K Number
K210090
Device Name
Impulse AM Interbody Fusion System
Manufacturer
Date Cleared
2021-08-30

(229 days)

Product Code
Regulation Number
888.3080
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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
More Information

Not Found

No
The document describes a passive implantable device (intervertebral body fusion device) and its material properties and mechanical testing. There is no mention of any computational or analytical functions, let alone AI/ML.

Yes
The device is described as an "intervertebral body fusion device" intended for therapeutic use in patients with Degenerative Disk Disease (DDD) to facilitate fusion, which is a treatment for a medical condition.

No

The described device is an implant for intervertebral body fusion, used in the treatment of Degenerative Disk Disease, not for diagnosing conditions.

No

The device description clearly states it is an additively manufactured implant made of titanium powder, which is a physical hardware component.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is an "intervertebral body fusion device" used in the lumbar spine to facilitate fusion in patients with Degenerative Disk Disease. This is a surgical implant used in the body, not a test performed on samples taken from the body.
  • Device Description: The description details a physical implant made of titanium, designed to be surgically inserted into the spine. This aligns with a medical device, not an IVD.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information based on laboratory testing.

IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a therapeutic implant used to treat a condition directly.

N/A

Intended Use / Indications for Use

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.

Product codes

MAX

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lumbar spine, L2-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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing was performed to demonstrate the DeGen Medical Impulse AM™ System is substantially equivalent to other predicate devices 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. 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
The results of these studies show the subject DeGen Medical Impulse AM™ System is substantially equivalent to the other predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K201287, K183705, K172816

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)

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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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.

1

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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Image /page/2/Picture/0 description: The image shows the logo for DeGen Medical. The logo features three curved lines emanating from three blue circles at the top, resembling a stylized representation of motion or connectivity. Below this graphic is the text "DeGen" in a bold, sans-serif font, with the word "Medical" in a smaller, lighter font underneath.

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)

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PSC Publishing Services (301)443-6740 EP

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Image /page/3/Picture/0 description: The image shows the logo for DeGen Medical. The logo features three curved lines emanating from a point on the left, each ending in a blue circle. The lines are also blue and appear to be in motion. Below the graphic is the text "DeGen" in a bold, blue font, with the word "Medical" in a smaller, gray font underneath.

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.

DateAugust 27, 2021
SponsorDeGen Medical
1321-C North Cashua Drive
Florence, SC 29501
Phone 877-240-7838
Fax 843-407-0545
510(k) ContactSecure BioMed Evaluations
Linda Braddon, Ph.D.
7828 Hickory Flat Highway
Suite 120
Woodstock, GA 30188
770-837-2681
Regulatory@SecureBME.com
Trade NameImpulse AM™ Interbody Fusion System
Common NameIntervertebral body fusion device
Code-MAX
Classification21 CFR 888.3080 : Class II
Primary PredicateDeGen Impulse™ Spacer K201287
Additional
PredicatesAlphatec Spine IdentiTi K183705
Choice Spine TiGer Shark K172816
Device DescriptionDeGen 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
Indications for UseThe 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.
Technological
CharacteristicsThe 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.
Performance
TestingNon-clinical testing was performed to demonstrate the DeGen
Medical Impulse AM™ System is substantially equivalent to
other predicate devices 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.
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
The results of these studies show the subject DeGen Medical
Impulse AM™ System is substantially equivalent to the other
predicate devices.
ConclusionsBased on the indications for use, technological characteristics,
performance testing, and comparison to predicate devices, the
subject DeGen Medical Impulse AM™ System is as safe and
as effective as the legally marketed predicates.

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Image /page/4/Picture/0 description: The image shows the logo for DeGen Medical. The logo features three curved lines emanating from three circles, resembling a stylized representation of motion or connectivity. Below the graphic is the text "DeGen" in a bold, blue font, with the word "Medical" in a smaller, gray font underneath.

510(k) Summary K210090