(129 days)
Not Found
No
The summary describes a physical implant (interbody fusion cage) and its mechanical testing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for treating Degenerative Disc Disease (DDD) by restoring spinal stability and alignment, which are therapeutic actions.
No
The device description clearly states it is an interbody fusion cage made from Ti-6Al-4V implant-grade titanium, and its intended use is for treating Degenerative Disc Disease (DDD) by providing spinal stability and alignment. It is a therapy device, not a diagnostic one.
No
The device description explicitly states the device consists of "interbody fusion cages made from Ti-6Al-4V implant-grade titanium using additive manufacturing technology," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for spinal fusion in patients with Degenerative Disc Disease. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as interbody fusion cages made from titanium. This is a physical implant, not a reagent, instrument, or system used to examine specimens from the human body.
- Performance Studies: The performance studies focus on the mechanical strength and safety of the implant (compression, shear, expulsion, subsidence, bacterial endotoxins). These are tests relevant to a surgical implant, not a diagnostic test.
IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not perform any such function.
N/A
Intended Use / Indications for Use
The HD Lumbar Interbody System 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. Patients should have received 6 months of non-operative treatment prior to treatment with the device must be used with supplemental fixation. 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 and allograft bone comprised of cancellous and/or corticocancellous bone.
Product codes
MAX
Device Description
The HD Lumbar Interbody System consists of interbody fusion cages made from Ti-6Al-4V implant-grade titanium using additive manufacturing technology. The implants of the HD Lumbar Interbody System are offered in a variety of lengths, widths and cross sectional geometries to accommodate patient anatomy and surgical approach. The implants of the HD Lumbar Interbody System are also offered in various lordotic configurations to ensure proper stability and alignment of the spine for differing patient anatomy. The implants are provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
one or two contiguous levels from L2-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
The Lumbar Interbody System has been tested in the following test modes:
- Static axial compression per ASTM F2077-14
- Static compressive shear per ASTM F2077-14
- Dynamic axial compression per ASTM F2077-14
- Dynamic compressive shear per ASTM F2077-14
- Static expulsion per ASTM Draft F-04.25.02.02
- Static subsidence per ASTM F2267-04
- Bacterial endotoxins test per ANSI/AAMI ST72:2011/(R) 2016, USP , USP , EP 2.6.14, and JP 4.01.
The results of this non-clinical testing show that the strength of the Lumbar Interbody System is sufficient for its intended use and is substantially equivalent to legally marketed 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
HD LifeSciences LLC % Mr. Kenneth C. Maxwell Regulatory and Quality Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918 July 13, 2017
Re: K170676
Trade/Device Name: HD Lumbar Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 25, 2017 Received: June 13, 2017
Dear Mr. Maxwell:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
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/ResourcesforYou/Industry/default.htm. 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.
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.
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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Indications for Use
510(k) Number (if known) K170676
Device Name HD Lumbar Interbody System
Indications for Use (Describe)
The HD Lumbar Interbody System 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. Patients should have received 6 months of non-operative treatment prior to treatment with the device must be used with supplemental fixation. 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 and allograft bone comprised of cancellous and/or corticocancellous bone.
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) |
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| Submitter's Name | HD LifeSciences LLC |
|---|---|
| Submitter's Address | 38 Montvale Ave Ste 380 |
| Stoneham, MA 02180 | |
| Submitter's Telephone | 978.595.6625 |
| Company Contact Person | Ian Helmar |
| Chief Product Officer, Director of Engineering | |
| ianhelmar@hdlifesciences.com | |
| Contact Person | Kenneth C. Maxwell II |
| Empirical Testing Corp. | |
| 719.291.6874 | |
| KMaxwell@empiricalconsulting.com | |
| Date Summary was Prepared | 10 July 2017 |
| Trade or Proprietary Name | HD Lumbar Interbody System |
| Common or Usual Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Classification | Class II per 21 CFR §888.3080 Device Classification |
| Product Code | MAX |
| Classification Panel | Division of Orthopedic Devices |
510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The HD Lumbar Interbody System consists of interbody fusion cages made from Ti-6Al-4V implant-grade titanium using additive manufacturing technology. The implants of the HD Lumbar Interbody System are offered in a variety of lengths, widths and cross sectional geometries to accommodate patient anatomy and surgical approach. The implants of the HD Lumbar Interbody System are also offered in various lordotic configurations to ensure proper stability and alignment of the spine for differing patient anatomy. The implants are provided sterile.
INDICATIONS FOR USE
The HD Lumbar Interbody System 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. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. 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 and allograft bone comprised of cancellous and/or corticocancellous bone.
The indications for use for the HD Lumbar Interbody System is similar to that of the predicates listed in Table 5-1.
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TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are the same between the subject and predicates:
- . Principle of Operation
- Indications for Use ●
- Materials of manufacture ●
| Table 5-1: Predicate Devices | |||
|---|---|---|---|
| -- | -- | ------------------------------ | -- |
| 510k
Number | Trade or Proprietary or
Model Name | Manufacturer | Predicate
Type |
|----------------|---------------------------------------|--------------|-------------------|
| K072791 | OPAL Spacer | Synthes | Primary |
| K072253 | ALIF Spacer | Synthes | Additional |
| K160547 | Cascadia Interbody System | K2M | Additional |
PERFORMANCE DATA
The Lumbar Interbody System has been tested in the following test modes:
- Static axial compression per ASTM F2077-14
- Static compressive shear per ASTM F2077-14 ●
- Dynamic axial compression per ASTM F2077-14
- Dynamic compressive shear per ASTM F2077-14
- Static expulsion per ASTM Draft F-04.25.02.02
- . Static subsidence per ASTM F2267-04
- Bacterial endotoxins test per ANSI/AAMI ST72:2011/(R) 2016, USP , USP , EP 2.6.14, and JP 4.01.
The results of this non-clinical testing show that the strength of the Lumbar Interbody System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Lumbar Interbody System is substantially equivalent to the predicate device.