(104 days)
Not Found
No
The summary describes a mechanical device for bone fracture reduction and void creation, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is intended for the "reduction of fractures and/or creation of a void in cancellous bone," which indicates a therapeutic purpose.
No
The device is a bone tamp used for fracture reduction and creating voids in bone, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (shaft, Y-Adapter, inflatable balloon) and the performance studies involve mechanical and functional testing of these physical components, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in vivo (within the body) for reducing fractures and creating voids in bone. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical device with a shaft, Y-adapter, and inflatable balloon, designed for surgical procedures. This is consistent with a medical device used directly on a patient, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on laboratory testing.
Therefore, the KYPHON Xpander™ II Inflatable Bone Tamp is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The KYPHON Xpander™ II Inflatable Bone Tamp 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 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
Device Description
The KYPHON Xpander™ II Inflatable Bone Tamps are designed for reduction of fractures. The main components are the shaft, Y-Adapter 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)
The KYPHON Xpander™ II Inflatable Bone Tamps met the Testing: specifications and performance characteristics and are substantially equivalent to the predicate devices. The testing included functional testing, such as balloon compliance, deflation time, insertion/withdrawal force and fatigue testing as well as mechanical testing, such as tensile strength and torsional strength testing.
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.
KyphX® Xpander Inflatable Bone Tamp (K041454)
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
K101864
OCT 1 4 2010
Pre-Market Notification [510(k)] SUMMARY
| Summary Date: | September 29, 2010 |
|---|---|
| Trade Name: | KYPHON Xpander TM II Inflatable Bone Tamp |
| Common Name: | Inflatable Bone Tamp |
| Classification Names: | Arthroscope (21CFR888.1100) |
| Orthopedic Manual Surgical Instrument (21CFR 888.4540) | |
| Device Codes: | HRX, HXG |
| Regulatory Class: | Class II |
| Manufacturer's Name: | Medtronic Spine LLC |
| Manufacturer's Address: | 1221 Crossman Avenue |
| Sunnyvale, CA 94089 | |
| Establishment Registration No. 2953769 | |
| Contact Person: | Heinz J. Steneberg |
| Senior Regulatory Affairs Program Manager | |
| Telephone: 408-548-6500 | |
| Fax: 408-548-6501 | |
| Performance Standards: | The requirements of the Food Drug and Cosmetic Act, under |
| section 514 for performance standards, are not applicable to the | |
| KYPHON Xpander TM II Inflatable Bone Tamps. | |
| Predicate Devices: | KyphX® Xpander Inflatable Bone Tamp (K041454) |
| Intended Use: | The KYPHON Xpander TM II Inflatable Bone Tamp 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 balloon kyphoplasty with a legally | |
| marketed PMMA-based bone cement that is cleared for use in | |
| kyphoplasty procedures) hand, tibia, radius and calcaneus. |
:
.
1
| Device Description: | The KYPHON Xpander™ II Inflatable Bone Tamps are designed for reduction of fractures. The main components are the shaft, Y-Adapter and the inflatable balloon located at the distal tip. |
|---|---|
| --------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
The KYPHON Xpander™ II Inflatable Bone Tamps met the Testing: specifications and performance characteristics and are substantially equivalent to the predicate devices. The testing included functional testing, such as balloon compliance, deflation time, insertion/withdrawal force and fatigue testing as well as mechanical testing, such as tensile strength and torsional strength testing.
Biocompatibility testing of the KYPHON Xpander™ Biocompatibility: II Inflatable Bone Tamps confirmed that the devices meet applicable requirements of the FDA Blue Book Memorandum #G95-1 entitled "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" and are biocompatible.
The KYPHON Xpander™ II Inflatable Bone Tamps will be Sterilization: provided sterile, for single-use only.
Packaging and Labeling: The KYPHON Xpander" II Inflatable Bone Tamps are packaged in a pouch made from polyamide, ultra-low density polyethylene and 1073B Tyvek® and a carton.
Substantial Equivalence: The information submitted in this premarket notification supports a determination that the KYPHON Xpander II Tamp is substantially equivalent Bone in Inflatable technological characteristics and intended use to the predicate devices. The products have the same fundamental scientific technology, basic design, functional characteristics and the same clinical application.
Submitted by:
Heinz J. Steneberg
MZ
Date Submitted:
September 29, 2010
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medtronic Spine LLC % Mr. Heinz J. Steneberg Senior Regulatory Affairs Program Manager 1221 Crossman Avenue Sunnyvale, California 94089
OCT 1 4 2010
Re: K101864
Trade/Device Name: KYPHON Xpander™ II Inflatable Bone Tamp Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, HXG Dated: September 08, 2010 Received: September 09, 2010
Dear Mr. Steneberg:
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
3
Page 2 - Mr. Heinz J. Steneberg
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 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/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,
ely yours,
Far
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K101864
OCT. 14 2010
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: KYPHON Xpander™ II Inflatable Bone Tamp
Indications for Use:
The KYPHON Xpander™ II Inflatable Bone Tamp 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 balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures) hand, tibia, radius and calcaneus.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (Over-The-Counter Use_
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature Sign-Off
n Sign-O (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number -
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