(93 days)
No reference device was used in this submission
No
The summary describes a xenograft biomaterial for bone grafting and does not mention any computational or analytical functions that would typically involve AI/ML.
Yes
The device is intended to treat and reconstruct bone defects, which is a therapeutic purpose.
No
This device is a Xenograft biomaterial intended for filling, augmenting, or reconstructing periodontal and bony defects. It is a treatment device, not a diagnostic one.
No
The device description clearly states that Wishbone HA is a xenograft biomaterial composed of deproteinized hydroxyapatite from bovine origin, supplied as particles in a blister, indicating it is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Wishbone HA's Function: Wishbone HA is a biomaterial intended to be implanted into the body to fill, augment, or reconstruct bone defects. It is a physical material used in a surgical procedure, not a test performed on a sample outside the body.
- Intended Use: The intended uses listed clearly describe surgical procedures involving the filling and augmentation of bone defects. None of these involve analyzing a sample from the patient to diagnose or monitor a condition.
- Device Description: The description details the composition and form of the material, not a diagnostic test kit or instrument.
Therefore, based on the provided information, Wishbone HA is a medical device used in surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Wishbone HA is intended for the following uses:
- Filling of infrabony periodontal defects;
- Filling of periodontal defects in conjunction with products intended for guided tissue regeneration and guided bone regeneration;
- Filling of defects after root resection, apicectomy and cystectomy;
- Filling of extraction sockets to enhance preservation of the alveolar ridge;
- Augmentation or reconstructive treatment of the alveolar ridge;
- Elevation of the maxillary sinus floor;
- Filling of peri-implant defects in conjunction with products intended for guided bone regeneration.
Product codes
NPM
Device Description
Wishbone HA is a xenograft biomaterial composed of deproteinized hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw.
Wishbone HA is supplied as a mix of cancellous and cortical particles size 0.25 to 1.0 mm) in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.
The device is intended to be used in medical procedures, by a qualified physician (academically trained dentists, periodontists and oral surgeons).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral, Periodontal
Indicated Patient Age Range
Adults
Intended User / Care Setting
Wishbone HA should only be used by trained dentists, periodontists or oral surgeons.
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: Wishbone HA was the subject of the full range of physical and chemical bench testing characterization tests recommended in the FDA's "Class II Special Controls Guidance Documents: Dental Bone Grafting Devices". These bench tests included chemical analysis, phase composition analysis, protein and organic content analysis, morphology analysis, porosity analysis, pH analysis, dissolution analysis and mechanical evaluation.
- Non-Clinical animal performance Testing: A pre-clinical GLP study was performed in canine mandibular defect model system in Beagle dogs to evaluate the in-vivo performance of the Wishbone HA. In this study the local effects of implantation of Wishbone HA in the target locations, as well as bone growth, at subchronic time-points (4, 12 and 26 weeks) were evaluated. By all parameters assessed at the 26 weeks time-point of the study, biocompatibility and regeneration of defects treated with Wishbone HA showed similar results to defects treated with the predicate device, Bio-Oss.
- Biocompatibility: Wishbone HA was the subject of a range of biocompatibility tests in accordance with ISO 10993 series. Test results confirmed that Wishbone HA is biocompatible for the stated intended use.
- Animal tissue: The methods of sourcing, collection and handling of the bovine-derived bones were assessed to demonstrate compliance with relevant requirements of ISO 22442 series and FDA guidance (2019). Wishbone HA is provided free from organic residues. Protein content is routinely controlled during the production process. The manufacturing process includes several steps intended to inactivate viruses. The results of the viral inactivation studies showed that the raw material and device manufacturing processes of the Wishbone HA are capable of achieving at least a 6-log viral reduction of selected model viruses which were tested.
- Sterilization: Wishbone HA is provided sterile and is intended for single patient use only. Wishbone HA is sterilized with gamma irradiation to meet a minimum sterility assurance level (SAL) of 10-6. Validation of the sterilization dose was conducted following VDmax method.
- Shelf life study: Supports a shelf life of 36 months for Wishbone HA when stored under the recommended environmental conditions. The shelf life studies confirmed that the packaging maintains the integrity of the device and its sterility throughout the shelf life of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference device was used in this submission
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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August 20, 2021
Wishbone SA Emilie Dory Operations Manager 1, Rue de 1'Expansion Flemalle, Liege 4400 BELGIUM
Re: K211551
Trade/Device Name: Wishbone HA Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPM Dated: June 7, 2021 Received: June 8, 2021
Dear Emilie Dory:
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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 (QS) 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 medical devices and radiation-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.
for Andrew Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Wishbone HA
Indications for Use (Describe)
Wishbone HA is intended for the following uses:
· Filling of infrabony periodontal defects;
· Filling of periodontal defects in conjunction with products intended for guided tissue regeneration and guided bone regeneration:
· Filling of defects after root resection, apicectomy and cystectomy;
- · Filling of extraction sockets to enhance preservation of the alveolar ridge;
- · Augmentation or reconstructive treatment of the alveolar ridge;
- · Elevation of the maxillary sinus floor;
· Filling of peri-implant defects in conjunction with products intended for guided bone regeneration.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
1. SUBMITTER
| Submitter Name: | Wishbone SA |
|---|---|
| Submitter Address: | 1, Rue de l'Expansion, |
| 4400 Flémalle - Belgium | |
| Phone Number: | +32484706172 |
| Contact Person: | Emilie Dory |
| Date Prepared: | 20 August 2021 |
| 2. DEVICE | |
| Device Trade Name: | Wishbone HA |
| Common Name: | Bone graft material |
| Classification Name, | |
| Number & | |
| Product Code: | Bone grafting material |
| 21 CFR 872.3930 | |
| NPM | |
| Class: | II |
| Classification Panel: | Dental |
3. PREDICATE DEVICE
K122894, Geistlich Bio-Oss, Geistlich Pharma AG Primary Predicate Device:
4. REFERENCE DEVICE
Reference Device: No reference device was used in this submission
5. DEVICE DESCRIPTION
Wishbone HA is a xenograft biomaterial composed of deproteinized hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw.
Wishbone HA is supplied as a mix of cancellous and cortical particles size 0.25 to 1.0 mm) in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.
The device is intended to be used in medical procedures, by a qualified physician (academically trained dentists, periodontists and oral surgeons).
4
6. INDICATIONS FOR USE
Wishbone HA is intended for the following uses:
- Filling of infrabony periodontal defects .
- Filling of periodontal defects in conjunction with products intended for guided tissue . regeneration and guided bone regeneration
- Filling of defects after root resection, apicectomy and cystectomy
- . Filling of extraction sockets to enhance preservation of the alveolar ridge
- . Augmentation or reconstructive treatment of the alveolar ridge
- Elevation of the maxillary sinus floor ●
- Filling of peri-implant defects in conjunction with products intended for quided bone . regeneration.
7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE
| New Device | Primary Predicate Device | |
|---|---|---|
| Device name | Wishbone HA | Geistlich Bio-Oss |
| 510(k) Number | K211551 | K122894 |
| Manufacturer | Wishbone SA | Geistlich Pharma AG |
| Regulation Number | 872.3930 | 872.3930 |
| Device | ||
| Classification Name | Bone grafting material | Bone grafting material |
| Product Code | NPM | NPM |
| Intended Use/ | ||
| Indications for use | • Filling of infrabony periodontal defects; | |
| • Filling of periodontal defects in conjunction with products intended for guided tissue regeneration and guided bone regeneration; | ||
| • Filling of defects after root resection, apicectomy and cystectomy; | ||
| • Filling of extraction sockets to enhance preservation of the alveolar ridge; | ||
| • Augmentation or reconstructive treatment of the alveolar ridge | ||
| • Elevation of the maxillary sinus floor; | ||
| • Filling of peri-implant defects in conjunction with products intended for guided bone regeneration. | - Augmentation or reconstructive treatment of the alveolar ridge; |
- Filling of infrabony periodontal defects;
- Filling of defects after root resection, apicoectomy, and cystectomy;
- Filling of extraction sockets to enhance preservation of the alveolar ridge;
- Elevation of the maxillary sinus floor;
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR). |
| Intended patient
population | Adults | Adults |
| Mode of action | Conductive bone graft | Conductive bone graft |
| | | |
| Anatomical sites | Oral, Periodontal | Oral, Periodontal |
| Environment of use | Wishbone HA should only be used
by trained dentists, periodontists or
oral surgeons. | Geistlich Bio-Oss® should only be
used by trained dentists or oral
surgeons. |
| Sterilization | Gamma irradiation | Gamma irradiation |
| Reusability | Single use only | Single use only |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Packaging | Wishbone HA particles are
packaged in a single use
thermoformed PETG
(Polyethylene Terephthalate
Glycol) blister (primary packaging)
hermetically sealed with a
Tyvek®. This package is placed in
a secondary thermoformed. | Double sterile barrier system
consisting of a glass vial and an
outer blister. |
| Source of materials | Bovine | Bovine |
| Chemical
Composition | Calcium: 30 - 40 % (w./w.)
Phosphorous: 15 - 20 % (w./w.)
Sodium: 0.0 - 1.0 % (w./w.)
Magnesium: 0.0 - 1.0 % (w./w.)
Summed up to 100% by mass: | From the original 510(k):
Calcium: 35% - 40% (w./w.)
Phosphorous: 13.5% - 18.5%
(w./w.)
Summed up to 100% by mass**: |
| | - Hydroxyapatite $Ca_5(PO_4)_3OH$
(CAS® 1306-06-5): ≥97%
- $CaCO_3$ (CAS® 471-34-1)
- $MgO$ * (CAS® 1309-48-4): ≤2%
- $H_2O$ (CAS® 7732-18-5): ≤1%
- Organic compounds: 0% | - Hydroxyapatite
(Pentacalciumhydroxy-[tri]- phosphate $Ca_5(PO_4)_3(OH)$ )
(93.6%), - Calcium carbonate ( $CaO_3$ )
(3,4%) - Water (3%)
- No organic components (0%) |
| Crystalline phases | Hydroxyapatite > 95% | Hydroxyapatite |
| Dosage form | Mix of cancellous and cortical
granules | Cancellous granules or porous
block |
| Particle sizes | 0.25 - 1.0 mm | 0.25 - 1.0 mm (small particles)
1.0 - 2.0 mm (large particles) |
| Product size (g) | 0.25, 0.5, 1.0, 2.0 | 0.25, 0.5, 2.0, 5.0 (0.25-1.0 mm)
0.5, 2.0 (1.0-2.0 mm)
For blocks: 1 X 1 X 2 cm (approx.) |
Table 1: Comparison of new device to predicate device
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6
| Biocompatibility testing | Chemical characterization
Toxicological evaluation
Cytotoxicity
Sensitization
Intracutaneous Reactivity/Irritation
Acute Systemic Toxicity
Material Mediated Pyrogenicity
Genotoxicity
Implantation | Per ISO 10993-1 for the intended use |
| -------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------- |
|---|
- Wishbone HA is composed of only bovine bone without any added components. The magnesium oxide (MgO) is not added to Wishbone HA but rather naturally appears during the sintering process in the form of magnesium oxide crystals.
** Data taken from 510(k) summary of Straumann® Cerabone® (K173594) which uses K122894 Geistlich Bio-Oss as the predicate device.
Equivalences:
The intended use is the same, and the technological characteristics are essentially the same as those of the predicate, K122894, Geistlich Bio-Oss. Both devices are made of deproteinized hydroxyapatite from bovine origin, intended to be implemented as a bone graft matrix in periodontal or bony defects. Both devices are intended to be used by dental health care professionals (e.g. dentists, periodontists and oral surgeons). Both devices are intended for single patient use and sterilized by gamma irradiation.
Differences that are demonstrated to be substantially equivalent:
As indicated in Table 1 above, several differences with respect to technological characteristics were identified between Wishbone HA and the primary predicate, namely the chemical composition, crystalline phases, dosage form, specific surface area and the packaging configuration.
Performance testing was conducted to demonstrate substantial equivalence of Wishbone HA to the predicate device. The test results are summarized below.
8. PERFORMANCE DATA
- Non-Clinical Wishbone HA was the subject of the full range of physical and chemical bench testing characterization tests recommended in the FDA's "Class II Special Controls Guidance Documents: Dental Bone Grafting Devices". These bench tests included chemical analysis, phase composition analysis, protein and organic content analysis, morphology analysis, porosity analysis, pH analysis, dissolution analysis and mechanical evaluation.
7
| Non-Clinical
animal
performance
Testing | A pre-clinical GLP study was performed in canine mandibular defect
model system in Beagle dogs to evaluate the in-vivo performance of the
Wishbone HA. In this study the local effects of implantation of Wishbone
HA in the target locations, as well as bone growth, at subchronic time-
points (4, 12 and 26 weeks) were evaluated. |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | By all parameters assessed at the 26 weeks time-point of the study,
biocompatibility and regeneration of defects treated with Wishbone HA
showed similar results to defects treated with the predicate device, Bio-
Oss®. |
| Biocompatibility | Wishbone HA was the subject of a range of biocompatibility tests in
accordance with ISO 10993 series. Test results confirmed that Wishbone
HA is biocompatible for the stated intended use. |
| Animal tissue | The methods of sourcing, collection and handling of the bovine-derived
bones were assessed to demonstrate compliance with relevant
requirements of ISO 22442 series and FDA guidance (2019). Wishbone
HA is provided free from organic residues. Protein content is routinely
controlled during the production process. The manufacturing process
includes several steps intended to inactivate viruses. The results of the |
viral inactivation studies showed that the raw material and device manufacturing processes of the Wishbone HA are capable of achieving at least a 6-log viral reduction of selected model viruses which were tested.
- Sterilization Wishbone HA is provided sterile and is intended for single patient use only. Wishbone HA is sterilized with gamma irradiation to meet a and shelf life minimum sterility assurance level (SAL) of 106. Validation of the sterilization dose was conducted following VDmax method.
Shelf life study supports a shelf life of 36 months for Wishbone HA when stored under the recommended environmental conditions. The shelf life studies confirmed that the packaging maintains the integrity of the device and its sterility throughout the shelf life of the device.
Validation studies for sterilization, packaging and shelf life conform to the following standards:
| Standard
| reference | Standard title |
|---|---|
| EN ISO 11607- | |
| 1:2020 | Packaging for terminally sterilized medical devices - |
| Part 1: Requirements for materials, sterile barrier | |
| systems and packaging systems | |
| EN ISO 11607- | |
| 2:2020 | Packaging for terminally sterilized medical devices - |
| Part 2: Validation requirements for forming, sealing | |
| and assembly processes | |
| EN ISO 11137- | |
| 1:2015/A2:2019 | Sterilization of health care products - Radiation - Part |
| 1: Requirements for development, validation and | |
| routine control of a sterilization process for medical | |
| devices | |
| EN ISO 11137- | |
| 2:2015 | Sterilization of health care products - Radiation - Part |
| 2: Establishing the sterilization dose | |
| EN ISO 11137- | |
| 3:2017 | Sterilization of health care products - Radiation - Part |
| 3: Part 3: Guidance on dosimetric aspects of | |
| development, validation and routine control | |
| EN ISO 11737- | |
| 1:2018 | Sterilization of medical devices - Microbiological |
| methods - Part 1: Determination of a population of | |
| microorganisms on products | |
| EN ISO 11737- | |
| 2:2009 | Sterilization of health care products - Microbiological |
| methods - Part 2: Tests of sterility performed in the | |
| definition, validation and maintenance of a sterilization | |
| process | |
| EN 868-5:2009 | Packaging for terminally sterilized medical devices - |
| Part 5: Sealable pouches and reels of porous | |
| materials and plastic film construction - Requirements | |
| and test methods | |
| ASTM F88F88M- | |
| 15 | Standard Test Method for Seal Strength of Flexible |
| Barrier Materials | |
| ASTM | |
| F1886F1886M-16 | Standard Test Method for Determining Integrity of |
| Seals for Flexible Packaging by Visual Inspection | |
| ASTM F1929-15 | Standard Test Method for Detecting Seal Leaks in |
| Porous Medical Packaging by Dye Penetration | |
| ASTM F1980-16 | Standard Guide for Accelerated Aging of Sterile |
| Barrier Systems for Medical Devices | |
| ASTM D642-15 | Standard Test Method for Determining Compressive |
| Resistance of Shipping Containers, Components, and | |
| Unit Loads | |
| ASTM D6344-04 | |
| (2017) | Standard Test Method for Concentrated Impacts to |
| Transport Packages | |
| ASTM D999-08 | |
| (2015) | Standard Test Methods for Vibration Testing of |
| Shipping Containers | |
| ASTM D4169-16 | Standard Practice for Performance Testing of Shipping |
| Containers and Systems | |
| ASTM D4332-14 | Standard Practice for Conditioning Containers. |
| Packages, or Packaging Components for Testing | |
| ASTM D4728-17 | Standard Test Method for Random Vibration Testing of |
| Shipping Containers | |
| ASTM D5276-98 | |
| (2017) | Standard Test Method for Drop Test of Loaded Containers by Free Fall |
| EN ISO 11140- | |
| 1:2014 | Sterilization of health care products - Chemical indicators - Part 1: General requirements |
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9. CONCLUSION
The information discussed above and provided in the 510(k) submission demonstrate that the Wishbone HA is substantially equivalent to the predicate.