(231 days)
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
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.
This document (K191737) is a 510(k) summary for a medical device called "The Graft Bone Substitute." It is for a bone grafting material used in dental surgery. The document is primarily focused on demonstrating substantial equivalence to a predicate device, not on presenting a clinical study that proves the device meets specific performance acceptance criteria for a diagnostic AI/ML device.
Therefore, most of the requested information regarding acceptance criteria and a study proving device performance (especially for AI/ML aspects like accuracy, sample sizes, expert ground truth, MRMC studies, etc.) is not applicable and not present in this document.
Here's why and what information can be extracted:
- This is a bone graft material, not a diagnostic AI/ML device. The questions are framed around AI/ML device validation (e.g., "effect size of how much human readers improve with AI vs without AI assistance," "standalone algorithm only without human-in-the-loop performance"). This document is about a physical material used in surgery.
- The focus is on "substantial equivalence" to a predicate device. The main purpose of this 510(k) is to show that the new device (with a changed syringe package material) is as safe and effective as a previously cleared device. This is done through non-clinical testing (physical, mechanical, biocompatibility) rather than clinical performance studies comparing it to a "ground truth" to establish diagnostic accuracy.
However, to address the prompt as best as possible given the provided document's content:
The document describes non-clinical testing criteria and their successful completion, which serve as "acceptance criteria" for establishing substantial equivalence for this type of medical device.
1. A table of acceptance criteria and the reported device performance:
Since this isn't a diagnostic AI/ML device, the performance isn't measured in terms of metrics like sensitivity, specificity, or AUC. Instead, the "performance" refers to meeting established standards for bone graft materials and biological safety.
| Test Category | Acceptance Criteria (Implicit from regulatory standards) | Reported Device Performance (as stated in document) |
|---|---|---|
| Mechanical & Physical Testing | Composition of Anorganic Bone for Surgical Implants (ASTM F1581 Standard Specification) | "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." (Implied: Criteria met) |
| Biocompatibility Testing | As per ISO 10993-1: "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing Within a Risk Management Process" and specific ISO 10993 sub-parts. Specific 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 <151>, <85>). | "All of the acceptance criteria were met." (for all listed biocompatibility tests) |
| Shelf-Life | Stability and performance maintained over specified shelf-life. (Not explicitly stated but implied as a required test for this type of device.) | Included in biocompatibility assessment. (Implied: Criteria met, as "All of the acceptance criteria were met" applies to the overall biocompatibility evaluation which includes shelf-life.) |
2. Sample sizes used for the test set and the data provenance:
- Sample Size: Not applicable in the context of human patients or image datasets for AI/ML. The "sample size" here would refer to the number of batches/units of the physical bone graft material tested in the labs. This information is not detailed in the document, nor is it typically provided in a 510(k) summary for material testing.
- Data Provenance: Not applicable in the geopolitical sense (country of origin of data). These are laboratory tests on manufactured materials. The manufacturer is "Purgo Biologics Inc." located in "Seongnam-si, Gyeonggi-do Republic of Korea." The tests are non-clinical, so "retrospective or prospective" does not apply in the typical clinical study sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No human "experts" are establishing ground truth for diagnostic decisions here, as it's a material. Ground truth is based on established laboratory testing standards (ASTM, ISO, USP) and analytical methods performed by qualified laboratory personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This is not a human reader study. Laboratory tests follow predefined protocols and pass/fail criteria.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm.
7. The type of ground truth used:
- For Mechanical and Physical Testing: Ground truth is defined by the ASTM F1581 Standard Specification for Composition of Anorganic Bone for Surgical Implants and FDA's Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.
- For Biocompatibility Testing: Ground truth is defined by International Standard ISO 10993-1 and its sub-parts (e.g., ISO 10993-5, 10993-10, 10993-11) and USP standards (Pharmacopeia). These standards specify the methods and acceptable limits for biological responses.
8. The sample size for the training set:
- Not Applicable. This device does not use an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. No training set is involved.
In summary, this document is a 510(k) summary for a traditional medical device (bone graft material) seeking clearance based on substantial equivalence, not an AI/ML diagnostic device with performance claims needing clinical study validation against human performance or ground truth.
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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
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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 |
|---|---|---|---|---|
| CancellousGranules | TG-AS25 | 0.25 ~ 1.00 mm | 0.25 cc | Syringe +Tyvek Pouch |
| TG-AS05 | 0.50 cc | |||
| TG-AS10 | 1.00 cc | |||
| CancellousGranules | 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.
| DescriptiveInformation | THE Graft BoneSubstitute(This submission) | THE Graft BoneSubstitute(K173188) | Porcine Anorganic BoneMineral in DeliveryApplicator (K162158) |
|---|---|---|---|
| Intended Use | THE Graft BoneSubstitute is intendedfor use as a bonegrafting material indental surgery such as:- Filling of infrabonyperiodontal defects- Elevation ofmaxillary sinusfloor | THE Graft BoneSubstitute is intendedfor use as a bonegrafting material indental surgery such as:- Filling of infrabonyperiodontal defects- Elevation ofmaxillary sinusfloor | Porcine Anorganic BoneMineral is intended foruse in dental surgery.The products may beused in surgicalprocedures such as:- Augmentation orreconstructivetreatment of alveolarridge- Filling of infrabonyperiodontal defects- Filling of defects afterroot resection,apicoectomy, andcystectomy- Filling of extractionsockets to enhancepreservation of thealveolar ridge- Elevation ofmaxillary sinus floor- Filling of periodontaldefects in conjunctionwith productsintended for GuidedTissue Regeneration(GTR) and GuidedBone Regeneration(GBR)- Filling of peri-implant defects inconjunction withproducts intended forGuided BoneRegeneration |
| MaterialSource | Porcine Bone | Porcine Bone | Porcine Bone |
| MaterialsComposition | Hydroxyapatite | Hydroxyapatite | Calcium phosphate |
| MineralStructure | Hydroxyapatite | Hydroxyapatite | Carbonate apatite |
| Form | Granules | Granules | Granules |
| Color | White | White | White |
| PhysicalAppearance | Porous, irregular-shapedparticles | Porous, irregular-shapedparticles | Porous, irregular-shapedparticles |
| 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 SizeRange | 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 |
| ResorptionProfile | Gradual resorption | Gradual resorption | Gradual resorption |
| Package | Polypropylene syringe ina single Tyvek Pouch | Glass Vial or glasssyringe in a single TyvekPouch | Pre-loaded into plasticdelivery applicator |
| Sterility | Sterile, SAL 10-6Gamma irradiation (ISO11137) | Sterile, SAL 10-6Gamma irradiation (ISO11137) | Sterile, SAL 10-6Gamma irradiation (ISO11137) |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Non-pyrogenic |
| SingleUse/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
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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 <151>, <85>) ●
- . 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.
§ 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.