(45 days)
The Epicage Interbody Fusion Device is intended for interbody fusion procedures and is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone. Patients should have received six months of non-operative treatment with the devices. The device is intended to be used with supplemental posterior fixation approved for use in the lumbar spine such as Alphatec Spine's Zodiac Polyaxial Spinal Fixation System and/or Illico Posterior Fixation System.
The Epicage System implants are manufactured from implant grade PEEK with a surgical grade titanium alloy pin and 2 tantalum beads to facilitate visualization. The delivery system contains portals in sizes to match the implants sizes and general surgical instruments to assist in preparation and device delivery. The portals are integral to the system and are considered an accessory (Class II) all other instruments are Class I. The system can be used with a mid-line portal for a modified TLIF procedure or an oblique portal for a traditional TLIF approach. The implants of the system are available non-sterilized.
The provided text describes a 510(k) summary for the "Epicage Interbody Fusion System." This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not involve a study evaluating the performance of a device against acceptance criteria in the context of diagnostic accuracy, human reader improvement with AI, or standalone algorithm performance.
Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the information contained in this document. The document discusses engineering and material performance testing of the device itself, not a clinical study on diagnostic or treatment efficacy that would typically involve acceptance criteria for metrics like sensitivity, specificity, or reader improvement.
Here's a breakdown of the information that is available and a note on what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Conducted | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Gamma Sterilization Validation | Not explicitly stated, but implied to meet sterilization standards for medical devices. | Accepted (All testing passed) |
| Sterile Package Performance Validation | Not explicitly stated, but implied to meet packaging integrity standards for sterile medical devices. | Accepted (All testing passed) |
| Static Axial Compression (ASTM F2077) | Not explicitly stated, but implied to meet or exceed the predicate device's performance for static axial compression. | Passed acceptance criteria; substantially equivalent to predicate device. |
| Static Torsion (ASTM F2077) | Not explicitly stated, but implied to meet or exceed the predicate device's performance for static torsion. | Passed acceptance criteria; substantially equivalent to predicate device. |
| Static Shear (ASTM F2077) | Not explicitly stated, but implied to meet or exceed the predicate device's performance for static shear. | Passed acceptance criteria; substantially equivalent to predicate device. |
| Dynamic Axial Compression (ASTM F2077) | Not explicitly stated, but implied to meet or exceed the predicate device's performance for dynamic axial compression. | Passed acceptance criteria; substantially equivalent to predicate device. |
| Dynamic Torsion (ASTM F2077) | Not explicitly stated, but implied to meet or exceed the predicate device's performance for dynamic torsion. | Passed acceptance criteria; substantially equivalent to predicate device. |
| Dynamic Shear (ASTM F2077) | Not explicitly stated, but implied to meet or exceed the predicate device's performance for dynamic shear. | Passed acceptance criteria; substantially equivalent to predicate device. |
| Subsidence (ASTM 2267) | Not explicitly stated, but implied to meet or exceed the predicate device's performance for subsidence. | Passed acceptance criteria; substantially equivalent to predicate device. |
| Expulsion (ASTM Draft F04.25.0202) | Not explicitly stated, but implied to meet or exceed the predicate device's performance for expulsion. | Passed acceptance criteria; substantially equivalent to predicate device. |
| Epicage Portal Evaluation | Not explicitly stated, but implied to meet functional and safety requirements for the delivery system portals. | Passed acceptance criteria. |
| User Validation Cadaver Lab | Not explicitly stated, but implied to demonstrate usability and safety in a simulated surgical environment. | Passed acceptance criteria. |
Note on Acceptance Criteria: For mechanical and sterilization testing, the acceptance criteria are generally established by the referenced ASTM standards and by demonstrating substantial equivalence to the predicate device. The document states, "All testing passed the acceptance criteria and the results were substantially equivalent to the predicate device," but does not explicitly detail the numerical or qualitative thresholds for each criterion beyond meeting the standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes non-clinical performance testing (mechanical, material, sterilization) rather than a clinical study with a patient test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth as typically defined for diagnostic device studies (e.g., expert consensus, pathology) is not relevant for this type of non-clinical engineering and materials testing. The "User Validation Cadaver Lab" involved "users" (likely surgeons or surgical residents) but their role was in evaluating usability, not establishing a diagnostic ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical test set requiring adjudication in the context of diagnostic accuracy.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an interbody fusion system, not an AI-powered diagnostic tool, and therefore no MRMC study comparing human readers with and without AI assistance would have been performed or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical engineering tests, the "ground truth" or reference for comparison would be the established ASTM standards and the performance of the predicate device. For the "User Validation Cadaver Lab," the "ground truth" would be the subjective and objective evaluation of the device's handling and fit during simulated surgical procedures by the users. This is not "ground truth" in the diagnostic sense.
8. The sample size for the training set
Not applicable. This document does not describe a machine learning algorithm or a training set.
9. How the ground truth for the training set was established
Not applicable.
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510(k) Summary
APR 1 8 2013
Submission Date:
Submitter Information:
March 1, 2013
Alphatec Spine 5818 El Camino Real Carlsbad, CA 92008
Ph# (760) 431-9286 Fax# (760) 431-0289
Nadine Smith Senior Regulatory Affairs Specialist Ph# (760) 494-6717
Trade/Model Name:
Common Name:
Contact:
Classification Regulation:
Orthosis, Intervertebral Body Fusion Device
Epicage Interbody Fusion System
21 CFR 888.3080 Class II
Product Code(s):
MAX
Device Description:
The Epicage System implants are manufactured from implant grade PEEK with a surgical grade titanium alloy pin and 2 tantalum beads to facilitate visualization. The delivery system contains portals in sizes to match the implants sizes and general surgical instruments to assist in preparation and device delivery. The portals are integral to the system and are considered an accessory (Class II) all other instruments are Class I. The system can be used with a mid-line portal for a modified TLIF procedure or an oblique portal for a traditional TLIF approach. The implants of the system are available non-sterilized.
Indications for Use:
The Epicage Interbody Fusion Device is intended for interbody fusion procedures and is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone. Patients should have received six months of non-operative treatment with the devices. The device is intended to be used with supplemental posterior fixation approved for use in the lumbar spine such as Alphatec Spine's Zodiac Polyaxial Spinal Fixation System and/or Illico Posterior Fixation System.
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Substantial Equivalence Claimed:
The subject Epicage Interbody Fusion System is substantially equivalent to the predicate Epicage Interbody Fusion System (K092901) with the same intended use and technological characteristics. The subject system is manufactured from the same materials and manufacturing processes with equivalent performance, labeling, biocompatibility, and standards.
Technical Characteristics
The implants of the Epicage System are available in sizes 25mm and 30mm with multiple heights (8mm, 10mm, 12mm 14mm) manufactured from polyetheretherketone (PEEK Optima LT1 conforming to ASTM F-2026), surgical grade titanium alloy (TI-6AI-4V ELI conforming to ASTM F-136) with radiographic markers made from tantalum (conforming to ASTM F-560). Implants are available both non-sterile and sterile. The delivery system portals are manufactured from stainless steel in sizes to match the implants. The midline portal supports a modified TLIF procedure and the oblique portals are designed for a traditional TLIF approach. The portals and instruments are provided non-sterile with validated cleaning and sterilization parameters.
Non-Clinical Performance Testing
The following testing was conducted to support substantial equivalence to the predicate device.
Sterilization testing:
- . Gamma Sterilization Validation
- Sterile Package Performance Validation
Performance testing:
- Static Axial Compression, Torsion, and Shear per ASTM F2077 .
- . Dynamic Axial Compression, Torsion, and Shear per ASTM F2077
- . Subsidence per ASTM 2267
- Expulsion per ASTM Draft F04.25.0202 ●
- . Epicage Portal Evaluation
- User Validation Cadaver Lab .
All testing passed the acceptance criteria and the results were substantially equivalent to the predicate device.
Conclusion
The Epicage Interbody Fusion System, demonstrated to be substantial equivalent to the Predicate Epicage System, is based on design, materials, intended use, and performance to the predicate systems identified.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
April 18, 2013
Alphatec Spine, Incorporated % Ms. Nadine Smith Senior Regulatory Affairs Specialist 5818 El Camino Real Carlsbad, California 92008
Re: K130548
Trade/Device Name: Epicage Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 14, 2013 Received: March 19, 2013
Dear Ms. Smith:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Nadine Smith
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Frin - Keith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K130548
Device Name: Epicage Interbody Fusion System
Indications For Use:
The Epicage Interbody Fusion Device is intended for interbody fusion procedures and is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone. Patients should have received six months of non-operative treatment with the devices. The device is intended to be used with supplemental posterior fixation approved for use in the lumbar spine such as Alphatec Spine's Zodiac Polyaxial Spinal Fixation System and/or Illico Posterior Fixation System.
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
Page I of I
§ 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.