(116 days)
Not Found
No
The summary describes a physical implantable device made of PEEK and titanium with radiopaque markers for positioning. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are bench tests of mechanical properties.
Yes
The device is used to treat degenerative disc disease and accompanying radicular symptoms by facilitating interbody fusion, which clearly aligns with the definition of a therapeutic device.
No
The device is an anterior cervical interbody fusion device, used for treatment (fusion) rather than diagnosis.
No
The device description clearly states it is a physical implant fabricated from PEEK and titanium alloy, which are hardware components. The performance studies also describe bench testing of the physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Synthes ACIS and Vertebral Spacer CR are described as anterior cervical interbody fusion devices. Their intended use is to be surgically implanted into the cervical spine to facilitate bone fusion in patients with degenerative disc disease.
- Lack of Biological Sample Testing: The description and intended use do not involve testing any biological samples from the patient. The device is a physical implant.
- Focus on Mechanical Properties: The performance studies mentioned are bench tests evaluating the mechanical properties of the device (compression, shear, torsion, subsidence). This is typical for surgical implants, not IVDs.
Therefore, the Synthes ACIS and Vertebral Spacer CR are surgical implants, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The Synthes ACIS is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the Synthes ACIS should be packed with autogenous bone graft and implanted via an anterior approach. The Synthes ACIS is intended to be used with supplemental fixation.
The Synthes Vertebral Spacer CR is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the Synthes Vertebral Spacer CR should be packed with autogenous bone graft and implanted via an anterior approach. The Synthes Vertebral Spacer CR is intended to be used with supplemental fixation.
Product codes
ODP
Device Description
The Synthes ACIS is a radiolucent cervical intervertebral body fusion device. The Synthes ACIS is fabricated from Invibio® PEEK-Optima® LT-1 (ASTM F2026-10) with two anterior and one posterior titanium alloy (Ti-6Al-4V ELI; TAV; ASTM F136-2a) radiopaque markers. The markers allow intra-operative radiographic assessment of the position of the implant.
The Synthes Vertebral Spacer CR is a radiolucent cervical intervertebral body fusion device. The Vertebral Spacer CR is fabricated from Invibio® PEEK-Optima® LT-1 (ASTM F2026-10) with two anterior and one posterior titanium alloy (Titanium-6Aluminum-7Niobium ASTM F1295-05) radiopaque markers. The markers allow intra-operative radiographic assessment of the position of the implant.
The Synthes Vertebral Spacer CR is available in a range of heights, and is available in three different sagittal profiles. Pyramidal teeth that assist in stabilization of the construct are located on the inferior and superior surfaces of the spacers. The open architecture of the device allows it to be packed with autogenous bone graft material, i.e., autograft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, one level from C2-T1
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)
Non-Clinical Performance and Conclusions:
Synthes conducted the following bench testing (as recommended within FDA Guidance and in accordance with ASTM F2077-03 and ASTM F2267-04): Static Axial Compression; Dynamic Axial Compression; Static Compression Shear; Dynamic Compression Shear; Static Torsion; Dynamic Torsion; and Subsidence.
The conclusions drawn from testing demonstrate that the Synthes ACIS device is substantially equivalent in performance to predicate devices.
The conclusions drawn from testing demonstrate that the Synthes Vertebral Spacer CR device is substantially equivalent in performance to predicate devices.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes Zero-P device (K072981), NuVasive CoRoent System (K081611), BAK Cervical Interbody Fusion System (P980048), Medtronic Cornerstone PSR (K100214), Medtronic Prevail (K073285), Globus PATRIOTTM Spacers (ColonialTM ACDF) (K072991)
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
MAY 2 5 2012
6 510(k) Summary
| 510(k) Summary –Synthes ACIS | |
|---|---|
| Name of Firm: | Synthes Spine |
| 1302 Wrights Lane East | |
| West Chester, PA 19380 | |
| 510(k) Contact: | Heather Guerin, Ph.D., P.E. |
| Senior Regulatory Affairs Specialist | |
| Telephone: 610-719-5432 Facsimile: 610-719-5102 | |
| Email: guerin.heather@synthes.com | |
| Date Prepared: | January 27, 2012 |
| Trade Name(s): | Synthes ACIS |
| Classification: | 21 CFR 888.3080 – Intervertebral fusion device |
| Class II (special controls) | |
| Orthopaedic and Rehabilitation Devices Panel (87) | |
| Product Code ODP (Intervertebral Fusion Device with Bone Graft, | |
| Cervical) | |
| Predicates: | Synthes Zero-P device (K072981) |
| NuVasive CoRoent System (K081611) | |
| BAK Cervical Interbody Fusion System (P980048) | |
| Medtronic Cornerstone PSR (K100214) | |
| Medtronic Prevail (K073285) | |
| Globus PATRIOTTM Spacers (ColonialTM ACDF) (K072991) | |
| Device | |
| Description(s): | The Synthes ACIS is a radiolucent cervical intervertebral body fusion |
| device. The Synthes ACIS is fabricated from Invibio® PEEK-Optima® | |
| LT-1 (ASTM F2026-10) with two anterior and one posterior titanium | |
| alloy (Ti-6Al-4V ELI; TAV; ASTM F136-2a) radiopaque markers. The | |
| markers allow intra-operative radiographic assessment of the position of | |
| the implant. | |
| Intended Use/ | |
| Indications for | |
| Use: | The Synthes ACIS is an anterior cervical interbody fusion device |
| indicated for use in skeletally mature patients with degenerative disc | |
| disease (DDD) with accompanying radicular symptoms at one level from | |
| C2-T1. DDD is defined as discogenic pain with degeneration of the disc | |
| confirmed by history and radiographic studies. These patients should | |
| have had six weeks of non-operative treatment. The interior of the | |
| Synthes ACIS should be packed with autogenous bone graft and | |
| implanted via an anterior approach. The Synthes ACIS is intended to be | |
| used with supplemental fixation. | |
| Comparison of | Synthes ACIS is substantially equivalent to the predicates in design, |
| the device to | |
| predicate | |
| device(s): | function, performance, material, and intended use. |
| Performance | |
| Date | |
| (Non-Clinical | |
| and/or Clinical): | Non-Clinical Performance and Conclusions: |
| Synthes conducted the following bench testing (as recommended within | |
| FDA Guidance and in accordance with ASTM F2077-03 and ASTM | |
| F2267-04): Static Axial Compression; Dynamic Axial Compression; | |
| Static Compression Shear; Dynamic Compression Shear; Static Torsion; | |
| Dynamic Torsion; and Subsidence. | |
| The conclusions drawn from testing demonstrate that the Synthes ACIS | |
| device is substantially equivalent in performance to predicate devices. |
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device. |
1
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2
.
| 510(k) Summary –Synthes Vertebral Spacer CR | |
|---|---|
| Name of Firm: | Synthes Spine |
| 1302 Wrights Lane East | |
| West Chester, PA 19380 | |
| 510(k) Contact: | Heather Guerin, Ph.D., P.E. |
| Senior Regulatory Affairs Specialist | |
| Telephone: 610-719-5432 Facsimile: 610-719-5102 | |
| Email: guerin.heather@synthes.com | |
| Date Prepared: | January 27, 2012 |
| Trade Name(s): | Synthes Vertebral Spacer CR |
| Classification: | 21 CFR 888.3080 – Intervertebral fusion device |
| Class II (special controls) | |
| Orthopaedic and Rehabilitation Devices Panel (87) | |
| Product Code ODP (Intervertebral Fusion Device with Bone Graft, Cervical) | |
| Predicates: | Synthes Zero-P device (K072981); |
| NuVasive CoRoent System (K081611); | |
| BAK Cervical Interbody Fusion System (P980048); | |
| Medtronic Cornerstone PSR (K100214); | |
| Medtronic Prevail (K073285); | |
| Globus PATRIOTTM Spacers (ColonialTM ACDF) (K072991) | |
| Device | |
| Description(s): | The Synthes Vertebral Spacer CR is a radiolucent cervical intervertebral |
| body fusion device. The Vertebral Spacer CR is fabricated from Invibio® | |
| PEEK-Optima® LT-1 (ASTM F2026-10) with two anterior and one | |
| posterior titanium alloy (Titanium-6Aluminum-7Niobium ASTM F1295- |
- radiopaque markers. The markers allow intra-operative radiographic
assessment of the position of the implant.
The Synthes Vertebral Spacer CR is available in a range of heights, and is
available in three different sagittal profiles. Pyramidal teeth that assist in
stabilization of the construct are located on the inferior and superior
surfaces of the spacers. The open architecture of the device allows it to be
packed with autogenous bone graft material, i.e., autograft. |
| Intended Use/
Indications for
Use: | The Synthes Vertebral Spacer CR is an anterior cervical interbody fusion
device indicated for use in skeletally mature patients with degenerative
disc disease (DDD) with accompanying radicular symptoms at one level
from C2-T1. DDD is defined as discogenic pain with degeneration of the
disc confirmed by history and radiographic studies. These patients should
have had six weeks of non-operative treatment. The interior of the
Synthes Vertebral Spacer CR should be packed with autogenous bone
graft and implanted via an anterior approach. The Synthes Vertebral
Spacer CR is intended to be used with supplemental fixation. |
| Comparison of
the device to
predicate | Synthes Vertebral Spacer CR is substantially equivalent to the predicates
in design, function, performance, material, and intended use. |
| 510(k) Summary -Synthes Vertebral Spacer CR | |
| device(s): | |
| Performance
Date
(Non-Clinical
and/or Clinical): | Non-Clinical Performance and Conclusions:
Synthes conducted the following bench testing (as recommended within
FDA Guidance and in accordance with ASTM F2077-03 and ASTM
F2267-04): Static Axial Compression; Dynamic Axial Compression;
Static Compression Shear; Dynamic Compression Shear; Static Torsion;
Dynamic Torsion; and Subsidence.
The conclusions drawn from testing demonstrate that the Synthes
Vertebral Spacer CR device is substantially equivalent in performance to
predicate devices. |
| | Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device. |
·
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4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring. MD 20993-0002
Synthes Spine % Heather Guerin, Ph.D., P.E. Senior Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
MAY 2 5 2012
Re: K120275
Trade/Device Name: ACIS Spacer and Vertebral Spacer CR Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: April 24, 2012 Received: April 26, 2012
Dear Dr. Guerin:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Heather Guerin, Ph.D., P.E.
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 Mellerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement 5
510(k) Number: (if known)
K 120275
Device Name:
Synthes ACIS
Indications for Use:
The Synthes ACIS is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment. The interior of the spacer of the Synthes ACIS should be packed with autogenous bone graft and implanted via an anterior approach. The Synthes ACIS is intended to be used with supplemental fixation.
Prescription Use X (21 CFR 801 Subpart D) AND / OR
Over-the-Counter Use (21 CFR 801 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)
Vivision of Surgical, Orthopedic, and Restorative Devices
KI20275 510(k) Number_
Page 1/2
7
510(k) Number: (if known)
K 120275
Device Name:
Synthes Vertebral Spacer CR
Indications for Use:
The Synthes Vertebral Spacer CR is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the Synthes Vertebral Spacer CR should be packed with autogenous bone graft and implanted via an anterior approach. The Synthes Vertebral Spacer CR is intended to be used with supplemental fixation.
Prescription Use X (21 CFR 801 Subpart D) AND / OR
Over-the-Counter Use (21 CFR 801 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)
Digision of Surgical, Orthopedic, and Restorative Devices
K120275 510(k) Number_
Page 2/2
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