(59 days)
Not Found
No
The summary describes a mechanical fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "Fixation Rod System" intended for "treating fractures," which explicitly indicates a therapeutic purpose.
No
Explanation: The "Intended Use" section states that the device is "intended for use in treating fractures," which indicates a therapeutic purpose rather than a diagnostic one.
No
The device description clearly outlines physical components (Transverse Connector Hook, Inner Screw, Transverse Connector Assembly, 3mm Fixation Rod) which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for treating fractures of specific anatomical sites (pelvis, acetabulum, clavicle, scapula, and distal humerus). This is a therapeutic use, not a diagnostic one.
- Device Description: The description details components like rods, hooks, and screws, which are used for mechanical fixation of bones. This aligns with a surgical or orthopedic device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information.
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical support and fixation of fractures.
N/A
Intended Use / Indications for Use
The DePuy Motech PEAK 3mm Fixation Rod System is intended for use in treating fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus.
Product codes (comma separated list FDA assigned to the subject device)
87 HRS
Device Description
The DePuy Motech PEAK 3mm Rod Fixation System is intended for use in treating fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus. The predicate system consists of 3mm rods in various lengths, rod connectors, pin nut, and bone screws. The subject devices consist of a Transverse Connector Hook used to connect the 3mm rods at right angles or transversely across the fracture: an Inner Screw used to hold the rods and hook connectors together; and the Transverse Connector Assembly that consists of the subject Transverse Hook Connector, subject Inner Set Screw, and the predicate 3mm Fixation Rod (K980368).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvis, acetabulum, clavicle, scapula, and distal humerus.
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)
Mechanical testing provided with the premarket notification for the DePuy Motech PEAK 3mm Fixation Rod System exceeds that of the ACE 3.5mm Reconstruction Plate System.
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.
Not Found
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.
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
《关注》
OF SAFETY AND EFFECTIVENESS 510(k) SUMMARY
| NAME OF FIRM: | DePuy, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Arlene C. Saull, RAC
Sr. Submissions Associate
DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, IN 46581-0988 |
| TRADE NAME: | Motech PEAK™ Fixation System |
| COMMON NAME: | Bone Fixation Appliance |
| CLASSIFICATION: | Class II, per 21 CFR, 888.3030: Single/multiple component
metallic bone fixation appliances and accessories. |
| DEVICE PRODUCT CODE: | 87 HRS Plate, Fixation, Bone |
| SUBSTANTIALLY
EQUIVALENT DEVICES: | DePuy Motech PEAK™ 3mm Rod Fixation System
ACE Universal Reconstruction Plates |
INTENDED USE AND DEVICE DESCRIPTION: (The subject devices are part of the DePly Motech PEAK 3mn Rod Fixation System.)
The DePuy Motech PEAK 3mm Rod Fixation System is intended for use in treating fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus. The predicate system consists of 3mm rods in various lengths, rod connectors, pin nut, and bone screws. The subject devices consist of a Transverse Connector Hook used to connect the 3mm rods at right angles or transversely across the fracture: an Inner Screw used to hold the rods and hook connectors together; and the Transverse Connector Assembly that consists of the subject Transverse Hook Connector, subject Inner Set Screw, and the predicate 3mm Fixation Rod (K980368).
BASIS OF SUBSTANTIAL EQUIVALENCE:
The subject devices are made from similar material as the predicate DePuy Motech PEAK 3mm Rod Fixation System, and the predicate ACE Universal Reconstruction Plates. Both predicate systems and the subject devices are intended to treat fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus, using rigid fixation to secure the fracture. Mechanical testing provided with the premarket notification for the DePuy Motech PEAK 3mm Fixation Rod System exceeds that of the ACE 3.5mm Reconstruction Plate System.
0000009
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP I 4 1998
Arlene C. Saull, RAC Senior Submissions Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
K982483 Re: DePuy Motech™ PEAK™ Transverse Connector Trade Name: Requlatory Class: II Product Code: HRS Dated: July 15, 1998 Received: July 17, 1998
Dear Ms. Saull:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Arlene C. Saull, RAC
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device; please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain:html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS
510(k) Number (if known)
PEAKTM Fixation System 3.0mm Device Name
The subject devices (inner screw, transverse connector hook and transverse rod connector assembly) are being added to the 3.0mm PEAK Fixation System.
Indications for Use:
....
The DePuy Motech PEAK 3mm Fixation Rod System is intended for use in treating fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus.
Concurrence of CDRH, Office of Device Evaluation:
Sign Off
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K982483
Prescription Use Over-The Counter Use ____(Per 21 CFR 801.109) OR