(109 days)
Not Found
No
The summary describes a synthetic bone void filler material and its physical properties and performance in animal studies. There is no mention of any computational or analytical functions, let alone AI/ML.
Yes.
The device is a bone void filler intended for use in bony defects, aiding in the healing process by being resorbed and replaced with host bone. This directly addresses a medical condition (bony voids/gaps) to facilitate healing.
No.
The device, ReBOSSIS85, is a synthetic, resorbable bone void filler intended for use in bony voids or gaps. Its function is to provide a material that is resorbed during the healing process, not to diagnose medical conditions.
No
The device description clearly states it is a synthetic, resorbable bone void filler made of physical materials (beta-tricalcium phosphate, siloxane-containing vaterite, and poly(L-lactide-co-glycolide)) in a "glass wool-like physical form." This indicates a physical medical device, not a software-only one.
Based on the provided information, ReBOSSIS85 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that ReBOSSIS85 is a bone void filler intended for use in bony voids or gaps within the skeletal system. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details the composition and physical form of the material, which is designed to fill bone defects and be resorbed by the body. This aligns with a medical device used for treatment or repair, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, ReBOSSIS85 is a medical device used for bone repair, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ReBOSSIS85 is intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. ReBOSSIS85 is indicated to be packed gently into bony voids or gaps of the skeletal system (extremities, pelvis, and posterolateral spine). In the extremities and pelvis ReBOSSIS85 may be used without hydrated with blood. In the posterolateral spine ReBOSSIS85 is to be used hydrated with bone marrow aspirate and mixed with autograft bone. The device provides a bone void filler that is resorbed with host bone during the healing process.
Product codes
MOV,MQV
Device Description
ReBOSSIS85 is a synthetic, resorbable bone void filler. It is composite material consisting of (by weight) 40% beta-tricalcium phosphate (B-TCP), 30% siloxane-containing vaterite (a form of calcium carbonate, CaCO3), and 30% poly(L-lactide-co-glycolide). The electrospinning process used in manufacturing ReBOSSIS85 results in a glass wool-like physical form. Due to its physical form, ReBOSSIS85 is flexible and can easily fill defects in appropriate amounts. ReBOSSIS85 is provided sterile for single-patient, single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bony voids or gaps of the skeletal system (extremities, pelvis, and posterolateral spine)
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
Non-clinical testing data submitted to demonstrate substantial equivalence included chemical characterization, physical characterization, sterilization, shelf life validation, biocompatibility, and in vivo (animal) performance.
Characterization of the ReBOSSIS85 material included: true density by pycnometry, chemical composition by energy dispersive x-ray spectrometry (EDX), trace elemental analysis by inductively coupled plasmalmass spectroscopy (ICP-MS) and inductively coupled plasma/atomic emission spectroscopy (ICP-AES), residual solvents by the methods described in USP , surface microstructure by scanning electron microscopy (SEM), and polymer properties by gel permeation chromatography (GPC) and differential scanning calorimetry (DSC). ReBOSSIS85 also was characterized by a variety of techniques at baseline (time zero) and after immersion in TRIS-HCl buffer media at 37 °C. The evaluations performed included: in vitro release kinetics of Si, Ca, and P ions using inductively coupled plasma spectroscopy (ICP); the pH of the solution; imaging of the material (after drying) by scanning electron microscopy (SEM); and polymer weight-average molecular weight by gel permeation chromatography (GPC).
Sterilization validation, sterile barrier shelf life, and product shelf life testing were performed using methods described in AAMI/ANSI/ISO 11137-1, AAMI/ANSI/ISO 11137-2, ASTM F1140/F1140M, and ASTM F2096.
Biocompatibility testing was performed using methods described in AAMI/ANSI/ISO 10993-1. AAMI/ANSI/ISO 10993-5, ISO 10993-10, ISO 10993-11, and ISO 10993-12. Pyrogenicity and bacterial endotoxin testing were performed using methods described in USP 39-NF 34 and USP 39-NF 34 .
Animal testing performed to demonstrate substantial equivalence included determination of the radiographic, histologic, and histomorphometric characteristics of the subject device and the predicate device in a rabbit posterolateral fusion model. The study time points included 4 weeks, and 12 weeks. Evaluation endpoints included radiography, manual palpation, non-destructive biomechanical testing, micro-computed tomography (micro-CT) imaging, non-decalcified histologic analysis, and non-decalcified histomorphometric analysis. Histology sections also were graded according to AAMI/ANSVISO 10993-6 (Annex E).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and consists of the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
December 15, 2017 ORTHOREBIRTH Co., Ltd. % Kevin Thomas, Ph.D. Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K172573
Trade/Device Name: ReBOSSIS85 Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: November 15, 2017 Received: November 16, 2017
Dear Dr. Thomas:
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. 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 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); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Vincent J. Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
ReBOSSIS85
Indications for Use (Describe)
ReBOSSIS85 is intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. ReBOSSIS85 is indicated to be packed gently into bony voids or gaps of the skeletal system (extremities, pelvis, and posterolateral spine). In the extremities and pelvis ReBOSSIS85 may be used without hydrated with blood. In the posterolateral spine ReBOSSIS85 is to be used hydrated with bone marrow aspirate and mixed with autograft bone. The device provides a bone void filler that is resorbed with host bone during the healing process.
| 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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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
510(k) Summary ReBOSSIS85 ORTHOREBIRTH Co., Ltd.
August 25, 2017
ADMINISTRATIVE INFORMATION
| Manufacturer Name | ORTHOREBIRTH Co., Ltd. | |
|---|---|---|
| 3-17-43 Chigasaki Higashi | ||
| Tsuzuki-ku Yokohama, Kanagawa, 224-0033, Japan | ||
| Telephone: | +81-45532-3650 | |
| Fax: | +81-45532-3691 | |
| Official Contact | Yasutoshi Nishikawa, CEO | |
| Representative/Consultant | Kevin A. Thomas, PhD | |
| Floyd G. Larson, MS, MBA | ||
| PaxMed International, LLC | ||
| 12264 El Camino Real, Suite 400 | ||
| San Diego, CA 92130 | ||
| Telephone: | +1-858-792-1235 | |
| Fax: | +1-858-792-1236 | |
| Email: | kthomas@paxmed.com | |
| flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | ReBOSSIS85 |
|---|---|
| Common Name | Filler, bone void, calcium compound |
| Classification Name | Resorbable calcium salt bone void filler device |
| Classification Regulations | 21 CFR 888.3045, Class II |
| Product Code | MQV |
| Classification Panel | Orthopaedic and Rehabilitation Devices Panel |
| Reviewing Branch | Restorative and Repair Devices Branch (RRDB) |
PREDICATE DEVICE INFORMATION
Primary Predicate K140375, MASTERGRAFT® Strip; MASTERGRAFT® Putty, Medtronic Sofamor Danek USA, Inc.
Reference Predicate K170620, ReBOSSIS85, ORTHOREBIRTH Co., Ltd.
4
INDICATIONS FOR USE
ReBOSSIS85 is intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. ReBOSSIS85 is indicated to be packed gently into bony voids or gaps of the skeletal system (extremities, pelvis, and posterolateral spine). In the extremities and pelvis ReBOSSIS85 may be used without hydration or hydrated with blood. In the posterolateral spine ReBOSSIS85 is to be used hydrated with bone marrow aspirate and mixed with autograft bone. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.
DEVICE DESCRIPTION
ReBOSSIS85 is a synthetic, resorbable bone void filler. It is composite material consisting of (by weight) 40% beta-tricalcium phosphate (B-TCP), 30% siloxane-containing vaterite (a form of calcium carbonate, CaCO3), and 30% poly(L-lactide-co-glycolide). The electrospinning process used in manufacturing ReBOSSIS85 results in a glass wool-like physical form. Due to its physical form, ReBOSSIS85 is flexible and can easily fill defects in appropriate amounts. ReBOSSIS85 is provided sterile for single-patient, single-use.
PERFORMANCE DATA
Non-clinical testing data submitted to demonstrate substantial equivalence included chemical characterization, physical characterization, sterilization, shelf life validation, biocompatibility, and in vivo (animal) performance.
Characterization of the ReBOSSIS85 material included: true density by pycnometry, chemical composition by energy dispersive x-ray spectrometry (EDX), trace elemental analysis by inductively coupled plasmalmass spectroscopy (ICP-MS) and inductively coupled plasma/atomic emission spectroscopy (ICP-AES), residual solvents by the methods described in USP , surface microstructure by scanning electron microscopy (SEM), and polymer properties by gel permeation chromatography (GPC) and differential scanning calorimetry (DSC). ReBOSSIS85 also was characterized by a variety of techniques at baseline (time zero) and after immersion in TRIS-HCl buffer media at 37 °C. The evaluations performed included: in vitro release kinetics of Si, Ca, and P ions using inductively coupled plasma spectroscopy (ICP); the pH of the solution; imaging of the material (after drying) by scanning electron microscopy (SEM); and polymer weight-average molecular weight by gel permeation chromatography (GPC).
Sterilization validation, sterile barrier shelf life, and product shelf life testing were performed using methods described in AAMI/ANSI/ISO 11137-1, AAMI/ANSI/ISO 11137-2, ASTM F1140/F1140M, and ASTM F2096.
Biocompatibility testing was performed using methods described in AAMI/ANSI/ISO 10993-1. AAMI/ANSI/ISO 10993-5, ISO 10993-10, ISO 10993-11, and ISO 10993-12. Pyrogenicity and bacterial endotoxin testing were performed using methods described in USP 39-NF 34 and USP 39-NF 34 .
Animal testing performed to demonstrate substantial equivalence included determination of the radiographic, histologic, and histomorphometric characteristics of the subject device and the predicate device in a rabbit posterolateral fusion model. The study time points included 4 weeks, and 12 weeks. Evaluation endpoints included radiography, manual palpation, non-destructive biomechanical testing, micro-computed tomography (micro-CT) imaging, non-decalcified histologic analysis, and non-decalcified histomorphometric analysis. Histology sections also were graded according to AAMI/ANSVISO 10993-6 (Annex E).
5
EQUIVALENCE TO MARKETED DEVICE
The subject device is substantially equivalent in indications and design principles to the predicate devices listed above. A summary table comparing the Indications for Use statement and the technological characteristics of the subject device and the predicate devices is provided in the following table.
| Subject Device | Primary Predicate Device | Reference Predicate Device | |
|---|---|---|---|
| Comparison | ReBOSSIS85 | ||
| ORTHOREBIRTH Co., Ltd. | K140375 | ||
| MASTERGRAFT® Strip; MASTERGRAFT® | |||
| Putty | |||
| Medtronic Sofamor Danek USA, Inc. | K170620 | ||
| ReBOSSIS85 | |||
| ORTHOREBIRTH Co., Ltd. | |||
| Indications for Use | |||
| Statement | ReBOSSIS85 is intended for use in bony voids or | ||
| gaps that are not intrinsic to the stability of the | |||
| bony structure. These defects may be surgically | |||
| created osseous defects or osseous defects created | |||
| from traumatic injury to the bone. ReBOSSIS85 | |||
| is indicated to be packed gently into bony voids | |||
| or gaps of the skeletal system (extremities, pelvis, | |||
| and posterolateral spine). In the extremities and | |||
| pelvis ReBOSSIS85 may be used without | |||
| hydration or hydrated with blood. In the | |||
| posterolateral spine ReBOSSIS85 is to be used | |||
| hydrated with bone marrow aspirate and mixed | |||
| with autograft bone. The device provides a bone | |||
| void filler that is resorbed and replaced with host | |||
| bone during the healing process. | MASTERGRAFT® Putty combined with either | ||
| autogenous bone marrow, and/or sterile water, | |||
| and/or autograft is indicated as a bone void filler | |||
| for bony voids or gaps that are not intrinsic to the | |||
| stability of the bony structure: Additionally. | |||
| MASTERGRAFT® Putty can be used with | |||
| autograft as a bone graft extender. | |||
| MASTERGRAFT® Putty is to be gently packed | |||
| into bony voids or gaps of the skeletal system | |||
| (e.g., the posterolateral spine, pelvis. ilium. | |||
| and/or extremities). These defects may be | |||
| surgically created osseous defects or osseous | |||
| defects created from traumatic injury to the bone. | |||
| MASTERGRAFT® Putty resorbs and is replaced | |||
| with bone during the healing process. | ReBOSSIS85 is intended for use in bony voids or | ||
| gaps that are not intrinsic to the stability of the | |||
| bony structure. These defects may be surgically | |||
| created osseous defects or osseous defects | |||
| created from traumatic injury to the bone. | |||
| ReBOSSIS85 is indicated to be packed gently | |||
| into bony voids or gaps of the skeletal system | |||
| (extremities and pelvis), and may be used | |||
| without hydration or hydrated with blood. The | |||
| device provides a bone void filler that is resorbed | |||
| and replaced with host bone during the healing | |||
| process. | |||
| Product Code | MQV | MQV | MQV |
| Intended Use | Bone void filler for skeletal system | ||
| (extremities, pelvis, and posterolateral spine) | Bone void filler for skeletal system | ||
| (extremities, pelvis, and posterolateral spine) | Bone void filler for skeletal system | ||
| (extremities, pelvis) | |||
| Design | |||
| Form | Glass wool-like, produced by electrospinning | Granules uniformly dispersed in collagen | |
| scaffold | Glass wool-like, produced by electrospinning | ||
| Granule Size | Not applicable | 0.5 mm - 1.6 mm in diameter | Not applicable |
| Fiber Size | nominal diameter range: 3 μm to 150 μm | ||
| specification of maximum diameter: 250 μm | Not applicable | nominal diameter range: 3 μm to 150 μm | |
| specification of maximum diameter: 250 μm | |||
| Porosity | Approximately 98 % (dry, no hydration) | Granules 80% | Approximately 98 % (dry, no hydration) |
| Materials | |||
| Calcium salts | β-tricalcium phosphate, 40 % by weight | ||
| Siloxane-containing vaterite (SiV), 30 % by | |||
| weight | β-tricalcium phosphate (85%) and | ||
| Hydroxyapatite (15%) | β-tricalcium phosphate, 40 % by weight | ||
| Siloxane-containing vaterite (SiV), 30 % by | |||
| weight | |||
| Silicon | Approximately 0.7 % by weight | ||
| Range, 0.5 % - 1 % by weight | Not applicable | Approximately 0.7 % by weight | |
| Range, 0.5 % - 1 % by weight | |||
| Scaffold/Binder | Poly(L-lactide-co-glycolide), 30% by weight | Type I bovine collagen | Poly(L-lactide-co-glycolide), 30% by weight |
| How Provided | |||
| Sizes | Provided in 0.4, 0.7, 1, and 2 gram packages | ||
| Approximate volume: | |||
| 10-50 cc (dry, no hydration) | |||
| 4-20 cc (after hydration) | Provided in 0.75 cc, 1.5 cc, 3.0 cc, 6.0 cc, | ||
| and 9.0 cc packages | Provided in 0.5, 1, and 2 gram packages | ||
| Approximate volume: | |||
| 13-50 cc (dry, no hydration) | |||
| 5-20 cc (after hydration) | |||
| Hydration prior to | |||
| use | Bone marrow aspirate (required) | Bone marrow aspirate and/or sterile water | |
| (required) | Blood (optional) | ||
| Sterility | Provided sterile to end-user | Provided sterile to end-user | Provided sterile to end-user |
| Sterilization | Gamma irradiation | Not stated | Gamma irradiation |
| Usage | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use |
| Table of Substantial Equivalence |
|---|
| ---------------------------------- |
The primary predicate device is K140375 for substantial equivalence in the animal model performance testing. The reference predicate device is K170620 in support of substantial equivalence in the physical form and the material composition.
The subject device and the primary predicate device have intended uses, the same product classification and product code (MQV), and have similar Indications for Use statements. The subject device and the primary predicate devices are bone void fillers that are intended for bony voids or gaps that are not intrinsic to the stability
6
of the bony structure. The subject device and primary predicate device are indicated for use as in the posterolateral spine with autograft bone (extender), and the subject device and primary predicate device are to be hydrated with bone marrow aspirate (primary predicate device with sterile water). Although the subject device and the primary predicate device have slightly different Indications for Use language, these differences do not change the intended use as a bone void filler in the posterolateral spine.
The subject device and the predicate devices all incorporate materials within a polymer scaffold or binder. The subject device polymer scaffold is poly(L-lactide-co-glycolide), the predicate K140375 scaffold is type I bovine collagen. The subject device is identical to the reference predicate device K170620. The subject device and the predicate devices are provided sterile for single-use in similar ranges of graft volumes.
The radiographic, histologic, and histomorphometric performance of the subject device were compared to that of the primary predicate device K140375 in a rabbit posterolateral fusion model. The results of the study demonstrated that the performance of the subject ReBOSSIS85 device was equivalent to that of the predicate device K140375.
No clinical data were included in this submission.
CONCLUSION
The subject device and the predicate devices have the same intended use, have similar technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in similar materials and are sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate device listed above.