(269 days)
Not Found
No
The 510(k) summary describes a bone graft substitute material and its performance in animal studies, with no mention of AI or ML technology.
Yes.
The device is a bone void filler intended for use as a therapeutic agent to aid in bone healing and regeneration by filling gaps in the skeletal system and being replaced by bone during the healing process.
No
The device, Sorrento Bone Graft Substitute, is a bone void filler and graft material intended to treat osseous defects, not to diagnose medical conditions.
No
The device description clearly states it is a physical bone graft substitute made from collagen and tricalcium phosphate granules, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fill bone voids and defects in the skeletal system. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The device is a bone graft substitute made of collagen and tricalcium phosphate. This is a material intended for implantation and tissue regeneration, not for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample to provide diagnostic information. The device is placed directly into the body to facilitate healing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
Sorrento Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities and pelvis not intrinsic to the stability of the bony structure. Sorrento Bone Graft Substitute is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitute must be wetted with bone marrow aspirate. Following placement in the bony void or gap (defect), Sorrento Bone Graft Substitute is resorbed and replaced with bone during the healing process.
Product codes
MQV
Device Description
Sorrento Bone Graft Substitute is a resorbable bone void filler made from a matrix of highly purified collagen (ASTM F2212) that has high porosity beta tricalcium phosphate (TCP) granules (ASTM F1088) dispersed throughout. The implant is provided as sterile, non-pyrogenic, and for single use in double peel packages.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremities and pelvis
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)
Non-Clinical Testing: Distal femoral defect model in rabbits was used to compare the subject device to the predicate device at 6 and 12 weeks following implantation. Performance was evaluated radiographically and histomorphometrically. Study data demonstrated that the subject device is substantially equivalent with the predicate device. In addition, substantial equivalence of the Sorrento Bone Graft Substitute was supported by evaluation per ASTM F1088 (for beta tricalcium phosphate) and ASTM F2212 (for collagen).
Clinical Testing: Clinical performance data were not required to determine substantial equivalence.
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
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 23, 2015
Haider Biologics, LLC Gustavo R. Prado. PhD Vice President of R&D 9930 Mesa Rim Road San Diego, California 92121
Re: K141429
Trade/Device Name: Sorrento™ Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: January 22, 2015 Received: January 26, 2015
Dear Dr. Prado:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 – Gustavo R. Prado, PhD
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 Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141429
Device Name Sorrento™ Bone Graft Substitute
Indications for Use (Describe)
Sorrento Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities and pelvis not intrinsic to the stability of the bony structure. Sorrento Bone Graft Substitute is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitute must be wetted with bone marrow aspirate. Following placement in the bony you'd or gap (defect), Sorrento Bone Graft Substitute is resorbed and replaced with bone during the healing process.
| 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) |
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510(k) Summary
Submitter:
Haider Biologics, LLC 9930 Mesa Rim Drive, San Diego, CA 92121
Phone: (858) 202-1540 Fax: (858) 202-1549
Contact: Gustavo R. Prado, PhD Title: Vice President of R&D E-mail: gprado@haiderbiologics.com
Date Prepared:
February 18, 2015
Subject Device:
Trade Name: Sorrento™ Bone Graft Substitute Common Name: Bone Void Filler
Classification Name: Resorbable Calcium Salt Bone Void Filler Device Regulation: 21 CFR 888.3045
Device Class: Class II Product Code: MQV Review Panel: Orthopedic
Predicate Devices:
| 510(k) # | Trade Name | Product Code |
|---|---|---|
| K032288 | Vitoss® Scaffold Foam Bone Graft Material | |
| (Orthovita, Inc.) | MQV |
Device Description:
Sorrento Bone Graft Substitute is a resorbable bone void filler made from a matrix of highly purified collagen (ASTM F2212) that has high porosity beta tricalcium phosphate (TCP) granules (ASTM F1088) dispersed throughout. The implant is provided as sterile, non-pyrogenic, and for single use in double peel packages.
Indications for Use:
Sorrento Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities and pelvis not intrinsic to the stability of the bony structure. Sorrento Bone Graft Substitute is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitute must be wetted with bone marrow aspirate. Following placement in the bony void or gap (defect), Sorrento Bone Graft Substitute is resorbed and replaced with bone during the healing process.
4
Technological Characteristics:
The subject device is substantially equivalent to the cited legally marketed predicate device. The subject device has the same technological characteristics including design, materials, operating principle and indications for use.
Chart comparing subject device to the predicate device:
| Characteristic | Substantially Equivalent? | Impact on Safety &
Performance |
|---------------------------------|---------------------------|-----------------------------------|
| Design | YES | None |
| Material Characterization | YES | None |
| Biocompatibility | YES | None |
| Sterilization | YES | None |
| Components of Device (Material) | YES | None |
| Dimensional Specifications | YES | None |
| Physical Form (Sponge) | YES | None |
Non-Clinical Testing:
Distal femoral defect model in rabbits was used to compare the subject device to the predicate device at 6 and 12 weeks following implantation. Performance was evaluated radiographically and histomorphometrically. Study data demonstrated that the subject device is substantially equivalent with the predicate device.
In addition, substantial equivalence of the Sorrento Bone Graft Substitute was supported by evaluation per ASTM F1088 (for beta tricalcium phosphate) and ASTM F2212 (for collagen).
Clinical Testing:
Clinical performance data were not required to determine substantial equivalence
Conclusions:
Conclusions drawn from the non-clinical tests demonstrated that the subject device possessed at least equivalent performance characteristics as the predicate device, and that overall the subject device is substantially equivalent.