(16 days)
Not Found
No
The device description focuses on the mechanical design and materials of a bone fixation plate, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is described as a surgical implant (plate) used for fixation of fractures, which is a structural support and not a device that provides therapy for a disease or condition.
No
The device description clearly states it is a "plate" used for "fixation of metaphyseal fractures," indicating it is an orthopedic implant for treatment, not diagnosis. Its function is to stabilize bone fractures, and there is no mention of it acquiring or analyzing patient data for diagnostic purposes.
No
The device description clearly describes a physical implantable plate with specific dimensions, materials (implied by "low profile"), and features designed to engage bone, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device's purpose as the fixation of bone fractures in various anatomical locations. This is a surgical intervention, not a diagnostic test performed on biological samples.
- Device Description: The description details a physical implant (a plate with spikes and a screw hole) designed to be surgically placed to stabilize bone. This is consistent with a medical device used for treatment, not diagnosis.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
- Fixation of Metaphyseal Fractures of the Distal Tibia
- Proximal Metaphyseal Tibial Fractures
- Calcaneus Body Fractures
- Proximal Humeral Head/Shaft Fractures
- Distal Femur Fracture -- Comminuted Shaft Fractures
Product codes (comma separated list FDA assigned to the subject device)
HRS, HTN
Device Description
The DePuy ACE Spider Plate is a low profile, "one-hole plate" design with a family of diameters to account for various fracture locations and spiked projections to engage the metaphyseal bone in any anatomic region. Five different overall diameters (three small, two large) have been designed to provide adequate clinical flexibility. The top profile has an overall diameter with a central hole for screw fixation; two of the washers have an offset screw hole with an additional k-wire hole. There are eight radiused cutouts producing eight arms that are designed to engage the metaphyseal bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Metaphyseal Fractures of the Distal Tibia, Proximal Metaphyseal Tibial Fractures, Calcaneus Body, Proximal Humeral Head/Shaft, Distal Femur Fracture
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)
Not Found
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.
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
DEC 31 1998
Image /page/0/Picture/2 description: The image shows the logo for DePuy ACE. The logo consists of a black circle on the left, followed by the text "DePuy ACE" in black, bold letters. The letters are sans-serif and the word "ACE" is slightly smaller than "DePuy". There is a trademark symbol to the right of the letter E.
510(k) SUMMARY
NAME OF FIRM:
510(k) CONTACT PERSON:
DePuy ACE Medical Company 2260 East El Segundo Boulevard El Segundo. CA 90245
Kathleen Dragovich Regulatory Affairs Specialist DePuv ACE Medical Company 310 414-6257
TRADE NAME:
COMMON NAME:
CLASSIFICATION:
DEVICE CODE:
SUBSTANTIALLY EQUIVALENT DEVICE:
DePuy ACE Spider Plate
Plate, Fixation, Bone
888.3030 Single/Multiple component metallic bone fixation appliances and accessories
87HRS
Acumed Suture Washer DePuy ACE Orthopaedic Washer
INTENDED USE:
- · Fixation of Metaphyseal Fractures of the Distal Tibia
- · Proximal Metaphyseal Tibial Fractures
- · Calcaneus Body Fractures
- · Proximal Humeral Head/Shaft Fractures
- · Distal Femur Fracture -- Comminuted Shaft Fractures
DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:
The DePuy ACE Spider Plate is a low profile, "one-hole plate" design with a family of diameters to account for various fracture locations and spiked projections to engage the metaphyseal bone in any anatomic region. Five different overall diameters (three small, two large) have been designed to provide adequate clinical flexibility. The top profile has an overall diameter with a central hole for screw fixation; two of the washers have an offset screw hole with an additional k-wire hole. There are eight radiused cutouts producing eight arms that are designed to engage the metaphyseal bone.
The Acumed Suture Washer (K965028) is intended for small and large bone fixation and is used in conjunction with a titanium bone screw. The DePuy ACE Spider Plate and the Acumed Suture Washer are similar in design and function. Based on the above, DePuy ACE Medical Company considers the DePuy ACE Spider Plate to be substantially equivalent to the Acumed Suture Washer.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the bird figure in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 3 1 1998
Mr. Paul Doner Director, Regulatory and Clinical Affairs DePuy ACE Medical Company 2260 East El Segundo Boulevard El Segundo, California 90245-4694
K984458 Re: Spider Plate Regulatory Class: II Product Codes: HRS and HTN Dated: December 11, 1998 Received: December 15, 1998
Dear Mr. Doner:
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 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). 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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.
2
Page 2 - Paul Doner
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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours.
Russell J. Pagano
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
Image /page/3/Picture/0 description: The image shows the logo for DePuy ACE. The logo consists of a black circle followed by the text "DePuy ACE" in a bold, sans-serif font. The letters are all capitalized, and the "TM" symbol is located in the bottom right corner of the "E" in "ACE". The logo is simple and professional, and the black color gives it a strong and authoritative look.
510(k) Number (if known)
DePuy ACE Spider Plate Device Name:
Indication for User:
- · Fixation of Metaphyseal Fractures of the Distal Tibia
- · Proximal Metaphyseal Tibial Fractures
- · Calcaneus Body Fractures
- · Proximal Humeral Head/Shaft Fractures
- Distal Femur Fracture Comminuted Shaft Fractures
Concurrence of CDRH, Office of Device Evaluation
Prescription Use
(Per 21 CFR 801.109) X
OR
Over-The-Counter
Russell V. Payano for cmw
(Division Sign-Off) Division of General Re: 510(k) Number