(108 days)
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as providing "immobilization of spinal segments as an adjunct to fusion" and "stabilization to promote fusion," which are therapeutic functions aimed at treating instabilities, fractures, and degenerative diseases of the spine.
No
Explanation: The Black Diamond™ POCT Spinal System is described as a "posterior cervico-thoracic fixation system intended to provide stabilization to promote fusion." Its intended use cases involve "immobilization of spinal segments as an adjunct to fusion" for various instabilities, and it consists of components like rods and screws. These descriptions indicate a system designed for therapeutic intervention (stabilization and fusion) rather than for identifying or diagnosing a condition.
No
The device description explicitly lists hardware components such as rods, screws, and connectors, indicating it is a physical implant system, not software.
Based on the provided information, the Black Diamond™ POCT Spinal System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for the immobilization and stabilization of spinal segments as an adjunct to fusion. This is a surgical implant used directly on the patient's body.
- Device Description: The description details components like rods, screws, and connectors, which are all physical implants used in surgery.
- 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 treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. The Black Diamond™ POCT Spinal System is an in vivo (within the body) surgical implant.
N/A
Intended Use / Indications for Use
The Black Diamond™ POCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (Cl to C7) and the upper thoracic spine (TI-T3); traumatic spinal fractures and/or traumatic dislocations: instability or deformity: failed previous fusion (e.g., pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin, as confirmed by radiographic studies, and degenerative disease with instability. The Black Diamond™ POCT Spinal System is also intended to restore the integrity of the spinal column even in the absences of fusion for a limited time period in patients with advanced stage tumors in whom if e expectancy is of insufficient duration to permit achievement of fusion. To achieve additional levels offixation, the Black Diamond™ POCT Spinal System may be comected to the Osseus Black Diamond™ Pedicle Screw System using transition rods or anatomically-bent rods.
Product codes (comma separated list FDA assigned to the subject device)
NKG
Device Description
The Black Diamond™ POCT Spinal System is a posterior cervico-thoracic fixation system intended to provide stabilization to promote fusion of the cervical spine and upper thoracic spine. The Black Diamond™ system contains rods in multiple shapes and sizes, polyaxial screws, set screws, rod connectors and transverse connectors. Connecting components can be locked to the rod in various configurations to accommodate individual patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (Cl to C7) and the upper thoracic spine (TI-T3)
Indicated Patient Age Range
Not Found
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)
Mechanical testing was performed on the Black Diamond System in static compression, dynamic compression, and static torsion per ASTM F1717.
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.
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.
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
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
0
November 3, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The Department of Health & Human Services seal is a stylized representation of a human figure. The FDA acronym is in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font.
Osseus Fusion Systems % Daniel Johnson Regulatory Engineer Jalex Medical LLC 27865 Clemens Rd Suite 3 Westlake, Ohio 44145
Re: K222107
Trade/Device Name: Black Diamond™ POCT Spinal System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: NKG Dated: August 5, 2022 Received: August 8, 2022
Dear Daniel Johnson:
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,
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
Enclosure
2
Indications for Use
510(k) Number (if known) K222107
Device Name
Black Diamond™ POCT Spinal System
Indications for Use (Describe)
The Black Diamond™ POCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (Cl to C7) and the upper thoracic spine (TI-T3); traumatic spinal fractures and/or traumatic dislocations: instability or deformity: failed previous fusion (e.g., pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin, as confirmed by radiographic studies, and degenerative disease with instability. The Black Diamond™ POCT Spinal System is also intended to restore the integrity of the spinal column even in the absences of fusion for a limited time period in patients with advanced stage tumors in whom if e expectancy is of insufficient duration to permit achievement of fusion. To achieve additional levels offixation, the Black Diamond™ POCT Spinal System may be comected to the Osseus Black Diamond™ Pedicle Screw System using transition rods or anatomically-bent rods.
| 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)
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."
3
Image /page/3/Picture/0 description: The image shows the logo for OSSEUS. The logo consists of a square with a rounded corner and a dot in the center, followed by the text "OSSEUS". The logo is colored in a gradient from purple to blue.
510(k) Summary
| Submitted By: | Osseus Fusion Systems
1931 Greenville Ave.
Suite 200
Dallas, TX 75206 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | 07/15/22 |
| Contact Person: | Daniel Johnson, Regulatory Engineer |
| Contact Telephone: | (440) 541-0060 |
| Contact Fax: | (440) 933-7839 |
| Device Trade Name: | Black Diamond™ POCT Spinal System |
| Device Classification Name: | Posterior Cervical Screw System |
| Device Classification: | Class II |
| Classification Regulation: | 21 CFR 888.3075 |
| Reviewing Panel: | Orthopedic |
| Product Code: | NKG |
| Predicate Device: | K172495 – Precision Spine Reform POCT System |
| Reference Predicate: | K131810/K192121 – Osseus Black Diamond™ Pedicle Screw
System |
| Additional Predicates: | K190071- Spineart Perla Posterior Cervico-Thoracic Fixation
System
K171444 – K2M Yukon OCT Spinal System
The predicate devices have not been subject to any design related recalls. |
Device Description:
The Black Diamond™ POCT Spinal System is a posterior cervico-thoracic fixation system intended to provide stabilization to promote fusion of the cervical spine and upper thoracic spine. The Black Diamond™ system contains rods in multiple shapes and sizes, polyaxial screws, set screws, rod connectors and transverse connectors. Connecting components can be locked to the rod in various configurations to accommodate individual patient anatomy.
Indications for Use Statement:
The Black Diamond™ POCT Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3); traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusion (e.g., pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin, as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Black Diamond™ POCT Spinal System is also intended to restore the integrity
4
Image /page/4/Picture/0 description: The image shows the logo for Osseus. The logo consists of a square with rounded corners and a circle inside, followed by the text "OSSEUS" in a stylized font. The color scheme transitions from purple to blue.
of the spinal column even in the absences of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. To achieve additional levels of fixation, the Black Diamond™ POCT Spinal System may be connected to occipital cervical thoracic or thoracolumbar stabilization systems ranging in diameter from 3.5mm to 5.5mm using transition rods or anatomically-bent rods.
Summary of Technological Characteristics:
The Black Diamond™ POCT Spinal System was found to be substantially equivalent to the predicate devices in terms of device description, intended use, implant materials, mechanical testing, biocompatibility and other technological characteristics including size offerings.
Non-clinical Testing:
Mechanical testing was performed on the Black Diamond System in static compression, dynamic compression, and static torsion per ASTM F1717.
Conclusion:
Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.