(29 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation system with various components. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The device description focuses solely on the physical components and their intended use in spinal fusion.
No
Explanation: A therapeutic device is used to treat a disease or condition. This device, the Blackstone Ascent POCT System, is a spinal implant system used to provide stability and promote fusion within the spine, which is a treatment for various spinal conditions, but it is a temporary implant of components that build a spinal implant, which is not considered a therapeutic device. Instead this is a surgical device.
No
The provided text describes the Blackstone Ascent POCT System as a temporary, titanium alloy, multiple component system used to build a spinal implant construct for conditions like degenerative disc disease, spondylolisthesis, and fractures. Its function is to promote fusion and provide mechanical support, not to diagnose medical conditions.
No
The device description explicitly states it is a "temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components" including rods, screws, hooks, plates, etc., which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system designed to promote fusion of the spine. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is described as a system of components like rods, screws, hooks, etc., which are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used for diagnostic purposes by analyzing samples outside the body. This device is a surgical implant used for treatment.
N/A
Intended Use / Indications for Use
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Blackstone Ascent POCT System is indicated for:
- a) degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies:
- b) spondylolisthesis:
- c) fracture/dislocation:
- d) spinal stenosis:
- e) atlanto-axial fracture with instability;
- f) occipito-cervical dislocation:
- g) tumors;
- h) revision of previous cervical spine surgery
The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) for the treatment of thoracic conditions only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (T1-T3). The hooks are intended to be placed from C1 to T3. The Songer Cable (titanium) System to be used with the Blackstone Ascent POCT System allows for wire/cable attachment to the posterior cervical spine.
The Blackstone Ascent POCT System can also be linked to the Blackstone Spinal Fixation System using the Blackstone Ascent Axial or Parallel Connector.
Product codes
KWP
Device Description
The Blackstone Ascent POCT System is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The Ascent POCT System consists of an assortment of rods, setscrews, cross connectors, axial connectors, lateral offset adapters, multi-axial screws, hooks, plates, bone screws, and Songer Cables.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
occipito-cervico-thoracic spine, occiput, T3, thoracic spine (T1-T3), C1
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K030197, K040034, K033980, K042100, K073654
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
Premarket Notification Special 510(k) Blackstone Medical, Inc. Blackstone™ Ascent* POCT System Plate and Rod Modifications (System Modification) Confidential
510(K) SUMMARY
| Name of Firm: | Blackstone Medical, Inc.
1211 Hamburg Turnpike
Wayne, NJ 07470 | MAR 13 2008 |
|------------------------------|-------------------------------------------------------------------------------|-------------|
| 510(k) Contact: | Whitney Törning, Senior Director of Regulatory Affairs &
Quality Assurance | |
| Submitter: | Martin Sprunck, Regulatory Affairs Manager | |
| Trade Name: | Blackstone™ Ascent® Posterior Occipital Cervico-
Thoracic (POCT) System | |
| Common Name: | Rod and screw spinal instrumentation | |
| Device Classification: | Class II | |
| Classification Product Code: | KWP – 888.3050 – Spinal Interlaminal Fixation Orthosis | |
Substantially Equivalent Devices:
Blackstone™ Posterior Cervical System (K030197 SE 6-12-03) Blackstone™ Ascent POCT System Lateral Offset Adaptors (K040034 SE 2-11-04) Blackstone™ Ascent POCT System Hooks (K033980 SE 3-3-04) Blackstone™ Ascent POCT System 5.5mm/3.0mm Single Axial Connector (K042100 SE 9-20-04) Blackstone™ Ascent POCT System Parallel Rod Connectors (K073654 SE 1-24-08)
Device Description:
Description: The Blackstone Ascent POCT System is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The Ascent POCT System consists of an assortment of rods, setscrews, cross connectors, axial connectors, lateral offset adapters, multi-axial screws, hooks, plates, bone screws, and Songer Cables.
Levels of Use: When used in the occipito-cervico-thoracic spine, the Blackstone Posterior Cervical System may be used from the occiput to T3.
1
Indications: When intended to promote fusion of the cervical spine and occipito-cervicothoracic junction (occiput-T3), the Blackstone Ascent POCT System is indicated for:
- a) degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies:
- b) spondylolisthesis:
- c) fracture/dislocation:
- d) spinal stenosis:
- e) atlanto-axial fracture with instability;
- f) occipito-cervical dislocation:
- g) tumors;
- h) revision of previous cervical spine surgery
The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) for the treatment of thoracic conditions only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (T1-T3). The hooks are intended to be placed from C1 to T3. The Songer Cable (titanium) System to be used with the Blackstone Ascent POCT System allows for wire/cable attachment to the posterior cervical spine.
The Blackstone Ascent POCT System can also be linked to the Blackstone Spinal Fixation System using the Blackstone Ascent Axial or Parallel Connector.
Basis of Substantial Equivalence:
The modified Blackstone™ Ascent Occipital Plate and Occipital-Transition Rod are substantially equivalent to the identified predicate systems, which have been cleared by FDA for the purpose of building a spinal implant construct in the occipito-cervico-thoracic spine.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure embracing a globe, symbolizing the agency's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 2008
Blackstone Medical, Inc. % Ms. Whitney Törning Senior Director of Regulatory Affairs and Quality Assurance 1211 Hamburg Turnpike, Suite 300 Wayne, NJ 07470
K080394 Re:
Trade/Device Name: Ascent® Posterior Occipital Cervico-Thoracic (POCT) System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: February 11, 2008 Received: February 13, 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.
3
Page 2 - Ms. Whitney 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 the reporting 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 yours,
Mark N Millen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Blackstone™ Ascent Posterior Occipital Cervical Thoracic System (POCT) System
Indications for Use:
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Blackstone Ascent POCT System is indicated for:
- degenerative disc disease (defined as neck pain of discogenic origin with degeneration of a) the disc confirmed by patient history and radiographic studies;
- spondylolisthesis; b)
- fracture/dislocation; c)
- spinal stenosis; d)
- atlanto-axial fracture with instability; e)
- occipito-cervical dislocation; f)
- tumors; g)
- h) revision of previous cervical spine surgery
The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) for the treatment of thoracic conditions only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (T1-T3). The hooks are intended to be placed from C1 to T3. The Songer Cable (titanium) System to be used with the Blackstone Ascent Posterior Occipital Cervical Thoracic System allows for wire/cable attachment to the posterior cervical spine.
The Blackstone Ascent Posterior Occipital Cervical Thoracic System can also be linked to the Blackstone Spinal Fixation System using the Blackstone Ascent Axial or Parallel Rod Connector.
Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Page 1 of
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Dykman
Division of General, Restorative, and Neurological Devices
510(k) Number K080394