(114 days)
ROP Bone Hemostasis Material is a water-soluble material indicated for use to control bleeding from bone surfaces.
The ROP Bone Hemostasis Material is a blend of water-soluble alkylene oxide copolymers. It contains no additives or colorants. The product is provided in a stick-like form, contained in a capped delivery tube. Each tube contains approximately 6.0 grams of the material. It is to be extruded from the container by rotation of the base of the tube for application to bleeding bone defect. The ROP Bone Hemostasis Material is, as the predicate, a water soluble wax-like substance and is slippery when wet. The delivery tube is a barrier between the surgeon's wet gloved hand and the material, permitting application to the boney defect in the manner similar to handling a crayon. ROP Bone Hemostasis Material is sterilized by a validated gamma irradiation process. It is labeled for single surgical use and is not to be resterilized. The tube is provided in a secondary wrap to permit delivery into a sterile field. The device is a resorbable material in contact with bone tissue for less than 30 days.
The provided text describes a 510(k) premarket notification for the "ROP Resorbable Hemostasis Material" (K153095). However, the document does not present specific acceptance criteria in a quantifiable manner (e.g., a specific percentage of bleeding control or a fixed resorption rate within a certain timeframe that the device must meet).
Instead, the study aims to demonstrate substantial equivalence to a predicate device, Ostene® CT Soluble Bone Hemostasis Implant Material. The acceptance criteria for this type of submission are generally met by showing that the new device performs similarly to the legally marketed predicate device with respect to safety and effectiveness for its intended use.
Therefore, the "acceptance criteria" can be inferred as:
- Similarity in hemostatic performance to the predicate.
- Similarity in adherence to bone to the predicate.
- Similarity in resorption profile to the predicate.
- No negative impact on bone healing compared to the predicate.
- Biocompatibility according to ISO 10993 standards.
- Material and device characterization matching established specifications.
- Sterilization and shelf life validation.
Here's an attempt to structure the information based on the provided text, interpreting "acceptance criteria" as demonstrating similarity or compliance with established standards, and "reported device performance" as the study's findings regarding this similarity/compliance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Inferred) | Acceptance Criteria (Specific) | Reported Device Performance and Study Findings |
|---|---|---|
| Hemostatic Performance | Device must control bleeding from bone surfaces similarly to the predicate device. | "Results showed the ROP material performed similarly to the predicate Ostene." (from in vivo performance testing) |
| Adherence to Bone | Device must adhere to bone surfaces similarly to the predicate device. | "Results showed the ROP material performed similarly to the predicate Ostene... adhere to bone." (from in vivo performance testing and ignition potential study) |
| Resorption Profile | Device must resorb completely within a certain timeframe, similarly to the predicate device, and not negatively impact bone healing. | "Testing has shown the device is completely resorbed between the 2- and 7-day evaluation time points." "Results showed the ROP material performed similarly to the predicate Ostene... resorb and do not show a negative impact on bone healing." (from in vivo) |
| Biocompatibility | Device must be biocompatible and non-toxic according to ISO 10993 standards for intended body contact (resorbable material in contact with bone tissue for less than 30 days). | Extensive biocompatibility testing performed according to ISO 10993 standards (e.g., Cytotoxicity, Irritation, Sensitization, Genotoxicity, Systemic Toxicity, Pyrogenicity, Bone Implantation Study). Data provided in 510(k) demonstrated biocompatibility and non-toxicity. |
| Material & Device Characterization | Consistent material properties (formaldehyde/ethylene oxide content, impurities, leachable compounds, stiffness, melting point, viscosity, appearance/texture, weight consistency, pH, molecular weight, ID) and no ignition potential. Must be water-soluble alkylene oxide copolymer. | Laboratory testing performed for all listed characteristics (e.g., ASTM, USP, EPA methods). Product identified as a blend of water-soluble alkylene oxide copolymers. No evidence of ignition observed. |
| Sterilization & Shelf Life | Device must be terminally sterilized and maintain stability for a specified shelf life. | Sterilized via validated gamma irradiation. Validated shelf life of 3 years. |
| Comparison to Predicate (Overall Equivalence) | Device should have the same intended use, principles of operation, and be substantially equivalent in material composition to the predicate, with any differences not raising new safety/effectiveness questions. | "Same intended use and same principles of operation." "Composed of a material that is substantially equivalent to the predicate: both are water-soluble, resorbable, alkylene oxide copolymers." Differences in packaging and sterilization "do not raise new safety and effectiveness questions." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size:
- Animal Testing (In vivo performance and ISO 10993-6 study): The document specifies "ISO Bone Implantation Study in the mid shaft femur of rabbits, 48 hours, 1 and 4 weeks." While the specific number of rabbits (sample size) is not explicitly stated in the provided text, "rabbits" is mentioned, implying a multi-animal study.
- Biocompatibility Testing: Many tests listed use animal models (e.g., "ISO Modified Intracutaneous Irritation in the Rabbit," "Guinea Pig Maximization Sensitization Test," "Mouse Peripheral Blood Micronucleus Study," "Dose Range Finding Study with a Definitive Mouse Lymphoma Assay," "Systemic Toxicity in Mice," "ISO Systemic Toxicity in the Rat," "USP Rabbit Pyrogen Study"). The exact number of animals for each test is not detailed in this summary.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the studies are described as "Non-clinical testing" conducted in accordance with FDA guidance and standards, indicating laboratory and animal testing. This is typically prospective.
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)
- The document does not mention the use of human experts to establish "ground truth" for the test set in the traditional sense of medical image interpretation or clinical diagnosis. The studies described are primarily non-clinical laboratory and animal studies. The "ground truth" or evaluative criteria would be based on scientific and biological endpoints (e.g., histological analysis of tissue response, observation of hemostasis, measurement of resorption) as assessed by researchers or pathologists involved in the studies, rather than subjective expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. The reported studies are non-clinical (laboratory and animal) and do not involve human reader interpretation or adjudication of results in the way a clinical imaging study would.
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. The device is a "Bone Hemostasis Material," not an AI diagnostic or assistive tool. The studies focus on the intrinsic properties and performance of the material itself.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable, as this is a physical medical device, not a software algorithm. The "standalone" performance refers to the device's inherent function, which was evaluated through laboratory and animal testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for the non-clinical studies was established through:
- Pathology/Histology: For tissue response, bone healing, and resorption evaluation in animal studies.
- Physical and Chemical Measurements: For material and device characterization (e.g., melting point, pH, molecular weight, formaldehyde content, stiffness).
- Biological Endpoints/Observations: For hemostasis, adherence to bone, and biocompatibility endpoints in animal models.
- Comparisons: Performance was assessed relative to a legally marketed predicate device (Ostene).
8. The sample size for the training set
- Not applicable. This is a physical medical device, and the described studies are non-clinical evaluations for regulatory clearance, not a machine learning study requiring training data.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set mentioned or implied for this type of device submission.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 17, 2016
Resorbable Orthopedic Products, LLC % Ms. Patsy Trisler Regulatory Consultant Trisler Consulting 5600 Wisconsin Ave Chevy Chase, Maryland 20815
Re: K153095
Trade/Device Name: ROP Resorbable Hemostasis Material Regulatory Class: Unclassified Product Code: MTJ Dated: October 23, 2015 Received: October 26, 2015
Dear Ms. Trisler:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
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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/ResourcesforYou/Industry/default.htm. 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
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
for 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)
K153095
Device Name
ROP Bone Hemostasis Material
Indications for Use (Describe)
ROP Bone Hemostasis Material is a water-soluble material indicated for use to control bleeding from bone surfaces.
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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K153095 510(k) Summary
| Submitter Name: | Resorbable Orthopedic Products, LLC |
|---|---|
| Submitter Address: | 16633 Dallas Parkway, Suite 250Addison, TX 75001 |
| Contact Person: | Barry E. ConstantineBconst191@aol.com |
| Phone Number: | 732-831-1797 |
| Date Prepared: | October 23, 2015 |
| Device Trade Name: | ROP Bone Hemostasis Material |
| Common Name: | Wax, Bone |
| ClassificationNumber: | Unclassified |
| Product Code: | MTJ |
| Device Class: | Unclassified |
| Predicate Device(s): | K082491, Ostene® CT Soluble Bone Hemostasis Implant Material,AOC™ Ostene™, Osteotene™, Ceretene™, Ceremed, Inc. |
| Indications for UseStatement: | ROP Bone Hemostasis Material is a water-solublematerialindicated for use to control bleeding from bone surfaces. |
| Device Description: | Device Identification and Materials of Use:The ROP Bone Hemostasis Material is a blend of water-solublealkylene oxide copolymers. It contains no additives or colorants.The product is provided in a stick-like form, contained in a cappeddelivery tube. Each tube contains approximately 6.0 grams of thematerial. It is to be extruded from the container by rotation of thebase of the tube for application to bleeding bone defect. The ROPBone Hemostasis Material is, as the predicate, a water solublewax-like substance and is slippery when wet. The delivery tube is abarrier between the surgeon's wet gloved hand and the material,permitting application to the boney defect in the manner similar tohandling a crayon.ROP Bone Hemostasis Material is sterilized by a validated gammairradiation process. It is labeled for single surgical use and is not tobe resterilized. The tube is provided in a secondary wrap to permitdelivery into a sterile field.Body Contact:The device is a resorbable material in contact with bone tissue for |
less than 30 days.
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Mechanism of Action:
The ROP Bone Hemostasis Material acts as a physical hemostasis agent, by means of a tamponade action. It stops bleeding by sealing the damaged bone and plugging the vessels. Testing has shown the device is completely resorbed between the 2- and 7-day evaluation time points.
Environment of Use:
The device is for use only in a health care facility/hospital during surgical procedures.
- Summary of Non-clinical testing has been performed in accordance with FDA Testing: quidance and standards as follows.
Material and Device Characterization Testing
Laboratory Testing
Raw Material Testing:
- Formaldehyde Content (VOL): ASTM #D6007
- Formaldehyde and Ethylene Oxide Content: EPA Method-. 316, ASTM #D6330
- Ethylene Glycol, Diethylene Glycol Impurities: USP-37
- Leachable Organic Compounds: USP-37 <1663/1634. . ASTM #D7823
- . Stiffness: ASTM#D6828
Device Characterization testing was performed as follows:
- . Melting point: USP-37<741>
- Viscosity: The product is a solid at room temperature.
- . Adherence to bone surface (as part of the implantation study and the ignition potential study)
- Appearance/Texture: Visual/Tactile USP-37
- Weight Consistency: Gravimetric
- . pH: USP-37 <791>
- Molecular Weight (Saybolt Viscocity): USP 37 <911>
- Molecular Weight (Thermo Gravimetry): ASTM #E1269
- ID: FT-IR USP-37 <197M)
- . Ignition Potential was evaluated by an independent test laboratory, with no evidence of ignition observed.
Swelling - a characteristic critical to assess in many bone tissue contact products, is not pertinent because the ROP Bone Hemostasis Material dissolves in water, and therefore does not swell.
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Animal Testing
In vivo performance testing was conducted as part of the ISO 10993-6 study to evaluate the following in addition to local tissue response:
- . Hemostasis
- . Device Adherence to bone
- Resorption ●
- . Bone defect healing
Results showed the ROP material performed similarly to the predicate Ostene. Both are hemostatic, adhere to bone, resorb and do not show a negative impact on bone healing.
Biocompatibility Testing:
The following testing was performed according to ISO 10993 and data are provided in the 510(k) which demonstrate the device is biocompatible and non-toxic.
- . Cytotoxicity: Certified to ISO 13485 and Accredited to ISO 17025 and 10993 Part 5
- . ISO Modified Intracutaneous Irritation in the Rabbit: ISO 10993-10
- . Guinea Pig Maximization Sensitization Test: ISO 10993-1, -2, -10, -12 and ISO 13485.
- . Genotoxicity: 1.) Mouse Peripheral Blood Micronucleus Study: OECD Test No. 474. 2.) Bacterial Reverse Mutation Study with Dose Range Finding Study: ISO 10993, OECD 471.
- . Dose Range Finding Study with a Definitive Mouse Lymphoma Assay: ASTM #E-1280, Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity and the OECD Test #476.
- . ISO Bone Implantation Study in the mid shaft femur of rabbits, 48 hours, 1 and 4 weeks: ISO 10993-6
- Systemic Toxicity in Mice: USP/NF <88>, ISO 10993-11
- . ISO Systemic Toxicity in the Rat following Subcutaneous implantation, 4 weeks: ISO 10993-11 and ISO 10993-6
- USP Rabbit Pvrogen Study: USP/NF <151>. ISO 10993-11 .
Sterilization and Shelf life:
The final packaged product is sterilized via gamma irradiation. The validated shelf life of the ROP Bone Hemostasis Material will be 3 years.
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Comparison to the ROP Bone Hemostasis Material has the same intended use Predicate Devices: and the same principles of operation as the predicate device - to stop bleeding bone tissue by a physical means and to resorb in situ.
It is composed of a material that is substantially equivalent to the predicate: both are water-soluble, resorbable, alkylene oxide copolymers.
The predicate bone hemostasis material is provided in a peel-back foil packet, which is different from the tube in which the ROP Bone Hemostasis Material is provided.
The ROP Bone Hemostasis Material is sterilized via Gamma Irradiation, while the Ostene product is sterilized via Electron Beam Irradiation.
These differences in packaging and sterilization methods do not raise new safety and effectiveness questions.
Substantial Based on the above comparisons, as well as the study data Equivalence presented in the 510(k) in which the proposed device was Conclusion: evaluated in comparison to the predicate device in the expanded ISO 10993-6 study, it is concluded that the ROP Bone Hemostasis Material is substantially equivalent to the predicate Ostene Hemostasis Material.
N/A