(114 days)
No
The 510(k) summary describes a passive implant (interbody spacer) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML. The device description focuses on material, design, and mechanical properties.
Yes
The device is indicated for intervertebral body fusion procedures for degenerative disc disease to alleviate neck pain due to disc degeneration, which is a therapeutic purpose.
No
Explanation: This device is an implantable interbody spacer used for spinal fusion and stabilization, not for diagnosing a condition. Its purpose is therapeutic.
No
The device description clearly states it is an implant made of PEEK or titanium, which are physical materials, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The ALTA Cervical Interbody Spacer is an implantable device designed to be surgically placed in the cervical spine to facilitate bone fusion. It is a physical device used in vivo (within the body), not a test performed in vitro (outside the body) on a specimen.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVDs.
This device is a surgical implant used for structural support and fusion in the spine.
N/A
Intended Use / Indications for Use
The ALTA Cervical Interbody Spacer is indicated for intervertebral body fusion procedures with degenerative disc disease (DDD) of the cervical spine at disc levels (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with supplemental internal fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cages.
Product codes
ODP
Device Description
The ALTA Cervical Interbody Spacer was developed as implants for the stabilization of the cervical column. The devices have trapezoidal footprints and multiple sizes to accommodate patient anatomy. This device is offered in two material choices: PEEK and titanium. The PEEK implants have unidirectional teeth on both of their inferior and superior surfaces to prevent migration/expulsion, and graft windows which help facilitate bony integration. X-ray markers are integrated for visualization of the implants during and after surgery. The titanium implants have roughened superior and inferior surfaces to prevent migration of the spacer post implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine at disc levels (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 Test Summary: The following analyses were conducted: Static and dynamic compression per ASTM F2077 Static and dynamic torsion per ASTM F2077 Subsidence per ASTM F2267 Expulsion testing per ASTM F04.25.02.02. The results of these evaluations indicate that the ALTA Cervical Interbody Spacer is equivalent to predicate devices.
Clinical Test Summary: No clinical studies were performed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K073351, K100889, P980048 S3, K091088
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 is circular and features the department's name around the perimeter. In the center is an abstract image of a bird-like figure, composed of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2016
Astura Medical % Mr. J.D. Webb President The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K160154
Trade/Device Name: ALTA Cervical Interbody Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: March 25, 2016 Received: March 29, 2016
Dear Mr. Webb:
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 Parts 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 (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" (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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
ALTA Cervical Interbody Spacer
Indications for Use (Describe)
The ALTA Cervical Interbody Spacer is indicated for intervertebral body fusion procedures with degenerative disc disease (DDD) of the cervical spine at disc levels (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with supplemental internal fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cages.
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 FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
510(k) Summary: ALTA Cervical Interbody Spacer
| Date Prepared | March 25, 2016 |
|---|---|
| Submitted By | Astura Medical, LLC |
| 5670 El Camino Real, Suite B | |
| Carlsbad, CA 92008 | |
| 760-814-8047 Tele | |
| Contact | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 Tele | |
| 512-692-3699 Fax | |
| e-mail: jdwebb@orthomedix.net | |
| Trade Name | ALTA Cervical Interbody Spacer |
| Common Name | intervertebral body fusion device |
| Classification Name | Intervertebral body fusion device - cervical |
| Class | II |
| Product Code | ODP |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | Spinal Elements, Crystal Cervical Cage (K073351) |
| Additional Predicate | |
| Devices | Titan, Endoskeleton® TC (K100889) |
| Zimmer, BAK/C Vista Interbody Fusion (P980048 S3) | |
| LDR Spine Cervical Interbody Fusion System (K091088) | |
| Titan Spine Endoskeleton TC (K100889) | |
| Device Description | The ALTA Cervical Interbody Spacer was developed as implants for the |
| stabilization of the cervical column. The devices have trapezoidal footprints and | |
| multiple sizes to accommodate patient anatomy. This device is offered in two | |
| material choices: PEEK and titanium. | |
| The PEEK implants have unidirectional teeth on both of their inferior and superior | |
| surfaces to prevent migration/expulsion, and graft windows which help facilitate | |
| bony integration. X-ray markers are integrated for visualization of the implants during and after surgery. | |
| The titanium implants have roughened superior and inferior surfaces to prevent migration of the spacer post implantation. | |
| Materials | Vestakeep® i4R PEEK conforming to ASTM F2026 |
| Unalloyed tantalum conforming to ASTM F560 | |
| Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 | |
| Substantial | |
| Equivalence Claimed | |
| to Predicate Devices | The ALTA Cervical Interbody Spacer is substantially equivalent to the predicate |
| devices in terms of intended use, design, materials used, mechanical safety and | |
| performances. | |
| Indications for Use | The ALTA Cervical Interbody Spacer is indicated for intervertebral body |
| fusion procedures in skeletally mature patients with degenerative disc | |
| disease (DDD) of the cervical spine at disc levels (C2-T1). Cervical | |
| degenerative disc disease is defined as neck pain of discogenic origin with | |
| degeneration of the disc confirmed by history and radiographic studies. | |
| This device is intended for use with supplemental internal fixation systems | |
| and autogenous bone graft implanted via an open, anterior approach. | |
| Patients should have at least six weeks of non-operative treatment prior | |
| to treatment with intervertebral cages. | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| Static and dynamic compression per ASTM F2077Static and dynamic torsion per ASTM F2077Subsidence per ASTM F2267Expulsion testing per ASTM F04.25.02.02The results of these evaluations indicate that the ALTA Cervical Interbody Spacer | |
| is equivalent to predicate devices. | |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non- | |
| clinical and Clinical | Astura Medical, LLC considers the ALTA Cervical Interbody Spacer to be |
| equivalent to the predicate devices listed above. This conclusion is based | |
| upon the devices' similarities in principles of operation, technology, | |
| materials, and indications for use. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
4