(91 days)
Not Found
Not Found
No
The device description and performance studies focus on mechanical properties and surgical fixation, with no mention of AI/ML terms or functionalities.
No
The device is described as an implant system for fixation of ligament and tendon grafts, which is a structural support/fixation function rather than a therapeutic (treating disease or illness) function.
No
The device is described as an "Absorbable ACL Reconstruction System" used for fixation of ligament and tendon grafts in cruciate ligament reconstructions. Its function relates to surgical implantation for reconstruction, not to diagnosing a condition or disease.
No
The device description clearly outlines a system composed of physical implants, instrumentation, and a sterilization tray, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of ligament and tendon grafts in cruciate ligament reconstructions." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device is an implantable system used during surgery to secure grafts. This is consistent with a surgical device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The intended use of the Scandius ACL Reconstruction System is for fixation of ligament and tendon grafts in cruciate ligament reconstructions.
The Scandius Absorbable ACL Reconstruction System is intended for use in fixation of ligament and tendon grafts in cruciate ligament reconstructions.
Product codes (comma separated list FDA assigned to the subject device)
MAI, HWC
Device Description
The Absorbable ACL Reconstruction System consists of a two piece implant The Absorbion FOD receible action action. The graft block secures the ucsigned to naution both masic placed transversely to the femoral tunnel secures the graft block in place.
The System includes instrumentation to create the bone tunnel and place the device as well as a sterilization tray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 following performance data was provided in support of the substantial equivalence determination:
- Mechanical ultimate failure strength .
- In-Vitro Analysis .
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.
The predicate device used to determine substantial equivalence for the Scandius ACL Reconstruction System was the Depuy Linx HT.
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
§ 888.3040 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.
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K04.196/ page 14-
OCT 2 0 2004
510(k) SUMMARY
1. SUBMITTER:
Scandius Biomedical, Inc. 11A Beaver Brook Road Littleton, MA 01460
Contact: Eric Bannon, Regulatory Consultant Date Prepared: July 16, 2004
2. DEVICE:
Trade Name: Scandius Absorbable ACL Reconstruction System Trade Name: Doance: Fastener, Fixation, Biodegradable, Soft Tissue The Product Code: MAI
3. PREDICATE DEVICE:
The predicate device used to determine substantial equivalence for the Scandius ACL Reconstruction System was the Depuy Linx HT.
4. DEVICE DESCRIPTION:
The Absorbable ACL Reconstruction System consists of a two piece implant The Absorbion FOD receible action action. The graft block secures the ucsigned to naution both masic placed transversely to the femoral tunnel secures the graft block in place.
The System includes instrumentation to create the bone tunnel and place the device as well as a sterilization tray.
5. INTENDED USE:
The intended use of the Scandius ACL Reconstruction System is for fixation of ligament and tendon grafts in cruciate ligament reconstructions.
6. COMPARISON OF CHARACTERISTICS:
- The devices have the same intended and indication for use; have similar . technical characteristics and principles of operation.
- The devices use different implant materials .
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page 2 of 2
- Bench testing demonstrates that any minor technological differences do not . Benefi to new questions of safety and effectiveness.
7. PERFORMANCE DATA:
The following performance data was provided in support of the substantial equivalence determination:
- Mechanical ultimate failure strength .
- In-Vitro Analysis .
2
Image /page/2/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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 0 2004
Mr. Eric Bannon Regulatory Consultant Scandius BioMedical, Inc. 11A Beaver Brook Road Littleton, Massachusetts 01460
Re: K041961
R041701
Trade/Device Name: Scandius Absorbable ACL Reconstruction System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MAI Dated: July 20, 2004 Received: July 23, 2004
Dear Mr. Bannon:
We have reviewed your Section 510(k) premarket notification of intent to market the device t we nave reviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosure) to regally annual can of the Medical Device American processor and Province commerce proof to May 20, 1978, the cities of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). alle Costiette Act (11ct) that to not requent in the general controls provisions of the Act. The I ou may, merciolo, market the act include requirements for annual registration, listing of general controls provision 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 If your device is classified (600 a00 of ols. Existing major regulations affecting your device can may be subject to base at 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 r that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a aved regulations administered by other Federal agencies. You must of any I outlar statutes and equirements, 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 form in the ation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Eric Bannon
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 (240)276-0120. 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 may be obtained 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,
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):_K o 41 9 b /
Device Name: Scandius Absorbable ACL Reconstruction System
Indications for Use: The Scandius Absorbable ACL Reconstruction System is intended
ed the former of the sense and tander grafts in cruciate ligament reconstructions. Indications for Use: The Scandius Absorbable AUD Recomment of the Scarpent reconstructions.
for use in fixation of ligament and tendon grafts in cruciate ligament reconstruct
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use 22 (Per 21 C.F.R. 801 409) OR
Over-The-Counter Use
Mark A. Muller
(Division Sign-C Division of General, Restorative, and Neurological Devices
510(k) Number_
(Optional Format 1-2-96)
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