(299 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use and anatomical sites described are consistent with traditional bone graft materials.
No
The device is used for augmentation or reconstructive treatment, filling various types of defects, elevating the maxillary sinus floor, and enhancing preservation of the alveolar ridge, which are all structural or restorative functions rather than treating a disease or disorder.
No
The Intended Use/Indications for Use describe reconstructive treatments and filling of defects, which are therapeutic procedures, not diagnostic ones.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. The "Intended Use" and "Anatomical Site" sections describe the application of a device, but do not specify its nature (software, hardware, or a combination). Without a description of the device itself, it's impossible to ascertain if it's solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to surgical procedures and the repair or augmentation of bone and tissue within the mouth and jaw. These are clinical procedures performed directly on the patient's body.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. The intended uses described here do not involve the analysis of such specimens.
- Device Description: While the device description is "Not Found," the intended uses clearly point to a device used in vivo (within the living body) rather than in vitro (in a lab setting).
Therefore, this device falls under the category of a surgical or implantable device, not an IVD.
N/A
Intended Use / Indications for Use
Augmentation or reconstructive treatment of alveolar ridge Filling of periodontal defects Filling of defects after root resection, apicoectomy, and cystectomy rilling of extraction sockets to enhance preservation of the alveolar ridge Elevation of maxillary sinus floor
Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration(GTR) and Guided Bone Regeneration(GBR).
Filling of peri-implant defects in-conjunction with products-intended for Guided Bone Regeneration(GBR)
Product codes
LYC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar ridge, periodontal, maxillary sinus, peri-implant
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.
Not Found
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
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or other bird, with its wings spread.
SEP 1 6 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Geistlich-Pharma C/O Mr. Peter S. Reichertz Attorneys at Law Arent Fox Kintner and Kahn, PLLC 1050 Connecticut Avenue, NW Washington, DC 20036-5339
Re : K974399 Bio-Oss Collagen Trade Name: Regulatory Class: Unclassified Product Code: LYC Dated: August 11, 1998 Received: August 18, 1998
Dear Mr. Reichertz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Reichertz
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general ---information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices ... ... ... Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
S 10(k) Nunber (if known): K974399
Device Name: __ BI0-0SS Collagen
Indications For Use:
Augmentation or reconstructive treatment of alveolar ridge Filling of periodontal defects Filling of defects after root resection, apicoectomy, and cystectomy rilling of extraction sockets to enhance preservation of the alveolar ridge Elevation of maxillary sinus floor
Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration(GTR) and Guided Bone Regeneration(GBR).
Filling of peri-implant defects in-conjunction with products-intended for Guided Bone Regeneration(GBR)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEROPED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device
510(k) Number
Prescription Use 1 (Per 21 CFR 801.109) OR
Over-The-Counter Use