Osteo-site Vertebral Balloon
Device Facts
| Record ID | K200763 |
|---|---|
| Device Name | Osteo-site Vertebral Balloon |
| Applicant | Izi Medical |
| Product Code | HRX · Orthopedic |
| Decision Date | Aug 12, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.1100 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Osteo-site® Vertebral Balloon is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for Kyphoplasty.
Device Story
Osteo-site® Vertebral Balloon is a catheter-based device used in kyphoplasty procedures to reduce vertebral fractures and create a void in cancellous bone. The device consists of a Y-connector, catheter with mandrel, and a polyurethane balloon. The physician inserts the balloon into the vertebral body; contrast fluid is delivered through the luer connector and catheter to inflate the balloon, which compresses the cancellous bone. Radiopaque markers (platinum/iridium) on the mandrel and balloon provide imaging reference for placement. The mandrel controls longitudinal balloon expansion. The device is used in a clinical setting by a physician. The output is the physical creation of a void or reduction of a fracture, which facilitates subsequent bone cement injection. The device benefits patients by restoring vertebral height and stabilizing fractures.
Clinical Evidence
No clinical testing was conducted for this submission. Substantial equivalence is supported by bench testing, including unconstrained burst volume, constrained burst pressure, inflated balloon dimensions, deflation time, tensile force testing, and fatigue testing.
Technological Characteristics
Materials: Polyurethane balloon and catheter, platinum/iridium radiopaque markers. Design: Y-connector with luer fitting, mandrel-controlled longitudinal expansion. Dimensions: 15mm balloon, 240mm catheter. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Biocompatibility: Evaluated per ISO 10993-1 (cytotoxicity, irritation, sensitization, pyrogenicity, systemic toxicity).
Indications for Use
Indicated for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for Kyphoplasty in patients requiring such procedures.
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
- AVAMax Vertebral Balloon (K103064)
- Modified Winch Kyphoplasty (15 And 20 Mm) 11 Gauge Balloon Catheters (K172214)
Submission Summary (Full Text)
{0}------------------------------------------------
August 12, 2020
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring an abstract symbol. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
IZI Medical Products, LLC Qiang Cao Director of QA and RA 5 Easter Court, Suite J Owings Mills, Maryland 21117
Re: K200763
Trade/Device Name: Osteo-site® Vertebral Balloon Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, NDN Dated: June 29, 2020 Received: July 2, 2020
Dear Qiang Cao:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
{1}------------------------------------------------
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Laura C. Rose, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
#### Indications for Use
510(k) Number (if known) K200763
Device Name Osteo-site® Vertebral Balloon
#### Indications for Use (Describe)
The Osteo-site® Vertebral Balloon is intended to be used for the reduction and fixation of a void in cancellous bone in the spine for Kyphoplasty.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/2 description: The image shows the logo for IZI Medical. The logo consists of two overlapping hexagons, one orange and one yellow. To the right of the hexagons is the text "IZI Medical" in a simple, sans-serif font. The text is black and the logo is set against a white background.
#### Submitter
| Submitter Name: | IZI Medical Products LLC |
|----------------------|---------------------------------------------------|
| Submitter Address: | 5 Easter Court, Suite J<br>Owings Mills, MD 21131 |
| Telephone Number: | (410) 594-9403 |
| Fax Number: | (410) 594-0540 |
| Contact Person: | Qiang Cao |
| Registration Number: | 1123169 |
#### Device Name:
| Trade Name: | Osteo-site® Vertebral Balloon |
|--------------------------------|------------------------------------------------------------------|
| Common or Usual Name: | Vertebral Balloon |
| Primary Classification Name: | Cement, Bone Vertebroplasty (21 CFR §888.3027, Product Code NDN) |
| Secondary Classification Name: | Arthroscope (21 CFR §888.1100, Product Code HRX) |
# Predicate Devices:
- AVAMax Vertebral Balloon [K103064]
- . Modified Winch Kyphoplasty (15 And 20 Mm) 11 Gauge Balloon Catheters [K172214]
#### Device Description
The Osteo-site® Vertebral Balloon consists of a Y-connector with luer fitting, catheter with mandrel, and a balloon with radiopaque markers. The Y-connector is adhered to a strain relief fitting which is then adhered to the proximal end of the outer shaft. The mandrel ball is placed in a socket at the proximal end of the Y-connector that is coaxial to the catheter. The distal end of the catheter is welded to the proximal end of the balloon and the distal end of the mandrel is screwed into the distal end of the balloon. This construction allows for fluid to fill from the angled section of the Y-connector, around the mandrel, and into the balloon without obstruction. The mandrel can move freely longitudinally until the ball end meets the limits of the socket at the proximal end of the Y-connector. This controls the balloon expansion longitudinally. The radiopaque markers at the distal end of the mandrel are an imaging reference of balloon placement for the user. The proximal markers are visual indication of the balloon's placement. The exterior surface of the balloon is covered by a lubricant which eases access through the introducer cannula.
{4}------------------------------------------------
#### Indications for use
The Osteo-site® Vertebral Balloon is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for Kyphoplasty.
#### Technological Characteristics
The design and technological characteristics of the predicate AVAmax balloon are substantially equivalent to the proposed Osteo-site® Vertebral Balloon.
Both the proposed and predicate device use the same technological characteristics for creation of the void within bone. Both devices use radio fluorescent markers to identify placement of the device. In both cases contrast is used to inflate a polyurethane balloon in order to compress cancellous bone within the vertebral body. Lastly, in both cases the contrast is delivered through a luer connector at the proximal end of the balloon and the contrast flows along a catheter shaft until reaching the balloon at the distal end of the assembly.
| Technological Comparison | | | |
|--------------------------------------|-----------------------------------------|-------------------------------|--------------------------------------|
| Description | Osteo-site®<br>Vertebral Balloon | Predicate AVAmax<br>[K103064] | Predicate Modified<br>Winch [172214] |
| Prescription/over the<br>counter use | Prescription | Prescription | Prescription |
| Sterilization Method | EO | EO | EO |
| Balloon size | 15mm | 15mm | 15mm |
| Max Balloon Volume | 4mL | 4mL | 4mL |
| Max Inflation<br>Pressure | 400 psi | 400 psi | 400 psi |
| Siliconization | Yes | No | Yes |
| Packaging<br>configuration | Tyvek sealed tray<br>within Tyvek pouch | Tyvek sealed tray | Tyvek pouch |
| Markers | Platinum/Iridium | Platinum/Iridium | Platinum/Iridium |
| Catheter length | 240mm | 189mm | 241mm |
| Balloon Material | Polyurethane | Polyurethane | Polyurethane |
| Catheter Material | Polyurethane | Polyurethane | Polyurethane |
The design and technological characteristics of the predicate AVAmax and Modified Winch balloons are substantially equivalent to the proposed Osteo-site® Vertebral Balloon.
# Performance Testing
The following testing was conducted to prove substantial equivalence with the predicate device (AVAmax Vertebral Balloon [K103064]).
{5}------------------------------------------------
| Test Performed | Acceptance Criteria |
|---------------------------------------|---------------------------------------------------------------------------------------------|
| Unconstrained Burst Volume | Proposed device exceeds the predicates<br>maximum rated volume before burst<br>failure |
| Constrained Burst Pressure | Proposed device exceeds the predicates<br>maximum rated pressure while<br>constrained |
| Inflated Balloon Dimensions | Proposed inflated balloon dimensions are<br>similar to the predicate device |
| Deflation Time with Contrast Solution | Deflation time is similar to the predicate<br>device of the same size and volume<br>profile |
| Tensile Force Testing | Device material and bond strengths are<br>similar to the predicate device. |
| Fatigue Testing | Proposed device must withstand three<br>cycles of inflation at max psi. |
No clinical testing was conducted for this submission.
# Sterilization and Shelf-Life
The device will be ETO sterilized. The Sterility Assurance Level (SAL) is 10 °.
The device has a shelf-life of 12 months based on an accelerated aging study.
# Biocompatibility
The biocompatibility evaluation for the Osteo-site® Vertebral Balloon was conducted in accordance with ISO-10993-1, Biological Evaluation of Medical Devices. Testing included the following:
- Cytotixicity ●
- Irritation ●
- Sensitization
- Pyrogenicity ●
- . Systemic Toxicity
The Osteo-site® Vertebral Balloon is considered indirect blood contacting for a duration of less than 24 hours.
# Summary of Substantial Equivalence
Based on the indications for use, intended use, design, safety and performance testing, the proposed Osteo-site® Vertebral Balloon meets the requirements that are considered essential for its intended use and is substantially equivalent to the Predicate Devices, AVAmax Vertebral
{6}------------------------------------------------
Balloon [K103064] and Modified Winch Kyphoplasty (15 And 20 Mm) 11 Gauge Balloon Catheters [K172214].
