(507 days)
Not Found
No
The description focuses on the material properties and clinical performance of a bone augmentation material, with no mention of AI or ML.
Yes
The device is used for the "fixation of pathological fractures of the vertebral body using vertebral augmentation" to treat painful vertebral compression fractures, indicating a therapeutic purpose.
No
The document explicitly states the device is a "Bone Augmentation Material" used for "fixation of pathological fractures" and functions as a "strengthening agent". This description aligns with a therapeutic device, not a diagnostic one which identifies or characterizes a disease or condition.
No
The device description clearly states that Cortoss is a "composite material" and an "injectable, nonresorbable synthetic material," indicating it is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of pathological fractures of the vertebral body using vertebral augmentation." This describes a procedure performed directly on the patient's body to treat a physical condition.
- Device Description: The device is a "composite material that functions as a strengthening agent for injection into vertebral bodies." This is a material implanted into the body.
- 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, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) as a therapeutic material.
N/A
Intended Use / Indications for Use
CORTOSS Bone Augmentation Material is indicated for the fixation of pathological fractures of the vertebral body using vertebral augmentation. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Product codes (comma separated list FDA assigned to the subject device)
NDN
Device Description
Cortoss is a composite material that functions as a strengthening agent for injection into vertebral bodies with compression fractures or weakened bone stock. This injectable, nonresorbable synthetic material is generically referred to as a resin-based, bis-glycidal dimethacrylate (Bis-GMA) composite.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vertebral body
Indicated Patient Age Range
Not Found
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)
Performance testing was conducted to ensure that Cortoss met its design specifications and performed in a manner substantially similar to the predicate devices. In all instances, Cortoss functioned as intended.
Human clinical studies were conducted in over 500 patients at 43 clinical sites to demonstrate the safety and effectiveness of Cortoss for the treatment of vertebral compression fractures.
In the U.S., data was collected in 40 patients in two pilot studies and in 256 patients (162 Cortoss: 94 control) in a prospective, randomized, multi-center, pivotal, single-blind pivotal study. In the E.U., data was collected in over 300 patients, including a multi-center, single arm, prospective study. These European studies were conducted in four countries (France, Italy, Sweden and the UK), with follow-up ranging from six months to over three years.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K032945, K043593, K053336, K063606, K060300
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 CORTOSS® Bone Augmentation Material
May 28, 2009
510(k) Number (if known): K080108
1. Contact Person
Catherine Moffa Director, Regulatory Affairs (e-mail) cmoffa@orthovita.com
Orthovita, Inc. 45 Great Valley Parkway Malvern, PA 19355 (t) 610-640-1775 - (f) 610-640-1714
2. Device Name and Classification
| Product Name: | Cortoss Bone Augmentation Material |
|---|---|
| Classification Name: | Cement, Bone, Vertebroplasty |
| Common or Usual Name: | Vertebral Augmentation Material |
| Classification Panel: | Orthopedic |
| Regulation Number: | 888.3027 |
| Device Class: | Class II |
| Product Code: | NDN |
3. Substantial Equivalence
Cortoss is substantially equivalent to the following medical devices in commercial distribution:
| Predicate Device | Company | FDA Clearance Number |
|---|---|---|
| Spineplex Radiopaque Bone Cement | Stryker | K032945 |
| Spine-Fix Biomimetic Bone Cement | Teknimed | K043593 |
| Staxx Fx System | Spine Wave | K053336, K063606 |
| Confidence High Viscosity Bone Cement | Disc-O-Tech | K060300 |
Cortoss has the same intended use and indications, similar technological characteristics, and similar principles of operation as its predicate devices. The minor technological differences between Cortoss and its predicate devices raise no new issues of safety or effectiveness. Performance and clinical data demonstrate that Cortoss is as safe and effective as its predicate devices. Thus, Cortoss is substantially equivalent.
1
4. Device Description
Cortoss is a composite material that functions as a strengthening agent for injection into vertebral bodies with compression fractures or weakened bone stock. This injectable, nonresorbable synthetic material is generically referred to as a resin-based, bis-glycidal dimethacrylate (Bis-GMA) composite.
5. Indications for Use
CORTOSS Bone Augmentation Material is indicated for the fixation of pathological fractures of the vertebral body using vertebral augmentation. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
6. Performance Data
Performance testing was conducted to ensure that Cortoss met its design specifications and performed in a manner substantially similar to the predicate devices. In all instances, Cortoss functioned as intended.
7. Clinical Data
Human clinical studies were conducted in over 500 patients at 43 clinical sites to demonstrate the safety and effectiveness of Cortoss for the treatment of vertebral compression fractures.
In the U.S., data was collected in 40 patients in two pilot studies and in 256 patients (162 Cortoss: 94 control) in a prospective, randomized, multi-center, pivotal, single-blind pivotal study. In the E.U., data was collected in over 300 patients, including a multi-center, single arm, prospective study. These European studies were conducted in four countries (France, Italy, Sweden and the UK), with follow-up ranging from six months to over three years.
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Orthovita, Inc. % Ms. Catherine Moffa Director, Regulatory Affairs 45 Great Valley Parkway Malvern, Pennsylvania 19355
JUN - 5 2009
Re: K080108
Trade/Device Name: CORTOSS® Bone Augmentation Material Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN Dated: March 31, 2009 Received: April 1, 2009
Dear Ms. Moffa:
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 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 (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.
3
Page 2- Ms. Catherine Moffa
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information.regarding.the reporting of adverse events, please go.to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K080108
Device Name:
CORTOSS® Bone Augmentation Material
INDICATIONS FOR USE:
CORTOSS® Bone Augmentation Material is indicated for the fixation of pathological fractures of the vertebral body using vertebral augmentation. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
///
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K080108