(204 days)
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.
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.
This document describes the regulatory approval of a medical device, the HALF DOME Posterior Lumbar Interbody System, and focuses on its substantial equivalence to previously approved predicate devices. It does not present a study proving the device meets specific performance acceptance criteria for an AI or diagnostic algorithm.
The document explicitly states: "No clinical studies were performed" for this specific submission (K172947). Instead, the substantial equivalence claim is based on non-clinical tests (mechanical and material properties) demonstrating similarity to predicate devices.
Therefore, I cannot provide the information requested in your prompt as it pertains to a study evaluating an AI or diagnostic algorithm's performance. The prompt's requirements (e.g., sample size, expert consensus, MRMC study, ground truth) are not applicable to this type of medical device submission.
The "acceptance criteria" discussed in this document are primarily related to:
- Mechanical and material performance: Ensuring the device is structurally sound and made of appropriate biocompatible materials.
- Intended Use: The device performs its designed function within the specified patient population and anatomical locations.
- Substantial Equivalence: The new device is as safe and effective as a legally marketed predicate device.
If you had provided a document describing a study for an AI/diagnostic algorithm, I would have extracted the requested information. However, based on the provided text, this is a traditional medical device (implant) approval lacking the type of performance study you are asking about.
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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.
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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 forintervertebral body fusion procedures in skeletally mature patients withdegenerative disc disease (DDD) of the lumbar spine at one or twocontiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic painwith degeneration of the disc confirmed by history and radiographicstudies. These DDD patients may also have up to Grade I spondylolisthesisor retrolisthesis at the involved level(s). Half Dome implants are to beused with autogenous bone graft and supplemental fixation. Patientsshould have at least six (6) months of non-operative treatment prior totreatment with an intervertebral cage. |
| Non-clinical TestSummary | The following analyses were conducted:• Static and dynamic compression per ASTM F2077• Subsidence per ASTM F2267The results of these evaluations indicate that the PEEK-OPTIMA LT120HA(PEEK-OPTIMA HA Enhanced) Half Dome implants are equivalent topredicate devices. |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non-Clinicaland Clinical | Astura Medical considers the Half Dome Posterior Lumbar InterbodySystem PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) Spacers tobe equivalent to the predicate devices listed above. This conclusion isbased upon the devices' similarities in principles of operation, technology,materials and indications for use. |
§ 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.