(236 days)
Not Found
No
The 510(k) summary describes a mechanical screw system for bone repair and does not mention any AI or ML components or functionalities.
Yes
The device is described as a "screw system" intended to "repair an acute fracture, mal-union or non-union of the clavicle," indicating a direct therapeutic intervention.
No
Explanation: This device is an implantable screw system used for repairing clavicle fractures, not for diagnosing medical conditions.
No
The device description explicitly states it includes "screws with associated instruments," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "repair an acute fracture, mal-union or non-union of the clavicle." This describes a surgical procedure to fix a bone, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The device includes "screws with associated instruments." This is consistent with a surgical implant and tools, not a diagnostic test kit or instrument.
- 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 those samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly intended for surgical intervention to treat a physical injury to the clavicle.
N/A
Intended Use / Indications for Use
The Acumed Clavicle Screw System is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.
Product codes
JDW
Device Description
The Acumed Clavicle Screw System includes screws with associated instruments to repair acute fractures, mal-unions or non-unions of the clavicle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle
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
A cadaver study using the Acumed Clavicle Screw was performed to help demonstrate substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K991649, K934148, K903258, K863734, K792022
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K083144 pg 1 of 2
| 510(k) Summary | JUN 1 6 2009 |
|---|---|
| Contact: | Alyssa Thomas |
| Acumed, LLC | |
| 5885 NW Cornelius Pass Rd. | |
| Hillsboro, OR 97124-9432 | |
| (503) 627-9957 x1294 | |
| FAX: (503) 686-7102 | |
| Device Trade Name: | Acumed Clavicle Screw System |
| Manufacturer: | Acumed, LLC |
| 5885 NW Cornelius Pass Rd. | |
| Hillsboro, OR 97124-9432 | |
| Common Name: | Pin, Fixation, Threaded |
| Classification: | 21 CFR 888.3040 |
| Class: | II |
| Product Code: | JDW |
Indications for Use:
The Acumed Clavicle Screw System is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.
Device Description:
The Acumed Clavicle Screw System includes screws with associated instruments to repair acute fractures, mal-unions or non-unions of the clavicle.
Technological Characteristics:
The screws are made of titanium alloy per ASTM F136. The screw is supplied in multiple diameters and multiple lengths. The predicate devices share these dimensional and material characteristics.
Performance Data:
A cadaver study using the Acumed Clavicle Screw was performed to help demonstrate substantial equivalence. .
A discussion of clinical and non-clinical tests is not applicable.
Acumed LLC Page 5.2a
1
K083144 pg 2 of 2
AGUMED® LLC
5885 NW Cornelius Pass Road, Hillsboro, OR 97124 Phone: (503) 627-9957 Fax: (503) 686-7102
Predicate Device(s):
DePuy Rockwood Clavicle Pin - K991649 True/Flex Clavicle Rod System - K934148 Hagie Pin - K903258 Steinmann, Knowles, and Hagie Pins - K863734 Herbert Bone Screw - K792022
Based upon the similarities of the Acumed Clavicle Screw System and the predicated devices studied, the safety and effectiveness of the Acumed Clavicle Screw System is substantially equivalent to the predicate devices referenced.
Acumed LLC Page 5.3a
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three overlapping wing segments, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
Public Health Service
od and Drug Administratio 200 Corporate Boulevard Rockville MD 20850
JUN 1 6 2009
Acumed, LLC % Ms. Alyssa Thomas 5885 NW Cornelius Pass Road Hillsboro, OR 97124
Re: K083144
Trade/Device Name: Acumed Clavicle Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener accessories Regulatory Class: II Product Code: JDW Dated: May 14, 2009 Received: May 18, 2009
Dear Ms. Thomas:
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, 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 (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 (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.
3
Page 2 - Ms. Alyssa Thomas
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Barbara Buchner
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): KOK 3 | 4 9
Device Name: Acumed Clavicle Screw System
Indications for Use:
The Acumed Clavicle Screw System is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.
Prescription Use _ × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sonitu
Jen (Division Sign-Off) Sign Ofn
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number .