(41 days)
K100042, P960025
No
The summary describes a physical implant and associated instruments for spinal fusion, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is an intervertebral body fusion system, which is an implant designed to facilitate fusion, not a therapeutic device that delivers treatment.
No
Explanation: The document describes a surgical implant used for spinal fusion and related instruments, not a device that diagnoses medical conditions.
No
The device description explicitly details physical components made of PEEK and tantalum, along with surgical instruments made of stainless steel. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, 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 the Integrity Spine Lumbar Interbody Fusion System is an implantable device used for spinal fusion surgery. It is a physical device inserted into the body to provide structural support and facilitate bone growth.
- Lack of Diagnostic Function: The device does not perform any tests on bodily samples, nor does it provide diagnostic information about a patient's condition based on such tests. Its function is purely therapeutic and structural.
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 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 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.
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) mav be implanted:
- bi-laterally in pairs via a posterior (PLIF) approach;
- as a single device via an oblique (OLIF) approach: a
- 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.
The Integrity Spine System is comprised of various device configurations based on surgical 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.
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
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)
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
Key Results: 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K100042, P960025
Reference Device(s)
K090064, P970015, K082310, K130573, K092193
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
§ 890.5950 Powered heating unit.
(a)
Identification. A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to convey the department's mission of protecting and promoting the health and well-being of Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JAN 1 0 2017
Mr. Robert Kelly C Change Surgical, LLC 101 N. Chestnut Street, Suite 301 Winston-Salem, NC 27101
Re: K051819
Trade/Device Name: C Change Solution Warmer Regulation Number: 21 CFR 890.5950 Regulation Name: Powered Heating Unit Regulatory Class: Class I Product Code: LHC Dated: July 1, 2005 Received: July 7, 2005
Dear Mr. Kelly:
This letter corrects our substantially equivalent letter of August 15, 2005.
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 Parts 801 and 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
1
Page 2 - Mr. Robert Kelly
as set forth in the quality systems (OS) 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 Parts 801 and 809), 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.
Erin I. Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
. .
510(k) Number (if known): _ KOSIBIS -
C Change Solution Warmer Device Name: _
Indications for Use:
The C Change Solution Warmer is designed to warm and maintain the temperature of surgical solutions prior to their use.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Haubara Buchep for Mellekerson
Division of General, Restorative, and Neurological Devices
Page _ 1_ of _1
510(k) Number K051819.
3
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
Ipeterson@kaedonconsulting.com |
| DATE PREPARED | October 12, 2015 |
| CLASSIFICATION NAME | Intervertebral Body Fusion Device |
| DEVICE CLASS | Class II |
| REGULATION NUMBER | 888.3080 (Product Code MAX) |
| COMMON NAME | Intervertebral Fusion Device with Bone Graft, Lumbar |
| PROPRIETARY NAME | Integrity Spine Lumbar Interbody Fusion System |
4
IDENTIFICATION OF PREDICATE DEVICE(S)
Predicate devices include various cleared interbody fusion systems:
Primary
- 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 ı (K090064)
- Medtronic: InterFix System (P970015) ,
- SeaSpine: SeaSpine Spacer System (K082310) .
- Tyber Medical: Tyber Medical Interbody System ﺎ (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) mav be implanted:
- bi-laterally in pairs via a posterior (PLIF) approach;
- as a single device via an oblique (OLIF) approach: a
- 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 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 surgical 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 contiguous 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 ー
- Static and dynamic torsion testing, conducted in accordance with ASTM F2077-11 l
- 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.