(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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 30, 2016
Orthocon, Inc. Howard Schrayer Official Correspondent 1 Bridge Street, Suite 121 Irvington, New York 10533
Re: K153317
Trade/Device Name: Hemasorbplus Resorbable Hemostatic Bone Putty Regulatory Class: Unclassified Product Code: MTJ Dated: November 21, 2016 Received: November 22, 2016
Dear Mr. Schrayer:
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 (reporting of medical devicerelated 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,
David-Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153317
Device Name
HemasorbPlus Resorbable Hemostatic Bone Putty
Indications for Use (Describe)
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.
| 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 (Per 21 CFR 807.92)
General Company Information
Name: Orthocon. Inc. Contact: Howard Schrayer Requlatory Affairs Consultant Address: 1 Bridge Street, Suite 121 Irvington, NY 10533 Telephone: (609) 924 - 9510 Fax: (914) 231 - 7884
Date Prepared November 29, 2016
General Device Information
510(k) Number: K153317 Product Name: HEMASORBPLUS™ Resorbable Hemostatic Bone Putty Classification: "Bone Wax", Product code: MTJ Requlation: Unclassified
Predicate Device
Orthocon. Inc. - Hemostatic Bone Putty 3 510(k) Number: K123243
Description
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.
Indications For Use
Orthocon HEMASORBPLUS Resorbable Hemostatic Bone Putty is indicated for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.
Purpose of Submission
Orthocon is proposing to modify the labeling (Instructions for Use) to provide information regarding use of this device when mixed in a 1:1 ratio with autograft.
Testing Completed on Original Configuration
The following testing was completed on the original (predicate) device and is referenced in the 510(k) Notice because the device formulation is unchanged;
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Performance Data
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. The following bench studies were completed: smearability. stickiness, stiffness, temperature sensitivity, and dissolution and swelling.
Biocompatibility Testing
Testing was conducted to evaluate the device's biocompatibility in accordance with the recommendations of ISO 10993. The following biocompatibility studies were conducted on the final, finished, gamma-irradiation sterilized device and in accordance with the GLP requirements: cytotoxicity, irritation, sensitization, acute systemic toxicity, implantation / subacute toxicity, hemolysis, and pyrogenicity.
In Vivo Performance Testing
Testing included animal studies to demonstrate intraoperative in vivo hemostasis, resistance to irrigation, ability to remove the device, and to characterize its safety and absorption time.
Testing Completed to Support Mixing with Autograft
In accordance with design control procedures, Orthocon, Inc. performed a risk analysis for the proposed removal of the "Warning" statement that advised users not combine HEMASORBPLUS Resorbable Hemostatic Bone Putty with autograft. This design control process was based on an FMEA approach. Based on the results of the risk analysis, a study was conducted in laboratory animals to confirm that mixture with autograft in a 1:1 ratio (by volume) provided hemostasis and did not interfere with the normal bone healing process when compared with autograft alone.
Substantial Equivalence and Conclusions
This submission supports the position that the Orthocon HEMASORBPLUS Resorbable Hemostatic Bone Putty is substantially equivalent and is exactly the same as the predicate Orthocon HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty [cleared under 510(k) K123243]. Orthocon, Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as Orthocon HEMASORBPLUS Resorbable Hemostatic Bone Putty and that Substantial Equivalence to the predicate device has been established. The data presented demonstrate that the device is suitable for its indicated use. The materials from which the Orthocon device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA quidelines.
N/A