(66 days)
No
The 510(k) summary describes a physical spinal implant made of PEEK with radiopaque markers. There is no mention of software, algorithms, image processing, AI, ML, or any computational components. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is indicated for intervertebral body fusion of the lumbar spine to treat degenerative disc disease, facilitating fusion to alleviate back pain. This aligns with the definition of a therapeutic device as it is intended to treat a pathological condition.
No
The device description indicates it is an implantable lumbar intervertebral body fusion device used for treatment, not for diagnosing conditions.
No
The device description explicitly states it is an implant manufactured from PEEK Optima LT1 with radiopaque tantalum markers, and includes bone screws and an anterior cover plate assembly, all of which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "intervertebral body fusion of the lumbar spine." This is a surgical implant used in vivo (within the body) to treat a structural issue.
- Device Description: The description details a physical implant made of PEEK material with tantalum markers, designed to be surgically implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
The device described is a surgical implant used for spinal fusion.
N/A
Intended Use / Indications for Use
The Cynch System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment.
The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
The Cynch System Visualif is a stand-alone device intended to be used with the two bone screws provided and the accompanying anterior cover plate. Should the physician choose to use fewer than the two screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided.
Product codes
MAX, OVD
Device Description
The Visualif System is part of the Cynch Spinal System and is available in various sizes to accommodate individual patient anatomy. The Visualif implant is a lumbar intervertebral body fusion device that is intended to be implanted singularly via an open anterior approach. Visualif is a stand-alone device intended to be used with two (2) bone screws provided and the accompanying anterior cover plate assembly. NOTE: The cover plate assembly and screws are part of the implant construct.
Addition of an ALIF version to the existing Cynch System is intended to provide surgeons with additional surgical approach options. There are no changes with respect to indications or intended use as compared to the Cynch Spinal System cleared previously via K090376.
The Cynch System implants are manufactured from PEEK Optima LT1 and contain three (3) radiopaque tantalum markers to assist the surgeon with proper placement of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, from L2 to SI
Indicated Patient Age Range
skeletally mature patients
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
The following non-clinical tests were conducted:
- Static and dynamic compression testing, conducted in accordance with ASTM F2077-03
- Static and dynamic compression-shear testing, conducted in accordance with ASTM F2077-03
- Subsidence testing, conducted in accordance with ASTM F2267-04
- Expulsion testing, conducted in accordance with ASTM Draft Standard F-04.25.02.02
- Wear Debris Characterization, conducted in accordance to ASTM F1877.
The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the Visualif System is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
SpineSmith Cynch Spinal System - Visualif Interbody Fusion Implant System
| 510(k) Summary of Safety and Effectiveness | ||
|---|---|---|
| SUBMITTED BY | SpineSmith Partners, LP | |
| 93 Red River | ||
| Austin, TX 78701 | ||
| ESTABLISHMENT | ||
| REGISTRATION NUMBER | 3006404071 SEP 30 2010 | |
| CONTACT PERSON | Laura LeBoeuf | |
| Vice President - Quality and Regulatory Affairs | ||
| Phone: 512-637-2068 | ||
| Fax: 512-302-4920 | ||
| Email: lleboeuf@spinesmithusa.com | ||
| SUBMISSION PREPARED BY | Lisa Peterson | |
| Kaedon Consulting, LLC | ||
| Phone: 512-507-0746 | ||
| DATE PREPARED | July 10, 2010 | |
| CLASSIFICATION NAME | Intervertebral Fusion Device with Bone Graft, Lumbar | |
| (Product Code: MAX) | ||
| DEVICE CLASS | Class II | |
| REGULATION NUMBER | 888.3080 | |
| COMMON NAME | Intervertebral Body Fusion Device | |
| PROPRIETARY NAME | SpineSmith Cynch Spinal System - Visualif Interbody | |
| Fusion Implant System |
IDENTIFICATION OF PREDICATE DEVICES:
The SpineSmith Visualif System was determined to be substantially equivalent to the previously cleared Cynch System (K090376, SpineSmith; Cleared 4/1/2009).
DEVICE DESCRIPTION:
The Visualif System is part of the Cynch Spinal System and is available in various sizes to accommodate individual patient anatomy. The Visualif implant is a lumbar intervertebral body fusion device that is intended to be implanted singularly via an open anterior approach. Visualif is a stand-alone device intended to be used with two (2) bone screws provided and the accompanying anterior cover plate assembly. NOTE: The cover plate assembly and screws are part of the implant construct.
Addition of an ALIF version to the existing Cynch System is intended to provide surgeons with additional surgical approach options. There are no changes with respect to indications or intended use as compared to the Cynch Spinal System cleared previously via K090376.
p.
g 1 of 2
1
INDICATIONS:
The Cynch System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment.
The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
The Cynch System Visualif is a stand-alone device intended to be used with the two bone screws provided and the accompanying anterior cover plate. Should the physician choose to use fewer than the two screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
The purpose of this submission is to add the Visualif device, which may be implanted via an open anterior approach. The Cynch System implants are manufactured from PEEK Optima LT1 and contain three (3) radiopaque tantalum markers to assist the surgeon with proper placement of the device. The subject device (Visualif - ALIF device) has similar technological characteristics as the predicate devices identified above (SpineSmith's Cynch System per K090376). Specifically, the following characteristics support this conclusion:
- Intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis.
- 'U' shaped implant design to allow for placement of autograft bone -
- Implant material: PEEK Optima LT1 per ASTM F2026 with radiopaque tantalum marker . bar per ASTM F-560-05, and Titanium alloy screws/cover plate assembly per ASTM F-136
- Substantially equivalent results of non-clinical testing relative to static and dynamic . testing (per ASTM F2077-03), subsidence (per ASTM F2267-04), and expulsion (per ASTM Draft Standard F-04.25.02.02)
DISCUSSION OF NON-CLINICAL TESTING:
The following non-clinical tests were conducted:
- Static and dynamic compression testing, conducted in accordance with ASTM F2077-03 ,
- Static and dynamic compression-shear testing, conducted in accordance with ASTM . F2077-03
- Subsidence testing, conducted in accordance with ASTM F2267-04 -
- Expulsion testing, conducted in accordance with ASTM Draft Standard F-04.25.02.02 -
- Wear Debris Characterization, conducted in accordance to ASTM F1877. -
CONCLUSIONS:
The subject and predicate device share the same intended use, primary implant design and material of manufacture. The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the Visualif System is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird symbol, composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
SEP 1 2 2011
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Spine Smith Partners, LP % Ms. Laura LeBoeuf Vice President - Quality and Regulatory Affairs 93 Red River Austin, Texas 78701
Re: K102090
Trade/Device Name: Cynch Spinal System - Visualif Interbody Fusion Implant System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: September 1, 2010 Received: September 3, 2010
Dear Ms. LeBoeuf:
This letter corrects our substantially equivalent letter of September 30, 2010.
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 (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 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
3
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark M. Milkersen
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known):
102090
SEP 30 2010
SpineSmith Cynch Spinal System - Visualif Interbody Fusion Implant System
Indications for Use:
Device Name:
The Cynch System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment.
The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
The Cynch System Visualif is a stand-alone device intended to be used with the two bone screws provided and the accompanying anterior cover plate. Should the physician choose to use fewer than the two screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
tion (SDL)
(Div/sion Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
KID 2010 510(k) Number_