(244 days)
Not Found
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is an intervertebral body fusion device used to stabilize lumbar segments of the spine and promote fusion, which aligns with the definition of a therapeutic device.
No
This device is an implantable surgical device (intervertebral body fusion device) designed for stabilization and support in the spine, not for diagnosing medical conditions.
No
The device description explicitly states that the device is an implantable intervertebral body fusion device made of physical materials (Titanium, Cobalt Chrome) and includes bone screws. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical implant for spinal fusion. It focuses on treating degenerative disc disease and degenerative scoliosis by providing structural support and stabilization to the spine. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device is described as an expandable intervertebral body fusion device made of various metals. This is consistent with a surgical implant, not a device used for in vitro testing.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.
Therefore, the SAHARA Stabilization System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SAHARA Stabilization System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the SAHARA implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
Hyperlordotic (angles > 15°) and Lateral implants must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Additional supplemental fixation (i.e. pedicle screw and rod system) is needed when used as an adjunct to fusion for degenerative scoliosis. Otherwise, the SAHARA Stabilization System implants may be used as a stand-alone device, which is intended to be used with the bone screws provided.
Product codes (comma separated list FDA assigned to the subject device)
OVD, MAX
Device Description
The subject of this 510(k) submission is the addition of lateral implants to the previously cleared SAHARA Stabilization System. The implants function as an expandable intervertebral body fusion device to provide support and stabilization to the lumbar segments of the spine through a lateral approach. The system includes lateral interbody devices as well as bone screws for integrated fixation. The implants are manufactured from Titanium (ASTM F67), Titanium Alloy (ASTM F136, ASTM F1472, ASTM F3001) and Cobalt Chrome (ASTM F1537). The implants contain components that are additively manufactured.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar segments of the spine, L2 to S1
Indicated Patient Age Range
skeletally mature
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)
The following mechanical tests were performed:
Static Compression per ASTM F2077 Static Compression Shear per ASTM F2077 Static Torsion per ASTM F2077 Subsidence per ASTM F2267 Expulsion Dynamic Compression per ASTM F2077 Dynamic Compression Shear per ASTM F2077 Dynamic Torsion per ASTM F2077
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.
K151481, K171097, K133614, K172941
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.
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October 3, 2019
K2M, Inc. % Renee Norby Regulatory Affairs Specialist Stryker Spine 2 Pearl Court Allendale, New Jersey 07401
Re: K190179
Trade/Device Name: SAHARA Stabilization System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX Dated: July 3, 2019 Received: September 3, 2019
Dear Renee Norby:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Ronald P. Jean. PhD Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190179
Device Name SAHARA Stabilization System
Indications for Use (Describe)
The SAHARA Stabilization System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the SAHARA implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
Hyperlordotic (angles > 15°) and Lateral implants must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Additional supplemental fixation (i.e. pedicle screw and rod system) is needed when used as an adjunct to fusion for degenerative scoliosis. Otherwise, the SAHARA Stabilization System implants may be used as a stand-alone device, which is intended to be used with the bone screws provided.
| 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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Image /page/3/Picture/0 description: The image shows the Stryker logo at the top. Below the logo, the text "2 510(k) Summary" is displayed in a golden color. The number 2 is separated from the rest of the text. The text appears to be part of a document or presentation.
| 510(k) Summary: SAHARA Stabilization System | |
|---|---|
| Submitter: | K2M, Inc. |
| Contact Person : | Name: Renee Norby |
| Phone: 201-749-8074 | |
| Email: renee.norby@stryker.com | |
| Date Prepared: | 2-October-2019 |
| Trade Name: | SAHARA Stabilization System |
| Common Name: | Spinal Fixation System |
| Proposed Class: | Class II, 21 CFR 888.3080 |
| Classification Name: | Intervertebral Fusion Device with Integrated Fixation, Lumbar (OVD) |
| Intervertebral Fusion Device with Bone Graft, Lumbar (MAX) | |
| Product Code: | OVD; MAX |
| Predicate Devices: | Primary Predicate: SAHARA Stabilization System (K151481) |
Additional Predicates: MOJAVE Expandable Interbody System (K171097),
Aleutian IBF System (K133614), and Cascadia Interbody System (K172941) |
| Device Description: | The subject of this 510(k) submission is the addition of lateral implants to the
previously cleared SAHARA Stabilization System. The implants function as an
expandable intervertebral body fusion device to provide support and
stabilization to the lumbar segments of the spine through a lateral approach.
The system includes lateral interbody devices as well as bone screws for
integrated fixation. The implants are manufactured from Titanium (ASTM
F67), Titanium Alloy (ASTM F136, ASTM F1472, ASTM F3001) and Cobalt
Chrome (ASTM F1537). The implants contain components that are additively
manufactured. |
| Intended Use: | The SAHARA Stabilization System implants are intervertebral body fusion
devices indicated for use with autograft and/or allogenic bone graft
comprised of cancellous and/or corticocancellous bone graft when used as an
adjunct to fusion in patients with degenerative disc disease (DDD) at one
level or two contiguous levels from L2 to S1. DDD is defined as back pain of
discogenic origin with degeneration of the disc confirmed by history and
radiographic studies. The DDD patients may also have up to Grade I
spondylolisthesis or retrolisthesis at the involved level(s). These patients
should be skeletally mature and have six months of nonoperative therapy.
Additionally, the SAHARA implants can be used as an adjunct to fusion in
patients diagnosed with degenerative scoliosis |
| 510(k) Summary: SAHARA Stabilization System | |
| Hyperlordotic (angles > 15°) and Lateral implants must be used with
supplemental fixation (i.e., posterior pedicle screw and rod system) cleared
for use in the lumbar spine, in addition to the bone screws provided.
Additional supplemental fixation (i.e. pedicle screw and rod system) is
needed when used as an adjunct to fusion for degenerative scoliosis.
Otherwise, the Sahara Stabilization System implants may be used as a stand-
alone device, which is intended to be used with the bone screws provided. | |
| Summary of the
Technological
Characteristics | The subject SAHARA Lateral Expandable Interbody System and the
predicate was shown to be substantially equivalent based on material,
design, and mechanical performance. |
| Summary of the
Performance Data | The following mechanical tests were performed:
Static Compression per ASTM F2077 Static Compression Shear per ASTM F2077 Static Torsion per ASTM F2077 Subsidence per ASTM F2267 Expulsion Dynamic Compression per ASTM F2077 Dynamic Compression Shear per ASTM F2077 Dynamic Torsion per ASTM F2077 |
| Conclusion | Based on the design features, feature comparisons, indications for use,
and results of mechanical testing, the SAHARA Lateral Expandable
Interbody System has demonstrated substantial equivalence to the
identified predicate devices. |
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