(231 days)
Not Found
No
The summary describes a physical implant and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an intervertebral body fusion system, which is a type of implant used in surgical procedures to treat degenerative disc disease and facilitate fusion of the lumbar spine. This directly contributes to restoring health and function.
No
The device is an intervertebral body fusion system, intended for treatment of degenerative disc disease by facilitating fusion, not for diagnosing conditions.
No
The device description clearly states that the Sypher Spacer System is comprised of physical implants made of PEEK, tantalum, and titanium alloys, which are hardware components. The performance studies also focus on the mechanical properties of these physical implants.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Sypher Spacer System Function: The Sypher Spacer System is an implantable medical device designed to be surgically placed in the lumbar spine to facilitate intervertebral body fusion. It is a physical device used within the body, not to test samples from the body.
The description clearly outlines its use in a surgical procedure for treating degenerative disc disease, which is a clinical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Sypher Spacer System is an intervertebral body fusion system indicated for intervertebral body fusion procedures in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use with autogenous bone graft at one or two contiguous levels of the lumbar spine (from L2 to S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). 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 to facilitate fusion.
Product codes (comma separated list FDA assigned to the subject device)
OVD, MAX
Device Description
The Sypher Spacer System implants are cylinder shaped blocks made of PEEK Optima® LT1 (Polyether ether ketone per ASTM F2026), with tantalum alloy radiological position markers (per ASTM F560), titanium alloy self-drilling and self-tapping bone screws (per ASTM F136), and titanium alloy cage lock assemblies (per ASTM F136).
The implants are available in a variety of footprints, heights and lordotic angles. The shape of the Sypher product allows for a larger implant (height and width) to be used allowing for more surface area contact. The Sypher Spacer System is offered in a closed graft space design. The implants incorporate integrated anterior screw holes to allow for medial placement of screws, as well as a titanium alloy cage lock assembly for securing the screws once in place. Additional or other supplemental fixation may be used, as patient needs dictate. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and to prevent movement of the implants. The Sypher Spacer System is intended to be used with autologous bone graft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine (from L2 to S1)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Sypher Spacer System has been tested in the following test modes:
- Static axial compression bending per ASTM F2077-11
- o Static compressive shear per ASTM 2077-11
- Static subsidence per ASTM F2267-04 and ASTM 2077-11
- Dynamic axial compression per ASTM 2077-11
- Dynamic compressive shear per ASTM 2077-11
- Expulsion per ASTM Draft Standard F-04.25.02.02
The results of this non-clinical testing show that the strength of the Sypher Spacer System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K120031, K100089, K103034, K130913
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of human profiles facing right, suggesting a sense of community and care. The text is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 19, 2015
Biogennix, LLC % Ms. Meredith May Empirical Consulting 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K141798
Trade/Device Name: Sypher Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX Dated: January 21, 2015 Received: January 23, 2015
Dear Ms. May:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Meredith May
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141798
Device Name Sypher Spacer System
Indications for Use (Describe)
The Sypher Spacer System is an intervertebral body fusion system indicated for intervertebral body fusion procedures in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use with autogenous bone graft at one or two contiguous levels of the lumbar spine (from L2 to S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). 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 to facilitate fusion.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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5.510(K) SUMMARY
| Submitter's Name: | Biogennix, LLC |
|---|---|
| Submitter's Address: | 18011 Sky Park Circle, Suite M |
| Irvine, CA 92614 | |
| Submitter's Telephone: | 949.253.0994 |
| Contact Person: | Meredith L. May, MS |
| Empirical Testing Corp. | |
| 719.337.7579 | |
| Date Summary was Prepared: | 01-Jul-14 |
| Trade or Proprietary Name: | Sypher Spacer System |
| Common or Usual Name: | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | MAX |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Sypher Spacer System implants are cylinder shaped blocks made of PEEK Optima® LT1 (Polyether ether ketone per ASTM F2026), with tantalum alloy radiological position markers (per ASTM F560), titanium alloy self-drilling and self-tapping bone screws (per ASTM F136), and titanium alloy cage lock assemblies (per ASTM F136).
The implants are available in a variety of footprints, heights and lordotic angles. The shape of the Sypher product allows for a larger implant (height and width) to be used allowing for more surface area contact. The Sypher Spacer System is offered in a closed graft space design. The implants incorporate integrated anterior screw holes to allow for medial placement of screws, as well as a titanium alloy cage lock assembly for securing the screws once in place. Additional or other supplemental fixation may be used, as patient needs dictate. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and to prevent movement of the implants. The Sypher Spacer System is intended to be used with autologous bone graft.
INDICATIONS FOR USE
The Sypher Spacer System is an intervertebral body fusion system indicated for intervertebral body fusion procedures in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use with autogenous bone graft at one or two contiguous levels of the lumbar spine (from L2 to S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). 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 to facilitate fusion.
TECHNOLOGICAL CHARACTERISTICS
Biogennix, LLC Sypher Spacer System
4
Sypher Spacer System is made from PEEK Optima® LT1, Tantalum, and Titanium alloy that conforms to ASTM F2026, ASTM F560, and ASTM F136, respectively. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are similar or identical between the subject and predicates:
- Intended Use
- Materials of manufacture ●
- Structural support mechanism ●
- Indications for Use ●
| Table 5-1 Predicate Devices |
|---|
| 510k
| Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
|---|---|---|---|
| K120031 | Chesapeake® Anterior-Lumbar | ||
| Stabilization System | K2M | Primary | |
| K100089 | T-PAL Spacer | Synthes | Additional |
| K103034, | |||
| K130913 | Apache™ Lateral Lumbar Interbody | ||
| Fusion System | Genesys Spine | Additional |
PERFORMANCE DATA
The Sypher Spacer System has been tested in the following test modes:
- Static axial compression bending per ASTM F2077-11 ●
- o Static compressive shear per ASTM 2077-11
- Static subsidence per ASTM F2267-04 and ASTM 2077-11 ●
- Dynamic axial compression per ASTM 2077-11
- Dynamic compressive shear per ASTM 2077-11 ●
- Expulsion per ASTM Draft Standard F-04.25.02.02
The results of this non-clinical testing show that the strength of the Sypher Spacer System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Sypher Spacer System is substantially equivalent to the predicate device.