(231 days)
Not Found
No
The device description and performance studies focus solely on the material composition and biological properties of a bone graft substitute, with no mention of AI or ML technologies.
Yes.
The device is a bone grafting material used in dental surgery to facilitate bone regeneration and healing, which are therapeutic actions.
No
The device is a bone substitute material used in dental surgery, not a device that identifies or characterizes a disease or 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 it's for use as a bone grafting material in dental surgery. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details a resorbable bone graft material made of porcine cancellous bone. This is a physical material intended to be implanted, not a reagent or instrument used to examine specimens from the human body.
- Performance Studies: The performance studies focus on material composition, biocompatibility, and shelf-life, which are relevant for an implantable device, not for evaluating the performance of a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.), detecting specific analytes, or providing information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. This device is used in vivo (inside the body) for a therapeutic purpose (bone grafting).
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
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 vial or syringe. It is produced by removal of all organic components from porcine bone. The composition of THE Graft Bone Substitute meets the requirements of ASTM F1581 Standard Specification for Composition of Anorganic Bone for Surgical Implants. Due to its natural structure of macro and microscopic structures, the anorganic 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 favored 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.
THE Graft Bone Substitute is not intended to be marketed or sold with multiple components and/or accessories.
| Type | Model No. | Particle Size
(mm) | Capacity | Packaging |
|---|---|---|---|---|
| Cancellous
Granules | TG-AS25 | 0.25 ~ 1.00 mm | 0.25 cc | Syringe +
Tyvek Pouch |
| | TG-AS05 | | 0.50 cc | |
| | TG-AS10 | | 1.00 cc | |
| Cancellous
Granules | TG-BS25 | 1.00 ~ 2.00 mm | 0.25 cc | Syringe +
Tyvek Pouch |
| | TG-BS05 | | 0.50 cc | |
| | TG-BS10 | | 1.00 cc | |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-clinical testing data:
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: "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)
- Pyrogen Testing (ISO 10993-11 / USP , )
- Shelf-Life
All of the acceptance criteria were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 14, 2020
Purgo Biologics Inc. Eun Kim R&D Staff E-607, 700, Pangyo-ro Bundang-gu Seongnam-si, 13516 Kr
Re: K191737
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: July 1, 2020 Received: August 1, 2020
Dear Eun Kim:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Image /page/2/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, connected by a line to the larger circle. 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.
Indication for Use
510(K) Number (if known): K191737
Device Name: The Graft Bone Substitute
Indication 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
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter _ (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
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Image /page/3/Picture/0 description: The image shows the logo for Purgo Dental Biologics Solution. The word "Purgo" is in a large, purple font. To the left of the word "Purgo" is a gray icon that looks like a microscope. To the right of the word "Purgo" are the words "Dental Biologics Solution" in a smaller, purple font.
K191737 510(k) Summary
Submitter
Purgo Biologics Inc. EUN HO KIM E-607, 700, Pangyo-ro, Bundang-gu Seongnam-si, Gyeonggi-do Republic of Korea. 13516 Email: RA@purgo.co.kr Tel. +82-31-698-4969
Device Information
- Trade Name: The Graft Bone Substitute ●
- Common Name: Bone Grafting Material
- Classification Name: Bone Grafting Material, Animal Source
- Product Code: NPM
- Panel: Dental
- Regulation Number: 21 CFR 872.3930
- Device Class: Class II
- Date Prepared: 02/13/2020
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
- K173188, The Graft Bone Substitute by Purgo Biologics Inc. ●
- K162158, Porcine Anorganic Bone Mineral in Delivery Applicator by Collagen Matrix Inc. ●
Indication 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
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 vial or syringe. It is produced by removal of all organic components from porcine bone. The composition of THE Graft Bone Substitute meets the requirements of ASTM F1581 Standard Specification for Composition of Anorganic Bone for Surgical Implants. Due to its natural structure of macro and microscopic structures, the anorganic 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
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Image /page/4/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 line extending to a smaller circle above it. 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.
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 favored 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.
THE Graft Bone Substitute is not intended to be marketed or sold with multiple components and/or accessories.
| Type | Model No. | Particle Size
(mm) | Capacity | Packaging |
|------------------------|-----------|-----------------------|----------|--------------------------|
| Cancellous
Granules | TG-AS25 | 0.25 ~ 1.00 mm | 0.25 cc | Syringe +
Tyvek Pouch |
| | TG-AS05 | | 0.50 cc | |
| | TG-AS10 | | 1.00 cc | |
| Cancellous
Granules | TG-BS25 | 1.00 ~ 2.00 mm | 0.25 cc | Syringe +
Tyvek Pouch |
| | TG-BS05 | | 0.50 cc | |
| | TG-BS10 | | 1.00 cc | |
List of product models seeking clearance in this submission:
Previous submission information:
Previous submission: THE Graft Bone Substitute(K173188)
This submission is to change syringe package material from the predicate.
The glass vial models of THE Graft Bone Substitute remains unchanged from the previous submission K173188.
There is no significant difference between the predicate device and subject device. It is substantially equivalent with the subject device in design, function, material, operational principle.
Summary of Technological Characteristics:
THE Graft Bone Substitute is substantially equivalent to the predicate device; Porcine Anorganic Bone Mineral, in which the basic features, raw materials and intended uses are the same. Any differences between THE Graft Bone Substitute and the predicate device are considered minor or insignificant. Therefore, it does not raise any questions concerning safety and effectiveness when comparing the subject device to its predicate device.
The table in the following pages summarizes the comparison of technical characteristics.
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Image /page/5/Picture/0 description: The image shows the logo for Purgo Dental Biologics Solution. The word "Purgo" is in a large, purple font, and to the left of it is a gray atom-like symbol. To the right of "Purgo" are the words "Dental Biologics Solution" stacked on top of each other in a smaller, purple font.
| Descriptive
Information | THE Graft Bone
Substitute
(This submission) | THE Graft Bone
Substitute
(K173188) | Porcine Anorganic Bone
Mineral in Delivery
Applicator (K162158) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | THE Graft Bone
Substitute is intended
for use as a bone
grafting material in
dental surgery such as:
- Filling of infrabony
periodontal defects - Elevation of
maxillary sinus
floor | THE Graft Bone
Substitute is intended
for use as a bone
grafting material in
dental surgery such as: - Filling of infrabony
periodontal defects - Elevation 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 |
| Material
Source | Porcine Bone | Porcine Bone | Porcine Bone |
| Materials
Composition | Hydroxyapatite | Hydroxyapatite | Calcium phosphate |
| Mineral
Structure | Hydroxyapatite | Hydroxyapatite | Carbonate apatite |
| Form | Granules | Granules | Granules |
| Color | White | White | White |
| Physical
Appearance | Porous, irregular-shaped
particles | Porous, irregular-shaped
particles | Porous, irregular-shaped
particles |
| Product Sizes | 0.25cc, 0.5cc, 1.0cc, | 0.15g, 0.25g, 0.50g,
1.00g, 2.00g, 5.00g,
0.18cc, 0.25cc, 0.5cc,
1.0cc, 2.0cc, and 5.0cc | 0.25cc and 0.5cc |
| Particle Size
Range | 0.25 – 1 mm | 0.2 - 0.355 mm, 0.25 - 1 mm | 0.25 – 1 mm and 1 - 2 mm |
| | and 1 - 2 mm | and 1 - 2 mm | |
| pH | 7.0 | 7.0 | 7.3 ± 0.1 |
| Resorption
Profile | Gradual resorption | Gradual resorption | Gradual resorption |
| Package | Polypropylene syringe in
a single Tyvek Pouch | Glass Vial or glass
syringe in a single Tyvek
Pouch | Pre-loaded into plastic
delivery applicator |
| Sterility | Sterile, SAL 10-6
Gamma irradiation (ISO
-
| 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 logo features a gray atom-like graphic on the left, 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.
Non-clinical testing 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
7
Image /page/7/Picture/0 description: The image contains the logo for Purgo Dental Biologics Solution. The logo consists of a gray atom-like graphic on the left, 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. The overall design is clean and professional, suggesting a focus on scientific or medical solutions within the dental field.
Biocompatibility testing
The biocompatibility evaluation for THE Graft Bone Substitute was conducted in accordance with the International Standard ISO 10993-1: "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.
The device used for testing is as follows: THE Graft Bone Substitute, Syringe Model Model Number: TG-AS10 Particle size: 0.25 ~ 1.00 mm Volume: 1.00 cc Primary packaging: Polypropylene Syringe Secondary packaging: Tyvek pouch Tertiary packaging: Product carton box
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)
- Pyrogen Testing (ISO 10993-11 / USP , ) ●
- . Shelf-Life
All of the acceptance criteria were met.
Conclusion:
Based on the information provided within this Traditional 510(k) submission, Purgo Biologics Inc. concludes that polypropylene syringe models of THE Graft Bone Substantially equivalent in safety and performance to the legally marketed predicate device listed according to the requirements of the Federal Food, Drug, and Cosmetic Act.