(106 days)
Not Found
No
The summary describes a physical implant device and its mechanical testing, with no mention of software, algorithms, or data processing related to AI/ML.
Yes
The device is a medical implant designed to treat degenerative disc disease by facilitating anterior cervical interbody fusion.
No
The device is described as an anterior cervical interbody fusion system, indicated for surgical procedures in patients with degenerative disc disease. Its function is to facilitate spinal fusion, not to diagnose a medical condition.
No
The device description clearly states it is a PEEK implant cage with tantalum markers, which are physical hardware components, not software. The performance studies also focus on mechanical testing of the physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for anterior cervical interbody fusion. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is described as a PEEK implant cage with radiographic markers, designed to be surgically implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Exactech 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 Exactech 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
Cervical Spacer System implants are anterior cervical interbody devices consisting of a PEEK (polyetheretherkeytone) implant cage with tantalum radiographic markers.
The Cervical Spacer System is intended for use as an interbody fusion device and offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The devices features a chamber intended to be filled with autogenous bone graft material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical interbody, 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Cervical Spacer System has been tested in the following test modes:
- Static axial compression per ASTM F2077-11
- Static torsion per ASTM F2077-11
- o Static Subsidence per ASTM F2267-04
- Static Expulsion per ASTM F-04.25.02.02 (draft)
- Dynamic axial compression bending fatigue per ASTM F2077-11
- Dynamic Torsion per ASTM F2077-11
The results of this non-clinical testing show that the strength of the Cervical Spacer System is sufficient for its intended use and is substantially equivalent to the legally marketed predicate devices, for which there may be no publically available published performance data.
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.
K121649, K090064, K120486, K130317, K103034, K121103, K113559, K091088, K130948
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The profiles are rendered in black against a white background.
August 15, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Exactech, Incorporated % Ms. Meredith L. May, MS, RAC Empirical Consulting, LLC 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K141129
Trade/Device Name: Exactech Cervical Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: July 14, 2014 Received: July 18, 2014
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) 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 yours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| See PRA Statement on last page. | |
| Indications for Use | |
| 510(k) Number (if known) | K141129 |
| Device Name | Exactech Cervical Spacer System |
| Indications for Use (Describe) | |
| The Exactech 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 Exactech 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) | |
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This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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5.510(K) SUMMARY
| Submitter's Name: | Exactech |
|---|---|
| Submitter's Address: | 2320 NW 66th Court |
| Gainesville, Florida 32653 | |
| Submitter's Telephone: | (352) 377-1140 |
| Contact Person: | Meredith L. May MS, RAC |
| Empirical Testing Corp. | |
| 719.337.7579 | |
| Date Summary was Prepared: | 30 April 2014 |
| Trade or Proprietary Name: | Exactech Cervical Spacer System |
| Common or Usual Name: | Intervertebral Fusion Device With Bone Graft, Cervical |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | ODP |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
Cervical Spacer System implants are anterior cervical interbody devices consisting of a PEEK (polyetheretherkeytone) implant cage with tantalum radiographic markers.
The Cervical Spacer System is intended for use as an interbody fusion device and offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The devices features a chamber intended to be filled with autogenous bone graft material.
INDICATIONS FOR USE
The Exactech 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 Exactech 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 Cervical Spacer System is similar to that of the predicate devices.
TECHNOLOGICAL CHARACTERISTICS
The Exactech Cervical Spacer System is an anterior cervical interbody composed of the PEEK Optima® LT1 trapezoidal shaped implant with tantalum radiographic markers that is similar to many devices cleared for sale in the United States, including the referenced predicate devices. 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
5
enclosed chamber intended to be filled with autogenous bone graft material. The implants are intended for single use only.
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 identical between the subject and predicates:
- Indications for Use
- Materials of manufacture
- Structural support mechanism ●
| 510(k) Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K121649 | CONSTRUX™ MINI Spacer System | Orthofix |
| Spinal | ||
| K090064 | Copperhead System | Eminent Spine |
| K120486 | AVS AS System | Stryker Spine |
| K130317, | ||
| K103034 | Apache™ Interbody Fusion System Star Cervical | |
| PEEK | Genesys Spine | |
| K121103, | ||
| K113559, | ||
| K091088 | Spine MC+ Cervical Cage | LDR |
| K130948 | Cervical IBFD | Southern Spine |
Table 5-1 Predicate Devices
PERFORMANCE DATA
The Cervical Spacer System has been tested in the following test modes:
- Static axial compression per ASTM F2077-11 ●
- Static torsion per ASTM F2077-11
- o Static Subsidence per ASTM F2267-04
- Static Expulsion per ASTM F-04.25.02.02 (draft) ●
- Dynamic axial compression bending fatigue per ASTM F2077-11 ●
- Dynamic Torsion per ASTM F2077-11 ●
The results of this non-clinical testing show that the strength of the Cervical Spacer System is sufficient for its intended use and is substantially equivalent to the legally marketed predicate devices, for which there may be no publically available published performance data.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Cervical Spacer System is substantially equivalent to the predicate devices.