(94 days)
Not Found
No
The summary describes a mechanical external fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for fixation of fractures, arthrodesis, limb lengthening, osteotomy, and correction of deformities and defects, which are all therapeutic interventions.
No
The device is an external fixation system used for treating bone fractures and deformities, not for diagnosing medical conditions.
No
The device description clearly states it is an "External Fixation System," which is a hardware-based medical device used for bone fixation. There is no mention of software being the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the fixation of bone fractures and deformities within the body. This is a surgical/orthopedic application, not a diagnostic test performed on samples outside the body.
- Device Description: The description of a "highly versatile frame" and "modular system" for constructing frames further supports its use as an external fixation device applied to the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The updated ACE-Fischer® External Fixation System is 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
KTT, JDW
Device Description
The updated ACE-Fischer® External Fixation System is a highly versatile frame that can be constructed for applications ranging from simple fractures to complex reconstruction. This modular system can be configured for many different applications.
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)
Equivalence was confirmed through bench testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K801594, K860014, K875012, K955388
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR 2 3 2009
510(k) Summary
| Submitted by: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, IN 46581
Phone: (305) 269-6386
(305) 269-6441
Fax: | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Contact Person: | Suzana Otaño, Project Manager, Regulatory Affairs | |
| Date Prepared: | December 18, 2008 | |
| General
Provisions | The name of the device is: | |
| | Proprietary Name | Common or Usual Name |
| | | |
| | ACE-Fischer External Fixation | Single/multiple component metallic bone |
| | System | fixation appliances and accessories |
| | | |
| Name of Predicate
Devices | The device is substantially equivalent to the currently marketed DePuy ACE-
Fischer External Fixation system that consists of K801594: ACE-Fischer External
Fixation System, K860014: Fischer Wire/Pin Clamp, K875012: ACE-Fischer
Percutaneous Half Pins and K955388: ACE Dupont Composite Rings. | |
| Classification | Class II, 21 CFR 888.3030 and 888.3040 | |
| Performance
Standards | Performance standards have not been established by the FDA under section 514
of the Food, Drug and Cosmetic Act for these devices. | |
| Indications for
Use | The updated ACE-Fischer® External Fixation System is 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. | |
| Device
Description | The updated ACE-Fischer® External Fixation System is a highly versatile
frame that can be constructed for applications ranging from simple fractures to
complex reconstruction. This modular system can be configured for many
different applications. | |
| Biocompatibility | The updated ACE-Fischer® External Fixation System does not require
biocompatibility testing. | |
| Summary of
Substantial
Equivalence | The updated ACE-Fischer® External Fixation System is substantially
equivalent to the predicate devices. Equivalence was confirmed through bench
testing. | |
1
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular fashion around the bird symbol.
MAR 2 3 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Orthopaedics, Inc. % Ms. Suzana Otaño Project Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581
Re: K083789
Trade/Device Name: ACE-Fischer External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and
accessories
Regulation Class: Class II Product Code: KTT, JDW Dated: February 18, 2009 Received: February 19, 2009
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.
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
2
Page 2 - Ms. Suzana Otaño
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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Samghim, m.D. for
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K083789 510(k) Number:
ACE-Fischer® External Fixation System Device Name:
Indications For Use:
The updated ACE-Fischer® External Fixation System is 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) 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)
Sh. Arim, M.D.
storative.
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5100k)
DePuy ACE-Fischer External Fixation System Special 510(k)
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