(537 days)
No
The summary describes a biological material graft for bone augmentation and does not mention any computational or analytical functions that would involve AI/ML.
Yes
The device is described for "filling of extraction sockets to enhance preservation of the alveolar ridge" and "filling of bone defects and bone augmentation," which are therapeutic applications involving the treatment and restoration of tissue.
No
The device is described as a material for filling extraction sockets and bone augmentation, acting as a scaffold for new bone growth. It is a regenerative or reconstructive device, not one that identifies or analyzes medical conditions.
No
The device description clearly states it is a physical implant composed of porcine derived bone mineral matrix and collagen, available in various block sizes. It is a physical medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Filling of extraction sockets to enhance preservation of the alveolar ridge." This describes a surgical procedure and a material used within the body, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a bone graft material composed of bone mineral matrix and collagen. This is a therapeutic device intended for implantation.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information
- Using reagents or assays
The device is clearly described as a material for bone grafting and augmentation, which falls under the category of medical devices used for treatment or structural support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
THE Graft Collagen is recommended for:
- Filling of extraction sockets to enhance preservation of the alveolar ridge.
Product codes (comma separated list FDA assigned to the subject device)
NPM
Device Description
THE Graft Collagen, composed of porcine derived bone mineral matrix from cancellous bone and Type I Collagen from porcine tendon. The bone mineral matrix is similar to physical and chemical aspects of the mineralized matrix of human bone. Hydrated collagen components have viscosity that facilitates for blending of the bone mineral matrix. With this characterization, it can be trimmed and/or molded to the various shapes of defects. THE Graft Collagen is sterilized using gamma irradiation and recommended for the patient who needs filling of bone defects and bone augmentation.
THE Graft Collagen is available in various sizes.
| Type | Sizes |
|---|---|
| Block | (Height x Length x Width) |
| 3 x 5 x 7 mm, 5 x 5 x 5 mm, 5 x 5x 10 mm, 7 x 7x 7 mm |
THE Graft Collagen contains 85% The Graft Bone Substitute (K173188) granules and 15% porcine collagen in a block form. The Graft Bone Substitute (K173188) is a porous bone mineral matrix available in cancellous granules made of porcine bone. Granules serve as a scaffold for new bone, and collagen holds the granules not to break away from the implanted site and facilitates handling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar ridge, bone defects
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 performance testing of the subject device was conducted to demonstrate substantial equivalence to the predicate devices. The following performance data are provided in support of the substantial equivalence determination.
· Bench testing was performed to evaluated the physicochemical properties of the device as followings:
- Ca/P ratio
- Residue on ignition
- Heavy metal
- pH
- Compressive strength
· Biocompatibility was evaluated in accordance with ISO 10993-1 as followings:
- Cytotoxicity per ISO 10993-5
- Irritation per ISO 10093-10
- Sensitization per ISO 10993-10
- Genotoxicity per ISO 10993-3
- Acute toxicity per ISO 10993-11
- Subchronic toxicity per ISO 10993-11
- Implantation per ISO 10993-6
- Pyrogenicity per ISO 10993-11
· Material-mediated pyrogenicity testing per ISO 10993-11 and endotoxin testing (LAL, Limulus Amebocyte Lysate) per USP were performed demonstrating non-pyrogenicity.
• Sterilization process validation was performed accordance with ISO 11137 demonstrating a sterility assurance level (SAL) of 10-6.
• Real time aging shelf-life study was performed accordance with ISO 11607 demonstrating product stability and packaging integrity.
- · The control of animal origin materials was performed as followings:
- Controls on sourcing, collection, and handling per ISO 22442-2
- Viral Inactivation per ISO 22442-3
The in-vivo performance of the subject device in a beagle mandibular intraoral model was compared to that of the primary predicate device, Bio-Oss Collagen. Histology, histomorphometry and Micro-CT analyses were conducted for the subject device, primary predicate device and negative control at 4, 8, 12, 16 and 24 weeks. The results demonstrated that the performance of the subject and primary predicate devices was substantially equivalent.
No clinical data from clinical trial were included in this submission.
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 the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
July 24, 2024
Purgo Biologics Inc. Byungsun Kim RA Team Manager #812, 27 Dunchon-daero 457beon-gil, Jungwon-gu Seongnam-si, Gyeonggi-do 13219 KOREA, SOUTH
Re: K230305
Trade/Device Name: THE Graft Collagen Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPM Dated: June 21, 2024 Received: June 24, 2024
Dear Byungsun 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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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,
Sherrill Lathrop Blitzer
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K230305
Device Name THE Graft Collagen
Indications for Use (Describe)
THE Graft Collagen is recommended for:
- Filling of extraction sockets to enhance preservation of the alveolar ridge.
| 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) |
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Image /page/4/Picture/0 description: The image shows the logo for Purgo Dental Biologics Solution. The logo features a gray atom-like symbol 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 on top of each other, also in purple.
510(k) Summary
07/24/2024
1. Company
| Submitter | |
|---|---|
| Name | Purgo Biologics Inc. |
| Address | #812, 27 Dunchon-daero 457beon-gil, Jungwon-gu, Seongnam-si, |
| Gyeonggi-do, Korea 13219 | |
| Phone/Fax | Tel. +82-70-4827-0451, Fax. +82-70-8673-0660 |
| Contact person | Byungsun Kim / RA |
| kimbs@purgobio.com | |
| Summary Date | 07/24/2024 |
2. Device Name
| Trade name | : | THE Graft Collagen |
|---|---|---|
| Regulation number | : | 21 CFR 872.3930 |
| Regulation Description | : | Bone Grafting Material |
| Product code | : | NPM |
| Classification name | : | Bone Grafting Material, Animal Source |
| Device class | : | Class II |
| Classification Panel | : | Dental |
3. Predicate Device
Primary predicate device K122894 Bio-Oss® Collagen
Reference predicate device K173188 The Graft Bone Substitute
5
4. Description
THE Graft Collagen, composed of porcine derived bone mineral matrix from cancellous bone and Type I Collagen from porcine tendon. The bone mineral matrix is similar to physical and chemical aspects of the mineralized matrix of human bone. Hydrated collagen components have viscosity that facilitates for blending of the bone mineral matrix. With this characterization, it can be trimmed and/or molded to the various shapes of defects. THE Graft Collagen is sterilized using gamma irradiation and recommended for the patient who needs filling of bone defects and bone augmentation.
THE Graft Collagen is available in various sizes.
| Type | Sizes |
|---|---|
| Block | (Height x Length x Width) |
| 3 x 5 x 7 mm, 5 x 5 x 5 mm, 5 x 5x 10 mm, 7 x 7x 7 mm |
THE Graft Collagen contains 85% The Graft Bone Substitute (K173188) granules and 15% porcine collagen in a block form. The Graft Bone Substitute (K173188) is a porous bone mineral matrix available in cancellous granules made of porcine bone. Granules serve as a scaffold for new bone, and collagen holds the granules not to break away from the implanted site and facilitates handling.
5. Indication for use
THE Graft Collagen is recommended for:
- Filling of extraction sockets to enhance preservation of the alveolar ridge.
6. Summary of Data to Support Substantial Equivalence
Non-clinical performance testing of the subject device was conducted to demonstrate substantial equivalence to the predicate devices. The following performance date are provided in support of the substantial equivalence determination.
· Bench testing was performed to evaluated the physicochemical properties of the device as followings:
- Ca/P ratio
510(k) Summary
6
Image /page/6/Picture/0 description: The image contains the logo for Purgo Biologics Solution. The logo features a gray atom-like symbol on the left, followed by the word "Purgo" in a bold, purple font. To the right of "Purgo", the words "Dental Biologics Solution" are stacked vertically, also in purple. The overall design is clean and modern, suggesting a focus on scientific or medical solutions.
- Residue on ignition
- Heavy metal
- pH
- Compressive strength
- · Biocompatibility was evaluated in accordance with ISO 10993-1 as followings:
- Cytotoxicity per ISO 10993-5
- Irritation per ISO 10093-10
- Sensitization per ISO 10993-10
- Genotoxicity per ISO 10993-3
- Acute toxicity per ISO 10993-11
- Subchronic toxicity per ISO 10993-11
- Implantation per ISO 10993-6
- Pyrogenicity per ISO 10993-11
· Material-mediated pyrogenicity testing per ISO 10993-11 and endotoxin testing (LAL, Limulus Amebocyte Lysate) per USP were performed demonstrating non-pyrogenicity.
• Sterilization process validation was performed accordance with ISO 11137 demonstrating a sterility assurance level (SAL) of 10-6.
• Real time aging shelf-life study was performed accordance with ISO 11607 demonstrating product stability and packaging integrity.
- · The control of animal origin materials was performed as followings:
- Controls on sourcing, collection, and handling per ISO 22442-2
- Viral Inactivation per ISO 22442-3
The in-vivo performance of the subject device in a beagle mandibular intraoral model was compared to that of the primary predicate device, Bio-Oss Collagen. Histology, histomorphometry and Micro-CT analyses were conducted for the subject device, primary predicate device and negative control at 4, 8, 12, 16 and 24 weeks. The results demonstrated that the performance of the subject and primary predicate devices was substantially equivalent.
510(k) Summary
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Image /page/7/Picture/0 description: The image shows the logo for Purgo Biologics Solution. The logo consists of a gray atom-like symbol on the left, followed by the word "Purgo" in purple. To the right of "Purgo" are the words "Dental Biologics Solution" stacked on top of each other, also in purple. The logo is simple and modern, with a focus on the company's name and area of expertise.
No clinical data from clinical trial were included in this submission.
7. Technological Characteristics and Substantial Equivalence
The following comparison table of the technological characteristics of the subject device and the predicate device outlines and provides the substantial equivalency of the subject device and the predicate.
| | Subject device | Primary
predicate device | Reference
predicate device | Discussion | | | |
|-----------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|--------------------|------------|
| Device name | THE Graft Collagen | Bio-Oss® Collagen | The Graft Bone Substitute | - | | | |
| Manufacturer | Purgo Biologics Inc. | Geistlich Pharma Ag | Purgo Biologics Inc. | - | | | |
| 510(k) Number | K230305 | K122894 | K173188 | - | | | |
| Product Code | NPM | NPM | NPM | Same | | | |
| Indication for
Use | 1) Filling of extraction
sockets to enhance
preservation of the
alveolar ridge. | 1) Augmentation or
reconstructive treatment
of the alveolar ridge.
2) Filling of periodontal
defects.
3) Filling of defects after
root resection,
apicoectomy, and
cystectomy.
4) Filling of extraction
sockets to enhance
preservation of the
alveolar ridge.
5) Elevation of the maxillary
sinus floor.
6) Filling of periodontal
defects in conjunction
with products intended for | 1) Filling of extraction
sockets to enhance
preservation of the
alveolar ridge.
2) Grafting of maxillary
sinus floor | Equivalent
The indication for
Use of the subject
device is a subset of
that of the primary
predicate device. | | | |
| | | Guided Tissue
Regeneration (GTR) and
Guided Bone
Regeneration (GBR).
7) Filling of peri-implant
defects in conjunction
with products intended for
Guided Bone
Regeneration (GBR). | | | | | |
| Function | | The Graft Collagen
contains 85% The Graft
Bone Substitute granules
and 15% porcine
collagen.
Granules serve as a
scaffold for new bone.
Collagen holds the
granules and facilitates
handling. | Bio-Oss® Collagen contains
90% Bio-Oss® granules and
10% porcine collagen.
Granules serve as a scaffold
for new bone. Collagen
holds the granules and
facilitates handling. | The Graft Bone Substitute
granules serve as a
scaffold for new bone. | Equivalent | | |
| | Material
Composition | | • Porcine-derived
hydroxyapatite bone
mineral
• Porcine-derived
type I collagen | • Bovine-derived
hydroxyapatite bone
mineral
• Porcine-derived
type I collagen | • Porcine-derived
hydroxyapatite bone
mineral | Equivalent | |
| | | Form | | Block | Block | Granules | Equivalent |
| | | Color | | White to off-white | White to off-white | White to off-white | Same |
| | Size | | 3 x 5 x 7 mm,
5 x 5 x 5 mm,
5 x 5x 10 mm,
7 x 7x 7 mm, | 2.5 x 5 x 7.5 mm (50mg)
5 x 5 x 7 mm (100mg)
7 x 7 x 7 mm (250mg)
10 x 10 x 7 mm (500mg) | 0.15g, 0.25g, 0.5g, 1.0g,
2.0g, 5.0g | Equivalent | |
| | | Biocompatibility | | Biocompatible | Biocompatible | Biocompatible | Same |
| | | Sterilization | | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | Same |
| Sterility | | | Sterile, SAL 10-6 | Sterile, SAL 10-6 | Sterile, SAL 10-6 | Same | |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Non-pyrogenic | Same | | | |
| Use | Prescription | Prescription | Prescription | Same | | | |
| Single Use Only | Yes | Yes | Yes | Same | | | |
Comparison of Characteristics
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Image /page/8/Picture/0 description: The image contains the logo for Purgo Biologics Solution. The logo features a gray circular icon with a smaller circle inside, resembling a magnifying glass. 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.
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Image /page/9/Picture/0 description: The image shows the logo for Purgo Dental Biologics Solution. The logo features a gray atom-like symbol on the left, followed by the word "Purgo" in purple. To the right of "Purgo" are the words "Dental Biologics Solution" stacked vertically, also in purple. The logo is clean and modern, suggesting a focus on scientific and biological solutions for dental care.
The subject device is substantially equivalent to the primary predicate device K122894 in indication for use, function, material, design, biocompatibility and sterilization. Differences include the size range, composition of bone mineral and collagen, and animal origin of bone mineral.
Discussion on the differences
-
· Size range
-
The subject and primary predicate devices can be trimmed to fit the defect shapes, so the sizes do not affect usage.
-
Composition of bone mineral and collagen
-
The subject device contains 85% The Graft Bone Substitute (K173188) granules and 15% porcine collagen. The primary predicate device contains 90% Bio-Oss® granules and 10% porcine collagen. In both devices, granules serve as a scaffold for new bone and collagen is used to hold the granules. So, composition of collagen does not affect to the intended use.
-
· Animal origin of bone mineral
- Bone mineral of the subject device is derived from porcine and that of the predicate device is derived from bovine. The animal origin is different, but the safety of material was verified through biocompatibility tests and virus inactivation validation.
8. Conclusion
Based on the information provided, the subject device is substantially equivalent to the primary predicate device.