(56 days)
Not Found
No
The description focuses on the mechanical function and design of the bone tamp, with no mention of AI or ML capabilities.
No
The device is described as a bone tamp for reducing fractures and creating voids, which is a surgical tool, not a therapeutic device meant to provide therapy over time, but rather perform an acute mechanical function.
No
The device is described as a bone tamp used for the reduction of fractures and/or creation of a void in cancellous bone. Its function is interventional (mechanical), not diagnostic (identifying a disease or condition).
No
The device description clearly details a physical, inflatable bone tamp with a catheter shaft, lumens, and a balloon component. This is a hardware device, not software.
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.
- KyphX Device Function: The KyphX Directional Inflatable Bone Tamps are surgical tools used within the body to manipulate bone tissue during procedures. They are not used to analyze samples taken from the body.
The description clearly indicates its use in surgical procedures for fracture reduction and void creation in bone, which is an in-vivo (within the living body) application, not an in-vitro (in glass/outside the living body) diagnostic test.
N/A
Intended Use / Indications for Use
KyphX® Directional Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneous.
Product codes
HRX,HXG
Device Description
The KyphX Directional Inflatable Bone Tamps (IBTs) are designed to compress cancellous bone and/or move cortical bone as they inflate. The inflatable component of the IBT is near the distal tip of the device. The catheter shaft contains an outer lumen for IBT inflation and a central lumen for a stylet to facilitate catheter introduction. At full inflation volume, the balloon design allows directionality of inflation with a maximum inflated diameter that is perpendicular to the catheter shaft. One design has a uniform balloon that is concentric to the catheter shaft. Another design has a non-uniform balloon that is tangential to the catheter shaft. Directionality of the balloon is indicated by external markers on the proximal Y-adapter component. Each design enables fluoroscopic visualization of the deflated balloon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic visualization
Anatomical Site
spine, hand, tibia, radius and calcaneous
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)
Mechanical testing of the KyphX Directional Inflatable Bone Tamps verifies the devices meet the performance specifications of the IBT predicates.
The materials used in the construction of the KyphX Directional Inflatable Bone Tamps meet the requirements for "Externally Communicating Devices, Tissue/Dentin/Bone, Limited Contact" described in the FDA Blue Book Memorandum #G95-1, "Use of Standard ISO-10993, International Biological Evaluation of Medical Devices Part 1: Evaluation and Testing".
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/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
SEP 3 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cindy Domecus Vice President Clinical Research and Regulatory Affairs Kyphon Inc. 1221 Crossman Avenue Sunnyvale, California 94089
Re: K032212
Trade/Device Name: KyphX Directional Inflatable Bone Tamps Regulation Number: 21CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: July 16, 2003 Received: July 21, 2003
Dear Ms. Domecus:
This letter corrects our substantially equivalent letter of September 15, 2003.
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 (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.
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); 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.
1
Page 2- Ms. Cindy Domecus
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark McMahon
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Kyphon Inc
KyphX Directional Inflatable Bone Tamp - Traditional 510(k)
Tab 4
Indications For Use
510(k) Number: KO 3 2d 1 L
Device Name: KyphX® Directional Inflatable Bone Tamps
Indications for Use:
KyphX® Directional Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneous.
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Mulhern
miriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K032212
Prescription Use
(per 21 CFR 801.109) $\underline{V}$
OR
Over-The-Counter Use_
3
Kyphon Inc.
Kyphx Directional Inflatable Bone Tamp -- Traditional 510(k)
SEP 1 5 2003
Ko32212
Tab 5
Premarket Notification [510(k)] Summary
- July 16, 2003
| Trade Name: | Kyphx Directional Inflatable Bone Tamps |
|---|---|
| Common Name: | Inflatable Bone Tamp |
| Classification /Name: | Class II |
| Tamp: HXG; 21 CFR section 888.4540 | |
| Arthroscope: HRX; 21 CFR section 888.1100 | |
| Manufacturer's Name: | |
| Address: | Kyphon Inc. |
| 1350 Bordeaux Drive | |
| Sunnyvale, CA 94089 | |
| Corresponding Official: | Tim Reeves |
| Regulatory Affairs Manager | |
| Address: | 1350 Bordeaux Drive |
| Sunnyvale, CA 94089 | |
| Telephone: | 408-548-6500 |
| Predicate Device(s): | KyphX Inflatable Bone Tamp, K010246 |
| Kyphon Inflatable Bone Tamp, K981251 | |
| Device Description: | The KyphX Directional Inflatable Bone Tamps (IBTs) |
| are designed to compress cancellous bone and/or | |
| move cortical bone as they inflate. The inflatable | |
| component of the IBT is near the distal tip of the | |
| device. The catheter shaft contains an outer lumen | |
| for IBT inflation and a central lumen for a stylet to | |
| facilitate catheter introduction. At full inflation volume, | |
| the balloon design allows directionality of inflation with | |
| a maximum inflated diameter that is perpendicular to | |
| the catheter shaft. One design has a uniform balloon | |
| that is concentric to the catheter shaft. Another | |
| design has a non-uniform balloon that is tangential to | |
| the catheter shaft. Directionality of the balloon is | |
| indicated by external markers on the proximal Y- | |
| adapter component. Each design enables | |
| fluoroscopic visualization of the deflated balloon. |
4
K0322/2
Kyphon Inc.
Kyphx Directional Inflatable Bone Tamp - Traditional 510(k)
- KyphX Directional Inflatable Bone Tamps Intended Use: are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneous.
- The KyphX Directional Inflatable Bone Tamps are Sterilization: sterilized using gamma radiation and meet the requirement of ANSI/AAMI/ISO11137 for gammasterilized devices.
- Mechanical Tests: Mechanical testing of the KyphX Directional Inflatable Tamps verifies the devices meet Bone the performance specifications of the IBT predicates.
- Biocompatibility: The materials used in the construction of the KyphX Inflatable Bone Tamps meet Directional the requirements for "Externally Communicating Devices, Tissue/Dentin/Bone, Limited Contact" described in the FDA Blue Book Memorandum #G95-1, "Use of Standard ISO-10993, International Biological Evaluation of Medical Devices Part 1: Evaluation and Testing".
- The KyphX Directional Inflatable Bone Tamps meet Substantial Equivalence: physical and performance specifications the established for the IBT predicates. The products have the same fundamental scientific technology and intended use as the IBT predicates. The information submitted in this pre-market notification support a determination that the KyphX Directional Inflatable Bone Tamps are substantially equivalent to the IBT predicates.
As with Kyphon's cleared KyphX™ Inflatable Bone Tamp 510(k)s, K981251 and K102046, any statement regarding "substantial equivalence" made in this submission only relates to whether the product can be lawfully marketed without premarket approval or reclassification, and is not intended to be interpreted as an admission or any other type of evidence in patent infringement litigation. The present submission is therefore not related to the coverage of any patent or whether these products or their uses may be considered distinct from a patent point of view.
014