(161 days)
Not Found
No
The summary describes a mechanical interbody fusion device and does not mention any AI or ML components or functions.
Yes
The device is intended to treat degenerative disc disease by providing structural stability and promoting bone fusion in the spine, which aligns with the definition of a therapeutic device.
No
The device is described as an "interbody fusion device" and an "expandable lumbar interbody fusion device used to provide structural stability." Its intended use is to treat degenerative disc disease by providing structural support, not to diagnose it.
No
The device description clearly states the device is a physical implant made of titanium alloy, PEEK polymer, and cobalt chromium alloy, intended for surgical implantation. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The SABLE™ Expandable Spacer is an implantable surgical device used to provide structural support in the spine during fusion surgery. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or diagnostic information being generated by the device.
The SABLE™ Expandable Spacer is a surgical implant used in the treatment of degenerative disc disease.
N/A
Intended Use / Indications for Use
SABLE™ Expandable Spacer 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 spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone and is to be used with supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The SABLE™ Expandable Spacer is an expandable lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The device is available in various heights and geometric options to fit the anatomical needs of a wide variety of patients.
SABLE™ Spacers are manufactured from titanium alloy. The endplates are additively manufactured from titanium alloy powder and an internal component is manufactured from radiolucent PEEK polymer. The drive screw is manufactured from cobalt chromium alloy.
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)
Mechanical testing (static and dynamic compression and compression-shear, and subsidence) was conducted in accordance with the "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, ASTM F2077, and ASTM F2267 to demonstrate substantial equivalence to the predicate devices. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
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.
RISE® Spacer (K113447), ALTERA® Spacer (K140411), SUSTAIN® Spacers (K181357), NeoFuse Ti3D Interbody (K170318)
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
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January 14, 2020
Globus Medical Inc. Kelly Baker, PhD Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Ave. Audubon, Pennsylvania 19403
Re: K192115
Trade/Device Name: SABLE™ Expandable Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 13, 2019 Received: December 16, 2019
Dear Dr. Baker:
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 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 (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 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, PhD Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name SABLE™ Expandable Spacer
Indications for Use (Describe)
SABLE™ Expandable Spacer 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 spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone and is to be used with supplemental fixation.
| 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: SABLE™ Expandable Spacer
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
610-930-1800 |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kelly Baker, Ph.D.
Senior Vice President, Regulatory and Clinical Affairs |
| Date Prepared: | August 5, 2019 |
| Device Name: | SABLE™ Expandable Spacer |
| Common Name: | Intervertebral Body Fusion Device |
| Classification: | Per 21 CFR as follows:
§888.3080 Intervertebral Body Fusion Device
Product Code(s): MAX
Regulatory Class: II, Panel Code: 87 |
| Primary Predicate: | RISE® Spacer (K113447) |
Additional
| Predicates: | ALTERA® Spacer (K140411) |
|---|---|
| SUSTAIN® Spacers (K181357) | |
| NeoFuse Ti3D Interbody (K170318) |
Purpose:
The purpose of this submission is to request clearance for the SABLE™ Expandable Spacer.
Device Description:
The SABLE™ Expandable Spacer is an expandable lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The device is available in various heights and geometric options to fit the anatomical needs of a wide variety of patients.
SABLE™ Spacers are manufactured from titanium alloy. The endplates are additively manufactured from titanium alloy powder and an internal component is manufactured from radiolucent PEEK polymer. The drive screw is manufactured from cobalt chromium alloy.
4
Indications for Use:
SABLE™ Expandable Spacer 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 nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone and is to be used with supplemental fixation.
Performance Data:
Mechanical testing (static and dynamic compression and compression-shear, and subsidence) was conducted in accordance with the "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, ASTM F2077, and ASTM F2267 to demonstrate substantial equivalence to the predicate devices. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
Technological Characteristics:
Subject implants have the same technological characteristics as the predicate devices including design, intended use, material composition, and range of sizes.
Basis of Substantial Equivalence:
Subject interbody spacers have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject spacers to the predicate devices.