(173 days)
Not Found
No
The document describes a bone void filler material and its components. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies focus on material properties and biological response.
Yes
The device is a bone void filler intended to facilitate bone healing by resorbing and being replaced with bone, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Callos® ProModel Bone Void Filler is clearly described as a material used to fill bony voids and aid in healing, not to diagnose medical conditions. Its intended use is therapeutic, providing a bone void filler that resorbs and is replaced with bone during the healing process.
No
The device description explicitly states that Callos ProModel Bone Void Filler is a physical, moldable composite material and includes hardware components like a mixing system and cannula. It is a physical medical device, 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 the device is used to fill bony voids or gaps within the skeletal system. This is a direct intervention on the patient's body.
- Device Description: The description details a material (calcium phosphate/calcium sulphate composite) and components for mixing and applying it to the bone. This is consistent with a surgical or implantable material.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. Callos ProModel is a material implanted into the body for structural support and bone regeneration.
N/A
Intended Use / Indications for Use
Callos® ProModel Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos ProModel is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
Callos ProModel Bone Void Filler is a moldable and biocompatible calcium phosphate/calcium sulphate composite bone void filler. The single-use Callos ProModel kit contains the necessary components for mixing of the bone void filler. The Callos ProModel sterile kit contains: Calcium Phosphate/Calcium Sulfate Powder, Dilute Sodium Silicate Liquid, a Mixing System (Mixer and Syringe) and a Cannula.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e. extremities, posterolateral spine, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of biocompatibility testing demonstrated that Callos ProModel met the standards set forth in ISO 10993-1. Biological Evaluation of Medical Devices, and the radiation sterilization validation is in compliance to ANSI/A AMI/ISO 11137-2:2006.
Bench testing demonstrated that Callos ProModel is substantially equivalent to the marketed predicate devices. The results indicated that the device met performance criteria outlined for its intended use.
The animal study provided data that Callos ProModel elicited similar biologic response in a large animal critical size defect model as compared to predicate devices for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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KI12383 PAGE 2 OF 2
FEB - 7 2012
Image /page/0/Picture/2 description: The image shows the logo for Skeletal Kinetics. The logo consists of a circular graphic to the left of the text "Skeletal Kinetics". The graphic is a circle with a complex network of lines inside, resembling a geodesic dome or a stylized representation of a cell structure. The text "Skeletal Kinetics" is in a bold, sans-serif font.
A COLSON ASSOCIATE
510(k) Summary
General Information as required by 21 CFR 807.92 (a) (1)
| Submitters Name/address: | Skeletal Kinetics® LLC
10201 Bubb Road
Cupertino, CA 95014, USA |
|--------------------------|----------------------------------------------------------------------------------------------------------------------|
| Date: | February 2, 2012 |
| Contact Person: | Christine Kuo,
Director, Regulatory Affairs and Quality Assurance
Phone: (408) 350-5842
Fax: (408) 366-1077 |
Device Name as required by 21 CFR 807.92 (a) (2)
| Trade Name: | Callos ProModel Bone Void Filler |
|---|---|
| Regulation Number: | 21 CFR 888.3045 |
| Regulation Name: | Resorbable calcium salt bone void filler device |
| Regulatory Class: | II |
| Product Code: | MQV |
Predicate Devices as required by 21 CFR 807.92 (a) (3)
The subject device is substantially equivalent to the following legally marketed devices (predicates):MIIG® SR Bone Void Filler (K060011), PRO-DENSE™ Bone Graft Substitute (K070437) and Callos® Bone Void Filler (K051123).
Device Description as required by 21 CFR 807.92 (a) (4)
Callos ProModel Bone Void Filler is a moldable and biocompatible calcium phosphate/calcium sulphate composite bone void filler. The single-use Callos ProModel kit contains the necessary components for mixing of the bone void filler. The Callos ProModel sterile kit contains: Calcium Phosphate/Calcium Sulfate Powder, Dilute Sodium Silicate Liquid, a Mixing System (Mixer and Syringe) and a Cannula.
1
Intended Use as required by 21 CFR 807.92 (a) (5)
Callos ProModel is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos ProModel is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced with bone during the healing process
Summary of Technological Characteristics as required by 21 CFR 807.92 (a) (6)
Callos ProModel consists of calcium phosphate/calcium sulfate powder and sodium silicate solution; when mixed together it forms a paste that can be applied directly to the injured bone.
The intended use, operating principles, design features, and materials of Callos ProModel is substantially equivalent to predicate devices.
Summary of Non-clinical Tests as required by 21 CFR 807.92 (b) (1)
The results of biocompatibility testing demonstrated that Callos ProModel met the standards set forth in ISO 10993-1. Biological Evaluation of Medical Devices, and the radiation sterilization validation is in compliance to ANSI/A AMI/ISO 11137-2:2006.
Bench testing demonstrated that Callos ProModel is substantially equivalent to the marketed predicate devices. The results indicated that the device met performance criteria outlined for its intended use.
The animal study provided data that Callos ProModel elicited similar biologic response in a large animal critical size defect model as compared to predicate devices for its intended use.
Summary of Clinical Tests as required by 21 CFR 807.92 (b) (2)
Callos ProModel does not meet the criteria to require clinical testing.
Conclusion as required by 21 CFR 807.92 (3)
In vitro and in vivo performance demonstrate that Callos ProModel is substantially equivalent to legally marketed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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, facing right. The eagle is composed of three thick, curved lines. 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
Skeletal Kinectics® LLC % Ms. Christine Kuo Director, Regulatory Affairs and Quality Assurance 10201 Bubb Road Cupertino, California 95014
Re: K112383
Trade/Device Name: Callos® ProModel Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV · Dated: January 17, 2012 Received: January 18, 2012
Dear Ms. Kuo:
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 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.
- 7 2012 FEB
3
Page 2 - Ms. Christine Kuo
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you active spective ad 100 boutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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 nove the regulation unities, 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. Molkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4: Indications for Use
510(K) Number (if Known):
Device Name:
Callos® ProModel Bone Void Filler
Indications for Use:
Callos® ProModel Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos ProModel is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21CFR 801 Subpart C
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
x
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Division Slon-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112383