(180 days)
Not Found
No
The summary describes a physical implant device and its mechanical properties, 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 interbody fusion, directly addressing a medical condition.
No
The device is an interbody fusion device, not a diagnostic device. It is used in treatment for degenerative disc disease, not for diagnosing it.
No
The device description clearly states it is a physical implant made of PEEK, titanium alloy, and tantalum, and is accompanied by a complete instrumentation system. This indicates it is a hardware medical device, not software-only.
Based on the provided information, the Exactech Acapella One Cervical Spacer System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for an anterior cervical interbody fusion procedure, which is a surgical intervention performed in vivo (within the body). IVD devices are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a physical implant designed to be placed within the body to facilitate bone fusion. It's made of materials like PEEK, titanium, and tantalum, which are common for surgical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples, providing diagnostic information based on laboratory tests, or having any components related to in vitro analysis.
In summary, the Exactech Acapella One Cervical Spacer System is a surgical implant, not an IVD device.
N/A
Intended Use / Indications for Use
The Exactech Acapella One 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 Acapella One 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.
Product codes (comma separated list FDA assigned to the subject device)
OVE
Device Description
The Acapella One Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK (polyetheretherkeytone) implant cage with tantalum radiographic markers and two titanium alloy internal anchors. 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 a chamber intended to be filled with autogenous bone graft material. The Acapella One Cervical Spacer System is intended to be used with supplemental fixation (i.e., an anterior cervical plate).
Acapella One Cervical Spacer System implants are composed of PEEK Optima Grade LT1, Ti-6Al-4V, and tantalum. The body of the implant is composed of PEEK Optima Grade LT1 (ASTM 2026). The PEEK Optima Grade LT1 used in Acapella implants is manufactured using the same processes used to manufacture Exactech Octane-A implants (K082270).
The material used to construct the anchors is titanium alloy Ti-6AI-4V per ASTM F136, which has a long history of safe and effective use in orthopedic implants.
The radiographic markers are composed of tantalum per ASTM F560, which also has a long history of safe and effective use in orthopedic implants.
The Acapella One Cervical Spacer System is accompanied by a complete instrumentation system to assist the surgeon in the implantation of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 Testing:
The following tests were performed to demonstrate Acapella One Cervical Spacer System devices function as intended and are substantially equivalent to cited predicates:
Tests:
- Static Compression
- Static Compression Shear
- Static Torsion
- Static Torsion
- Subsidence - Anchors Deployed
- Subsidence - Anchors Not Deployed
- Expulsion - Anchors Deployed
- Expulsion - Anchors Not Deployed
- Dynamic Compression
- Dynamic Compression Shear
- Dynamic Torsion
- Wear
Key Results: Mechanical testing confirmed Acapella One Cervical Spacer System devices demonstrated equivalent performance to cited predicates under the same test conditions.
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.
K103655, K082801, KI 13559, K082270
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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K132582- Page 1 of 3
Exactech® Acapella™ One Cervical Spacer System Traditional 510(k)
510(k) Summary
| Company: | Exactech, Inc
2320 NW 66th Court
Gainesville, FL 32653 |
|----------------------|--------------------------------------------------------------------------------------------------------|
| Date: | February 10, 2014 |
| Contact Person: | Patrick Hughes
Senior Regulatory Affairs Specialist
Phone: (352) 327-4762
Fax: (352) 378-2617 |
| Proprietary Name: | Exactech® Acapella® One Cervical Spacer System |
| Common Name: | Interbody Spacer |
| Classification Name: | 21 CFR 888.3080
Intervertebral Fusion Device with Integrated Fixation,
Cervical
Class II |
| Product Code: | OVE |
Legally Marketed Devices to Which Substantial Equivalence Is Claimed
- K103655 Octane-C Interbody Fusion System .
- K082801 US Spine Phantom Plus Cage ●
- KI 13559 LDR ROI-C Cervical Cage Implant Lordotic .
- K082270 Octane-A Interbody Fusion System (material composition only) .
Device Description
The Acapella One Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK (polyetheretherkeytone) implant cage with tantalum radiographic markers and two titanium alloy internal anchors. 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 a chamber intended to be filled with autogenous bone graft material. The Acapella One Cervical Spacer System is intended to be used with supplemental fixation (i.e., an anterior cervical plate).
Acapella One Cervical Spacer System implants are composed of PEEK Optima Grade LT1, Ti-6Al-4V, and tantalum. The body of the implant is composed of PEEK Optima Grade LT1 (ASTM 2026). The PEEK Optima Grade LT1 used in Acapella implants is manufactured using the same processes used to manufacture Exactech Octane-A implants (K082270).
1
Exactech® Acapella™ One Cervical Spacer System Traditional 510(k)
The material used to construct the anchors is titanium alloy Ti-6AI-4V per ASTM F136, which has a long history of safe and effective use in orthopedic implants.
The radiographic markers are composed of tantalum per ASTM F560, which also has a long history of safe and effective use in orthopedic implants.
The Acapella One Cervical Spacer System is accompanied by a complete instrumentation system to assist the surgeon in the implantation of the device.
Indications for Use
The Exactech Acapella One 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 Acapella One 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.
Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following device characteristics:
-
. Indications for Use
The proposed Acapella One Cervical Spacer System and predicate LDR ROI-C have similar indications for use statements. -
Materials . Both proposed Acapella One Cervical Spacer System and predicate LDR ROI-C devices are composed of similar biocompatible materials conforming to recognized industry standards for permanent implants.
-
Design Features/Functions . Proposed Acapella One Cervical Spacer System and cited predicate devices share similar basic design features and functions.
-
Dimensions . Proposed Acapella One Cervical Spacer System devices are dimensionally similar to cited predicate devices.
-
. Sterilization Proposed Acapella One Cervical Spacer System devices and cited predicate devices are provided sterile for single use only.
-
. Performance specifications
Mechanical testing confirmed Acapella One Cervical Spacer System devices demonstrated equivalent performance to cited predicates under the same test conditions.
2
Exactech® Acapella™ One Cervical Spacer System Traditional 510(k)
Non-Clinical Testing
The following tests were performed to demonstrate Acapella One Cervical Spacer System devices function as intended and are substantially equivalent to cited predicates:
Table 1: Acapella One Testing
| Test | Standard |
|---|---|
| Static Compression | F2077 |
| Static Compression Shear | F2077 |
| Static Torsion | F2077 |
| Static Torsion | F2077 |
| Subsidence - Anchors Deployed | F22674 |
| Subsidence - Anchors Not Deployed | F22674 |
| Expulsion - Anchors Deployed | N/A |
| Expulsion - Anchors Not Deployed | N/A |
| Dynamic Compression | F2077 |
| Dynamic Compression Shear | F2077 |
| Dynamic Torsion | F2077 |
| Wear | F1877 |
Substantial Equivalence Conclusion
The proposed Acapella One Cervical Spacer System has the same intended use, similar Indications for Use, the same technological characteristics, and the same principles of operation as the Exactech Octane-C, US Spine Phantom Plus, and LDR ROI-C Cervical Cage systems. In addition, proposed Acapella One implants are made from the same materials as predicate Exactech Octane-A devices. Information provided in this submission shows the proposed Acapella One Cervical Spacer System is substantially equivalent to the cited predicates.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the HHS logo, which is a stylized caduceus-like symbol with three wavy lines, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2014
Exactech, Incorporated Mr. Patrick Hughes Senior Regulatory Affairs Specialist 2320 Northwest 66th Court Gainesville, Florida 32653
Re: K132582
Trade/Device Name: Exactech® Acapella® One Cervical Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: January 14, 2014 Received: January 15, 2014
Dear Mr. Hughes,
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
4
Page 2 - Mr. Patrick Hughes
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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,
Vincent訂@evlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132582
Device Name
Exactech® Acapella® One Cervical Spacer System
Indications for Use (Describe)
The Exactech Acapella One Cervical Spacer System is interior cervical interbody fusion procedures in skeletally mature patients with degenerative 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 nonoperative treatment. The Exactech Acapella One 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.
Type of Use (Select one or both, as applicable)
X 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 FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FO Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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