(54 days)
No
The summary describes a bone graft substitute material and its physical properties and intended use, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a bone graft substitute intended to fill bone voids and promote bone healing, falling under the definition of a therapeutic device.
No
Explanation: This device is described as a bone graft substitute used for filling bone voids or gaps in the skeletal system. Its function is to facilitate bone regeneration, not to diagnose a condition.
No
The device description clearly states it is a "resorbable porous bone void filler" and an "implant," which are physical hardware components, not software.
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 FM-02 Bone Graft Substitute is a bone void filler for surgical and traumatic bone defects. It is implanted directly into the body to aid in bone regeneration.
- Device Description: The description details a resorbable porous implant designed to be placed within the skeletal system.
- Lack of Diagnostic Function: There is no mention of this device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is an implantable medical device used within the body for therapeutic purposes (bone regeneration).
N/A
Intended Use / Indications for Use
FM-02 Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. FM-02 is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.
FM-02 Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral spine), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Product codes
MQV
Device Description
FM-02 Bone Graft Substitute is a resorbable porous bone void filler for the repair of bony defects. It is an osteoconductive, porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is >70% porous and the pore diameters range from 1 um to 1000 um.
FM-02 Bone Graft Substitute guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When FM-02 Bone Graft Substitute is placed in direct contact with host bone, new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scàffold.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., the extremities, pelvis and posterolateral spine)
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)
Comparative testing included wettability, fluid retention, wash away resistance, homogeneity, radiopacity, bioactivity, and SEM comparisons. XRD, FTIR ICP and porosity were evaluated for the predicate device. Biocompatibility of the implant has been established in accordance with ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing. Data supplied demonstrate that FM-02 Bone Graft Substitute is substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness.
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
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
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Orthovita, Inc. FM-02 Bone Graft Substitute Special 510(k)
510(k) SUMMARY FM-02 Bone Graft Substitute October 26, 2010
510(k) Number (if known): K102545
OCT 2 7 2010
- Contact Person
Deborah L. Jackson, RAC Senior Regulatory Affairs Specialist (e-mail) djackson(@orthovita.com
Orthovita, Inc. 45 Great Valley Parkway Malvern, PA 19355 (t) 610-640-1775 - (f) 484-323-8803
2. Device Name and Classification
| Product Name: | FM-02 Bone Graft Substitute |
|---|---|
| Classification Name: | Resorbable calcium salt bone void filler device |
| Common or Usual Name: | Bone Void Filler |
| Classification Panel: | Orthopedic |
| Regulation Number: | 888.3045 |
| Device Class: | Class II |
| Product Code: | MQV |
3. Predicate Device(s)
Vitoss Bioactive Foam Bone Graft Substitute (K072184) Vitoss Bioactive Foam Bone Graft Substitute STRIP and PACK (K081439) Vitoss Bioactive Foam Bone Graft Substitute STRIP and PACK (K083033)
4. Device Description
FM-02 Bone Graft Substitute is a resorbable porous bone void filler for the repair of bony defects. It is an osteoconductive, porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is >70% porous and the pore diameters range from 1 um to 1000 um.
FM-02 Bone Graft Substitute guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When FM-02 Bone Graft Substitute is placed in direct contact with host bone, new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scàffold.
5. Intended Use / Indications for Use
FM-02 Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. FM-02 is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.
1
FM-02 Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral spine), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
6. Performance Data
FM-02 is a medical grade beta-tricalcium phosphate which satisfies the requirements of ASTM F 1088-04a. Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation. Comparative testing included wettability, fluid retention, wash away resistance, homogeneity, radiopacity, bioactivity, and SEM comparisons. XRD, FTIR ICP and porosity were evaluated for the predicate device. Biocompatibility of the implant has been established in accordance with ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing. Data supplied demonstrate that FM-02 Bone Graft Substitute is substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness.
7. Substantial Equivalence
FM-02 Bone Graft Substitute, subject of the Special 510(k), is a product line extension to the Vitoss Bioactive Foam product line. FM-02 Bone Graft Substitute has the same intended uses and indications, technological characteristics, and principles of operation as its predicate device. The minor differences between FM-02 Bone Graft Substitute and the predicate device raise no new issues of safety or effectiveness. Thus, FM-02 Bone Graft Substantially equivalent to Vitoss Bioactive Foam.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Orthovita, Inc. % Ms. Deborah L. Jackson, RAC Senior Regulatory Affairs Specialist 45 Great Valley Parkway Malvern, Pennsylvania 19355
OCT 2 7 2010
Re: K102545
Trade Name: FM-02 Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: October 1, 2010 Received: October 4, 2010
Dear Ms. Jackson:
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 - Ms. Deborah L. Jackson, RAC
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/CDRH0ffices/ucm1115809.html 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" (21CFF) Pact 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 yours,
Mark N. Meller for
Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Orthovita, Inc. FM-02 Bone Graft Substitute Special 510(k)
Indications for Use Statement
510(k) Number (if known): 〈につってく
Device Name:
FM-02 Bone Graft Substitute
OCT 2 7 2010
Indications for Use:
FM-02 Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. FM-02 is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.
FM-02 Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral spine), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR 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)
Signature
X
(Division Sign. Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102545
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