(140 days)
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.
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.
The provided text describes a 510(k) submission for the Synthes Hemostatic Bone Putty (HBP) and mentions a variety of non-clinical tests performed for substantial equivalence comparison. However, it does not contain the detailed acceptance criteria or numerical performance data of the device in a structured table, nor does it present a study proving the device meets specific performance criteria.
The document primarily focuses on establishing "substantial equivalence" of HBP to a predicate device (Ostene CT Soluble Hemostasis Implant Material, K082491), rather than demonstrating direct performance against predefined acceptance criteria. Substantial equivalence in this context means the device is as safe and effective as a legally marketed predicate device.
Therefore, many of the requested sections regarding acceptance criteria, reported performance, sample sizes, ground truth, and expert involvement cannot be extracted directly from this document.
Here's what can be inferred or stated based on the provided text, while also explicitly noting what is not available:
1. Table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document lists several non-clinical tests that were performed, but it does not specify quantitative acceptance criteria for these tests or present the reported numerical performance of the device against such criteria. The studies listed are:
- Cytotoxicity Study Using the ISO Elution Method
- Mouse Peripheral Blood Micronucleus Study
- ISO Modified Intracutaneous Study, Solution with Measurement
- Genotoxicity: 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
The document states that "Documentation is provided that demonstrates that Synthes Hemostatic Putty is substantially equivalent' to other legally" marketed devices. This implies that the results of these tests were considered satisfactory to demonstrate equivalence, but the specific performance outcomes or the acceptance thresholds are not detailed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document lists several in vivo and in vitro animal studies.
- Animal Models Used: Rat, Rabbit, Sheep.
- Sample sizes for these studies are not specified in the provided text.
- Data Provenance: Not explicitly stated, though the applicant is Synthes USA Products, LLC, with an address in West Chester, PA, USA. The studies likely originated from contract research organizations or internal labs, but the specific country of origin for the data is not mentioned.
- Retrospective or Prospective: These would be prospective animal studies, as they involve active experimentation to test the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the evaluation is for a physical medical device (hemostatic bone putty) through non-clinical (animal and lab) studies, not a diagnostic AI device requiring expert consensus or ground truth derived from human interpretation. The "ground truth" would be the biological and physical measurements and observations from the animal models, analyzed by researchers/pathologists. The specific qualifications of those interpreting the animal study results are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable to the non-clinical studies described, which are not based on human-in-the-loop diagnostic interpretations. The evaluation relies on laboratory and in vivo observation methods.
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 is not applicable. The device is a hemostatic bone putty, not an AI or diagnostic imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a hemostatic bone putty, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the in vivo studies, the "ground truth" would be established through direct observation, physiological measurements, histology, pathology, and possibly imaging (e.g., to assess bone healing), as performed by qualified personnel in the animal studies.
- For the resorption rate studies in rats and rabbits, the ground truth would be the measured presence/absence and degradation of the putty.
- For bone healing studies in rats and sheep, the ground truth would be pathological and histological assessment of bone regeneration and healing.
- For the hemostasis evaluation in sheep, the ground truth would be direct observation and measurement of bleeding control.
- For in vitro studies like cytotoxicity, genotoxicity, and sensitization, the ground truth would be laboratory assays according to ISO standards.
8. The sample size for the training set:
This is not applicable. The device is a physical medical product, not an AI model requiring a training set. The term "training set" is typically used in the context of machine learning.
9. How the ground truth for the training set was established:
This is not applicable, as there is no training set for a physical medical device.
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1. 510(k) Summary
. . . . . .
.
| Sponsor: | Synthes USA Products, LLC1230 Wilson DriveWest Chester, PA 19380 | MAY 19 2011 | |
|---|---|---|---|
| Date Prepared | April 20, 2011 | ||
| CompanyContact | Jeffrey L. Dow, JDDirector, Clinical & Regulatory AffairsSynthes Biomaterials484 356 9720dow.jeffrey@synthes.com | ||
| Device Name: | Synthes Hemostatic Bone Putty | ||
| Classification: | Unclassified | ||
| Product Code | MTJ | ||
| PredicateDevices: | Ceremed, Inc.Ostene CT Soluble Hemostasis Implant MaterialK082491 | ||
| DeviceDescription: | Synthes Hemostatic Bone Putty (HBP) stops bone bleedingby establishing a physical barrier along the edges of bonesthat have been damaged by trauma or cut during the surgicalprocedure. When applied as directed, HBP forms amechanical barrier that occludes the vascular openings in thedamaged bone. This barrier prevents further bleeding duringthe surgical procedure and dissolves postoperatively,permitting normal tissue healing and bone regeneration. HBPis a blend of synthetic water soluble polymers that form aready-to-use hemostatic agent that is substantially eliminatedfrom the defect site in less than 48 hours. | ||
| The constituents of Synthes Hemostatic Bone Putty andOstene, the predicate, are similar. Ostene is comprised of aproprietary mixture of water soluble alkylene oxidecopolymers. HBP is also comprised of water soluble alkyleneoxide polymers. The remainder of HBP is a polysaccharide,carboxymethylcellulose (CMC), to improve handling. Ostenedoes not contain CMC. |
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| Non-clinical testsused forsubstantialequivalencecomparison | 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. |
| SubstantialEquivalence: | 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.
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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
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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
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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
N/A