(759 days)
No
The summary describes a mechanical system for delivering bone cement and does not mention any AI/ML components or capabilities.
Yes.
The device is intended to provide control of cement flow during injection of bone cement for the treatment of painful osteoporotic compression fractures, which is a therapeutic purpose.
No
The device is described as a system for controlling cement flow during vertebral augmentation for osteoporotic compression fractures, which is a treatment procedure, not a diagnostic one.
No
The device description explicitly details hardware components including a cement director (permanent implant), a delivery system, and instruments for percutaneous access and cavity creation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure performed on the patient's body (in vivo) to treat vertebral compression fractures. It involves implanting a device and injecting bone cement directly into the vertebrae.
- Device Description: The device components are instruments and an implant used for a surgical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) outside of the body (in vitro) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body, while this device is used for a therapeutic intervention directly within the body.
N/A
Intended Use / 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.
Product codes
NDN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vertebrae at levels T4 - L5
Indicated Patient Age Range
adult
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)
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 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
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
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
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.(b)
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.”
0
510(k) Summary
DEC - 8 2011
| Owner's Name: | Soteira, Inc. |
|---|---|
| Address: | 14 Tech Circle |
| Natick, MA 01760 | |
| Telephone Number: | (508) 651-2611 |
| Fax Number: | (508) 651-3611 |
| 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) |
| 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 (800) 638-2041 or (301) 796-7100 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