(127 days)
S1 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, apicocectomy, and cystectomy
- · Filling of extraction sockets to enhance preservation of the alveolar ridge
- · Elevation of the maxillary sinus floor
· Filling of periodontal defects in conjuncts 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 (GBR).
S1 is intended for filling and augmentation of bony voids and gaps in maxillofacial surgery, implantology, and periodontology according to the intended use of the product.
S1 is serving as a matrix consisting of interconnected macro- and micropores. The material is porous and has inner surface area.
S1 is a mixture of Hydroxyapatite (HAp) and hydroxypropyl methylcellulose (HPMC). Hydroxyapatite (HAp) is made from bovine cancellous bone and is mineralized hydroxyapatite.
The bone particle size is 0.2 ~ 1.0mm for the powder type and 1.0 ~ 2.0 mm for the chip type. S1 is packaged in vials and it is supplied sterile by gamma irradiation and is for single use only.
The provided text describes a 510(k) submission for a bone grafting material called "S1," manufactured by MedPark Co., Ltd. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
However, the document does not contain any information about an AI/ML-based medical device or a study proving its performance against specific acceptance criteria for such a device. The device "S1" is a physical bone grafting material, and the tests described are non-clinical (physical, chemical, biocompatibility, sterilization, packaging, and animal studies) typically performed for such medical implants.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are relevant to AI/ML device evaluations, not to the physical bone grafting material described in this document.
The document focuses on comparing the physical, chemical, and biological properties of S1 to predicate bone grafting materials (Geistlich Bio-Oss® and MBCP Gel™) to demonstrate substantial equivalence for regulatory clearance.
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October 13, 2023
MedPark Co., Ltd. Woojong Kim Official Correspondent Busan Venture Tower 606-ho, 22, Mora-ro Sasang-gu, Busan KOREA, SOUTH
Re: K231672
Trade/Device Name: S1 Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPM Dated: July 04, 2023 Received: July 17, 2023
Dear Woojong 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.
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"
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(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 OS 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.
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
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231672
Device Name
ਟ I
Indications for Use (Describe)
S1 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, apicocectomy, and cystectomy
- · Filling of extraction sockets to enhance preservation of the alveolar ridge
- · Elevation of the maxillary sinus floor
· Filling of periodontal defects in conjuncts 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 (GBR).
| Type of Use (Select one or both, as applicable) |
|---|
| Research involving NIH-funded Stem Cells Grantee-owned or held Stem Cells for future use |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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| Image: MedPark logoYour Reliable Partner | 510(k) Submission Files | Revision No.0 |
|---|---|---|
| Revision DateOctober-13-2023 | ||
| S1 | Page1 / 7 |
K231672
Submitter
MedPark Co., Ltd. Woojong Kim 24, Nakdong-daero 1570 beon-gil, Buk-gu, Busan Republic of Korea Email: qm@medpark.net Phone: +82-51-301-8777 Fax: +82-50-5877-7778
Official Correspondent
MedPark Co., Ltd. Woojong Kim Busan Venture tower 606-ho, 22, Mora-ro, Sasang-gu, Busan, Republic of Korea Email: qm@medpark.net Phone: +82-51-301-8777 Fax: +82-50-5877-7778
Device Information
- Trade Name: S1
- Common Name: Bone Grafting Material
- Classification Name: Bone Grafting Material, Animal Source
- Device Panel: Dental
- Regulation Number: 21 CFR 872.3930
- Product Code: NPM
- Device Class: Class II
- Date Prepared: O October/13/2023
Primary Predicate
The subject device is substantially equivalent to the following predicate device
- · K122894, Geistlich Bio-Oss® manufactured by Geistlich Pharma AG
Reference Device
- K060732, MBCP Gel™ manufactured by BIOMATLANTE
Indication for Use
S1 is intended for the following uses:
- Augmentation or reconstructive treatment of the alveolar ridge
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| Image: MedPark logoYour Reliable Partner | 510(k) Submission Files | Revision No. | 0 |
|---|---|---|---|
| S1 | Revision Date | October-13-2023 | |
| Page | 2 / 7 |
- . Filling of infrabony periodontal defects
- Filling of defects after root resection, apicocectomy, 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)
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
Device Description
S1 is intended for filling and augmentation of bony voids and gaps in maxillofacial surgery, implantology, and periodontology according to the intended use of the product.
S1 is serving as a matrix consisting of interconnected macro- and micropores. The material is porous and has inner surface area.
S1 is a mixture of Hydroxyapatite (HAp) and hydroxypropyl methylcellulose (HPMC). Hydroxyapatite (HAp) is made from bovine cancellous bone and is mineralized hydroxyapatite.
The bone particle size is 0.2 ~ 1.0mm for the powder type and 1.0 ~ 2.0 mm for the chip type. S1 is packaged in vials and it is supplied sterile by gamma irradiation and is for single use only.
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| Image: MedPark logoYour Reliable Partner | 510(k) Submission Files | Revision No. | 0 |
|---|---|---|---|
| S1 | Revision Date | October-13-2023 | |
| Page | 3 / 7 |
Summary of Technological Characteristics
| Descriptive Information | Subject Device | Primary Predicate | Reference Predicate | Remark | |
|---|---|---|---|---|---|
| K number | Unknown | K122894 | K060732 | ||
| Manufacturer | MedPark Co., Ltd. | Geistlich Pharma Ag | BIOMATLANTE | ||
| Model (Device name)/ Type (Product name) | S1 | Bio-Oss® | MBCP Gel™ | ||
| Product Code | NPM | NPM | LYC | Same | |
| Regulation number | 21CFR872.3930 | 21CFR872.3930 | 21CFR872.3930 | Same | |
| Intended Use | Intended for filling of bonedefects and bone augmentation | Intended for filling of bonedefects and bone augmentation | Intended for use as bonegrafting material to fill,augment or reconstruct osseousbone defects in particular inperiodontal oral/maxillofacialapplications. | Same | |
| Target Population | Adults ( => 22 years old ) | Adults | Adults | Same | |
| Anatomical site | Oral, periodontal | Oral, periodontal | Oral, periodontal | Same | |
| DeviceDesign | SourceBone | Bovine bone- Cancellous | Bovine bone- Cancellous | Biphasic Calcium Phosphate(60% Hydroxyapatite and 40%beta-Tricalcium Phosphate) | Similar |
| Particle sizerange | 0.2 - 1.0 mm1.0 - 2.0 mm | 0.25 - 1.0 mm1.0 - 2.0 mm | 0.5 - 1.0 mm | Similar | |
| Form | Granules | Granules | Granules (Putty type) | Same | |
| Reusable | Single Use only | Single Use only | Single Use only | Same | |
| Sterilization | Gamma Irradiation | Gamma Irradiation | Not identified | Same | |
| Compositionof Materials | Chemicalcomposition | Hydroxyapatite with excipientvehicle of pharmaceutical gradequality (hydroxypropyl-methylcellulose) | Hydroxyapatite | Biphasic Calcium Phosphatewith excipient vehicle ofpharmaceutical grade quality(hydroxypropyl-methylcellulose) | Different(Biocompatibility,animalperformance, andbench testing wasperformed to |
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| MedParkYour Reliable Partner | 510(k) Submission Files | Revision No. | 0 |
|---|---|---|---|
| S1 | Revision Date | October-13-2023 | |
| Page | 4 / 7 |
| demonstratesubstantialequivalence.) | |||||
|---|---|---|---|---|---|
| PhysicalProperties | Phasepurity | Ca5(PO4)3(OH) (≥95%) | Ca5(PO4)3(OH) (≥95%) | Not identified | Same |
| Shelf-life | 2 years | 3 years | Not identified | The Validation ofGammaSterilization(Report No.210107-E-2) | |
| Performance | Bone formation | Bone formation | Bone formation | Same | |
| Biocompatibility | Yes | Yes | Yes | Same | |
| Indication for use | S1 is intended for the followinguses:• Augmentation orreconstructive treatment of thealveolar ridge;• Filling of infrabonyperiodontal defects;• Filling of defects after rootresection, apicoectomy, andcystectomy;• Filling of extraction socketsto enhance preservation of thealveolar ridge;• Elevation of the maxillarysinus floor;• Filling of periodontaldefects in conjunction withproducts intended for GuidedTissue Regeneration (GTR) andGuided Bone Regeneration(GBR); and• Filling of peri-implant | Bio-OSS® is intended for thefollowing uses:• Augmentation orreconstructive treatment of thealveolar ridge;• Filling of infrabonyperiodontal defects;• Filling of defects after rootresection, apicoectomy, andcystectomy;• Filling of extraction socketsto enhance preservation of thealveolar ridge;• Elevation of the maxillarysinus floor;• Filling of periodontaldefects in conjunction withproducts intended for GuidedTissue Regeneration (GTR) andGuided Bone Regeneration(GBR); and• Filling of peri-implant | MBCP Gel™ is intended foruse as a bone grafting materialto fill, augment or reconstructosseous bone defects inaprticular in periodontal ororal/maxillofacial application.Theses defects may besurgically created osseousdefects or osseous defectscreated from traumatic injury tothe bone.MBCP Gel™ can generally beused for bone filling in closedcavities.MBCP Gel™ can be used withautogenous bone graftingmaterials.Typical uses include but are notlimited to:• Periodontal/Infrabony defects• Ridge augmentation | Same |
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| Image: MedPark logo | 510(k) Submission Files | Revision No. | 0 |
|---|---|---|---|
| Your Reliable Partner | S1 | Revision Date | October-13-2023 |
| Page | 5 / 7 |
| defects in conjunction withproducts intended for GuidedBone Regeneration (GBR). | defects in conjunction withproducts intended for GuidedBone Regeneration (GBR). | • Extractions sites (implantpreparation/placement)• Sinus lifts• Cystic cavities |
|---|---|---|
| ----------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------- |
Similarity and Equivalence Discussion
Device characteristics with the Primary predicate device, suceal shape, sizes, structure, findamental technologies and applied production method are equivalent.
- The new device has the same intended use (as discussed above).
- . The main material of both the primary predicate device and S1 is the Hydroxyapatite (HAp).
- Through the Biocompatibility Test and Animal Performance Test, it was verformance of S1 are equivalent . to the Primary Predicate device.
Difference Discussion
The difference compared to the primary predicate device(Bio-Oss® K122894) is that S1 is provided as a mixture of Hydroxyapatite (HAp) and hydroxypropyl methylcellulose (HPMC).
The hydroxypropyl methylcellulose (HPMC) used as an additive is pharmaceutical grade, and was also used in Reference Predicate Device.
Through the Biocompatibility Test and Animal Test, it was verformance of S1 were equivalent to that of the Primary Predicate device.
Non-clinical testing data
- The subject device was evaluated its substantial equvalence through physical tests according to ISO 13779-3:2018 as the below table.
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| Test Item | Methods/Standards | Criteria | Result |
|---|---|---|---|
| Crystallinity Ratio | ISO 13779-3 | The crystallinity ratioshould be more than 95%. | 100 % |
| Ca/P ratio | ISO 13779-3 | Ratio of calcium (Ca) andphosphate (P) must be$1.66\pm0.1$ . | 1.66 |
| Hydroxyapatite(HAp)Contents | ISO 13779-3 | The content ofHydroxyapatite(HAp)should be more than 97wt%. | 100 wt% |
| Heavy metals | ASTM F1581-08,ISO 13779-3 | As $\leq$ 3 mg/kgPb $\leq$ 30 mg/kgHg $\leq$ 5 mg/kgCd $\leq$ 5 mg/kg(The total contents ofheavy metal shall be lessthan 50 mg/kg.) | As: Not DetectedPb: 0.8 mg/kgHg: 0.012 mg/kgCd: Not Detected |
- Sterilization Validation Test according to ISO 11137-1:2006 , ISO 11137-2:2013, ISO ● 11137-3:2017
- Packaging and shelf-life testing according to ASTM F1980-16, ASTM F1980, ASTM F88-15, ASTM F1140, ASTM F2096, ASTM D4169-22, ISO 11607-1:2019, ISO 11607-2:2019, ASTM F1929-15, ISO 13779-3:2018, ISO 11737-2:2019
- Biocompatibility testing according to ISO 10993-1:2018, ISO 10993-3:2014. ISO 10993-4:2017, ISO 10993-5:2009, ISO 10993-6:2016, ISO 10993-10:2010 and ISO 10993-11:2017, ISO 10993-12:2012, ISO 10993-23:2021, USP (151)
- Medical devices utilizing animal tissues and their derivatives according to ISO 22442-1:2020, ISO 22442-2:2020
- Virus Inactivation Testing according to ISO 22442-3:2007
S1 was the subject of the full range of biocompatibility test recommended in the FDA's "Class II Special Controls Guidance Documents: Dental Bone Grafting Devices" and in accordance with ISO 10993-1. Test results confirmed product safety. In addition, virus inactivation study was conducted. Further, the product is sterilized to achieve a sterility assurance level SAL 1 X10-6.
The results of these studies confirm the substantial equivalence of S1 to its predicate devices.
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| Image: Your Reliable Partner | Revision Date | October-13-2023 | |
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Animal Test
The performance of the beagle mandibular defect model was compared to the performance of the predicate device, Bio-Oss®. Radiographic, Micro CT, Histology and Histomorphometry analyses were conducted following implantation at 4, 8, and 12 weeks for the subject device, predicate device and negative control.
The predicate device Bio-Oss® and the subject device S1 were compared in the preclinical study, and the results demonstrated substantially equivalent performances under intended uses.
Eventually, the majority of the device will be resorbed by 24 months or more, and was found to be similar to the predicate device Bio-Oss®.
Conclusion
S1 constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate devices. The conclusions drawn from the nonclinical tests demonstrate that the device is substantially equivalent to its predicate devices.
§ 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.