(119 days)
Not Found
No
The summary describes a bone graft substitute material and its composition, intended use, and performance testing. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is a bone graft substitute used to fill voids or gaps in the skeletal system, which directly contributes to the healing process of bone injuries or defects.
No
The device description indicates Calcigen™ PSI is a bone graft substitute, meant to fill bony voids and resorb as new bone grows. Its function is to facilitate healing and structural support, not to diagnose medical conditions or analyze patient data.
No
The device description clearly states it is a bone graft substitute composed of physical materials (hydroxyapatite and tri-calcium phosphate) in various forms (granules, cubes, cylinders), indicating it is a physical medical device, 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.
- Calcigen™ PSI Function: Calcigen™ PSI is a bone graft substitute. Its intended use is to fill bony voids or gaps in the skeletal system and provide a scaffold for bone regeneration. It is implanted directly into the body.
- Lack of Diagnostic Testing: The description clearly states its purpose is to aid in bone healing, not to perform any diagnostic tests on patient samples.
The information provided describes a surgically implanted device used for structural support and bone regeneration, which falls under a different category of medical devices than IVDs.
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 bone graft substitute can be combined with autogeneous bone marrow aspirate or autogenous blood. Calcigen™ PSI resorbs and is replaced with bone during the healing process.
Product codes
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.
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: Non-clinical laboratory testing and literature review determined the device will function as indicated. Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K030178, K022629, K014156, K024336
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
NOV 2 0 2003
Image /page/0/Picture/2 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are outlined in black, with the interior of the letters being white. The letters are all capitalized and evenly spaced. The overall impression is one of a strong, established brand.
510(k) Summary
| Applicant/Sponsor: | Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw, Indiana 46581-0587 |
|--------------------|------------------------------------------------------------------------|
| Contact Person: | Tracy J. Bickel
Telephone: (574) 267-6639
Fax: (574) 372-1683 |
Calcigen™ PSI Bone Graft Substitute Proprietary Name:
- Bone graft substitute; bone void filler Common Name:
Classification Name: Resorbable Calcium Salt Bone Void Filler (MQV)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Calcigen™ PSI Bone Graft Substitute-K030178 (Biomet. Inc.); WMT-TCP Bone Graft Substitute- K022629 (Wright Medical Technology, Inc.); Cerasorb Ortho- K014156 (Curasan AG); MIIG™ II-K024336 (K022629 (Wright Medical Technology, Inc.).
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.
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 bony structure. These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. Calcigen™ PSI bone graft substitute can be combined with autogeneous bone marrow aspirate or autogenous blood. Calcigen™ PSI resorbs and is replaced with bone during the healing process.
Summary of Technologies: The technological characteristics (materials, design sizes, and indications) are similar to or identical to that of the predicate devices.
Non-Clinical Testing: Non-clinical laboratory testing and literature review determined the device will function as indicated.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc.
MAHANG ADDRESS P.O. Box 587 Warsaw, IN 46581 0587
트
Supping Address 56 E. Bell Drive Warsaw, IN 46582
피
Opener 57.1.267.6634)
1:-Млн. biomet@biomet.com
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 image of three human profiles facing right, with flowing lines above them that resemble wings or feathers.
Public Health Service
NOV 2 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tracy J. Bickel Regulatory Associate Biomet Orthopedics, Inc. P.O Box 587 Warsaw, Indiana 46581-0587
Re: K032286
Trade Name: Calcigen PSI Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: October 21, 2003 Received: October 17, 2003
Dear Ms. Bickel:
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. Tracy J. Bickel
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,
Miriam C. Provost
for 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 _ of _
03228 510(k) Number (if known): 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 bone graft substitute can be combined with autogeneous bone marrow aspirate or autogenous blood. Calcigen™ PSI resorbs and is replaced with 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 (Optional Format 1-2-96)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K032286