(144 days)
Orthostat Bone Hemostat Matrix Applicator is indicated for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries
This submission is for Orthostat packaged in a syringe type applicator containing 3.5g of Orthostat bone hemostat. This will allow convenient discharge of the purgeon's hand, onto a surgical instrument, or directly onto bleeding bone. The tip of the applicator is tapered and made from a softer material to assist with spreading the material onto the bone.
This 510(k) submission (K102762) is for a medical device called the "Orthostat Bone Hemostat Matrix Applicator," which is intended for controlling bleeding from bone. The submission focuses on demonstrating substantial equivalence to a predicate device, the "Orthostat Bone Hemostat Matrix," rather than proving clinical effectiveness through a new clinical study. Therefore, much of the information typically associated with studies proving device performance against acceptance criteria for diagnostic AI/software devices is not directly applicable here.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This device is not an AI/software diagnostic device, so typical performance metrics like sensitivity, specificity, or AUC are not relevant. Instead, the "acceptance criteria" are related to safety, biocompatibility, and functional equivalence to the predicate device.
| In Vitro Test Description | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Material Safety | Biocompatible; no extractables or plasticizers (as per predicate) | Material is biocompatible and has no extractables or plasticizers. |
| Tip Tensile Strength | Acceptable tip attachment after simulated use (as per predicate) | Tip attachment is acceptable and is acceptable after simulated use conditions. |
| Handling and Usability | Effective application of Orthostat (equivalent to predicate) | The product effectively applies Orthostat during animal and human cadaver evaluation. |
| Biocompatibility Tests | Pass criteria for each test (as per ISO 10993 standards, implied for medical devices) | Results |
| Cytotoxicity | Pass | Pass |
| Sensitization | Pass | Pass |
| Irritation/Intracutaneous Injection | Pass | Pass |
| Acute Systemic Toxicity | Pass | Pass |
| Pyrogen | Pass | Pass |
| Sterilization Method | Radiation (consistent with predicate) | Radiation |
| Sterility Assurance Level (SAL) | $10^{-6}$ (consistent with predicate) | $10^{-6}$ |
| Sterile Barrier | Foil Pouch (consistent with predicate) | Foil Pouch |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "No clinical tests were performed to determine substantial equivalence." Therefore, there is no clinical test set for performance comparison in the traditional sense for human efficacy.
For the non-clinical tests:
- Handling and Usability: This was evaluated during "animal and human cadaver evaluation." No specific sample sizes for these evaluations are provided.
- Material Safety, Tip Tensile Strength, Biocompatibility: These are typically conducted on material samples or device prototypes, not on a "test set" from a patient population. Sample sizes would be determined by relevant ASTM or ISO standards for mechanical and biocompatibility testing. The data provenance is laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. As no clinical tests were performed, there was no expert-adjudicated ground truth established for a clinical test set. The non-clinical tests rely on established scientific methods and standards.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring expert adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This submission focuses on a new applicator for an existing device, not a diagnostic AI or imaging analysis tool that would typically involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical applicator, not an algorithm or software.
7. The Type of Ground Truth Used
The "ground truth" for this submission is established through:
- Predicate Device Equivalence: The primary ground for substantial equivalence is the prior FDA-cleared predicate device (Orthostat Bone Hemostat Matrix, K043260, K091121).
- Non-Clinical Test Results: The "ground truth" for the non-clinical tests (material safety, tip tensile strength, handling, usability, biocompatibility) is determined by the specific pass/fail criteria defined by relevant industry standards and internal specifications, which were met. For biocompatibility, it's typically based on ISO 10993 standards.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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510(k) Summary - K102762
Date: February 9, 2010
FEB 15 2011
Sponsor of the 510(k)
Orthocon, Inc. 1 Bridge Street, Suite 121 Irvington, NY 10533 FDA Establishment Registration number: 3005972619 Contact: Brian Kunst, Vice President, Regulatory Affairs and Quality Assurance 914-357-2660
Device Identification:
| Proprietary Name: | Orthostat Applicator |
|---|---|
| Common Name: | Bone Hemostat |
| Classification Name: | Bone Wax |
| Classification Number: | Unclassified Preamendment |
| Classification Panel: | General and Plastic Surgery |
| Product Code: | MTJ |
| Regulatory Class: | Unclassified Preamendment |
Legally marketed device to which equivalence is claimed:
Orthostat Bone Hemostat Matrix
Intended Use / Indications
Orthostat Bone Hemostat Matrix Applicator is indicated for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries
Device Description
This submission is for Orthostat packaged in a syringe type applicator containing 3.5g of Orthostat bone hemostat. This will allow convenient discharge of the purgeon's hand, onto a surgical
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102762 2083
instrument, or directly onto bleeding bone. The tip of the applicator is tapered and made from a softer material to assist with spreading the material onto the bone.
| Question | YES | NO |
|---|---|---|
| Is the device intended for prescription use (21 CFR 801 Subpart D)?^ | X | |
| Does the device contain components derived from a tissue or other biologicsource? | X | |
| Is the device provided sterile? | X | |
| Is the device intended for single use? | X | |
| Is the device a reprocessed single use device? | X | |
| Does the device contain a drug? | X | |
| Does the device contain a biologic? | X | |
| Does the device use software? | X | |
| Does the submission include clinical information? | X |
Device comparison table
i
| Orthostat Applicator | OrthostatK043260, K091121 | |
|---|---|---|
| Intended use | Hemostasis on cut or traumatized bone. | Hemostasis on cut or traumatized bone. |
| HemostaticCompound | Orthostat | Orthostat |
| Packaging | PETG Syringe | PETG Tray |
| Amount of Putty | 3.5g | 2.0g |
| Sterilization Method | Radiation | Radiation |
| SAL | $10^{-6}$ | $10^{-6}$ |
| Sterile Barrier | Foil Pouch | Foil Pouch |
:
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Summary of the non-clinical performance data
| In Vitro Test Description | Results |
|---|---|
| Material Safety | Material is biocompatible and has no extractables or plasticizers. |
| Tip Tensile Strength | Tip attachment is acceptable and is acceptable after simulated use conditions. |
| Handling and Usability | The product effectively applies Orthostat during animal and human cadaver evaluation |
| Biocompatibility Test Description | Results |
|---|---|
| Cytotoxicity | Pass |
| Sensitization | Pass |
| Irritatiion/Intracutaneous Injection | Pass |
| Acute Systemic Toxicity | Pass |
| Pyrogen | Pass |
Summary of the clinical performance data
No clinical tests were performed to determine substantial equivalence.
Conclusions drawn from the non-clinical performance data
The non-clinical tests demonstrate the Orthostat applicator is equivalent to commercially available Orthostat.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle.
Food and Druq Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Orthocon, Inc. % Ms. Rosemary Harry VP, Regulatory Affairs & Quality Assurance 1 Bridge Street, Suite 121 Irvington, New York 10553
FEB 15 201
Re: K102762
Trade/Device Name: Orthostat Bone Hemostat Matrix Applicator Regulatory Class: Unclassified Product Code: MTJ Dated: February 9, 2011 Received: February 10, 2011
Dear Ms. Harry:
:
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
-
- 1
the submit the state of the state of the states of the states of
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Page 2 - Ms. Rosemary Harry
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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electionic 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 far. 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" (21155), Previ 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/Resourcesfor.You/Industry/default.htm.
Sincerely yours,
A. B. nt
for
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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Indications for Use Statement
Indications for Use
510(k) Number: K102762
Orthostat Bone Hemostat Matrix Applicator Device Name:
Indications for Use:
Orthostat is indicated for use in the control of bleeding from cut or damaged bone by acting Orthostar is indicated for use in the control of the may be used during surgical procedures and in treating traumatic injuries.
X ____________________________________________________________________________________________________________________________________________________________________________ AND/OR Prescription Use __ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ (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)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102762
N/A