SHIELD KYPHOPLASTY SYSTEM

K093477 · Soteira, Inc. · NDN · Dec 8, 2011 · Orthopedic

Device Facts

• Record ID: K093477
• Device Name: SHIELD KYPHOPLASTY SYSTEM
• Applicant: Soteira, Inc.
• Product Code: NDN · Orthopedic
• Decision Date: Dec 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Soteira Shield Kyphoplasty System (SKS) is intended to provide control of cement flow during injection of PMMA bone cement that has been cleared for use in vertebral augmentation for the treatment of acute, persistently painful (after a minimum of 6 weeks of conservative care), stable, anterior column osteoporotic compression fractures (wedge or concave) of the vertebrae at levels T4 - L5 in the adult spine.

Device Story

The Shield Kyphoplasty System is a surgical kit used for vertebral augmentation. It includes a permanent cement director implant, a delivery system, and access instruments to create a cavity within the vertebral body. The system is used in conjunction with commercially available PMMA bone cement. Operated by physicians in a clinical setting, the device provides controlled cement flow during injection to stabilize osteoporotic compression fractures. By directing the cement, the system aims to reduce the risk of cement leakage compared to standard vertebroplasty. The output is the stabilized vertebral body, which helps alleviate pain and restore function in patients with spinal fractures.

Clinical Evidence

Clinical evidence included a pilot study and a prospective randomized study comparing the Shield Kyphoplasty System to vertebroplasty. Total of 69 subjects (102 levels) treated with the subject device and 28 subjects (38 levels) with the control. Primary endpoints included pain and functional improvement, which showed equivalent initial and sustained benefits at one year. The subject device demonstrated fewer asymptomatic leaks than the control. Adverse events were similar between groups, including death, adjacent/distant level fractures, and refracture.

Technological Characteristics

System includes a permanent cement director implant, delivery system, and access instruments. Materials are biocompatible per ISO 10993. The device is MR-conditional per ASTM F2503-05. The system is a mechanical device used for manual delivery of PMMA bone cement; it does not utilize electronic energy sources or software algorithms.

Indications for Use

Indicated for adult patients with acute, persistently painful, stable, anterior column osteoporotic compression fractures (wedge or concave) of the vertebrae at levels T4-L5, following at least 6 weeks of conservative care.

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

• Stryker SpinePlex™ Bone Cement (K032945)
• Kyphon Kyphx® Inflatable Bone Tamp (K041454)

Submission Summary (Full Text)

{0}------------------------------------------------

## 510(k) Summary

DEC - 8 2011

| Owner's Name: | Soteira, Inc. |
|------------------------|-----------------------------------------------------------------------------------------|
| Address: | 14 Tech Circle<br>Natick, MA 01760 |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Contact Person: | John V. Hamilton, Director of Spinal Programs |
| Subject Device Name: | Shield Kyphoplasty System |
| Trade Name: | Shield Kyphoplasty System |
| Classification Name: | Polymethylmethacrylate (PMMA) Bone Cement |
| Product Code: | NDN |
| Regulation: | 21 CFR 888.3027 |
| Device Classification: | Class II device |
| Predicate Devices: | Stryker SpinePlex™ Bone Cement (K032945)<br>Kyphon Kyphx® Inflatable Bone Tamp (K041454 |

### Device Description

The Soteira Shield Kyphoplasty System consists of a cement director (permanent implant), a delivery system (used to place the cement director within the vertebral body) and instruments that are used to achieve percutaneous access to the vertebral body and to create a cavity into which the cement director implant will be placed. The system is intended for use with commercially available PMMA bone cement.

#### Indications for Use

The Soteira Shield Kyphoplasty System (SKS) is intended to provide control of cement flow during injection of PMMA bone cement that has been cleared for use in vertebral augmentation for the treatment of acute, persistently painful (after a minimum of 6 weeks of conservative care), stable, anterior column osteoporotic compression fractures (wedge or concave) of the vertebrae at levels T4 - L5 in the adult spine.

#### Performance Testing

Pre-clinical testing included cadaveric bench testing, biocompatibility and MRI compatibility. The cadaveric bench tests consisted of static and cyclic mechanical testing of osteoporotic vertebral bodies treated with the Soteira Shield Kyphoplasty System and vertebroplasty. The Soteira Shield Kyphoplasty System demonstrated equivalent behavior under both test conditions. Biocompatibility testing was performed in accordance with ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing demonstrated the combination of the Soteira Shield implant and PMMA bone cement is biocompatible. The implant and bone cement have been tested for MRI compatibility and have been determined to be "MR-conditional" in accordance with the ASTM standard F2503-05 Standard Practice for Marking Medical Devices and Other Item for Safety in the Magnetic Resonance Environment.

Clinical testing consisted of a pilot study and a prospective randomized study using vertebroplasty as the control device. All subjects were diagnosed with osteoporotic compression fractures that had undergone conservative care for a minimum of 6 weeks or had

{1}------------------------------------------------

been hospitalized for pain. A total of 69 subjects and 102 levels were treated with the Soteira Shield Kyphoplasty System and 28 subjects and 38 levels were treated with the control device. Pain and functional testing demonstrated equivalent initial improvements and sustained benefits out to one year. The Soteira Shield Kyphoplasty System showed less assymptomatic leaks than the control (vertebroplasty). For the Soteira device adverse events included ; death, adjacent and distant level fractures, incomplete filling, refracture and retreatment of the treated levels while the control exhibited; death, adjacent and distant level fractures,and , refracture of a treated level

## Conclusion

The Soteira Shield Kyphoplasty System has been demonstrated, through labeling, descriptive characteristics and performance testing data, to be substantially equivalent to the predicate devices.

{2}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three parallel lines forming its body and wings. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Soteria, Inc. % Delphi Medical Device Consulting, Inc. Ms. Pamela Papineau 5 Whitcomb Avenue Ayer, Massachusetts 01432

DEC 0 8 2011

Re: K093477

Trade/Device Name: Shield Kyphoplasty System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: September 15, 2011 Received: October 24, 2011

Dear Ms. Papineau:

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

{3}------------------------------------------------

Page 2 - Ms. Pamela Papineau

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 (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/CDRH/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/or You/Industry/default.htm.

Sincerely yours,

F-R

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use Statement

510(k) Number (if known): K093477

Device Name:

Shield Kyphoplasty System

Indications for Use:

The Soteira Shield Kyphoplasty System (SKS) is intended to provide control of cement flow during injection of PMMA bone cement that has been cleared for use in vertebral augmentation for the treatment of acute, persistently painful (after a minimum of 6 weeks of conservative care), stable, anterior column osteoporotic compression fractures (wedge or concave) of the vertebrae at levels T4 - L5 in the adult spine.

Prescription Use X (Per 21 CFR 801 Subpart D)

OR

Over-the -Counter Use (Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093477