(14 days)
Not Found
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, or any related computational processing.
Yes
The device is described as being used for "reduction of fractures and/or creation of a void in cancellous bone," which indicates a therapeutic purpose to treat a medical condition.
No
Explanation: The device is an inflatable bone tamp used for fracture reduction and creating a void in cancellous bone, which are therapeutic rather than diagnostic functions.
No
The device description clearly outlines physical components like a shaft, adapter, and inflatable balloon, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical tool used for reducing fractures and creating voids in bone. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a physical device with a balloon for inflation, designed for mechanical manipulation of bone.
- 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 treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The KYPHON Xpander™ II Inflatable Bone Tamps and Kyphon® Express™ II Inflatable Bone Tamps are 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 balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.
Product codes (comma separated list FDA assigned to the subject device)
HRX, HXG, NDN
Device Description
The Kyphon® Express™ II Inflatable Bone Tamps are designed for reduction of fractures. The main components are a coaxial dual 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
Prescription Use
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 and other verification/validation activities, including tolerance analyses 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): 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.
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
§ 888.1100 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
K12377
Kyphon® Express™ II Inflatable Bone Tamp 510(k) Summarv December 6, 2012
DEC 2 1 2012
| I. Company: | Medtronic Sofamor Danek
1800 Pyramid Place
Memphis, TN 38132
Telephone: (901) 396-3133
FAX: (901) 346-9738 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------|
| II. Contact: | Hetal Jawahar Thakker
Senior Regulatory Affairs Specialist |
| III. Proprietary Trade Name: | Kyphon® Express™ II Inflatable Bone Tamp |
| IV. Common Name: | Inflatable Bone Tamp |
| V. Classification Name: | Arthroscope (21CFR888.1100)
Orthopedic Manual Surgical Instrument (21CFR 888.4540) |
| Class: | II |
| Product Code: | HRX, HXG |
VI. Product Description
The Kyphon® Express™ II Inflatable Bone Tamps are designed for reduction of fractures. The main components are a coaxial dual lumen shaft. Y .- Adapter with a port to connect the inflation syringe for inflation/deflation, and the inflatable balloon located at the distal tip.
VII. Indications for Use
The KYPHON Xpander™ II Inflatable Bone Tamps and Kyphon® Express™ II Inflatable Bone Tamps are 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 balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.
VIII. Summary of Technological Characteristics
The fundamental scientific technology of the subject Kyphon® Express™ II Inflatable Bone Tamps is identical to the predicate KYPHON Xpander™ II Inflatable Bone Tamps.
Both the subject Kyphon® Express™ II Inflatable Bone Tamps and predicate KYPHON Xpander™ II Inflatable Bone Tamps consist of shaft, Y-Adapter and the inflatable balloon located at the distal tip. The Inflatable Bone Tamp is connected to an inflation syringe in order to inflate/deflate the balloon. Two radiopaque markers located at the distal and proximal end of the deflated balloon allow fluoroscopic visualization of the IBT during positioning prior to inflation. Once positioned, the balloon is inflated with contrast-media solution to create a cavity in the vertebral body, which may be subsequently filled with bone cement.
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IX. Identification of the Legally Marketed Predicate Device Used to Claim Substantial Equivalence
In order to demonstrate substantial equivalence to legally marketed predicate devices, KYPHON Xpander™ II Inflatable Bone Tamp (K101864, SE Oct 14, 2010) is used as the predicate for the Kyphon® Express™ II Inflatable Bone Tamps.
X. Brief Discussion of the Non-Clinical Tests Submitted
Assessment of the device modifications have been completed in accordance with Medtronic design control processes. The Kyphon® Express™ II Inflatable Bone Tamps have the same design characteristics, packaging, use the same sterilization process, and are made of equivalent materials as the predicate KYPHON Xpander™ II Inflatable Bone Tamps. Mechanical testing and other verification/validation activities, including tolerance analyses were conducted to confirm that the modified device functions as intended and does not raise any new issues of safety or effectiveness.
XI. Conclusions Drawn from the Non-Clinical Tests
The subject and predicate Inflatable Bone Tamps are identical in terms of indications for use, intended use, performance specifications, and fundamental technological characteristics. A risk analysis and associated verification/validation testing was completed for the device modifications. Based on the risk analysis and additional supporting documentation provided in this premarket notification. Medtronic believes the subject Kyphon® Express™ II Inflatable Bone Tamps to be substantially equivalent to the legally marketed predicate KYPHON Xpander™ II Inflatable Bone Tamps.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic % Medtronic Spine, LLC Hetal Jawahar Thakker Senior Regulatory Affairs Specialist 1221 Crossman Avenue Sunnyvale, California 94089
Re: K123771
Trade/Device Name: Kyphon® Express™ II Inflatable Bone Tamps Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, HXG, NDN Dated: December 6, 2012 Received: December 7, 2012
Dear Hetal Jawahar Thakker:
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
December 21, 2012
3
Page 2 - Hetal Jawahar Thakker
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Kyphon® Express™ II Inflatable Bone Tamps
Indications for Use:
The KYPHON Xpander™ II Inflatable Bone Tamps and Kyphon® Express™ II Inflatable Bone Tamps are 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 balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
(Division of Orthopedic Devices : iu(k) Number_ 1237