(72 days)
The Acumed Small Bone Locking Rod II System is indicated for use in fractures and osteotomies of the fibula, radius, and ulna. These are similar to intended use of predicate devices and do not raise new issues of safety and effectiveness.
The Acumed Small Bone Locking Rod II is an intramedullary rod with solid and cannulated versions. Rods are manufactured in multiple lengths (110 mm to 270mm) and diameters (3.0 to 4.5 mm). The rod has openings used in conjunction with titanium alloy cortical screws, which lock it in place.
This device, the Acumed Small Bone Locking Rod System II, is a medical implant intended for use in fractures and osteotomies of the fibula, radius, and ulna. The provided 510(k) summary does not contain information about a study proving the device meets specific acceptance criteria based on performance data or clinical/non-clinical tests.
Instead, the submission states that "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable."
The basis for regulatory clearance (Substantial Equivalence) is primarily due to the device's technological characteristics and intended use being similar to legally marketed predicate devices.
Therefore, I cannot populate the table or provide detailed information for points 2 through 9 as requested, because this type of study information is explicitly stated as "not applicable" in the provided document for this device's 510(k) submission.
Here's a summary of what can be extracted based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable | Not applicable |
| (No specific performance criteria or data were assessed for this 510(k) submission.) | (The device's safety and effectiveness were based on substantial equivalence to predicate devices, not on a new performance study.) |
Information that cannot be provided from the text:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no new performance or clinical study data was presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no new performance or clinical study data was presented.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no new performance or clinical study data was presented.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this device is a physical intramedullary rod and not an AI/software device involving reader performance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this device is a physical intramedullary rod.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no new performance or clinical study data was presented.
- The sample size for the training set: Not applicable, as no new performance or clinical study data was presented.
- How the ground truth for the training set was established: Not applicable, as no new performance or clinical study data was presented.
Reasoning from the document:
The 510(k) summary explicitly states: "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable." This indicates that the device's clearance was based on demonstrating "substantial equivalence" to existing predicate devices, rather than on new performance studies with acceptance criteria, test sets, or ground truth establishment. The similarities cited are in intended use and material (titanium 6AL EVI alloy conforming to ASTM F136, similar to predicate devices made of identical titanium alloy or stainless steel).
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31438 Page 1/1
JUL 17 2003
AGUMEDILLC
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) 716-1001 |
| Contact: | Ed Boehmer, Regulatory Specialist |
| Classification Name: | Rod, Fixation, Intramedullary and Accessories |
|---|---|
| Common Name: | Radius, Ulna, and Fibula Rods |
| Proprietary Name: | Acumed Small Bone Locking Rod System II |
| Proposed Regulatory Class: | Class II, 21 CFR 888.3020 |
| Device Product Code: | HSB |
| Legally Marketed Equivalent Device(s): | Acumed Small Bone Locking Rod System K951673Biomet Inc. Titanium Intramedullary Rods Various Sizes K982953Biomet Inc. S.S.T. Small Bone Locking Nail K# unknownEncore Orthopedics Inc. True/Flex Intramedullary Rod K913949 |
Device Description: The Acumed Small Bone Locking Rod II is an intramedullary rod with solid and cannulated versions. Rods are manufactured in multiple lengths (110 mm to 270mm) and diameters (3.0 to 4.5 mm). The rod has openings used in conjunction with titanium alloy cortical screws, which lock it in place.
Intended Use: The Acumed Small Bone Locking Rod II System is indicated for use in fractures and osteotomies of the fibula, radius, and ulna. These are similar to intended use of predicate devices and do not raise new issues of safety and effectiveness.
Technological Characteristics: The Acumed Small Bone Locking Rods II are slightly bowed rods made from titanium 6AL EVI alloy in conformance with ASTM F136. The predicate devices are made of identical titanium alloy or stainless steel. Both titanium alloy and stainless steel have been successfully used in numerous intramedullary rods. There are no technological characteristics that raise new issues of safety or effectiveness.
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 Small Bone Rod II System and the predicate devices studied, the safety and effectiveness of the Acumed Small Bone Rod II System is substantially equivalent to the predicate devices referenced.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles connected to three wave-like shapes, which is a common symbol associated with the department.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 2003
Mr. Ed Boehmer Regulatory Specialist Acumed LLC 5885 N.W. Cornelius Pass Road Hillsboro, Oregon 97124
Re: K031438
Trade Name: Small Bone Locking Rod System II Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: May 1, 2003 Received: May 6, 2003
Dear Mr. Boehmer:
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 provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting 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 (PMA), 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 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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1 Page
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Small Bone Locking Rod System II Device Name:
Indications For Use:
The Acumed Small Bone Locking System II and accessories are designed specifically for fractures and osteotomies of the fibula, radius, and ulna.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Milliken
storative
510(k) Noran
(Optional Format 3-10-98)
Page 74 Acumed LLC
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.