Impulse Interbody Fusion System by DeGen Medical

The DeGen Medical Impulse implant is an intervertebral body fusion device intended for use in skeletally mature patients with Degenerative Disc 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 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.

Device Description

DeGen Medical Impulse System is a lumbar interbody fusion device for posterior and transforaminal lumbar fusion procedures. The Impulse system includes various lengths, widths, heights, and endplate shapes (curvatures include neutral, lordotic, and anatomic). The DeGen Medical Impulse device is comprised of a single component that is traditionally machined. The superior and inferior endplates are coated with a porous coating to facilitate bony ingrowth and 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 Impulse System is made from Titanium (ASTM F67) and Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

AI/ML Overview

The provided text describes the DeGen Medical Impulse Interbody Fusion System and its FDA 510(k) clearance. However, it does not contain the specific information requested in your prompt regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

This document is a 510(k) summary, which is a regulatory filing demonstrating substantial equivalence to a legally marketed predicate device, as opposed to a full clinical study report demonstrating new safety and effectiveness. The performance testing mentioned is primarily non-clinical (mechanical testing) and is conducted to show that the device performs similarly to predicate devices, not to establish specific clinical performance metrics against defined acceptance criteria in the way you might see for an AI/ML device or a novel therapeutic.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as pass/fail metrics. The "acceptance" for this type of device is demonstrating substantial equivalence to predicate devices through a battery of non-clinical tests.
Reported Device Performance:
- Non-clinical testing performed:
  - Static and dynamic compression testing per ASTM F2077
  - Static and dynamic compression shear testing per ASTM F2077
  - Subsidence testing via ASTM F2267
  - Expulsion Testing
  - Wear debris analysis via ASTM F1877
- Results: "The results of these studies show the subject DeGen Medical Impulse System is substantially equivalent to the other predicate devices."

What is missing: Specific numerical results of these tests and their direct comparison to pre-defined numerical acceptance criteria for a "device performance" table as typically seen for AI/ML or diagnostic devices. The acceptance is implied by the comparison to predicates and relevant ASTM standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing: This information is not present. The document focuses on non-clinical (mechanical) testing, not clinical data sets, and therefore doesn't discuss test sets in the context of patient data or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Missing: This information is not present. No clinical ground truth or expert review is described for the evaluation of this medical device in this summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Missing: This information is not present. No clinical adjudication method is described.

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

Missing: This information is not present. This device is an intervertebral body fusion system, not an AI/ML diagnostic or assistive device, so MRMC studies in this context are not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Missing: This information is not present. This device is an implantable surgical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Ground Truth (for mechanical testing): The "ground truth" for the mechanical performance of this device is established by adherence to recognized ASTM standards (e.g., F2077, F2267, F1877) and demonstrating performance equivalent to legally marketed predicate devices. This is a non-clinical "ground truth."
Missing: Clinical ground truth, pathology, or outcomes data related to device performance in patients is not detailed in this 510(k) summary.

8. The sample size for the training set

Missing: This information is not present. No training set is involved in the evaluation described.

9. How the ground truth for the training set was established

Missing: This information is not present as there is no training set mentioned.

Summary of what the document does provide:

Device Name: Impulse Interbody Fusion System
Indications for Use: Skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine (L2-S1) with up to Grade 1 Spondylolisthesis at one or two contiguous levels. Used with autograft/allograft and supplemental fixation systems, after 6 months of nonoperative treatment.
Technological Characteristics Comparison: Compared to predicates in intended use, indications for use, design, function, and technology.
Performance Testing: Static/dynamic compression, compression shear, subsidence, expulsion, and wear debris analysis (all per specific ASTM standards).
Conclusion: Substantially equivalent to predicate devices based on indications for use, technological characteristics, and performance testing.

Summary

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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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

December 22, 2020

DeGen Medical % Linda Braddon, Ph.D. President/CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188

Re: K201287

Trade/Device Name: Impulse Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 16, 2020 Received: December 17, 2020

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 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)

K201287

Device Name

DeGen Medical Impulse Interbody Fusion System

ndications for Use (Describe)

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

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Image /page/3/Picture/1 description: The image shows the logo for DeGen Medical. The logo features three curved lines emanating from a point on the left side, with the lines getting progressively longer and thicker as they move to the right. The lines are blue, and each ends in a blue circle. Below the lines, the text "DeGen" is written in a bold, blue font, and below that, the word "Medical" is written in a smaller, gray font.

510(k) Summary K201287

Date	December 15, 2020
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 Interbody Fusion System
Common Name	Intervertebral body fusion device
Code-Classification	MAX21 CFR 888.3080 : Class II
Primary Predicate	Globus Sustain K130478
Additional Predicates	Medtronic Capstone K073291Astura Medical Half Dome K163481ShurFit Precision Spine K092193Alphatec Spine IdentiTi K183705
Device Description	DeGen Medical Impulse System is a lumbar interbody fusion devicefor posterior and transforaminal lumbar fusion procedures. The Impulsesystem includes various lengths, widths, heights, and endplate shapes(curvatures include neutral, lordotic, and anatomic). The DeGen MedicalImpulse device is comprised of a single component that is traditionallymachined. The superior and inferior endplates are coated with aporous coating to facilitate bony ingrowth and mitigate subsidence andexpulsion. The anatomic, lordotic, and neutral configurations feature aposterior face 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 aninstrument for surgical insertion. Superior and inferior faces feature acentral aperture to constrain bone graft. DeGen Medical ImpulseSystem is made from Titanium (ASTM F67) and Titanium alloy (Ti-6Al-4VELI) per ASTM F136.
Indications for Use	The DeGen Medical Impulse implant is an intervertebral body fusion deviceintended for use in skeletally mature patients with Degenerative Disc Disease(DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or twocontiguous levels from L2-S1. DDD is defined as discogenic back pain withdegeneration of the disc confirmed by history and radiographic studies. TheDeGen Medical Impulse System is indicated to be used with autograft and/orallograft comprised of cancellous and/or corticocancellous bone graft tofacilitate fusion and are intended to be used with supplemental fixationsystems cleared for use in the lumbar spine. The device is to be used inpatients who have had six months of nonoperative treatment.

TechnologicalCharacteristics	The technological design features of the subject implants were compared tothe predicates in intended use, indications for use, design, function andtechnology and it was demonstrated that they are substantially equivalent.Non-clinical testing was performed to demonstrate the DeGen MedicalImpulse System is substantially equivalent to other predicate devices inaccordance with "Guidance for Industry and FDA Staff, Guidance forSpinal System 510(k)s", May 3, 2004 and Class II Special Controls GuidanceDocument: Intervertebral Body Fusion Device, June 12, 2007.
Performance Testing	The following tests were performed:• Static and dynamic compression testing per ASTM F2077• Static and dynamic compression shear testing per ASTM F2077• Subsidence testing via ASTM F2267• Expulsion Testing• Wear debris analysis via ASTM F1877The results of these studies show the subject DeGen Medical ImpulseSystem is substantially equivalent to the other predicate devices.
Conclusions	Based on the indications for use, technological characteristics,performance testing, and comparison to predicate devices, the subjectDeGen Medical Impulse System is as safe and as effective as the legallymarketed predicates

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Image /page/4/Picture/0 description: The image shows the logo for DeGen Medical. The logo features a stylized graphic of three curved lines emanating from a single point, with the lines terminating in circles. The lines and circles are in shades of blue. Below the graphic, the word "DeGen" is written in a bold, sans-serif font, also in blue. Underneath "DeGen," the word "Medical" is written in a smaller, lighter font.

510(k) Summary K201287

Regulation Number and Section

§ 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.