(66 days)
Beta-bsm Injectable Bone Substitute Material is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects 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. Beta-bsm Injectable Bone Substitute Material is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Gamma-bsm Moldable Bone Substitute Material is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects 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. Gamma-bsm Moldable Bone Substitute Material is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
EquivaBone Osteoinductive Bone Graft Substitute is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix combined with demineralized bone matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects 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. EquivaBone Osteoinductive Bone Graft Substitute is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Beta-bsm Injectable Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a paste. Mixing is facilitated by a syringe-to-syringe mixing system. The resulting paste can be administered to the treatment site under direct visualization using the syringe or manual application. The material can be shaped into a desired form in-situ prior to implantation. After the paste is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. Beta-bsm Injectable Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
Gamma-bsm Moldable Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a putty. The resulting putty is administered to the treatment site by manual application. The material can be shaped into a desired form in-situ prior to implantation. After the putty is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. Gamma-bsm Moldable Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
EquivaBone is a biocompatible bone graft substitute material consisting of synthetic calcium phosphate, carboxymethyl cellulose (CMC) and human demineralized bone matrix (DBM). It is supplied in a single use kit as sterile powders and hydration solution that are mixed together at the time of use in the operating room to form flowable putty which is implanted manually or can be extruded through a syringe. After implantation the product hardens at body temperature and resorbs and remodels during the healing process. Each lot of DBM contained within EquivaBone is assayed for osteoinductive potential in an athymic nude mouse model. This may or may not be predictive of EquivaBone osteoinductivity in humans.
Here's an analysis of the provided text to extract the acceptance criteria and study information for the Beta-bsm, Gamma-bsm, and EquivaBone devices:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for these devices are primarily based on demonstrating substantial equivalence to predicate devices, especially regarding their intended use and technological characteristics. The performance data is assessed against the requirements outlined in the "Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005)."
The reported device performance, for all three devices (Beta-bsm, Gamma-bsm, and Equivabone), is that they are "safe and effective for its intended use and performs as well as the predicate device."
| Criterion | Beta-bsm Injectable Bone Substitute Material Performance | Gamma-bsm Moldable Bone Substitute Material Performance | EquivaBone Osteoinductive Bone Graft Substitute Performance |
|---|---|---|---|
| Intended Use | Filling and/or augmentation of bone voids, gaps or defects not intrinsic to bony structure stability, including dental intraosseous, intraoral, and maxillofacial defects (periodontal/infrabony defects; alveolar ridge augmentation; dental extraction sites; sinus lifts; cystic defects; craniofacial augmentation). Device forms a nano-crystalline matrix that resorbs and is replaced with new bone during healing. | Filling and/or augmentation of bone voids, gaps or defects not intrinsic to bony structure stability, including dental intraosseous, intraoral, and maxillofacial defects (periodontal/infrabony defects; alveolar ridge augmentation; dental extraction sites; sinus lifts; cystic defects; craniofacial augmentation). Device forms a nano-crystalline matrix that resorbs and is replaced with new bone during healing. | Filling and/or augmentation of bone voids, gaps or defects not intrinsic to bony structure stability, including dental intraosseous, intraoral, and maxillofacial defects (periodontal/infrabony defects; alveolar ridge augmentation; dental extraction sites; sinus lifts; cystic defects; craniofacial augmentation). Device forms a nano-crystalline matrix combined with demineralized bone matrix that resorbs and is replaced with new bone during healing. Each lot of DBM contained within EquivaBone is assayed for osteoinductive potential in an athymic nude mouse model. This may or may not be predictive of EquivaBone osteoinductivity in humans. |
| Biomaterial | Proprietary calcium phosphate formula | Proprietary calcium phosphate formula | Proprietary calcium phosphate formula, carboxymethyl cellulose (CMC), demineralized bone matrix (DBM) |
| Primary Hydration Media | 0.9% sodium chloride solution conforming with the monograph for 0.9% Sodium Chloride Injection USP | 0.9% sodium chloride solution conforming with the monograph for 0.9% Sodium Chloride Injection USP | 0.9% sodium chloride solution conforming with the monograph for 0.9% Sodium Chloride Injection USP |
| Alternate Hydration Media | None (for Beta-bsm Injectable) - Note: The predicate for Orthopedic indications (K101557) had an "alternate Hydration Solution," suggesting the current submission for dental indications either doesn't provide one or the change is specifically about the provided one. | Autologous whole blood, autologous bone marrow aspirate | Autologous whole blood, autologous bone marrow aspirate |
| Sterilization | Gamma irradiation | Gamma irradiation | Gamma irradiation |
| Safety and Effectiveness | Assessed as safe and effective for intended use, performing as well as the predicate device, based on performance data submitted consistent with "Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005)." | Assessed as safe and effective for intended use, performing as well as the predicate device, based on performance data submitted consistent with "Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005)." | Assessed as safe and effective for intended use, performing as well as the predicate device, based on performance data submitted consistent with "Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005)." For EquivaBone, the osteoinductive potential of each DBM lot is assayed in an athymic nude mouse model. |
| Substantial Equivalence (SE) | The FDA determined the device is substantially equivalent to legally marketed predicate devices. | The FDA determined the device is substantially equivalent to legally marketed predicate devices. | The FDA determined the device is substantially equivalent to legally marketed predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The documents state that non-clinical testing was performed "consistent with Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005)."
- Sample Size: The specific sample sizes for non-clinical tests (e.g., in-vitro, bench studies, animal studies) are not detailed in the provided summaries. The summaries only state that testing was performed according to the guidance.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that they are non-clinical studies for device clearance, they would typically involve studies conducted in a controlled lab environment.
For EquivaBone specifically: There's mention of DBM being "assayed for osteoinductive potential in an athymic nude mouse model." This indicates an animal model study was part of the non-clinical testing for this specific characteristic. The sample size for this mouse model is not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
No information is provided regarding traditional "ground truth" establishment by experts in the context of diagnostic performance or clinical outcomes for these devices.
Since the submission is for a "Special 510(k) Submission - Alternate Hydration Solution" and relies on non-clinical testing and substantial equivalence, the "ground truth" is established by demonstrating that the modified device (with the alternate hydration solution) maintains the same performance characteristics as the predicate device and meets established material and biological safety standards. This is typically assessed by regulatory bodies (like the FDA) and their expert reviewers, rather than external clinical experts establishing a ground truth for a test set in the way one might for an AI diagnostic device.
4. Adjudication Method for the Test Set
Not applicable. This is not a clinical trial involving human subject adjudication of diagnostic findings. The regulatory review process involves evaluation of non-clinical data by regulatory scientists and engineers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study is not mentioned as it is not typically required for this type of device modification (alternate hydration solution) and regulatory pathway (Special 510(k) based on substantial equivalence and non-clinical data). The focus is on demonstrating that the new hydration solution does not negatively impact the established performance and safety of the device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
Not applicable. These are inert/resorbable bone graft substitute materials, not AI algorithms or diagnostic devices.
7. Type of Ground Truth Used
The "ground truth" in this context is implicitly "performance equivalence to the predicate device and adherence to recognized material and biological safety standards." This is established through non-clinical testing (e.g., material characterization, biocompatibility testing, mechanical properties, resorbability studies) as outlined by the "Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices."
For EquivaBone, an additional "ground truth" element for osteoinductivity is established via the athymic nude mouse model for each lot of DBM.
8. Sample Size for the Training Set
Not applicable. These are physical medical devices, not AI models that require training sets. The "training" for the device's development would involve R&D and engineering, but not in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of AI. The development process for these medical devices involves established engineering and scientific principles, quality systems, and regulatory guidelines to ensure safety and effectiveness.
{0}------------------------------------------------
0 = 3 = 3 = 2010
Special 510(k) Submission - Alternate Hydration Solution
5. 510(k) Summary
- 5.1 510(k) Summary - Beta-bsm
| Submitter: | ETEX Corporation |
|---|---|
| 38 Sidney Street | |
| Cambridge, MA 02139 | |
| Registration No.: | 1225112 |
| Owner/Operator No.: | 9014709 |
Christopher Klaczyk Contact Person: Regulatory Affairs Manager (617) 577-7270 x160 Office: Mobile: (617) 710-8091 (617) 577-7170 Fax: cklaczyk@etexcorp.com E-Mail:
Date Prepared: September 27, 2010
Product Code(s): LYC (21 CFR 872.3930)
Device Class: II (21 CFR 872.3930)
Classification Panel: Dental
Classification Name: Bone Grafting Material, Synthetic (21 CFR 872.3930)
Proprietary Name: Beta-bsm Injectable Bone Substitute Material
Predicate Device(s): Beta-bsm Injectable Bone Substitute Material (cleared for Dental and Maxillofacial indications per K091729) Beta-bsm Injectable Bone Substitute Material (alternate Hydration Solution cleared for Orthopedic indications per K101557)
Device Description: Beta-bsm Injectable Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a paste. Mixing is facilitated by a syringe-to-syringe mixing system. The resulting paste can be administered to the treatment site under direct visualization using the syringe or manual application. The material can be shaped into a desired form in-situ prior to implantation. After the paste is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end
ETEX Corporation
Page 5-1
{1}------------------------------------------------
Special 510(k) Submission - Alternate Hydration Solution
product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. Beta-bsm Injectable Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
Intended Use: Beta-bsm Injectable Bone Substitute Material is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects 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.
Beta-bsm Injectable Bone Substitute Material is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These include, defects ---------------------------------------------------------------------------------------------------------------------------------------------------------------------to. periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Technological Characteristics:
| Characteristic | Subject | Predicate |
|---|---|---|
| Biomaterial | Proprietary calcium phosphate formula | Proprietary calcium phosphate formula |
| Hydration Media(provided) | 0.9% sodium chloridesolution conformingwith the monographfor 0.9% SodiumChloride InjectionUSP | 0.9% SodiumChloride InjectionUSP |
| Hydration Media(not provided) | None | None |
| Sterilization | Gamma irradiation | Gamma irradiation |
Materials:
Synthetic calcium phosphate
Non-Clinical Test:
Testing consistent with Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005) has been submitted.
{2}------------------------------------------------
Special 510(k) Submission -- Alternate Hydration Solution
Clinical Test: Per Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005), clinical testing is not required for the subject devices.
Based upon our assessment of the performance data, the Conclusions: revised device is safe and effective for its intended use and performs as well as the predicate device.
{3}------------------------------------------------
Klo2812
ﻟﻠﻘﻀﺎﺀ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ
Special 510(k) Submission - Alternate Hydration Solution
510(k) Summary - Gamma-bsm 5.2
| Submitter: | ETEX Corporation38 Sidney StreetCambridge, MA 02139Registration No.: 1225112Owner/Operator No.: 9014709 | DEC - 3 |
|---|---|---|
| ------------ | ------------------------------------------------------------------------------------------------------------------------- | --------- |
Contact Person: Christopher Klaczyk Regulatory Affairs Manager Office: (617) 577-7270 x160 Mobile: (617) 710-8091 Fax: (617) 577-7170 E-Mail: cklaczyk@etexcorp.com
Date Prepared: September 27, 2010
Product Code(s): LYC (21 CFR 872.3930)
Device Class: II (21 CFR 872.3930)
Classification Panel: Dental
Classification Name: Bone Grafting Material, Synthetic (21 CFR 872.3930)
Proprietary Name: Gamma-bsm Moldable Bone Substitute Material
Predicate Device(s): Gamma-bsm Moldable Bone Substitute Material (cleared for Dental and Maxillofacial indications per K091729) Gamma-bsm Moldable Bone Substitute Material (alternate Hydration Solution cleared for Orthopedic indications per K101557)
Device Description: Gamma-bsm Moldable Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form aTraditional 510(k) Submission -- Bone Grafting Material putty. The resulting putty is administered to the treatment site by manual application. The material can be shaped into a desired form in-situ prior to implantation. After the putty is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural
{4}------------------------------------------------
Special 510(k) Submission - Alternate Hydration Solution
bone minerals. Gamma-bsm Moldable Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
Intended Use: Gamma-bsm Moldable Bone Substitute Material is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects 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.
Gamma-bsm Moldable Bone Substitute Material is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Technological Characteristics:
| Characteristic | Subject | Predicate |
|---|---|---|
| Biomaterial | Proprietary calciumphosphate formula | Proprietary calciumphosphate formula |
| Hydration Media(provided) | 0.9% sodium chloridesolution conformingwith the monographfor 0.9% SodiumChloride InjectionUSP | 0.9% SodiumChloride InjectionUSP |
| Hydration Media(not provided) | Autologous wholeblood, autologousbone marrow aspirate | Autologous wholeblood, autologousbone marrow aspirate |
| Sterilization | Gamma irradiation | Gamma irradiation |
Materials: Synthetic calcium phosphate
Non-Clinical Test: Testing consistent with Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005) has been submitted.
Clinical Test:
Per Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005), clinical testing is not required for the subject devices.
{5}------------------------------------------------
Special 510(k) Submission – Alternate Hydration Solution
Conclusions:
Based upon our assessment of the performance data, the revised device is safe and effective for its intended use and performs as well as the predicate device.
:
{6}------------------------------------------------
Special 510(k) Submission – Alternate Hydration Solution
5.3 510(k) Summary – EquivaBone
| Submitter: | ETEX Corporation38 Sidney StreetCambridge, MA 02139Registration No.: 1225112Owner/Operator No.: 9014709 | DEC - 3 2010 |
|---|---|---|
| Contact Person: | Christopher KlaczykRegulatory Affairs ManagerOffice: (617) 577-7270 x160Mobile: (617) 710-8091Fax: (617) 577-7170E-Mail: cklaczyk@etexcorp.com | |
| Date Prepared: | September 27, 2010 | |
| Product Code(s): | NUN (21 CFR 872.3930) | |
| Device Class: | II (21 CFR 872.3930) | |
| Classification Panel: | Dental | |
| Classification Name: | Bone Grafting Material, Human Source (21 CFR 872.3930) | |
| Proprietary Name: | EquivaBone Osteoinductive Bone Graft Substitute | |
| Predicate Device(s): | EquivaBone Osteoinductive Bone Graft Substitute (clearedfor Dental and Maxillofacial indications per K091729)EquivaBone Osteoinductive Bone Graft Substitute(alternate Hydration Solution cleared for Orthopedicindications per K101557) | |
| Device Description: | EquivaBone is a biocompatible bone graft substitutematerial consisting of synthetic calcium phosphate,carboxymethyl cellulose (CMC) and human demineralizedbone matrix (DBM). It is supplied in a single use kit asTraditional 510(k) Submission -Bone Grafting Materialsterile powders and hydration solution that are mixedtogether at the time of use in the operating room to formflowable putty which is implanted manually or can beextruded through a syringe. After implantation the producthardens at body temperature and resorbs and remodelsduring the healing process. Each lot of DBM containedwithin EquivaBone is assayed for osteoinductive potentialin an athymic nude mouse model. This may or may not bepredictive of EquivaBone osteoinductivity in humans. |
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
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- Intended Use: EquivaBone Osteoinductive Bone Graft Substitute is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix combined with demineralized bone matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects 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.
EquivaBone Osteoinductive Bone Graft Substitute is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Technological Characteristics:
| Characteristic | Subject | Predicate |
|---|---|---|
| Biomaterial | Proprietary calciumphosphate formula,carboxymethylcellulose (CMC),demineralized bonematrix (DBM) | Proprietary calciumphosphate formula,carboxymethylcellulose (CMC),demineralized bonematrix (DBM) |
| Hydration Media(provided) | 0.9% sodium chloridesolution conformingwith the monographfor 0.9% SodiumChloride InjectionUSP | 0.9% SodiumChloride InjectionUSP |
| Hydration Media(not provided) | Autologous wholeblood, autologousbone marrow aspirate | Autologous wholeblood, autologousbone marrow aspirate |
| Sterilization | Gamma irradiation | Gamma irradiation |
Materials:
Synthetic calcium phosphate, sodium carboxymethyl cellulose (CMC) and demineralized bone matrix (DBM)
Non-Clinical Test:
Testing consistent with Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005) has been submitted.
and the comments of the comments of the comments of
{8}------------------------------------------------
Special 510(k) Submission – Alternate Hydration Solution
Clinical Test: Per Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005), clinical testing is not required for the subject devices. Conclusions: Based upon our assessment of the performance data, the revised device is safe and effective for its intended use and
performs as well as the predicate device.
{9}------------------------------------------------
Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is rendered in blue and consists of a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the caduceus in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Christopher Klaczyk Regulatory Affairs Manager ETEX Corporation 38 Sidney Street Cambridge, Massachusetts 02139
JAN 1 2 2011
Re: K102812
Trade/Device Name: Beta-bsm Injectable Bone Substitute Material Gamma-bsm Moldable Bone Substitute Material EquivaBone Osteoinductive Bone Graft Substitute Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NUN, LYC Dated: November 3, 2010 Received: November 5, 2010
Dear Mr. Klaczyk:
This letter corrects our substantially equivalent letter of December 3, 2010.
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 (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.
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.
{10}------------------------------------------------
Page 2 - Mr. Klaczyk
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
for
Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{11}------------------------------------------------
Special 510(k) Submission - Alternate Hydration Solution
4. Indications For Use
4.1 Indications For Use - Beta-bsm
11/02812 510(k) Number (if known):
Device Name:
Beta-bsm Injectable Bone Substitute Material
Indications for Use:
Beta-bsm Injectable Bone Substitute Material is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects 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.
Beta-bsm Injectable Bone Substitute Material is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospi. Infection Control and Dental Devices | |
| 510(k) Number: | K140282 |
{12}------------------------------------------------
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: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : . . スティース - 1 ਾ ਦੇ ਸੰਬਰ ਦੇ ਸਮੇਂ ਦ ਸਾਲ ਵਿੱਚ ਸਾਰਕ ਸਾਰੀ ਦਾ ਸਾਰੀ ਕਰ ਸਾਰੀ ਦੇ ਸਾਰੇ ਦੇ ਸਾਰੇ ਦੇ ਸਾਰੇ ਦੇ ਸਾਰੇ ਦੇ ਸੰਗ 11 11:1 00-11-2017 11:00:00 来源: ಾರ್ ಅಥವಾ ಸಾಮಿತ್ಯ ಸಿಜಯ ಮಹಾರಾಯ ಚಿತ್ರಿಕೆಯ te in the varieten திருக்கு விளைவிடம் இருக்கும் இருக்கும் இது முறைக . and and the first of the state
ਾ ਦੀ ਸਾਹਿਤ ਕਿ ਸਾਰੇ ਦੇ ਸਿੰਘ ਸੀ। a marka masa da katika masa mandu ara : : िक्स के समुद्री के साथ की मानवान के साथ से समय में बाद में बाद में बाद में बाद में बाद में बाद में बाद में बाद में कि में बाद में कि में बाद में कि में बाद में कि में बाद मे : . m on the final comments of the production of the comments of the : ..... ಿ ಸಿಂದಿಸಿದ ಹಿಂದೆ ಮಾರ್ ಅವರಿಗೆ ಮಾರ್ ಮತ್ತು ಒಂದು ಮಾರ್ ಅಂದರ್ ಅಂದು ಪ್ರಾ . . . . . .
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{13}------------------------------------------------
4.2 Indications For Use - Gamma-bsm
1102812 510(k) Number (if known):
Device Name:
Gamma-bsm Moldable Bone Substitute Material
Indications for Use:
Gamma-bsm Moldable Bone Substitute Material is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects 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.
Gamma-bsm Moldable Bone Substitute Material is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defecto. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Deyice Evaluation (ODE)
Susan Kenaus
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
510(k) Number: K2812
{14}------------------------------------------------
agared Printers - Bal . 9 11 11 1 . . . . . . . . . . . . . .
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11 2011 11:11
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e general de la provinsion in de comment de la program discussi ය කියන පිහිටා අනුව අධිකානු විය. i respect production and political considere contrasse consideration Children Children : मुंबई के बाद में समस्या कर रहे हैं कि मिल के बाद में कि मिली है कि में बना दे कि महिला में कि महिला में कि महिला में कि महिला में कि महिला में कि महिला में कि महिला में कि osten opera programade and sommercial programment proposes e voël ogste e komunistry versi me namerika
ക്കുന്നു. അവലംബം ಾರ್ - ਹੈ ਅਤੇ ਇਸ ਨੇ ਮੈਨੀਆਂ ਦੇ ਸ਼ਹਿਰ ਅਤੇ ਪਾਰਟ ਕਰ ਦਾ ਹੈ ਅਨੁਸਾਰ ਦੇ ਵਾਲੀ ਸ਼ੁਰੂਆਂ ਦੀ ਮਾਰਤ ਦੀ ਸਾਰੀ ਦੇ ਸਾਰ gris Frances of the production and province of the provided to and the p ് വേണ്ടി വിവിധ വിവിധ വിവിധ വിശ്വാഭ്യമായ വാഹിത്രക്രി എന്ന വിവരുവിന്റെയും വിക്കുന്നത്. ் ஆவது முறைய நக .
ਸੀ। ਦੀ ਸਾਹਿਤ ਮਾਲਕ ਦਾ ਸਾਲ ਪਿਆ ਸਿੰਘ ਸਿਰਮ ਲਾਈ ਦੀ ਦੇ ਪਿੰਡ ਬਣਾ 1 11:50:1
ਦੀ ਕਰ ਦੇ ਮਾਰਕ ਦਾ ਸੁਰੂ ਇੱਕ ਸੂਬਿਆ ਸੀ। ਉਸਦਾ ਸੀ। ਉਹ ਸਾਰਕ ਦਾ ਸਾਰ ਪਿੰਡ
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{15}------------------------------------------------
4.3 Indications For Use - EquivaBone
R102812 510(k) Number (if known):
EquivaBone Osteoinductive Bone Graft Substitute
Indications for Use:
Device Name:
EquivaBone Osteoinductive Bone Graft Substitute is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix combined with demineralized bone matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects 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.
EquivaBone Osteoinductive Bone Graft Substitute is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control and Dental Devices | |
| 510(k) Number: |
{16}------------------------------------------------
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§ 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.