Beta TCP Granules Bone Void Filler (BVF) is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Beta TCP Granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Beta TCP Granules BVF will resorb and be replaced with bone during the healing process.

Device Description

Beta TCP Granules Bone Void Filler is composed of porous, osteoconductive, resorbable beta- tricalcium phosphate (B-TCP) granules for repair of bony defects. The single use Beta TCP Granules sterile kit contains: Calcium Phosphate granules contained in a plastic vial packaged within two industry standard peel pouches that provide a double sterile barrier.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Beta TCP Granules device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Chemistry	Phase pure beta-tricalcium phosphate	Composed of phase pure beta-tricalcium phosphate (via FTIR and XRD)
Crystallinity	Crystalline, phase-pure beta-tricalcium phosphate with no other crystalline or amorphous phases	Crystalline, phase-pure beta-tricalcium phosphate with no other crystalline or amorphous phases detected (via X-ray Diffraction)
Physical Form	Porous granules	Porous granules (via Scanning Electron Microscopy). Subject device is spherical; predicate device is irregular.
Porosity	Interconnected porosity within the range of currently approved beta tricalcium phosphate bone void fillers	Interconnected porosity falls within the range (via Mercury Intrusion Porosimetry)
Solubility	Similar solubility profiles to predicate device	Demonstrated similar solubility profiles (via in vitro dissolution measuring Ca2+ ion concentration)
Biocompatibility	Compliant with ISO 10993-1	Biocompatible and meets requirements of ISO standards
Sterility	Sterility Assurance Level (SAL) 10^-6	Validated to SAL 10^-6 with radiation dose of 25kGy - 40 kGy (in accordance with ISO 11137-2006)
Risk Management	Identified hazards acceptable and/or mitigated to an acceptable level	Identified hazards acceptable and/or mitigated, residual risk deemed acceptable
Resorption & Bone Ingrowth	Resorbed over time and allows bone ingrowth	Resorbed over time and allows bone ingrowth (demonstrated in animal model)
Safety Profile	Maintain previously demonstrated safety profile of beta-TCP materials	Maintains previously demonstrated safety profile of beta-TCP materials

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

The primary "test set" for demonstrating substantial equivalence was a comparison of critical specifications between the Beta TCP Granules and the predicate device, Cerasorb M Ortho (K040216). This involves direct laboratory analysis of material properties rather than human patient data.
Data Provenance: The document does not explicitly state the country of origin for the lab-based material characterization studies. It is implicitly "prospective" in the sense that these tests were conducted on the Beta TCP Granules product for the submission.
Animal Study: A "large animal, cancellous bone defect model" was used for non-clinical animal data. The document does not specify the exact sample size (number of animals) for this study, nor its country of origin. This would be considered prospective animal data specifically generated for this submission.

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

This device submission relies on non-clinical testing (material characterization and animal studies), not on human clinical data or expert interpretation of images/diagnoses.
Therefore, the concept of "experts establishing ground truth for the test set" in the context of human clinical data or diagnostic accuracy studies is not applicable here. The "ground truth" for the material properties was established by validated analytical methods and scientific standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this submission relies on non-clinical laboratory and animal studies, not human clinical data that would require adjudication of findings.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device is a resorbable bone void filler and does not involve AI or human image interpretation for diagnosis or treatment planning in a clinical setting.

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

Not applicable. This device is a material product, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission is based on:
- Scientific and Analytical Measurements: For chemistry, crystallinity, physical form, porosity, and solubility, the ground truth was established by validated laboratory techniques (FTIR, XRD, SEM, Mercury Intrusion Porosimetry, ICP-AES) according to scientific standards.
- Biological Standards: For biocompatibility, the ground truth was adherence to ISO 10993-1.
- Validated Sterilization Protocols: For sterility, adherence to ISO 11137-2006 for SAL 10^-6.
- Animal Model Outcomes: For resorption and bone ingrowth, the ground truth was the observation of these phenomena in a "large animal, cancellous bone defect model."

8. The Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI. The product itself is the subject of characterization.

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

Not applicable. As there is no training set, there is no ground truth to establish for it.

Summary

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K120354

MAR 2 1 2013

Image /page/0/Picture/2 description: The image shows the logo for Skeletal Kinetics. The logo consists of a globe-like image on the left and the words "Skeletal Kinetics" on the right. The words are stacked on top of each other, with "Skeletal" on top and "Kinetics" on the bottom.

A COLSON ASSOCIATE

510(k) Summary

General Information as required by 21 CFR 807.92 (a) (1)

Submitters Name/address:

Date:

Contact Person:

Skeletal Kinetics® LLC 10201 Bubb Road Cupertino, CA 95014, USA March 18, 2013 Christine Kuo, Director, Regulatory Affairs and Quality Assurance Phone: (408) 350-5842 Fax: (408) 366-1077

Device Name as required by 21 CFR 807.92 (a) (2)

Trade Name:	Beta TCP Granules
Regulation Number:	21 CFR 888.3045
Regulation Name:	Resorbable calcium salt bone void filler device
Regulatory Class:	II
Product Code:	MQV

Predicate Devices as required by 21 CFR 807.92 (a) (3)

The subject device is substantially equivalent in safety and effectiveness to the following legally marketed device (predicate) - Cerasorb M Ortho (K040216).

Device Description as required by 21 CFR 807.92 (a) (4)

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vial packaged within two industry standard peel pouches that provide a double sterile barrier.

Intended Use as required by 21 CFR 807.92 (a) (5)

Summary of Technological Characteristics as required by 21 CFR 807.92 (a) (6)

Beta TCP Granules consists of beta-tricalcium phosphate (ß-TCP) that can be applied directly to the intended sites. The intended use, and critical specifications (chemistry, crystallinity, physical form, porosity, and solubility) of Beta TCP Granules are substantially equivalent to the predicate device, Cerasorb M Ortho (K040216).

Summary of Non-clinical Tests as required by 21 CFR 807.92 (b) (1)

Critical specifications (chemistry, crystallinity, physical form, porosity, and solubility) of Beta TCP Granules were compared with those of Cerasorb M Ortho. Chemistry was determined by Fourier Transformed Infrared Spectroscopy (FTIR) and X-ray Diffraction (XRD) techniques. Both devices are composed of phase pure beta-tricalcium phosphate. Crystallinity was determined by X-ray Diffraction, and both materials consist of crystalline, phase-pure beta-tricalcium phosphate with no other crystalline or amorphous phases detected. Physical form was determined by Scanning Electron Microscopy, both devices are porous granules. The subject device is spherical in shape and the predicate device is composed of irregular granules. Porosity was determined by Mercury Intrusion Porosimetry, the interconnected porosity for both devices fall within a range porosities available in currently approved beta tricalcium phosphate bone void fillers. Solubility was measured by in vitro dissolution method measuring Ca2+ ion concentration in solution using Inductively Coupled Plasma - Atomic Emission Spectroscopy. Both devices demonstrated similar solubility profiles. Performance test results demonstrated

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that Beta TCP has substantially equivalent critical specifications (chemistry, crystallinity, physical form, porosity, and solubility) as the predicate device Cerasorb M Ortho (K040216).

Beta TCP Granules biocompatibility testing was performed in accordance with the standards set forth in ISO 10993-1, Biological Evaluation of Medical Devices and the test results demonstrated that Beta TCP Granules is biocompatible and meets the requirements of the ISO standards.

Beta TCP Granules will be provided as a single use, sterile product. The radiation dose of 25kGy - 40 kGy will be validated in accordance with ISO 11137-2006, Sterilization of Health Care Products - Radiation to Sterility Assurance Level (SAL) 10-6.

The results of risk management indicate that the identified hazards were acceptable and/or mitigated to an acceptable level with the residual risk evaluation deemed as acceptable per defined procedures.

Non-clinical animal data in a large animal, cancellous bone defect model demonstrated that Beta TCP Granules is resorbed over time and allows bone ingrowth as the device is resorbing. Beta TCP Granules maintain the previously demonstrated safety profile of beta-TCP materials and is substantially equivalent to Cerasorb M Ortho (K040216).

Summary of Clinical Tests as required by 21 CFR 807.92 (b) (2)

Beta TCP Granules does not require clinical testing.

Conclusion as required by 21 CFR 807.92 (3)

The manufacturer compared the critical specifications - chemistry, crystallinity, physical form, porosity, dissolution/solubility of Beta TCP Granules with the predicate device. The results indicated that the device characteristics for Beta TCP Granules were the same as those of the predicate device. Non-clinical animal data in a large animal, cancellous bone defect model demonstrated that Beta TCP Granules is resorbed over time and allows bone ingrowth as the device is resorbing. Beta TCP Granules maintain the

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previously demonstrated safety profile of beta-TCP materials and is substantially equivalent to Cerasorb M Ortho (K040216).

the country of the country of the country of the country

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and features the department's name around the perimeter. In the center is a stylized image of an eagle with three lines representing its wings and body. The logo is black and white.

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

March 21, 2013

Skeletal Kinetics, LLC % Ms. Christine Kuo Director, Regulatory Affairs and Quality Assurance 10201 Bubb Road Cupertino, California 95014

Re: K120354

Trade/Device Name: Beta TCP Granules Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: . MQV Dated: February 8, 2013 Received: February 13, 2013

Dear Ms. Kuo:

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

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Page 2 - Ms. Christine Kuo

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Erin Dieith

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): K120354

Device Name: Beta TCP Granules

Indications for Use:

Prescription Use x _ AND/OR (Per 21 CFR 801 Subpart D)

Over-the-Counter Use (21CFR 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 DAGoyne -A

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K120354

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.