(513 days)
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No
The summary describes a bone substitute material, which is a physical substance, and there is no mention of software, algorithms, or any computational processing that would involve AI/ML.
No
The device is a bone filling augmentation material used for reconstruction and preservation, which are considered restorative and preventative measures, not therapeutic in the sense of treating a disease or disorder.
No
The device is described as a "bone filling augmentation material" used for reconstruction and filling, which indicates a therapeutic or restorative purpose rather than a diagnostic one.
No
The device description and intended use clearly describe a physical bone substitute material, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a material used for augmentation and reconstruction of bone in the mouth (alveolar ridge, periodontal defects, extraction sockets). This is a surgical or therapeutic application, not a diagnostic one.
- Lack of Diagnostic Activity: IVDs are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. The description of the BBP™ Bone Substitute does not involve any such examination of specimens. It is a material being placed into the body.
- No Mention of Diagnostic Processes: The description doesn't mention any processes related to analyzing biological samples, detecting markers, or providing diagnostic information.
Therefore, the BBP™ Bone Substitute falls under the category of a medical device used for surgical or therapeutic purposes, not an IVD.
N/A
Intended Use / Indications for Use
The BBP™ Bone Substitute is a bone filling augmentation material used for augmentation or reconstruction of the alveolar ridge, filling of periodontal bony defects, and filling of extraction sockets to enhance preservation of alveolar ridge.
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
alveolar ridge
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)
Not Found
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2004
OCT USA, Incorporated C/O Mr. Kevin Walls Principal Consultant Regulatory Insight, Incorporated 13 Red Fox Lane Littleton, Colorado 80127
Re: K030195
Trade/Device Name: BBP Bone Substitute Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LYC Dated: April 8, 2004 Received: April 9, 2004
Dear Mr. Walls:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reveal 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, of to arrives and Cosmetic Act (Act) that do not require approval of a premarket the Federal F 600; Drag). You may, therefore, market the device, subject to the general approvisions 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 such additional controls. Existing major regulations affecting (1 Nr.), It may of stay of 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.
1
Page 2 - Mr. Walls
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advisod that 1 Dr. e levels mination that your device complies with other requirements mount mat r Dr mas mass statutes and regulations administered by other Federal agencies. of the Act of ally I oderal butter are quirements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice alla listing (21 CFR Part 867), lability (2) regulation (21 CFR Part 820); and if requirements as set form in the quality sion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to objact finding of substantial equivalence of your device to a premarket nothreation. - The PDF 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), IT you desire specific at 110 to 10 years at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Driver (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu-Liang, Ph.D.
Chiu Lin, Ph.D. Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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K030195 510(k) Number (if known):
BBP™ Bone Substitute Device Name:
- Indications for Use: The BBP™ Bone Substitute is a bone filling augmentation material used for augmentation or reconstruction of the alveolar ridge, filling of periodontal bony defects, and filling of extraction sockets to enhance preservation of alveolar ridge.
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices 510(k) Number _ × Prescription Use (Per 21 CFR 801.109)
Anesthesiology, General Hospital.
510(k) Number: K630195