(89 days)
P960025, bd20019, K072791
P960025, bd20019, K072791
No
The summary describes a physical implantable device (spacer) and its intended use, without mentioning any software, algorithms, or data processing that would involve AI/ML.
Yes
The device is indicated for spinal fusion procedures for degenerative disc disease and a partial vertebral body replacement for tumors and fractures, which are medical treatments for conditions.
No.
The PILLAR™ Spacer System is an intervertebral body fusion device and a partial vertebral body replacement system, designed to restore spinal stability and facilitate fusion, not to diagnose conditions.
No
The device description explicitly states the components are a PEEK Spacer and Tantalum Markers, which are physical hardware components. The intended use also describes surgical implantation of these physical spacers.
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.
- Device Description and Intended Use: The PILLAR™ Spacer System is a physical implant designed for spinal fusion and partial vertebral body replacement. It is surgically implanted into the body to provide structural support and facilitate bone fusion.
- Lack of Diagnostic Function: The device does not analyze biological samples or provide diagnostic information about a patient's health status. Its function is purely structural and therapeutic.
Therefore, the PILLAR™ Spacer System falls under the category of a medical device (specifically, an implantable surgical device), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
When used as an intervertebral body fusion device, the PILLAR™ Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous nonfusion surgery at the involved level(s).
The PILLAR™ Spacer System is intended for use with autograft and supplemental internal fixation, e.g .: the Blackstone Medical ICON Modular Pedicle Screw System, or the Blackstone Medical Inc. SFS Spinal Fixation System.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PILLARTM Spacer System.
The PILLARTM PL spacer is used singly or in pairs, and is implanted using a posterior approach.
The PILLARTM TL spacer is used singly or in pairs, and is implanted using a transforaminal approach.
The PILLARTM AL spacer is used singly, and is implanted using an anterior approach.
When used as a Partial Vertebral Body Replacement (VBR) System, the PILLARTM Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLARTM Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.
The PILLAR™ Spacer System is designed to restore the biomechanical integrity of the anterior. middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft.
The PILLAR™ Spacer System is intended for use with internal fixation. The supplemental internal fixation system that may be used with the PILLAR™ Spacer System is the Blackstone Medical Spinal Fixation System.
Product codes
MAX, MQP
Device Description
The PILLAR Spacer System components consist of:
-
A PEEK Spacer
-
Tantalum Markers
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine (L2-S1), Thoracolumbar spine (T1-L5)
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)
Mechanical testing of the Blackstone Medical, Inc. PILLARTM Spacer System was conducted which demonstrates that the system is substantially equivalent to predicate devices that have the same intended use, similar indications, technological characteristics and principles of operation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DePuy Acromed Saber™ Lumbar I/F Cage®, (P960025), Surgical Dynamics, Inc. Ray Threaded Fusion Cage (TFC) (bd20019), Synthes Spine Opal Spacer System (K072791 SE 12-26-07)
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
K081177 (pg. 1 of 3)
JUL 2 3 2008
Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone PILLAR™ Spacer System Confidential
510(k) SUMMARY
Blackstone Medical, Inc. PILLAR™ Spacer System
| Sponsor: | Blackstone Medical, Inc.
1211 Hamburg Turnpike
Suite 300
Wayne, NJ 07470 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------|
| Registration Number: | 3004606875 |
| Contact Person: | Whitney G. Törning, Senior Director of Regulatory Affairs
& Quality Assurance
|
| Telephone Number: | 973.406.2838 |
| Fax Number: | 973.406.2938 |
| Email: | wtorning@blackstonemedical.com |
| Submitter: | Martin G. Sprunck
Regulatory Affairs Manager |
| Manufacturer: | Blackstone Medical, Inc.
90 Brookdale Drive
Springfield, MA 01104 |
| Registration Number: | 1225457 |
| Contract Manufacturer: | Marox Corporation
373 Whitney Avenue
Holyoke, MA 01040-2766 |
| Trade Name(s): | PILLAR AL, PILLAR PL, PILLAR TL Spacers |
| System Name: | PILLAR™ Spacer System |
| Product Codes: | MAX - Intervertebral Fusion Device with Bone Graft,
Lumbar
MQP - Spinal Intervertebral Body Fixation Orthosis |
| Common Name: | Intervertebral body fusion device |
| Regulatory Classification: | Class II - 888.3080 - Intervertebral body fusion device
888.3060 - Spinal Intervertebral Body Fixation Orthosis |
| Review Panel: | Orthopedic Device Panel |
PILLAR™ Spacer System – 510(k) Summary Page 1 of 3
1
K081177 (pg. 2 of 3)
Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone PILLARTM Spacer System Confidential
DePuy Acromed Saber™ Lumbar I/F Cage®, (P960025) Predicate Devices: Surgical Dynamics, Inc. Ray Threaded Fusion Cage (TFC) (bd20019) Synthes Spine Opal Spacer System (K072791 SE 12-26-07)
Intended Use / Indications for Use
When used as an intervertebral body fusion device, the PILLAR™ Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous nonfusion surgery at the involved level(s).
The PILLAR™ Spacer System is intended for use with autograft and supplemental internal fixation, e.g .: the Blackstone Medical ICON Modular Pedicle Screw System, or the Blackstone Medical Inc. SFS Spinal Fixation System.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PILLARTM Spacer System.
The PILLARTM PL spacer is used singly or in pairs, and is implanted using a posterior approach.
The PILLARTM TL spacer is used singly or in pairs, and is implanted using a transforaminal approach.
The PILLARTM AL spacer is used singly, and is implanted using an anterior approach.
When used as a Partial Vertebral Body Replacement (VBR) System, the PILLARTM Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLARTM Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.
The PILLAR™ Spacer System is designed to restore the biomechanical integrity of the anterior. middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft.
The PILLARTM Spacer System is intended for use with internal fixation. The supplemental internal fixation system that may be used with the PILLAR™ Spacer System is the Blackstone Medical Spinal Fixation System.
2
K081177 (pg. 3 of 3)
Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone PILLARTM Spacer System Confidential
Technological Characteristics
The PILLAR Spacer System components consist of:
-
A PEEK Spacer
-
Tantalum Markers
Performance Data
Mechanical testing of the Blackstone Medical, Inc. PILLARTM Spacer System was conducted which demonstrates that the system is substantially equivalent to predicate devices that have the same intended use, similar indications, technological characteristics and principles of operation.
Substantial Equivalence
The PILLAR Spacer System, the DePuy Acromed Saber™ Lumbar I/F Cage®, the Surgical Dynamics, Inc. Ray Threaded Fusion Cage and the Synthes Spine Opal Spacer System (K072791 SE 12-26-07) have the same intended use and similar indications, technological characteristics and principles of operation. The only technological differences between the PILLAR Spacer System and its predicates are minor dimensional characteristics and have been addressed mechanical verification testing. These differences do not present any new issues of safety or effectiveness. therefore, the PILLAR Spacer System is substantially equivalent to its predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Blackstone Medical, Inc. % Ms. Whitney G. Törning Senior Director of Regulatory Affairs and Quality Assurance 1211 Hamburg Turnpike, Suite 300 Wayne, NJ 07470
JUL 2 3 2008
Re: K081177
Trade/Device Name: PILLAR™ Spacer System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MAX, MOP Dated: April 23, 2008 Received: April 28, 2008
Dear Ms. Törning:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Ms. Whitney G. Törning
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1
Indications for Use Statement
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: PILLARTM Spacer System
Indications for Use:
When used as an intervertebral body fusion device, the PILEAR7M Spacer System is indicated for spinal fusion procedures in skelelally mature patients with degenerative disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s),
The PILLAR™ Spacer System is intended for use with autograft and supplemental internal fixation, e.g.; the Blackstone Medical ICON Modular Pedicle Screw System, or the Blackstone Medical Inc. SFS Spinal Fixation System.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment with the PILLARTM Spacer System.
The PILLAR™ PL spacer is used singly or in pairs, and is implanted using a posterior approach. The PILLAR™ TL spacer is used singly or in pairs, and is implanted using a transforaminal approach. The PILLARTM AL spacer is used singly, and is implanted using an anterior approach.
When used as a Partial Vertebral Body Replacement (VBR) System, the PILLARM Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLARTM Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.
The PILLAR™ Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft.
The PILLAR™ Spacer System is intended for use with internal fixation. The supplemental internal fixation system that may be used with the PILLAR™ Spacer System is the Blackstone Medical Spinal Fixation System.
Prescription Use (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nl
510(k) Number | (66)