(83 days)
Not Found
No
The summary describes a physical intervertebral body fusion device made of PEEK with a titanium coating. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies focus on the mechanical properties of the device.
No.
The device is an intervertebral body fusion device used to facilitate fusion, not to provide therapy itself. Devices that facilitate fusion are structural components, not therapeutic.
No
The Abacus™ Spacer System is an intervertebral body fusion device used for treatment of degenerative disc disease, not for diagnosis.
No
The device description clearly states it is a physical intervertebral body fusion device made from PEEK-OPTIMA with tantalum markers and a titanium coating. It is a hardware 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, which is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a physical implant made of PEEK and titanium, designed to be placed between vertebrae.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Abacus™ 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 radios. These DDD patients may have up to Grade I spondylolisthesis 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.
Product codes
MAX
Device Description
The Abacus™ Spacer System is an intervertebral body fusion device manufactured from PEEK-OPTIMA (ASTM F2026) with tantalum markers (ASTM F560) and a plasmasprayed commercially pure titanium coating (ASTM F1580). The Abacus™ Spacer System is available in a variety of shapes and sizes to accommodate variations in anatomy. The Abacus™ Spacer System is a rectangular-shaped device with the titanium coating on both the superior and inferior surfaces. 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 tests were performed for characterization of the commercially pure titanium coating:
- Coating Microstructure (ASTM F1854) .
- . Shear Fatigue Testing (ASTM F1160)
- Static Shear Testing (ASTM F1044) ●
- Tensile Testing (ASTM F1147) .
- . Abrasion Testing (ASTM F1978)
The following tests were performed to demonstrate the substantial equivalence of the Abacus™ Spacer System to its predicate:
- Static axial compression (per ASTM F2077)
- Static and dynamic compression shear (per ASTM F2077)
- Wear debris analysis (ASTM F1877) .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2014
Spine Wave Incorporated Ms. Roaida R. Johnson Regulatory Affairs Manager Three Enterprise Drive, Suite 210 Shelton, Connecticut 06484
Re: K142101
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: July 31, 2014 Received: August 1, 2014
Dear Ms. Johnson:
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
Page 2 - Ms. Roaida R. Johnson
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/Resourcesfor You/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.
Ronald P. Jean –S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
K142101 Page 1 of 1
510(k) Number (if known)
K142101
Device Name Abacus™ Spacer System
Indications for Use (Describe)
The Abacus™ 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 radios. These DDD patients may have up to Grade I spondylolisthesis 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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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SPINE 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: | Roaida R. Johnson |
| Date Prepared: | October 1, 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 to add a commercially pure titanium coating to the Abacus™ Spacer System.
4. Predicate Device Information
The Abacus™ Spacer System described in this submission is substantially equivalent to the following predicates:
| Primary Predicate Device | Manufacturer | 510(k) No. |
|---|---|---|
| Abacus™ Spacer System | Spine Wave, Inc. | K140007 |
| Additional Predicate Device | Manufacturer | 510(k) No. |
|---|---|---|
| CapStone PTC™ Spinal Systems | Medtronic Sofamor Danek | K133205 |
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5. Device Description
The Abacus™ Spacer System is an intervertebral body fusion device manufactured from PEEK-OPTIMA (ASTM F2026) with tantalum markers (ASTM F560) and a plasmasprayed commercially pure titanium coating (ASTM F1580). The Abacus™ Spacer System is available in a variety of shapes and sizes to accommodate variations in anatomy. The Abacus™ Spacer System is a rectangular-shaped device with the titanium coating on both the superior and inferior surfaces. The device also incorporates an internal cavity that allows for the placement of autograft material.
6. Intended Use
The Abacus™ 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 nonoperative 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 tests were performed for characterization of the commercially pure titanium coating:
- Coating Microstructure (ASTM F1854) .
- . Shear Fatigue Testing (ASTM F1160)
- Static Shear Testing (ASTM F1044) ●
- Tensile Testing (ASTM F1147) .
- . Abrasion Testing (ASTM F1978)
The following tests were performed to demonstrate the substantial equivalence of the Abacus™ Spacer System to its predicate:
- Static axial compression (per ASTM F2077)
- Static and dynamic compression shear (per ASTM F2077)
- Wear debris analysis (ASTM F1877) .
5
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.