(154 days)
OsteoSeal® Bone Hemostat is indicated for use in the control of bleeding from cut or damaged bone surfaces by acting as a mechanical barrier. The material may be used during surgical procedures or in treating traumatic injuries. OsteoSeal® Bone Hemostat is intended for use under the direction of a licensed healthcare provider.
The Hemostasis OsteoSeal® Bone Hemostat stops bone bleeding by establishing a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. When applied as directed, OsteoSeal® forms a mechanical barrier that occludes the vascular openings in the damaged bone. This barrier prevents further bleeding during the surgical procedure. OsteoSeal® is based upon known biodegradable polymeric chemistry that forms a ready-to-use bone hemostatic agent. OsteoSeal® Bone Hemostat consists of a dispersion of hydroxyapatite particles within a proprietary synthetic polylactic acid polymer. The material is virtually odorless, off-white in color and can be spread easily. OsteoSeal® is available in two forms: a bone hemostat ingot and a bone hemostat stick in an applicator. The bone hemostat ingot can be molded and formed by the surgeon to fit the damaged bone, while the applicator allows direct application of the bone hemostat to the bleeding area.
The provided document is a 510(k) premarket notification for the OsteoSeal® Bone Hemostat. It describes the device, its indications for use, and the testing performed to demonstrate its substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and study information provided in the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of "acceptance criteria" with specific quantitative targets. Instead, it refers to "product specifications" and general performance evaluations.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Hemostasis | Met product specifications for hemostasis; performed at least as well, and in some cases better, than the standard commercially available bone wax control. |
| Placement Retention | Met product specifications for placement retention; performed at least as well, and in some cases better, than the standard commercially available bone wax control. |
| Appearance | Design verification bench testing included appearance. (No specific detail on meeting a criterion, only that it was tested). |
| Handling | Design verification bench testing included handling. (No specific detail on meeting a criterion, only that it was tested). |
| Applicator Function | Design verification bench testing included applicator function. (No specific detail on meeting a criterion, only that it was tested). |
| Melt Point | Design verification bench testing included melt point. (No specific detail on meeting a criterion, only that it was tested). |
| Biocompatibility | Complies with biocompatibility requirements for its intended use, based on ISO 10993 and FDA guidance. |
| Sterility | Sterilized using a validated gamma radiation method to assure a sterility assurance level (SAL) of 10-6. |
| Packaging & Shelf Life | Successfully completed testing. |
| Pathological Safety (Tissue Irritation) | Demonstrated tissue irritation results that were at least as good, and in some cases better, than the standard commercially available bone wax control in a 13-week rabbit implant study. |
| Pathological Safety (Bone Healing) | Demonstrated bone healing results that were at least as good, and in some cases better, than the standard commercially available bone wax control in a 13-week rabbit implant study. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Animal Studies):
- Acute Porcine Animal Model: Not specified, only referred to as "an acute porcine animal model."
- 13-week Rabbit Implant Study: Not specified, only referred to as "a 13 week rabbit implant study."
- Data Provenance: The document does not specify the country of origin for the animal studies or whether they were retrospective or prospective. Given the context of a 510(k) submission, these would typically be prospective studies conducted in a controlled environment (e.g., contract research organization).
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 are animal models and bench tests, not human reader studies requiring expert consensus or ground truth establishment in the clinical sense. Pathological safety in the rabbit study would likely be assessed by a veterinary pathologist, but details are not given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. The studies described are not "test sets" in the context of diagnostic performance involving human interpretation or 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
This information is not applicable and therefore not provided. The device (bone hemostat) is not an AI diagnostic tool and does not involve human readers in the way an MRMC study would assess.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical device (bone hemostat), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the hemostasis and placement retention in the acute porcine model, "product specifications" served as the basis for evaluation, implying predefined objective measures or expert veterinary assessment of outcomes. The "control" was a standard commercially available bone wax.
- For the pathological safety (tissue irritation and bone healing) in the 13-week rabbit implant study, histopathological examination would be the ground truth, comparing the device to a control bone wax. This is a form of pathology data.
- For the bench testing (appearance, handling, applicator function, melt point), the ground truth would be engineering specifications and direct measurements/observations.
8. The sample size for the training set
This information is not applicable and therefore not provided. The device is a physical product and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided, as there is no "training set" for this type of device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2015
Hemostasis, LLC Mr. Bernard Horwath Hemostasis Regulatory Affairs 5000 Township Parkway Saint Paul, Minnesota 55110
Re: K142348
Trade/Device Name: OsteoSeal® Bone Hemostat Regulatory Class: Unclassified Product Code: MTJ Dated: December 23, 2014 Received: December 24, 2014
Dear Mr. Horwath:
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
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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director
Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K142348
Device Name OsteoSeal® Bone Hemostat
Indications for Use (Describe)
OsteoSeal® Bone Hemostat is indicated for use in the control of bleeding from cut or damaged bone surfaces by acting as a mechanical barrier. The material may be used during surgical procedures or in treating traumatic injuries. OsteoSeat® Bone Hemostat is intended for use under the direction of a licensed healthcare provider.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary OsteoSeal® Bone Hemostat
Date Prepared: August 20, 2014 (Revised Dec 12, 2014)
- Submitter: Hemostasis, LLC 5000 Township Parkway St. Paul, MN 55110 Telephone: 651- 855-1466 Fax: 651-855-1465
- Contact: Mr. Bernard Horwath Hemostasis Regulatory Affairs St. Paul, MN 55110 Telephone: 651- 231-1761
Proprietary Name: OsteoSeal® Bone Hemostat
Common/Usual Name: Bone Wax
Classification Name: Bone Wax, Unclassified, Product Code MTJ
Establishment Registration Number: 3007225047
Description:
The Hemostasis OsteoSeal® Bone Hemostat stops bone bleeding by establishing a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. When applied as directed, OsteoSeal® forms a mechanical barrier that occludes the vascular openings in the damaged bone. This barrier prevents further bleeding during the surgical procedure.
OsteoSeal® is based upon known biodegradable polymeric chemistry that forms a ready-to-use bone hemostatic agent. OsteoSeal® Bone Hemostat consists of a dispersion of hydroxyapatite particles within a proprietary synthetic polylactic acid polymer. The material is virtually odorless, off-white in color and can be spread easily. OsteoSeal® is available in two forms: a bone hemostat ingot and a bone hemostat stick in an applicator. The bone hemostat ingot can be molded and formed by the surgeon to fit the damaged bone, while the applicator allows direct application of the bone hemostat to the bleeding area.
Indications for Use:
OsteoSeal® Bone Hemostat is indicated for use in the control of bleeding from cut or damaged bone surfaces by acting as a mechanical barrier. The material may be used during surgical procedures or in treating traumatic injuries.
OsteoSeal® Bone Hemostat is intended for use under the direction of a licensed healthcare provider.
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Substantial Equivalence:
OsteoSeal® Bone Hemostat is substantially equivalent to the following predicate devices:
- Skeletal Kinetics CAAP Bone Wax K111538 .
- Synthes Hemostatic Bone Putty K113079 .
- Orthocon Orthostat Hemostatic Bone Putty/Applicator K091121/K102762 ●
- Ethicon Bone Wax Preamendment ●
Biocompatibility:
Biocompatibility testing was performed using ISO 10993 - Biological Evaluation of Medical Devices and FDA guidance document Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices May 1, 1995 (G95-1), including Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Genotoxicity, Subchronic Implant and LAL testing. The OsteoSeal® Bone Hemostat and applicator comply with the biocompatibility requirements for its intended use.
Sterilization:
The OsteoSeal® Bone Hemostat is sterilized using a validated gamma radiation method to assure a sterility assurance level (SAL) of 106. Packaging and Shelf Life testing were successfully completed.
Performance Testing:
Design verification testing and animal testing were performed for the OsteoSeal® Bone Hemostat to demonstrate physical and functional requirements were met. Design verification bench testing included appearance, handling and applicator function, and melt point. Animal performance testing in an acute porcine animal model test confirmed that OsteoSeal® Bone Hemostat met its product specifications for hemostasis and placement retention and performed at least as well, and in some cases better, than the standard commercially available bone wax control. In addition, a 13 week rabbit implant study confirmed the pathological safety of the OsteoSeal® Bone Hemostat, which demonstrated tissue irritation and bone healing results that were at least as good, and in some cases better, than the standard commercially available bone wax control.
Conclusion:
Through the data and information presented, Hemostasis, LLC, considers the OsteoSeal® Bone Hemostat substantially equivalent to the predicate devices already on the market (cleared by the 510(k) process) in terms of indications for use, scientific technology, design and functional performance and present no new concerns about safety and effectiveness.
N/A