(153 days)
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.
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).
This document describes the HBP7 Settable Hemostatic Bone Putty, a medical device indicated for controlling bleeding from cut or damaged bone by acting as a mechanical barrier. The device's substantial equivalence to predicate devices is established through a series of performance tests.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for HBP7 Settable Hemostatic Bone Putty in the format of a table with specific thresholds. Instead, it describes various performance tests conducted to demonstrate substantial equivalence to predicate devices. The "reported device performance" is largely qualitative, indicating that the device "demonstrates" or "verifies" certain properties or functions similar to the predicates.
| Acceptance Criteria Category | Description of Performance/Test Conducted | Reported Device Performance |
|---|---|---|
| Bench Testing | Handlings properties, performance over a range of temperatures, dissolution properties. Includes: relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility, dissolution, and swelling. | "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 specific results meeting acceptance for each sub-test are implied by the statement: "demonstrate that the device is substantially equivalent to the predicate devices in intended use, technological characteristics, and performance." |
| Biocompatibility | Evaluated in accordance with ISO 10993 recommendations. Includes: cytotoxicity, irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, local tissue toxicity, hemolysis, endotoxicity, and pyrogenicity. | "Biocompatibility Testing was conducted to evaluate the device's biocompatibility in accordance with the recommendations of ISO 10993." The tests were conducted on the "final, finished, gamma-irradiated sterile device in accordance with the GLP requirements." Implied successful outcome as part of demonstrating substantial equivalence. |
| Animal Functionality | In vivo hemostasis and resistance to irrigation. | "Animal Testing included animal studies to demonstrate intraoperative in vivo hemostasis and resistance to irrigation." Implied successful outcome in demonstrating substantial equivalence. |
| Intended Use | Control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. | "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." This aligns with the predicate devices' intended use for bone hemostasis through mechanical tamponade. Its mechanism of action is identical to the predicates (mechanical tamponade occluding vascular openings). |
| Sterility | Provided sterile. | "Provided sterile for single use by gamma irradiation." This is consistent with the predicate devices. |
| Set Time | Ability to set (harden) within minutes of application. | "Sets (hardens) within minutes of application." This is a characteristic shared with the MONTAGE predicate device (K141502 and K152005), which also "Sets (hardens) within minutes of application." CP Medical Bone Wax (K024372) is "N/A" for set time because it hardens after application through kneading, not a chemical set. |
| Form of Device | Two-part putty/putty device that forms a settable (hardening) putty when manually mixed. | HBP7 "is formulated as a two-part putty/putty device that forms a 'settable' (hardening) putty when manually mixed at the time of surgery." This is analogous to MONTAGE, which is also a "two-part putty/putty device that forms a 'settable' (hardening) putty when manually mixed." CP Medical Bone Wax is a single component to be kneaded. |
| Materials | Sterile mixture of two components of putty-like consistency: granular calcium phosphate (hydroxyapatite and β-tricalcium phosphate), paraffin, vitamin E acetate, triacetin, and a mixture of nonabsorbable polymers. Primarily comprised of calcium phosphate. | The materials described are consistent with the device description and the comparison to predicates, particularly MONTAGE, which also contains granular calcium phosphate, vitamin E acetate, and polymers, differing primarily in the absorbability of its polymers. The HBP7 device's composition is stated to be primarily comprised (>60% by weight) of calcium phosphate. |
| Absorbability | Nonabsorbable. | "No" (nonabsorbable). In vivo residence time is a "Permanent Implant." This differs from MONTAGE (absorbable) but is consistent with CP Medical Bone Wax (nonabsorbable). |
| Degradation Process | Nonabsorbable in the body; permanent implant. | "Nonabsorbable in the body - permanent implant." This is identical to CP Medical Bone Wax. MONTAGE has a degradation process involving dissolution and hydrolysis. |
| Radiopacity | Contains hydroxyapatite and β-tricalcium phosphate resulting in radiopacity. | "Radiopaque - Contains hydroxyapatite and β-tricalcium phosphate." This is similar to MONTAGE (also radiopaque due to these components) but differs from CP Medical Bone Wax (not radiopaque). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes for the "test set" in terms of how many devices, animals, or specimens were used for the bench, biocompatibility, or animal studies. It states that tests were "conducted" and "demonstrate" substantial equivalence.
The data provenance (country of origin, retrospective/prospective) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The studies performed (bench, biocompatibility, animal) do not typically rely on expert consensus for "ground truth" in the way an AI diagnostic device would. Instead, their "ground truth" comes from established scientific methods, laboratory observations, and medical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and is not provided. Adjudication methods like "2+1" are relevant for expert review of images or data, typically in diagnostic AI studies. The tests described here are physical, chemical, and biological evaluations, not requiring such adjudication.
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
A multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The HBP7 is a physical medical device (bone putty) and not an AI-powered diagnostic tool, so such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm was not done. The HBP7 is a physical medical device, not an algorithm, so this concept does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench testing, the "ground truth" would be objective measurements and observations against pre-defined engineering and material science standards (e.g., stiffness measurements, dissolution rates).
For biocompatibility testing, the "ground truth" is derived from established biological assays and observation protocols outlined in ISO 10993, assessed by scientists/toxicologists.
For animal testing, the "ground truth" for hemostasis is direct observation of bleeding control and resistance to irrigation in a live animal model, assessed by veterinary surgical staff and researchers.
There is no "expert consensus" or "pathology" in the typical sense of diagnostic ground truth. Outcomes data for patients is not mentioned, as this is a premarket notification, not a large-scale clinical trial.
8. The sample size for the training set
This information is not applicable and is not provided. The HBP7 is a physical medical device, not an AI model, therefore it does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" for this physical device.
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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
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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
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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@lucidmedical.net |
|---|---|
| Date Prepared: | August 17, 2020 |
| Device Trade Name: | HBP7 Settable Hemostatic Bone Putty |
| Manufacturer: | Orthocon, Inc.1 Bridge Street, Suite 121Irvington, NY 10533 |
| Common Name: | Bone wax |
| Classification: | Unclassified |
| Product Code: | MTJ |
| Predicate Devices | Primary PredicateCP Medical Bone Wax A formulation based onbeeswax, paraffin and isopropyl palmitate[510(k) K024372]Reference PredicateOrthocon, Inc.HBP4 Hardening, Resorbable Hemostatic Bone Putty510(k) K141502Orthocon, Inc. MONTAGE Settable Hemostatic BonePutty510(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 HemostaticBone Putty | CP Medical Bone Wax | MONTAGE™ Settable,Resorbable Hemostatic BonePutty | |
| 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 HemostaticBone Putty is indicated in thecontrol of bleeding from cut ordamaged bone by acting as amechanical barrier ortamponade | The CP Medical Bone Wax isindicated for use in the controlof bleeding from bonesurfaces. | MONTAGE Settable,Resorbable Hemostatic BonePutty is indicated in the controlof 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 | HBP7 Settable HemostaticBone Putty is formulated as atwo-part putty/putty device thatforms a "settable" (hardening)putty when manually mixed atthe time of surgery. | CP Medical Bone Wax is aputty-like material formulatedfrom bee's wax, isopropylpalmitate and paraffin that iskneaded to soften and applyand then forms a firmtamponade after application. | MONTAGE Settable,Resorbable Hemostatic BonePutty is formulated as a two-part putty/putty device thatforms a "settable" (hardening)putty when manually mixed atthe 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 ResidenceTime | Permanent Implant | Permanent Implant | Greater than 30 daysprimarily due to presence ofcalcium 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 | |
| DegradationProcess | Nonabsorbable in the body -permanent implant | Nonabsorbable in the body -permanent implant | The non-calcium salt andnon-polymeric componentsdegrade via dissolution; thepolymer degrades viahydrolysis and calcium saltsdegrade via chemicaldissolution and/or cellularremoval | |
| Sterility | Provided sterile for single useby gamma irradiation | Provided sterile for single useby gamma irradiation | Provided sterile for single useby gamma irradiation | |
| Set Time | Sets (hardens) within minutes ofapplication | N/A | Sets (hardens) within minutesof application |
Predicate Comparison Table
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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.
N/A