Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and biological properties of the bone putty, with no mention of AI or ML.

Therapeutic

Yes
The device is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade, which is a therapeutic function.

Diagnostic

No

Explanation: The device description clearly states its purpose is to control bleeding by acting as a mechanical barrier or tamponade, not to diagnose any condition.

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is a physical material (putty) comprised of various chemical components, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to control bleeding from bone by acting as a mechanical barrier. This is a direct therapeutic action on the body, not a diagnostic test performed on a sample taken from the body.
Device Description: The description details a material applied directly to bone for hemostasis. It does not describe a test or analysis of a biological sample.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and therapeutic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

HBP7 Settable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

Product codes

MTJ

Device Description

HBP7 Settable Hemostatic Bone Putty is a sterile, biocompatible, nonabsorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The single use HBP7 device contains two separate components of putty-like consistency comprised of granular calcium phosphate, paraffin oil, vitamin E acetate, a triglyceride, and a mixture of nonabsorbable, polyetherbased polymers. When mixed together, the components of the HBP7 device form a nonabsorbable putty-like material that can be applied directly to bleeding bone. The resulting material is primarily comprised of calcium phosphate. HBP7 must be mixed immediately prior to use.

When applied to surgically cut or traumatically broken bone. HBP7 Settable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

bone surfaces, surgically cut or traumatically broken bone

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench testing, biocompatibility and animal functionality testing performed on HBP7 Settable Hemostatic Bone Putty demonstrate that the device is substantially equivalent to the predicate devices 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 bench studies 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: cytotoxicity, irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, local tissue toxicity, hemolysis, endotoxicity and pyrogenicity.

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K024372

Reference Device(s)

K141502, K152005

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 19, 2021

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

Re: K202363

Trade/Device Name: HBP7 Settable Hemostatic Bone Putty Regulatory Class: Unclassified Product Code: MTJ Dated: December 17, 2020 Received: December 18, 2020

Dear 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

1

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 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. 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) K202363

Device Name HBP7 Settable Hemostatic Bone Putty

Indications for Use (Describe)

HBP7 Settable 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)

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

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510(k) Summary

| Contact: | Howard Schrayer
Orthocon, Inc.
1 Bridge Street, Suite 121
Irvington, NY 10533
Telephone: 914-357-2600
Fax: 914-231-7884
hs.ss@lucidmedical.net |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | August 17, 2020 |
| Device Trade Name: | HBP7 Settable Hemostatic Bone Putty |
| Manufacturer: | Orthocon, Inc.
1 Bridge Street, Suite 121
Irvington, NY 10533 |
| Common Name: | Bone wax |
| Classification: | Unclassified |
| Product Code: | MTJ |
| Predicate Devices | Primary Predicate
CP Medical Bone Wax A formulation based on
beeswax, paraffin and isopropyl palmitate
[510(k) K024372]

Reference Predicate
Orthocon, Inc.
HBP4 Hardening, Resorbable Hemostatic Bone Putty
510(k) K141502

Orthocon, Inc. MONTAGE Settable Hemostatic Bone
Putty
510(k) K152005 |

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Indications for Use:

HBP7 Settable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

Device Description:

HBP7 Settable Hemostatic Bone Putty is a sterile, biocompatible, nonabsorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The single use HBP7 device contains two separate components of putty-like consistency comprised of granular calcium phosphate, paraffin oil, vitamin E acetate, a triglyceride, and a mixture of nonabsorbable, polyetherbased polymers. When mixed together, the components of the HBP7 device form a nonabsorbable putty-like material that can be applied directly to bleeding bone. The resulting material is primarily comprised of calcium phosphate. HBP7 must be mixed immediately prior to use.

When applied to surgically cut or traumatically broken bone. HBP7 Settable Hemostatic Bone Putty 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 wax devices including CP Medical Bone Wax (K024372), HBP4 Hardening Resorbable Hemostatic Bone Putty (K141502) and Montage Settable Hemostatic Bone Putty (K152005).

Performance Testing:

Bench testing, biocompatibility and animal functionality testing performed on HBP7 Settable Hemostatic Bone Putty demonstrate that the device is substantially equivalent to the predicate devices 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 bench studies 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: cytotoxicity, irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, local tissue toxicity, hemolysis, endotoxicity and pyrogenicity.

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

The following table summarizes the substantial equivalence of HBP7 to the predicate devices.

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Manufacturer	Orthocon, Inc.	CP Medical	Orthocon, Inc.
Trade Name	HBP7 Settable Hemostatic
Bone Putty	CP Medical Bone Wax	MONTAGE™ Settable,
Resorbable Hemostatic Bone
Putty
510(k) Number	Subject Device - TBD	K024372	K141502 and K152005
Type of Device/
Product Code	Bone wax / MTJ	Bone wax / MTJ	Bone wax / MTJ
Indications for Use	HBP7 Settable Hemostatic
Bone Putty is indicated in the
control of bleeding from cut or
damaged bone by acting as a
mechanical barrier or
tamponade	The CP Medical Bone Wax is
indicated for use in the control
of bleeding from bone
surfaces.	MONTAGE Settable,
Resorbable Hemostatic Bone
Putty is indicated in the control
of bleeding from cut or
damaged bone by acting as a
mechanical barrier or
tamponade
	Intended Use	Bone hemostasis	Bone hemostasis	Bone hemostasis
	Mechanism of
Action	Mechanical tamponade that
occludes vascular openings in
damaged bone	Mechanical tamponade that
occludes vascular openings in
damaged bone	Mechanical tamponade that
occludes vascular openings in
damaged bone
Form of Device		HBP7 Settable Hemostatic
Bone Putty is formulated as a
two-part putty/putty device that
forms a "settable" (hardening)
putty when manually mixed at
the time of surgery.	CP Medical Bone Wax is a
putty-like material formulated
from bee's wax, isopropyl
palmitate and paraffin that is
kneaded to soften and apply
and then forms a firm
tamponade after application.	MONTAGE Settable,
Resorbable Hemostatic Bone
Putty is formulated as a two-
part putty/putty device that
forms a "settable" (hardening)
putty when manually mixed at
the time of surgery.
			Radiopaque - Contains	Not radiopaque
	Radiopacity	hydroxyapatite and β-tricalcium phosphate		hydroxyapatite and β-tricalcium phosphate
	Materials	Sterile mixture of two components of putty-like consistency comprised of granular calcium phosphate, (hydroxyapatite and β-tricalcium phosphate), paraffin, vitamin E acetate, triacetin, and a mixture of nonabsorbable polymers. HBP7 is to be mixed immediately prior to use. Resulting settable material from the two putties is primarily comprised (> 60% by weight) of calcium phosphate similar to the mineral phase of native bone tissue.	Sterile mixture of bee's wax, isopropyl palmitate and paraffin that forms a putty-like consistency with no chemical interactions.	Sterile mixture of two components of putty-like consistency comprised of granular calcium phosphate, (hydroxyapatite and β-tricalcium phosphate), calcium stearate, vitamin E acetate, triacetin, 1,4-butanediol and a mixture of a lactide-diester and polyester-based (lactide and caprolactone) absorbable polymers. MONTAGE is to be mixed immediately prior to use. Resulting settable material from the two putties is primarily comprised (> 60% by weight) of calcium phosphate similar to the mineral phase of native bone tissue.
	Absorbable	No	No	Yes
	In Vivo Residence
Time	Permanent Implant	Permanent Implant	Greater than 30 days
primarily due to presence of
calcium phosphate
	Method of	Manually applied and spread	Manually applied and spread	Manually applied and spread
Application	onto bone tissue	onto bone tissue	onto bone tissue
Degradation
Process	Nonabsorbable in the body -
permanent implant	Nonabsorbable in the body -
permanent implant	The non-calcium salt and
non-polymeric components
degrade via dissolution; the
polymer degrades via
hydrolysis and calcium salts
degrade via chemical
dissolution and/or cellular
removal
Sterility	Provided sterile for single use
by gamma irradiation	Provided sterile for single use
by gamma irradiation	Provided sterile for single use
by gamma irradiation
Set Time	Sets (hardens) within minutes of
application	N/A	Sets (hardens) within minutes
of application

Predicate Comparison Table

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7

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Conclusion

HBP7 is substantially equivalent to previously cleared bone hemostasis devices with
respect to intended use, general technological characteristics and performance.