Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml
Device Facts
| Record ID | K150607 |
|---|---|
| Device Name | Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml |
| Applicant | Osseon, LLC |
| Product Code | NDN · Orthopedic |
| Decision Date | Apr 9, 2015 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 888.3027 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Osseoflex® SB is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal polymethymethacrylate (PMMA) bone cements for use during percutaneous vertebral augmentation, such as kyphoplasty.
Device Story
Osseoflex SB is an inflatable bone tamp used in balloon kyphoplasty. Device consists of a balloon catheter inserted into the vertebral body via a pre-existing access channel. Physician inflates the distal balloon using a contrast medium to create a cavity and reduce vertebral fractures. Once the void is created, the balloon is deflated and removed; the physician then injects PMMA bone cement through an Osseoflex needle to stabilize the fracture. Used in clinical settings by physicians. The device facilitates fracture reduction and provides a space for cement interdigitation, potentially restoring vertebral height and alleviating pain.
Clinical Evidence
Bench testing only. Tests included balloon profile, working length, balloon compliance, maximum pressure (27 atm/400 psi), bond tensile strength (ISO 10555 standard), maximum volume, fatigue (20 cycles), and inflation/deflation time (< 5 seconds). All tests met or exceeded acceptance criteria.
Technological Characteristics
Inflatable bone tamp; balloon material: polyurethane; inflation medium: 60% contrast; max pressure: 400 psi (27 ATM); max inflation volume: 2ml or 4ml; balloon shapes: spherical or cylindrical; dimensions: 14-18mm diameter, 14-21mm length; stylet type: straight; sterilization: not specified; connectivity: none.
Indications for Use
Indicated for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during percutaneous vertebral augmentation (e.g., kyphoplasty) using cleared spinal PMMA bone cements.
Regulatory Classification
Identification
Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
Predicate Devices
- Osseoflex SB, 10 Gauge (K141930)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 9, 2015
Osseon LLC Mr. Keith Burger Director of Research and Development 2330 Circadian Way Santa Rosa, California 95407
Re: K150607
Trade/Device Name: Osseoflex SB Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: March 6, 2015 Received: March 10, 2015
Dear Mr. Burger:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Keith Burger
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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 vours.
# Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
510(k) Number (if known) K150607
Device Name Osseoflex SB
Indications for Use (Describe)
The Osseoflex® SB is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal polymethymethacrylate (PMMA) bone cements for use during percutaneous vertebral augmentation, such as kyphoplasty.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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## 9.0 510(K) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
#### I. SUBMITTER
Osseon LLC 2305 Circadian Way Santa Rosa, CA 95407
Phone: 707-636-5940 Fax: 707-636-5941
Contact Person: Keith Burger, Director of Research and Development Date Prepared: April 7, 2015
#### II. DEVICE
Name of Device: Osseoflex SB Common or Usual Name: Inflatable Bone Tamp Classification Name: Primarily - Arthroscope; Secondarily - Cement, Bone Vertebroplasty Regulatory Class: Class II per 21CFR §888.1100; Class II per 21CFR §888.3027 Product Code: NDN; HRX
#### III. PREDICATE DEVICE
Osseoflex SB, 10 Gauge K141930, August 21, 2014
#### DEVICE DESCRIPTION IV.
The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA is injected through an Osseoflex® needle to fill the previously created void(s).
An access channel is required for Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device.
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#### INDICATIONS FOR USE V.
The Osseoflex® SB is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal polymethymethacrylate (PMMA) bone cements for use during percutaneous vertebral augmentation, such as kyphoplasty.
### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
| Summary of Technological Characteristics of the Additional Size | | | | |
|-----------------------------------------------------------------|--------------------------|--------------------------|--------------------------|--------------------------|
| Compared to the Current Size (Predicate) | | | | |
| Characteristic | Line Extension | | Current Size (Predicate) | |
| Trade Name, Model | Osseoflex SB,<br>OT-0224 | Osseoflex SB,<br>OT-0222 | Osseoflex SB,<br>OF-0224 | Osseoflex SB,<br>OF-0222 |
| Cannula size | 10G | | | |
| Max inflation volume | 4ml | 2ml | 4ml | 2ml |
| Balloon Inflation Medium | 60% Contrast | | | |
| Balloon Material | Polyurethane | | | |
| Balloon Diameter at nominal<br>volume | 18 mm | 14 mm | 18 mm | 14 mm |
| Balloon Length at nominal<br>volume | 21 mm | 14 mm | 21 mm | 14 mm |
| Balloon Shape | Cylindrical | Spherical | Cylindrical | Spherical |
| Max inflation pressure | 400 psi (27 ATM) | | | |
| Device Modification | Straight<br>Stylet | Straight<br>Stylet | Steerable<br>Stylet | Steerable<br>Stylet |
The overall materials, specifications and manufacturing processes for the current device to the line extension device have not changed.
The only difference is the replacement of the steerable stylet in the current device with a straight stylet in the modified device.
#### VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
| Bench Tests Performed | Acceptance Criteria |
|-------------------------------------------------------|---------------------------------------------------------------------------------------|
| Balloon Profile and Tamp<br>(Catheter) Working Length | • Balloon profile ≤ 2.79 mm (0.109 in)<br>• Balloon catheter working length > 16.5 cm |
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| (TM-003) | |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Balloon Compliance (TM-004): | Balloon working length (L) $\leq$ 24 mm Balloon diameter (D) $\leq$ 19 mm |
| Maximum Pressure (TM-006) | The inflatable bone tamp exceeds the maximum inflation pressure, 27 atm (~400 psi) without failure. |
| Bond Tensile Strengths (TM-007) | Bond tensile strength $\geq$ 15 N (3.37 lbf). The tensile force specification was adopted directly from ISO 10555 (Single Use Intravascular Catheters) requirements. This tensile force maybe applied to the device during use when the balloon is deflated and retracted back through the access cannula. |
| Balloon Maximum Volume (TM-008) | Maximum inflation volume to be greater than the maximum recommended volume with 95% confidence and 90% reliability. |
| Balloon Fatigue, Unconstrained (TM-009) | Inflate to maximum recommended volume of, hold for 30 seconds / deflate; without leaks for 20 cycles. |
| Balloon Inflation, Deflation Time (TM-010) | Deflation times to be < 5 seconds with 90/90% confidence/ reliability. |
#### CONCLUSION VIII.
The results of the non-clinical tests show that the Osseoflex SB, 10 Gauge Straight Balloon meets or exceed all performance requirements, and are substantially equivalent to the predicate device.
