(127 days)
No
The summary describes a physical implant device and its mechanical testing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used to treat degenerative disc disease and facilitate fusion between vertebrae, which are therapeutic indications.
No
This device is a cervical spacer system intended for anterior cervical interbody fusion procedures, which is a treatment for degenerative disc disease, not a diagnostic tool.
No
The device description clearly states it is a physical implant made of PEEK and titanium, intended for surgical implantation. It is a hardware device, 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 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 Ascendant™ Cervical Spacer System is a physical implant designed to be surgically placed in the spine to facilitate bone fusion. It is a medical device used in vivo (within the body), not a test performed in vitro (outside the body).
The information clearly describes a surgical implant used for structural support and fusion in the cervical spine. It does not involve the analysis of biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Ascendant™ Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (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 Ascendant™ Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The Ascendant™ Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK Optima® LT1 (polyetheretherkeytone) implant cage with CP titanium coating and tantalum radiographic markers. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints and lordotic angles to accommodate varying anatomical conditions. The device features an enclosed chamber intended to be filled with autogenous bone graft material.
The Ascendant™ Cervical Spacer System is intended to be used with supplemental fixation (i.e., an anterior cervical plate).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical (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)
The Ascendant™ Cervical Spacer System, Ti Coated has been tested in the following test modes:
- Static Compressive Shear per ASTM F2077
- Static Expulsion per ASTM F-04.25.02.02
- Dynamic Axial Compression per ASTM F2077 .
- Dynamic Compressive Shear per ASTM F2077
- Dynamic Torsion per F2077
- Percent Porosity per ASTM F1854-09 .
- Coating Thickness per ASTM F1854-09 .
- Static Shear per ASTM F1044-05
- Static Tensile per ASTM F1147-05
- Shear Fatigue per ASTM F1160-05
- Abrasion per ASTM F1978-00
The results of this non-clinical testing show that the strength of the Cervical Spacer System, Ti Coated 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.
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.
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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 28, 2015
Exactech, Incorporated % Kenneth Maxwell Regulatory and Quality Specialist Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K150130
Trade/Device Name: Ascendant™ Cervical Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: April 27, 2015 Received: April 28, 2015
Dear Mr. Maxwell,
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
1
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 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 yours,
Mark N. Melkerson -S
Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page. |
| ------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------- |
|---|
Indications for Use
| 510(k) Number (if known) | K150130 |
|---|---|
| Device Name | Ascendant™ Cervical Spacer System |
| Indications for Use (Describe) |
The Ascendant™ Cervical Spacer System is indicated for anterior cervical interbody fusion
procedures in skeletally mature patients with degenerative disc disease at one disc level from
C2-T1. Degenerative Disc Disease (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 Ascendant™ Cervical Spacer System is to be used with
autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is
implanted via an open, anterior approach. Patients with previous non-fusion spinal surgery at
involved level may be treated with the device.
| 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) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
|---|---|
| ------------------------------------------------------------------------------ | -- |
FORM FDA 3881 (9/13) for the sake of the project.
3
510(K) SUMMARY
| Submitter's Name: | Exactech |
|---|---|
| Submitter's Address: | 2320 NW 66th Court |
| Gainesville, FL 32658 | |
| Submitter's Telephone: | 352.377.1140 |
| Contact Person: | Kenneth C. Maxwell |
| Empirical Testing Corp. | |
| 719.291.6874 | |
| Date Summary was Prepared: | 28 April 2015 |
| Trade or Proprietary Name: | Ascendant™ Cervical Spacer System |
| Common or Usual Name: | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | ODP |
| Classification Panel: | Orthopedic |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Ascendant™ Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK Optima® LT1 (polyetheretherkeytone) implant cage with CP titanium coating and tantalum radiographic markers. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints and lordotic angles to accommodate varying anatomical conditions. The device features an enclosed chamber intended to be filled with autogenous bone graft material.
The Ascendant™ Cervical Spacer System is intended to be used with supplemental fixation (i.e., an anterior cervical plate).
INDICATIONS FOR USE
The Ascendant™ Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (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 Ascendant™ Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
The indications for use for the Ascendant™ Cervical Spacer System, Ti Coated is identical to that of the Exactech Cervical Spacer System (K141129).
TECHNOLOGICAL CHARACTERISTICS
The subject device is identical to the primary predicate with the exception of the subject device being Ti coated.
4
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Type |
|---|---|---|---|
| K141129 | Cervical Spacer System | Exactech | Primary |
| K123909 | CeSpace XP Intervertebral Body Fusion | ||
| System | Aesculap | Reference |
Table 5-1 Predicate Devices
PERFORMANCE DATA
The Ascendant™ Cervical Spacer System, Ti Coated has been tested in the following test modes:
- Static Compressive Shear per ASTM F2077 ●
- Static Expulsion per ASTM F-04.25.02.02 ●
- Dynamic Axial Compression per ASTM F2077 .
- Dynamic Compressive Shear per ASTM F2077 ●
- Dynamic Torsion per F2077 ●
- Percent Porosity per ASTM F1854-09 .
- Coating Thickness per ASTM F1854-09 .
- Static Shear per ASTM F1044-05
- Static Tensile per ASTM F1147-05 ●
- Shear Fatigue per ASTM F1160-05 ●
- Abrasion per ASTM F1978-00 ●
The results of this non-clinical testing show that the strength of the Cervical Spacer System, Ti Coated 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 Ascendant™ Cervical Spacer System, Ti Coated is substantially equivalent to the predicate device.