(104 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the KYPHON Xpander™ II Inflatable Bone Tamp, based on the provided text:
Important Note: This device is a physical medical instrument (inflatable bone tamp), not an AI/software device. Therefore, many of the questions related to AI performance metrics (like human reader improvement with AI, standalone AI performance, training/test set provenance, expert ground truth for imaging, MRMC studies) are not applicable to this type of submission. The provided text details engineering and biocompatibility testing, not clinical performance studies involving interpretation of data by humans or AI.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Test | Reported Device Performance |
|---|---|---|
| Functional Testing | Balloon compliance | Met specifications and performance characteristics |
| Deflation time | Met specifications and performance characteristics | |
| Insertion/withdrawal force | Met specifications and performance characteristics | |
| Fatigue testing | Met specifications and performance characteristics | |
| Mechanical Testing | Tensile strength testing | Met specifications and performance characteristics |
| Torsional strength testing | Met specifications and performance characteristics | |
| Biocompatibility | Compliance with ISO-10993 (Part 1) | Confirmed that the devices meet applicable requirements and are biocompatible |
| Sterilization | Provided sterile, for single-use only | Will be provided sterile, for single-use only (statement of intent and process) |
| Packaging & Labeling | Proper packaging in specified materials | Packaged in a pouch (polyamide, ultra-low density polyethylene, 1073B Tyvek®) and a carton. |
| Substantial Equivalence | Same fundamental scientific technology as predicate | Confirmed |
| Same basic design as predicate | Confirmed | |
| Same functional characteristics as predicate | Confirmed | |
| Same clinical application as predicate | Confirmed |
Study Details (Applicable to this device type)
-
Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for each individual test (e.g., how many tamps were subjected to fatigue testing, how many units were tested for balloon compliance).
- The testing described is in vitro (bench testing) and in vivo (biocompatibility). Data provenance would be from laboratory experiments conducted by the manufacturer. No country of origin for data is specified for these tests, though the manufacturer is US-based.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For this type of physical device, "ground truth" is established by engineering specifications, material standards, and validated test methods, not by expert consensus on clinical data interpretation. The "experts" would be the engineers, material scientists, and testers involved in conducting and verifying the performance tests, whose qualifications are inherent in their roles within a medical device manufacturer.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for disagreements in human interpretation of data/images, often in clinical or diagnostic studies. This is a report of engineering and biocompatibility testing. The "adjudication" for these tests comes from the test protocols, acceptance criteria, and quality control processes of the manufacturer.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a manual surgical instrument, not an AI or imaging-related device that would involve human readers or AI assistance in interpretation.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual surgical instrument and does not incorporate an algorithm or AI.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the functional and mechanical testing: Engineering specifications and validated test methods/standards. The device's performance is measured against predefined physical parameters and tolerances.
- For biocompatibility: International standard ISO-10993 (Part 1), which defines the biological evaluation of medical devices.
-
The sample size for the training set:
- Not applicable. There is no "training set" for this type of physical medical device. Training sets are relevant for machine learning algorithms.
-
How the ground truth for the training set was established:
- Not applicable. As above, no training set exists for this device.
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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 AvenueSunnyvale, CA 94089Establishment Registration No. 2953769 |
| Contact Person: | Heinz J. StenebergSenior Regulatory Affairs Program ManagerTelephone: 408-548-6500Fax: 408-548-6501 |
| Performance Standards: | The requirements of the Food Drug and Cosmetic Act, undersection 514 for performance standards, are not applicable to theKYPHON 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 intendedto be used as a conventional bone tamp for the reduction offractures and/or creation of a void in cancellous bone in thespine (including use during balloon kyphoplasty with a legallymarketed PMMA-based bone cement that is cleared for use inkyphoplasty procedures) hand, tibia, radius and calcaneus. |
:
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| 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
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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
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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
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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 -
Page ___ of_
§ 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.