(144 days)
Not Found
No
The summary describes a mechanical applicator for a bone hemostat matrix and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade, which is a therapeutic function.
No
Explanation: The device is indicated for use in the control of bleeding by acting as a mechanical barrier or tamponade, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a syringe-type applicator containing a material (Orthostat bone hemostat) and has a physical tip, indicating it is a hardware device for delivering a substance.
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 by acting as a mechanical barrier. This is a direct therapeutic action on the patient's body.
- Device Description: The device is a syringe-type applicator for delivering a bone hemostat matrix. This is a delivery system for a therapeutic material.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of disease or impairment.
IVD devices are used to perform tests on samples taken from the body (like blood, urine, tissue) to provide diagnostic information. This device is used directly on the patient's bone during surgery or trauma to stop bleeding.
N/A
Intended Use / Indications for Use
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
Product codes
MTJ
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical procedures and in treating traumatic injuries.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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
1
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 biologic | ||
| source? | 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 | Orthostat
K043260, K091121 |
|------------------------|----------------------------------------|----------------------------------------|
| Intended use | Hemostasis on cut or traumatized bone. | Hemostasis on cut or traumatized bone. |
| Hemostatic
Compound | 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 |
:
2
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.
3
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
4
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
5
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