(70 days)
No
The summary describes a passive implant (lumbar spacer) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The K7 Lumbar Spacers are implanted devices intended for intervertebral body fusion of the lumbar spine to treat degenerative disc disease, which is a therapeutic purpose.
No
Explanation: The device is an intervertebral body fusion device (spacer) used for the treatment of degenerative disc disease and spondylolisthesis, not for diagnosis.
No
The device description clearly states that the K7 Lumbar Spacers are a collection of radiolucent interbody devices, which are physical implants, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the K7 Lumbar Spacers are for intervertebral body fusion of the lumbar spine. This is a surgical procedure involving the implantation of a device into the body.
- Device Description: The device is described as a collection of radiolucent interbody devices with specific shapes and features designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. The K7 Lumbar Spacers are used in vivo (inside the body) as an implant.
N/A
Intended Use / Indications for Use
The K7 Lumbar Spacers are 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. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and with autograft to facilitate fusion
Product codes
MAX
Device Description
The K7 Lumbar Spacers are a collection of radiolucent interbody devices having variously shaped cross-sections. The superior and inferior surfaces are open with parallel serrations to facilitate implant stability. The implants are available in an assortment of height, length, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements.
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)
Mechanical testing of the worst case K7 Lumbar Spacer was performed according to ASTM F2077 and included static and dynamic compression. The subsidence properties were evaluated according to ASTM F2267. The mechanical test results demonstrate that the K7 Lumbar Spacers performance is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Eminent Spine, Eminent Spine Interbody Fusion System (K090064), DePuy AcroMed, Lumbar I/F Cage® (P960025), DePuy Spine, Cougar LS Lateral Cage System (K090899, K110454), Choice Spine LP, ORIA Natura® (K073669), K2M, Aleutian® IBF System (K082698, K101302 and K110843), Stryker Spine, AVS® PEEK Spacers (K073470, K082014, K101051), Icotec, ETurn Spinal Implant (K100305)
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
:
.
| 510(k) Summary | ||
|---|---|---|
| Date: | 26 September 2013 | DEC - 9 2013 |
| Sponsor: | K7 LLC | |
| 54 Moonrise Way | ||
| Henderson, NV 89074 | ||
| Phone: 817.219.4441 | ||
| Facsimile: 817.326.5524 | ||
| Contact Person: | Michael D. Smith, Manager | |
| Trade Names: | K7 Lumbar Spacers | |
| Device Classification | Class II | |
| Classification Name: | Intervertebral fusion device with bone graft, lumbar | |
| Regulation: | 888.3080 | |
| Device Product | ||
| Code: | MAX | |
| Device Description: | The K7 Lumbar Spacers are a collection of radiolucent interbody | |
| devices having variously shaped cross-sections. The superior and | ||
| inferior surfaces are open with parallel serrations to facilitate implant | ||
| stability. The implants are available in an assortment of height, | ||
| length, width and anteroposterior angulation combinations to | ||
| accommodate a variety of anatomic requirements. | ||
| Intended Use: | The K7 Lumbar Spacers are 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. DDD is defined as back pain of | ||
| discogenic origin with degeneration of the disc confirmed by history | ||
| and radiographic studies. The device is intended for use with | ||
| supplemental fixation and with autograft to facilitate fusion | ||
| Materials: | K7 Lumbar Spacers are manufactured from polyetheretherketone | |
| (PEEK) per ASTM F2026 (VESTAKEEP® i4 R, Evonik Polymers | ||
| Technologies GmbH). Integral marker pins are manufactured from | ||
| tantalum according to ASTM F560. | ||
| Predicate Devices: | Eminent Spine, Eminent Spine Interbody Fusion System (K090064) | |
| DePuy AcroMed, Lumbar I/F Cage® (P960025) | ||
| DePuy Spine, Cougar LS Lateral Cage System (K090899, K110454) | ||
| Choice Spine LP, ORIA Natura® (K073669) | ||
| K2M, Aleutian® IBF System (K082698, K101302 and K110843) | ||
| Stryker Spine, AVS® PEEK Spacers (K073470, K082014, K101051) | ||
| Icotec, ETurn Spinal Implant (K100305) |
.
. . . .
.
.
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:
1
Performance Data: Mechanical testing of the worst case K7 Lumbar Spacer was performed according to ASTM F2077 and included static and dynamic compression. The subsidence properties were evaluated according to ASTM F2267. The mechanical test results demonstrate that the K7 Lumbar Spacers performance is substantially equivalent to the predicate devices. Technological The K7 Lumbar Spacers possess the same technological Characteristics: characteristics as the predicate devices. These include: intended use (as described above), . . basic design (hollow column), material (PEEK polymer and tantalum), and . sizes (widths, lengths and heights are within the range(s) . offered by the predicate systems).
Therefore the fundamental scientific technology of the K7 Lumbar Spacers is the same as previously cleared devices.
The K7 Lumbar Spacers possess the same intended use and technological characteristics as the predicate devices. Therefore the K7 Lumbar Spacer system is substantially equivalent for its intended use.
Conclusion:
Page 119
2
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 9. 2013
K7. LLC % BackRoads Consulting, Incorporated Karen E. Warden. Ph.D. 8202 Sherman Road Chesterland, Ohio 44026
Re: K133126
Trade/Device Name: K7 Lumbar Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 26, 2013 Received: September 30, 2013
Dear Dr. Warden:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Karen E. Warden, Ph.D.
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 Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21 CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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,
Ronalde Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 7 - Indications for Use Statement
510(k) Number:_K133126
Device Name: K7 Lumbar Spacers
Indications for Use:
The K7 Lumbar Spacers are 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. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and with autograft to facilitate fusion.
Prescription Use X OR Over-the-Counter Use_ ________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices