(71 days)
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 (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
b) spondylolisthesis
c) spinal stenosis
d) fracture/dislocation
e) atlanto/axial fracture with instability
f) occipitocervical dislocation
g) revision of previous cervical spine surgery
h) tumors
The occipital bone screws are limited to occipital fixation only.
The hooks placement is indicated from C1-T3.
The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The Songer Cable System to be used with the Blackstone™ POCT System allows for wire/cable attachment to the posterior cervical spine.
The Blackstone™ Ascent POCT System is a 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 system's design is intended promote immobilization and stabilization of spinal segments as an adjunct to fusion of the cervical and/or upper thoracic spine. The Blackstone™ Ascent POCT System consists of an assortment of rods, setscrews, cross connectors, multi-axial screws, plates, bone screws, and Songer Cables. The hooks are designed to be compatible with and work in conjunction with the components in the current Blackstone Ascent POCT System.
This 510(k) premarket notification (K033980) does not describe a study involving acceptance criteria or device performance. Instead, it is a Premarket Notification for a System Modification for the Blackstone™ Ascent Posterior Occipital-Cervical-Thoracic System Hooks.
The basis for this submission is Substantial Equivalence to a previously cleared device (Blackstone™ Ascent POCT System, K030197), not a new study demonstrating performance against specific acceptance criteria.
Therefore, most of your requested information (1-9) cannot be provided from the given document, as it pertains to a performance study which was explicitly not conducted or presented in this 510(k).
Here's what can be inferred or stated based on the provided text:
- 1. A table of acceptance criteria and the reported device performance: Not applicable. No performance study was conducted or reported in this 510(k). The device is cleared based on demonstrating substantial equivalence to a predicate device.
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set or data provenance is mentioned as part of a performance study.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. No test set or ground truth establishment is described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical implant system, not an AI-assisted diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a surgical implant system, not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable. No training set is relevant for this type of submission.
- 9. How the ground truth for the training set was established: Not applicable.
Summary of the document's approach:
The manufacturer, Blackstone Medical, Inc., is seeking clearance for new "Hooks" components as a modification to their existing Blackstone™ Ascent POCT System (K030197). Their basis for substantial equivalence hinges on the new hooks being compatible with and working in conjunction with the components of the already cleared system. The FDA's letter confirms that they have reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices, meaning it allows the device to proceed to market without requiring new clinical performance studies because it is sufficiently similar to an already approved device.
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Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone™ Ascent Posterior Occipital-Cervical-Thoracic System Hooks (System Modification)
K033980
Page 1 of 2
アレットが出掛けない。 600×100×1000
510(K) SUMMARY
| Name of Firm: | Blackstone Medical, Inc.90 Brookdale DriveSpringfield, MA 01104 |
|---|---|
| 510(k) Contact: | Dean E. CiporkinDirector, Regulatory Affairs and Quality Assurance |
| Trade Name: | Blackstone™ Ascent POCT System Hooks |
| Common Name: | Rod and screw spinal instrumentation |
| Device Product Code& Classification: | MNI - 888.3070 - Pedicle Screw Spinal SystemKWP- 888.3050 - Spinal Interlaminal Fixation Orthosis |
| SubstantiallyEquivalent Devices: | Blackstone™ Ascent POCT System (K030197) |
Device Description:
MAR - 3 2004
The Blackstone™ Ascent POCT System is a 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 system's design is intended promote immobilization and stabilization of spinal segments as an adjunct to fusion of the cervical and/or upper thoracic spine. The Blackstone™ Ascent POCT System consists of an assortment of rods, setscrews, cross connectors, multi-axial screws, plates, bone screws, and Songer Cables. The hooks are designed to be compatible with and work in conjunction with the components in the current Blackstone Ascent POCT System.
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Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone™ Ascent Posterior Occipital-Cervical-Thoracic System Hooks (System Modification)
K033480 Page 2 of 2
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 (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- b) spondylolisthesis
- c) spinal stenosis
- d) fracture/dislocation
- e) atlanto/axial fracture with instability
- occipitocervical dislocation f)
- g) revision of previous cervical spine surgery
- h) tumors
The occipital bone screws are limited to occipital fixation only.
The hooks placement is indicated from C1-T3.
The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The Songer Cable System to be used with the Blackstone™ POCT System allows for wire/cable attachment to the posterior cervical spine.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Blackstone™ Ascent POCT System Hooks are substantially equivalent to the Blackstone Ascent POCT System (K030197), which has been cleared by FDA for posterior fixation applications to the occipito-cervico-thoracic junstion (occiput-T3)
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle with three wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 3 2004
Mr. Dean E. Ciporkin Director, Regulatory Affairs and Quality Assurance Blackstone Medical, Inc. 90 Brooksdale Drive Springfield, MA 01104
Re: K033980
Trade/Device Name: Blackstone™ Ascent Posterior Occipital-Cervical-Thoracic System Regulation Number: 21 CFR 888.3050; 21 CFR 888.3070 Regulation Name: Spinal interlaminal fixation orthosis; Pedicle screw spinal system Regulatory Class: Class II Product Code: KWP, MNI Dated: December 1, 2003 Received: December 29, 2003
Dear Mr. Ciporkin:
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 may or career to one 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 or any I 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.
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Page 2 – Mr. Dean E. Ciporkin
This letter will allow you to begin marketing your device as described in your Section 5 10(k) This letter will allow you to ocgin marketing your antial equivalence of your device to a legally premarket notification. The PDA midning of backandal expand 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 entiled If you desire specific advice for your ac not on one of the regulation entitled.
contact the Office of Compliance at (301) 594-4659. Also, please note the regulation contact the Office of Compliance at (301) 37 - 1007 (21 CFR Part 807.97). You may obtain "Misbranding by reference to premation inclification of Street the Act from the Division of Small other general Information on your responsion.com its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at the local demoments http:// Manufacturers, International and Collisaner Piscessor.cdrb/dsma/dsmamain.html
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Witten, Ph.D., M.D. Celia Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K033980
Page 1 of 1
Device Name: Blackstone™ Ascent Posterior Occipital-Cervical-Thoracic System
Indications for Use:
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Blackstone Ascent Posterior Occipital Cervical Thoracic 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 multiaxial 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 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| Prescription Use | X |
|---|---|
| (Per 21 CFR801.109) | |
| 510(k) Number | K035980 |
| Over-The-Counter Use |
§ 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.