(109 days)
No
The summary describes a mechanical interbody fusion device made of titanium alloy with no mention of software, algorithms, or data processing capabilities that would indicate AI/ML.
Yes.
The device is an interbody fusion device intended for patients with degenerative disc disease, aiming to promote fusion in the lumbosacral spine, which makes it a therapeutic device.
No
Explanation: This device is an interbody fusion device designed for surgical implantation to treat degenerative disc disease by promoting spinal fusion. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is fabricated from titanium alloy and includes physical components like implants and screws, indicating it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of potential donors and recipients, or to monitor therapeutic measures.
- Device Description: The ProLift® Lateral HELO Fixated is described as an interbody fusion device made of titanium alloy, intended to be implanted into the lumbosacral spine. It is designed to promote bone fusion and provide structural support.
- Intended Use: The intended use is for patients with degenerative disc disease, to be implanted surgically.
- Lack of Specimen Examination: The description does not mention the examination of any human specimens (blood, tissue, etc.) for diagnostic purposes.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The ProLift® Lateral HELO Fixated is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ProLift® Lateral HELO Fixated is to be filled with autograft and/or allogenic bone graft comprised of cancellous bone. The ProLift® Lateral HELO Fixated must be used with FDA cleared supplemental fixation. The ProLift® Lateral HELO Fixated may optionally be used with two bone screws.
Product codes
OVD, MAX
Device Description
The ProLift® Lateral HELO Fixated is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-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. The screws are manufactured in variable and fixed configurations with diameters of 5.5mm and 6.5mm and lengths of 25mm-60mm. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient.
All implants are provided and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the ProLift® Lateral HELO Fixated with components from any other System or manufacturer. The ProLifi® Lateral HELO Fixated 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
lumbosacral spine (L2-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)
Static axial compression, dynamic axial compressive shear and dynamic compressive shear testing according to ASTM F2077, was presented to demonstrated that the ProLifi® Lateral HELO Fixated is safe, effective and substantially equivalent to the Pro-Lift Expandable System (K173182).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Life Spine ProLift Lateral Fixated (K200338), Life Spine TruLift Expandable Cage (K201721), Life Spine ProLift Expandable System (K173182), Globus Elsa Spacer (K161379), Life Spine Plateau Spacer System (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). On the left is the Department of Health and 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.
April 30, 2021
Life Spine, Inc. Ms. Angela Batker RA/OA Manager 13951 S. Quality Drive Huntley, Illinois 60142
Re: K210061
Trade/Device Name: ProLift® Lateral HELO Fixated Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX Dated: January 28, 2021 Received: February 1, 2021
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/cdrb/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 vou. 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
1
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(@;tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Brent Showalter -S
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
510(k) Number (if known) K210061
Device Name ProLift Lateral HELO Fixated
Indications for Use (Describe)
The The ProLift® Lateral HELO Fixated is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogence back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ProLift® Lateral HELO Fixated is to be filled with autograft and/or allogenic bone graft comprised of cancellous bone. The ProLift® Lateral HELO Fixated must be used with FDA cleared supplemental fixation. The ProLift® Lateral HELO Fixated may optionally be used with two bone screws.
| 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)
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3
K210061 510(k) Summary ProLift Lateral HELO Fixated
| 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: | April 5th, 2021 |
| Trade Name: | ProLift Lateral HELO Fixated |
| Common Name: | Intervertebral Body Fusion Device |
| Classification: | MAX, CFR 888.3080, Class II
OVD, CFR 888.3080, Class II |
| Primary Predicate: | Life Spine ProLift Lateral Fixated (K200338) |
| Additional Predicate: | Life Spine TruLift Expandable Cage (K201721)
Life Spine ProLift Expandable System (K173182)
Globus Elsa Spacer (K161379)
Life Spine Plateau Spacer System (K080411) |
Device Description:
The ProLift® Lateral HELO Fixated is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-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. The screws are manufactured in variable and fixed configurations with diameters of 5.5mm and 6.5mm and lengths of 25mm-60mm. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient.
All implants are provided and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the ProLift® Lateral HELO Fixated with components from any other System or manufacturer. The ProLifi® Lateral HELO Fixated components should never be reused under any circumstances.
4
Indications for Use:
The ProLift® Lateral HELO Fixated is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ProLift® Lateral HELO Fixated is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. The ProLift® Lateral HELO Fixated must be used with FDA cleared supplemental fixation. The ProLift® Lateral HELO Fixated may optionally be used with two bone screws.
Technological Characteristics:
The ProLifi® Lateral HELO Fixated has the same technological charrateristics as the predicates devices including design, intended use, material composition, function and range of sizes.
Material:
This submission seeks clearance of a device made from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. This this is the same material used in the predicate devices.
Performance Data:
Static axial compression, dynamic axial compressive shear and dynamic compressive shear testing according to ASTM F2077, was presented to demonstrated that the ProLifi® Lateral HELO Fixated is safe, effective and substantially equivalent to the Pro-Lift Expandable System (K173182).
Substantial Equivalence:
The ProLift Lateral HELO Fixated 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 ProLift Lateral HELO Fixated.