(378 days)
Orthocon HemasorbPlus Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.
HEMASORBPLUS™ Resorbable Hemostatic Bone Putty is a sterile, biocompatible, resorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The material contains a mixture of alkylene oxide polymer based materials, vitamin E acetate, granular calcium phosphate and sodium carboxymethylcellulose. HEMASORBPLUS™ Resorbable Hemostatic Bone Putty is virtually odorless, off-white in color and can be spread easily onto bone with minimal adhesion to surgical gloves. The putty requires no kneading or warming prior to application. When applied to surgically cut or traumatically broken bone, HEMASORBPLUS™ Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). HEMASORBPLUS Resorbable Hemostatic Bone Putty has been shown to be mixable with autograft in a 1:1 volume ratio.
This document is a 510(k) summary for the Orthocon HemasorbPlus Resorbable Hemostatic Bone Putty. It describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device.
1. Acceptance Criteria and Reported Device Performance:
The document implicitly refers to acceptance criteria by stating that "Testing was conducted to verify the device's handling properties, to characterize the device's performance over a range of temperatures and to evaluate the device's dissolution and swelling properties." and that the "data presented demonstrate that the device is suitable for its indicated use." However, specific numerical acceptance criteria (e.g., "smearability shall be X," "dissolution rate shall be Y") and detailed reported device performance values are not explicitly provided in this summary.
The summary lists the following studies and their general findings:
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Handling properties (smearability, stickiness, stiffness) | Tested and verified |
| Performance over a range of temperatures | Tested and characterized |
| Dissolution and swelling properties | Tested and evaluated |
| Biocompatibility (cytotoxicity, irritation, sensitization, acute systemic toxicity, implantation/subacute toxicity, hemolysis, pyrogenicity) | Tested in accordance with ISO 10993 recommendations; all GLP requirements met. |
| In vivo hemostasis | Demonstrated intraoperative in vivo hemostasis |
| Resistance to irrigation | Demonstrated |
| Ability to remove the device | Demonstrated |
| Safety and absorption time | Characterized |
| Hemostasis when mixed with autograft (1:1 ratio) | Provided hemostasis and did not interfere with normal bone healing compared to autograft alone. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated for bench, biocompatibility, or in vivo studies.
- Data Provenance: The studies were conducted by Orthocon, Inc. and are described as "bench studies," "biocompatibility testing," and "in vivo performance testing." The in vivo testing included "animal studies," implying the data provenance is from animals, rather than human patients. The country of origin is not specified but implicitly in the USA as it is for FDA approval in the US. The studies are assumed to be prospective as they were conducted to support the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The ground truth for bench, biocompatibility, and animal studies is typically established through direct measurement, laboratory assays, and observations by trained personnel, not through expert consensus in the same way clinical image interpretation might require.
4. Adjudication Method for the Test Set:
Not applicable. This type of device testing (bench, animal) does not typically involve adjudication methods like those used for human-in-the-loop diagnostic studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. The HemasorbPlus is a resorbable hemostatic bone putty and does not involve human readers interpreting data generated by the device itself in a diagnostic capacity.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the device performance tests described are inherently "standalone" in the sense that they evaluate the device's physical, chemical, and biological properties and direct effect on bleeding, independent of human interpretive input. The core functionality and safety of the putty were evaluated.
7. The Type of Ground Truth Used:
- Bench Studies: Objective measurements of physical properties (e.g., smearability metrics, stiffness measurements, temperature effects, dissolution rates, swelling properties).
- Biocompatibility Testing: Laboratory assay results (e.g., cytotoxicity assays, irritation scores, sensitization responses, acute systemic toxicity observations, pathology from implantation, hemolysis assays, pyrogenicity tests) against established biological safety standards (ISO 10993).
- In Vivo Performance Testing (Animal Studies): Direct observation and measurement of hemostasis, resistance to irrigation, ability to remove, and characterization of safety and absorption time in animal models. For the autograft study, histological analysis (pathology) would likely be the ground truth for "normal bone healing."
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML-based diagnostic or predictive algorithm that requires a "training set" in the conventional sense. The "training" for such a device comes from understanding material science, biocompatibility principles, and surgical hemostasis.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for this type of medical device.
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