(229 days)
The DeGen Medical Impulse AM™ implant is an intervertebral body fusion device intended for use in skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The DeGen Medical Impulse AM™ System is indicated to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and are intended to be used with supplemental fixation systems cleared for use in the lumbar spine. The device is to be used in patients who have had six months of nonoperative treatment.
DeGen Medical Impulse AM™ System is a lumbar interbody fusion device for posterior and transforaminal lumbar fusion procedures. The Impulse AM™ system includes various lengths, widths, heights, and endplate shapes (curvatures include neutral, lordotic, and anatomic). The DeGen Medical Impulse AM™ device is comprised of a single component that is additively manufactured. The superior and inferior endplates feature porous surfaces to mitigate subsidence and expulsion. The anatomic, lordotic, and neutral configurations feature a posterior face with a threaded hole and slots to rigidly connect to an instrument for surgical insertion. The hyperlordotic configuration features a posterior face with slots to rigidly connect an instrument for surgical insertion. Superior and inferior faces feature a central aperture to constrain bone graft. DeGen Medical's Impulse AM™ Spacers are additively manufactured from Puri-Ti™ titanium powder having a chemical composition conforming to ASTM B348
This FDA 510(k) summary is for a medical device, the DeGen Medical Impulse AM™ Interbody Fusion System, which is an intervertebral body fusion device. The document focuses on demonstrating substantial equivalence to predicate devices, rather than providing a study that establishes acceptance criteria for new performance claims for the device itself.
Therefore, the information requested about acceptance criteria and a study proving the device meets those criteria (especially regarding AI/algorithm performance) is not available in the provided text. This document describes the device and its intended use, and then lists non-clinical performance testing against established ASTM standards and FDA guidance for intervertebral body fusion devices, which are mechanical performance tests rather than clinical or AI algorithm performance evaluations.
Here's a breakdown of what can be extracted from the provided text, and what cannot:
Information Not Available in the Provided Text:
- Acceptance Criteria for an AI/Algorithm: The document does not describe acceptance criteria for an AI or algorithm's performance, as the device itself is a physical intervertebral body fusion system, not an AI software.
- Reported Device Performance (for AI/Algorithm): Since there's no AI/algorithm, there's no reported performance for one.
- Sample size for test set and data provenance: Not applicable.
- Number of experts used to establish ground truth & qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth (for AI/algorithm): Not applicable.
- Sample size for training set (for AI/algorithm): Not applicable.
- How ground truth for training set was established (for AI/algorithm): Not applicable.
Information Related to Device Performance (Non-Clinical/Mechanical) that is Available:
The "Performance Testing" section (on page 3 of the input) indicates that non-clinical testing was performed to demonstrate substantial equivalence to other predicate devices. This testing was conducted in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s" (May 3, 2004) and "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" (June 12, 2007).
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Standards/Guidance) | Reported Device Performance |
|---|---|
| Static and dynamic compression testing per ASTM F2077 (Standard Specification for Intervertebral Body Fusion Devices) | The results of these studies show the device is substantially equivalent to predicate devices. |
| Static and dynamic compression shear testing per ASTM F2077 | The results of these studies show the device is substantially equivalent to predicate devices. |
| Subsidence testing via ASTM F2267 (Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression) | The results of these studies show the device is substantially equivalent to predicate devices. |
| Expulsion Testing (likely following FDA guidance for intervertebral body fusion devices) | The results of these studies show the device is substantially equivalent to predicate devices. |
Note: The specific numerical acceptance criteria (e.g., minimum load to failure, maximum subsidence) are not provided in this summary but would be detailed in the full test reports referenced by the ASTM standards and FDA guidance documents. The summary only states that the device met these criteria, demonstrating substantial equivalence.
2. Sample sized used for the test set and the data provenance
The document does not specify the sample sizes (e.g., number of devices tested) for each of the non-clinical mechanical tests. Data provenance is implied to be from laboratory testing performed by DeGen Medical (or its contractors) specifically for the purpose of this 510(k) submission. These are in vitro tests, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this refers to a physical device undergoing mechanical testing, not a diagnostic or AI algorithm requiring human expert ground truth.
4. Adjudication method for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used
For mechanical testing, the "ground truth" is typically defined by the physical properties of the materials and the design, measured against established engineering standards (ASTM standards in this case) using calibrated equipment.
8. The sample size for the training set
Not applicable. There is no AI algorithm with a training set described.
9. How the ground truth for the training set was established
Not applicable.
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August 30, 2021
DeGen Medical % Linda Braddon, Ph.D. President/CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188
Re: K210090
Trade/Device Name: Impulse AM™ Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 30, 2021 Received: August 2, 2021
Dear Dr. Braddon:
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.
Brent L. 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K210090
Device Name
DeGen Medical Impulse AM™ Interbody Fusion System
Indications for Use (Describe)
The DeGen Medical Impulse AM™ implant is an intervertebral body fusion device intended for use in skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or two contiquous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The DeGen Medical Impulse AM™ System is indicated to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and are intended to be used with supplemental fixation systems cleared for use in the lumbar spine. The device is to be used in patients who have had six months of nonoperative treatment.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301)443-6740 EP
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510(k) Summary K210090
In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the DeGen Medical Impulse AM™ System is provided below.
| Date | August 27, 2021 |
|---|---|
| Sponsor | DeGen Medical1321-C North Cashua DriveFlorence, SC 29501Phone 877-240-7838Fax 843-407-0545 |
| 510(k) Contact | Secure BioMed EvaluationsLinda Braddon, Ph.D.7828 Hickory Flat HighwaySuite 120Woodstock, GA 30188770-837-2681Regulatory@SecureBME.com |
| Trade Name | Impulse AM™ Interbody Fusion System |
| Common Name | Intervertebral body fusion device |
| Code- | MAX |
| Classification | 21 CFR 888.3080 : Class II |
| Primary Predicate | DeGen Impulse™ Spacer K201287 |
| AdditionalPredicates | Alphatec Spine IdentiTi K183705Choice Spine TiGer Shark K172816 |
| Device Description | DeGen Medical Impulse AM™ System is a lumbar interbodyfusion device for posterior and transforaminal lumbar fusionprocedures. The Impulse AM™ system includes various lengths,widths, heights, and endplate shapes (curvatures include neutral,lordotic, and anatomic). The DeGen Medical Impulse AM™device is comprised of a single component that is additivelymanufactured. The superior and inferior endplates featureporous surfaces to mitigate subsidence and expulsion. Theanatomic, lordotic, and neutral configurations feature a posteriorface with a threaded hole and slots to rigidly connect to aninstrument for surgical insertion. The hyperlordotic configurationfeatures a posterior face with slots to rigidly connect an instrumentfor surgical insertion. Superior and inferior faces feature a centralaperture to constrain bone graft. DeGen Medical's Impulse AM™Spacers are additively manufactured from Puri-Ti™ titaniumpowder having a chemical composition conforming to ASTMB348 |
| Indications for Use | The DeGen Medical Impulse AM™ implant is an intervertebralbody fusion device intended for use in skeletally mature patientswith Degenerative Disk Disease (DDD) of the lumbar spine withup to Grade 1 Spondylolisthesis at one or two contiguous levelsfrom L2-S1. DDD is defined as discogenic back pain withdegeneration of the disc confirmed by history and radiographicstudies. The DeGen Medical Impulse AM™ System is indicatedto be used with autograft and/or allograft comprised of cancellousand/or corticocancellous bone graft to facilitate fusion and areintended to be used with supplemental fixation systems clearedfor use in the lumbar spine. The device is to be used in patientswho have had six months of nonoperative treatment. |
| TechnologicalCharacteristics | The technological design features of the subject implants werecompared to the predicates in intended use, indications for use,design, function and technology and it was demonstrated thatthey are substantially equivalent. |
| PerformanceTesting | Non-clinical testing was performed to demonstrate the DeGenMedical Impulse AM™ System is substantially equivalent toother predicate devices in accordance with “Guidance forIndustry and FDA Staff, Guidance for Spinal System 510(k)s",May 3, 2004 and Class II Special Controls GuidanceDocument: Intervertebral Body Fusion Device, June 12, 2007.The following tests were performed:• Static and dynamic compression testing per ASTMF2077• Static and dynamic compression shear testing perASTM F2077• Subsidence testing via ASTM F2267• Expulsion TestingThe results of these studies show the subject DeGen MedicalImpulse AM™ System is substantially equivalent to the otherpredicate devices. |
| Conclusions | Based on the indications for use, technological characteristics,performance testing, and comparison to predicate devices, thesubject DeGen Medical Impulse AM™ System is as safe andas effective as the legally marketed predicates. |
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510(k) Summary K210090
§ 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.