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.
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).
The provided text describes the HBP4™ Hardening, Resorbable Hemostatic Bone Putty and its substantial equivalence to predicate devices, rather than a study with acceptance criteria for a specific outcome measure like AI performance. Therefore, I cannot construct a table of acceptance criteria and reported device performance from the given information in the context of AI.
However, I can extract the testing performed to demonstrate substantial equivalence, which aims to show the device meets certain performance characteristics relative to existing devices.
Here's a breakdown of the requested information based on the provided text, adapted to reflect what is available:
Acceptance Criteria and Study for HBP4™ Hardening, Resorbable Hemostatic Bone Putty
The document describes performance testing conducted to demonstrate the substantial equivalence of the HBP4™ device to legally marketed predicate devices. The "acceptance criteria" in this context are implicitly met if the HBP4™ device demonstrates similar performance and characteristics to the predicate devices across various tests.
1. Table of Acceptance Criteria and Reported Device Performance
As the document is a 510(k) summary, it focuses on demonstrating substantial equivalence rather than explicit quantitative acceptance criteria for a novel AI device. Therefore, a direct table of acceptance criteria in the AI sense and reported performance is not present. However, the document does list the types of tests performed to demonstrate acceptable performance relative to predicate devices. The "reported device performance" in this context refers to the successful completion of these tests, implying the device performed comparably to or within acceptable limits of the predicate devices.
| Performance Characteristic (Type of Test) | Implied Acceptance Criteria (relative to predicates) | Reported Device Performance (as stated in document) |
|---|---|---|
| Bench Testing | Demonstrate appropriate handling properties, performance over temperature range, and dissolution properties. | "Bench testing... demonstrate that the device is substantially equivalent to predicate devices in intended use, technological characteristics, and performance." This included relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility, dissolution, and swelling tests. |
| Biocompatibility Testing | Meet ISO 10993 recommendations for biological safety. | "Biocompatibility Testing was conducted to evaluate the device's biocompatibility in accordance with the recommendations of ISO 10993." Studies included irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, subacute systemic toxicity, chronic systemic toxicity, hemolysis, endotoxicity, and pyrogenicity. |
| Animal Testing | Demonstrate intraoperative in vivo hemostasis, resistance to irrigation, and characterize resorption time comparable to predicates. | "Animal Testing included animal studies to demonstrate intraoperative in vivo hemostasis, resistance to irrigation, and to characterize resorption time." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for each test. The document mentions "animal studies" but does not give the number of animals used.
- Data Provenance: The studies were conducted by Orthocon, Inc. specific to the HBP4™ device. The nature of these studies (e.g., in-house bench tests, contracted animal studies) implies prospective testing for this specific submission. Country of origin not specified, but the submission is to the US FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This device is a medical product (bone putty), not an AI algorithm requiring expert-established ground truth for a test set. Its performance is evaluated through material science, biological, and in-vivo testing, not diagnostic accuracy reviews.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI device.
7. The Type of Ground Truth Used
- For Bench Testing: Measurements against established material science parameters and potentially comparison to predicate device characteristics.
- For Biocompatibility Testing: Adherence to ISO 10993 standards and established biological responses from in-vitro and in-vivo models.
- For Animal Testing: Direct observation of hemostasis, resistance to irrigation, and histological/imaging assessment of resorption in animal models.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI device. There is no concept of a "training set" for this product.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. See point 8.
Summary of Device and its Purpose:
The HBP4™ Hardening, Resorbable Hemostatic Bone Putty is a sterile, biocompatible, resorbable material designed to control bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. It consists of two components that are mixed prior to use to form a hardening putty. Its 510(k) clearance was based on demonstrating substantial equivalence to several predicate bone wax and hemostatic implant devices.
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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.
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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/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
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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 SchrayerOrthocon, Inc.1 Bridge Street, Suite 121Irvington, NY 10533Telephone: 914-357-2600Fax: 914-231-7884hs.ss@verizon.net |
|---|---|
| Date Prepared: | September 24, 2014 |
| Device Trade Name: | HBP4™ Hardening, Resorbable Hemostatic Bone Putty |
| Manufacturer: | Orthocon, Inc.1 Bridge Street, Suite 121Irvington, NY 10533 |
| Common Name: | Calcium phosphate bone hemostasis material |
| Classification: | Unclassified |
| Product Code: | MTJ |
| Primary Predicate: | Skeletal Kinetics CAAP (Calcium Apatite) Bone Wax510(k) K111538 |
| Additional predicates: | US Surgical Auto Suture Bone Wax510(k) K971680 |
| CP Medical Bone Wax510(k) K024372 | |
| Ceremed Ostene® CT Bone Hemostasis Implant510(k) K102071 | |
| Orthocon Hemostatic Bone Putty 3510(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, ResorbableHemostatic Bone Putty | CAAP (Calcium Apatite) BoneWax | 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, ResorbableHemostatic Bone Putty isindicated in the control ofbleeding from cut or damagedbone by acting as amechanical barrier ortamponade | CAAP (Calcium Apatite) BoneWax is indicated to controlbleeding from cut or damagedbone by acting as amechanical barrier ortamponade | Auto Suture Bone Wax isindicated for use in the controlof bleeding from bonesurfaces |
| Intended Use | Bone hemostasis | Bone hemostasis | Bone hemostasis |
| Mechanism ofAction | Mechanical tamponade thatoccludes vascular openings indamaged bone | Mechanical tamponade thatoccludes vascular openings indamaged bone | Mechanical tamponade thatoccludes vascular openings indamaged bone |
| Form of Device | HBP4 Hardening, ResorbableHemostatic Bone Putty isformulated as a two-partputty/putty device that forms a"settable" (hardening) puttywhen manually mixed at thetime of surgery. | CAAP (Calcium Apatite) BoneWax is formulated as a two-part powder/liquid system thatforms a "settable" (hardening)putty when manually mixed atthe time of surgery. | Paste-like material. |
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| 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 |
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| 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 BoneHemostasis Implant | Hemostatic Bone Putty 3Resorbable Hemostatic BonePutty |
| 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 isindicated for use in the controlof bleeding from bonesurfaces. | Ostene® CT is indicated foruse as a water-solubleimplant material and for usein the control of bleeding frombone surfaces incardiothoracic surgeryfollowing sternotomy | Hemostatic Bone Putty 3 isindicated for thecontrol of bleeding from cut ordamaged bone by acting as amechanical barrier ortamponade. |
| Intended Use | Bone hemostasis | Bone hemostasis | Bone hemostasis |
| Mechanism ofAction | Mechanical tamponade thatoccludes vascular openings indamaged bone | Mechanical tamponade thatoccludes vascular openings indamaged bone | Mechanical tamponade thatoccludes vascular openings indamaged bone |
| Form of Device | A hard wax-like material thatmust be warmed by kneadingprior to use, | An odorless, opaque wax-likematerial designed to beutilized directly out of thepackage. It can be softenedand increased in stickiness bywarming and by additionalhandling andmanipulation | Putty-like material that doesnot require kneading prior toapplication. |
| Radiopacity | Not Radiopaque | Not Radiopaque | Radiopaque - Contains β-tricalcium phosphate |
| Materials | CP Medical bone wax is asterile mixture of bees waxand paraffin. | Ostene® CT is a sterilemixture of water-solublealkylene oxide copolymers | Hemostatic Bone Putty 3 is amixture of alkylene oxidepolymer-based materials,vitamin E acetate, granularcalcium phosphate andcarboxymethylcellulosesodium salt. |
| Resorbable | Non-resorbable | Yes | Yes |
| Resorption Time | Permanent implant | Less than 30 days | Greater than 30 daysprimarily due to presence ofcalcium phosphate. |
| Method ofApplication | Manually applied and spreadonto bone tissue | Manually applied and spreadonto bone tissue | Manually applied and spreadonto bone tissue |
| DegradationProcess | Does not degrade - has beenfound to be present yearsafter implantation | Degrades via dissolution | The non-calcium salt degradevia dissolution; the calciumsalts degrade via chemicaldissolution and/or cellularremoval |
| Sterility | Provided sterile for single useby gamma irradiation | Provided sterile for single useby irradiation | Provided sterile for single useby gamma irradiation |
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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.
N/A