K Number
K173189
Device Name
Lumfuse TP
Date Cleared
2018-06-08

(249 days)

Product Code
Regulation Number
888.3080
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Lumfuse-TP cage is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the Lumfuse-TP cage is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These patients should be skeletally mature and have had six months of nonoperative treatment. The Lumfuse-TP cage is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.
Device Description
The Lumfuse-TP cage consists of PEEK cages of various lengths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are made from PEEK radiolucent material (ASTM F2026) with embedded tantalum x-ray markers (ASTM F560 or ISO 13782). Two versions of the Lumfuse-TP cage are available: cages coated with medical grade CP Ti (ASTM F1580) and non-coated cages, both of which are provided sterile. The device must be used with supplemental fixation. The purpose of this submission is to gain initial marketing authorization in the United States for the non-coated, sterile and TPS coated Lumfuse-TP devices. Associated instrumentation has already been cleared in K171630.
More Information

Not Found

No
The summary describes a physical implant (spinal cage) and its materials, intended use, and mechanical testing. There is no mention of software, algorithms, image processing, AI, or ML.

Yes
The Lumfuse-TP cage is intended for use in spinal fusion procedures to treat Degenerative Disc Disease, which makes it a device aimed at treating a disease or condition, fitting the definition of a therapeutic device.

No

Explanation: The Lumfuse-TP cage is an implantable device used during spinal fusion procedures to provide support and correction. It is a treatment device, not a diagnostic one. Its stated use is for patients diagnosed with Degenerative Disc Disease, indicating diagnosis happens prior to its use.

No

The device description clearly states it is a physical implantable cage made of PEEK with tantalum markers, intended for spinal fusion procedures. It is a hardware device.

Based on the provided information, the Lumfuse-TP cage is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use clearly describes a surgical implant for spinal fusion procedures to treat Degenerative Disc Disease. This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body) on biological specimens.
  • Device Description: The device is a physical implant made of PEEK and tantalum, designed to be inserted into the body. It does not involve reagents, assays, or analysis of biological samples.
  • Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological specimens (blood, urine, tissue, etc.)
    • Detecting or measuring substances in biological samples
    • Providing information for diagnosis, monitoring, or screening of diseases or conditions

The Lumfuse-TP cage is a medical device, specifically a spinal implant, used in a surgical procedure.

N/A

Intended Use / Indications for Use

The Lumfuse-TP cage is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the Lumfuse-TP cage is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These patients should be skeletally mature and have had six months of nonoperative treatment. The Lumfuse-TP cage is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.

Product codes (comma separated list FDA assigned to the subject device)

MAX

Device Description

The Lumfuse-TP cage consists of PEEK cages of various lengths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are made from PEEK radiolucent material (ASTM F2026) with embedded tantalum x-ray markers (ASTM F560 or ISO 13782). Two versions of the Lumfuse-TP cage are available: cages coated with medical grade CP Ti (ASTM F1580) and non-coated cages, both of which are provided sterile. The device must be used with supplemental fixation.

The purpose of this submission is to gain initial marketing authorization in the United States for the non-coated, sterile and TPS coated Lumfuse-TP devices. Associated instrumentation has already been cleared in K171630.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lumbar or lumbosacral vertebral bodies (specifically L2 to S1)

Indicated Patient Age Range

skeletally mature

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:
The worst case devices were evaluated for mechanical performance in Static and Dynamic Axial Compression and Static and Dynamic Compression Shear according to ASTM F2077-14, and Subsidence according to ASTM F2267-04(2011). Cleaning and sterilization processes as well as implantable device biocompatibility endpoints were evaluated.

Clinical testing:
Clinical testing was not required to demonstrate substantial equivalence in this premarket notification.

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.

Precifit LUMFUSE-TP (K171630), Medtronic® CAPSTONE PTC (K133205), Precifit CERVAGE (K172568)

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.

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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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Precifit Medical Ltd % Kellen Hills Quality and Regulatory Consultant Orchid Design 4600 E Shelby Dr Memphis, Tennessee 38118

June 8, 2018

Re: K173189

Trade/Device Name: Lumfuse TP Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: May 8, 2018 Received: May 11, 2018

Dear Mr. Hills:

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. 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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

1

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173189

Device Name Lumfuse-TP

Indications for Use (Describe)

The Lumfuse-TP cage is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the Lumfuse-TP cage is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These patients should be skeletally mature and have had six months of nonoperative treatment. The Lumfuse-TP cage is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summ [As Required by 21 CFR 807.92]

[As Required by 21 C.F.R. 807.87]

(a)(1) Submitted By: Address:

Phone: Date: Contact Persons Primary: Secondary:

  • (a)(2) Proprietary Name: Common Name:
    Classification Name and Reference:

Product Code:

(a)(3) Predicate Devices: Primary: Additional: Additional:

PRECIFIT MEDICAL LTD 2233 5th Street East, St. Paul, MN, 55119 901-433-1990 May 8, 2018

Kellen Hills (Orchid Design Consulting) Eric Wu (Precifit Medical Ltd)

Lumfuse-TP Lumbar interbody fusion device, interbody cage 21 CFR 888.3080: Intervertebral Fusion Device, Lumbar MAX

Precifit LUMFUSE-TP (K171630) Medtronic® CAPSTONE PTC (K133205); Precifit CERVAGE (K172568);

Device Description: (a)(4)

The Lumfuse-TP cage consists of PEEK cages of various lengths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are made from PEEK radiolucent material (ASTM F2026) with embedded tantalum x-ray markers (ASTM F560 or ISO 13782). Two versions of the Lumfuse-TP cage are available: cages coated with medical grade CP Ti (ASTM F1580) and non-coated cages, both of which are provided sterile. The device must be used with supplemental fixation.

The purpose of this submission is to gain initial marketing authorization in the United States for the non-coated, sterile and TPS coated Lumfuse-TP devices. Associated instrumentation has already been cleared in K171630.

  • (a)(5) Indications for Use:
    The Lumfuse-TP cage is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the Lumfuse-TP cage is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These patients should be skeletally mature and have had six months of nonoperative treatment. The Lumfuse-TP cage is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.

  • (a)(6) Comparison of Technological Characteristics:

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The Lumfuse-TP has the same intended use and is similar in basic shape, material and performance characteristics to the predicate device. The technological characteristics demonstrate substantial equivalence to the identified predicate devices.

  • (b)(1) Non-clinical testing:
    The worst case devices were evaluated for mechanical performance in Static and Dynamic Axial Compression and Static and Dynamic Compression Shear according to ASTM F2077-14, and Subsidence according to ASTM F2267-04(2011). Cleaning and sterilization processes as well as implantable device biocompatibility endpoints were evaluated.

  • (b)(2) Clinical testing:
    Clinical testing was not required to demonstrate substantial equivalence in this premarket notification.

  • Conclusions: (b)(3)
    Based on the information provided in this premarket notification, we believe that the subject Lumfuse-TP demonstrates substantial equivalence to the identified predicate devices.