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 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 Connector.

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.

AI/ML Overview

The provided 510(k) summary for the Blackstone™ Ascent® Posterior Occipital Cervico-Thoracic (POCT) System is a pre-market notification seeking clearance based on substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving device performance in the way a clinical trial or performance study would for a diagnostic or AI-driven device.

Instead, the submission focuses on:

Device Description: What the device is made of and its components.
Intended Use/Indications: The medical conditions and anatomical regions for which the device is designed.
Substantial Equivalence: How this new device is similar to previously cleared devices.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for test/training sets, training set sample size, ground truth establishment for training set) are not applicable to this type of submission.

Here is a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance
This document, K073420, is a 510(k) summary for a spinal implant system. Performance for such devices is typically assessed through mechanical testing (e.g., strength, fatigue) and biocompatibility, as well as by demonstrating substantial equivalence to predicate devices. The document does not provide a table of specific quantitative acceptance criteria or a report of measured device performance against such criteria. The "performance" claimed is its substantial equivalence to other legally marketed spinal fixation systems for the stated indications.

2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This document does not describe a clinical performance study with a "test set" of patients or data in the context of diagnostic or AI device evaluation. The assessment is based on a comparison to predicate devices, material specifications, and design.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth establishment by experts is not a component of this 510(k) submission for a spinal implant.

4. Adjudication Method for the Test Set
Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic device or an AI-assisted device.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. This is a physical medical implant, not an algorithm.

7. Type of Ground Truth Used
Not applicable in the context of clinical "ground truth" for diagnostic evaluation. The "ground truth" for this device's safety and effectiveness is established by its similarity (substantial equivalence) to devices that have been deemed safe and effective in prior regulatory clearances, along with meeting recognized material and mechanical engineering standards.

8. Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an algorithmic or AI device.

9. How the Ground Truth for the Training Set Was Established
Not applicable.

Summary of Device Rationale from the Document:

The basis of substantial equivalence is stated as: "The modified Blackstone™ Ascent Multiaxial Screws 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." This implies that the device's design, materials, and intended use are sufficiently similar to approved devices that it is expected to perform in a similar safe and effective manner, without requiring new clinical efficacy trials. The predicate devices listed are other spinal fixation systems.

Summary

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K073420

Page 1 of 2

FEB 14 2008

510(K) SUMMARY

Name of Firm:	Blackstone Medical, Inc.1211 Hamburg TurnpikeWayne, NJ 07470
510(k) Contact:	Whitney Törning, Director of Regulatory Affairs
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) DePuy Spine Summit and Mountaineer OCT Spinal Systems (K042508 SE 10-7-04) Stryker Spine Oasys System (K062853 SE 10-24-06) Medtronic Sofamor Danek Vertex Reconstruction System (K070742 SE 9-14-07)

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.

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K073420

Page 2 of 2

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;
occipito-cervical dislocation; f)
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 Connector.

Basis of Substantial Equivalence:

The modified Blackstone™ Ascent Multiaxial Screws 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird with three wing-like shapes.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 14 2008

Blackstone Medical, Inc. % Ms. Whitney Törning Director of Regulatory Affairs 1211 Hamburg Turnpike Wayne, NJ 07470

Re: K073420

Trade/Device Name: Blackstone™ 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: January 17, 2008 Received: January 18, 2008

Dear Ms. Torning:

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.

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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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its 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

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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)
g) tumors;
h) revision of previous cervical spine surgery

The Blackstone Ascent Posterior Occipital Cervical Thoracic System can also be linked to the Blackstone Spinal Fixation System using the Blackstone Ascent Axial Connector.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1 -

barbare boueux

Division of General, Restorative, and Neurological Devices

510(k) Number K073420

Regulation Number and Section

§ 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.