(50 days)
Not Found
No
The 510(k) summary describes a physical, resorbable membrane material for hemostasis. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on material properties, biocompatibility, and hemostatic function, not algorithmic performance.
Yes
The device is intended for use in the control of bleeding from bone surfaces, which is a therapeutic action (treating a condition).
No
Explanation: The "Intended Use / Indications for Use" states that MP 719 is for use as an implant material and for controlling bleeding, and the "Device Description" states it is a sterile, resorbable, non-woven membrane for managing bleeding. These descriptions indicate a therapeutic rather than a diagnostic function.
No
The device is described as a "sterile, resorbable, non-woven membrane material" and is available in various sizes. The performance studies involve benchtop tests on the material itself and animal studies evaluating its physical and biological properties. This clearly indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that MP 719 is an "implant material" and is used for "control of bleeding from bone surfaces" during surgical procedures and in treating traumatic injuries. This describes a device that is applied directly to the body for a therapeutic purpose (hemostasis).
- Device Description: The description details a "sterile, resorbable, non-woven membrane material" used for "management of bleeding." This further reinforces its function as a topical hemostatic agent applied to the body.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any testing of biological specimens or diagnostic purposes.
Therefore, MP 719 is a medical device used in vivo (within the body) for hemostasis, not an IVD.
N/A
Intended Use / Indications for Use
MP 719 is indicated for use as an implant material and for use in the control of bleeding from bone surfaces. The material may be used during surgical procedures and in treating traumatic injuries.
Product codes
MTJ
Device Description
MP 719 is a sterile, resorbable, non-woven membrane material comprised of shortened fibers of poly-N-acetyl glucosamine, isolated from microalgae, intended for use in the management of bleeding.
MP 719 is available in a range of sizes from 4cm x 4cm to 10cm x 10cm.
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
under the direction of a healthcare professional.
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
Bench Top:
- Chemical Analysis: Chemical/Physical tests, IR identification, elemental analysis, ash, absence of protein, % moisture. Conclusion: pass according to specifications.
- Safety: Safety tests, bioburden, endotoxin. Conclusion: pass according to specifications.
- Shelf Life: Stability, 3 year real time Stability Study. Conclusion: pass according to specifications.
- Device Hardness: Mechanical, Hardness Testing of MP719. Conclusion: MP719 and Bone Wax exhibit similar mechanical properties.
- Handling Properties: Bench top, Hardness Testing of MP719. Conclusion: MP719 and Bone Wax handle similarly in bench top experiments.
Animal Studies:
- in vivo: Evaluation of Hemostasis produced by MP719 Implanted in Cortical Defects in the Rabbit Femur. Conclusion: MP719 and Bone Wax handle similarly in in vivo experiments.
- Biocompatibility - Cytotoxicity: L929 MEM Elution Test. Conclusion: No biological reactivity (Grade 0).
- Biocompatibility - Sensitization: Kligman Maximization Test. Conclusion: 0% sensitization.
- Biocompatibility - Irritation: Intrancutaneous Injection Test. Conclusion: Negligible irritant.
- Biocompatibility: USP Class VI - Intracutaneous Injection in rabbits. Conclusion: no signs of erythema or edema.
- Biocompatibility - Genotoxicity: Samonella typhimurium REVERSE MUTATION ASSAY. Conclusion: non-mutagenic.
- Biocompatibility: Mammilian Genotoxicity Publication. Conclusion: non-mutagenic.
- Biocompatibility - Implantation: USP Class VI - Intramuscular Implantation in Rabbits. Conclusion: no inflamation, encapsulation, hemmorrhage, necrosis or discoloration.
- Biocompatibility - Implantation: Intramuscular Implantation Test- ISO, 2 week. Conclusion: non-reactive.
- Biocompatibility - Implantation: Intramuscular Implantation Test- ISO, 4 week. Conclusion: non-reactive.
- Biocompatibility - Implantation: Intramuscular Implantation Test- ISO, 12 week. Conclusion: non-reactive.
- Biocompatibility - Hemocompatibility: ASTM Hemolysis Testing on MP719. Conclusion: both test article and test article extract are non-hemolytic.
- Biocompatibility - Systemic Toxicity: USP Class VI -Systemic Injection in Mice. Conclusion: no significantly greater biological reactivity than control.
Comparison of MP 719 and legally marketed bone wax:
- Implantation: Bone Implant, Implantation Study of MP719 in Femur Cortical Bone of Rabbit. Conclusion: Both MP719 and Bone Wax lacked any macroscopically detectable adverse reactions.
- Hemostasis: Comparative Hemostasis, Evaluation of Hemostasis produced by MP719 Implanted in Cortical Defects in the Rabbit Femur. Conclusion: MP719 and Bone Wax were considered equivalent in their hemostatic performance.
Key Metrics
Not Found
Predicate Device(s)
K070557, K091636, K063330, K971680
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K11524 Page 1 of 2 Marine Polymer Technologies
VIII. 510(k) Summary
| A. Sponsor/Submitter: | Marine Polymer Technologies, Inc.
107 Water Street
Danvers, MA 01923
Phone: 781-270-3200
Fax: 781-270-1133 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------|
| B. Contact Person | Sergio Finkielsztein
President
Phone: 781-270-3200 |
| C. Date of Submission: | June 1, 2011 |
| D. Trade (Brand) Name: | MP 719 |
| E. Common Name: | Bone Hemostasis Implant Material |
| F. Classification Number/ Name: | "Bone Wax" |
| G. Regulatory Class: | Unclassified |
| H. Product Code: | MTJ |
| I. Predicate Devices: | |
ู้ .. .
Marine Polymer Technologies, Inc.- Taliderm (K070557) Ceremed, Inc. Ostene CT Soluble Bone Hemostasis Implant Material (K091636) Orthocon, Inc. HemaSorb™ Resorbable Hemostatic Bone Putty (K063330)
United States Surgical Corporation Bone Wax – ( K971680)
1
J. Intended Use:
MP 719 is indicated for use as an implant material and for use in the control of bleeding from bone surfaces. The material may be used during surgical procedures and in treating traumatic injuries.
K. Device Description:
MP 719 is a sterile, resorbable, non-woven membrane material comprised of shortened fibers of poly-N-acetyl glucosamine, isolated from microalgae, intended for use in the management of bleeding.
MP 719 is available in a range of sizes from 4cm x 4cm to 10cm x 10cm.
L. Summary of Substantial Equivalence:
Summary of Safety and Effectiveness Data Table
| TEST | DESCRIPTION | STUDY | CONCLUSION | |
|---|---|---|---|---|
| BENCH TOP | Chemical Analysis | Chemical/Physical tests | IR identification, elemental analysis, ash, absence of protein, % moisture | pass according to specifications |
| Safety | Safety tests | bioburden, endotoxin | pass according to specifications | |
| Shelf Life | Stability | 3 year real time Stability Study | pass according to specifications | |
| Device Hardness | Mechanical | Hardness Testing of MP719 | MP719 and Bone Wax exhibit similar mechanical properties | |
| Handling Properties | Bench top | Hardness Testing of MP719 | MP719 and Bone Wax handle similarly in bench top experiments | |
| ANIMAL | ||||
| STUDIES | in vivo | Evaluation of Hemostasis produced by MP719 | ||
| Implanted in Cortical Defects in the Rabbit Femur | MP719 and Bone Wax handle similarly in in vivo experiments. | |||
| Biocompatibility | Cytotoxicity | L929 MEM Elution Test | No biological reactivity (Grade 0) | |
| Sensitization | Kligman Maximization Test | 0% sensitization | ||
| Irritation | Intrancutaneous Injection Test | Negligible irritant | ||
| USP Class VI - Intracutaneous Injection in rabbits | no signs of erythema or edema | |||
| Genotoxicity | Samonella typhimurium REVERSE MUTATION ASSAY | non-mutagenic | ||
| Mammilian Genotoxicity Publication | non-mutagenic | |||
| Implantation | USP Class VI - Intramuscular Implantation in Rabbits | no inflamation, encapsulation, hemmorrhage, necrosis or discoloration | ||
| Intramuscular Implantation Test- ISO, 2 week | non-reactive | |||
| Intramuscular Implantation Test- ISO, 4 week | non-reactive | |||
| Intramuscular Implantation Test- ISO, 12 week | non-reactive | |||
| Hemocompatibility | ASTM Hemolysis Testing on MP719 | both test article and test article extract are non-hemolytic | ||
| Systemic Toxicity | USP Class VI -Systemic Injection in Mice | no significantly greater biological reactivity than control | ||
| Comparison | ||||
| of MP 719 | ||||
| and legally | ||||
| marketed | ||||
| bone wax | Implantation | Bone Implant | Implantation Study of MP719 in Femur Cortical Bone of Rabbit | Both MP719 and Bone Wax lacked any macroscopically detectable adverse reactions. |
| Hemostasis | Comparative | |||
| Hemostasis | Evaluation of Hemostasis produced by MP719 | |||
| Implanted in Cortical Defects in the Rabbit Femur | MP719 and Bone Wax were considered equivalent in their | |||
Marine Polymer Technologies has submitted information for use, biocompatibility and performance characteristics to establish that MP 719 is substantially equivalent to currently marketed predicate devices. MP 719 has essentially the same intended use as the predicate devices. Results of scientific testing have ensured that the material is biocompatible, no new adverse effects were introduced and physical properties are appropriate for the intended use. Non-clinical testing was conducted. Animal testing was performed to simulate clinical conditions with no adverse effects noted.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains an image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the perimeter of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Marine Polymer Technologies, Inc. % Mr. Sergio Finklesztein President 107 Water Street Danvers, Massachusetts 01923
JUL 222 2011
Re: K111524
Trade/Device Name: MP 719 Regulatory Class: Unclassified Product Code: MTJ Dated: June 28, 2011 Received: June 29, 2011
Dear Mr. Finklesztein:
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. Iisting 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
3
Page 2 - Mr. Sergio Finklesztein
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vou
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Appendix 2:
Indications for Use Statement
INDICATIONS FOR USE
510(k) Number KIII 524
Device Name MP 719
INDICATIONS:
MP719 is indicated for use as an implant material and for use in the control of bleeding from bone surfaces. The material may be used during surgical procedures and in treating traumatic injuries.
MP719 is intended for use under the direction of a healthcare professional.
Prescription Use X (Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kane for MXM
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111524