(595 days)
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No
The document describes a bone graft material and does not mention any computational or analytical capabilities, let alone AI/ML.
Yes
The device is intended for augmentation or reconstructive treatment of various defects, which falls under therapeutic use.
No
The device is described as "Anorganic Bovine Bone" and its intended use is for filling various types of defects, augmentation, and preservation, which are all therapeutic or reconstructive actions, not diagnostic ones.
No
The device description explicitly states "Anorganic Bovine Bone," indicating a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used for surgical procedures to augment or reconstruct bone defects in the body (alveolar ridge, periodontal defects, etc.). This is a therapeutic or reconstructive use, not a diagnostic one.
- Device Description: The device is described as "Anorganic Bovine Bone," which is a material used for bone grafting. This is a physical material implanted or used in a surgical procedure, not a reagent or instrument used to test samples from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to physically fill or augment bone defects.
N/A
Intended Use / Indications for Use
Augmentation or reconstructive treatment of alveolar ridge s also of any indeasal defects Filling of periodontal defects Filling of defects after root resection, apicoectony, and cyscecomy, and cyscecomy of the also and of and and and and enhance preservarion of- the alveola Filling of defects after root teseccion, approactory, and of the alvestar ridge Elevacion of maxillary sinus floor Filling of periodontal defects in conjunction with products intended for Filling of periodontal defects in conjunector aren production (GBR). Guided Tissue Regeneration(GTR) and Guided Bone Regeneration(GBR). villag of peri-implant defects in conjunction with products intended for the before Bear archier/GRP) Guided Bone Regeneration (GBR)
Product codes
LYC
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" written around it. Inside the circle is a stylized image of an eagle or bird with outstretched wings.
SEP 1 5 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 : K970321 Bio-Oss® Anorganic Bovine Bone Trade Name: Regulatory Class: Unclassified Product Code: LYC Dated: May 14, 1998 Received: May 14, 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 against 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. A 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 through 542 of the Act for devices ander of other Federal laws or requlations.
This letter will allow you to begin marketing your device as Info recter will ario (k) premarket notification.
described in your 510 (k) premarket of your dowige The FDA described in your 510(x) pivalence of your device to a legally marketed predicate device results in a classification for your marketed predicate device readite in a sized.
device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling II you desire Bpccirie and additionally 809.00 for in vitro diagnostic devices), please contact the Office of vitro diagnostic devices), prease othoually, for questions on Compilance at (501) 334 403ng of your device, please contact the Office of Compliance at (301) 594-4639. Àlso, please note the regulation entitled, "Misbranding by reference to Other general · ' premarket notification" (21CFR 807.97). premation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance oblained from the Drylaion of Omars Handressed on 1301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Clus E/sn
Struther L. Ulothski
Imothy A. Ulatows Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
1970321 510(k) Number (if known): _ Anorganic Device Name: BI0-OSS Indications For Use: Augmentation or reconstructive treatment of alveolar ridge
s also of any indeasal defects Filling of periodontal defects Filling of defects after root resection, apicoectony, and cyscecomy, and cyscecomy
of the also and of and and and and enhance preservarion of- the alveola Filling of defects after root teseccion, approactory, and of the alvestar ridge Elevacion of maxillary sinus floor Filling of periodontal defects in conjunction with products intended for Filling of periodontal defects in conjunector aren production (GBR).
Guided Tissue Regeneration(GTR) and Guided Bone Regeneration(GBR). villag of peri-implant defects in conjunction with products intended for
the before Bear archier/GRP) Guided Bone Regeneration (GBR)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
coursence of CDRH Office
Susan Dunphy
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K970321
Prescription Use
(Per 21 CFR 801.109)
.. . . . . . .
OR
Over-The Counter Use
(Optional Formal 1-2-96)