(147 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a bone paste for hemostasis, with no mention of AI or ML technologies.
Yes
The device is indicated for the control of bleeding from cut or damaged bone, which is a therapeutic function.
No
The device is a hemostatic bone paste intended to control bleeding by acting as a mechanical barrier. It does not gather information about a patient's health condition or make a diagnosis.
No
The device description clearly states it is a "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" and is applied with a "single-use applicator (delivery device)". This describes a physical material and a hardware delivery mechanism, not software.
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.
- Device Description: The device is a paste applied directly to the bone surface. It is a physical material that interacts with the tissue.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the body (like blood, urine, or tissue) to provide information about a disease or condition. IVDs are used for diagnosis, monitoring, or screening.
This device falls under the category of a therapeutic medical device, specifically a hemostatic agent for bone.
N/A
Intended Use / 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.
Product codes
MTJ
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).
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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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3
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
4
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:
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).
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.
5
| Predicate Comparison Table | ||
|---|---|---|
| Manufacturer | Orthocon, Inc. | Orthocon, Inc. |
| Trade Name | HBP6 Settable, Resorbable Hemostatic | |
| Bone Paste | MONTAGE-QS™ Settable, Resorbable | |
| Hemostatic Bone Putty | ||
| 510(k) Number | K193052 | K191140 |
| Type of Device/ | ||
| Product Code | Bone wax / MTJ | Bone wax / MTJ |
| Indications for Use | HBP6 Settable, Resorbable Hemostatic | |
| Bone Paste is indicated in the control of | ||
| bleeding from cut or damaged bone by | ||
| acting as a mechanical barrier or | ||
| tamponade | MONTAGE-QS™ 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 |
| Mechanism of | ||
| Action | Mechanical tamponade that occludes | |
| vascular openings in damaged bone | Mechanical tamponade that occludes | |
| vascular openings in damaged bone | ||
| Form of Device | HBP6 Settable, Resorbable Hemostatic | |
| Bone Paste is formulated as a two-part | ||
| paste/paste device that forms a | ||
| "settable" (hardening) paste when | ||
| manually mixed at the time of surgery. | MONTAGE-QS™ Settable, Resorbable | |
| Hemostatic Bone Putty is formulated as | ||
| a two-part putty/putty device that forms a | ||
| "settable" (hardening) putty when mixed | ||
| at the time of surgery. |
Predicate Comparison Table
6
| | Radiopaque - Contains hydroxyapatite
and β-tricalcium phosphate | Radiopaque - Contains hydroxyapatite
and β-tricalcium phosphate | |
|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Radiopacity | Radiopaque - Contains hydroxyapatite
and β-tricalcium phosphate | Radiopaque - Contains hydroxyapatite
and β-tricalcium phosphate | |
| Composition | Sterile mixture of two separate
components of paste-like consistency
comprised of granular calcium
phosphate, (hydroxyapatite and β-
tricalcium phosphate), calcium stearate,
vitamin E acetate, triacetin, 1,4-
butanediol, triethanolamine and a
mixture of a lactide-diester and
polyester-based (lactide and
caprolactone) absorbable polymers.
HBP6 is to be mixed immediately prior
to use. Resulting settable device from
the two pastes is primarily comprised of
calcium phosphate similar to the
mineral phase of native bone tissue. | Sterile mixture of two separate
components of putty-like consistency
comprised of granular calcium phosphate,
(hydroxyapatite and β-tricalcium
phosphate), calcium stearate, vitamin E
acetate, triacetin, 1,4-butanediol,
triethanolamine and a mixture of a
lactide-diester and polyester-based
(lactide and caprolactone) absorbable
polymers. MONTAGE-QS is to be mixed
immediately prior to use. Resulting
settable device from the two putties is
primarily comprised of calcium phosphate
similar to the mineral phase of native
bone tissue. | |
| | Resorbable | 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 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Method of
Application | Manually applied with delivery
instrument 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 | 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 |
| Set Time | Sets within 5-minutes of application | Sets within 5-minutes of application |
8
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.