(56 days)
When used as a vertebral body replacement, the Crystal device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft. When used as an intervertebral body fusion device, the Crystal device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.
Spinal Elements' Crystal device is a generally box-shaped devices with various holes located throughout its geometry and teeth on the superior and inferior surfaces. The device may be made from titanium alloy (Ti-6Al-4V) or polyetheretherketone (PEEK).
Here is an analysis of the provided 510(k) summary regarding the Crystal® device:
Acceptance Criteria and Device Performance Study for Crystal®
The provided document describes a 510(k) premarket notification for the Crystal® Intervertebral Body Fusion Device. It outlines the device's description, intended use, and a claim of substantial equivalence. However, it does not explicitly detail acceptance criteria or a clinical study proving device performance against those criteria in the way a typical AI/software device submission would.
For medical devices, particularly those claiming substantial equivalence, the "acceptance criteria" are often implied by meeting the performance characteristics of the predicate device(s) and relevant FDA guidance. The "study" typically refers to specific testing (mechanical, biocompatibility, etc.) that demonstrates the device's safety and effectiveness for its intended use, aligning with the performance of predicate devices.
Based on the provided text, here is the information:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not provide a table of explicit acceptance criteria or detailed performance metrics from a clinical study. Instead, it states that the device was found substantially equivalent to predicate devices based on mechanical testing. The "acceptance criteria" can be inferred as meeting the mechanical performance standards of similar legally marketed intervertebral body fusion devices.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Biomechanical/Mechanical Performance: Capable of performing in accordance with its intended use (stability, load-bearing capacity, fatigue resistance, etc.) as demonstrated by comparison to predicate devices. | "Mechanical testing indicates that the Crystal device is capable of performing in accordance with its intended use." The product was found "substantially equivalent" to predicate intervertebral body fusion devices. |
| Material Biocompatibility: Materials (Ti-6Al-4V or PEEK) are biocompatible and safe for implantation. | (Not explicitly stated as a test result, but implied by the use of commonly accepted medical-grade materials and the substantial equivalence claim). |
| Device Design/Dimensions: Physical characteristics, including holes for bone graft and teeth for stability, are comparable to predicate devices. | "Crystal was shown to be substantially equivalent through comparison to predicate intervertebral body fusion devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of this 510(k) submission. This document describes mechanical testing and a comparison to predicate devices, not a clinical trial with a "test set" of patients.
- Data Provenance: Not applicable. The "data" refers to mechanical test results, which would have been generated in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. There was no "ground truth" derived from human experts in the context of a clinical test set for this type of device submission. Ground truth for mechanical devices is typically established through recognized engineering standards and validated testing methodologies.
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical test set requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. This device is a passive implantable medical device (an intervertebral body fusion device), not an imaging or AI-assisted diagnostic tool that would typically involve an MRMC study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This is a physical medical device, not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.
7. Type of Ground Truth Used
- Mechanical Performance Standards and Predicate Device Characteristics: The "ground truth" for this device's performance would be the established biomechanical properties and safety profiles of legally marketed predicate intervertebral body fusion devices, as demonstrated through adherence to relevant ASTM or ISO standards for spinal implants, and successful performance in preclinical mechanical testing (e.g., compression, shear, fatigue, expulsion resistance).
8. Sample Size for the Training Set
- Not applicable. This is a physical medical device, not a software or AI device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there was no training set.
Summary of the K073351 Filing:
The provided 510(k) summary for the Crystal® Intervertebral Body Fusion Device indicates that substantial equivalence was established through mechanical testing comparing Crystal® to legally marketed predicate intervertebral body fusion devices. The FDA's letter concurs with this determination, allowing the device to be marketed. This type of filing for a physical implantable device relies heavily on engineering data and material science rather than clinical trials with patient populations or studies involving expert consensus on images, which are more common for AI/software devices.
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JAN 2 4 2008
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510(k) Summary Crystal® K073351 510(k) Number
| Manufacturer Identification | |
|---|---|
| Submitted by: | Spinal Elements, Inc. |
| 2744 Loker Ave. W., Suite 100 | |
| Carlsbad, CA 92010 | |
| 760-607-0121 | |
| Contact Information: | Kerri DiMartino |
| Regulatory Affairs Specialist | |
| Spinal Elements, Inc. | |
| 2744 Loker Ave. W., Suite 100 | |
| Carlsbad, CA 92010 | |
| 760-607-1816 | |
| kdimartino@spinalelements.com | |
| Date Prepared: | November 28, 2007 |
| Device Indentification | |
| Proprietary Name: | Crystal® |
| Common Name: | Intervertebral Body Fusion Device |
| Device Classification: | 21 CFR 888.3080 (orthosis, spinal intervertebral |
| fusion) |
Device Description
Spinal Elements' Crystal device is a generally box-shaped devices with various holes located throughout its geometry and teeth on the superior and inferior surfaces. The device may be made from titanium alloy (Ti-6Al-4V) or polyetheretherketone (PEEK).
Intended Use of the Device
When used as a vertebral body replacement, the Crystal device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft
When used as an intervertebral body fusion device, the Crystal device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with
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Spinal Elements, Inc. Premarket Notification - Crystal®
Page 2 of 2
degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.
Substantial Equivalence
Crystal was shown to be substantially equivalent through comparison to predicate intervertebral body fusion devices.
Performance Data
Mechanical testing indicates that the Crystal device is capable of performing in accordance with its intended use.
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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 and Human Services. The logo consists of a stylized eagle with three tails, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2008
Spinal Elements, Incorporated c/o Ms. Kerri DiMartino Regulatory Affairs Specialist 2744 Loker Avenue West, Suite 100 Carlsbad, CA 92010
Re: K073351
Trade/Device Name: Crystal Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: November 28, 2007 Received: November 29, 2007
Dear Ms. DiMartino:
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 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.
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Page 2 - Ms. Kerri DiMartino
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Mark M. Mckesson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K073351
Page 1 of 1
Indications for Use
K073351 510(k) Number (if known):
Crystal® Device Name:
Indications for Use:
When used as a vertebral body replacement, the Crystal device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.
When used as an intervertebral body fusion device, the Crystal device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.
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 CDRH. Office of Device Evaluation (ODE)
Mark A. Milliman
Page 1 of 1
Division of General, Restorative, corological Devices
510(k) Number K07339
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.