K Number
K022965
Device Name
BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE
Date Cleared
2003-03-28

(203 days)

Product Code
Regulation Number
888.3060
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Blackstone Medical Inc. "Classic" Anterior Cervical Plate is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include: a) degenerative disc disease (ddd)* * As defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies: b) spondylolisthesis; c) fracture; d) spinal stenosis: e) deformities (i.e., scoliosis, kyphosis, and/or lordosis); tumor; f) g) pseudoarthrosis; h) revision of previous surgery
Device Description
The Blackstone™ "Classic" Anterior Cervical Plate is a titanium alloy; multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build an anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation, which assists in the surgical implantation of the devices.
More Information

Not Found

No
The 510(k) summary describes a mechanical implant system (plates and screws) for spinal fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.

Yes

The device is an implantable system for anterior fixation to the cervical spine, indicated for various spinal conditions such as degenerative disc disease, fractures, and deformities, which are therapeutic medical conditions.

No
Explanation: The device is a temporary implant used for anterior fixation to the cervical spine, not for diagnosing medical conditions.

No

The device description explicitly states it is a titanium alloy, multiple component system comprised of screws, plates, and associated instrumentation, which are physical hardware components.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
  • Device Description: The provided text describes a surgical implant (an anterior cervical plate) that is physically placed within the body to stabilize the spine. It is a mechanical device, not a diagnostic test performed on a sample.
  • Intended Use: The intended use is for anterior fixation to the cervical spine for various conditions, which is a surgical treatment, not a diagnostic process.

The description clearly indicates a surgical implant used for treatment, not a device used for testing biological samples.

N/A

Intended Use / Indications for Use

The Blackstone Medical Inc. "Classic" Anterior Cervical Plate is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

  • a) degenerative disc disease (ddd)*
  • As defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies:
  • b) spondylolisthesis;
  • c) fracture;
  • d) spinal stenosis:
  • e) deformities (i.e., scoliosis, kyphosis, and/or lordosis);
  • tumor; f)
  • g) pseudoarthrosis;
  • h) revision of previous surgery

Product codes

KWQ

Device Description

The Blackstone™ "Classic" Anterior Cervical Plate is a titanium alloy; multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build an anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation, which assists in the surgical implantation of the devices.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cervical spine from C2 to C7

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)

K012184, K974885

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.

0

K 0 2 2 9 6 5

MAR 2 8 2003

Premarket Notification Blackstone Medical, Inc. Blackstone ™ "Classic" Anterior Cervical Plate Confidential

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| Name of Firm: | Blackstone Medical, Inc.
90 Brookdale Drive
Springfield, MA 01104 |
|---------------------------------------|-------------------------------------------------------------------------|
| 510(k) Contact: | Alan Lombardo
Director of Engineering |
| Trade Name: | Blackstone™ "Classic" Anterior Cervical Plate |
| Common Name: | Cervical Plating Instrumentation |
| Device Product Code & Classification: | KWQ 888.3060 - Spinal Intervertebral Body Fixation
Orthosis |

Substantially

Equivalent Devices:

Blackstone™ III° Anterior Cervical Plating System (K012184) Blackstone™ Anterior Cervical Plate System (K974885)

Device Description:

The Blackstone™ "Classic" Anterior Cervical Plate is a titanium alloy; multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build an anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation, which assists in the surgical implantation of the devices.

Intended Use / Indications for Use:

The Blackstone Medical Inc. "Classic" Anterior Cervical Plate is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

  • a) degenerative disc disease (ddd)*
  • As defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies:
  • b) spondylolisthesis;
  • c) fracture;
  • d) spinal stenosis:
  • e) deformities (i.e., scoliosis, kyphosis, and/or lordosis);
  • tumor; f)
  • g) pseudoarthrosis;
  • h) revision of previous surgery

1

Premarket Notification Blackstone Medical, Inc. Blackstone ™ "Classic" Anterior Cervical Plate Confidential

BASIS OF SUBSTANTIAL EQUIVALENCE:

The Blackstone™ "Classic" Anterior Cervical Plate System by its very nature is substantially equivalent to the Blackstone™ III° Anterior Cervical Plating System (K012184) and the Blackstone™ Anterior Cervical Plate System (K974885). The FDA has cleared this device, for anterior fixation to the cervical spine from C2 to C7.

2

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing, ribbon-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2003

Mr. Alan Lombardo Vice President, Product Development Blackstone Medical Incorporated 90 Brookdale Drive Springfield, Massachusetts 01104

Re: K022965

Trade Name: Blackstone "Classic" Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: January 2, 2003 Received: January 3, 2003

Dear Mr. Lombardo:

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. Iisting 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 - Mr. Alan Lombardo

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 Office of Compliance at (301) 594- . . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

sincerely, yours,

Mark McMullen

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

KO22965 510(k) Number:

Device Name: Blackstone™ III° Anterior Cervical Plating System

Indications for Use:

Blackstone™ III° Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

  • a) degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
  • b) spondylolisthesis;
  • c) fracture;
  • d) spinal stenosis;
  • e) deformities (i.e., scoliosis, kyphosis, and/or lordosis);
  • tumor; f)
  • g) pseudarthrosis;
  • h) revision of previous surgery

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Melkerson

Division of General. Rest ative and Neurological Devices

510(k) Number_

2296