(73 days)
No
The provided text describes a mechanical expandable interbody fusion device made of titanium alloy. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML for its function or intended use.
Yes.
The device is used to treat degenerative disc disease and promote spinal fusion, which are therapeutic interventions.
No
This device is described as an "interbody fusion device," specifically an "Expandable Spacer System," intended for "spinal fusion procedures." Its purpose is to physically fuse vertebrae, not to diagnose a condition.
No
The device description explicitly states it is fabricated from titanium alloy and is a physical implant (expandable spacer system).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion procedures. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of titanium alloy, designed to be surgically placed in the spine. This is consistent with a medical device used for treatment.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. The device's function is mechanical support and promoting fusion.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The MEBO Wound Dressing is indicated for management of the following types of wound:-Skin graft recipient sites Newly sutured wounds Lacerations and abrasions Minor or superficial-partial thickness burns
When used as an interbody fusion device, the TRULIFT® Expandable Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.
Product codes
MAX
Device Description
The TRULIFT® Expandable Spacer System is available in a range of sizes and footprints and can expand to the desired height (8mm to 16mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6AI-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.
All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the TRULIFT® Expandable Spacer System components with components from any other system or manufacturer. The TRULIFT® Expandable Spacer System components should never be reused under any circumstances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Static Axial compression, Static Compressive Shear, Static Expulsion, Dynamic Axial Compression and Dynamic Compressive Shear to ASTM F2077, was presented to demonstrate the substantial equivalency of the Pro-Lift Expandable System (K190488).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K190488, K173182, K133717, K080411
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 4, 2020
Life Spine Inc. Angela Batker RA/OA Manager 13951 S. Quality Drive Huntley, Illinois 60142
Re: K201721
Trade/Device Name: TruLift Expandable Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 26, 2020 Received: August 27, 2020
Dear Ms. Batker:
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.
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
1
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 (OS) 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 mediation-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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193439
Device Name MEBO Wound Dressing
Indications for Use (Describe) The MEBO Wound Dressing is indicated for management of the following types of wound:-Skin graft recipient sites Newly sutured wounds Lacerations and abrasions Minor or superficial-partial thickness burns
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary TruLift Expandable Spacer System
| Submitted By: | Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Angela Batker
Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
| Date Prepared: | June 16th, 2020 |
| Trade Name: | TruLift Expandable Spacer System |
| Common Name: | Intervertebral Body Fusion Device |
| Classification: | MAX, 21 CFR 888.3080, Class II |
| Primary Predicate: | Life Spine ProLift Expandable System (K190488) |
| Additional Predicate: | Life Spine ProLift Expandable System (K173182)
Life Spine Longbow (K133717)
Life Spine Plateau Spacer (K080411) |
Device Description:
The TRULIFT® Expandable Spacer System is available in a range of sizes and footprints and can expand to the desired height (8mm to 16mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6AI-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.
All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the TRULIFT® Expandable Spacer System components with components from any other system or manufacturer. The TRULIFT® Expandable Spacer System components should never be reused under any circumstances.
4
Indications for Use:
When used as an interbody fusion device, the TRULIFT® Expandable Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.
Technological Characteristics:
The TRULIFT® Expandable Spacer System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing.
Material:
This submission seeks clearance of a device made from titanium alloy (Ti-6AI-4V ELI) as described by ASTM F136. This this is the same material used in the predicate devices.
Performance Data:
Static Axial compression, Static Compressive Shear, Static Expulsion, Dynamic Axial Compression and Dynamic Compressive Shear to ASTM F2077, was presented to demonstrate the substantial equivalency of the Pro-Lift Expandable System (K190488).
Substantial Equivalence:
The TRULIFT® Expandable Spacer System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance.
Conclusion:
The information presented demonstrates the substantial equivalency of the TRULIFT® Expandable Spacer System.