(162 days)
Not Found
No
The summary describes a synthetic bone void filler and does not mention any AI or ML components.
Yes.
The device is described as a "Bone Void Filler" used to fill bony voids, which implies it directly treats a physical condition (bone defects) to restore function and promote healing.
No
The device is described as a bone void filler and graft substitute, intended for filling bony voids, not for diagnosing medical conditions.
No
The device description clearly states it is a synthetic, self-setting paste provided in pre-measured quantities of powder and setting solution, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fill bony voids 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 device is a synthetic, self-setting paste applied directly to bone defects. This is a physical intervention, not a diagnostic assay.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
Calcigen™-NaP Bone Void Filler is intended for filling bony voids of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. The device is intended for bone voids or gaps that are not intrinsic to the structural integrity of the bony structure.
Product codes
MQV
Device Description
Calcigen™-NaP Bone Void Filler is a synthetic, self-setting paste for use as a bone graft substitute. The product is provided in pre-measured quantities of powder and setting solution. The two components are mixed together intra-operatively to form a thick, moldable paste that is then applied to the bone void or defect. The paste can be shaped to completely fill the bone defect and hardens in-situ to prevent migration out the defect area. It is designed to be applied/delivered to the defect either using a spatula or equivalent instrument or injected thru a syringe into open defects. The material is resorbed and replaced by bone during the healing process.
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
Non-Clinical Testing: The information presented demonstrates that the Calcigen™-NaP Bone Void Filler is substantially equivalent to currently marketed predicate devices. The differences between Calcigen™-NaP Bone Void Filler and the predicates are not significant and have already been shown not to present additional safety or efficacy issues.
Clinical Testing: None is provided as the basis of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K011386, K011048, K990131, K980817, K011897, K003493
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
APR 2 7 2004
Image /page/0/Picture/2 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and outlined in black. The word appears to be a logo or brand name.
510(k) Summary
| Applicant/Sponsor: | Biomet Manufacturing Corp. |
|---|---|
| Contact Person: | Mary L. Verstynen |
| Director of Clinical Affairs | |
| Proprietary Name: | Calcigen™-NaP Bone Void Filler |
| Common Name: | Calcium Sodium Phosphate Bone Void Filler |
| Classification Name: | |
| (21 CFR 888.3045) | Resorbable calcium salt bone void filler device |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
- · EBI OsteoStim™ Granules Resorbable Bone Graft Substitute (EBI L.P .; K011386)
- · α-BSM® Bone Substitute Material (DePuy Orthopaedics, Inc; K011048)
- · Pro Osteon® 500R Resorbable Bone Graft Substitute (Interpore Cross; K990131. K980817)
- · Norian® SRS® Bone Void Filler (Synthes USA; K011897)
- · 3i® Calcium Sodium Phosphate Bone Cement (Biomet, Inc; K003493)
Device Description:
Calcigen™-NaP Bone Void Filler is a synthetic, self-setting paste for use as a bone graft substitute. The product is provided in pre-measured quantities of powder and setting solution. The two components are mixed together intra-operatively to form a thick, moldable paste that is then applied to the bone void or defect. The paste can be shaped to completely fill the bone defect and hardens in-situ to prevent migration out the defect area. It is designed to be applied/delivered to the defect either using a spatula or equivalent instrument or injected thru a syringe into open defects. The material is resorbed and replaced by bone during the healing process.
Intended Use:
Calcigen™-NaP Bone Void Filler is intended for filling bony voids of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. The device is intended for bone voids or gaps that are not intrinsic to the structural integrity of the bony structure.
MAILING ADDRESS Box 587 Box 587 - 3 - 3 - 3 - 3 - - - - - - - - - - - - - - - - - - - - - - - Warsaw, IN 46582
.
SHIPPING ADDRESS
で
()FFICE 574.267.6639
FAX 574.267.8137
E-MAIL biomet@biomet@biomet.com
1
Summary of Technologies:
Calcigen™-NaP Bone Void Filler is shown by analysis of available information to be identical in intended use and equivalent in materials and form to currently marketed similar products. The product is identical in chemistry and formulation to 3i® Calcium Sodium Phosphate Bone Cement.
Non-Clinical Testing:
The information presented demonstrates that the Calcigen™-NaP Bone Void Filler is substantially equivalent to currently marketed predicate devices. The differences between Calcigen™-NaP Bone Void Filler and the predicates are not significant and have already been shown not to present additional safety or efficacy issues.
Clinical Testing:
None is provided as the basis of substantial equivalence.
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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 2004
Ms. Mary L. Verstynen Director of Clinical and Regulatory Affairs Biomet Manufacturing Corporation 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K033611
Trade/Device Name: Calcigen™-NaP Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcıum salt bone void filler Regulatory Class: II Product Code: MQV Dated: January 28, 2004 Received: January 30, 2004
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 Mcdical 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 (sec 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 he 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 - Ms. Mary L. Verstynen
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.
Miriam C. Provost
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
Enclosurc
4
Indications for Use
510(k) Number (if known): K033611
Device Name: Calcigen™-NaP Bone Void Filler
Incications For Use:
Calcigen™-NaP Bone Void Filler is intended for filling bony voids of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. The device is intended for bone volds or gaps that are not intrinsic to the structural integrity of the bony structure.
Prescription Use ﻟﺮ (Part 2 1 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
uriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K033611