(85 days)
The Quantum Cement Restrictor is indicated for use as a cement restrictor in the femur, tibia, or humerus. This device is not intended for spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.
The Quantum Cement Restrictor is a generally box-shaped device with various holes located throughout its geometry to hold bone cement. The exterior surface of the device has teeth to help keep the device from migrating once placed in its desired location. It is available in a multitude of sizes to suit the individual pathology and anatomic condition of the patient. The device may be made from titanium, polyetheretherketone (PEEK), or ceramic materials.
This 510(k) summary describes a traditional medical device (cement restrictor), not an AI/ML-enabled device. Therefore, the information requested, such as acceptance criteria, performance metrics, sample sizes for test/training sets, expert involvement, and comparative effectiveness studies, which are standard for AI/ML device evaluations, are not applicable to this submission.
The 510(k) submission for the Quantum Cement Restrictor focuses on demonstrating substantial equivalence to previously cleared predicate devices based on indications for use, design, function, and materials. It does not involve a performance study with acceptance criteria in the way an AI/ML device would.
Here's an breakdown of why the requested information doesn't apply based on the provided document:
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Acceptance Criteria and Reported Device Performance: Not applicable. For a traditional device like this, the "performance" is primarily assessed through design, materials, and functional equivalence to predicates, not through quantitative metrics against a defined acceptance threshold in a clinical or retrospective study. The submission asserts substantial equivalence, which is the "performance" goal for 510(k) devices of this type.
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Sample Size for Test Set and Data Provenance: Not applicable. There is no "test set" in the context of an AI/ML study. The evaluation is based on product specifications and comparison to predicates.
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Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable. There is no ground truth establishment in the context of an AI/ML study. The determination of substantial equivalence is made by the FDA based on the provided documentation and comparison to predicate devices.
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Adjudication Method: Not applicable. There is no data to adjudicate.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not an AI/ML device, so no such study would be conducted.
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Standalone Performance Study: Not applicable. "Standalone performance" in the AI/ML context refers to the algorithm's performance without human intervention. This is a physical device, so the concept does not apply.
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Type of Ground Truth Used: Not applicable.
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Sample Size for the Training Set: Not applicable. There is no training set for a traditional medical device.
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How the Ground Truth for the Training Set was Established: Not applicable.
Summary of Device Evaluation in the Provided Document:
The FDA determined that the Quantum Cement Restrictor is substantially equivalent to legally marketed predicate devices. This determination was based on:
- Indications for Use: As a cement restrictor in the femur, tibia, or humerus.
- Design: Generally box-shaped with various holes and exterior teeth.
- Function: To hold bone cement and resist migration.
- Materials: Titanium, PEEK, or ceramic.
A key part of the FDA's review was to add a warning to the labeling: "THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED." This indicates specific boundaries of the device's acceptable use and indirectly highlights that performance for unintended uses was not established (and explicitly stated could cause harm).
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APR 3 0 2004
510(k) Summary Quantum Cement Restrictor
510(k) Number K046276
| Manufacturer Identification | |
|---|---|
| Submitted by: | Quantum Orthopedics, Inc. |
| 32896 Saint Moritz Drive | |
| Evergreen, CO 80439 | |
| 303-679-8895 | |
| Contact Information: | Jason Blain |
| Chief Technology Officer | |
| Quantum Orthopedics, Inc. | |
| 11662 Corte Guera | |
| San Diego, CA 92128 | |
| 858-451-8698 | |
| jblain@quantumorthopedics.com | |
| Date Prepared: | February 4, 2004 |
| Device Indentification | |
| Proprietary Name: | Quantum Cement Restrictor |
| Common Name: | Cement Restrictor |
| Classification Name: | Surgical Mesh/Prosthesis, Hip, Cement Restrictor |
Predicate Devices
The subject device is substantially equivalent to proviously cleared devices.
Device Description
The Quantum Ccment Restrictor is a generally box-shaped device with various holes located throughout its geometry to hold bone cement. The exterior surface of the device has teeth to help kecp the device from migrating once placed in its desired location. It is available in a multitude of sizes to suit the individual pathology and anatomic condition of the patient. The device may be made from titanium, polyetheretherketone (PEEK), or ceramic materials.
page 1 of 2
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Intended Use of the Device
The Quantum Cement Restrictor is indicated for use as a cement restrictor in the femur, tibia, or humerus.
This device is not intended for spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established
Substantial Equivalence
The Quantum Cement Restrictor was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.
Image /page/1/Picture/6 description: The image shows the text "page 2 of 2" in handwritten form. The word "page" is written in lowercase cursive, followed by the number "2". The phrase "of 2" is written above and to the right of the word "page", also in handwritten form. The handwriting appears to be in black ink on a white background.
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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 top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 2004
Mr. Jason Blain Chief Technology Officer Quantum Orthopedics, Inc. 11662 Corte Guera San Diego, California 92128
Re: K040276
Device Name: Quantum Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: February 4, 2004 Received: February 6, 2004
Dear Mr. Blain:
We have reviewed your Section 510(k) pre-market notification of intent to market the device referenced above and we 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 (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's package insert and also as a Warning on the product label:
WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS.
THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.
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Page 2 - Mr. Jason Blain
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.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
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
Daniel G. Schultz, M.D.
Director Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K040276
Device Name: Quantum Cement Restrictor
Indications For Use:
The Quantum Cement Restrictor is indicated for use as a cement restrictor in the femur, tibia, or humerus.
This device is not intended for spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of C of Device Evaluation (ODE) RH. Office
Mark H. Milken
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K041027 Page 1 of 1
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.