(209 days)
Not Found
No
The summary describes a bone void filler material and its physical and biological properties, with no mention of AI or ML technology.
No.
A therapeutic device is typically understood to actively treat or cure a disease or medical condition. While Calcigen™-S Bone Void Filler assists in the healing process of bone voids, its primary function is as a filler and scaffold for new bone growth rather than an active therapeutic agent itself. It supports the body's natural healing rather than directly therapeutic action.
No
Explanation: The device is a bone void filler and is indicated to fill bony voids or gaps of the skeletal system. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a bone filler available in paste and granules, indicating 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 of Calcigen™-S Bone Void Filler is to fill bony voids or gaps in the skeletal system. This is a therapeutic and structural function performed in vivo (within the body).
- Device Description: The device is a bone filler that resorbs and is replaced by bone during healing. This describes a material used for surgical implantation and repair, not for analyzing samples in vitro.
- 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, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. Calcigen™-S Bone Void Filler is used inside the body for structural support and bone regeneration.
N/A
Intended Use / Indications for Use
Calcigen™-S Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from a traumatic injury to the bone. Calcigen™-S Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.
Product codes
MQV
Device Description
Calcigen™-S Bone Void Filler is a bone filler that resorbs and is replaced with bone during the healing process. The product is available in two forms, paste and granuales.
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)
Non-Clinical Testing: Non-clinical testing included material properties such as set time, exothermic temperature, purity, porosity and mass/volume ratio. Biocompatability testing showed the montoxic, non-mutagenic, non-hemolytic, non-cytotoxic, and non-pyrogenic. Comparative testing with the predicate device showed equivalence in terms of dissolution rate, and surface pH. Animal testing demonstrated equivalence with the predicate in an in vivo situation both histologically and mechanically.
Clinical Testing: none provided
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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UN 1 1 2002
CORPORA ARTERS
Summary of Safety and Effectiveness
| Applicant/Sponsor: | Biomet Orthopedics, Inc.
56 Bell Drive
P.O. Box 587
Warsaw, Indiana 46581-0587 |
| -------------------- | ----------------------------------------------------------------------------------------- |
|---|
Contact Person: Patricia Sandborn Beres Telephone: (219) 267-6639 Fax: (219) 372-1683
Calcigen™-S Bone Void Filler Proprietary Name:
Calcium Sulfate Dihydrate Common Name:
Filler, Calcium Sulfate (Unclassified) Classification Name:
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Calcigen™-S Bone Void Filler is substantially equivalent to Wright Plaster of Paris Pellets (OsteoSet® Pellets) (K960978, K963562, K963587) and Wright Plaster of Paris Bone Void Filler Kit (CaSor powder)(K963587) manufactured by Wright Medical Technology, Inc., Arlington, TN.
Device Description: Calcigen™-S Bone Void Filler is a bone filler that resorbs and is replaced with bone during the healing process. The product is available in two forms, paste and granuales.
Intended Use: Calcigen™-S Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from a traumatic iniury to the bone. Calcigen™ -S Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.
Summary of Technologies: Similar to the predicate device. Calcigen™-S Bone Void Filler is a resorbable. radiopaque, osteoconductive, isothermic calcium sulfate based material intended for identical indications.
Non-Clinical Testing: Non-clinical testing included material properties such as set time, exothermic temperature, purity, porosity and mass/volume ratio. Biocompatability testing showed the montoxic, non-mutagenic, non-hemolytic, non-cytotoxic, and non-pyrogenic. Comparative testing with the predicate device showed equivalence in terms of dissolution rate, and surface pH. Animal testing demonstrated equivalence with the predicate in an in vivo situation both histologically and mechanically.
Clinical Testing: none provided
All trademarks are owned by Biomet, Inc .except for the following: OsetoSet is a trademark of Wright Medical Technology, Inc.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
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SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
.
OFFICE 219.267.6639
Image /page/0/Picture/19 description: The image shows the word "FAX" in bold, centered above a phone number. The phone number is "219.267.8137" and is located directly below the word "FAX". The text is in a simple, sans-serif font and is likely part of a document or letterhead.
E-MAIL biomet@biomet.com
000352
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
JUN 1 1 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet, Inc. P.O Box 587 Warsaw, Indiana 46581-0587
Re: Re: K013790 Trade Name: Calcigen-S Bone Void Filler Regulatory Class: unclassified Product Code: MQV Dated: March 12, 2002 Received: March 14, 2002
Dear Ms. Beres:
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 Mav 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.
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Page 2 - Ms. Patricia Sandborn Beres
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 A. Millbern
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices
Enclosure
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510(k) Number (if known): K013790
Device Name: Calcigen™-S Bone Void Filler
Indications For Use:
Calcigen™-S Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from a traumatic injury to the bone. Calcigen™-S Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.
Mark A. Mikkelsen
(Division Sign-Off) Division of General, Restorative and Neurological Devices KO13790
510(k) Number -
(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
(Optional Format 1-2-96)
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