Predicate Devices

K111538, K971680, K024372, K102071, K123243

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties and mechanical function of the bone putty, with no mention of AI or ML technologies.

Therapeutic

No
The device is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier. It does not treat or cure a disease or condition, but rather assists in a surgical procedure.

Diagnostic

No

The device description clearly states its purpose is to control bleeding by acting as a mechanical barrier or tamponade, which is a therapeutic function rather than a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "sterile, biocompatible, resorbable material of putty-like consistency" comprised of various physical components that are mixed and applied directly to bone. This describes a physical medical device, 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 "for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade." This describes a direct therapeutic action on the patient's body to stop bleeding.
Device Description: The description details a material applied directly to bone surfaces to form a physical barrier. It does not involve analyzing samples from the body (like blood, urine, or tissue) to provide diagnostic information.
Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, measure a substance in the body, or provide information about a patient's health status based on in vitro analysis.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description. It is a therapeutic device used to control bleeding.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

HBP4 Hardening, Resorbable 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

HBP4 Hardening, 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 single use HBP4 device contains two separate components of putty-like consistency comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the HBP4 device form a resorbable putty-like material that can be applied directly to bleeding bone. The resulting hardening material is primarily comprised of calcium phosphate. HBP4 must be mixed immediately prior to use.

When applied to surgically cut or traumatically damaged bone. HBP4 Hardening, Resorbable 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

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

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: irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, subacute systemic toxicity, chronic systemic toxicity, hemolysis, endotoxicity and pyrogenicity.

Animal Testing included animal studies to demonstrate intraoperative in vivo hemostasis, resistance to irrigation, and to characterize resorption time.

Key Metrics

Not Found

Predicate Device(s)

K111538, K971680, K024372, K102071, K123243

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

0

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a stylized eagle with three human profiles incorporated into its design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 3, 2014

Orthocon Incorporated Mr. Howard Schrayer 1 Bridge Street, Suite 121 Irvington, New York 10533

Re: K141502

Trade/Device Name: HBP4™ Hardening, Resorbable Hemostatic Bone Putty Regulatory Class: Unclassified Product Code: MJT Dated: July 7, 2014 Received: July 8, 2014

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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,

Binita S. Ashar -S 2014.10.03 15:55:00 -04'00'

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

2

Indications for Use

510(k) Number (if known) K141502

Device Name

HBP4TM Hardening, Resorbable Hemostatic Bone Putty

Indications for Use (Describe)

HBP4 Hardening, 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)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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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@verizon.net |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | September 24, 2014 |
| Device Trade Name: | HBP4™ Hardening, Resorbable Hemostatic Bone Putty |
| Manufacturer: | Orthocon, Inc.
1 Bridge Street, Suite 121
Irvington, NY 10533 |
| Common Name: | Calcium phosphate bone hemostasis material |
| Classification: | Unclassified |
| Product Code: | MTJ |
| Primary Predicate: | Skeletal Kinetics CAAP (Calcium Apatite) Bone Wax
510(k) K111538 |
| Additional predicates: | US Surgical Auto Suture Bone Wax
510(k) K971680 |
| | CP Medical Bone Wax
510(k) K024372 |
| | Ceremed Ostene® CT Bone Hemostasis Implant
510(k) K102071 |
| | Orthocon Hemostatic Bone Putty 3
510(k) K123243 |

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Indications for Use:

HBP4 Hardening, Resorbable 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:

HBP4 Hardening, 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 single use HBP4 device contains two separate components of putty-like consistency comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the HBP4 device form a resorbable putty-like material that can be applied directly to bleeding bone. The resulting hardening material is primarily comprised of calcium phosphate. HBP4 must be mixed immediately prior to use.

When applied to surgically cut or traumatically damaged bone. HBP4 Hardening, Resorbable 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 Skeletal Kinetics CAAP (Calcium Apatite) Bone Wax (K111538), US Surgical Auto Suture Bone Wax (K971680), CP Medical Bone Wax (K024372), Ceremed Ostene CT Bone Hemostasis Implant (K102071) and Orthocon Hemostatic Bone Putty 3 Resorbable Hemostatic Bone Putty (K123243). Additional bone wax devices are available in a variety of forms (e.g., waxes, putties, and hardening materials) and some are permanent implants while others are resorbable.

Technological Characteristics:

The tables below provide comparisons of HBP4 Hardening, Resorbable Hemostatic Bone Putty with the predicate devices.

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Predicate Comparison Table

Manufacturer	Orthocon, Inc.	Skeletal Kinetics	US Surgical
Trade Name	HBP4 Hardening, Resorbable
Hemostatic Bone Putty	CAAP (Calcium Apatite) Bone
Wax	Auto Suture Bone Wax
510(k) Number	Subject Device	K111538	K971680
Type of Device/
Product Code	Bone hemostat / MTJ	Bone hemostat / MTJ	Bone hemostat / MTJ
Indications for Use	HBP4 Hardening, Resorbable
Hemostatic Bone Putty is
indicated in the control of
bleeding from cut or damaged
bone by acting as a
mechanical barrier or
tamponade	CAAP (Calcium Apatite) Bone
Wax is indicated to control
bleeding from cut or damaged
bone by acting as a
mechanical barrier or
tamponade	Auto Suture Bone Wax is
indicated for use in the control
of bleeding from bone
surfaces
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	HBP4 Hardening, 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.	CAAP (Calcium Apatite) Bone
Wax is formulated as a two-
part powder/liquid system that
forms a "settable" (hardening)
putty when manually mixed at
the time of surgery.	Paste-like material.

6

Radiopacity	Radiopaque – Contains calcium phosphate	Radiopaque – Contains calcium apatite	Radiopaque – Contains β-tricalcium phosphate
Materials	Sterile mixture of two separate components of putty-like consistency comprised of calcium phosphate, calcium stearate, vitamin E acetate, triglyceride, polyalcohol and a mixture of a lactide-diester and polyester-based absorbable polymers. HBP4 is to be mixed immediately prior to use. Resulting hardening material from the two putties is primarily comprised of calcium phosphate similar to the mineral phase of native bone tissue.	A sterile kit containing calcium phosphate powder, dilute sodium silicate liquid, and a mixing system (mixing bowl, pestle and spatula). CAAP Bone wax is to be mixed immediately prior to use. Resulting hardening material from the paste is primarily comprised of calcium phosphate, similar to the mineral phase of native bone tissue.	A sterile mixture of glycolide, caprolactone, mannitol and β-tricalcium phosphate. The copolymer derived from glycolide and caprolactone is the same copolymer used to coat US Surgical's POLYSORB Suture.
Resorbable	Yes	Yes	Yes

7

Resorption Time	Greater than 30 days primarily due to presence of calcium phosphate.	Greater than 30 days primarily due to presence of calcium phosphate	Greater than 30 days primarily due to presence of calcium phosphate.
Method of Application	Manually applied and spread onto bone tissue	Manually applied and spread onto bone tissue	Manually applied and spread onto bone tissue
Degradation Process	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	Believed to be combination of chemical dissolution and/or cellular removal	Copolymer degrades via hydrolysis; calcium phosphate degrades via combination of chemical dissolution and 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

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Predicate Comparison Table (cont'd)

Manufacturer	CP Medical	Ceremed	Orthocon, Inc.
Trade Name	CP Medical Bone Wax	Ostene® CT Bone
Hemostasis Implant	Hemostatic Bone Putty 3
Resorbable Hemostatic Bone
Putty
510(k) Number	K024372	K102071	K123243
Type of Device/
Product Code	Bone hemostat / MTJ	Bone hemostat / MTJ	Bone hemostat / MTJ
Indications for Use	The CP Medical Bone Wax is
indicated for use in the control
of bleeding from bone
surfaces.	Ostene® CT is indicated for
use as a water-soluble
implant material and for use
in the control of bleeding from
bone surfaces in
cardiothoracic surgery
following sternotomy	Hemostatic Bone Putty 3 is
indicated for 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	A hard wax-like material that
must be warmed by kneading
prior to use,	An odorless, opaque wax-like
material designed to be
utilized directly out of the
package. It can be softened
and increased in stickiness by
warming and by additional
handling and
manipulation	Putty-like material that does
not require kneading prior to
application.
Radiopacity	Not Radiopaque	Not Radiopaque	Radiopaque - Contains β-tricalcium phosphate
Materials	CP Medical bone wax is a
sterile mixture of bees wax
and paraffin.	Ostene® CT is a sterile
mixture of water-soluble
alkylene oxide copolymers	Hemostatic Bone Putty 3 is a
mixture of alkylene oxide
polymer-based materials,
vitamin E acetate, granular
calcium phosphate and
carboxymethylcellulose
sodium salt.
Resorbable	Non-resorbable	Yes	Yes
Resorption Time	Permanent implant	Less than 30 days	Greater than 30 days
primarily due to presence of
calcium phosphate.
Method of
Application	Manually applied and spread
onto bone tissue	Manually applied and spread
onto bone tissue	Manually applied and spread
onto bone tissue
Degradation
Process	Does not degrade - has been
found to be present years
after implantation	Degrades via dissolution	The non-calcium salt degrade
via dissolution; the 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 irradiation	Provided sterile for single use
by gamma irradiation

9

10

Performance Testing:

Bench testing, biocompatibility and animal functionality testing performed on HBP4 ™ Hardening, Resorbable Hemostatic Bone Putty demonstrate that the device is substantially equivalent to 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: irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, subacute systemic toxicity, chronic systemic toxicity, hemolysis, endotoxicity and pyrogenicity.

Animal Testing included animal studies to demonstrate intraoperative in vivo hemostasis, resistance to irrigation, and to characterize resorption time.

Conclusion

HBP4 is substantially equivalent to previously cleared bone wax devices with respect to intended use, general technological characteristics and performance.