(140 days)
Not Found
No
The device description focuses on the physical and chemical properties of the bone putty and its mechanical function in controlling bleeding. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for use in the control of bleeding from bone surfaces and establishes a physical barrier to prevent further bleeding during surgical procedures, directly treating a physiological condition.
No
Explanation: The device is indicated for controlling bleeding from bone surfaces by forming a physical barrier, which is a therapeutic function, not a diagnostic one. It doesn't identify or analyze a medical condition.
No
The device description clearly states it is a "water-soluble implant material" and a "blend of synthetic water soluble polymers," indicating it is a physical substance, 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 by forming a physical barrier. This is a direct therapeutic action on the patient's body.
- Device Description: The description details a material that is applied to bone surfaces to physically stop bleeding and then dissolves. This is a topical application for hemostasis.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide information about a disease, condition, or state of health.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide diagnostic information. This device is used in vivo (inside the body) for a therapeutic purpose (hemostasis).
N/A
Intended Use / Indications for Use
Synthes Hemostatic Bone Putty is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Product codes
MTJ
Device Description
Synthes Hemostatic Bone Putty (HBP) stops bone bleeding by establishing a physical barrier along the edges of bones that have been damaged by trauma or cut during the surgical procedure. When applied as directed, HBP forms a mechanical barrier that occludes the vascular openings in the damaged bone. This barrier prevents further bleeding during the surgical procedure and dissolves postoperatively, permitting normal tissue healing and bone regeneration. HBP is a blend of synthetic water soluble polymers that form a ready-to-use hemostatic agent that is substantially eliminated from the defect site in less than 48 hours. The constituents of Synthes Hemostatic Bone Putty and Ostene, the predicate, are similar. Ostene is comprised of a proprietary mixture of water soluble alkylene oxide copolymers. HBP is also comprised of water soluble alkylene oxide polymers. The remainder of HBP is a polysaccharide, carboxymethylcellulose (CMC), to improve handling. Ostene does not contain CMC.
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
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)
Non-clinical tests used for substantial equivalence comparison:
- Cytotoxicity Study Using the ISO Elution Method – 1X MEM Extract
- Mouse Peripheral Blood Micronucleus Study
- ISO Modified Intracutaneous Study, Solution with Measurement
- Genotoxcity: Bacterial Reverse Mutation Assay
- Genotoxicity: Mouse Lymphoma Assay
- ISO Guinea Pig Maximization Sensitization Test-Solution
- Systemic Toxicity Study
- An In Situ Study to Determine the HBP Resorption Rate in a Rat Craniotomy Model
- In Vivo Resorption Rate of a Hemostatic Bone Putty Subcutaneously Implanted in the Rabbit at 2, 4, 7, 14 Days.
- In Vivo evaluation of Hemostatic Bone Putty in a sheep vertebral body defect at 7 days
- Evaluation of Hemostatic Bone Putty in a Sheep Vertebral Body Defect
- An In Vivo Study to Determine Hemostatic Bone Putty Effect on Bone Healing In A Rat Craniotomy Model at 3, 6, and 12 Weeks
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
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1. 510(k) Summary
. . . . . .
.
| Sponsor: | Synthes USA Products, LLC
1230 Wilson Drive
West Chester, PA 19380 | | MAY 19 2011 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------|
| Date Prepared | April 20, 2011 | | |
| Company
Contact | Jeffrey L. Dow, JD
Director, Clinical & Regulatory Affairs
Synthes Biomaterials
484 356 9720
dow.jeffrey@synthes.com | | |
| Device Name: | Synthes Hemostatic Bone Putty | | |
| Classification: | Unclassified | | |
| Product Code | MTJ | | |
| Predicate
Devices: | Ceremed, Inc.
Ostene CT Soluble Hemostasis Implant Material
K082491 | | |
| Device
Description: | Synthes Hemostatic Bone Putty (HBP) stops bone bleeding
by establishing a physical barrier along the edges of bones
that have been damaged by trauma or cut during the surgical
procedure. When applied as directed, HBP forms a
mechanical barrier that occludes the vascular openings in the
damaged bone. This barrier prevents further bleeding during
the surgical procedure and dissolves postoperatively,
permitting normal tissue healing and bone regeneration. HBP
is a blend of synthetic water soluble polymers that form a
ready-to-use hemostatic agent that is substantially eliminated
from the defect site in less than 48 hours. | | |
| | The constituents of Synthes Hemostatic Bone Putty and
Ostene, the predicate, are similar. Ostene is comprised of a
proprietary mixture of water soluble alkylene oxide
copolymers. HBP is also comprised of water soluble alkylene
oxide polymers. The remainder of HBP is a polysaccharide,
carboxymethylcellulose (CMC), to improve handling. Ostene
does not contain CMC. | | |
1
| Non-clinical tests
used for
substantial
equivalence
| comparison | Cytotoxicity Study Using the ISO Elution Method – 1X MEM Extract Mouse Peripheral Blood Micronucleus Study ISO Modified Intracutaneous Study, Solution with Measurement Genotoxcity: Bacterial Reverse Mutation Assay Genotoxicity: Mouse Lymphoma Assay ISO Guinea Pig Maximization Sensitization Test-Solution Systemic Toxicity Study An In Situ Study to Determine the HBP Resorption Rate in a Rat Craniotomy Model In Vivo Resorption Rate of a Hemostatic Bone Putty Subcutaneously Implanted in the Rabbit at 2, 4, 7, 14 Days. In Vivo evaluation of Hemostatic Bone Putty in a sheep vertebral body defect at 7 days Evaluation of Hemostatic Bone Putty in a Sheep Vertebral Body Defect An In Vivo Study to Determine Hemostatic Bone Putty Effect on Bone Healing In A Rat Craniotomy Model at 3, 6, and 12 Weeks |
|---|---|
| Intended Use: | Synthes Hemostatic Bone Putty is indicated for use as a water-soluble implant material for use in the control of bleeding from bone surfaces. |
| Substantial | |
| Equivalence: | Documentation is provided that demonstrates that Synthes Hemostatic Putty is substantially equivalent' to other legally |
I The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended, 21 USC §301 et seq., and as applied under 21 CFR Part 807, Subpart E, under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalence under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein, shall be construed as an admission against interest under the U.S. patent laws or their application by the courts.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 9 2011
Synthes USA Products, LLC % Jeffrey L. Dow, JD 1230 Wilson Drive West Chester, Pennsylvania 19380
Re: K103822
Trade/Device Name: Synthes Hemostatic Bone Putty Regulatory Class: Unclassified Product Code: MTJ Dated: April 21, 2011 Received: April 22, 2011
Dear Dr. Dow:
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
3
Page 2 - Jeffrey L. Dow, JD
device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fdagov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.hun 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
P. Thom. D.E.P. V.A.
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the word "SYNTHES" in a stylized font. The letters are bold and slightly slanted to the right. The letters are also filled with small dots, giving them a textured appearance. To the left of the word is a logo that appears to be a stylized representation of a medical device or implant. To the right of the word is a registered trademark symbol.
1. Indications for Use
510(k) Number (if known): K 10 38 2 2
.. .' .
Indications:
Synthes Hemostatic Bone Putty is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Prescription Use _ X Over-The-Counter Use AND/OR (Per 21 CFR 801 Subpari D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Keane
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103822
Confidential: Contains trade secret information