(88 days)
Not Found
No
The summary describes a bone void filler material and its physical and biological properties. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies focus on material characteristics and biological response, not algorithmic performance.
Yes
The device fills bony voids or gaps of the skeletal system and is replaced by bone during the healing process, indicating a direct role in medical treatment and recovery.
No
The device is a bone void filler, used to fill bony voids or gaps. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is an "injectable, moldable and biocompatible bone void filler," which is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Callos Bone Void Filler's Function: The provided text clearly states that Callos Bone Void Filler is a material intended to be implanted into the body to fill bony voids or gaps. It is a therapeutic device used in vivo (within the living organism) to aid in bone healing.
The description focuses on its physical properties, biocompatibility, and performance in filling bone defects within the skeletal system. This is entirely different from the function of an IVD.
N/A
Intended Use / Indications for Use
Callos Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, and 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)
87 MVQ
Device Description
Callos Bone Void Filler is an injectable, moldable and biocompatible bone void filler. Callos Bone Void Filler resorbs and is replaced with bone during the healing process. The 3 cc, 5 cc, and 10 cc Callos Bone Void Filler kits are provided sterile and are for single use only.
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, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing included material properties such as density, porosity, dimensional stability, injectability, setting time, working time, pH, and setting temperature. Biocompatibility testing demonstrated that the material is non-cytotoxic, non-systemic toxic, non-mutagenic, non-irritative, non-pyrogenic, and non-sensitizing. Comparative testing with the predicate device showed equivalence in terms of solubility and dissolution rate, X-Ray Diffraction (XRD), Fourier Transform Infrared (FTIR) spectroscopy and elemental analysis. Animal testing demonstrated substantial equivalence to the predicate device following in vivo implantation. Histological, chemical, crystallographical, and mechanical analyses showed substantial equivalence.
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
K0305541
MAY 2 0 2003
510(k) Summary
| Sponsor: | Skeletal Kinetics, LLC
10201 Bubb Road, Cupertino, CA 95014 |
|-----------------|----------------------------------------------------------------|
| Contact Person: | Duran Yetkinler, M.D., Ph.D. |
| Phone Number: | 408 366 5002 |
| Fax Number: | 408 366 1077 |
| Prepared: | February 18, 2003 |
Trade Name: Callos™M Bone Graft Substitute Common Name: Classification: Unclassified Product Code: 87 MVQ
Predicate Device: Callos Bone Void Filler is substantially equivalent to Norian SRS Bone Void Filler (K011897).
Device Description: Callos Bone Void Filler is an injectable, moldable and biocompatible bone void filler. Callos Bone Void Filler resorbs and is replaced with bone during the healing process. The 3 cc, 5 cc, and 10 cc Callos Bone Void Filler kits are provided sterile and are for single use only.
Intended Use/Indications for Use: Callos Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, and 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.
Technological Characteristics: Similar to the predicate device. Callos Bone Void Filler is an injectable, moldable, biocompatible, resorbable calcium phosphate based material intended for identical indications.
Performance Data: Non-clinical testing included material properties such as density, porosity, dimensional stability, injectability, setting time, working time, pH, and setting temperature. Biocompatibility testing demonstrated that the material is non-cytotoxic, non-systemic toxic, non-mutagenic, non-irritative, non-pyrogenic, and non-sensitizing. Comparative testing with the predicate device showed equivalence in terms of solubility and dissolution rate, X-Ray Diffraction (XRD), Fourier Transform Infrared (FTIR) spectroscopy and elemental analysis. Animal testing demonstrated substantial equivalence to the predicate device following in vivo implantation. Histological, chemical, crystallographical, and mechanical analyses showed substantial equivalence.
Basis for Substantial Equivalence: The Callos Bone Void Filler has the same intended use, identical indications, and very similar technological characteristics as the predicate device. Any minor technological differences between Callos Bone Void Filler and its predicate device do not raise any new issues of safety or effectiveness.
Skeletal Kinetics, LLC - Confidential
page 1 of 2 Appendix C
1
Functional, biocompatibility, and animal testing results show that the Callos Bone Void Filler is as safe and effective as the predicate device. Thus, the Callos Bone Void Filler is substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 2003
Skeletal Kinetics, LLC c/o Mr. Howard Holstein Regulatory Counsel Hogan & Hartson, LLC 555 13th Street, N.W. Washington, DC 20004
Re: K030554
Trade/Device Name: Callos™ Bone Void Filler Regulatory Class: Unclassified Product Code: MQV Dated: February 20, 2003 Received: February 21, 2003
Dear Mr. Holstein:
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. 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.
3
Page 2 - Mr. Howard Holstein
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), please contact the Office of Compliance at (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N. Milkman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Indications for Use
510(k) Number (if known):
Device Name:
Callos Bone Void Filler
403055
Page
of
Indications for use:
Callos Bone Void Filler 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use
(Division Sign-Off)
Division of General, Restorative and
Neurological Devices
510(k) Number K030554