(31 days)
Not Found
No
The summary describes a bone void filler material and its intended use, with no mention of AI or ML technology in the device description, intended use, or any other section.
No.
The intended use describes filling bony voids or gaps and providing a space for bone replacement, which is a structural or supportive function, not a therapeutic treatment of a disease or condition.
No
Explanation: The device, Callos, is described as a bone void filler used to fill bony voids or gaps. Its function is to provide material that resorbs and is replaced by bone during healing, indicating a therapeutic or reconstructive purpose rather than a diagnostic one. It does not identify or detect diseases or conditions.
No
The device description explicitly states that Callos is a calcium phosphate bone void filler, which is a physical material, 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 Callos is used to fill bony voids or gaps in the skeletal system. This is a therapeutic and structural application within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The description confirms it's a bone void filler that is injected or impacted into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Callos does not fit this description.
N/A
Intended Use / Indications for Use
Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler 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 by bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
Callos is a calcium phosphate bone void filler which can either be injected or digitally impacted into the targeted void. It is a single use only proudct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e. extremities, 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)
Not Found
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.
0
JUN 3 - 2005
510(k) Summary
Skeletal Kinetics, LLC Callos™ Bone Void Filler
General Information
| Submitters Name/Address: | Skeletal Kinetics 10201 Bubb Road Cupertino, CA 95014 |
|---|---|
| Establishment Registration Number: | 3003890476 |
| Contact Person: | Duran Yetkinler Vice President, Product Development and Regulatory Affairs |
| Phone Number: | (408) 366.5002 |
| Date Prepared: | April 28, 2005 |
Device Description
| Trade Name: | Callos™ Bone Void Filler |
|---|---|
| Generic/Common Name: | Bone Void Filler |
| Classification Name: | 87 MVQ |
Predicate Devices
| Callos Bone Void Filler | K030554; cleared on May 20, 2003 |
|---|---|
| ------------------------- | ---------------------------------- |
Product Description
Callos is a calcium phosphate bone void filler which can either be injected or digitally impacted into the targeted void. It is a single use only proudct.
Intended Use
Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler 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 by bone during the healing process.
1
Substantial Equivalence
This Special 510(k) proposes a modification in materials for Callos, which was previously cleared under K030554 on May 20, 2003. The indications for use, technology, principle of operation, packaging, and sterilization parameters of Callos remain the same as in the predicate cleared 510(k)s.
Summary of Safety and Effectiveness
Callos, as described in this submission, is substantially equivalent to the predicate, unmodified Callos. The proposed modification in materials, is not a substantial change or modification, and does not significantly affect the safety or efficacy of Callos.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 - 2005
Duran Yetkinler, M.D., Ph.D. Vice President, Product Development and Regulatory Affairs Skeletal Kinetics, LLC 10201 Bubb Road Cupertino, CA 95014
Re: K051123
Callos Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV Dated: April 28, 2005 Received: May 3, 2005
Dear Dr. Yetkinler:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Duran Yetkinler, M.D., Ph.D.
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), n you acontact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
KORII23 510(k) Number (if known):
Callos™ Bone Void Filler Device Name:
Indications for Use:
Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler 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 by bone during the healing process.
X AND/OR Over-the-Counter Use Prescription Use (21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K051123