(53 days)
Acumed Bone Graft System, Spine-Tech Bone Harvester, Non-Powered General and Orthopedic Surgical Instruments, Accessories/Attachments
Not Found
No
The device description and intended use focus on mechanical cutting and collection of bone graft, with no mention of AI/ML technologies or data processing.
No
The device is described as a "Bone Harvester," indicated for cutting and collecting bone graft, which is an instrument used in a surgical procedure, not a device for treating or preventing a disease or condition itself.
No
The device is described as a "Bone Harvester" intended for cutting and collecting bone graft, which is an interventional/surgical function, not a diagnostic one.
No
The device description explicitly lists physical components made of stainless steel, polycarbonate, and acetal copolymer, indicating it is a hardware device.
Based on the provided information, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Spine-Tech Bone Harvester is a surgical instrument used to collect bone graft material directly from a patient's body (iliac crest, tibia, or femur). It is a tool for a surgical procedure, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for "cutting and collection of morselized autogenous bone graft" for surgical procedures requiring bone graft. This is a surgical intervention, not a diagnostic test.
Therefore, the Spine-Tech Bone Harvester falls under the category of a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Spine-Tech Bone Harvester is indicated for the cutting and collection of morselized autogenous bone graft from the anterior or posterior iliac crest, tibia or femur.
This device is intended to cut and collect finely morselized autogenous bone graft for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects. These procedures include; spinal fusion, joint arthrodesis, total joint replacement, fracture repair, maxillofacial reconstruction and tumor removal.
All components of the Spine-Tech Bone Harvested are intended for single use only.
Product codes
Not Found
Device Description
The Spine-Tech Bone Harvester consists of two cutting head/collection tube sizes, Hudson or Hall fitting adapter for power use, trocar and plunger. The cutting heads and trocar are constructed from stainless steel. The collection tube and adapter are constructed from medical grade polycarbonate. The plunger is constructed from acetal copolymer.
After cutting and collection of morselized bone graft, the cutting head is removed from the collection tube with the trocar and bone is pushed out of the collection tube with the plunger.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior or posterior iliac crest, tibia or femur
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)
Biocompatibility testing has been performed on the materials used in the construction of this device and is documented in the ASTM Standard.
Performance and quality testing of the product included bench testing, dimensional and workmanship inspection. All testing of the device yielded acceptable results.
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.
Acumed Bone Graft System, Spine-Tech Bone Harvester, Non-Powered General and Orthopedic Surgical Instruments, Accessories/Attachments
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
Not Found
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
510(k) Summary
Spine-Tech Bone Harvester
General Information
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
Classification
Trade Name
Class I
Submitter
Spine-Tech, Inc.
Spine-Tech Bone Harvester
FEB 28 1997
7375 Bush Lake Road Minneapolis, MN 55439-2029 (612) 832-5600
David A. Cannistraci Director of Regulatory Affairs (612) 832-5600
Predicate Devices
Contact
Acumed Bone Graft System Spine-Tech Bone Harvester, Non-Powered General and Orthopedic Surgical Instruments, Accessories/Attachments
Intended Use
The Spine-Tech Bone Harvester is indicated for the cutting and collection of morselized autogenous bone graft from the anterior or posterior iliac crest, tibia or femur.
This device is intended to cut and collect finely morselized autogenous bone graft for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects. These procedures include; spinal fusion, joint arthrodesis, total joint replacement, fracture repair, maxillofacial reconstruction and tumor removal.
All components of the Spine-Tech Bone Harvested are intended for single use only.
1
Device Description
The Spine-Tech Bone Harvester consists of two cutting head/collection tube sizes, Hudson or Hall fitting adapter for power use, trocar and plunger. The cutting heads and trocar are constructed from stainless steel. The collection tube and adapter are constructed from medical grade polycarbonate. The plunger is constructed from acetal copolymer.
After cutting and collection of morselized bone graft, the cutting head is removed from the collection tube with the trocar and bone is pushed out of the collection tube with the plunger.
Testing
Biocompatibility testing has been performed on the materials used in the construction of this device and is documented in the ASTM Standard.
Performance and quality testing of the product included bench testing, dimensional and workmanship inspection. All testing of the device yielded acceptable results.
Summary of Substantial Equivalence
The Spine-Tech Bone Harvester is substantially equivalent in material, design, and function to Acumed Bone Graft System and other general and orthopedic surgical instruments used for the harvesting of autogenous bone.
Due to the similarity of materials and design to both pre-enactment and postenactment devices, Spine-Tech believes that the Spine-Tech Bone Harvester does not raise any new safety or effectiveness issues.