(126 days)
Not Found
No
The summary describes a bone graft substitute material and its physical properties, with no mention of software, algorithms, or any AI/ML related terms or functionalities.
No
The device is a bone grafting material for filling, augmenting, or reconstructing bone defects, which assists in the body's natural healing and remodeling processes, rather than directly applying therapy.
No
Explanation: The device description states it is a bone graft substitute used to fill, augment, or reconstruct defects, and it slowly resorbs while being replaced by bone and soft tissues. This describes a therapeutic or reconstructive function, not a diagnostic one.
No
The device description clearly states that Periophil ß -TCP is a bone graft substitute, a physical material (granules) used to fill defects. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Periophil ß -TCP is a bone grafting material used to fill, augment, or reconstruct defects in the body (periodontal or oral/maxillofacial). This is a therapeutic use, not a diagnostic one.
- Device Description: The description details the material composition and physical properties of the bone graft substitute. It does not mention any components or functions related to analyzing samples from the human body to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of providing information about a patient's health status, disease, or condition based on such analysis.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. Periophil ß -TCP is used in vivo (inside the body) for therapeutic purposes.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
LYC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periodontal or oral/maxillofacial defects
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 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.
0
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. Bowers |
| VP Medical Affairs | |
| Address: | Cytophil, Inc. |
| 2485 Corporate Circle, Suite 2 | |
| East 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
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.
4.3 Substantial Equivalence
1
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.
2
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.
3
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
5
SECTION 2
2.0 Indications for Use
510(k) Number: K093871
Device Name: Periophil ß -TCP
Indications 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.
(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.
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