(222 days)
Not Found
No
The summary describes a traditional, machined intervertebral body fusion device made of titanium with a porous coating. There is no mention of AI, ML, image processing, or any software-driven features that would suggest the use of these technologies. The performance studies are standard mechanical and wear tests for implants.
Yes
The device is an intervertebral body fusion device intended to facilitate fusion for patients with Degenerative Disc Disease, which is a therapeutic purpose.
No
The device is an implantable intervertebral body fusion device used to facilitate fusion in the lumbar spine, not to diagnose a condition.
No
The device description clearly states it is a physical implant made of Titanium and Titanium alloy, intended for surgical insertion. It describes physical characteristics, coatings, and materials, indicating it is a hardware device, not software-only.
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 DeGen Medical Impulse implant is a physical implant designed to be surgically placed in the lumbar spine to facilitate bone fusion. It is a medical device used within the body, not for testing samples outside the body.
- Intended Use: The intended use is to treat Degenerative Disc Disease by providing structural support and promoting fusion in the spine. This is a therapeutic intervention, not a diagnostic test.
The information provided clearly describes a surgical implant, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes
MAX
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.
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
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 F1877
The results of these studies show the subject DeGen Medical Impulse System is substantially equivalent to the other predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K130478, K073291, K163481, K092193, K183705
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: 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.
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 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)
Device Name
DeGen Medical Impulse Interbody Fusion System
ndications for Use (Describe)
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.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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 Medical |
| 1321-C North Cashua Drive | |
| Florence, SC 29501 | |
| Phone 877-240-7838 | |
| Fax 843-407-0545 | |
| 510(k) Contact | Secure BioMed Evaluations |
| Linda Braddon, Ph.D. | |
| 7828 Hickory Flat Highway | |
| Suite 120 | |
| Woodstock, GA 30188 | |
| 770-837-2681 | |
| Regulatory@SecureBME.com | |
| Trade Name | Impulse Interbody Fusion System |
| Common Name | Intervertebral body fusion device |
| Code-Classification | MAX |
| 21 CFR 888.3080 : Class II | |
| Primary Predicate | Globus Sustain K130478 |
| Additional Predicates | Medtronic Capstone K073291 |
| Astura Medical Half Dome K163481 | |
| ShurFit Precision Spine K092193 | |
| Alphatec Spine IdentiTi K183705 | |
| 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. | |
| Indications for Use | 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. | |
| Technological | |
| Characteristics | 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. | |
| Non-clinical testing was performed to demonstrate the DeGen Medical | |
| Impulse 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. | |
| 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 F1877 | |
| The results of these studies show the subject DeGen Medical Impulse | |
| System 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 subject | |
| DeGen Medical Impulse 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 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.