(89 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fusion system and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are mechanical tests, not clinical or algorithmic performance evaluations.
Yes
The device is an intervertebral body fusion system intended for spinal fusion procedures, which is a therapeutic intervention for degenerative disc disease.
No.
The ProAM ACDF System is an intervertebral body fusion system, which is a surgical implant designed for spinal fusion procedures. It is not intended to diagnose conditions but rather to treat them by providing stabilization and promoting fusion of the vertebrae.
No
The device description clearly states it is an intervertebral body fusion system consisting of physical components made of titanium alloy (intervertebral body fusion device and screws).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The ProAM ACDF System is a physical implant (intervertebral body fusion device and screws) designed to be surgically placed in the spine.
- Intended Use: Its purpose is to provide structural support and facilitate fusion in the cervical spine for patients with degenerative disc disease. This is a therapeutic intervention, not a diagnostic test.
The information provided clearly describes a surgical implant used for treatment, not a test performed on a sample outside the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The ProAM ACDF System is a standalone intervertebral body fusion system intended for spinal fusion procedures of the cervical (C2-T1) spine in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies (radiographs, CT. MRI).
The ProAM ACDF System is intended to be used at multiple contiguous levels of the cervical spine (C2-T1). The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.
The ProAM ACDF System is intended for use on patients who have had at least six weeks of nonoperative treatment. It is intended to be used with autogenous and/or allogeneic bone graft comprised of cortical, cancellous, and/or corticocancellous bone graft.
Product codes
OVE, ODP
Device Description
The ProAM™ ACDF 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 trapezoidal, 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 meant for direct anterior insertion and has 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 screws 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
cervical (C2-T1) 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
Static and dynamic torsion 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)
K202065, K233414, K240126, K151939
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
November 20, 2024
Pro Surgical, Inc. Jason Blain Chief Executive Officer 1910 Palomar Point Way, Suite 201 Carlsbad, California 92008
Re: K242517
Trade/Device Name: ProAM ACDF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: August 23, 2024 Received: October 24, 2024
Dear Jason 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"
1
(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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
2
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
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
ProAM ACDF System
Indications for Use (Describe)
The ProAM ACDF System is a standalone intervertebral body fusion system intended for spinal fusion procedures of the cervical (C2-T1) spine in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies (radiographs, CT. MRI).
The ProAM ACDF System is intended to be used at multiple contiguous levels of the cervical spine (C2-T1). The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.
The ProAM ACDF System is intended for use on patients who have had at least six weeks of nonoperative treatment. It is intended to be used with autogenous and/or allogeneic bone graft comprised of cortical, cancellous, and/or corticocancellous bone graft.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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, with the "Pro" portion in a darker shade and the "Surgical" portion in a lighter shade.
510(k) Summary
K242517 Page 1 of 3
510(k) Number K242517
Date Prepared: October 24, 2024
Submitted By
Pro Surgical, Inc. 1910 Palomar Point Way, Suite 201 Carlsbad, CA 92008 760-542-2333
Contact: Jason Blain jblain@pro-surgical.com 858-761-6262
Device Name
| Device Trade Name: | ProAM ACDF System |
|---|---|
| Common Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Fusion Device with Integrated Fixation, Cervical |
| Device Class: | Class II |
| Regulation Number: | 12 CFR § 888.3080 |
| Product Code: | OVE |
Predicate Devices
Primary Predicate Device Astura DOLOMITE Anterior Cervical Stabilization System - K202065
Additional Predicate Devices SeaSpine Shoreline ACS Interbody System - K233414 Pro Surgical ProAM ALIF System – K240126 Globus Coalition – K151939
Device Description
The ProAM™ ACDF 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).
5
Image /page/5/Picture/0 description: The image contains the logo for ProSurgical. The logo consists of a circular design on the left and the text "ProSurgical" on the right. The circular design features a series of dark blue circles of varying sizes arranged vertically within a light gray circle. The text "ProSurgical" is written in a blue sans-serif font, with "Pro" in a slightly darker shade of blue than "Surgical".
The intervertebral body fusion device has a cross-sectional shape that is trapezoidal, 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 meant for direct anterior insertion and has 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 screws 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 ACDF System is a standalone intervertebral body fusion system intended for spinal fusion procedures of the cervical (C2-T1) spine in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies (radiographs, CT, MRI).
The ProAM ACDF System is intended to be used at multiple contiguous levels of the cervical spine (C2-T1). The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.
The ProAM ACDF System is intended for use on patients who have had at least six weeks of nonoperative treatment. It is intended to be used with autogenous and/or allogeneic bone graft comprised of cortical, cancellous, and/or corticocancellous bone graft.
Indications for Use Comparison
The Indications for Use of the ProAM ACDF System are identical to those for the listed predicate devices.
Technological Comparison
The ProAM ACDF System is substantially equivalent to the predicate devices when considering design, configurations and sizes, intended use, material composition, manufacture, function, and mechanical performance.
6
Image /page/6/Picture/0 description: The image shows the logo for ProSurgical. The logo consists of a circular symbol on the left and the text "ProSurgical" on the right. The circular symbol features a series of dots arranged vertically within a circle, resembling a spine. The text "ProSurgical" is written in a sans-serif font, with "Pro" in a darker blue color and "Surgical" in a lighter blue color.
Performance Data
The following mechanical testing was performed:
Static and dynamic compression testing per ASTM F2077 Static and dynamic compression-shear testing per ASTM F2077 Static and dynamic torsion 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
The ProAM ACDF 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.