(59 days)
PolyGrafi™ BGS
Not Found
No
The summary describes a bone void filler made from processed bovine bone. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on material properties and viral inactivation, not algorithmic performance.
No
The device is a bone void filler intended to remodel into the skeletal system, which serves a structural and regenerative purpose rather than actively treating a disease or condition.
No
The device description indicates it is a bone graft product used to fill bony voids, not to diagnose medical conditions.
No
The device description clearly states the product is manufactured from bovine bone and provided in physical sizes and volumes, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a void filler for bony voids or gaps in the skeletal system. This is a therapeutic or structural application, not a diagnostic one.
- Device Description: The device is made from processed bovine bone and is used as a physical filler. This is consistent with a medical device used for structural support or repair, not for analyzing biological samples to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) to provide information about a patient's health status or disease.
- Performance Studies: The performance studies focus on remodeling in an animal model and viral inactivation, which are relevant to the safety and efficacy of a bone graft material, not a diagnostic test.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for structural support and repair.
N/A
Intended Use / Indications for Use
STERLING® Cancellous Chips and STERLING® Cancellous Cubes are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., extremities, spine, ilium and/or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a void filler that remodels into the recipient's skeletal system.
Product codes
MQV
Device Description
STERLING® Cancellous Chips and STERLING* Cancellous Cubes are manufactured from bovine bone processed with the BioCleanse" Tissue Sterilization Process. STERLING® Cancellous Chips and STERLING® Cancellous Cubes are provided in 1-10mm sizes, with 15-90cc per package.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (e.g., extremities, spine, ilium and/or pelvis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
STERLING® Cancellous Chips and STERLING* Cancellous Cubes have been shown to remodel comparably to allograft in an animal model. A viral inactivation study using a worst-case representation of the BioCleanse® process, used in the manufacture of STERLING® Cancellous Chips and STERLING® Cancellous Cubes, has shown a greater than six log reduction of a panel of viruses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PolyGrafi™ BGS
Reference Device(s)
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
§ 888.3045 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.
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Image /page/0/Picture/0 description: The image shows the logo for Regeneration Technologies, Inc. The logo consists of a black square on the left, followed by the word "Regeneration" in bold, black letters. Below "Regeneration" is the text "TECHNOLOGIES, INC." in a smaller, sans-serif font. The letters are spaced out, and the "TM" symbol is located to the right of the word "Regeneration".
J162
Pos
Alach
. . . 11621 Research Circle ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Alachua, FL 32616-2650 USA
Tel 386.418.8888 Toll Free 877.343.683 Fax 386.418.0342 www.rtix.com
AUG 1 5 2005
510(K) Summary
K051615 Date: August 5, 2005
Submitted by: Carrie Hartill Regeneration Technologies, Inc. 11621 Research Circle Alachua, FL 32615 Phone: 386-418-8888 x4382 Fax: 386-462-3821
Proprictary Name: STERLING® Cancellous Chips STERLING® Cancellous Cubes
Common Name: Filler, bone void, calcium compound
Classification: MQV, Orthopedics Panel
Code Section: 21 CFR 888.3045
Substantial Equivalence:
STERLING" Cancellous Chips and STERLING" Cancellous Cubes are substantially equivalent to PolyGrafi™ BGS in design and function, and are composed of bovine bone processed in the same manner as the STERLING* Interference Screw ST.
Description:
STERLING® Cancellous Chips and STERLING* Cancellous Cubes are manufactured from bovine bone processed with the BioCleanse" Tissue Sterilization Process. STERLING® Cancellous Chips and STERLING® Cancellous Cubes are provided in 1-10mm sizes, with 15-90cc per package.
Intended Use:
STERLING* Cancellous Chips and STERLING* Cancellous Cubes are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., extremities, spine, ilium and/or pelvis). These defects may be surgically created
1
Image /page/1/Picture/0 description: The image shows a black and white abstract design. The design features a series of diagonal, curved lines that create a sense of movement. The spaces between the lines are filled with a textured, speckled pattern, contrasting with the smooth, solid black lines. The overall effect is visually dynamic and somewhat chaotic.
osseous defects or osseous defects created from traumatic injury to the bone. The product provides a void filler that remodels into the recipient's skeletal system.
Summary of Technological Characteristics:
STERLING® Cancellous Chips, STERLING® Cancellous Cubes, and PolyGraft™ BGS have substantially equivalent design and function, but are composed of different materials. The STERLING® Cancellous Chips and STERLING* Cancellous Cubes are constructed of bovine bone processed in the same manner as the STERLING* Interference Screw ST. The source of bovine bone used in the manufacture of STERLING® Cancellous Chips and STERLING® Cancellous Cubes is a closed herd located in the U.S.A.
STERLING® Cancellous Chips and STERLING* Cancellous Cubes have been shown to remodel comparably to allograft in an animal model. A viral inactivation study using a worst-case representation of the BioCleanse® process, used in the manufacture of STERLING® Cancellous Chips and STERLING® Cancellous Cubes, has shown a greater than six log reduction of a panel of viruses.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.
AUG 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Carrie Hartill Regeneration Technologies, Inc. 11621 Research Circle Alachua, Florida 32615
Re: K051615
Trade/Device Name: STERLING® Cancellous Chips STERLING® Cancellous Cubes Regulation Number: 21 CFR 888.3045 Regulation Name: Reabsorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: August 5, 2005 Received: August 8, 2005
Dear Ms. Hartill:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. Carrie Hartill
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milken
Mark Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): STERLING® Cancellous Chips Device Name: STERLING® Cancellous Cubes Indications for Use: STERLING® Cancellous Chips and STERLING® Cancellous Cubes are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., extremities, spine, ilium and/or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a void filler that remodels into the recipient's skeletal system.
Prescription Use Over-The-Counter Use x AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Mark A. Millman
.
ivision Sign-Off) Triston of General, Restorative Id Neurological