(344 days)
No
The summary describes a spinal implant made of titanium alloy with a specific shape and manufacturing method. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on mechanical testing, not algorithmic performance.
Yes
The device is described as an implant system used in spinal fusion procedures to treat degenerative disc disease, which falls under the definition of a therapeutic device designed to treat a medical condition.
No
Explanation: The Ghost Spacer System is an implant used in spinal fusion procedures to promote fusion and provide stability. It is a treatment device, not a diagnostic one.
No
The device description explicitly states that the Ghost Spacer System consists of implants made of titanium alloy, which are physical hardware components.
Based on the provided text, 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 the physical characteristics, material, and manufacturing method of a spinal implant. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device is implanted directly into the body.
IVD devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Ghost 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. 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 Ghost Spacer System consists of implants made of titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The spacers have a basic rectangular shape, a hollow center for placement of autograft bone graft and/or allogeneic bone composed of cancellous and/or corticocancellous bone to help promote fusion and a smooth bullet shaped distal surface. They are available in an assortment of height, length and anteroposterior angulations to accommodate many different anatomic requirements. The implants are delivered via a posterior, transforaminal, lateral or anterior approach. The devices are manufactured using the Electron Beam Melting (EBM) additive manufacturing method. All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the GHOST Spacer System components with components from any other system or manufacturer. The GHOST 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
Spinal, 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)
Testing completed according to ASTM F2077 included Static and Dynamic Axial Compression & Compressive Shear Testing and Static subsidence testing to ASTM F2267 was presented to demonstrate the substantial equivalency of the Life Spine Plateau (K080411 & K111569).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Life Spine Plateau (K080411 & K111569), Life Spine Plateau-A Ti (K201500), Life Spine ProLift Expandable Spacer System (K190488), Life Spine Pro Lift Post-Pack (K173182), ChoiceSpine's Tiger Shark Spacer System (K172816)
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
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September 29, 2022
Life Spine, Inc. Angela Batker RA/OA Manager 13951 S. Quality Drive Huntley, Illinois 60142
Re: K213417
Trade/Device Name: Ghost Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 25, 2022 Received: September 2, 2022
Dear Angela 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) K213417
Device Name Ghost Spacer System
Indications for Use (Describe)
The Ghost 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. 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.
| 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
510(k) Summary Ghost 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: | September 27, 2021 |
| Trade Name: | Life Spine Ghost Spacer System |
| Common Name: | Intervertebral Body Fusion Device |
| Classification: | MAX, 21 CFR 888.3080, Class II |
| Primary Predicate: | Life Spine Plateau (K080411 & K111569) |
| Secondary Predicate: | Life Spine Plateau-A Ti (K201500)
Life Spine ProLift Expandable Spacer System (K190488)
Life Spine Pro Lift Post-Pack (K173182)
ChoiceSpine's Tiger Shark Spacer System (K172816) |
Device Description:
The Ghost Spacer System consists of implants made of titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The spacers have a basic rectangular shape, a hollow center for placement of autograft bone graft and/or allogeneic bone composed of cancellous and/or corticocancellous bone to help promote fusion and a smooth bullet shaped distal surface. They are available in an assortment of height, length and anteroposterior angulations to accommodate many different anatomic requirements. The implants are delivered via a posterior, transforaminal, lateral or anterior approach. The devices are manufactured using the Electron Beam Melting (EBM) additive manufacturing method. All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the GHOST Spacer System components with components from any other system or manufacturer. The GHOST Spacer System components should never be reused under any circumstances.
4
Intended Use of the Device:
The GHOST 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. 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 Life Spine Ghost Spacer System is substantially equivalent to the predicate systems in terms of design, indications for use and sizing.
Material:
This submission seeks clearance of a device made from implant grade (Ti-6AL-4V) Titanium alloy according to ASTM F3001.
Performance Data:
Testing completed according to ASTM F2077 included Static and Dynamic Axial Compression & Compressive Shear Testing and Static subsidence testing to ASTM F2267 was presented to demonstrate the substantial equivalency of the Life Spine Plateau (K080411 & K111569).
Substantial Equivalence:
The Life Spine Ghost 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 Life Spine Ghost Spacer System.