(135 days)
Not Found
Not Found
No
The summary describes an external fixator system and its MR compatibility, with no mention of AI or ML.
Yes
The device, an external fixator, is indicated for fracture fixation, arthrodesis, limb lengthening, osteotomy, and reconstruction, all of which are therapeutic interventions.
No
Explanation: The device is indicated for fracture fixation, arthrodesis, limb lengthening, osteotomy, reconstruction, and correction of defects/deformities. These are all therapeutic and structural interventions, not diagnostic ones. The mentions of "MR compatibility" and "MR unsafe" relate to the device's interaction with MRI machines during clinical use, not its function as a diagnostic tool.
No
The device description explicitly states it covers "external fixators," which are hardware devices used for bone fixation. The submission focuses on the performance of these hardware devices in an MR environment.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided information clearly describes a device used for external fixation of long bone fractures. This is a surgical procedure performed directly on the patient's body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing.
Therefore, based on the provided information, this device falls under the category of a surgical implant/device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Indicated for open and closed long bone fracture fixation to include tensioned wire fixation of periarticular fractures, arthrodesis, limb lengthening, osteotomy, reconstruction, non-unions, pseudoarthrosis, correction of bony or soft tissue defects and deformities.
Product codes (comma separated list FDA assigned to the subject device)
KTT, JDW
Device Description
This submission covers DePuy Orthopaedics' external fixators and their performance in the MR environment. The ACE-Fischer system is classified as MR Unsafe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bone
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)
Evaluation was done based on ASTM F2052 to determine MR compatibility.
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.
The devices are substantially equivalent to their currently marketed versions.
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.
Not Found
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
| Submitted by: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, IN 46581
Phone: (305) 269-6386
Fax: (305) 269-6441 |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Suzana Otaño, Project Manager, Regulatory Affairs |
| Date Prepared: | August 1, 2011 |
| Proprietary Name: | ACE-Fischer® External Fixation System |
| Common Name: | External Fixation Systems |
| Classification Name: | Appliance, fixation, nail/blade/plate combination, multiple
component (21 CFR § 888.3030), KTT; Smooth or threaded metallic
bone fixation fastener (21 CFR § 888.3040), JDW |
| Predicate Devices: | The devices are substantially equivalent to their currently marketed
versions. |
| Device Description: | This submission covers DePuy Orthopaedics' external fixators and
their performance in the MR environment. The ACE-Fischer system
is classified as MR Unsafe. |
| Indications for Use: | Indicated for open and closed long bone fracture fixation to include
tensioned wire fixation of periarticular fractures, arthrodesis, limb
lengthening, osteotomy, reconstruction, non-unions,
pseudoarthrosis, correction of bony or soft tissue defects and
deformities. |
| Technological
Characteristics: | The technological characteristics of the devices that are the subject
of this submission remain unchanged from the predicate in design,
material and performance. |
| Summary of
Substantial
Equivalence: | The products that are the subject of this submission are
equivalent to the predicates and the design and
technological characteristics remain unchanged. Evaluation
was done based on ASTM F2052 to determine MR
compatibility. |
Page 1 of 1
DEC 1 5 2011
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DePuy Orthopaedics, Inc. % Ms. Suzana Otaño Senior Regulatory Affairs Specialist 700 Orthopaedics Drive Warsaw. Indiana 46581-0988
DEC 1 5 2011
Re: K112218
Trade/Device Name: ACE-Fischer External Fixator Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT. JDW Dated: August 25, 2010 Received: August 26, 2010
Dear Ms. Otaño:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
2
Page 2 - Ms. Suzana Otaño
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/ResourcesforYou/Industry/default.htm.
Sincerely vou
for
Mark N. Mel Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section 4 – Indications for Use Statement
| 510(k) Number: | K112218 |
|---|---|
| Device Name: | ACE-Fischer External Fixation System |
| Indications For Use: | Indicated for open and closed long bone fracture fixation to include tensioned wire fixation of periarticular fractures, arthrodesis, limb lengthening, osteotomy, reconstruction, non-unions, pseudoarthrosis, correction of bony or soft tissue defects and deformities. |
| Prescription Use (Per 21 CFR 801 Subpart D) | X |
| AND/OR Over-the-Counter (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for MXU
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
: 1 - 1 - 1 - 1 - 1 -
510(k) Number K112218
Page 1 of 1
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