Bioactive Bone Graft Putty is a bone void filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Bioactive Bone Graft Putty is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities, pelvis and posterolateral spine fusion procedures). Bioactive Bone Graft Putty can also be used with autograft as a bone graft extender in the posterolateral spine. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.

Device Description

Bioactive Bone Graft Putty is a synthetic bone void filler comprised of a mixture of calcium phosphate granules and bioactive glass granules suspended in a resorbable polymer carrier that facilitates handling and delivery of the granule components. The device is supplied as putty, pre-loaded in a syringe applicator and packaged in a sterile barrier foil pouch. The device is provided sterile, for single use, in a variety of sizes.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Bioactive Bone Graft Putty, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a submission for a medical device (Bioactive Bone Graft Putty) seeking 510(k) clearance, which means demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel device. Therefore, the "acceptance criteria" are implicitly the requirements for demonstrating substantial equivalence. The reported "device performance" refers to the results of the studies used to support this equivalence.

Category	Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
Material Characterization	Meet ASTM standards for raw materials: F1538-03, F1185-03, F1088-04a, F1929/F1926M, and USP NF.	Performed as applicable. (Specific results not detailed, but implied to meet standards).
Biocompatibility	Demonstrate biocompatibility and non-toxicity according to ISO 10993 for a long-term implant product.	Device is biocompatible and non-toxic.
Packaging	Meet ISO 11607, ASTM F2096-11, F88-09, and F1929-98.	Testing performed. (Specific results not detailed, but implied to meet standards).
Sterilization	Meet ISO 11137.	Testing performed. (Specific results not detailed, but implied to meet standards).
Shelf Life	Meet ASTM F1980.	Testing performed. (Specific results not detailed, but implied to meet standards).
Bioactivity (in vitro)	Show apatite layer formation on the surface of the implant following immersion in simulated body fluid (SBF).	Demonstrated apatite layer formation. (Note: These results have not been correlated to clinical performance).
In vivo Performance	Demonstrate equivalent safety, graft resorption, and new bone formation compared to a predicate device in relevant animal models (femoral cancellous defect and posterolateral spine fusion).	The test results showed equivalent in vivo performance in safety, graft resorption, and new bone formation when compared to a predicate device in rabbit models.
Technological Equivalence	Demonstrate that technological differences (e.g., material composition) do not raise new issues of safety or effectiveness.	The technological differences presented by the composition of materials do not raise new issues of safety or effectiveness, as demonstrated by side-by-side evaluation in animal performance studies.
Intended Use	Same intended use as predicate devices: bone void filler in bony voids/gaps not intrinsic to stability, including surgically created or traumatic defects, extremities, pelvis, and posterolateral spine fusion; can be used with autograft as a bone graft extender; resorbed and replaced with host bone.	Bioactive Bone Graft Putty has the same intended use as all the predicate devices.
Principles of Operation	Same principles of operation as predicate devices: serve as osteoconductive matrices for new bone formation.	Bioactive Bone Graft Putty has the same principles of operation as all the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The text states "Animal performance testing was performed in femoral cancellous defect and posterolateral spine fusion (PLF) rabbit models." It does not specify the exact number of rabbits used in these models.
Data Provenance: The animal studies were performed in "rabbit models." This indicates a pre-clinical, prospective study design, typically conducted in a controlled laboratory environment. The country of origin is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the text. The animal studies would typically involve veterinary pathologists or researchers to assess outcomes (e.g., new bone formation, graft resorption), but the number and qualifications of such experts are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the text. Given the nature of animal studies assessing histological or radiographic outcomes, there might have been independent assessment by experts, but the adjudication method (e.g., 2+1, 3+1) is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. This type of study typically involves human readers interpreting medical images or data, which is not applicable to the animal performance testing described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A. This device is a bone graft putty, not an algorithm or an AI-powered diagnostic tool. The concept of "standalone performance" for an algorithm is not relevant here.

7. The Type of Ground Truth Used

For the animal performance testing, the ground truth was established through direct observation and histopathological assessment of the animal models. This would include:

Histopathology: Examining tissue samples under a microscope to evaluate new bone formation, graft resorption, and inflammatory reactions.
Radiographic imaging (implied): While not explicitly stated for confirming the "outcome" in the way pathology would, it's common in bone healing studies to use imaging to track progress. However, the direct measure for bone formation and resorption would largely rely on pathology.

8. The Sample Size for the Training Set

This is not applicable for this device. The Bioactive Bone Graft Putty is a physical medical device, not an AI model requiring a training set. The "testing" mentioned refers to traditional pre-clinical and bench testing.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no AI model or "training set" for this device.

Summary

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K 132071

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Submitter:
BioStructures, LLC

Bioactive Bone Graft Putty

510(k) SUMMARY

Submitter Name:	BioStructures, LLC
Submitter Address:	1201 Dove Street, Suite 470Newport Beach, CA 92660JAN 10 2014
Contact Person:	John Brunelle, Ph.D.Director of R&D/ Manufacturing
Phone Number:	949.553.1717
Date Prepared:	July 2, 2013
Device Trade Name:	Bioactive Bone Graft Putty
Device Classification:	Class II
Classification Name:	Filler, Bone Void, Calcium Compound
Classification Number:	21 CFR 888.3045
Product Code:	MQV
Predicate Device(s):	K071206, Actifuse® ABX, ApaTech LimitedK043005, MBCP™™, BiomatlanteK112857, Interface Bone Void Filler, BioStructures, LLCK020078, Exactech Resorbable Bone Paste, Exactech, Inc.
Indications for UseStatement:	Bioactive Bone Graft Putty is a bone void filler device intended foruse in bony voids or gaps that are not intrinsic to the stability ofthe bony structure. These defects may be surgically createdosseous defects or osseous defects created from traumatic injuryto the bone. Bioactive Bone Graft Putty is indicated to be packedgently into bony voids or gaps of the skeletal system (i.e.,extremities, pelvis and posterolateral spine fusion procedures).Bioactive Bone Graft Putty can also be used with autograft as abone graft extender in the posterolateral spine. The deviceprovides a bone void filler that is resorbed and replaced with hostbone during the healing process.
Device Description:	Bioactive Bone Graft Putty is a synthetic bone void filler comprisedof a mixture of calcium phosphate granules and bioactive glassgranules suspended in a resorbable polymer carrier that facilitateshandling and delivery of the granule components. The device issupplied as putty, pre-loaded in a syringe applicator and packagedin a sterile barrier foil pouch. The device is provided sterile, forsingle use, in a variety of sizes.
Summary of Testing:	Non-clinical testing was performed in accordance with FDArecognized consensus standards and FDA guidance documentsas applicable.Raw materials characterization testing was performed accordingto ASTM standards: F1538-03, F1185-03, F1088-04a,F1929/F1926M and USP NF.

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Submitter:	BioStructures, LLC
------------	--------------------	--

Bioactive Bone Graft Putty Traditional 510(k)

Biocompatibility testing, according to ISO 10993 for a long-term implant product. demonstrated the device is biocompatible and non-toxic.

Packaging, sterilization and shelf life testing according to the following standards were presented in the 510(k):

Packaging: ISO11607, ASTM F2096-11, F88-09 and . F1929-98; and ISO 11137.
Sterilization and Shelf Life; ISO 11137 and ASTM F1980. .

The device is considered bioactive based on in vitro studies that show apatite laver formation on the surface of the implant following immersion in simulated body fluid (SBF). These results have not been correlated to clinical performance.

Animal performance testing was performed in femoral cancellous defect and posterolateral spine fusion (PLF) rabbit models to evaluate the safety and performance of the Bioactive Bone Graft Putty compared to a predicate device. The test results showed equivalent in vivo performance in safety, graft resorption and new bone formation.

Bioactive Bone Graft Putty has the same intended use and the same principles of operation as all the predicates, which serve as osteoconductive matrices for new bone formation.

Bioactive Bone Graft Putty is similar technologically to the four predicates.

The technological differences presented by the composition of materials in Bioactive Bone Graft Putty do not raise new issues of safety or effectiveness, as demonstrated by the side-by-side evaluation in the animal performance studies.

The comparisons and study data presented in the 510(k) lead to the conclusion that Bioactive Bone Graft Putty is substantially equivalent to the predicate devices.

Comparison to the Predicate Devices:

Substantjal Equivalence Conclusion:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three overlapping wings, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle symbol in a circular fashion.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 10, 2014

BioStructures, LLC % Patsy J. Trisler, JD, RAC Trisler Consulting 5600 Wisconsin Avenue #509 Chevy Chase, Maryland 20815

Re: K132071

Trade/Device Name: Bioactive Bone Graft Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: December 2, 2013 Received: December 3, 2013

Dear Ms. Trisler:

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 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.

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Page 2 - Patsy J. Trisler. JD, RAC

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" (21 CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Ronalden - Jean - S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K132071

Device Name:

Bioactive Bone Graft Puttv

Indications for Use:

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D) (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: K132071

Section 4.0

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Regulation Number and Section

§ 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.