(87 days)
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);
f) tumor:
g) pseudarthrosis;
h) revision of previous surgery
The Cover Plate addition for the Blackstone™ III° Anterior Cervical Plating System is a titanium alloy (6AL-4V ELI, per ASTM F136) device which is a non-sterile, single use component. When used with the Blackstone™ III° Anterior Cervical Plating System a surgeon can build an anterior cervical implant construct. The system's design is intended to stabilize the cervical spinal operative site during the fusion process of a bone graft in the disc space.
This document is a 510(k) premarket notification for a medical device: the Blackstone™ III Anterior Cervical Plating System Cover Plate (System Addition). It describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices.
Here's an analysis of the provided text in relation to the requested information about acceptance criteria and a study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided text, there are no specific acceptance criteria or detailed device performance metrics reported for this particular submission. The document focuses on establishing substantial equivalence to predicate devices rather than presenting the results of a performance study with pre-defined acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
No test set, sample size, or data provenance (country of origin, retrospective/prospective) is mentioned in this 510(k) submission. This is a premarket notification for an addition to an existing system, and the primary argument for clearance is substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. No ground truth establishment related to a test set is discussed.
4. Adjudication Method for the Test Set:
Not applicable. No test set or adjudication method is discussed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. There is no mention of an MRMC study or any comparison of human readers with and without AI assistance. This device is a physical implant, not an AI-driven diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is a physical medical implant, not an algorithm or AI system.
7. Type of Ground Truth Used:
Not applicable. There is no mention of a ground truth in the context of device performance, as the submission focuses on substantial equivalence.
8. Sample Size for the Training Set:
Not applicable. As this is not an AI/algorithm-based device, there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reason as above.
Summary of Findings Regarding Device Acceptance and Study:
The provided 510(k) submission for the Blackstone™ III Anterior Cervical Plating System Cover Plate (System Addition) does not contain information regarding acceptance criteria or a study proving the device meets those criteria in the way typically expected for an AI or diagnostic device.
Instead, the submission relies entirely on the concept of substantial equivalence to predicate devices that have already been cleared by the FDA. The argument for substantial equivalence is based on:
- Identical Indications for Use: The new Cover Plate, when used with the existing system, has the same intended use and indications (anterior fixation to the cervical spine from C2 to C7 for various conditions) as the predicate devices.
- Similar Technology/Materials: The Cover Plate is made of titanium alloy (6AL-4V ELI, per ASTM F136), which is standard for such implants.
- Existing Regulatory Clearance: The predicate devices (Blackstone™ III Anterior Cervical Plating System (K012184) and Blackstone™ Anterior Cervical Plate System (K974885)) were previously cleared by the FDA for the same indications.
The FDA's response letter confirms the finding of "substantial equivalence," allowing the device to be marketed. This regulatory pathway does not typically require new clinical or performance studies with specific acceptance criteria if equivalence to a legally marketed predicate can be adequately demonstrated. Therefore, the "study" proving the device's compliance is, in this context, the demonstration of substantial equivalence to existing, cleared devices.
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020620 p 1/2
MAY 2 3 2002
Premarket Notification Blackstone Medical, Inc. Blackstone™ III Anterior Cervical Plating System Cover Plate (System Addition)
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Name of Firm: | Blackstone Medical, Inc.90 Brookdale DriveSpringfield, MA 01104 |
|---|---|
| 510(k) Contact: | Alan LombardoDirector of Engineering |
| Trade Name: | Blackstone™ III° Anterior Cervical Plating System |
| Common Name: | Cervical Plating Instrumentation |
| Device Product Code& Classification: | KWQ 888.3060 - Spinal Intervertebral Body FixationOrthosis |
Substantially Equivalent Devices:
Blackstone™ III° Anterior Cervical Plating System (K012184) Blackstone™ Anterior Cervical Plate System (K974885)
Device Description:
The Cover Plate addition for the Blackstone™ III° Anterior Cervical Plating System is a titanium alloy (6AL-4V ELI, per ASTM F136) device which is a non-sterile, single use component. When used with the Blackstone™ III° Anterior Cervical Plating System a surgeon can build an anterior cervical implant construct. The system's design is intended to stabilize the cervical spinal operative site during the fusion process of a bone graft in the disc space.
Intended Use / 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);
- f) tumor:
- g) pseudarthrosis;
- h) revision of previous surgery
Summary
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K020620 p²/₂
Premarket Notification Blackstone Medical, Inc. Blackstone™ III® Anterior Cervical Plating System Cover Plate (System Addition)
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Cover Plate addition for the Blackstone™ III° Anterior Cervical Plating System by its very nature is substantially equivalent to the predicate devices listed below:
Blackstone™ III° Anterior Cervical Plating System (K012184) Blackstone™ Anterior Cervical Plate System (K974885)
The FDA has cleared each of these devices, for anterior fixation to the cervical spine from C2 to C7.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2002
Mr. Alan Lombardo Director of Engineering Blackstone Medical, Inc. 90 Brookdale Drive Springfield, Massachusetts 01104
Re: K020620
Trade/Device Name: Blackstone™ III° Anterior Cervical Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: February 21, 2002 Received: February 22, 2002
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, 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 - 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
l. Mark N. Millman
Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket Notification Blackstone Medical, Inc. Blackstone™ III° Anterior Cervical Plating System Cover Plate (System Addition)
510(k) Number: (d2062
page 1 of 1
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:
- degenerative disc disease (as defined as back pain of discogenic origin with a) degenerative disc confirmed by patient history and radiographic studies);
- b) spondylolisthesis;
- fracture; c)
- d) spinal stenosis;
- deformities (i.e., scoliosis, kyphosis, and/or lordosis); e)
- 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)
for Mark A. Millikin
eneral. Restorative
510(k) Number .
§ 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.