KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A

K032212 · Kyphon, Inc. · HRX · Sep 15, 2003 · Orthopedic

Device Facts

• Record ID: K032212
• Device Name: KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A
• Applicant: Kyphon, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Sep 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Device is an inflatable bone tamp (IBT) used to compress cancellous bone or move cortical bone. Features a catheter shaft with an outer inflation lumen and a central stylet lumen. Distal tip contains an inflatable balloon; designs include uniform (concentric) or non-uniform (tangential) configurations. Directionality is indicated by external markers on the proximal Y-adapter. Operated by physicians under fluoroscopic visualization. Used in clinical settings to create voids or reduce fractures; benefits include controlled bone compression and fracture reduction. Device is manual; no software or automated processing.

Clinical Evidence

Bench testing only. Mechanical testing verified performance specifications against predicate devices. Biocompatibility testing performed per ISO-10993 requirements for limited contact, tissue/bone communicating devices.

Technological Characteristics

Inflatable bone tamp; catheter shaft with dual lumens (inflation and stylet). Materials meet ISO-10993 requirements for limited contact, tissue/bone communicating devices. Sterilized via gamma radiation per ANSI/AAMI/ISO 11137. Manual operation; no electronic or software components.

Indications for Use

Indicated for patients requiring reduction of fractures or creation of a void in cancellous bone in the spine, hand, tibia, radius, and calcaneus.

Regulatory Classification

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.

Predicate Devices

• KyphX Inflatable Bone Tamp (K010246)
• Kyphon Inflatable Bone Tamp (K981251)

Submission Summary (Full Text)

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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.

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#### 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 [phone]. 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 [phone] or [phone] 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

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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_

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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<br>Arthroscope: HRX; 21 CFR section 888.1100 |
| Manufacturer's Name:<br>Address: | Kyphon Inc.<br>1350 Bordeaux Drive<br>Sunnyvale, CA 94089 |
| Corresponding Official: | Tim Reeves<br>Regulatory Affairs Manager |
| Address: | 1350 Bordeaux Drive<br>Sunnyvale, CA 94089 |
| Telephone: | 408-548-6500 |
| Predicate Device(s): | KyphX Inflatable Bone Tamp, K010246<br>Kyphon Inflatable Bone Tamp, K981251 |
| Device Description: | The KyphX Directional Inflatable Bone Tamps (IBTs)<br>are designed to compress cancellous bone and/or<br>move cortical bone as they inflate. The inflatable<br>component of the IBT is near the distal tip of the<br>device. The catheter shaft contains an outer lumen<br>for IBT inflation and a central lumen for a stylet to<br>facilitate catheter introduction. At full inflation volume,<br>the balloon design allows directionality of inflation with<br>a maximum inflated diameter that is perpendicular to<br>the catheter shaft. One design has a uniform balloon<br>that is concentric to the catheter shaft. Another<br>design has a non-uniform balloon that is tangential to<br>the catheter shaft. Directionality of the balloon is<br>indicated by external markers on the proximal Y-<br>adapter component. Each design enables<br>fluoroscopic visualization of the deflated balloon. |

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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.

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