(95 days)
Not Found
No
The summary describes a passive implantable device made of PEEK with tantalum markers, designed for spinal fusion. There is no mention of any computational or analytical capabilities, let alone AI/ML. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is indicated for intervertebral body fusion procedures for degenerative disc disease, which is a medical condition, making it a therapeutic device.
No
The AbacusTM Spacer System is an intervertebral body fusion device used for spinal fusion procedures, not for diagnosing medical conditions. Its purpose is to facilitate fusion, not to identify or characterize disease.
No
The device description clearly states the device is manufactured from PEEK-OPTIMA and includes tantalum markers, indicating it is a physical implant, not software.
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 spinal fusion. This is a therapeutic procedure performed in vivo (within the body).
- Device Description: The device is a physical implant made of PEEK and tantalum, designed to be surgically placed between vertebrae.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition. The device itself is the treatment.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The AbacusTM Spacer System is indicated for interverebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-L5. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The AbacusTM Spacer System is to be used with autogenous bone grafi and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device.
Product codes
MAX
Device Description
The Abacus™ Spacer System is an intervertebral body fusion device manufactured from PEEK-OPTIMA (ASTM F2026) and includes tantalum markers (ASTM 560/ISO 13782). The Abacus™ Spacer System is available in a variety of shapes and sizes to accommodate variations in anatomy. The Abacus™M Spacer System is a rectangular-shaped device with a textured "tooth" pattern on both the superior and inferior surfaces designed to resist migration of the device once it is surgically positioned. The device also incorporates an internal cavity that allows for the placement of autograft material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine at one or two contiguous levels from L2-L5
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 following mechanical tests were performed to demonstrate the substantial equivalence of the Abacus The Spacer System to its predicate:
- Static and dynamic axial compression (per ASTM F2077) .
- Static and dynamic compression shear (per ASTM F2077) .
- Subsidence (per ASTM F2267)
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.
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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K140007 Page 1 of 2
APR 0 7 2014
Image /page/0/Picture/2 description: The image shows the word "SpineWave" in a bold, sans-serif font. The word is all capitalized except for the "W", which is larger than the other letters. A curved line runs underneath the word, starting below the "E" in "Spine" and ending below the "E" in "Wave".
510(k) Summary Abacus™ Spacer System
1. Submitter Information
Submitter: | Spine Wave, Inc. |
---|---|
Address: | Three Enterprise Drive |
Suite 210 | |
Shelton, CT 06484 | |
Telephone: | 203-712-1839 |
Telefax: | 203-944-9493 |
Contact: | Joseph Mercado |
Date Prepared: | March 25, 2014 |
2. Device Information
Trade Name: | Abacus™ Spacer System |
---|---|
Common Name: | Intervertebral Body Fusion Device |
Classification: | Class II (special controls) per 21 CFR 888.3080 |
Classification Name: | Intervertebral Fusion Device with Bone Graft, Lumbar |
Product Code: | MAX |
3. Purpose of Submission
The purpose of this submission is to gain clearance for a new intervertebral body fusion device.
4. Predicate Device Information
The Abacus™ Spacer System described in this submission is substantially equivalent to the following predicates:
Predicate Device | Manufacturer | 510(k) No. |
---|---|---|
StaXx® IBL System | Spine Wave, Inc. | K131071, K132719 |
CoRoent® System | NuVasive, Inc. | K071795 |
1
5. Device Description
The Abacus™ Spacer System is an intervertebral body fusion device manufactured from PEEK-OPTIMA (ASTM F2026) and includes tantalum markers (ASTM 560/ISO 13782). The Abacus™ Spacer System is available in a variety of shapes and sizes to accommodate variations in anatomy. The Abacus™M Spacer System is a rectangular-shaped device with a textured "tooth" pattern on both the superior and inferior surfaces designed to resist migration of the device once it is surgically positioned. The device also incorporates an internal cavity that allows for the placement of autograft material.
6. Intended Use
The Abacus "10 Spacer System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-L5. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Abacus™ Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
7. Comparison of Technological Characteristics
The substantial equivalence of the Abacus™ Spacer System to the predicates is shown by similarity in intended use, indications for use, materials and performance.
8. Performance Data
The following mechanical tests were performed to demonstrate the substantial equivalence of the Abacus The Spacer System to its predicate:
- Static and dynamic axial compression (per ASTM F2077) .
- Static and dynamic compression shear (per ASTM F2077) .
- Subsidence (per ASTM F2267)
9. Conclusion
Based on the indications for use, technological characteristics, performance testing and comparison to the predicates, the Abacus™ Spacer System has been shown to be substantially equivalent to the predicate devices identified in this submission, and does not present any new issues of safety or effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 7, 2014
Spine Wave, Incorporated Mr. Joseph Mercado Regulatory Affairs Specialist Three Enterprise Drive, Suite 210 Shelton, Connecticut 06484
Re: K140007
Trade/Device Name: Abacus™ Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: January 16, 2014 Received: January 17, 2014
Dear Mr. Mercado:
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
3
Page 2 - Mr. Joseph Mercado
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" (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/McdicalDevices/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Ronald: P.Jean -S for
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140007
Device Name AbacusTM Spacer System
Indications for Use (Describe)
The AbacusTM Spacer System is indicated for interverebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-L5. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The AbacusTM Spacer System is to be used with autogenous bone grafi and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion 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 Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page,