(45 days)
Not Found
No
The document describes a mechanical device (inflatable bone tamp) and its intended use. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on mechanical testing and equivalence to a predicate device.
Yes
Explanation: The device is intended for the reduction of fractures and/or creation of a void in cancellous bone, which are therapeutic interventions.
No
The device is described as an inflatable bone tamp for reducing fractures and creating voids in bone, which are therapeutic functions, not diagnostic.
No
The device description clearly outlines physical components like a shaft, Y-Adapter, and inflatable balloon, indicating it is a hardware device, not software-only.
No, 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, tissue) to provide information about a person's health.
- Device Function: The KYPHON ELEMENT™ Inflatable Bone Tamp is a surgical tool used within the body to reduce fractures and create voids in bone. It is a mechanical device used for a surgical procedure, not for analyzing biological samples.
- Intended Use: The intended use clearly describes a surgical procedure involving bone manipulation, not diagnostic testing.
Therefore, based on the provided information, the KYPHON ELEMENT™ Inflatable Bone Tamp is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The KYPHON ELEMENT™ Inflatable Bone Tamp (IBT) is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during a balloon kyphoplasty procedure with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.
Product codes
HRX, HXG
Device Description
The KYPHON ELEMENT™ Inflatable Bone Tamp is designed for the reduction of fractures. The main components are a single lumen shaft, Y-Adapter with a port to connect the inflation syringe for inflation/deflation, and the inflatable balloon located at the distal tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine, hand, tibia, radius, and calcaneus
Indicated Patient Age Range
Not Found
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)
Assessment of the device modifications have been completed in accordance with Medtronic design control processes. The KYPHON ELEMENT™ Inflatable Bone Tamp has the same design characteristics, packaging, sterilization processes and is made of equivalent materials as the predicate, KYPHON® XPANDER® Inflatable Bone Tamps. Mechanical testing, biocompatibility testing and other verification activities were conducted to confirm that the modified device functions as intended and does not raise any new issues of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. 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 § 888.9.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that they appear to be emerging from a single point. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Incorporated Ms. Pamela Edwards Principal Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
July 23, 2015
Re: K151532
Trade/Device Name: KYPHON ELEMENT™ Inflatable Bone Tamp Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, HXG Dated: June 9, 2015 Received: June 10, 2015
Dear Ms. Edwards:
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
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.
For
Sincerely yours.
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151532
Device Name KYPHON ELEMENT™ Inflatable Bone Tamp
Indications for Use (Describe)
The KYPHON ELEMENT™ Inflatable Bone Tamp (IBT) is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during a balloon kyphoplasty procedure with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K)Summary
| I. SUBMITTER NAME & ADDRESSS: | Medtronic Sofamor Danek USA, Inc | ||
|---|---|---|---|
| 1800 Pyramid Place | |||
| Memphis, Tennessee 38132 | |||
| Telephone: (901) 396-3133 | |||
| Fax: (901) 346-9738 | |||
| Establishment Registration: 1030489 | |||
| CONTACT PERSON: | Pamela Edwards | ||
| Principal Regulatory Affairs Specialist | |||
| DATE PREPARED: | June 5, 2015 |
- II. PROPOSED PROPRIETARY TRADE NAME: KYPHON ELEMENT™ Inflatable Bone Tamp Arthroscope (21 CFR 888.1100) DEVICE CLASSIFICATION NAME/ Orthopedic Manual Surgical Instrument REGULATION NUMBER: (21 CFR 888.4540) PRODUCT CODE: HRX, HXG CLASSIFICATION: II
III. IDENTIFICATION OF LEGALLY MARKETED DEVICES:
| Table 1. Legally Marketed Devices | ||
|---|---|---|
| Device name | 510(k) number | Substantial Equivalence date |
| KYPHON® XPANDER® Inflatable Bone | ||
| Tamps | K041454 | 07/09/2004 |
IV. DEVICE DESCRIPTION:
The KYPHON ELEMENT™ Inflatable Bone Tamp is designed for the reduction of fractures. The main components are a single lumen shaft, Y-Adapter with a port to connect the inflation syringe for inflation/deflation, and the inflatable balloon located at the distal tip.
V. INDICATIONS FOR USE:
4
The KYPHON ELEMENT™ Inflatable Bone Tamp (IBT) is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during a balloon kyphoplasty procedure with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.
VI. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS:
The subject KYPHON ELEMENT™ Inflatable Bone Tamp has the same intended used, fundamental scientific technology, and sterilization as the predicate KYPHON® XPANDER® Inflatable Bone Tamps K041454 (S.E. 07/09/2004). The subject utilizes equivalent basic device design, materials and packaging.
VII. DISCUSSION OF NON-CLINICAL TESTING:
Assessment of the device modifications have been completed in accordance with Medtronic design control processes. The KYPHON ELEMENT™ Inflatable Bone Tamp has the same design characteristics, packaging, sterilization processes and is made of equivalent materials as the predicate, KYPHON® XPANDER® Inflatable Bone Tamps. Mechanical testing, biocompatibility testing and other verification activities were conducted to confirm that the modified device functions as intended and does not raise any new issues of safety or effectiveness.
VIII. CONCLUSION:
Documentation provided in this submission demonstrates that the subject device KYPHON ELEMENT™ Inflatable Bone Tamp is substantially equivalent to the previously cleared KYPHON® XPANDER® Inflatable Bone Tamps K041454 (S.E. 07/09/2004).The subject device is substantially equivalent to predicate in several categories including: intended use, performance specifications and fundamental technological characteristics .