(55 days)
Not Found
No
The summary describes a mechanical spinal implant system and its components, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies focus on mechanical testing.
Yes
The device is a pedicle screw system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for a variety of spinal conditions, which directly addresses medical conditions.
No
The device description indicates that the Salvo® Spine System is an implantable system composed of screws, rods, and connectors designed for immobilization and stabilization of spinal segments as an adjunct to fusion. This is a treatment device, not a diagnostic one.
No
The device description explicitly states that the Salvo® Spine System consists of physical implants manufactured from titanium alloy, commercially pure titanium, cobalt-chromium alloy, and PEEK-OPTIMA LT1. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system designed to provide immobilization and stabilization of the spine as an adjunct to fusion. This is a therapeutic and structural function within the body.
- Device Description: The device description details a system of screws, rods, and connectors made from various biocompatible materials, which are typical components of surgical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. The Salvo® Spine System is implanted within the body to provide structural support.
N/A
Intended Use / Indications for Use
The Salvo® Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).
When used in a percutaneous approach with minimally instrumentation, the Salvo® Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scolosis; spinal tumor; and failed previous fusion (pseudarthrosis).
Product codes
NKB
Device Description
The Salvo® Spine System is a thoracolumbosacral pedicle screw system designed through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V EL) per ASTM F136, commercially pure titanium per ASTM F67, cobaltchromium alloy per ASTM F 1537, and PEEK-OPTIMA LT1 with BaSO4. The System consists of a variety of screws, rods, and connectors that create a rigid construct as an adjunct to fixation and stabilization of the thoracic, lumbar, and sacral spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine
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)
Nonclinical testing was performed on the Salvo® Spine System to support substantial equivalence to the predicate device. Dynamic axial compression bending testing per ASTM F1717 was performed.
Clinical testing is not applicable.
Evaluation of the subject device performance data as compared to the predicate system has found that the Salvo® Spine System is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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Image /page/0/Picture/10 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Spine Wave, Inc. Mr. Ronald Smith Executive Vice President, Quality, Regulatory & Clinical Affairs Three Enterprise Drive Suite 210 Shelton, Connecticut 06484
Re: K240685
Trade/Device Name: Salvo® Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: March 12, 2024 Received: March 12, 2024
Dear Mr. Ronald Smith:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
May 6, 2024
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Eileen
Digitally signed
by Eileen Cadel
S
Cadel -S Date: 2024.05.06
15:23:45 -04'00'
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
Salvo® Spine System
Indications for Use (Describe)
The Salvo® Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).
When used in a percutaneous approach with minimally invasive surgery (MIS) instrumentation, the Salvo® Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
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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K240685 - Page 1 of 2
510(k) Summary
21 CFR 807.92(a)(1)
Prepared on: 2024-05-02
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Spine Wave, Inc. | |
|---|---|---|
| Applicant Address | Three Enterprise Drive Suite 210 Shelton CT 06484 United States | |
| Applicant Contact Telephone | 203-712-1846 | |
| Applicant Contact | Mr. Ronald Smith | |
| Applicant Contact Email | rsmith@spinewave.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | Salvo® Spine System | |
| Common Name | Thoracolumbosacral pedicle screw system | |
| Classification Name | Thoracolumbosacral Pedicle Screw System | |
| Regulation Number | 888.3070 | |
| Product Code(s) | NKB | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K222362 | Salvo® Spine System | NKB |
| K160003 | Sniper® Spine System | MNI |
Device Description Summary
The Salvo® Spine System is a thoracolumbosacral pedicle screw system designed through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V EL) per ASTM F136, commercially pure titanium per ASTM F67, cobaltchromium alloy per ASTM F 1537, and PEEK-OPTIMA LT1 with BaSO4. The System consists of a variety of screws, rods, and connectors that create a rigid construct as an adjunct to fixation and stabilization of the thoracic, lumbar, and sacral spine.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(4)
The Salvo® Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).
When used in a percutaneous approach with minimally instrumentation, the Salvo® Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scolosis; spinal tumor; and failed previous fusion (pseudarthrosis).
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K240685 - Page 2 of 2
21 CFR 807.92(a)(5)
Indications for Use Comparison
The Salvo® Spine System is substantially equivalent to the primary predicate, cleared in K222362. The Salvo® Spine System has the same intended use as the primary predicate. Specifically, the devices are used to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion. The subject Salvo® Spine System is substantially equivalent to its predicate in intended use, and no new issues of safety and effectiveness are raised.
Technological Comparison
The Salvo® Spine System has technological characteristics equivalent to those of the predicate device, including design, and material composition.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Nonclinical testing was performed on the Salvo® Spine System to support substantial equivalence to the predicate device. Dynamic axial compression bending testing per ASTM F1717 was performed.
Clinical testing is not applicable.
Evaluation of the subject device performance data as compared to the predicate system has found that the Salvo® Spine System is substantially equivalent to the predicate device.