(170 days)
Tactoset® Injectable Bone Substitute is a synthetic, biocompatible material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the skeletal system (i.e. extremities and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgicallycreated osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, selfsetting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process. Tactoset® Injectable Bone Substitute can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
Tactoset® Injectable Bone Substitute is an injectable, settable osteoconductive calcium phosphate bone graft substitute material. It is provided to the end-user as two components (a dry powder and an aqueous solution in separate pre-loaded syringes) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a cohesive paste. The dry powder component is composed of the alpha phase of tricalcium phosphate [Ca3(PO4)2], calcium carbonate [CaCO3], and monocalcium phosphate [Ca(H2PO4)2]. The liquid component is composed of sodium phosphate dibasic [Na2HPO4], citric acid [C6H8O7], hyaluronic acid (HA), Iohexol (C19H26J3N309) and water for injection. Tactoset is provided sterile for single use.
This document describes the FDA 510(k) premarket notification for the Tactoset® Injectable Bone Substitute. It is a medical device, specifically a resorbable calcium salt bone void filler. The information provided heavily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a clinical study evaluating the performance of an AI/ML powered device.
Therefore, many of the requested criteria regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML powered device (e.g., sample size for test sets, expert ground truth establishment, MRMC studies, standalone performance) are not applicable to this document, as it is about a different type of medical device (a bone substitute) and its premarket clearance process based on substantial equivalence.
However, I can extract information related to the performance testing and comparison for this specific device type, which serves a similar purpose of demonstrating safety and effectiveness.
Here's an analysis of the provided text based on your request, focusing on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in the typical sense of numerical thresholds for a clinical study endpoint for an AI/ML device. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests and comparisons. The "performance" is shown by comparing the subject device's properties and animal study results to those of the predicates.
| Test/Property | Acceptance Criteria (Implied: Substantial Equivalence to Predicate) | Reported Device Performance (Tactoset with Iohexol vs. Predicate Tactoset) |
|---|---|---|
| Analytical Characterization | Similar to predicate | Conducted, results support substantial equivalence |
| Chemical Composition | Similar to predicate | Conducted, results support substantial equivalence |
| Physical Properties | Similar to predicate | Conducted, results support substantial equivalence |
| Mechanical Testing (Pull-Out, Compressive Strength, Bone Alignment) | Similar to predicate | Conducted, results support substantial equivalence |
| New Bone Formation (Rabbit Model, 26 weeks) | Similar to predicate | ~17% (Tactoset with Iohexol) vs. ~17% (Predicate Tactoset) |
| Implant Material Remaining (Rabbit Model, 26 weeks) | Similar to predicate | ~61% (Tactoset with Iohexol) vs. ~59% (Predicate Tactoset) |
| Empty Defect Bone (Rabbit Model, 12 weeks) | (Baseline for comparison) | ~6% |
| Physical Form | Injectable Paste/Putty | Injectable Paste/Putty |
| Device Volume (CC) | 4 | 4 |
| Mixing Time (Min) | 1 | 1 |
| Working Time (Minute) | 7-18 | 7-18 |
| Setting Time (Minute) | 10 | 10 |
| Sterility Method | Single Use, Sterile, SAL 10-6 | Single Use, Sterile, SAL 10-6 |
| Pyrogenicity | LAL < 20 EU/device | LAL < 20 EU/device |
| Packaging | Similar packaging to primary predicate | Identical to primary predicate |
2. Sample size used for the test set and the data provenance
The primary "test set" described is the animal functional study using a rabbit critical sized femoral defect model.
- Sample Size: The document does not explicitly state the number of animals used. It refers to "an average new bone formation" and "an average implant material remained," implying a group of animals for each.
- Data Provenance: The study was conducted in a "rabbit critical sized femoral defect model." The country of origin is not specified. It is a prospective study (animal study specifically conducted for this submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not directly applicable to an animal study for a bone substitute. The "ground truth" here would be the biological and material outcomes measured in the rabbit model (e.g., new bone formation, remaining implant material). These measurements are typically quantifiable and do not rely on expert consensus in the same way an imaging AI ground truth would.
4. Adjudication method for the test set
Not applicable in the context of this type of animal study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This is not an AI/ML device, and no MRMC study was conducted. The clearance is based on substantial equivalence to existing bone substitute devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
For the animal study, the "ground truth" was quantifiable biological and material outcomes measured directly from the animal model (e.g., percentage of new bone formation, percentage of implant material remaining) at specified time points (12 and 26 weeks). This would typically involve histological analysis, imaging, and potentially other standardized measurements.
8. The sample size for the training set
Not applicable. This is not an AI/ML device. There is no concept of a "training set" for this type of device submission.
9. How the ground truth for the training set was established
Not applicable.
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December 20, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Anika Therapeutics, Inc. % Mehdi Kazemzadeh-Narbat, PhD, PMP, CQA Associate Director, Regulatory Affairs MCRA, LLC 1050 K Street NW. Suite 1000 Washington, District of Columbia 20001
Re: K231968
Trade/Device Name: Tactoset® Injectable Bone Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: December 1, 2023 Received: December 1, 2023
Dear Dr. Kazemzadeh-Narbat:
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.
Sara S. Thompson -S
For
Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices
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Enclosure
Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known)
K231968
Device Name Tactoset® Injectable Bone Substitute
Indications for Use (Describe)
Tactoset® Injectable Bone Substitute is a synthetic, biocompatible material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the skeletal system (i.e. extremities and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgicallycreated osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, selfsetting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process.
Tactoset® Injectable Bone Substitute can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
| Device Trade Name: | Tactoset |
|---|---|
| Manufacturer: | Anika Therapeutics, Inc.32 Wiggins AvenueBedford, MA 01730 |
| Contact: | Wei ZhaoExecutive Director, Regulatory AffairsMobile: (978)888-5948E-Mail: wzhao@anika.com |
| Prepared by: | Mehdi Kazemzadeh-Narbat, PhD, PMP, CQAAssociate Director, Regulatory Affairs,MCRA, LLC1050 K Street NW, Suite 1000Washington, DC 20001Office: 202.552.6011mkazemzadeh@mcra.com |
| Date Prepared: | December 19, 2023 |
| Classifications: | 21 CFR §880.3045, Resorbable calcium salt bone void filler device |
| Class: | II |
| Product Codes: | MQV |
| Primary Predicate: | Tactoset (K212083) |
| Additional Predicates: | Tactoset (K223915)Cerament Bone Void Filler (K201535) |
Indications For Use:
Tactoset® Injectable Bone Substitute is a synthetic, biocompatible bone graft substitute material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the skeletal system (i.e. extremities and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgically-created osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, self-setting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process. Tactoset Injectable Bone Substitute can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
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Device Description:
Tactoset® Injectable Bone Substitute is an injectable, settable osteoconductive calcium phosphate bone graft substitute material. It is provided to the end-user as two components (a dry powder and an aqueous solution in separate pre-loaded syringes) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a cohesive paste. The dry powder component is composed of the alpha phase of tricalcium phosphate [Ca3(PO4)2], calcium carbonate [CaCO3], and monocalcium phosphate [Ca(H2PO4)2]. The liquid component is composed of sodium phosphate dibasic [Na2HPO4], citric acid [C6H8O7], hyaluronic acid (HA), Iohexol (C19H26J3N309) and water for injection. Tactoset is provided sterile for single use.
Predicate Device:
Anika Therapeutics, Inc. submits the following in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, Tactoset is substantially equivalent in indications, design principles, and performance to the following predicate devices, which have been determined by FDA to be substantially equivalent to preamendment devices:
| Primary Predicate: | Tactoset (K212083) |
|---|---|
| Additional Predicates: | Tactoset (K223915)Cerament Bone Void Filler (K201535) |
Performance Testing Summary:
Bench testing data including analytical characterization, chemical composition, physical properties, mechanical testing (Pull-Out. Compressive Strength, Bone Alignment) and animal functional study were conducted for the subject Tactoset and the predicate devices. The results of the study demonstrate substantial equivalence to the predicate devices. The performance of Tactoset containing iohexol radiopacifier was compared to the predicate device, Tactoset (without iohexol), in a rabbit critical sized femoral defect model. At the 26-week timepoint, animal study data demonstrated an average new bone formation of approximately 17% in the Tactoset with iohexol group, and 17% in the Tactoset (predicate) group. Animal study data at 26 weeks demonstrated that approximately 61% of implant material remained in the Tactoset with iohexol group, and 59% remained in the Tactoset (predicate) group, with respect to the geometry of the defect filled with implant material at the time of surgery. At 12 weeks the empty defect contained approximately 6% bone. Clinical performance has not been evaluated.
Substantial Equivalence:
The Subject Device is substantially equivalent to the primary predicate Tactoset (K212083) in terms of material composition, manufacturing process, sterilization, and packaging and both are manufactured in the same facility. The Subject Device and the predicate devices (primary and additional) have the same intended uses, the same product classification and product code (MOV) and have similar "Indications for Use" statements in the extremities and pelvis. The Subject Device and the predicate devices are bone void fillers that are intended for bony voids or gaps that are not intrinsic to the stability of the bony structure. The Subject Device and the primary predicate incorporate the same basic design, incorporates similar materials, have identical manufacturing process, identical packaging and are both provided sterile for singlepatient, single-use in the same device volume.
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The Subject Device and additional predicate Cerament Bone Void Filler (K201535) uses an identical contrast agent/radiopacifier (Iohexol) in its formulation.
No clinical data were required to support the substantial equivalence.
| Information | Subject Device(Tactoset) | PrimaryPredicate(Tactoset) | AdditionalPredicate(Tactoset) | AdditionalPredicate(Cerament) |
|---|---|---|---|---|
| Manufacturer | Anika Therapeutics,Inc. | Anika Therapeutics,Inc. | Anika Therapeutics,Inc. | Bone Support AB |
| Trade Name | Tactoset | Tactoset | Tactoset | Cerament Bone VoidFiller |
| 510(k)Number | TBD | K212083 | K223915 | K201535 |
| Product Code | MQV | MQV | MQV | MQV |
| DeviceClassificationName | Resorbable calciumsalt bone void fillerdevice | Resorbable calciumsalt bone void fillerdevice | Resorbable calciumsalt bone void fillerdevice | Resorbable calciumsalt bone void fillerdevice |
| Physical Form | InjectablePaste/Putty | Injectable Paste/Putty | Injectable Paste/Putty | Injectable Paste |
| DeviceVolume (CC) | 4 | 4 | 4 | 5, 10, 18 |
| Mixing Time(Min) | 1 | 1 | 1 | 0.5 |
| WorkingTime (Minute) | 7-18 | 7-18 | 7-18 | 3 to 5 |
| Setting Time(Minute) | 10 | 10 | 10 | Not available |
| SterilityMethod | Single Use, Sterile,SAL 10-6Setting Solution:Autoclave and VHPPowder Component:Gamma Irradiation | Single Use, Sterile,SAL 10-6Setting Solution:Autoclave and VHPPowder Component:Gamma Irradiation | Single Use, Sterile,SAL 10-6Setting Solution:Autoclave and VHPPowder Component:Gamma Irradiation | Single Use, Sterile,SAL 10-6Gamma irradiation;Steam; and Ethyleneoxide |
| Pyrogenicity | LAL < 20 EU/device | LAL < 20 EU/device | LAL < 20 EU/device | LAL < 20 EU/device |
| Packaging | The liquid syringe isdouble packaged inheat-sealed Tyvekpouches. The cementpowder is providedin a mixing syringepackaged in a foilpouch. The foilpouch is thenpackaged in a plastictray with a Tyvek lid | The liquid syringe isdouble packaged inheat-sealed Tyvekpouches. The cementpowder is provided ina mixing syringepackaged in a foilpouch. The foilpouch is thenpackaged in a plastictray with a Tyvek lid | The liquid syringe isdouble packaged inheat-sealed Tyvekpouches. The cementpowder is provided ina mixing syringepackaged in a foilpouch. The foilpouch is thenpackaged in a plastictray with a Tyvek lid | Blister tray packed ina Tyvek-PET/PEpouch |
Table 6-1. Substantial Equivalence of the Subject and Predicate Devices.
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Conclusion:
The Subject Device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in identical materials and are sterilized using identical methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above. Tactoset is as safe, as effective, and performs as well as, or better, than the predicate devices.
§ 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.