(56 days)
The Acumed Lower Extremity Congruent Plate System provides fixation during fractures, fusions, and osteotomies for the phalanges, metatarsals, tibia and fibula.
The Acumed Lower Extremity Congruent Plate System consists of bone plates and screws for fractures, fusions, and osteotomes: 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 F136. Plates and screws are provided non-sterile.
This document describes a 510(k) submission for the Acumed Lower Extremity Congruent Plate System. The submission aims to demonstrate substantial equivalence to previously marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
As per the 510(k) summary, "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable." Therefore, there are no specific performance acceptance criteria or reported device performance metrics provided in this submission in the way one might expect for a software or diagnostic device.
The "acceptance criteria" in this context are implicitly that the technological characteristics of the new device are substantially equivalent to those of the predicate devices such that it raises no new issues of safety or effectiveness.
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Material Composition: Device is manufactured from a biocompatible surgical-grade material. | Acumed Lower Extremity Congruent Plate System is made out of Titanium as per ASTM F136. Predicate devices use either 316L stainless steel or Titanium as per ASTM F136, demonstrating material equivalence for their stated purpose. |
| Intended Use: Device performs its intended function (fixation during fractures, fusions, osteotomies) in a similar manner to predicate devices. | The Acumed Lower Extremity Congruent Plate System is indicated for use in providing fixation during fractures, fusions, and osteotomies for specific lower extremity bones (phalanges, metatarsals, tarsals, tibia, and fibula). This is stated as "similar to intended use of predicate devices and do not raise new issues of safety and effectiveness." |
| Technological Characteristics: Device design and function are sufficiently similar to predicate devices. | The bone plates are pre-bent to minimize-intraoperative bending, a design feature. No specific performance tests are reported, but the overall design is considered sufficiently similar to predicates to avoid new safety/effectiveness concerns. |
2. Sample Size Used for the Test Set and Data Provenance
This is a submission for a medical device (bone plates and screws), not a diagnostic or AI device that relies on a "test set" of data in the traditional sense. Therefore, there is no test set sample size or data provenance provided. The safety and effectiveness are established through demonstrating substantial equivalence to predicate devices, not through a separate performance study with a test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no test set or ground truth established by experts in this type of submission. The safety and effectiveness are primarily based on material safety standards (ASTM F136), manufacturing processes, and the long-standing safe use of similar predicate devices in the market.
4. Adjudication Method for the Test Set
As there is no test set, there is no adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices or AI algorithms where human readers' performance is being evaluated with and without AI assistance. This submission is for a surgical implant (bone plates and screws).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study was not done. This submission is for a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this type of device is established through:
- Material standards: Conformance to ASTM F136 for titanium, ensuring biocompatibility and mechanical properties.
- Clinical history of predicate devices: The safe and effective use of the legally marketed equivalent devices serves as the primary "ground truth" for the new device as their designs, materials, and intended uses are analogous.
- General understanding of orthopedic fixation principles: The scientific and clinical consensus on the effectiveness of bone plates and screws for fracture fixation, fusions, and osteotomies.
8. The Sample Size for the Training Set
There is no "training set" in the context of this traditional medical device submission.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set", there is no ground truth established for a training set.
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acum
5885 N.W. Cornelius Pass Road, Hillsboro, Oregon 97124-9432
Tel (503) 627-9957
510(k) Summary
This summary regarding 510(k) salcty and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Acumed LLC Submitter Information: 5885 N.W. Cornelius Pass Road Hillsboro, OR 97124-9432 USA Phone: (503) 627-9957 (503) 686-7102 FAX: Contact: Ed Boehmer, Regulatory & Documentation Supervisor
| Classification Name: | Single/multiple Component Metallic Bone Fixation Appliances andAccessories |
|---|---|
| Common Name: | Plate, Fixation, Bone |
| Proprietary Name: | Acumed Lower Extremity Congruent 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 K012655Synthes USA Modular Foot System K001941Synthes USA Cannulated Angle Blade Plate System K974537Depuy Ace Medical Co. Timax Pilon System K982347Synthes USA Calcaneal Plate K020401Depuy Ace Medical Co. Timax Calcaneal Peri-Articular PlateK981775 |
Device Description: The Acumed Lower Extremity Congruent Plate System consists of bone plates and screws for fractures, fusions, and osteotomes: 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 F136. Plates and screws are provided non-sterile.
Intended Use: The Acumed Lower Extremity Congruent Plate System is indicated for use in providing fixation during fractures, fusions, and osteolomies. The Acumed Lower Extremity Congruent Plate System includes plates and screws designed specifically for the phalanges, metatarsals, tarsals, tibia and fibula.
These are similar to intended use of predicate devices and do not raise new issues of safety and effectiveness.
Technological Characteristics: The Acumed Lower Extremity Congruent Plate System are made out of Titanium as per ASTM F136. The predicates devices listed use cither 316L stainless steel or Titanium as per 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 Lower Extremity Congruent Plate System and the predicate devices studied, the safety and effectiveness of the Acumed Lower Extremity Congruent Plate System is substantially equivalent to the predicate devices referenced.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2004
Mr. Ed Boehmer Regulatory and Documentation Supervisor Acumed LLC 5885 N.W. Cornelius Pass Road Hillsboro, Oregon 97124-9432
Re: K033639
K035057
Trade/Device Name: Acumed Lower Extremity Congruent Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HWC Dated: November 14, 2003 Received: November 24, 2003
Dear Mr. Boehmer:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate Tor use stated in the encrosure) to regally the enactment date of the Medical Device Amendments, or 10 commerce print to they 20, 1978, are eccordance with the provisions of the Federal Food. Drug. de necs that have boon reciasined require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, morelore, market and act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may be subject to sacer additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that I'DA's issuance of a substantial equivalence determination docs not mean I Toase be advised that I DPT of issuation its your device complies with other requirements of the Act that 1171 has made a sond regulations administered by other Federal agencies. You must or any I outhal bithe Act's requirements, including, but not limited to: registration and listing (21 ClFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Fart 8077, adomig (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Ed Boehmer
This letter will allow you to begin marketing your device as described in your Scction 510(k) rms letter with anow your to organization 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 If you desire specific arries 101 ) 594-4659. Also, please note the regulation entitled. Connior the Ories of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micrination of your Copymer 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,
Mark n Millerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
510(k) Number (if known): K033639
Device Name: Acumed Lower Extremity Congruent Plate System
Indications For Use:
The Acumed Lower Extremity Congruent Plate System provides fixation during fractures, fusions, and osteotomies for the phalanges, metatarsals, tibia and fibula.
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)
f Mark N. Milken
Division of O
Neurological L
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.