The HBP6 Settable, Resorbable Hemostatic Bone Paste is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

Device Description

The HBP6 Settable, Resorbable Hemostatic Bone Paste is a sterile, biocompatible, resorbable material for use in the control of bleeding from bone surfaces. The single use HBP6 device contains two separate components of paste-like consistency comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the HBP6 device form a resorbable paste-like material that can be applied directly to bleeding bone by means of a single-use applicator (delivery device). The resulting hardening paste is primarily comprised of calcium phosphate. HBP6 is mixed immediately prior to use.

When applied to surgically cut or traumatically broken bone, HBP6 Settable, Resorbable Hemostatic Bone Paste achieves local control of bleeding by acting as a mechanical barrier (tamponade).

AI/ML Overview

The provided document is a 510(k) summary for a medical device cleared by the FDA. It does not describe an AI/ML powered device, nor does it detail acceptance criteria and a study that proves the device meets those criteria in the context of an algorithm's performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, many of the requested categories (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this document's content, as it pertains to a physical medical device (hemostatic bone paste), not an AI algorithm.

However, I can extract the information relevant to the device's performance testing and how it demonstrates "acceptance" in the context of a 510(k) submission.

Device: HBP6 Settable, Resorbable Hemostatic Bone Paste

Acceptance Criteria & Device Performance (as demonstrated for Substantial Equivalence):

The "acceptance criteria" in the context of a 510(k) for a physical device like this are framed around demonstrating substantial equivalence to a legally marketed predicate device, largely through showing similar technological characteristics and comparable performance in relevant tests. The performance is "accepted" if it falls within expected ranges for the device type and is consistently similar to the predicate.

Acceptance Criteria Category (implied by 510(k) requirements for substantial equivalence)	Reported Device Performance (HBP6 vs. Predicate)
Intended Use	Identical: Control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.
Mechanism of Action	Identical: Mechanical tamponade that occludes vascular openings in damaged bone.
Form of Device	Similar: Both are two-part settable materials. HBP6 is paste/paste forming a "settable" (hardening) paste; Predicate is putty/putty forming a "settable" (hardening) putty. Functionally similar in application and outcome.
Composition	Similar: Both are sterile mixtures of two components with granular calcium phosphate (hydroxyapatite and β-tricalcium phosphate), calcium stearate, vitamin E acetate, triacetin, 1,4-butanediol, triethanolamine, and absorbable polymers (lactide-diester and polyester-based). The resulting settable device is primarily comprised of calcium phosphate.
Radiopacity	Identical: Radiopaque - Contains hydroxyapatite and β-tricalcium phosphate.
Resorbable	Identical: Yes.
Resorption Time	Identical: Greater than 30 days primarily due to presence of calcium phosphate.
Method of Application	Similar: Both are manually applied and spread onto bone tissue (HBP6 uses a delivery instrument).
Degradation Process	Identical: Non-calcium salt and non-polymeric components degrade via dissolution; polymer degrades via hydrolysis; calcium salts degrade via chemical dissolution and/or cellular removal.
Sterility	Identical: Provided sterile for single use by gamma irradiation.
Set Time	Identical: Sets within 5-minutes of application.
Handling Properties	Verified (Bench Testing): Relative stiffness, spreadability, stickiness acceptable.
Temperature Sensitivity	Evaluated (Bench Testing): Acceptable performance over a range of temperatures.
Electrocautery Compatibility	Evaluated (Bench Testing): Compatible.
Dissolution Properties	Acceptable (Bench Testing).
Swelling	Evaluated (Bench Testing): Acceptable.
Biocompatibility	Compliant with ISO 10993 (Biocompatibility Testing): No adverse effects demonstrated in irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, systemic toxicity, hemolysis, endotoxicity, and pyrogenicity studies.
Intraoperative In Vivo Hemostasis	Demonstrated (Animal Testing): Achieved hemostasis.
Resistance to Irrigation	Demonstrated (Animal Testing): Resisted irrigation.

Information Not Applicable or Not Provided in this Document (due to the nature of the device and submission type):

Sample size used for the test set and the data provenance: Not specified for bench or animal testing, as this typically isn't a statistical study to prove a diagnostic algorithm's performance on human data. The "test set" here refers to the actual samples or animals used in the physical properties and biological tests. Data provenance (country, retrospective/prospective) is not mentioned for animal or bench studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical hemostat is established via objective physical measurements (e.g., set time, dissolution rate) and observed biological effects (e.g., hemostasis in an animal model, toxicity in biocompatibility tests). There are no "experts" interpreting diagnostic images or clinical outcomes in this context.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is for diagnostic or AI-assisted devices, not a physical hemostat.
If a standalone performance was done: Not applicable in the context of an algorithm. For a physical device, "standalone performance" is implicitly demonstrated through the bench and animal tests, showing the device functions as intended on its own.
The type of ground truth used:
- Bench Testing: Mechanical properties (e.g., stiffness, set time, dissolution rates) are measured directly based on established testing standards.
- Biocompatibility Testing: Results are determined based on standardized ISO 10993 biological endpoints (e.g., cell viability, irritation scores, genetic mutations).
- Animal Testing: In vivo hemostasis and resistance to irrigation are direct observations in animal models.
The sample size for the training set: Not applicable; there is no "training set" for a physical medical device.
How the ground truth for the training set was established: Not applicable.

Summary

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March 27, 2020

Orthocon, Inc. Howard Schrayer Official Correspondent 1 Bridge Street, Suite 121 Irvington, New York 10533

Re: K193052

Trade/Device Name: HBP6 Settable, Resorbable Hemostatic Bone Paste Regulatory Class: Unclassified Product Code: MTJ Dated: February 26, 2020 Received: February 27, 2020

Dear Mr. Howard 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. 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 located 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.

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting

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combination-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 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/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,

Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K193052

Device Name

HBP6 Settable, Resorbable Hemostatic Bone Paste

Indications for Use (Describe)

The HBP6 Settable, Resorbable Hemostatic Bone Paste 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 K193052

Contact: Howard Schrayer Orthocon, Inc. 1 Bridge Street, Suite 121 Irvington, NY 10533 Telephone: 609-273-7350 Fax: 914-231-7884 hs.ss@lucidmedical.net
Date Prepared: March 23, 2020

Device Trade Name: HBP6 Settable, Resorbable Hemostatic Bone Paste

Manufacturer: Orthocon, Inc. 1 Bridge Street, Suite 121 Irvington, NY 10533
Common Name: Bone Wax
Classification: Unclassified
Product Code: MTJ

Predicate Devices

Orthocon, Inc. MONTAGE-QS Settable, Resorbable Hemostatic Bone Putty 510(k) K191140

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Indications for Use:

The HBP6 Settable, Resorbable Hemostatic Bone Paste is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

Device Description:

When applied to surgically cut or traumatically broken bone, HBP6 Settable, Resorbable Hemostatic Bone Paste achieves local control of bleeding by acting as a mechanical barrier (tamponade).

Substantial Equivalence and Predicate Devices:

The device was shown to be substantially equivalent to previously cleared bone hemostasis predicate device, Montage-QS Settable, Resorbable Hemostatic Bone Putty (K191140).

Technoloqical Characteristics:

The table below compares the technological characteristics of HBP6 and the predicate.

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Predicate Comparison Table
Manufacturer	Orthocon, Inc.	Orthocon, Inc.
Trade Name	HBP6 Settable, Resorbable HemostaticBone Paste	MONTAGE-QS™ Settable, ResorbableHemostatic Bone Putty
510(k) Number	K193052	K191140
Type of Device/Product Code	Bone wax / MTJ	Bone wax / MTJ
Indications for Use	HBP6 Settable, Resorbable HemostaticBone Paste is indicated in the control ofbleeding from cut or damaged bone byacting as a mechanical barrier ortamponade	MONTAGE-QS™ Settable, ResorbableHemostatic Bone Putty is indicated in thecontrol of bleeding from cut or damagedbone by acting as a mechanical barrieror tamponade
Intended Use	Bone hemostasis	Bone hemostasis
Mechanism ofAction	Mechanical tamponade that occludesvascular openings in damaged bone	Mechanical tamponade that occludesvascular openings in damaged bone
Form of Device	HBP6 Settable, Resorbable HemostaticBone Paste is formulated as a two-partpaste/paste device that forms a"settable" (hardening) paste whenmanually mixed at the time of surgery.	MONTAGE-QS™ Settable, ResorbableHemostatic Bone Putty is formulated asa two-part putty/putty device that forms a"settable" (hardening) putty when mixedat the time of surgery.

Predicate Comparison Table

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	Radiopaque - Contains hydroxyapatiteand β-tricalcium phosphate	Radiopaque - Contains hydroxyapatiteand β-tricalcium phosphate
Radiopacity	Radiopaque - Contains hydroxyapatiteand β-tricalcium phosphate	Radiopaque - Contains hydroxyapatiteand β-tricalcium phosphate
Composition	Sterile mixture of two separatecomponents of paste-like consistencycomprised of granular calciumphosphate, (hydroxyapatite and β-tricalcium phosphate), calcium stearate,vitamin E acetate, triacetin, 1,4-butanediol, triethanolamine and amixture of a lactide-diester andpolyester-based (lactide andcaprolactone) absorbable polymers.HBP6 is to be mixed immediately priorto use. Resulting settable device fromthe two pastes is primarily comprised ofcalcium phosphate similar to themineral phase of native bone tissue.	Sterile mixture of two separatecomponents of putty-like consistencycomprised of granular calcium phosphate,(hydroxyapatite and β-tricalciumphosphate), calcium stearate, vitamin Eacetate, triacetin, 1,4-butanediol,triethanolamine and a mixture of alactide-diester and polyester-based(lactide and caprolactone) absorbablepolymers. MONTAGE-QS is to be mixedimmediately prior to use. Resultingsettable device from the two putties isprimarily comprised of calcium phosphatesimilar to the mineral phase of nativebone tissue.
	Resorbable	Yes	Yes

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Resorption Time	Greater than 30 days primarily due topresence of calcium phosphate.	Greater than 30 days primarily due topresence of calcium phosphate
Method ofApplication	Manually applied with deliveryinstrument and spread onto bonetissue	Manually applied and spread onto bonetissue
DegradationProcess	The non-calcium salt and non-polymeric components degrade viadissolution; the polymer degrades viahydrolysis and calcium salts degradevia chemical dissolution and/or cellularremoval	The non-calcium salt and non-polymericcomponents degrade via dissolution; thepolymer degrades via hydrolysis andcalcium salts degrade via chemicaldissolution and/or cellular removal
Sterility	Provided sterile for single use bygamma irradiation	Provided sterile for single use by gammairradiation
Set Time	Sets within 5-minutes of application	Sets within 5-minutes of application

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Performance Testing:

Bench testing, biocompatibility and animal functionality testing performed on the predicate and HBP6 Settable, Resorbable Hemostatic Bone Paste demonstrate that the device is substantially equivalent to the predicate device in intended use, technological characteristics, and performance. This testing included the following:

Bench 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 properties. The following evaluations were completed: relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility, dissolution and swelling.

Biocompatibility 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-irradiated sterile device in accordance with the GLP requirements: irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, systemic toxicity, hemolysis, endotoxicity and pyrogenicity.

Animal Testing included studies to demonstrate intraoperative in vivo hemostasis and resistance to irrigation.

Conclusion

HBP6 is substantially equivalent to the predicate MONTAGE-QS Settable Hemostatic Bone Putty with respect to intended use, general technological characteristics and performance.

Regulation Number and Section

N/A