(119 days)
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.
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.
The provided text describes the 510(k) summary for the Calcigen™ PSI Bone Graft Substitute. Based on the information provided, here's a breakdown of the requested details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate devices/literature review) | Reported Device Performance (Calcigen™ PSI) |
|---|---|
| Material composition (60% Hydroxyapatite, 40% Tri-calcium phosphate) | Composed of 60% hydroxyapatite (HA) and 40% tri-calcium phosphate (TCP). |
| Physical form (granules, cubes, cylinders) | Available as granules, cubes, or cylinders. |
| Porosity (multidirectional interconnected pores resembling cancellous bone) | Porous with multidirectional interconnected pores resembling that of cancellous bone. |
| Osteoconductive properties | Resorbable osteoconductive scaffold. |
| Resorption and replacement with bone during healing | Resorbs and is replaced with bone during the healing process. |
| Similar indications for use (bony voids/gaps in skeletal system, combination with autogenous bone marrow aspirate or blood) | 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. Can be combined with autogeneous bone marrow aspirate or autogenous blood. |
| Safe and effective as legally marketed predicate devices | "The technological characteristics (materials, design sizes, and indications) are similar to or identical to that of the predicate devices." "Non-clinical laboratory testing and literature review determined the device will function as indicated." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This indicates that no clinical studies (and therefore no test set) were conducted with the Calcigen™ PSI device itself for this 510(k) submission. Substantial equivalence was claimed based on comparison to legally marketed predicate devices and non-clinical testing/literature review.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since no clinical testing was performed for the Calcigen™ PSI device in this submission, there was no test set requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable, as no clinical testing and test set were used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or referenced for this 510(k) submission. The document states "Clinical Testing: None provided as a basis for substantial equivalence."
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. This device is a bone graft substitute, not an algorithm, and its performance is not assessed in a standalone algorithmic manner.
7. Type of Ground Truth Used
For the Calcigen™ PSI device itself, no specific "ground truth" was established via clinical studies for this 510(k). Instead, the substantial equivalence relied on:
- Comparison of technological characteristics (materials, design, indications) to legally marketed predicate devices.
- Non-clinical laboratory testing and literature review, which would implicitly draw on established scientific understanding and historical data regarding bone graft substitutes.
8. Sample Size for the Training Set
Not applicable. This document pertains to a medical device (bone graft substitute), not an AI/algorithm-based device that would require a 'training set'.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device.
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NOV 2 0 2003
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510(k) Summary
| Applicant/Sponsor: | Biomet Orthopedics, Inc.P.O. Box 587Warsaw, Indiana 46581-0587 |
|---|---|
| Contact Person: | Tracy J. BickelTelephone: (574) 267-6639Fax: (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
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
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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
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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
§ 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.