(148 days)
Not Found
No
The 510(k) summary describes a physical interbody fusion device and its mechanical testing, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is described as an implant used for intervertebral body fusion procedures to treat degenerative disc disease, facilitating bone growth and acting as a substitute for bone graft blocks. These actions are therapeutic in nature, aimed at treating a medical condition and restoring function.
No
The device description indicates it is an implant for intervertebral body fusion procedures, not a diagnostic tool.
No
The device description clearly states it is an "implant" and describes physical characteristics like footprints, heights, a hollow center, and X-ray markers, indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a surgical implant (a cage) designed to be placed within the lumbar spine to facilitate bone fusion. It is a physical device used in vivo (within the body) during a surgical procedure.
- Intended Use: The intended use is for intervertebral body fusion procedures in patients with degenerative disc disease. This is a surgical treatment, not a diagnostic test performed on a specimen.
The device is a medical device, but specifically a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Half Dome Posterior Lumbar Interbody System are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to LS-S1. DDD is defined as discogenic with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Half Dome implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Half Dome Posterior Lumbar Interbody TLIF and OTLIF are implants developed for the substitution of the classical autogenous bone graft blocks. They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis). X-ray markers allow the position to be determined post- op.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine at one or two contiguous levels from L1-L2 to L5-S1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Test Summary:
• Static and dynamic compression per ASTM F2077
• Subsidence per ASTM F2267
The results of these evaluations indicate that the Half Dome Posterior Lumbar Interbody System is equivalent to predicate devices.
Clinical Test Summary:
No clinical studies were performed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K082310, K100089, P960025, P950019, K071724/K081968
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 28, 2016
Astura Medical % Mr. J. D. Webb Authorized Correspondent The Orthomedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K152512
Trade/Device Name: Half Dome Posterior Lumbar Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 23, 2015 Received: December 28, 2015
Dear Mr. Webb:
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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Half Dome Posterior Lumbar Interbody System
Indications for Use (Describe)
The Half Dome Posterior Lumbar Interbody System are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to LS-S1. DDD is defined as discogenic with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Half Dome implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
Type of Use (Select one or both, as applicable)
X | Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
K152512 Page 1 of 1
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510(k) Summary: Half Dome Posterior Lumbar Interbody System
| Date Prepared | December 10, 2015 |
|---|---|
| Submitted By | Astura Medical |
| 5670 El Camino Real, Suite B | |
| Carlsbad, CA 92008 | |
| 760-814-8047 Tele | |
| Contact | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 Tele | |
| 512-692-3699 Fax | |
| e-mail: jdwebb@orthomedix.net | |
| Trade Name | Half Dome Posterior Lumbar Interbody System |
| Common Name | intervertebral body fusion device |
| Classification Name | Intervertebral body fusion device - lumbar |
| Class | II |
| Product Code | MAX |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | SEASPINE Pacifica Cage (K082310) |
| Additional Predicate | |
| Devices | Synthes T-PAL Spacer (K100089) |
| DePuy Brantigan I/F Cage (P960025) | |
| Surgical Dynamics Ray Threaded Lumbar Fusion Cage (P950019) | |
| Spinal Elements Lucent Cage (K071724/K081968) | |
| Device Description | The Half Dome Posterior Lumbar Interbody TLIF and OTLIF are implants |
| developed for the substitution of the classical autogenous bone graft blocks. They | |
| are available in a range of footprints and heights to suit the individual pathology | |
| and anatomical conditions of the patient. The implants have a hollow center to | |
| allow placement of autogenous bone graft. The superior and inferior surfaces are | |
| open to promote contact of the bone graft with the vertebral end plates, allowing | |
| bone growth (arthrodesis). X-ray markers allow the position to be determined post- | |
| op. | |
| Materials | Vestakeep® PEEK per ASTM F2026 |
| Tantalum per ASTM F560 | |
| Substantial | |
| Equivalence Claimed | |
| to Predicate Devices | The Half Dome Posterior Lumbar Interbody System is substantially equivalent to |
| the predicate devices in terms of intended use, design, materials used, mechanical | |
| safety and performances. | |
| Indications for Use | The Half Dome Posterior Lumbar Interbody System is indicated for intervertebral |
| body fusion procedures in skeletally mature patients with degenerative disc | |
| disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to | |
| L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed | |
| by history and radiographic studies. These DDD patients may also have up to | |
| Grade I spondylolisthesis or retrolisthesis at the involved level(s). Half Dome | |
| implants are to be used with autogenous bone graft and supplemental fixation. | |
| Patients should have at least six (6) months of non-operative treatment prior to | |
| treatment with an intervertebral cage. | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| • Static and dynamic compression per ASTM F2077 | |
| • Subsidence per ASTM F2267 | |
| The results of these evaluations indicate that the Half Dome Posterior Lumbar | |
| Interbody System is equivalent to predicate devices. | |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non- | |
| clinical and Clinical | Astura Medical considers the Half Dome Posterior Lumbar Interbody System to be |
| equivalent to the predicate devices listed above. This conclusion is based upon | |
| the devices' similarities in principles of operation, technology, materials and | |
| indications for use |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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