(33 days)
Not Found
No
The device description and intended use focus on mechanical components for spinal fixation and do not mention any software, algorithms, or data processing capabilities that would indicate AI/ML.
No
The device is an implantable plating system and associated hardware for spinal fixation, not a therapeutic device designed to cure or alleviate a disease through treatment. Its purpose is mechanical stabilization.
No
The device is described as an anterior cervical plating system intended for fixation to the cervical spine, meaning it is a surgical implant used for treatment, not for diagnosing medical conditions.
No
The device description explicitly states it is comprised of titanium alloy components (screws, plates, and instrumentation), which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The Hallmark™ Anterior Cervical Plating System is described as a system of implants (screws, plates) made of titanium alloy that are surgically attached to the anterior aspect of the vertebral body. This is an implantable medical device used within the body.
- Intended Use: The intended use is for anterior fixation to the cervical spine for various conditions. This involves surgical intervention and implantation, not laboratory testing of specimens.
The description clearly indicates a surgical implant system, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Hallmark™ 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 Degonerative disc confirmed by patient history and radiographic studies);
- b) Spondylolisthesis;
- c) Fracture;
- d) Spinal stenosis;
- a) Opinarities (i.e., scoliosis, kyphosis, and/or lordosis)
- Tumor; f)
- g) Pseudoarthrosis;
- h) Revision of previous surgery
Product codes
KWQ
Device Description
The Hallmarl™ Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy (6AL-4V ELI, per ASTM F136) components that allow a 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)
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
Premarket Notification 510(k) Blackstone Medical, Inc. Hallmark™ Anterior Cervical Plate System
MAY 1 1 2005
510(K) SUMMARY
| Name of Firm: | Blackstone Medical, Inc.
90 Brookdale Drive
Springfield, MA 01104 |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Dean E. Ciporkin
Director, Regulatory Affairs and Quality Assurance |
| Trade Name: | Hallmark™ Anterior Cervical Plate System |
| Common Name: | Cervical Plating Instrumentation |
| Device Product Code
& Classification: | KWQ - 888.3060 - Spinal Intervertebral Body Fixation Orthosis |
| Substantially
Equivalent Devices: | Blackstone™ Fusion Anterior Cervical Plate System (K030595)
Blackstone™ III° Anterior Cervical Plating System (K012184) |
Device Description:
The Hallmarl™ Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy (6AL-4V ELI, per ASTM F136) components that allow a 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.
1
Premarket Notification 510(k) Blackstone Medical, Inc. Hallmark™ Anterior Cervical Plate System
Intended Use / Indications for Use:
The Hallmark™ 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) Pseudoarthrosis;
- h) Revision of previous surgery
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Hallmark™ Anterior Cervical Plating System is substantially equivalent to the predicate devices, the Blackstone™ III° Anterior Cervical Plating System (K012184) and the Blackstone™ Fusion Anterior Cervical Plate System (K030595), which have been cleared by FDA for anterior fixation to the cervical spine.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 11 2005
Mr. Dean E. Ciporkin Director Regulatory Affairs and Quality Assurance Blackstone Medical Incorporated 90 Brookdale Drive Springfield, MA 01104
Re: K050892
Trade/Device Name: HALLMARK Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 7, 2005 Received: April 11, 2005
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 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.
3
Page 2 – Mr. Dean E. Ciporkin
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc advised that I DTT o letting that your device complies with other requirements of the Act that I DA has made a aond regulations administered by other Federal agencies. You must or any i-cuclar statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY art 6077, and if your rail on (21 CFR Part 820); and if applicable, the electronic form in the quality of the (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation oonal of problem marketing your device as described in your Section 510(k) I mis letter will anow your to organismal equivalence of your device of your device to a legally prematics notification. The 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 If you desire specific aarroliance at (240) 276-0120. Also, please note the regulation entitled, Connact the Office of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micrinational 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/industry/support/index.html.
Sincerely yours,
Stpk Rhodes
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
KOSO92 510(k) Number (if known): __
Device Name: Hallmark™ Anterior Cervical Plate System
Indications for Use:
The Hallmark™ Anterior Cervical Plate 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 Degonerative disc confirmed by patient history and radiographic studies);
. -
b) Spondylolisthesis;
-
c) Fracture;
-
d) Spinal stenosis;
-
a) Opinarities (i.e., scoliosis, kyphosis, and/or lordosis)
-
Tumor; f)
-
g) Pseudoarthrosis;
-
h) Revision of previous surgery
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) nontrepode of CBRH, Office of Device Evaluation (ODE) Division Sign-Off) Division of General, Restorative. Page 1 of ____________________________________________________________________________________________________________________________________________________________________ and Neurological Devices
510(k) Number K050892