(99 days)
Not Found
No
The description focuses on the material composition and physical properties of a bone graft substitute, with no mention of AI or ML technologies.
Yes
The device is described as a bone grafting material intended to fill, augment, or reconstruct defects, which are therapeutic actions.
No
Explanation: The device is a bone grafting material intended for filling and augmenting defects, not for diagnosing conditions.
No
The device description clearly states that Periophil Biphasic is a bone graft substitute, a physical material (ceramic) 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 of Periophil Biphasic is to fill, augment, or reconstruct bone defects in the periodontal or oral/maxillofacial area. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device is a bone graft substitute made of calcium phosphate ceramic. It is implanted into the body to aid in bone repair. This is a medical device used for treatment, not for analyzing samples from the body to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or screening
- Using reagents or assays
In summary, Periophil Biphasic is a medical device used for bone grafting, which is a therapeutic procedure, not an in vitro diagnostic procedure.
N/A
Intended Use / Indications for Use
Periophil Biphasic is intended 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 Biphasic 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 Biphasic is a bone graft substitute. Periophil Biphasic is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% hydroxyapatite (HA) and 40% beta tricalcium phosphate (B-TCP). Periophil Biphasic is available as granules and is provided sterile for single patient use.
Periophil Biphasic is a multidirectional interconnected porosity structure, similar to that of human cancellous bone. Periophil Biphasic slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues. The progressive resorption of Periophil Biphasic resorbable bone filler is intended to prevent premature resorption.
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
SECTION 4
, A
4.0 510K (k) Summary of Safety and Effectiveness
| Trade Name: | Periophil Biphasic | DEC 1 8 2005 |
|---|---|---|
| Common Name: | Synthetic Bone Graft Material | |
| Classification Name: | Bone Filling and Augmentation Material | |
| Official Contact Name: | Victor M. Bowers | |
| VP Medical Affairs | ||
| Address: | Cytophil, Inc. | |
| 2485 Corporate Circle, Suite 2 | ||
| East Troy, WI 53120 | ||
| Phone: | ||
| Fax: | ||
| E-mail: | ||
| Date Prepared: | 262-642-2765 | |
| 262-642-2745 | ||
| vbowers@cytophil.com | ||
| 9/04/2008 |
Kog2788
4.1 Indication for Use
Periophil Biphasic is intended 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 Biphasic 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 Biphasic is a bone graft substitute. Periophil Biphasic is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% hydroxyapatite (HA) and 40% beta tricalcium phosphate (B-TCP). Periophil Biphasic is available as granules and is provided sterile for single patient use.
Periophil Biphasic is a multidirectional interconnected porosity structure, similar to that of human cancellous bone. Periophil Biphasic slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues. The progressive resorption of Periophil Biphasic resorbable bone filler is intended to prevent premature resorption.
4.3 Substantial Equivalence
1
4.8 Summary
In summary, Periophil Biphasic is substantially equivalent to the cited predicate devices. All have the same indication for use. Periophil Biphasic is intended 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 Biphasic 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 Biphasic and the predicate devices are biocompatible, based on the history and use in many medical devices as well as from preclinical testing. Periophil Biphasic is substantially equivalent in indication for use, technical characteristics, and is as safe as the predicate device K051885 - MBCP™ . BIOMATLANTE, ZA DES IV NATIONS, 5, rue Edouard Belin, -F- 44360 VIGNEUX DE BRETAGNE, France.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Mr. Victor M. Bowers Vice President of Medical Affairs Cytophil, Incorporated 2485 Corporate Circle, Unit 2 East Troy, Wisconsin 53120
DEC 1 8 2009
Re: K092788
Trade/Device Name: Periophil Biphasic Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: December 11, 2009 Received: December 16, 2009
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.
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.
3
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 (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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Wh for
Anthony D. 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
4
SECTION 2
2.0 Indications for Use
510(k) Number: KO 42288
Device Name: Periophil Biphasic
Indications for Use:
Periophil Biphasic is intended 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 Biphasic 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 __ or Over-the-Counter Use __
(Per 21 CFR 801.109)
R.S. Betz DDS /Jr Dr. K. P. Muly, (Acting)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092788