(124 days)
No
The device description and summary of performance studies focus on the mechanical properties and components of a bone plating system, with no mention of AI or ML.
Yes.
This device is intended for the management of fractures, fusions, and osteotomies, which are medical conditions that require treatment, thus qualifying it as a therapeutic device.
No
This device is a surgical plating system intended for the management of fractures, fusions, and osteotomies; it is not used to diagnose a medical condition.
No
The device description clearly states it consists of physical components like plates, screws, and k-wires made of titanium, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "management of fractures, fusions, and osteotomies of the distal, middle, and proximal phalanges and metacarpals and other bones of appropriate size". This describes a surgical implant used to fix bones.
- Device Description: The description details plates, screws, lag screws, and k-wires made of titanium. These are physical devices implanted into the body.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
This device is a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Acumed Hand Plating System is intended for the management of fractures, fusions, and osteotomies of the distal, middle, and proximal phalanges and metacarpals and other bones of appropriate size for the devices.
Product codes
HRS, HWC
Device Description
The Hand Plating System consists of plates, locking screws, lag screws, and k-wires.
Plates are available in a variety of shapes to accommodate varying fracture patterns and/or patient anatomy. The plates come in thicknesses of 0.8 mm to 1.3 mm. The locking screws and lag screws have major thread diameters of 1.5 mm to 2.3 mm, provided in lengths ranging from 5 mm to 20 mm. The lag screws and k-wires are used for fixation independent of the plates.
The plates are made of titanium per ASTM F-67. The screws, lag screws, and the k-wires are made of titanium alloy per ASTM F136.
All plates and screws are provided sterile and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal, middle, and proximal phalanges and metacarpals and other bones of appropriate size for the devices.
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)
The non-clinical testing enclosed in this submission includes static and cyclic performance testing and engineering analysis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K062498, K051567, K102537, K090522
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.
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Image /page/0/Picture/0 description: The image shows the word "ACUMED" in a stylized, sans-serif font. The letter "C" has a crosshair design in the center. A circled "R" symbol is present to the right of the word, indicating a registered trademark.
Acumed Hand Plating System - 510(k) Notification
Section 6: 510(k) Summary
| Device Trade Name: | Acumed Hand Plating System |
|---|---|
| Common Name: | Hand Plating System |
| Classification: | 21 CFR 888. 3030, (Single/multiple component metallic bone |
| fixation appliances and accessories ) | |
| Manufacturer: | Acumed, LLC |
| 5885 NW Cornelius Pass Road | |
| Hillsboro, OR 97124 | |
| Contact: | Ms. Mariah Knight |
| Regulatory Specialist | |
| Phone: 503-207-1530 | |
| Fax: 503-520-9618 | |
| Date Prepared: | August 30, 2013 |
| Class: | II |
| Product Code: | HRS, HWC |
| Device Description: | The Hand Plating System consists of plates, locking screws, lag |
| screws, and k-wires. | |
| Plates are available in a variety of shapes to accommodate | |
| varying fracture patterns and/or patient anatomy. The plates | |
| come in thicknesses of 0.8 mm to 1.3 mm. The locking screws | |
| and lag screws have major thread diameters of 1.5 mm to 2.3 | |
| mm, provided in lengths ranging from 5 mm to 20 mm. The lag | |
| screws and k-wires are used for fixation independent of the | |
| plates. | |
| The plates are made of titanium per ASTM F-67. The screws, | |
| lag screws, and the k-wires are made of titanium alloy per ASTM | |
| F136. | |
| All plates and screws are provided sterile and non-sterile. | |
| Intended Use: | The Acumed Hand Plating System is intended for the |
| management of fractures, fusions, and osteotomies of the | |
| distal, middle, and proximal phalanges and metacarpals and | |
| other bones of appropriate size for the devices. | |
| Legally Marketed | |
| Predicate Device(s): | The Hand Plating System has the following predicate devices: |
| Device: Profyle System | |
| 510(k): K062498 | |
| Applicant: Howmedica Osteonics Corp | |
| Product Code: HRS |
ﺴﺴ ـ
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Acumed Hand Plating System - 510(k) Notification
Device: APTUS Titanium Fixation System 510(k): K051567 Applicant: Medartis, Inc. Product Code: HRS Device: APTUS 1.5 TriLock 510(k): K102537 Medartis AG Applicant: Product Code: HRS Device: OsteoMed Hand Plate and Screw Fixation System 510(k): K090522 Applicant: OsteoMed L.P. Product Code: HRS, HWC
Substantial Equivalence:
The Acumed Hand Plating System is substantially equivalent to the previously cleared Howmedica Profyle System (K062498), Medartis APTUS Titanium Fixation System (K051567), Medartis APTUS 1.5 Trilock (K102537), and OsteoMed Hand Plate and Screw Fixation System (K090522). The safety and effectiveness is adequately supported by the substantial equivalence information, materials information, and analysis provided within this Premarket Notification.
The proposed Acumed Hand Plating System and the predicate devices consist of similar design features, operating principles, material of composition, and intended use.
The non-clinical testing enclosed in this submission includes
static and cyclic performance testing and engineering analysis.
Non-Clinical Testing:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with healthcare, with three parallel lines that curve upwards and to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6, 2014
Acumed, LLC Ms. Mariah Knight Regulatory Specialist 5885 Northwest Cornelius Pass Road Hillsboro, Oregon 97124
Re: K132769
Trade/Device Name: Hand Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: November 26, 2013 Received: December 2, 2013
Dear Ms. Knight:
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 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 (QS)
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Page 2 - Ms. Mariah Knight
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 contact 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Ronald Nean -S for
Mark N. Melkerson Director Division of Orthonedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K132769
Indications for Use
Device Name: Hand Plating System Indications for Use:
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The Acumed Hand Plating System is intended for the management of fractures, fusions, and osteotomies of the distal, middle, and proximal phalanges and metacarpals and other bones of appropriate size for the devices.
Prescription Use __ V Over-The-Counter Use _ 'AND/OR (Part 21 CFR 801 Subpart D) (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)
Elizabet标险所rank -S
Division of Orthopedic Devices