(85 days)
No
The 510(k) summary describes a mechanical interbody fusion device and its performance testing, with no mention of AI or ML technology.
Yes
The device is described as an intervertebral body fusion device for the lumbar spine, intended for the treatment of degenerative disc disease. This indicates it is used to treat a medical condition, which is the definition of a therapeutic device.
No
The device is an intervertebral body fusion device (implant) used for surgical treatment of degenerative disc disease, not for diagnostic purposes.
No
The device description clearly states that the device is an expandable interbody fusion implant made from Ti-6A1-4V ELI per ASTM F136, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Amplify Surgical DualXSLIM® T/PLIF is an implantable medical device designed for surgical use in the lumbar spine. It is a physical device inserted into the body to provide structural support and facilitate bone fusion.
- Intended Use: The intended use clearly states it is for "intervertebral body fusion of the lumbar spine." This is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
The information provided describes a surgical implant, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Amplify Surgical DualXSLIM® T/PLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are to be used in patients who have had at least six months of non-operative treatment. The Amplify Surgical DualXSLIM® T/PLIF is indicated for unilateral or bilateral implantation. The DualXSLIM® T/PLIF implants are intended for single use.
Product codes
MAX
Device Description
The purpose of this 510(k) is to offer the DualXSLIM® T/PLIF as additional sizes and lordosis options to the previously cleared DualX (K181397). The DualX implants are a family of expandable interbody fusion devices that expand sequentially in lateral and then vertical directions. The implants are designed to be used in minimally invasive spine surgery. The DualXSLIM® T/PLIF implants are offered in a variety of sizes to accommodate patient anatomical needs. All implant components are manufactured from Ti-6A1-4V ELI per ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
lumbar spine, from L2 to S1
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
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Summary of Performance Studies
The DualXSLIM® T/PLIF has been tested in the following test modes:
- Static & Dynamic Axial Compression per ASTM F2077
- Static & Dynamic Compression Shear per ASTM F2077
- Subsidence per ASTM F2267
The results of this non-clinical testing show that the strength of the DualXSLIM® T/PLIF is sufficient for its intended use and that the DualXSLIM® T/PLIF is substantially equivalent to legally marketed predicate devices.
Key Metrics
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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October 18, 2022
Amplify Surgical, Inc. % Nathan Wright Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K222203
Trade/Device Name: DualXSLIM® T/PLIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 10, 2022 Received: August 10, 2022
Dear Nathan Wright:
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.
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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 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.
for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K22203
Device Name DualXSLIM® T/PLIF
Indications for Use (Describe)
The Amplify Surgical DualXSLIM® T/PLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are to be used in patients who have had at least six months of non-operative treatment. The Amplify Surgical DualXSLIM® T/PLIF is indicated for unilateral or bilateral implantation. The DualXSLIM® T/PLIF implants are intended for single use.
Type of Use (Select one or both, as applicable) 図 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The Counter Use (21 CFR 801 Subpart C)
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| Submitter's Name: | Amplify Surgical, Inc. |
|---|---|
| Submitter's Address: | 9272 Jeronimo Rd., Suite 107B |
| Irvine, California 92618 | |
| Submitter's Telephone: | 949-698-4854 |
| Contact Person: | Nathan Wright MS |
| Empirical Technologies | |
| 719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was Prepared: | August 10, 2022 |
| Trade or Proprietary Name: | DualXSLIM® T/PLIF |
| Common or Usual Name: | Intervertebral Fusion Device with Bone Graft, Lumbar |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | MAX |
| Classification Panel: | Orthopedic Devices - Spinal Devices (DHT6B) |
K22203 - 510(K) SUMMARY
Description of the Device Subject to Premarket Notification:
The purpose of this 510(k) is to offer the DualXSLIM® T/PLIF as additional sizes and lordosis options to the previously cleared DualX (K181397).
The DualX implants are a family of expandable interbody fusion devices that expand sequentially in lateral and then vertical directions. The implants are designed to be used in minimally invasive spine surgery. The DualXSLIM® T/PLIF implants are offered in a variety of sizes to accommodate patient anatomical needs. All implant components are manufactured from Ti-6A1-4V ELI per ASTM F136.
INDICATIONS FOR USE
The Amplify Surgical DualXSLIM® T/PLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are to be used in patients who have had at least six months of non-operative treatment. The Amplify Surgical DualXSLIM® T/PLIF is indicated for unilateral or bilateral implantation.
The DualXSLIM® T/PLIF implants are intended for single use.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. The same to predicate device in the following ways:
- Indications for Use
- Structural support mechanism ●
Amplify Surgical, Inc. DualXSLIM® T/PLIF
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- Expansion mechanism
- Material
- Manufacturing and Biocompatibility ●
- Sizes
Predicate Devices
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
|---|---|---|---|
| K181397 | DualX™ | Innovasive, Inc. | Primary |
| K171633 | NuVasive® TLX Interbody System | NuVasive, Inc. | Additional |
| K152475 | FORZA® PTC Spacer System | Orthofix Inc. | Additional |
PERFORMANCE DATA
The DualXSLIM® T/PLIF has been tested in the following test modes:
- Static & Dynamic Axial Compression per ASTM F2077 ●
- Static & Dynamic Compression Shear per ASTM F2077 ●
- Subsidence per ASTM F2267 ●
The results of this non-clinical testing show that the strength of the DualXSLIM® T/PLIF is sufficient for its intended use and that the DualXSLIM® T/PLIF is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the DualXSLIM® T/PLIF is substantially equivalent to the predicate device.