Periophil ß -TCP is indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Periophil ß -TCP can be used with autogenous bone grafting materials. Typical uses include: periodontal/infrabony defects, ridge augmentation, extraction sites (implant preparation/placement), sinus lifts, and cystic cavities.

Device Description

Periophil 8 -TCP is a bone graft substitute. Periophil 3 -TCP is a microporous and macroporous calcium phosphate ceramic consisting of beta tricalcium phosphate (6-TCP). Periophil ß -TCP is available as granules and is provided sterile for single patient use.

Periophil B -TCP is a multidirectional interconnected porosity structure, similar to that of human cancellous bone. Periophil ß -TCP slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues. There is progressive resorption for 4 to 12 months (may vary patient to patient) of Periophil B -TCP resorbable bone filler.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called Periophil β -TCP, a synthetic bone graft material. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, many of the requested details about acceptance criteria, device performance, study design, and ground truth establishment are not explicitly present in this type of regulatory submission. This document highlights biocompatibility, sterilization, and material conformance to standards, which are aspects of safety and effectiveness, but not in the format of a clinical or standalone performance study as typically expected for diagnostic devices.

Here's a breakdown of the information that can be extracted or deduced, and what is absent:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as quantifiable performance targets. The "acceptance criteria" for this 510(k) submission are primarily based on demonstrating substantial equivalence to predicate devices regarding intended use, technological characteristics, safety, and effectiveness. The report indicates compliance with the ASTM F1088 "Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation" for chemical safety (heavy metal trace element levels).
Reported Device Performance:
- Biocompatibility: "non-toxic, non-allergenic, biocompatible, and elicit no inflammation. No adverse effects or foreign body reactions have been reported." This is based on documented history of β-TCP and identical materials to a predicate device (K063634).
- Sterilization: "Sterilized using gamma radiation," validated to "10 SAL" (Sterility Assurance Level).
- Resorption: "slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues. There is progressive resorption for 4 to 12 months (may vary patient to patient)." This is a general characteristic, not a reported performance metric from a specific study within this document.
- Chemical Safety: Conforms to ASTM F1088 for heavy metal trace element levels.

Table (based on available information):

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Devices	Stated to be substantially equivalent to K063634, K051885, and K082917 for indication for use, technical characteristics, and safety/effectiveness. Specifically, "Periophil β -TCP is substantially equivalent in indication for use, technical characteristics, and is as safe as the predicate device K063634 - RTR Syringe."
Biocompatibility (non-toxic, non-allergenic, non-inflammatory)	"well documented" for β-TCP. Utilizes identical materials to K063634 and "has the same type and duration of patient contact." "consistently proven to be non-toxic, non-allergenic, biocompatible, and elicit no inflammation. No adverse effects or foreign body reactions have been reported."
Sterility Assurance Level (SAL)	Achieved "10 SAL" using gamma radiation, validated via overkill methodology.
Chemical Safety (Heavy Metal Trace Elements)	Conforms to "ASTM F1088 "Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation"" required specifications.
Resorbability	"Slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues. There is progressive resorption for 4 to 12 months (may vary patient to patient) of Periophil β -TCP resorbable bone filler." (This is a product characteristic, not a measured performance against a quantitative target from a specific study described here.)
Risk Management (ISO 14971)	Risks identified through a risk assessment procedure in accordance with ISO 14971. (This indicates a process was followed, not specific performance metrics or outcomes).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Explicitly Stated: This document does not describe a clinical performance study with a "test set" in the context of device performance as one might expect for a diagnostic or AI-driven device. The pre-clinical tests performed relate to material specifications (ASTM F1088) and biocompatibility, which typically don't involve "test sets" of patient data in the same way. The biocompatibility claim references "well documented" evidence for β-TCP, implying existing literature, but no specific study with sample size, provenance, or retrospectivity/prospectivity is detailed within this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable / Not Stated: Since there is no described clinical "test set" requiring ground truth establishment, this information is not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not Stated: As there's no clinical test set described, no adjudication method is mentioned.

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 is a bone graft material, not an AI-driven diagnostic device, so an MRMC study and AI assistance effect size are not relevant or discussed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable: This is a physical bone graft material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Explicitly Stated in a clinical context: For the material properties, the "ground truth" is provided by compliance with the ASTM F1088 standard. For biocompatibility, it relies on "well documented" evidence for β-TCP and comparison to the predicate device's materials. No clinical outcomes data or pathology as "ground truth" for a specific performance study is detailed here.

8. The sample size for the training set

Not Applicable: This is not an AI/algorithm-based device and does not involve a training set.

9. How the ground truth for the training set was established

Not Applicable: As above, no training set for an algorithm is involved.

Summary of what the document does provide regarding "proof":

The "study that proves the device meets the acceptance criteria" in this 510(k) submission primarily relies on:

Predicate Device Comparison: Demonstrating substantial equivalence to existing legally marketed devices (K063634, K051885, K082917) in terms of Indications for Use, technological characteristics, safety, and effectiveness.
Compliance with Standards: Conformance to recognized consensus standards like ASTM F1088 for chemical safety.
Material Biocompatibility Documentation: Referencing existing knowledge and safety history of β-TCP as a biomaterial.
Validated Manufacturing Processes: Sterilization validation to a specific SAL.
Risk Assessment: Adherence to standards like ISO 14971 for risk identification.

In essence, this is a regulatory filing focused on establishing substantial equivalence rather than presenting a novel clinical performance study with defined acceptance criteria and performance metrics in the way a new diagnostic or AI device might.

Summary

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K093871

APR 2 2 2010

4.0 510K (k) Summary of Safety and Effectiveness

Trade Name:	Periophil β -TCP
Common Name:	Synthetic Bone Graft Material
Classification Name:	Bone Filling and Augmentation Materia
Official Contact Name:	Victor M. BowersVP Medical Affairs
Address:	Cytophil, Inc.2485 Corporate Circle, Suite 2East Troy, WI 53120
Phone:	262-642-2765
Fax:	262-642-2745
E-mail:	vbowers@cytophil.com
Date Prepared:	12/14/2009

4.1 Indication for Use

Periophil B -TCP is indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Periophil 3 - TCP can be used with autogenous bone grafting materials. Typical uses include: periodontal/infrabony defects, ridge augmentation, extraction sites (implant preparation/placement), sinus lifts, and cystic cavities.

4.2 Product Description

4.3 Substantial Equivalence

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The following are the predicate devices that are substantially equivalent to Periophil ß -TCP:

K063634 - RTR Syringe Septodont C/O Mr. Wayne H. Matelski Arent Fox, PLLC 1050 Connecticut Avenue, NW Washington, District of Columbia 20036-5339

K051885 - MBCP™ BIOMATLANTE ZA DES IV NATIONS 5. rue Edouard Belin -F- 44360 VIGNEUX DE BRETAGNE France

K082917 - Mastergraft Resorbable Ceramic Granules Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132

4.4 Biocompatibility Evaluations

The biocompatibility of B-TCP is well documented. This biomaterial has consistently proven to be non-toxic, non-allergenic, biocompatible, and elicit no inflammation. No adverse effects or foreign body reactions have been reported. Periophil 3 -TCP utilizes identical materials to K063634 - RTR Syringe, and has the same type and duration of patient contact.

4.5 Sterilization

Periophil 3 -TCP is sterilized using gamma radiation. Processing is performed by Steris Isomedix Services, a contract sterilization company, cycle parameters were validated using an overkill methodology to 10 SAL. Sterilization by the user is not required.

4.6 Pre-Clinical Tests Performed

Chemical safety of Periophil 3 - TCP is based on the recognized consensus standard specification ASTM F1088 "Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation". Periophil ß -TCP conforms to the required specifications for heavy metal trace element levels.

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4.7 Risk Assessment

The primary risks with Periophil ß -TCP have been identified through a risk assessment procedure in accordance with ISO 14971.

4.8 Summary

In summary, Periophil ß -TCP is substantially equivalent to the cited predicate devices. All have the same indication for use. Periophil ß-TCP is indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Periophil ß -TCP can be used with autogenous bone grafting materials. Typical uses include: periodontal/infrabony defects, ridge augmentation, extraction sites (implant preparation/placement), sinus lifts, and cystic cavities.

The components used in Periophil 3 -TCP and the predicate devices are biocompatible, based on the history and use in many medical devices, peer reviewed literature, and from preclinical testing. Periophil 3 -TCP is substantially equivalent in indication for use, technical characteristics, and is as safe as the predicate device K063634 - RTR Syringe, Septodont, C/O Mr. Wayne H. Matelski, Arent Fox, PLLC, 1050 Connecticut Avenue, NW, Washington, District of Columbia 20036-5339.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread, which is a common symbol of the United States.

APR 2 2 2010

Public Health Service

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

Mr. Victor M. Bowers Vice President Medical Affairs Cytophil, Incorporated 2485 Corporate Circle, Unit 2 East Troy, Wisconsin 53120

Re: K093871

Trade/Device Name: Periophil B-TCP Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: April 13, 2010 Received: April 15, 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, 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.

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Page 2- Mr. Bowers

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 (OS) 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/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.

h for

Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 2 2.0 Indications for Use

510(k) Number: K093871

Device Name: Periophil ß -TCP

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)

(Division Sign-Off)
Division of Anesthesiology, General Hospital

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K093871

Cytophil, Inc.

2-1

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.