(108 days)
Not Found
No
The document describes a physical medical device (an intervertebral body fusion system) and its mechanical properties and intended use. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The mentions of imaging modalities are for diagnostic purposes, not for the device itself to process or analyze.
Yes
The device is an intervertebral body fusion system intended for spinal fusion procedures in patients with degenerative disc disease, spondylolisthesis, and/or spinal stenosis, which aims to treat and alleviate these medical conditions.
No
Explanation: The ProAM ALIF System is an intervertebral body fusion device designed for spinal fusion procedures, meaning it is a therapeutic device implanted in the body. It takes no measurements, performs no analysis to determine a diagnosis, nor does it provide diagnostic information.
No
The device description clearly states that the ProAM ALIF System consists of physical components manufactured from titanium alloy (intervertebral body fusion device and screws). This indicates it is a hardware medical device, not software-only.
Based on the provided text, the ProAM ALIF System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- ProAM ALIF System Function: The ProAM ALIF System is a physical implantable device (an intervertebral body fusion device and screws) used in surgical procedures to fuse segments of the spine. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly describes a surgical procedure for spinal fusion, not a laboratory test or analysis of biological samples.
- Device Description: The device description details the materials and physical characteristics of the implant, not components for analyzing biological specimens.
Therefore, the ProAM ALIF System falls under the category of a surgical implant or medical device used for treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ProAM ALIF System is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels of the lumbrosacral (L2-S1) spine in skeletally mature patients with degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies (radiographs. CT. MRI). DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The ProAM ALIF System can be used as an adjunct to fusion in patients diagnosed with multilevel deqenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondylolisthesis and spinal stenosis at one or two adjacent levels, the system must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation.
Interbody devices used with three screws and which have a lordotic angle of 20° or less can be used as standalone interbody fusion devices at one or two contiguous levels without the need for supplemental fixation.
Interbody devices with a lordotic angle greater than 20° must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation. Interbody devices used with fewer than three screws (OLIF devices and 2-Hole ALIF devices) must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation.
The ProAM ALIF System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graff comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
Product codes
OVD
Device Description
The ProAM™ ALIF System is an intervertebral body fusion system that consists of an intervertebral body fusion device manufactured from titanium alloy (Ti-6Al-4V conforming to ASTM F3001) and screws manufactured from titanium alloy (Ti-6Al-4V conforming to ASTM F136).
The intervertebral body fusion device has a cross-sectional shape that is somewhat oval, and the device is otherwise box-shaped in stature with cavities for containment of bone graft material. The device is available in sizes that vary in footprint size, height, and lordotic angle. It is available in configurations meant for direct anterior insertion (ALIF) or oblique-anterior (OLIF) insertion. Devices for implantation via a direct anterior approach are available with 2 or 3 holes through which screws are placed to affix to bone. Devices for implantation via an oblique-anterior approach have 2 holes through which screws are placed to affix to bone. All devices have an open, porous architecture throughout and a pyramidal textured porous surface at the endplate contacting surfaces that helps prevent device migration.
The fixation devices consist of screws that are available in various diameters and lengths. Screws engage the vertebral bodies by passing through the intervertebral body fusion device and into bone. They are turned to fixate to the bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographs, CT, MRI
Anatomical Site
lumbrosacral (L2-S1) 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)
The following mechanical testing was performed:
Static and dynamic compression testing per ASTM F2077
Static and dynamic compression-shear testing per ASTM F2077
Subsidence testing per ASTM F2267
Expulsion
The mechanical testing demonstrated that the device performs as well or better than the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K230894, K223413, K222554, K083475, K232097
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 the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is a stylized depiction of a human figure. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 3, 2024
Pro Surgical, Inc. Jason Blain Chief Executive Officer 3875 Copper Crest Rd. Encinitas, California 92024
Re: K240126
Trade/Device Name: ProAM ALIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: January 16, 2024 Received: April 1, 2024
Dear Mr. Blain:
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).
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 OS 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,
Brent Showalter -S
Brent Showalter, Ph.D. 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)
K240126
Device Name
ProAM ALIF System
Indications for Use (Describe)
The ProAM ALIF System is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels of the lumbrosacral (L2-S1) spine in skeletally mature patients with degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies (radiographs. CT. MRI). DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The ProAM ALIF System can be used as an adjunct to fusion in patients diagnosed with multilevel deqenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondylolisthesis and spinal stenosis at one or two adjacent levels, the system must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation.
Interbody devices used with three screws and which have a lordotic angle of 20° or less can be used as standalone interbody fusion devices at one or two contiguous levels without the need for supplemental fixation.
Interbody devices with a lordotic angle greater than 20° must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation. Interbody devices used with fewer than three screws (OLIF devices and 2-Hole ALIF devices) must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation.
The ProAM ALIF System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graff comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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Image /page/4/Picture/0 description: The image shows the logo for ProSurgical. The logo consists of a circular icon on the left and the word "ProSurgical" on the right. The icon features a series of blue dots arranged vertically within a gray circle, resembling a spine. The word "ProSurgical" is written in blue and gray, with "Pro" in blue and "Surgical" in gray.
510(k) Summary
K240126 Page 1 of 3
510(k) Number K240126
Date Prepared: April 1, 2024
Submitted By
Pro Surgical, Inc. 3875 Copper Crest Rd. Encinitas, CA 92024 858-761-6262
Contact: Jason Blain jblain@pro-surqical.com 858-761-6262
Device Name
| Device Trade Name: | ProAM ALIF System |
|---|---|
| Common Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Fusion Device with Integrated Fixation, Lumbar |
| Device Class: | Class II |
| Regulation Number: | 12 CFR § 888.3080 |
| Product Code: | OVD |
Predicate Devices
Primary Predicate Device NuVasive Modulus ALIF System – K230894
Additional Predicate Devices
Osseus Fusion Systems Pisces-SA Standalone ALIF Interbody System – K223413 Astura El Capital Anterior Lumbar Interbody Fusion – K222554 Spinal Elements Magnum+ – K083475 ATEC IdentiTi Interbody Systems – K232097
Device Description
The ProAM™ ALIF System is an intervertebral body fusion system that consists of an intervertebral body fusion device manufactured from titanium alloy (Ti-6Al-4V
5
Image /page/5/Picture/0 description: The image shows the logo for ProSurgical. The logo consists of a circular design on the left and the word "ProSurgical" on the right. The circular design features a series of dots arranged in a vertical line, enclosed within a gray circle. The word "ProSurgical" is written in a blue, sans-serif font.
conforming to ASTM F3001) and screws manufactured from titanium alloy (Ti-6Al-4V conforming to ASTM F136).
The intervertebral body fusion device has a cross-sectional shape that is somewhat oval, and the device is otherwise box-shaped in stature with cavities for containment of bone graft material. The device is available in sizes that vary in footprint size, height, and lordotic angle. It is available in configurations meant for direct anterior insertion (ALIF) or oblique-anterior (OLIF) insertion. Devices for implantation via a direct anterior approach are available with 2 or 3 holes through which screws are placed to affix to bone. Devices for implantation via an oblique-anterior approach have 2 holes through which screws are placed to affix to bone. All devices have an open, porous architecture throughout and a pyramidal textured porous surface at the endplate contacting surfaces that helps prevent device migration.
The fixation devices consist of screws that are available in various diameters and lengths. Screws engage the vertebral bodies by passing through the intervertebral body fusion device and into bone. They are turned to fixate to the bone.
Indications for Use
The ProAM ALIF System is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiquous levels of the lumbosacral (L2-S1) spine in skeletally mature patients with degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies (radiographs, CT, MRI). DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The ProAM ALIF System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondylolisthesis and spinal stenosis at one or two adjacent levels, the system must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation.
Interbody devices used with three screws and which have a lordotic angle of 20° or less can be used as standalone interbody fusion devices at one or two contiguous levels without the need for supplemental fixation.
6
Image /page/6/Picture/0 description: The image shows the logo for ProSurgical. The logo consists of a circular design on the left, resembling a spine with several dots arranged vertically within a gray circle. To the right of the circular design, the word "ProSurgical" is written in a blue, sans-serif font. The word is written in a clean and modern style.
Interbody devices with a lordotic angle greater than 20° must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the egrated fixation. Interbody devices used with fewer than three screws (OLIF devices and 2-Hole ALIF devices) must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation.
e ProAM ALIF System is intended for use on patients who have had at least six months onoperative treatment. It is intended to be used with autograft and/or allogenic e graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
lications for Use Comparison
Indications for Use of the ProAM ALIF System are identical to those for the listed predicate devices.
chnological Comparison
ProAM ALIF System is substantially equivalent to the predicate devices when sidering design, configurations and sizes, intended use, material composition, manufacture, function, and mechanical performance.
Performance Data
The following mechanical testing was performed:
ic and dynamic compression testing per ASTM F2077 ic and dynamic compression-shear testing per ASTM F2077 Subsidence testing per ASTM F2267 Expulsion
The mechanical testing demonstrated that the device performs as well or better than the predicates.
Conclusions
e ProAM ALIF System is substantially equivalent to the legally marketed predicate devices based on a comparison of indications for use, design, intended use, material composition, function, and mechanical performance.