(302 days)
Not Found
No
The summary describes a physical interbody fusion device and its mechanical properties. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is an interbody fusion device, indicated for stabilizing the spine, not for therapy or treatment of symptoms.
No
The device is an interbody fusion device intended to provide structural stability during spinal fusion, not to diagnose medical conditions. Its function is to replace or support diseased discs, not to identify them.
No
The device description explicitly states that the device is a lumbar intervertebral spacer made from physical materials (PEEK Optima LT1, titanium alloy, CP titanium, Nitinol) and includes instruments made from other physical materials. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The Spinal Jaxx interbody fusion device is an implantable medical device designed to be surgically inserted into the spine to provide structural support and facilitate bone fusion. It is used within the body during a surgical procedure.
The description clearly indicates a surgical implant, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2 – S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The indicated patient population is skeletally mature patients who have had six (6) months of non-operative treatment. The Spinal Jaxx interbody fusion device must be used with autogenous bone graft material and with supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Spinal Jaxx Interbody Fusion device is a lumbar intervertebral spacer intended to provide structural stability in a skeletally mature individual based on the surgical intervention by the surgeon. The physician can insert it into the diseased disc space and adjust the height of the device as desired to create near normal disc height. The implants are made from PEEK Optima LT1, a medical grade titanium alloy, CP titanium and Nitinol. Implants are available in various sizes to accommodate patient anatomy. Instruments are made from stainless steel, aluminum, Nitinol, and silicone rubber.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral spine (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 (study type, sample size, AUC, MRMC, standalone performance, key results)
To demonstrate substantial equivalence to the predicate devices, mechanical testing was conducted in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device, June 12, 2007" including the ASTM standards:
- Static Compression and Static Compression Shear testing per ASTM F2077
- Dynamic Axial Compression and Dynamic Compression Shear testing per ASTM F2077
- Subsidence Testing per ASTM F2267-04
- Static Expulsion/Industry Standard per ASTM Draft Standard F-04.25.02.02
- Wear Debris analysis per ASTM F1877-05
- Cyclic Potentiodynamic Polarization Testing per ASTM F2129-15
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.
K102293, K113447, P960025, P950019, K072970, K140280
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of a bird or abstract shape formed by three overlapping profiles of human faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 29, 2016
NeuroPro Spinal Jaxx, Incorporated c/o Rich Jansen. Pharm.D. Consultant Silver Pine Consulting, LLC 11821 Bramble Cove Drive Fort Myers, Florida 33905
Re: K152501
Trade/Device Name: Spinal Jaxx Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 3, 2016 Received: June 6, 2016
Dear Dr. Jansen:
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 Parts 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/ResourcesforYou/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
2
Indications for Use
510(k) Number (if known) K152501
Device Name Spinal Jaxx Interbody Fusion Device
Indications for Use (Describe)
The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2 – S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The indicated patient population is skeletally mature patients who have had six (6) months of non-operative treatment. The Spinal Jaxx interbody fusion device must be used with autogenous bone graft material and with supplemental fixation.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) SUMMARY Interbody Fusion Syst
| Spinal Jaxx Interbody Fusion System | |
|---|---|
| Date Prepared: | June 24, 2016 |
| Company: | NeuroPro Spinal Jaxx, Inc. |
| 4707 Greenleaf Ct., Ste. C | |
| Modesto, CA 95356 | |
| Contact: | John Green, COO |
| Jgreen@neuroprotech.com | |
| 571-334-7424 | |
| Regulatory | |
| Contact | Rich Jansen, Pharm. D. |
| Silver Pine Consulting | |
| Device Name: | Spinal Jaxx Interbody Fusion Device |
| Classification: | Per 21 CFR 888.3080 |
| Intervertebral Body Fusion Device | |
| Product Code: MAX | |
| Regulatory Class II | |
| Panel Code 87 | |
| Predicate | |
| Devices: | The primary predicate is the CALIBER™ Spacer (K102293). Additional |
| predicate devices include the Rise Spacer (K113447), Brantigan Cage (AKA | |
| LT Cage & Jaguar Cage) (P960025), Ray Threaded Fusion Cage | |
| (P950019), Patriot Spacer (K072970) and the Nanovis Foricore device | |
| (K140280) |
Purpose:
The purpose of this submission is clearance of the Spinal Jaxx Interbody Fusion Device as a new medical device that is substantially equivalent to the predicate devices.
Device Description:
The Spinal Jaxx Interbody Fusion device is a lumbar intervertebral spacer intended to provide structural stability in a skeletally mature individual based on the surgical intervention by the surgeon. The physician can insert it into the diseased disc space and adjust the height of the device as desired to create near normal disc height. The implants are made from PEEK Optima LT1, a medical grade titanium alloy, CP titanium and Nitinol. Implants are available in various sizes to accommodate patient anatomy. Instruments are made from stainless steel, aluminum, Nitinol, and silicone rubber.
Indications for Use:
The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2 – S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The indicated patient population is skeletally mature patients who have had six (6) months of non-operative treatment. The Spinal Jaxx interbody fusion device must be used with autogenous bone graft material and with supplemental fixation.
Performance Data:
To demonstrate substantial equivalence to the predicate devices, mechanical testing was conducted in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device, June 12, 2007" including the ASTM standards:
4
- Static Compression and Static Compression Shear testing per ASTM F2077 ●
- Dynamic Axial Compression and Dynamic Compression Shear testing per ASTM F2077
- Subsidence Testing per ASTM F2267-04
- Static Expulsion/Industry Standard per ASTM Draft Standard F-04.25.02.02
- Wear Debris analysis per ASTM F1877-05
- Cyclic Potentiodynamic Polarization Testing per ASTM F2129-15
Technological Characteristics:
NeuroPro has compared the Spinal Jaxx Interbody Fusion System to the predicate devices in regards to indications for use, materials, function, sizes and mechanical test results. These comparisons demonstrate substantial equivalence to the predicate devices.
Conclusions:
The Spinal Jaxx Interbody Fusion System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.