(85 days)
Not Found
No
The summary describes a physical implant and associated instruments for spinal fusion, 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 fusion in the cervical spine, which directly addresses a medical condition.
No
The device is an intervertebral body fusion device (interbody system) used in surgery to promote spinal fusion, not to diagnose a condition.
No
The device description explicitly states it consists of physical components like interbody spacers made of titanium, bone screws, and reusable instruments made of stainless steel. It is a physical implant system, 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. It is used in the body to treat a physical condition (degenerative disc disease).
- Device Description: The device is described as an interbody fusion device made of titanium, designed to be implanted into the cervical spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. This device is an implantable medical device used inside the body.
N/A
Intended Use / Indications for Use
The IdentiTi™ Cervical Standalone Interbody System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of non-operative treatment with the device. The IdentiTi Cervical Standalone Interbody System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or cortico-cancellous bone and implanted via an open, anterior approach. The IdentiTi Cervical Standalone Interbody System is intended to be used with the bone screw fixation provided and requires no additional fixation.
Product codes
OVE
Device Description
The IdentiTiTM Cervical (IdentiTi-C) Standalone Interbody System is an integrated intervertebral body fusion device for use in Anterior Cervical Discectomy and Fusion (ACDF) Procedures. The IdentiTi Cervical Standalone Interbody System consists of integrated interbody spacers and bone screws in multiple configurations to accommodate individual patient anatomy.
The IdentiTi Cervical Standalone Interbody System interbody spacers are manufactured from a combination of commercially pure porous titanium (CP Ti Grade 2) per ASTM F67 and titanium alloy (Ti-6A1-4V ELI) per ASTM F136. The IdentiTi Cervical Standalone Interbody System interbody spacers are provided in multiple footprints with varying lengths, widths, heights, and angles of lordosis to accommodate individual patient anatomy.
The anterior face of the interbody spacer includes two screw holes to accept two bone screws that are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F136 in varying lengths and diameters. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage.
The subject interbody spacers are provided individually packed and sterile. The subject bone screws are provided non-sterile to be cleaned and steam-sterilized by the end user.
The system provides reusable instruments that support varying surgical techniques, common with the ACDF approach, and are made of stainless steel and other materials. They are provided non-sterile to be cleaned and sterilized by the end user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical (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)
Nonclinical testing supports substantial equivalence to the predicate devices. The following testing/analysis was performed:
- ASTM F2077 static & dynamic axial compression, static & dynamic compression-shear, static & dynamic torsion
- ASTM F1877 particulate analysis
- ASTM F1714 - gravimetric analysis
- ASTM F2267 subsidence
- ASTM F-04.25.02.02 push-out
- Static screw push-out
The results demonstrate that the proposed IdentiTiTM Cervical Standalone Interbody System is substantially equivalent to the predicate devices for nonclinical testing.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 18, 2020
Alphatec Spine, Inc. Ruby Zheng Regulatory Affairs Specialist 5818 El Camino Real Carlsbad, California 92008
Re: K202812
Trade/Device Name: IdentiTiTM Cervical Standalone Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: November 25, 2020 Received: November 27, 2020
Dear Ruby Zheng:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
IdentiTi™ Cervical Standalone Interbody System
Indications for Use (Describe)
The IdentiTi™ Cervical Standalone Interbody System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of non-operative treatment with the device. The IdentiTi Cervical Standalone Interbody System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or cortico-cancellous bone and implanted via an open, anterior approach. The IdentiTi Cervical Standalone Interbody System is intended to be used with the bone screw fixation provided and requires no additional fixation.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for "atec". The "a" is in green and the "tec" is in dark blue. There is a trademark symbol in the upper right corner of the logo.
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
| I. | SUBMITTER: | Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad, CA 92008
Phone: (760) 431-6884
Fax: (760) 431-0289 |
|-----|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Ruby Zheng
Regulatory Affairs Specialist
Contact Phone: (760) 494-6884 |
| | Date Summary Prepared: | November 25, 2020 |
| II. | DEVICE | |
| | Name of Device:
Common or Usual Name: | IdentiTiTM Cervical Standalone Interbody System
Intervertebral Fusion Device with Integrated
Fixation, Cervical |
| | Classification Name: | Intervertebral Body Fusion Device
(21 CFR 888.3080) |
| | Regulatory Class:
Product Code: | Class II
OVE |
III. LEGALLY MARKETED PREDICATE DEVICES
| 510(k) | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| Primary Predicate | |||
| K200543 | OVE | Nexxt Matrixx Stand | |
| Alone Cervical-Turn | |||
| Lock System | Nexxt Spine | ||
| Additional Predicate | |||
| K170953 | OVE | TOMCAT Cervical | |
| Spinal System | Choice Spine | ||
| K183705 | ODP, OVD, PHM, MAX | ATEC IdentiTi Porous | |
| Ti Interbody System | Alphatec Spine |
IV. DEVICE DESCRIPTION
The IdentiTill Cervical (IdentiTi-C) Standalone Interbody System is an integrated intervertebral body fusion device for use in Anterior Cervical Discectomy and Fusion (ACDF) Procedures. The IdentiTi Cervical Standalone Interbody System consists of
4
Image /page/4/Picture/1 description: The image shows the logo for "atec". The first letter of the logo is green, while the rest of the letters are black. There is a horizontal line underneath the logo.
integrated interbody spacers and bone screws in multiple configurations to accommodate individual patient anatomy.
The IdentiTi Cervical Standalone Interbody System interbody spacers are manufactured from a combination of commercially pure porous titanium (CP Ti Grade 2) per ASTM F67 and titanium alloy (Ti-6A1-4V ELI) per ASTM F136. The IdentiTi Cervical Standalone Interbody System interbody spacers are provided in multiple footprints with varying lengths, widths, heights, and angles of lordosis to accommodate individual patient anatomy.
The anterior face of the interbody spacer includes two screw holes to accept two bone screws that are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F136 in varying lengths and diameters. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage.
The subject interbody spacers are provided individually packed and sterile. The subject bone screws are provided non-sterile to be cleaned and steam-sterilized by the end user.
The system provides reusable instruments that support varying surgical techniques, common with the ACDF approach, and are made of stainless steel and other materials. They are provided non-sterile to be cleaned and sterilized by the end user.
V. INDICATIONS FOR USE
The IdentiTi™ Cervical Standalone Interbody System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of nonoperative treatment prior to treatment with the device. The IdentiTi Cervical Standalone Interbody System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or cortico-cancellous bone and implanted via an open, anterior approach. The IdentiTi Cervical Standalone Interbody System is intended to be used with the bone screw fixation provided and requires no additional fixation.
TECHNOLOGICAL COMPARISON TO PREDICATES VI.
The technological design features of the subject implants were compared to the predicates in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent.
VII. PERFORMANCE DATA
Nonclinical testing performed on the IdentiTi™ Cervical Standalone Interbody System supports substantial equivalence to the predicate devices. The following testing/analysis was performed:
- ASTM F2077 static & dynamic axial compression, static & dynamic ● compression-shear, static & dynamic torsion
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Image /page/5/Picture/1 description: The image shows the logo for "atec". The "a" is green and the "tec" is black. There is a trademark symbol in the upper right corner of the logo.
- ASTM F1877 particulate analysis ●
- ASTM F1714 - gravimetric analysis
- ASTM F2267 subsidence ●
- ASTM F-04.25.02.02 push-out ●
- Static screw push-out
The results demonstrate that the proposed IdentiTiM Cervical Standalone Interbody System is substantially equivalent to the predicate devices for nonclinical testing.
Clinical Information
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
VIII. CONCLUSION
Based upon the information provided in this 510(k) submission, it has been determined that the subject devices are substantially equivalent to legally marketed devices in regards to indications for use, intended use, design, technology, and performance.