(204 days)
No
The summary describes a physical implant (interbody cage) and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an implantable interbody fusion device used to treat degenerative disc disease, which involves replacing diseased discs and promoting bone growth. This directly addresses medical conditions and restores body function.
No
The device is an implantable intervertebral body fusion device used to substitute bone graft blocks and promote arthrodesis in patients with degenerative disc disease. Its function is therapeutic, not diagnostic.
No
The device description clearly states that the Half Dome Posterior Lumbar Interbody devices are implants, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a physical implant (Half Dome Posterior Lumbar Interbody devices) that is surgically placed in the lumbar spine to facilitate bone fusion. It is a structural device, not a device used for testing biological samples.
- Intended Use: The intended use is for surgical procedures to treat degenerative disc disease by replacing bone graft and promoting fusion. This is a therapeutic intervention, not a diagnostic test.
The description clearly indicates a surgical implant used in vivo (within the body), not a device used in vitro (in a lab setting) for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Half Dome Posterior Lumbar Intervertebral body fusion procedures in sketally 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 pain with degeneration of the disc confirmed by history and radios. 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.
Product codes
MAX
Device Description
The Half Dome Posterior Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). 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). The Half Dome cages are designed to be used in conjunction with supplemental spinal fixation instrumentation.
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
No clinical studies were performed.
Non-clinical tests performed:
- Static and dynamic compression per ASTM F2077
- Subsidence per ASTM F2267
Results indicate that the PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) Half Dome implants are equivalent to predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 18, 2018
Astura Medical Thomas Purcell Vice President 3186 Lionshead Ave. Suite 100 Carlsbad, California 92010
Re: K172947
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: March 21, 2018 Received: March 22, 2018
Dear Mr. Purcell:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for 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)
Device Name
HALF DOME Posterior Lumbar Interbody System
Indications for Use (Describe)
The Half Dome Posterior Lumbar Intervertebral body fusion procedures in sketally 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 pain with degeneration of the disc confirmed by history and radios. 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary: HALF DOME Posterior Lumbar Interbody System
PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) Spacers
April 16th, 2018 Date Prepared Submitted By Astura Medical 3186 Lionshead Ave, Suite 100 Carlsbad, CA 92010 Phone: 760-814-8047 Contact Thomas Purcell 3186 Lionshead Ave, Suite 100 Carlsbad, CA 92010 Phone: 760-814-8047 Email: thomas@asturamedical.com Trade Name HALF DOME Posterior Lumbar Interbody System Common Name Intervertebral body fusion device Classification Name Intervertebral body fusion device – lumbar ll Class Product Code MAX CFR Section 21 CFR section 888.3080 Device Panel Orthopedic Primary Predicate Device Astura Medical HALF DOME Posterior Lumbar Interbody System (K152512) Additional Predicate Cutting Edge Spine, LLC EVOS Lumbar Interbody System (K150321) Device(s) Device Description The Half Dome Posterior Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). 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). The Half Dome cages are designed to be used in conjunction with supplemental spinal fixation instrumentation. Materials PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) – MAF 2227 (added material) Tantalum per ASTM F560 Substantial Equivalence The Half Dome Posterior Lumbar Interbody System PEEK-OPTIMA Claimed to Predicate LT120HA (PEEK-OPTIMA HA Enhanced) Spacers are substantially equivalent to the predicate devices in terms of intended use, design,
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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| Devices | material, and 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 PEEK-OPTIMA LT120HA | |
| (PEEK-OPTIMA HA Enhanced) Half Dome implants are 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 PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) Spacers 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. |