(114 days)
Not Found
No
The device description and performance studies focus on the material properties and hemostatic function, with no mention of AI or ML.
No.
The device is used to control bleeding and does not appear to treat or cure a disease or condition, which are characteristics of a therapeutic device.
No
The device is a hemostatic material used to control bleeding during surgical procedures, not to diagnose a condition.
No
The device is a physical material (water-soluble alkylene oxide copolymers) provided in a delivery tube, intended for direct application to bone surfaces. It is 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 surfaces." This is a direct therapeutic intervention on the patient's body during surgery.
- Device Description: The device is a material applied directly to bone surfaces to stop bleeding. It is a physical substance used in a surgical procedure.
- Lack of Diagnostic Purpose: There is no mention of this device being used to analyze samples (like blood, tissue, etc.) to diagnose a condition, monitor a disease, or determine compatibility.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. This device is used in vivo (inside the body) for a therapeutic purpose (hemostasis).
N/A
Intended Use / Indications for Use
ROP Bone Hemostasis Material is a water-soluble material indicated for use to control bleeding from bone surfaces.
Product codes (comma separated list FDA assigned to the subject device)
MTJ
Device Description
Device Identification and Materials of Use:
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.
Body Contact:
The device is a resorbable material in contact with bone tissue for less than 30 days.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone surfaces
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Environment of Use:
The device is for use only in a health care facility/hospital during surgical procedures.
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)
- Summary of Non-clinical testing has been performed in accordance with FDA Testing: guidance 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
- 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
- Molecular Weight (Saybolt Viscocity): USP 37
- Molecular Weight (Thermo Gravimetry): ASTM #E1269
- ID: FT-IR USP-37 , 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 . 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other to create a sense of depth and unity.
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.
1
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
2
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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3
K153095 510(k) Summary
| Submitter Name: | Resorbable Orthopedic Products, LLC |
|---|---|
| Submitter Address: | 16633 Dallas Parkway, Suite 250 |
| Addison, TX 75001 | |
| Contact Person: | Barry E. Constantine |
| Bconst191@aol.com | |
| Phone Number: | 732-831-1797 |
| Date Prepared: | October 23, 2015 |
| Device Trade Name: | ROP Bone Hemostasis Material |
| Common Name: | Wax, Bone |
| Classification | |
| Number: | 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 Use | |
| Statement: | ROP Bone Hemostasis Material is a water-soluble |
| material | |
| indicated 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-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.
Body Contact:
The device is a resorbable material in contact with bone tissue for |
less than 30 days.
4
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
- 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
- Molecular Weight (Saybolt Viscocity): USP 37
- Molecular Weight (Thermo Gravimetry): ASTM #E1269
- ID: FT-IR USP-37 , 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 . 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.
6
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.