(135 days)
Not Found
No
The summary describes a physical implant device and its mechanical properties, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is used to treat degenerative disc disease and functions as an intervertebral body fusion device.
No
The device is an interbody fusion device, indicated for treating degenerative disc disease, not for diagnosing it.
No
The device description explicitly states that the device consists of interbody fusion cages made from titanium, 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 and Intended Use: The provided information clearly describes the HD LifeSciences Cervical IBFD System as an implantable device used for anterior cervical intervertebral body fusion. It is surgically placed within the body to facilitate bone fusion.
- Lack of Diagnostic Function: The device does not perform any tests on bodily samples to diagnose a condition or provide diagnostic information. Its function is structural and therapeutic (promoting fusion).
Therefore, based on the provided information, the HD LifeSciences Cervical IBFD System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The HD LifeSciences Cervical IBFD System is indicated for use anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at a single level from C2 to T1. Patients should have received 6 weeks of nonoperative treatment prior to treatment with the device is indicated to be used with allograft bone comprised of cancellous and/or corticocancellous bone. The HD LifeSciences Cervical IBFD System requires additional supplemental fixation cleared for the cervical spine.
Product codes
ODP
Device Description
The HD LifeSciences Cervical IBFD System consists of interbody fusion cages made from Ti-6Al-4V implant-grade titanium using additive manufacturing technology. The titanium takes the form of a highly porous core which is surrounded at the cephalad and caudal ends by protective solid titanium endplates. The implant is anatomic in shape and has teeth to ensure placement is maintained after implantation. This 510(k) submission seeks clearance for the subject Cervical IBFD System. The implants of the HD LifeSciences Cervical IBFD System are offered in a variety of lengths, widths and cross sectional geometries to accommodate patient anatomy and surgical approach. The implants are provided sterile, in validated sterile packaging, and are one-time use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical (single level from C2 to T1)
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 HD LifeSciences Cervical IBFD System has been tested in the following test modes:
- Static axial compression per ASTM F2077
- Static torsion per ASTM F2077
- Dynamic axial compression per ASTM F2077
- Dynamic torsion per ASTM F2077
- Static subsidence per ASTM F2267
- Static expulsion per ASTM F04.25.02.02
The results of this non-clinical testing show that the strength of the HD LifeSciences Cervical IBFD System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K120275, K171496, K162264, K170676
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.
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health and Human Services logo. The logo on the right is the FDA logo, which includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
HD LifeSciences LLC John Sullivan Director of Operations 38 Montvale Ave Ste 380 Stoneham. Massachusetts 02180
Re: K180364
Trade/Device Name: HD LifeSciences Cervical IBFD System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: April 24, 2018 Received: June 19, 2018
Dear Mr. Sullivan:
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. Iisting 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.
June 27, 2018
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 comprehensive regulatory information about mediation-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,
Melissa Hall-S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
510(k) Number (if known) K180364
Device Name HD LifeSciences Cervical IBFD System
Indications for Use (Describe)
The HD LifeSciences Cervical IBFD System is indicated for use anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at a single level from C2 to T1. Patients should have received 6 weeks of nonoperative treatment prior to treatment with the device is indicated to be used with allograft bone comprised of cancellous and/or corticocancellous bone. The HD LifeSciences Cervical IBFD System requires additional supplemental fixation cleared for the cervical spine.
| 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 | |
| Company Contact Person | John Sullivan |
| 602-234-4321 | |
| Contact Person | John Sullivan |
| 602-234-4321 | |
| johnsullivan@hdlifesciences.com | |
| Date Summary was | |
| Prepared | 07 February 2018 |
| Trade or Proprietary Name | HD LifeSciences Cervical IBFD System |
| Common or Usual Name | Intervertebral Fusion Device, Cervical |
| Classification | Class II per 21 CFR §888.3080 |
| Product Code | ODP |
| Classification Panel | Division of Orthopedic Devices |
510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The HD LifeSciences Cervical IBFD System consists of interbody fusion cages made from Ti-6Al-4V implant-grade titanium using additive manufacturing technology. The titanium takes the form of a highly porous core which is surrounded at the cephalad and caudal ends by protective solid titanium endplates. The implant is anatomic in shape and has teeth to ensure placement is maintained after implantation. This 510(k) submission seeks clearance for the subject Cervical IBFD System.
The implants of the HD LifeSciences Cervical IBFD System are offered in a variety of lengths, widths and cross sectional geometries to accommodate patient anatomy and surgical approach. The implants are provided sterile, in validated sterile packaging, and are one-time use only.
INDICATIONS FOR USE
The HD LifeSciences Cervical IBFD System is indicated for use anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at a single level from C2 to T1. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device is indicated to be used with allograft bone comprised of cancellous and/or corticocancellous bone. The HD LifeSciences Cervical IBFD System requires additional supplemental fixation cleared for the cervical spine.
4
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 compared to the predicates. Specifically the following characteristics are nearly identical between the subject and predicates:
- . Indications for Use
- Materials of Manufacture
- Principles of Operation
- . Implant Dimensions
Table 5-1: Predicate Devices
| 510k
Number | Trade or Proprietary or Model Name | Manufacturer | Predicate
Type |
|----------------|-------------------------------------|---------------------|-------------------|
| K120275 | ACIS | Synthes | Primary |
| K171496 | Tritanium® C Anterior Cervical Cage | Stryker | Additional |
| K162264 | Cascadia Interbody System | K2M | Additional |
| K170676 | HD Lumbar Interbody System | HD LifeSciences LLC | Additional |
Performance Data
The HD LifeSciences Cervical IBFD System has been tested in the following test modes:
- Static axial compression per ASTM F2077 ●
- . Static torsion per ASTM F2077
- . Dynamic axial compression per ASTM F2077
- Dynamic torsion per ASTM F2077 ●
- Static subsidence per ASTM F2267
- Static expulsion per ASTM F04.25.02.02 ●
The results of this non-clinical testing show that the strength of the HD LifeSciences Cervical IBFD 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 HD LifeSciences Cervical IBFD System is substantially equivalent to the predicate device.