(127 days)
Not Found
No
The summary describes a physical implant device and its intended use and materials. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is an implantable intervertebral body fusion device used to treat Degenerative Disk Disease of the lumbar spine, facilitating fusion and providing stability, which are therapeutic functions.
No
The device is described as an intervertebral body fusion device intended for use in treating degenerative disk disease of the lumbar spine, which performs a therapeutic function by facilitating fusion, not a diagnostic one.
No
The device description clearly states it is an additively manufactured implant made of titanium, 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 the device is an "intervertebral body fusion device intended for use in skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine". This describes a surgical implant used to treat a physical condition.
- Device Description: The description details a physical implant made of titanium, designed to be surgically inserted into the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are typically tests or kits used in a laboratory or point-of-care setting.
Therefore, the DeGen Medical Impulse AM™ implant is a surgical device, not an In Vitro Diagnostic device.
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 (comma separated list FDA assigned to the subject device)
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 facilitate fusion 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’s Impulse AM™ Spacers are additively manufactured from Puri-Ti™ unalloyed titanium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine
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 minor modifications in manufacturing of the subject device do not negatively impact the final device as compared to the originally cleared system in K210090.
The following tests were performed to show equivalency:
• Static and dynamic compression testing per ASTM F2077
• Dynamic compression shear testing per ASTM F2077
The results of these studies show the subject DeGen Medical Impulse AM™ System is substantially equivalent to the originally cleared system in K210090.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K210090 DeGen Medical Impulse AM™ Interbody Fusion System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
0
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.
March 17, 2023
DeGen Medical % Linda Braddon CEO Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, Georgia 30188
Re: K223418
Trade/Device Name: DeGen Impulse AMTM System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 1, 2023 Received: March 1, 2023
Dear Linda 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.
Katherine D. Kavlock -S
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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Page 1 of 1
510(k) Number (if known) K223418
Device Name DeGen Medical Impulse AM™ 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 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 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."
3
510(k) Summary of Safety and Effectiveness
Image /page/3/Picture/1 description: The image shows the text "K223418 Page 1 of 2" on the left side. On the right side is the DeGen Medical logo. The logo is blue and features three curved lines emanating from a point, with the text "DeGen Medical" below the lines. The word "Medical" is in a smaller font size than "DeGen".
In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the DeGen Medical Impulse AMTM System is provided below.
| Date | March 15, 2023 |
|---|---|
| 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. | |
| Justin Gracyalny, MSE | |
| 7828 Hickory Flat Highway | |
| Suite 120 | |
| Woodstock, GA 30188 | |
| 770-837-2681 | |
| Regulatory@SecureBME.com | |
| Trade Name | DeGen Impulse AM™ System |
| Common Name | Intervertebral body fusion device |
| Code-Classification | MAX |
| 21 CFR 888.3080 : Class II | |
| Primary Predicate | K210090 DeGen Medical Impulse AM™ Interbody Fusion System |
| 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 facilitate fusion 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's Impulse AM™ | |
| Spacers are additively manufactured from Puri-Ti™ unalloyed titanium. |
4
Image /page/4/Picture/1 description: The image shows the text "K223418 Page 2 of 2" on the left side. On the right side is a logo for DeGen Medical. The logo includes a graphic of three curved lines with dots at the end, and the text "DeGen Medical" is written below the graphic.
| Indications for Use | The DeGen Medical Impulse AMT™ 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 | |
| Characteristics | There are no technological differences between the subject and predicate device. 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 minor modifications in manufacturing of the subject device do not negatively impact the final device as compared to the originally cleared system in K210090. |
| Performance Testing | The following tests were performed to show equivalency:
• Static and dynamic compression testing per ASTM F2077
• Dynamic compression shear testing per ASTM F2077
The results of these studies show the subject DeGen Medical Impulse AM™ System is substantially equivalent to the originally cleared system in K210090. |
| Conclusions | Based on the indications for use, technological characteristics, performance testing, and comparison to the predicate device, the subject DeGen Medical Impulse AMT™ System is as safe and as effective as the legally marketed predicates |