(71 days)
The Scandius ACL Reconstruction System is intended for use in fixation of ligament and tendon grafts in cruciate ligament reconstructions.
The ACL Reconstruction System consists of a two piece implant designed to fixation soft tissue for ACL reconstruction. The graft block secures the soft tissue graft. A fixation pin 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.
This 510(k) premarket notification (K041749) for the Scandius ACL Reconstruction System focuses on substantial equivalence to a predicate device, the Depuy Linx HT, rather than establishing de novo acceptance criteria and performing a detailed study to prove the device meets these.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table with explicit, quantifiable acceptance criteria. Instead, it states:
| Criterion | Reported Performance |
|---|---|
| Mechanical Ultimate Failure Strength | "Bench testing demonstrate that any minor technological differences do not raise any new questions of safety and effectiveness." (Implies the Scandius system's ultimate failure strength is comparable to the predicate and safe/effective.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document only mentions "Bench testing."
- Data Provenance: Not specified, but generally, bench testing for medical devices is conducted in a laboratory setting. No country of origin for the data is mentioned, and it's inherently prospective in the sense that the tests are performed on the device being submitted.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. For mechanical bench testing, ground truth is established through validated testing methodologies and equipment, not typically by expert consensus in the way a clinical study's ground truth would be.
- Qualifications of Experts: Not applicable. The "experts" in this context would be the engineers or technicians performing the mechanical tests.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. Since this involves mechanical bench testing and not subjective interpretation, there is no need for an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No. This submission is for a medical device (an ACL reconstruction system) and not an imaging or diagnostic device that would typically involve human readers interpreting cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
- Standalone Performance: Not applicable. This device is an implantable surgical system, not an algorithm.
7. Type of Ground Truth Used:
- Type of Ground Truth: The ground truth for the "ultimate failure strength" would be the objectively measured force at which the device fails, determined by established mechanical testing standards and protocols.
8. Sample Size for the Training Set:
- Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training set" concept does not apply to the mechanical testing of a surgical implant.
9. How the Ground Truth for the Training Set Was Established:
- How Ground Truth Established: Not applicable, as there is no training set.
Summary of Acceptance Criteria and Study Approach in K041749:
The core of this 510(k) submission relies on demonstrating substantial equivalence to a predicate device (Depuy Linx HT). The primary "acceptance criterion" is implicitly that the Scandius ACL Reconstruction System performs at least as well as or similarly to the predicate device in terms of mechanical properties and does not raise new questions of safety or effectiveness.
The "study" conducted for this purpose was bench testing, specifically focusing on "Mechanical ultimate failure strength." The outcome of this testing likely showed that the Scandius system's mechanical strength was comparable to the predicate device, thereby fulfilling the requirement for substantial equivalence. The FDA's letter confirms substantial equivalence, indicating that they were satisfied with the provided performance data in comparison to the predicate.
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Irgelfs
SEP - 8 2004
510(k) SUMMARY
1. SUBMITTER:
Scandius Biomedical, Inc. 11A Beaver Brook Road Littleton, MA 01460
Contact: Eric Bannon, Regulatory Consultant Date Prepared: June 28, 2004
2. DEVICE:
Trade Name: Scandius ACL Reconstruction System Classification Name: Fastener, Fixation, Non-Degradable, Soft Tissue The Product Code: MBI HASC
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 ACL Reconstruction System consists of a two piece implant designed to fixation soft tissue for ACL reconstruction. The graft block secures the soft tissue graft. A fixation pin 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:
- 트 The devices have the same intended and indication for use, have similar technical characteristics and principles of operation.
- The devices use similar implant materials
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K07749 pge >gl
- Bench testing demonstrate that any minor technological differences do not . raise any 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
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2004
Mr. Eric Bannon Regulatory Consultant Scandius BioMedical, Inc. 11A Beaver Brook Road Littleton, Massachusetts 01460
Re: K041749
Trade/Device Name: Scandius ACL Reconstruction System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: June 28, 2004 Received: June 29, 2004
Dear Mr. Bannon:
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 for use stated in the encreative) it stgmy and ment date of the Medical Device American of to conninered processified in accordance with the provisions of the Federal Food, Drug, devices mat have been reciasined require approval of a premarket approval application (PMA). and Cosmetic real (110.) that to neview, subject to the general controls provisions of the Act. The r ou may, mereleve, mains of the Act include requirements for annual registration, listing of general controls proving 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 blussined (600 as cotrols. 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 r loase be devilode that i 1977 minution that your device complies with other requirements of the Act that I Dr has made a and regulations administered by other Federal agencies. You must or any I oderal butther and strequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OFF Part 8077, accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in also qualisms by by the estions 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) I his letter whil anow you to begin manteeing your antial equivalence of your device to a legally premarket notification. The PDA maing of basification 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 ac (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. IMisoranding of reference to pressessibilities under the Act may be obtained from the Other general information on your responsional 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 A Millburn
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):_K (041749
Device Name: Scandius ACL Reconstruction System
Indications for Use: The Scandius ACL Reconstruction System is intended for use in fixation of ligament and tendon grafts in cruciate ligament reconstructions.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Mark N. Milliken
(Division Sign-Off) (Division org-
Neurological Devices
510(k) Number K041749
12
§ 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.