(40 days)
Not Found
No
The device description focuses on the material composition and physical form of a bone graft substitute, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
Yes
The device is described as a "bone graft substitute" indicated for bony voids or gaps of the skeletal system to be replaced with bone during the healing process, aligning with the definition of a therapeutic device.
No
Explanation: The device is a bone graft substitute used to fill bone voids and is resorbed and replaced by bone during healing. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a resorbable osteoconductive scaffold composed of physical materials (hydroxyapatite and tri-calcium phosphate) and is available in physical forms (granules, cubes, or cylinders). This indicates a physical medical device, not a software-only one.
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 Calcigen™ PSI is a bone graft substitute used to fill bony voids or gaps in the skeletal system. This is a therapeutic and structural application within the body.
- Device Description: The description details the composition and form of the material, which is implanted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples and provide diagnostic information. Calcigen™ PSI is a device implanted within the body for structural support and bone regeneration.
N/A
Intended Use / Indications for Use
Calcigen™ PSI bone graft substitute is indicated for bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. Calcigen™ PSI resorbs and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
Calcigen™ PSI bone graft substitute is a resorbable osteoconductive scaffold composed of 60% hydroxyapatite (HA) and 40% tri-calcium phosphate (TCP). The device is available as granules, cubes, or cylinders. Calcigen™ PSI is porous with multidirectional interconnected pores resembling that of cancellous bone. Calcigen™ PSI is supplied sterile for single patient, one time 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., the 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)
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.
K020986, K013072, K011531, K013960, K013966, K014156, K014053, K011048, K994337, K990131
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
K 030178
Page 4 of 15
510(k) Summary [as required by 21 CFR 807.92(c)] 2
FFB 2 6 2003
Submitter's Name / Contact Person
| Biomet, Inc. | Contact |
|---|---|
| 56 East Bell Drive | Mary Verstynen |
| Warsaw. IN 46581-0587 | Director of Clinical Affairs |
General Information
| Trade Name | Calcigen™ PSI bone graft substitute | ||
|---|---|---|---|
| Common Name | Bone graft substitute; bone void filler | ||
| Classification Name | Resorbable Calcium Salt Bone Void Filler | ||
| Equivalent Devices | Product | Manufacturer | 510(k) # |
| Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | K020986 | |
| chronOS Tricalcium Phosphate | Synthes | K013072 | |
| Calcium Phosphate Granular Bone | |||
| Void Filler | Biomet, Inc. | K011531 | |
| Apatight HA-Bone Graft Substitute | Cerabio. LLC | K013960 | |
| Apatight-TCP Bone Graft Substitute | Cerabio, LLC | K013966 | |
| Cerasorb Ortho | Curasan Ag | K014156 | |
| Conduit TCP Granules | Depuy Acromed | K014053 | |
| BSM Bone Substitute Material | Depuy Orthopaedics, Inc. | K011048 | |
| Vitoss Scaffold Synthetic Cancellous | |||
| Bone Void Filler | Orthovita Co. | K994337 | |
| Pro Osteon Implant 500R Resorbable | |||
| Bone Graft Substitute | Interpore Cross Intl. | K990131 |
Device Description
Calcigen™ PSI bone graft substitute is a resorbable osteoconductive scaffold composed of 60% hydroxyapatite (HA) and 40% tri-calcium phosphate (TCP). The device is available as granules, cubes, or cylinders. Calcigen™ PSI is porous with multidirectional interconnected pores resembling that of cancellous bone. Calcigen™ PSI is supplied sterile for single patient, one time use only.
Intended Use
Calcigen™ PSI bone graft substitute is indicated for bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the bony structure. These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. Calcigen™ PSI resorbs and is replaced with bone during the healing process.
Substantial Equivalence Comparison
Calcigen™ PSI is biocompatible because it is comprised of medical grade HA and TCP, which are known to be biocompatible with human bony tissue. Because of its substantial similarity in materials, structure, and porosity to several other FDA-cleared calcium phosphate bone graft substitutes, Calcigen™ PSI can be assumed to have appropriate physicochemical properties to create an adequate environment for bone ingrowth, permit device resorption, and result in adequate formation of bone. The submitted information demonstrated that Calcigen™ PSI bone graft substantially equivalent to the currently marketed predicate devices.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol consisting of three stylized human profiles facing to the right, with flowing lines suggesting hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2003
Ms. Mary L. Verstynen Director of Clinical Affairs Biomet, Inc. P.O. Box 587 Warsaw, IN 46581-0587
Re: K030178 Calcigen™ PSI Bone Graft Substitute Regulatory Class: Unclassified Product Code: MQV Dated: January 15, 2003 Received: January 17, 2003
Dear Ms. Verstynen:
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 vour 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
2
Page 2 – Ms. Mary L. Verstynen
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), 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,
Mark N Mulbers
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
3
Page 1 of 1
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K030178
Device Name: Calcigen™ PSI bone graft substitute
Indications for Use:
Calcigen™ PSI bone graft substitute is indicated for bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. Calcigen™ PSI resorbs and is replaced with bone during the healing process.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Milkman
. Restorative
10(k) Number K030178