(127 days)
No
The summary describes a physical implant and surgical instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an intervertebral body fusion system intended for the treatment of degenerative disc disease and spondylolisthesis, which are medical conditions. Fusion devices are a type of therapeutic device used to stabilize and promote the union of adjacent bones in the spine, thereby alleviating pain and improving function. Its intended use clearly describes a treatment for a disease/condition.
No
Explanation: The device is an interbody fusion system designed for surgical implantation to facilitate spinal fusion, not for diagnosing medical conditions.
No
The device description explicitly details physical components made of PEEK and tantalum, as well as surgical instruments made of stainless steel. This indicates a hardware-based medical device, not a software-only one.
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 used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is an implantable system used for spinal fusion surgery. It is physically placed within the patient's body to stabilize the spine.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information. Its purpose is therapeutic (to facilitate fusion and stabilize the spine).
Therefore, the Integrity Spine Lumbar Interbody Fusion System falls under the category of an implantable surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Integrity Spine Lumbar Interbody Fusion is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Product codes
MAX
Device Description
The Integrity Spine Lumbar Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy. The Integrity Spine lumbar interbody fusion device(s) may be implanted:
- bi-laterally in pairs via a posterior (PLIF) approach;
- as a single device via an oblique (OLIF) approach:
- as a single device via a transforaminal (TLIF) approach; or
- as as a single device via an anterior or anterolateral (ALIF) approach.
The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, from L2 to S1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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
The following non-clinical tests were conducted:
- Static and dynamic compression testing, conducted in accordance with ASTM F2077-11
- Static and dynamic torsion testing, conducted in accordance with ASTM F2077-11
- Subsidence testing, conducted in accordance with ASTM F2267-04 -
- Expulsion testing, conducted in accordance with ASTM Draft Standard F-04.25.02.02 -
The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the Integrity Spine Lumbar Interbody Fusion System is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
DiFusion: Xiphos Interbody Fusion System (K100042)
Reference Device(s)
Eminent Spine: Eminent Spine Interbody Fusion System (K090064), Medtronic: InterFix System (P970015), SeaSpine: SeaSpine Spacer System (K082310), Tyber Medical: Tyber Medical Interbody System (K130573), Spinal USA: Spinal USA Interbody Fusion Device (K092193)
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 10, 2015
Integrity Spine % Ms. Lisa Peterson Principal Consultant Kaedon Consulting, LLC 14001 Hunters Pass Austin, Texas 78734
Re: K151819
Trade/Device Name: Integrity Spine Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: October 12, 2015 Received: October 15, 2015
Dear Ms. Peterson:
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
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
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) K151819
Device Name
Integrity Spine Lumbar Interbody Fusion System
Indications for Use (Describe)
The Integrity Spine Lumbar Interbody Fusion is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
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 Integrity Spine Lumbar Interbody Fusion System Premarket Notification
| SUBMITTED BY | Integrity Spine
2800 NE Loop 410 Suite 203
San Antonio, TX 78218 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| ESTABLISHMENT
REGISTRATION NUMBER | 3010763958 |
| OWNER/OPERATOR
NUMBER | 10046086 |
| CONTACT PERSON | Lisa Peterson
Kaedon Consulting, LLC
Phone: 512-507-0746
Fax: 512-266-3364
lpeterson@kaedonconsulting.com |
| DATE PREPARED | October 12, 2015 |
| CLASSIFICATION NAME | Intervertebral Body Fusion Device |
| DEVICE CLASS | Class II |
| REGULATION NUMBER | 21 CFR 888.3080 (Product Code MAX) |
| COMMON NAME | Intervertebral Fusion Device with Bone Graft, Lumbar |
| PROPRIETARY NAME | Integrity Spine Lumbar Interbody Fusion System |
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IDENTIFICATION OF PREDICATE DEVICE(S)
Predicate devices include various cleared interbody fusion systems:
Primarv
- DiFusion: Xiphos Interbody Fusion System (K100042) -
Secondary
Additional Predicate
- DePuy Acromed: Lumbar I/F Cage (P960025) -
Reference Devices
- Eminent Spine: Eminent Spine Interbody Fusion System । (K090064)
- Medtronic: InterFix System (P970015) -
- SeaSpine: SeaSpine Spacer System (K082310) -
- Tyber Medical: Tyber Medical Interbody System -(K130573)
- Spinal USA: Spinal USA Interbody Fusion Device -(K092193)
DEVICE DESCRIPTION
The Integrity Spine Lumbar Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy. The Integrity Spine lumbar interbody fusion device(s) may be implanted:
- bi-laterally in pairs via a posterior (PLIF) approach;
- as a single device via an oblique (OLIF) approach:
- as a single device via a transforaminal (TLIF) approach; or
- as as a single device via an anterior or anterolateral (ALIF) approach.
The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
INDICATIONS
The Integrity Spine Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine. from L2 to S1. in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
5
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The purpose of this premarket notification is to obtain clearance to market the Integrity Spine Lumbar Interbody Fusion System. The Integrity Spine System is comprised of various device configurations based on surqical approach and patient anatomy. The implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.
The subject system has similar technological characteristics as the predicate devices identified above. Specifically, the following characteristics support this conclusion:
- Intended for use at either one level or two contiquous levels, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
- -Substantially equivalent results of non-clinical testing relative to static and dynamic testing (per ASTM F2077-11 ), subsidence (per ASTM F2267-04), and expulsion (per ASTM Draft Standard F-04.25.02.02)
DISCUSSION OF NON-CLINICAL TESTING
The following non-clinical tests were conducted:
- Static and dynamic compression testing, conducted in accordance with ASTM F2077-11
- Static and dynamic torsion testing, conducted in accordance with ASTM F2077-11
- Subsidence testing, conducted in accordance with ASTM F2267-04 -
- Expulsion testing, conducted in accordance with ASTM Draft Standard F-04.25.02.02 -
CONCLUSIONS
The subject and predicate device(s) share the same intended use, primary implant design and equivalent material of manufacture. The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the Integrity Spine Lumbar Interbody Fusion System is substantially equivalent to the predicate device.