Osteophil B-TCP is a resorbable bone void filler intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

Device Description

Osteophil B-TCP is a porous calcium phosphate resorbable bone void filler for the repair of bony defects. The product consists of beta-Tricalcium Phosphate and is about 80% porous. The product is provided sterile and is available in granules 1-4 mm². Osteophil B-TCP has a multidirectional interconnected porosity structure, similar to that of human cancellous bone. Osteophil B-TCP slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues. The progressive resorption of Osteophil B-TCP resorbable bone filler is intended to prevent premature resorption.

AI/ML Overview

The provided document describes the Osteophil B-TCP device, a resorbable bone void filler. The submission is a 510(k) premarket notification, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. Therefore, the "acceptance criteria" and "study" described are focused on proving this substantial equivalence rather than on a clinical trial to establish device performance against specific clinical acceptance criteria.

Here's an analysis of the provided information:

Acceptance Criteria and Reported Device Performance

The document states that Osteophil B-TCP has "substantially equivalent critical specifications" and "substantially equivalent technical characteristics" as its predicate device, CAMCERAM TCP (K050357). The acceptance criteria are implicitly that all listed characteristics are substantially equivalent to the predicate. The "reported device performance" is that the device met these equivalence criteria through testing.

Characteristic	Acceptance Criteria (Substantially Equivalent to Predicate)	Reported Device Performance
Device Design	YES	YES
Material Characterization	YES	YES
Biocompatibility	YES	YES
Sterilization	YES	YES
Identification of Device Material	YES	YES
Additives	NA*	NA
Ca/Phosphorus Ratio	YES	YES
Elemental Analysis	YES	YES
X-Ray Diffraction Patterns	YES	YES
Dimensional Specifications	YES	YES
Physical Form of the Device	YES	YES
Device Density	YES	YES
Device Mass	YES	YES
Device Volume	YES	YES
Device Porosity (Total Porous Volume, Pore Diameter, Interconnectedness)	YES	YES
pH Testing	YES	YES
Dissolution Testing (mg/L/hr)	YES	YES
Energy Source	NA*	NA
Chemical Composition by XRD spectra (Phases present, Ca:P ratio)	YES	YES
Physical Properties (Physical Form, Dimensional Specifications, Porosity, Bulk density)	YES	YES
Performance Testing (pH, In vitro dissolution rate, Animal testing for bone in-growth and resorption)	YES	YES

*NA indicates 'Not Applicable', as described in the document.

Study Details

The study conducted is a bench and animal testing comparison study to demonstrate substantial equivalence to the predicate device, K050357 (CAMCERAM TCP). This is not a clinical study on human subjects but a comparison of technical and performance attributes.

Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated as a single "sample size" number in terms of human subjects or distinct clinical cases, as this is primarily a bench and animal study. For the specific technical characteristics, standard laboratory test methods were used, implying internal samples sizes as required for those tests (e.g., multiple samples for chemical analysis, dissolution testing). The document mentions "Animal testing to determine bone in-growth and resorption of the implant over time," which would involve an animal cohort, but its size is not specified.
- Data provenance: Not explicitly stated. Given it's a 510(k) submission for a medical device manufacturer (Cytophil, Inc. in East Troy, WI, USA), the testing would likely have been conducted in a laboratory setting, potentially internal or outsourced, presumably in the USA. The data is retrospective in the sense that it evaluates pre-existing device characteristics against a predicate rather than prospective clinical outcomes.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) submission. "Ground truth" in this context refers to the established standards and properties of the predicate device and the new device as determined by laboratory analyses and animal studies, not by expert human interpretation of images or clinical data.
Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical trials or diagnostic studies involving human interpretations, where conflicts in expert opinions need resolution. Here, the "truth" is determined by scientific measurement and comparison.
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 is not a diagnostic imaging device or an AI-assisted device. Therefore, no MRMC study was conducted, and there's no concept of human readers improving with or without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical resorbable bone void filler, not an algorithm or AI system.
The type of ground truth used:
- The "ground truth" for demonstrating substantial equivalence was established through standardized laboratory test methods for chemical composition, physical properties, pH, in vitro dissolution rate, and animal testing for bone in-growth and resorption. The predicate device's established characteristics serve as the benchmark for comparison.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set. The "training" for such a device would be the R&D and manufacturing process to ensure it consistently meets its specifications.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of this device and submission type.

Summary

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Chapter 5 510(k) Summary [per 21 CFR 807.92(c)]

5. 510(k) Summary as required by section 807.92(c)
5.1. FDA Contact Person		5.3. 510(k) Preparer/submitter
Victor Bowers		Victor Bowers
VP Medical Affairs		VP Medical Affairs
Phone (262) 642-2765Cell (262) 581-5161Fax (262) 642-2745Email vbowers@cytophil.com		Cytophil, Inc.
5.2. 510(k) Owner		2485 Corporate Circle, Suite 2
William G. Hubbard Ph.D.		East Troy, WI 53120
President & CEO		Phone (262)642-2765
Cytophil, Inc.		Cell (262) 581-5161
2485 Corporate Circle, Suite 2		Fax (262) 624-2745
East Troy, WI 53120		Email vbowers@cytophil.com
Phone (262)642-2765
Cell (262) 757-3081
Fax (262) 624-2745
Email bhubbard@cytophil.com
[807.92(a)(1)]
5.4. Device Name[per 807.92(a)(2)]
Trade (proprietary) name :	Osteophil B-TCP
Common name:	Synthetic Bone Graft Material

Resorbable Calcium Salt Bone Void Filler Classification name:

5.5. Legally Marketed device to which your firm is claiming equivalence [807.92(a)(3)]

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Equivalent legally marketed Device title	510(k) number
CAMCERAM TCP	K050357

5.6. Description of the device [807.92(a)(4)]

Osteophil B-TCP has a multidirectional interconnected porosity structure, similar to that of human cancellous bone. Osteophil B-TCP slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues. The progressive resorption of Osteophil B-TCP resorbable bone filler is intended to prevent premature resorption.

5.7. Intended use of the device [807.92(a)(5)]

This intended use of the device is identical to and, therefore, equivalent to predicate K050357 -CAMCERAM TCP.

5.8. Summary of the technological characteristics of your device compared to the predicate device. [807.92(a)(6)]

Osteophil B-TCP has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device, K050357 - CAMCERAM TCP. Following is a summary of the technological characteristics of Osteophil B-TCP in comparison to those of the predicate device, K050357 - CAMCERAM TCP.

Characteristic	Substantially Equivalent?	Impact on Safety & Performance
Device
Design	YES	None
Material Characterization	YES	None
Biocompatibility	YES	None
Sterilization	YES	None
Physical Properties
Identification of Device Material	YES	None
Additives	NA	NA
Ca/Phosphorus Ratio	YES	None

² 1-4 mm equals 1000 – 4000 um

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Elemental Analysis	YES	None
X-Ray Diffraction Patterns	YES	None
Dimensional Specifications	YES	None
Physical Form of the Device	YES	None
Device Density	YES	None
Device Mass	YES	None
Device Volume	YES	None
Device Porosity
• Total Porous Volume	YES	None
• Pore Diameter	YES	None
• Interconnectedness	YES	None
pH Testing	YES	None
Dissolution Testing (mg/L/hr)	YES	None
Energy Source	NA	NA

Osteophil B-TCP has substantially equivalent critical specifications as CAMCERAM TCP -K050357.

Osteophil B-TCP has substantially equivalent technical characteristics as the predicate K050357 -CAMCERAM TCP. The chemical and physical characteristics are compared in section 11.2. These characteristics include the following:

. Chemical Composition by XRD spectra
- o Phases present
- o Ca:P ratio
. Physical Properties
- o Physical Form
- Dimensional Specifications o
- Porosity o
- Bulk density o
. Performance Testing
- o pH
- o In vitro dissolution rate
- Animal testing to determine bone in-growth and resorption of the implant over o time

The characteristics were evaluated by performing testing using standardized laboratory test methods. The test results demonstrate the substantial equivalence of the technical characteristics of Osteophil B-TCP to the predicate.

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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & S" is arranged vertically along the left side of the logo.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Cytophil, Inc. % Victor M. Bowers 2485 Corporate Circle, Suite 2 East Troy. WI 53120

DEC 2 7 2010

Re: K102937

Trade/Device Name: Osteophil B-TCP Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: September 28, 2010 Received: October 4, 2010

Dear Mr. Bowers:

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. Ilsting 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 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutlTDA/CentersOffices/CDRH/CDRHOffices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Neil Ogden for

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

Enclosure

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4. Indication for Use Statement

DEC 2 7 2010

4.1. 510(k) Number

(If known): K 102937

4.2. Device Name

Osteophil B-TCP

4.3. Indications for Use

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X or Over-the-Counter Use _ [Per 21 CFR 801.109]

Nilk & Oyler
(Division Sign-Off)
for mxm

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102937

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.