(35 days)
Not Found
No
The summary describes a mechanical device for delivering bone cement and does not mention any computational or analytical functions that would suggest the use of AI/ML.
Yes
The device is intended to deliver bone cement to painful pathologic compression fractures of the vertebral body, which qualifies it as a therapeutic device.
No
The device is intended to deliver bone cement to treat painful pathologic compression fractures, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it consists of a shaft assembly and is made from materials like stainless steel and polymers, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Crosstrees® Pod device is a surgical tool used to deliver bone cement directly into a fractured vertebral body. It is a physical device used in vivo (within the body) during a surgical procedure.
- Intended Use: The intended use clearly states it's for delivering bone cement to treat painful pathologic compression fractures. This is a therapeutic intervention, not a diagnostic test.
- Device Description: The description details the physical components and materials of the device, which are consistent with a surgical instrument, not an IVD.
The device is a surgical delivery system, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Crosstrees® Pod device is intended to provide surgeons with a percutaneous means to deliver bone cement to painful pathologic compression fractures of the vertebral body in levels T4-L5 of the thoracic and lumbar spine. Pathologic fractures of the vertebral body may be caused by osteoporosis. It is intended to be used in combination with Crosstrees Fortibrae® Bone Cement when delivered by the Crosstrees CDrive® Bone Filler Delivery System.
Product codes (comma separated list FDA assigned to the subject device)
NDN, LOD
Device Description
The Crosstrees® PVA Pod device is designed to deliver bone cement to the fractured vertebral body in a controlled manner without the need for an additional permanent implant other than the bone cement. The device consists of a shaft assembly for delivery of PMMA cement to a fabric barrier. Following cement delivery, the fabric barrier is opened and withdrawn from the vertebral body. The Crosstrees® PVA Pod device is made from a variety of materials commonly used in orthopedic and radiological procedures including stainless steel and polymers. The device is available in either a 2.0 mL or 3.0 mL fill capacity. The device is provided with a number of class I tools that are used for surgical access and delivery of the Pod to the surgical site, as well as preparation and delivery of bone cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T4-L5 of the thoracic and lumbar spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons
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)
The Crosstrees® PVA Pod has the same sterilization process, same packaging, and is comprised of the same materials of construction as the predicate device. Device modifications have been assessed through Crosstrees design control process and the data generated demonstrates that the Crosstrees® PVA Pod device meets all performance characteristics and design specifications, thus supporting substantial equivalence to the predicate device. In all instances, the Crosstrees® PVA Pod device functioned as intended.
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.
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
Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared
Crosstrees Medical, Inc.
Submitter's Name:
Date Prepared:
Address: 4735 Walnut Street, Suite E Boulder, CO 80301 720-880-5811 Telephone: Fax: 303-484-6099
Contact Person: Robert Scribner 720-880-5811 Telephone:
November 1, 2013
DEC 0 6 2013
Name of Device and Name/Address of Sponsor Crosstrees® PVA Pod Device
Common Name
Bone Cement Delivery Device
Classification Name
888.3027 - Cement, Bone, Vertebroplasty 888.1100 - Arthroscope
Predicate Devices
Crosstrees® PVA Pod Device (K130089)
Intended Use
The Crosstrees® Pod device is intended to provide surgeons with a percutaneous means to deliver bone cement to painful pathologic compression fractures of the vertebral body in levels T4-L5 of the thoracic and lumbar spine. Pathologic fractures of the vertebral body may be caused by osteoporosis. It is intended to be used in combination with Crosstrees Fortibrae® Bone Cement when delivered by the Crosstrees CDrive® Bone Filler Delivery System.
Device Description
The Crosstrees® PVA Pod device is designed to deliver bone cement to the fractured vertebral body in a controlled manner without the need for an additional permanent implant other than the bone cement. The device consists of a shaft assembly for delivery of PMMA cement to a fabric barrier. Following cement delivery, the fabric barrier is opened and withdrawn from the vertebral body. The Crosstrees® PVA Pod device is made from a variety of materials commonly used in orthopedic and radiological procedures including stainless steel and polymers. The device is available in either a 2.0 mL or 3.0 mL fill capacity. The device is provided with a number of class I tools that are used for surgical access and delivery of the Pod to the surgical site, as well as preparation and delivery of bone cement.
1
Substantial Equivalence
The Crosstrees® PVA Pod has the same intended use, indications for use, and principles of operation, as well as very similar technological characteristics as its predicate device. The minor technological differences between the Crosstrees® PVA Pod and its predicate device, change in the pod fabric dimensional specification, and the removal of a yarn texturing process, raise no new issues of safety or effectiveness questions. Risk assessment of the modification and design verification testing, performed to support design control activities, demonstrates that the Crosstrees® PVA Pod performs as intended and is as safe and effective as the previously cleared device. Thus, the Crosstrees® PVA Pod is substantially equivalent.
| Device | Crosstrees® PVA Pod | Predicate
Crosstrees® PVA Pod
(K130089) |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Crosstrees® Pod device is
intended to provide surgeons with a
percutaneous means to deliver bone
cement to painful pathologic
compression fractures of the vertebral
body in levels T4-L5 of the thoracic
and lumbar spine. Pathologic
fractures of the vertebral body may
be caused by osteoporosis. It is
intended to be used in combination
with Crosstrees Fortibrae® Bone
Cement when delivered by the
Crosstrees CDrive® Bone Filler
Delivery System. | The Crosstrees® Pod device is
intended to provide surgeons with a
percutaneous means to deliver bone
cement to painful pathologic
compression fractures of the vertebral
body in levels T4-L5 of the thoracic
and lumbar spine. Pathologic
fractures of the vertebral body may
be caused by osteoporosis. It is
intended to be used in combination
with Crosstrees Fortibrae® Bone
Cement when delivered by the
Crosstrees CDrive® Bone Filler
Delivery System. |
| Materials | Woven Polymer, Stainless Steel, UV
Curable Adhesives, Thermoplastic
Injection Molded Handles/Hubs | Woven Polymer, Stainless Steel, UV
Curable Adhesives, Thermoplastic
Injection Molded Handles/Hubs |
| Major
Components | Expandable Member, Delivery Shaft | |
| Expandable
Member Material | Woven Polymer Fabric Pod
(Polyester) | Woven Polymer Fabric Pod
(Polyester) |
| Expandable
Member Length | 20mm | 15, 20mm |
| Expandable
Member Max
Volume | 2 mL | 2 mL, 3mL |
| Expandable
Member Shape | Cylindrical/Elliptical | Cylindrical/Elliptical |
| How Supplied | Sterile Single Use (ANSI/AAMI/ISO
11137-2006 Gamma Irradiation) | Sterile Single Use (ANSI/AAMI/ISO
11137-2006 Gamma Irradiation) |
2
K133372 Page 3 of 3
Performance Data
The Crosstrees® PVA Pod has the same sterilization process, same packaging, and is comprised of the same materials of construction as the predicate device. Device modifications have been assessed through Crosstrees design control process and the data generated demonstrates that the Crosstrees® PVA Pod device meets all performance characteristics and design specifications, thus supporting substantial equivalence to the predicate device. In all instances, the Crosstrees® PVA Pod device functioned as intended.
Conclusion
The Crosstrees® PVA Pod has the same intended use, indications for use, and principles of operation, as well as very similar technological characteristics as its predicate device. Testing conducted to support design control activities confirms that the product performs as intended. Therefore, the Crosstrees® PVA Pod is substantially equivalent to its predicate.
3
Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold font. The text is centered in the image. The text is likely the name of a government agency.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 6, 2013
Crosstrees Medical, Incorporated % Ms. Janice Hogan Partner Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K133372
Trade/Device Name: Crosstrees® PVA Pod Device Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, LOD Dated: November 12, 2013 Received: November 12, 2013
Dear Ms. Hogan:
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 (reporting of medical
4
Page 2 - Ms. Janice Hogan
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Lori A. Wigqins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Indications for Use Statement
K133372 510(k) Number (if known):
Device Name: Crosstrees® PVA Pod Device
Indications for Use:
The Crosstrees® Pod device is intended to provide surgeons with a percutaneous means to deliver bone cement to painful pathologic compression fractures of the vertebral body in levels T4-L5 of the thoracic and lumbar spine. Pathologic fractures of the vertebral body may be caused by osteoporosis. It is intended to be used in combination with Crosstrees Fortibrae® Bone Cement when delivered by the Crosstrees CDrive® Bone Filler Delivery System.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Laurence D. Coyne -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133372
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