(28 days)
The DSSTM Stabilization System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudarthrosis).
In addition, the DSSTM Stabilization System is indicated for use in patients:
- . Who are receiving fusions with autogenous graft only;
- Who are having the device fixed or attached to the lumbar or sacral spine; . ●
- Who are having the device removed after the development of a solid fusion mass. .
The DSS™ Stabilization System is comprised of a variety of pedicle screws sizes, and couplers that act as longitudinal spacers that are uniquely fitted for each individual case. The pedicle screws and couplers are manufactured from medical grade titanium alloy (Ti6Al4V).
The provided text is a 510(k) summary for the Paradigm Spine DSS™ Stabilization System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specified acceptance criteria as one might find for a novel drug or a high-risk device.
Based on the provided document, here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Soundness (Implicit based on predicate comparison) | "Testing performed indicate that the DSS™ is as mechanically sound as predicate devices." |
| Indications for Use Equivalence | "DSS™M Stabilization System was shown to be substantially equivalent to previously cleared devices and has the same indications for use..." |
| Design Equivalence | "...design..." |
| Function Equivalence | "...function..." |
| Material Equivalence | "...and materials used." |
Explanation: The acceptance criteria for a 510(k) submission like this are centered around demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device that is not subject to premarket approval. The primary "performance" is its equivalence to existing, cleared devices, particularly in mechanical properties and intended use. Specific quantitative performance metrics or thresholds are not detailed in this summary for the DSS™ system.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not describe a clinical study with a "test set" in the traditional sense of evaluating patient outcomes with the device. The "testing" mentioned refers to mechanical testing.
- Sample Size: Not specified for mechanical testing.
- Data Provenance: Not specified, but generally, mechanical testing data for device submissions originates from laboratory tests, not human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The submission focuses on mechanical equivalence, not human-read interpretations or diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. There's no mention of a test set requiring adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document does not describe an MRMC comparative effectiveness study. The focus is on demonstrating mechanical and functional equivalence to predicate devices, not on comparing performance with and without AI assistance or between different human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This device is a pedicle screw spinal system, a physical implant, not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
The "ground truth" here is the established safety and effectiveness of the identified predicate devices. The DSS™ Stabilization System's acceptability is based on its demonstrated equivalence to these already cleared devices, particularly in mechanical characteristics and intended use.
8. The Sample Size for the Training Set
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
Summary of Device Acceptance:
The Paradigm Spine DSS™ Stabilization System was accepted by the FDA based on a demonstration of substantial equivalence to already legally marketed predicate devices. The key "acceptance criteria" were implied to be:
- Mechanical Soundness: The device performs at least as well mechanically as predicate devices.
- Indications for Use: The device shares the same intended uses as predicate devices.
- Design, Function, and Materials: The device's fundamental aspects are comparable to predicate devices.
The "study" proving this was primarily mechanical testing (which "indicate[s] that the DSS™ is as mechanically sound as predicate devices") and a comparison of the device's characteristics and intended use to those of predicate devices. The specific details of this mechanical testing (e.g., sample size, methods, results) are not provided in this public summary but would have been part of the full 510(k) submission.
A crucial limitation added by the FDA regarding the device's labeling is: "The safety and effectiveness of this device for the indication of spinal stabilization without fusion have not been established." This indicates that while substantial equivalence was found for its use as an adjunct to fusion, its standalone use for stabilization was not supported by the provided evidence.
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Paradigm Spine DSSTM 510(k)
Confidential
MAY - 2 2008
5. 510(k) Summary
| Contact: | Mr. Justin EggletonMusculoskeletal Clinical & Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005202.552.5800 |
|---|---|
| Device Trade Name: | DSSTM Stabilization System |
| Manufacturer: | Paradigm Spine, LLC505 Park Ave. 14th FloorNew York, NY 10022 |
| Classification: | 21 CFR §888.3070, Pedicle screw spinal system |
| Class: | II |
| Product Code: | NOP |
Indications For Use:
The DSSTM Stabilization System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudarthrosis).
In addition, the DSSTM Stabilization System is indicated for use in patients:
- . Who are receiving fusions with autogenous graft only;
- Who are having the device fixed or attached to the lumbar or sacral spine; . ●
- Who are having the device removed after the development of a solid fusion mass. .
Device Description:
The DSS™ Stabilization System is comprised of a variety of pedicle screws sizes, and couplers that act as longitudinal spacers that are uniquely fitted for each individual case. The pedicle screws and couplers are manufactured from medical grade titanium alloy (Ti6Al4V).
Predicate Device(s):
DSS™M Stabilization System was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used.
Performance Standards:
Testing performed indicate that the DSS™ is as mechanically sound as predicate devices.
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Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is centered horizontally. The words are all capitalized and evenly spaced.
DEPARTMENT OF HEALTH & HUMAN SERVICES · USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Musculoskeletal Clinical Regulatory Advisers, LLC % Mr. Justin Eggleton 1331 H Street NW, 12th Floor Washington, DC 20005
MAY - 2 2008
Re: K080963
Trade/Device Name: DSS™ Stabilization System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: NQP Dated: April 3, 2008 Received: April 4, 2008
Dear Mr. Eggleton:
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). 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 labeling:
The safety and effectiveness of this device for the indication of spinal stabilization without fusion have not been established.
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.
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Page 2 - Mr. Justin Eggleton
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 Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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. 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 from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address
http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ashley B. Boan
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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Paradigm Spine DSS™ 510(k)
Confidential
4. Indications for Use
510(k) Number (if known): ____________________
Device Name: DSS™ Stabilization System
The DSSTM Stabilization System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudarthrosis).
In addition, the DSS™ Stabilization System is indicated for use in patients:
- Who are receiving fusions with autogenous graft only; .
- Who are having the device fixed or attached to the lumbar or sacral spine; .
- . Who are having the device removed after the development of a solid fusion mass.
Prescription Use 2 (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)
Mark N. Melkerson
Division of General, Restorative, and Neurological Devices
510(k) Number K080963
N/A