(291 days)
No
The device description and performance studies focus on the material properties and biological interactions of a bone graft substitute, with no mention of AI or ML.
Yes
The device is intended for use as a bone grafting material in dental surgery, which directly addresses a medical condition (bone defects) and promotes healing, thus falling under the definition of a therapeutic device.
No
Explanation: The device is a bone graft substitute intended for use in dental surgery to facilitate bone regeneration, not to diagnose a condition.
No
The device description clearly states it is a resorbable bone graft material made of porcine cancellous bone, which is a physical substance, 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 the device is a bone grafting material for use in dental surgery. This involves direct implantation into the body to support bone regeneration.
- Device Description: The description details a resorbable bone graft material made of porcine cancellous bone. It describes its physical and chemical properties and how it functions within the body during the healing process.
- Lack of In Vitro Diagnostic Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing samples like blood, urine, or tissue.
Therefore, THE Graft Bone Substitute is a medical device intended for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
THE Graft Bone Substitute is intended for use as a bone grafting material in dental surgery such as:
- Filling of extraction sockets to enhance preservation of the alveolar ridge
- Elevation of maxillary sinus floor
Product codes (comma separated list FDA assigned to the subject device)
NPM
Device Description
THE Graft Bone Substitute is a resorbable bone graft material made of porcine cancellous bone consisting of Hydroxyapatite(HA).
THE Graft Bone Substitute is a natural and porous bone mineral matrix available in cancellous granules packaged in a vial or syringe. It is manufactured by removal of most organic components from porcine bone. The composition of THE Graft Bone Substitute meets the requirements of ASTM F1581 Standard Specification for Composition of Anorqanic Bone for Surgical Implants. Due to its natural structure of macro and microscopic structures, the anorqanic bone mineral of THE Graft Bone Substitute is physically and chemically comparable to the mineralized matrix of human bone. When packed into a bony site, THE Graft Bone Substitute is gradually resorbed and replaced with new bone during the healing process. The formation and ingrowth of new bone at the implantation site of THE Graft Bone Substitute is due to its trabecular architecture, interconnecting macro and micro pores and its natural consistency.
THE Graft Bone Substitute is supplied sterile, non-pyrogenic, and for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar ridge, maxillary sinus floor
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental surgery
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)
Mechanical and Physical testing: Non-clinical laboratory performance testing was conducted to confirm that the composition of THE Graft Bone Substitute meets the requirements of ASTM F1581 Standard Specification for Composition of Anorganic Bone for Surgical Implants. This testing was performed in accordance with FDA's Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices, issued on April 28th of 2005.
Biocompatibility testing: The biocompatibility evaluation for THE Graft Bone Substitute was conducted in accordance with the International Standard ISO 10993-1:2009 "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA to further ensure substantial equivalence with the predicate device. Assessment of the candidate device included the following tests: Cytotoxicity (ISO 10993-5), Sensitization Test (ISO 10993-10), Intracutaneous Reactivity (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Subchronic Toxicity Test (ISO 10993-11), Genotoxicity (ISO 10993-3), Implantation Test (ISO 10993-6), Pyrogen Testing, Shelf-Life.
Sterilization: In accordance with ISO 11137-1. THE Graft Bone Substitute is sterilized with gamma radiation with the use of minimum dose 25 kGy for sterility assurance level of 10^-6. Tests included Sterilization Validation (ISO 11137-2), Endotoxin Test, Packaging Validation.
Viral Inactivation: Viral safety validation was performed and the result showed complete inactivation of viruses.
Non-clinical and Clinical Evaluation: In-vivo dog model was performed as well as Clinical data was provided to assess THE Graft and the predicate device as implantable materials.
All of the acceptance criteria were met.
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.
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.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services, which features a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo includes the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" written below in a smaller font.
PURGO BIOLOGICS INC. Hana Jung RA Manager E-607, 700, Pangyo-ro, Bundang-gu Seongnam-si, Gyeonggi-do, Korea
Re: K173188
Trade/Device Name: The Graft Bone Substitute Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPM Dated: June 14, 2018 Received: June 21, 2018
Dear Hana Jung:
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.
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 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);
July 20, 2018
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Mary S. Runner -S For Tina Kiang, Ph.D.
Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K173188
Device Name THE Graft Bone Substitute
Indications for Use (Describe)
THE Graft Bone Substitute is intended for use as a bone grafting material in dental surgery such as:
-
Filling of extraction sockets to enhance preservation of the alveolar ridge
-
Elevation of maxillary sinus floor
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Purgo Dental Biologics Solution. The logo consists of a gray circular icon with a smaller circle inside, followed by the word "Purgo" in a purple, sans-serif font. To the right of "Purgo" are the words "Dental Biologics Solution" stacked vertically, also in a purple, sans-serif font, but smaller in size.
510(k) Summary K173188
l. SUBMITTER
PURGO BIOLOGICS INC. E-607, 700, Pangyo-ro, Bundang-gu Seongnam-si, Gyeonggi-do, Korea Postal Code 13516
Contact Person: Hana Jung Regulatory Affairs Manager Phone: +82 70 4827 4863 Fax: +82 2 549 4003 Email: junghn@purgo.co.kr
Date Revised: 7-20-2018
II. DEVICE
Name of Device: THE Graft Bone Substitute Common or Usual Name: Bone Grafting Material Classification Name: Bone Grafting Material, Animal Source (21 CFR 872.3930) Regulatory Class: Class II (special controls) Product Code: NPM
III. PREDICATE DEVICE
Collagen Matrix Inc. Porcine Anorganic Bone Mineral, K140714
Reference device: Bio-Oss® , K952617 (Geistlich-Pharma)
IV. SPECIAL CONTROLS
FDA Guidance "Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices; Guidance for Industry and FDA Staff" was followed during the preparation of this submission.
510(k) Summary
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Image /page/4/Picture/0 description: The image contains the logo for "Purgo Dental Biologics Solution". The logo features a gray circular icon with a smaller circle inside and a line extending upwards to a small circle, followed by the word "Purgo" in a bold, purple font. To the right of "Purgo" are the words "Dental Biologics Solution" stacked vertically, also in purple.
V. DEVICE DESCRIPTION
THE Graft Bone Substitute is a resorbable bone graft material made of porcine cancellous bone consisting of Hydroxyapatite(HA).
THE Graft Bone Substitute is a natural and porous bone mineral matrix available in cancellous granules packaged in a vial or syringe. It is manufactured by removal of most organic components from porcine bone. The composition of THE Graft Bone Substitute meets the requirements of ASTM F1581 Standard Specification for Composition of Anorqanic Bone for Surgical Implants. Due to its natural structure of macro and microscopic structures, the anorqanic bone mineral of THE Graft Bone Substitute is physically and chemically comparable to the mineralized matrix of human bone. When packed into a bony site, THE Graft Bone Substitute is gradually resorbed and replaced with new bone during the healing process. The formation and ingrowth of new bone at the implantation site of THE Graft Bone Substitute is due to its trabecular architecture, interconnecting macro and micro pores and its natural consistency.
THE Graft Bone Substitute is supplied sterile, non-pyrogenic, and for single use only.
VI. INDICATIONS FOR USE
THE Graft Bone Substitute is intended for use as a bone grafting material in dental surgery such as:
- Filling of extraction sockets to enhance preservation of the alveolar ridge ।
- Grafting of maxillary sinus floor ।
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
THE Graft Bone Substitute is substantially equivalent to the predicate device: Porcine Anorganic Bone Mineral K140714, in which the basic features, raw materials, material composition, intended uses, technological characteristics and performance characteristics are similar.
THE Graft Bone Substitute and the predicate device have similar Indications for Use. Both devices are intended for the same population and sterilized by gamma irradiation. The devices are made of biocompatible calcium phosphate bone mineral derived from porcine cancellous tissue adequate for bone formation. The devices feature trabecular-like characteristics, including interconnected macro and micro pores.
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Image /page/5/Picture/0 description: The image contains the logo for Purgo Dental Biologics Solution. The logo consists of a gray circular icon with a smaller circle inside and a magnifying glass symbol attached to the top left. To the right of the icon, the word "Purgo" is written in a bold, purple font. Further to the right, the words "Dental Biologics Solution" are stacked vertically in a smaller, purple font.
| Item | THE Graft | ZCORE; K140714 | Bio-Oss; K952617 |
|---|---|---|---|
| Indications | |||
| for Use | THE Graft Bone | ||
| Substitute is intended for | |||
| use as a bone grafting | |||
| material in dental surgery | |||
| such as: |
- Filling of extraction sockets
to enhance preservation of
the alveolar ridge - Grafting of maxillary sinus
floor | Porcine Anorganic Bone
Mineral is intended for use in
dental surgery. The products
may be used in surgical
procedures such as: - Augmentation or
reconstructive treatment of
alveolar ridge - Filling of infrabony
periodontal defects - Filling of defects after root
resection, apicoectomy, and
cystectomy - Filling 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 | Geistlich Bio-Oss® is
intended for the following
uses: - Augmentation or
reconstructive treatment of
the alveolar ridge; - Filling of infrabony
periodontal defects; - Filling of defects after root
resection, apicoectomy, and
cystectomy; - Filling of extraction sockets
to enhance preservation of
the alveolar ridge; - Elevation of the maxillary
sinus floor; - Filling of periodontal
defects in conjunction with
products intended for
Guided Tissue Regeneration
(GTR) and Guided Bone
Regeneration (GBR); and - Filling of peri-implant
defects in conjunction with
products intended for
Guided Bone Regeneration
(GER). |
| Material
Source | Porcine | Porcine | Bovine |
| Materials
Composition | Calcium phosphate | Calcium phosphate | Calcium phosphate |
| Mineral
Structure | Hydroxyapatite
containing Carbonate | Carbonate apatite | Hydroxyapatite |
| Form | Granules | Granules | Granules |
| Color | White | White | White |
| Physical
Appearance | Porous, irregular-shaped
particles | Porous, irregular-shaped
particles | Porous, irregular-shaped
particles |
| Particle Size
Range | 0.2 – 0.355 mm,
0.25mm – 1.0mm or
1.00mm – 2.0mm | 0.25mm – 1.0mm or
1.00mm – 2.0mm | 0.25mm – 1.0mm or
1.00mm – 2.0mm |
| Resorption
Profile | Gradual resorption | Gradual resorption | Gradual resorption |
| Package | Glass Vial or Glass
Syringe in a single Tyvek
Pouch | Plastic Jar in a single
Blister Tray with Tyvek
Lid | Glass Vial in a single
Blister Tray with Tyvek Lid |
| Sterility | Sterile, SAL 10-6
Gamma irradiation
(ISO 11137) | Sterile, SAL 10-6
Gamma irradiation
(ISO 11137) | Sterile, SAL 10-6
Gamma irradiation
(ISO 11137) |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Non-pyrogenic |
| Single
Use/Reuse | Single use only | Single use only | Single use only |
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Image /page/6/Picture/0 description: The image contains the logo for "Purgo Dental Biologics Solution". The word "Purgo" is in a large, bold, purple font. To the left of the word is a gray icon that looks like a microscope. To the right of the word "Purgo" is the phrase "Dental Biologics Solution" in a smaller, stacked font.
VIII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Mechanical and Physical testing
Non-clinical laboratory performance testing was conducted to confirm that the composition of THE Graft Bone Substitute meets the requirements of ASTM F1581 Standard Specification for Composition of Anorganic Bone for Surgical Implants. This testing was performed in accordance with FDA's Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices, issued on April 28th of 2005.
Biocompatibility testing
The biocompatibility evaluation for THE Graft Bone Substitute was conducted in accordance with the International Standard ISO 10993-1:2009 "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA to further ensure substantial equivalence with the predicate device.
Assessment of the candidate device included the following tests:
- Cytotoxicity (ISO 10993-5) .
- 0 Sensitization Test (ISO 10993-10)
- Intracutaneous Reactivity (ISO 10993-10) .
- Acute Systemic Toxicity (ISO 10993-11) ●
- Subchronic Toxicity Test (ISO 10993-11) ●
- Genotoxicity (ISO 10993-3) 0
- Implantation Test (ISO 10993-6) 0
- . Pyrogen Testing
- Shelf-Life 0
Sterilization
In accordance with ISO 11137-1. THE Graft Bone Substitute is sterilized with gamma radiation with the use of minimum dose 25 kGy for sterility assurance level of 10 °.
- Sterilization Validation (ISO 11137-2) ●
- Endotoxin Test ●
- Packaging Validation
Viral Inactivation
Viral safety validation was performed and the result showed complete inactivation of viruses.
Non-clinical and Clinical Evaluation
In-vivo dog model was performed as well as Clinical data was provided to assess THE Graft and the predicate device as implantable materials.
All of the acceptance criteria were met.
510(k) Summary
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Image /page/7/Picture/0 description: The image shows the logo for Purgo Dental Biologics Solution. The logo features a gray circular icon with a smaller circle inside and a handle extending from the top. To the right of the icon, the word "Purgo" is written in a bold, purple font. Further to the right, the words "Dental Biologics Solution" are stacked vertically, also in purple.
IX. CONCLUSIONS
Based on the information provided within this 510(k) submission, Purgo Biologics Inc. concludes that THE Graft is substantially equivalent to the legally marketed predicate device listed according to the requirements of the Federal Food, Drug, and Cosmetic Act.