(15 days)
Not Found
No
The summary describes a traditional bone plate and screw system for fracture fixation and does not mention any AI/ML components or functionalities.
No
A therapeutic device is used to treat or cure a disease or condition. This device is used for fixation during fractures, fusions, and osteotomies, which are surgical procedures, not treatments in themselves. It aids in the healing process but doesn't "treat" the underlying condition as a drug or radiation therapy would.
No
Explanation: The device is a bone plate and screw system for fixation during fractures, fusions, and osteotomies of the scapula. It is an orthopedic implant used for treatment, not for diagnosing conditions.
No
The device description explicitly states it consists of bone plates and screws, which are hardware components. It also mentions instruments for insertion. This is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that the Acumed Scapula Congruent Bone Plate System consists of "bone plates and screws" used for "fixation during fractures, fusions, and osteotomies for the scapula." These are implanted devices used directly on the bone.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or any diagnostic function.
This device is a surgical implant used for orthopedic procedures, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Acumed Scapula Congruent Bone Plate System is indicated for use in providing fixation during fractures, fusions, and osteotomies. The Acumed Scapula Congruent Bone Plates plates and screws designed specifically for the scapula.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Acumed Scapula Congruent Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. All plates and screws are manufactured from titanium in conformance with ASTM F67 and ASTM F136. Plates and screws are provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scapula
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)
An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable.
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.
Acumed LLC Congruent Bone Plate System K012655, Synthes (USA) One-Third Tubular DCL Plate K011335
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
KOS1083
MAY 1 2 2005
அடிப்பு
]
5885 N.W. Cornelius Pass Road, Hillsboro, Oregon 97124-9432
Tel (503) 627-9957
510(k) Summary
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter Information: | Acumed LLC |
|---|---|
| 5885 N.W. Cornelius Pass Road | |
| Hillsboro, OR 97124-9432 | |
| USA | |
| Phone: (503) 627-9957 | |
| FAX: (503) 686-7102 | |
| Contact: Ed Boehmer, Regulatory & Documentation Supervisor |
| Classification Name: | Single/multiple Component Metallic Bone Fixation Appliances and
Accessories |
|----------------------------------------|-----------------------------------------------------------------------------------------------------|
| Common Name: | Plate, Fixation, Bone |
| Proprietary Name: | Acumed Scapula Congruent Bone Plate System |
| Proposed Regulatory Class: | Class II, 21 CFR 888.3030 |
| Device Product Code: | HRS |
| Legally Marketed Equivalent Device(s): | Acumed LLC Congruent Bone Plate System K012655
Synthes (USA) One-Third Tubular DCL Plate K011335 |
Device Description: The Acumed Scapula Congruent Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. All plates and screws are manufactured from titanium in conformance with ASTM F67 and ASTM F136. Plates and screws are provided non-sterile.
Intended Use: The Acumed Scapula Congruent Bone Plate System is indicated for use in providing fixation during fractures, fusions, and osteotomies. The Acumed Scapula Congruent Bone Plates plates and screws designed specifically for the scapula.
These are similar to intended use of predicate devices and do not raise new issues of safety and effectiveness.
Technological Characteristics: The Acumed Scapula Congruent Bone Plate System are made out of Titanium as per ASTM F136. The predicates devices listed use Titanium as per ASTM F67 and ASTM F136.
An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable.
Based upon the similarities of the Acumed Scapula Congruent Bone Plate System and the predicate devices studied, the safety and effectiveness of the Acumed Scapula Congruent Bone Plate System is substantially equivalent to the predicate devices referenced.
1
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 stylized eagle or bird-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 2 2005
Mr. Ed Boehmer Regulatory and Documentation Supervisor Acumed. LLC 5885 N.W. Cornelius Pass Road Hillsboro, Oregon 97124-9432
Re: K051083
Trade/Device Name: Acumed Scapula Congruent Bone Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: April 26, 2005 Received: April 27, 2005
Dear Mr. Boehmer:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bocater on (a) the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreate) to tegrees and the Medical Device Amendments, or 10 conninered pror to may 2003 received in accordance with the provisions of the Federal Food, Drug, de nees may nave been room do require approval of a premarket approval application (PMA). alla Cosmetic 71ct (71ct) that ad nevice, subject to the general controls provisions of the Act. The r out may, mercere, market are a Act include requirements for annual registration, listing of general controlo proficious proctice, labeling, and prohibitions against misbranding and adulteration.
ff your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is elaboritia dditional controls. Existing major regulations affecting your device it may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Could of I seems concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised that I Dr b ibeau.that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I cacial stututed and registerients, including, but not limited to: registration and listing (21 Comply with an the Act 31equirements)01); good manufacturing practice requirements as set CFN in the quality systems (21 CFR Part 820); and 1f applicable, the electronic forul in the quality bybiolis (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 – Mr. Ed Boehmer
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ough manies.ing of substantial equivalence of your device to a legally prematics notification. "The PDT Interlig cification 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 If you desire specific advice for your act 100 % or an other more the regulation entitled, Colliact the Office of Comphalled as (= + notification" (21CFR Part 807.97). You may obtain Misolanding by relevelee to promansonsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D.
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use
510(k) Number (if known): K051083
Device Name: Acumed Scapula Congruent Bone Plate System
Indications For Use:
The Acumed Scapula Congruent Bone Plate System provides fixation during fractures, fusions, and osteotomies for the scapula.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hypt. Edwards
(Divisi Division of General, Restorative, and Neurological Devices
510(k) Number K051083
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