(63 days)
Not Found
No
The summary describes a physical intervertebral fusion device and its mechanical testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as an intervertebral fusion device used to treat degenerative disc disease, which falls under the definition of a therapeutic device.
No
This device is a cervical intervertebral fusion device, which is an implant used for treatment, not diagnosis. Its purpose is to provide stability and facilitate fusion in the spine.
No
The device description clearly states it is 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 K7C™ spacers are used as a cervical intervertebral fusion device for the treatment of degenerative disc disease. This is a surgical implant used within the body.
- Device Description: The description details a physical implant designed to be placed in the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens 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. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
When used as a cervical intervertebral fusion device, the K7C™ spacers are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The K7C™ Spacer is a collection of radiolucent interbody devices having a keystone-shaped cross-section. 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
cervical spine, from C2-T1
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 K7C™ spacer was performed according to ASTM F2077 and included static and dynamic compression and static and dynamic torsion. The subsidence properties were evaluated according to ASTM F2267. The mechanical test results demonstrate that the K7C™ Spacers perform as well as or better than the predicate devices. Hence these devices are as safe and as effective as the predicates.
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.
K090064, P980048, K043479, K091088, K082698, K101302, K103169
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
510(k) Summary 8.
.
:
| Date: | 31 October 2012 |
|---|---|
| Sponsor: | K7 LLC |
| 54 Moonrise Way | |
| Henderson, NV 89074 | |
| Phone: 817.219.4441 | |
| Facsimile: 817.326.5524 | |
| JAN 0 4 2013 | |
| Contact Person: | Michael D. Smith, Manager |
| Trade Names: | K7C™ Spacer |
| Device Classification | Class II |
| Classification Name: | Intervertebral fusion device with bone graft, cervical |
| Regulation: | 888.3080 |
| Device Product | |
| Code: | ODP |
| Device Description: | The K7C™ Spacer is a collection of radiolucent interbody devices |
| having a keystone-shaped cross-section. 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: | When used as a cervical intervertebral fusion device, the K7C |
| spacers are indicated for use at one level in the cervical spine, from | |
| C2-T1, in skeletally mature patients who have had six weeks of non- | |
| operative treatment for the treatment of degenerative disc disease | |
| (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck | |
| pain of discogenic origin with degeneration of the disc confirmed by | |
| history and radiographic studies. The device is intended for use with | |
| autogenous bone graft and with supplemental fixation systems | |
| cleared for use in the cervical spine. | |
| Materials: | K7C™ 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 (K090064) |
| CenterPulse Spine-Tech (P980048) | |
| MC+ (K043479 and K091088) | |
| K2M, Inc. (K082698, K101302 and K103169) | |
| Technological | |
| Characteristics: | The K7C™ Spacers possess the same technological characteristics |
| as the predicate devices. These include: | |
| • intended use (as described above), | |
| • basic design (hollow column), | |
| • material (polymer), and | |
| • sizes (widths, lengths and heights are within the range(s) | |
| offered by the predicate systems). |
Spacers is the same as previously cleared devices.
1
Performance Data:
Mechanical testing of the worst case K7C™ spacer was performed according to ASTM F2077 and included static and dynamic compression and static and dynamic torsion. The subsidence properties were evaluated according to ASTM F2267. The mechanical test results demonstrate that the K7C™ Spacers perform as well as or better than the predicate devices. Hence these devices are as safe and as effective as the predicates.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing or being protected by a wing-like shape.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 4, 2013
K7, LLC % BackRoads Consulting, Incorporated Karen Warden, Ph.D. Representative/Consultant P.O. Box 566 Chesterland. Ohio 44026
Re: K123388
Trade/Device Name: K7CTM Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: October 31, 2012 Received: November 2, 2012
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. Iisting 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
3
Page 2 - Karen Warden, Ph.D.
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Image /page/3/Picture/7 description: The image shows the name "Erin DKeith" in a stylized font. The letters are bold and black, with a unique design that makes them stand out. The name appears to be a logo or a signature, possibly for a business or individual. The font is modern and eye-catching.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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7. Indications for Use Statement
510(k) Number: K123388
Device Name: K7C™ Spacer
Indications for Use:
When used as a cervical intervertebral fusion device, the K7C™ spacers are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine.
Prescription Use X (Per 21 CFR 801.109) OR
Over-the-Counter Use_____________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123388