire (K031127) .
-
- Description of the device:
K2M CoCr Wires are single stranded implants, with a diameter of 1.0mm (18 gauge).
Materials: The wires are manufactured from Cobalt Chrome per ASTM standards.
Function: K2M CoCr Wires are single use devices intended for the stabilization of bony segments.
5. Intended Use:
K2M CoCr Wires are intended for:
- . Bone fracture fixation
- . Osteotomy
- Arthrodesis
- . Correction of deformity
- . Revision procedures when other treatments or devices have been unsuccessful, and.
- Bone reconstruction procedures .
-
- Comparison of the technological characteristics of the device to predicate and legally marketed devices : The K2M CoCr Wires are manufactured in compliance with ASTM F1091. There are no significant differences between the K2M wire and other wires currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 2 0 2011
K2M, Inc. % Nancy Giezen 751 Miller Dr. SE Leesburg, VA 20175
Re: K103797
Trade/Device Name: K2M CoCr Wire Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Dated: May 11, 2011 Received: May 13, 2011
Dear-Ms-Giezen :-
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 Part 801); medical device reporting (reporting of medical
{2}------------------------------------------------
Page - 2 - Ms. Nancy Giezen
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
A.S. n
za nxn.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known): K103797 (pq 1/17
Device Name: K2M CoCr Wire
Indications for Use:
K2M CoCr Wires are intended for:
- . Bone fracture fixation
- . Osteotomy
- Arthrodesis .
- Correction of deformity .
- Revision procedures when other treatments or devices have been unsuccessful, and, .
- Bone reconstruction procedures .
| Prescription Use | X |
|---|---|
| ------------------ | --- |
(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)
for M. Melkersen
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103797
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.