(36 days)
The SpineSmith Cequence Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion in the treatment of the following indications:
- Degenerative disc disease [DDD] defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies
- Spondylolisthesis
- Spinal Stenosis
- Tumors
- . Trauma (i.e. fracture)
The Cequence anterior cervical plates are preassembled and are offered in both a constrained and semi-constrained configuration. Cequence consists of four (4) primary components: 1) anterior plate, 2) self-tapping bone screws, 3) locking screws and 4) locking plate.
Acceptance Criteria and Device Performance Study for SpineSmith Cequence Anterior Cervical Plate System
The SpineSmith Cequence Anterior Cervical Plate System's acceptance criteria and performance are established through mechanical testing demonstrating substantial equivalence to a predicate device.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device | Mechanical test results demonstrate that the proposed Cequence System is substantially equivalent to the predicate device. |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document refers to "mechanical test results" in general, but does not specify the number of devices or iterations tested.
- Data Provenance: Not explicitly stated, however, the data would be generated in a laboratory setting as part of the device's design verification and validation. This is a prospective study in that tests are conducted on newly manufactured devices.
3. Number and Qualifications of Experts for Ground Truth
- Not applicable. The ground truth for this device is established through objective mechanical testing against a predicate device, not through expert consensus on clinical cases.
4. Adjudication Method for Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective assessments (e.g., image interpretation), which is not relevant to mechanical testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is a medical device for spinal fixation, and its performance is evaluated through mechanical testing, not by human readers interpreting images. Therefore, an MRMC study is not relevant.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a physical implant, not an algorithm. Its performance is inherent to its design and material properties demonstrated through mechanical testing.
7. Type of Ground Truth Used
- Mechanical Test Standards and Predicate Device Performance: The ground truth is based on established mechanical testing standards relevant to spinal implants and the performance characteristics of a legally marketed predicate device. This involves objective, quantifiable measurements.
8. Sample Size for Training Set
- Not applicable. This is a physical medical device, not an algorithm that requires a training set.
9. How Ground Truth for Training Set Was Established
- Not applicable. This is a physical medical device, not an algorithm that requires a training set.
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K082821
Page 1 of 2
SpineSmith Cequence Anterior Cervical Plate System
510(k) Summary of Safety and Effectivencss
| SUBMITTED BY | SpineSmith Partners, LP8140 N. Mopac, Bldg II, Suite 120Austin, TX 78759 | OCT 31 2008 |
|---|---|---|
| ESTABLISHMENTREGISTRATION NUMBER | 3006404071 | |
| CONTACT PERSON | Robert JonesVice President, Research and DevelopmentPhone: 512-206-0770Fax: 512-637-6750Email: rjones@spinesmithusa.com | |
| SUBMISSION PREPARED BY | Lisa PetersonKaedon Consulting, LLCPhone: 512-507-0746 | |
| DATE PREPARED | September 22, 2008 | |
| CLASSIFICATION | KWQ 888.3060- Spinal Intervertebral Body FixationOrthosis | |
| COMMON NAME | Spinal Fixation System | |
| PROPRIETARY NAME | SpineSmith Cequence Anterior Cervical Plate System | |
| SUBSTANTIALEQUIVALENCE | The SpineSmith Cequence System was determined to besubstantially equivalent to the predicate device. |
DEVICE DESCRIPTION
1 - - - - - - -
The Cequence anterior cervical plates are preassembled and are offered in both a constrained and semi-constrained configuration. Cequence consists of four (4) primary components: 1) anterior plate, 2) self-tapping bone screws, 3) locking screws and 4) locking plate.
INDICATIONS:
The SpineSmith Cequence Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion in the treatment of the following indications:
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K082821
Page 2 of 2
- . Degenerative disc disease [DDD] -- defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
- Spondylolisthesis .
- Spinal Stenosis .
- Tumors .
- Trauma (i.e. fracture) .
MECHANICAL TEST DATA
ﭘﺎ ﻣﯿﮟ ﻭﺍﻗﻊ ﮨﮯ۔ ﺍﺱ ﮐﯽ ﻣ
Mechanical test results demonstrate that the proposed Cequence System is substantially cquivalent to the predicate device.
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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 features a stylized eagle with three stripes forming its wing and body. To the left of the eagle is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 31 2008
OCT 31 2008
% Mr. Robert Jones VP. Research and Development 8140 North Mopac, Building II, Suite 120 Austin, Texas 78759
Re: K082821
Spine Smith Partners, L.P.
Trade/Device Name: SpineSmith Partners, LP Cequence Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Names: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: September 22, 2008 Received: September 25, 2008
Dear Mr. Jones:
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. Robert Jones
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. 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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K082821
Page lot 1
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: SpineSmith Partners, LP Cequence Anterior Ccrvical Plate System
Indications for Use:
The SpineSmith Cequence Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion in the treatment of the following indications:
- Degenerative disc disease [DDD] defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies
- Spondylolisthesis �
- Spinal Stenosis ●
- Tumors .
- . Trauma (i.e. fracture)
Prescription Use X (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)
Concurrence of CDRH Office of Device Evaluation (ODE)
| -- | -------------------------------------------- |
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K082821 |
|---|---|
| --------------- | --------- |
§ 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.