(97 days)
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No
The 510(k) summary describes a set of surgical instruments for bone biopsy and cement injection, with no mention of AI or ML capabilities.
No.
The device is described as a biopsy tool for diagnostic purposes and a cement dispenser for vertebral body augmentation, which are interventional procedures rather than therapeutic in the sense of continuously treating a condition.
Yes
The device is described as "intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes".
No
The device description explicitly states it consists of "surgical instruments" and describes "cadaver testing," indicating it is a physical medical device, not software only.
Based on the provided information, the K2M Fenestrated Tap System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- K2M Fenestrated Tap System Function: The description clearly states the system is a surgical instrument used to:
- Remove a sample of bone tissue: This is a biopsy tool, which is a surgical procedure to obtain a sample, not a test performed on a sample.
- Provide and maintain access to a surgical site: This is a surgical access tool.
- Dispense cement: This is a surgical delivery tool.
While the system is used to obtain a sample for diagnostic purposes (the bone biopsy), the system itself is the tool used to obtain the sample, not the diagnostic test performed on the sample. The diagnostic testing would be performed separately in a laboratory setting on the bone tissue sample obtained using this system.
Therefore, the K2M Fenestrated Tap System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site.
When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared for use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.
Product codes
KNW, OAR
Device Description
The K2M Fenestrated Tap System consists of surgical instruments designed to access vertebral bodies via a posterior surgical approach.
Function: The K2M Fenestrated Tap System can be used to access the vertebral body for obtaining bone biopsies. This system can also be used for the injection of bone cement into the vertebral body using vertebroplasty or kyphoplasty procedures.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
vertebral body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The functional characteristics were evaluated in cadaver testing and the K2M Fenestrated Tap System was determined achieve its intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three faces in profile, representing the department's focus on health and human well-being. The logo is simple, using only black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 5, 2016
K2M, Incorporated Ms. Nancv Giezen Manager, Regulatory Affairs 751 Miller Drive Southeast Leesburg, Virginia 20175
Re: K152872
Trade/Device Name: K2M Fenestrated Tap System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW, OAR Dated: November 24, 2015 Received: November 25, 2015
Dear Ms. Giezen:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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/Resourcesfor You/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,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510{k} Number (if known) K152872
Device Name K2M Fenestrated Tap System
Indications for Use (Describe)
The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site.
When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared for use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.
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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510(k) SUMMARY K2M Fenestrated Tap System
Submitter
K2M, Inc. 751 Miller Drive SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: 703-777-3155 Date Prepared: 12/02/2015
Classification
Trade Name: Common Name: Regulatory Class:
K2M Fenestrated Tap System Spinal Fixation System Class II
Classification Name(s): Gastroenterology-Urology Biopsy Instrument (21 CFR 876.1075, Product Code KNW) Cement Dispenser (21 CFR 888.4200, Product Code OAR)
Predicate Device(s)
Primary Predicate: Abbott Spinnaker (K052638)
Device Description
The K2M Fenestrated Tap System consists of surgical instruments designed to access vertebral bodies via a posterior surgical approach.
Function: The K2M Fenestrated Tap System can be used to access the vertebral body for obtaining bone biopsies. This system can also be used for the injection of bone cement into the vertebral body using vertebroplasty or kyphoplasty procedures.
Intended Use
The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site.
When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared for use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.
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Technological Comparison to Predicate(s)
The K2M Fenestrated Tap System was compared to predicate systems and design features such as the materials, number of fenestrations, diameters and thread lengths were found to be substantially the same as these systems.
Non-clinical Performance Evaluation
The functional characteristics were evaluated in cadaver testing and the K2M Fenestrated Tap System was determined achieve its intended use.
Conclusion
There are no significant differences between the K2M Fenestrated Tap System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices when comparing materials, number of fenestrations, diameters and thread lengths. In addition the K2M Fenestrated Tap System is being offered for the same intended use as the predicates and was validated via cadaver testing.