(240 days)
Not Found
No
The summary describes a bone void filler made of beta tricalcium phosphate granules and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No.
The device is a bone void filler and scaffold, which aids in bone healing but does not directly treat a disease or condition in a therapeutic manner.
No
Explanation: The device is described as a bone void filler and osteoconductive scaffold used for repairing bony defects, not for diagnosing any condition.
No
The device description clearly states that GranOS™ is a porous, resorbable osteoconductive scaffold constructed of beta tricalcium phosphate granules, indicating it is a physical material, not software.
Based on the provided information, the GranOS™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that GranOS™ is a bone void filler placed into bony voids or gaps in the skeletal system. This is a therapeutic or reconstructive purpose, not a diagnostic one.
- Device Description: The description details a porous, resorbable osteoconductive scaffold made of beta tricalcium phosphate granules. This describes a material intended to interact with the body for healing, not to analyze samples from the body for diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition.
- Anatomical Site: The device is applied directly to the skeletal system, which is consistent with a therapeutic device, not an IVD that analyzes samples.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. GranOS™ does not fit this description.
N/A
Intended Use / Indications for Use
GranOS™ devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GranOS™ is indicated to be gently placed into bony voids or gaps of the skeletal system (ie the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Product codes
MQV
Device Description
GranOS™ is a porous, resorbable osteoconductive scaffold constructed of highly pure beta tricalcium phosphate granules for use in the repair of bony defects.
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, posterolateral spine, and pelvis)
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
Results of non-clinical performance tests has demonstrated that GranOS™ - beta tricalcium phosphate granules have the same critical specification (i.e. chemistry, crystallinity, physical form, porosity, dissolution/solubility) and the same intended use as the predicate device.
Key Metrics
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2015
TCM Associates Ltd Mr. Iain Alligan Technical Director 3 Hillgrove Business Park Nazeing Road Essex EN9 2HB United Kingdom
Re: K143692
Trade/Device Name: GranOS - beta tricalcium phosphate synthetic bone granules Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: July 13, 2015 Received: July 23, 2015
Dear Mr. Alligan:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K143692
Device Name
GranOSTM - beta tricalcium phosphate synthetic bone granules
Indications for Use (Describe)
GranOS™ devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GranOS™ is indicated to be gently placed into bony voids or gaps of the skeletal system (ie the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Section 5
Premarket Notification 510(k) Summary
beta tricalcium phosphate synthetic bone granules (Trade Name: GranOS™)
4
5.1 Premarket Notification 510(k) Summary
GranOS™ - beta tricalcium phosphate synthetic bone granules
(per 21 CFR 807.92)
| Submitter (Owner) | TCM Associates Ltd
3 Hillgrove Business Park
Nazeing Road
Nazeing
Essex
EN9 2HB
United Kingdom |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Iain Alligan, Technical Director
Phone: +44 (0) 1992 892 085
Fax: +44 (0) 1992 893 721 |
| Date prepared | 20th August 2015 |
| Trade Name | GranOS™ - beta tricalcium phosphate synthetic bone granules |
| Common Name | Synthetic bone void filler |
| Device Classification | Resorbable calcium salt bone void filler device |
| Regulation | Class II Special Controls as per 21 CFR 888.3045 |
| Device Product Code | MQV |
| Legally Marketed
Predicate Devices | βGran® Synthetic Osteoconductive Scaffold (K041616)
Cerasorb® ORTHO (K014156)
Vitoss® Scaffold Synthetic Cancellous Bone Void Filler K032409 |
| Device Description | GranOS™ is a porous, resorbable osteoconductive scaffold constructed of highly pure
beta tricalcium phosphate granules for use in the repair of bony defects. |
| Intended Use | GranOS™ devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the
bony structure. GranOS™ is indicated to be gently placed into bony voids or gaps of the skeletal
system (i.e. the extremities, posterolateral spine, and pelvis). These defects may be surgically created
osseous defects or osseous defects created from traumatic injury to the bone. The product provides
bone void filler that resorbs and is replaced with bone during the healing process |
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| 510k (Traditional) Premarket Submission | TCM Associates Ltd | ||
|---|---|---|---|
| Device: | GranOS™ - beta tricalcium phosphate synthetic bone granules | Issue: | 03 |
| Classification: | Resorbable calcium salt bone void filler device | Issue Date: | 20.08.2015 |
| Page Title: | Section 5: Premarket Notification 510(k) Summary |
| Technological Characteristics - Comparison to Predicates and Substantial Equivalence | |
|---|---|
| Trade Name | GranOS™ - beta
tricalcium phosphate
synthetic bone granules | βGran® synthetic
osteoconductive scaffold | Cerasorb® ORTHO | Vitoss® Scaffold
Synthetic Cancellous
Bone void Filler |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| 510(k)
Registration No: | K143692 | K041616 | K014156 | K032409 |
| Chemical
composition of the
material | beta tricalcium phosphate
Ca3(PO4)2 meeting the
requirements of
ASTM F 1088-04a (2010) | beta tricalcium phosphate
Ca3(PO4)2 meeting the
requirements of
ASTM F 1088-04a (2010) | beta tricalcium phosphate
Ca3(PO4)2 meeting the
requirements of ASTM F
1088-04a (2010) | beta tricalcium phosphate
Ca3(PO4)2 meeting the
requirements of
ASTM F 1088-04a (2010) |
| Patient Population | Individuals with bony
defects resulting from
surgery or trauma | Individuals with bony defects
resulting from surgery or
trauma | Patients with bone voids
or gaps caused by surgery
trauma or degeneration | Individuals with bony
defects resulting from
surgery or trauma |
| Anatomical
Locations | To be packed into the
irregular shaped bony voids
of the skeletal system i.e.
extremities, spine and pelvis | Bony voids or gaps of the
skeletal system i.e. the
extremities, spine and pelvis | Skeletal system
extremities, spine and
pelvis | Bony voids or gaps of the
skeletal system i.e. the
extremities, spine and
pelvis |
| Physical Structure
of the Material | Interconnected porosity | Interconnected porosity | Interconnected porosity | Trabecular structure
similar to cancellous
bone |
| Porosity | Approximately 70% | Approximately 70% | Approximately 60% - 70% | Approximately 90% |
| Pore Size (range) | Micropores 0