(136 days)
When mixed to the proper consistency using the pre-measured mixing solution supplied in each package, CalForma Calcium Sulfate Bone Graft Barrier can be formed over bony defects. When used over a bone graft, CalForma provides a stable barrier to graft material migration.
CalForma™ Calcium Sulfate Bone Graft Barrier is a pre-measured formulation containing a proprietary formulation of accelerated SGCSH and HPMC (surgical grade calcium sulfate [alpha] hemihydrate / hydroxypropyl methylcellulose [or hypromellose]) and a hydrating solution (sterile water).
The provided text describes the CalForma™ Calcium Sulfate Bone Graft Barrier and its substantial equivalence to a predicate device (CAPSET® Calcium Sulfate Bone Graft Barrier, K943186). However, it does not contain a detailed study with acceptance criteria and specific performance metrics in the format requested. The document focuses on establishing substantial equivalence based on overall safety and effectiveness without presenting quantitative acceptance criteria or a comprehensive study report to prove individual criteria are met.
Here's an attempt to extract and infer information, acknowledging that specific quantitative details are absent for many requested points:
Acceptance Criteria and Study Details for CalForma™ Calcium Sulfate Bone Graft Barrier
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance |
|---|---|
| Safety: | |
| - Biocompatibility | Met (In vitro and in vivo testing confirmed the modified device is biocompatible.) |
| - Overall Safety | Met (Modification does not affect the safety of the device.) |
| Effectiveness: | |
| - Function as a stable barrier over bony defects | Met (When mixed to proper consistency, can be formed over bony defects and provides a stable barrier to graft migration.) |
| - Performance characteristics (beyond handling) | Met (Performance characteristics were not affected by the modification.) |
| Handling Characteristics: | |
| - Improved handling (compared to predicate) | Met (Handling characteristics of CalForma™ were improved over the predicate.) |
Note: The document explicitly states "modification does not affect the safety or effectiveness of the device" and "handling characteristics of CalForma™ were improved over the predicate." These are general statements of attainment rather than quantifiable acceptance criteria with specific thresholds.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document mentions "Animal testing" and "in vitro and in vivo testing." There is no indication of human clinical trials for this 510(k) submission.
- Data Provenance: Not specified, but likely from internal company studies given the nature of a 510(k) submission for a modified device. The document does not mention country of origin or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable/Not specified. The assessment appears to be based on animal and in vitro/in vivo testing results rather than expert consensus on a test set.
4. Adjudication Method for the Test Set
- Not applicable/Not specified. There's no mention of a human expert-based test set that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This is not a diagnostic imaging device where MRMC studies are typically performed. The study focuses on the physical and biological properties of a bone graft barrier.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This is not an AI/algorithm-based device. The "performance" refers to the material's physical and biological behavior rather than an algorithm's output.
7. Type of Ground Truth Used
- For Safety and Effectiveness: The ground truth was established through animal testing (in vivo) and laboratory testing (in vitro) to assess biocompatibility and performance characteristics, comparing against the known characteristics of the predicate device.
- For Handling Characteristics: Ground truth was likely established through observational assessment during animal testing or potentially benchtop testing by researchers/technicians, comparing the handling of CalForma™ to CAPSET®.
8. Sample Size for the Training Set
- Not applicable/Not specified. This is a medical device, not an AI model, so there isn't a "training set" in the machine learning sense. The development of the device likely involved iterative testing and refinement, but this isn't framed as a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
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Section 10: Premarket Notification 510(k) Summary
FEB 1 4 2005
.. . . .
Submitter's Name / Contact Person 1.
Kim E. Aves Regulatory Affairs Manager Lifecore Biomedical, Inc. Ph: 952-368-6324
2. General Information
| Trade Name | CalForma™ Calcium Sulfate Bone Graft Barrier• 0.5 g CalForma™• 1.0 g CalForma™ |
|---|---|
| Common / UsualName | Surgical Grade Calcium Sulfate Hemihydrate (SGCSH)(Plaster of Paris)/ HPMC |
| ClassificationName | None (unclassified)No formal classification of Calcium Sulfate or Plaster ofParis has been determined. Reference FDA Publication 91-4246. |
| Equivalent Device | K943186 - CAPSET® Calcium Sulfate Bone Graft Barrier |
3. Device Description
CalForma™ Calcium Sulfate Bone Graft Barrier is a pre-measured formulation containing a proprietary formulation of accelerated SGCSH and HPMC (surgical grade calcium sulfate [alpha] hemihydrate / hydroxypropyl methylcellulose [or hypromellose]) and a hydrating solution (sterile water).
Indications For Use 4.
When mixed to the proper consistency using the pre-measured mixing solution supplied in each package, CalForma Calcium Sulfate Bone Graft Barrier can be formed over bony defects. When used over a bone graft, CalForma provides a stable barrier to graft material migration.
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Technological Characteristic Comparisons 5.
CalForma™ Calcium Sulfate Bone Graft Barrier is a modification of Lifecore Biomedical's CAPSET® Calcium Sulfate Bone Graft Barrier (K943186). The modification is the addition of a small amount of an excipient, HPMC, to the accelerated calcium sulfate in order to improve handling characteristics of the device when used as a barrier over bony defects in dental applications.
In vitro and in vivo testing demonstrated that this modification does not affect the safety or effectiveness of the device.
Performance Data 6.
Animal testing established that the handling characteristics of CalForma™ were improved over the predicate, and that performance characteristics and safety were not affected by the modification.
7. Biocompatibility
In vitro and in vivo testing confirmed that the modified device is biocompatible.
8. Conclusion (statement of equivalence)
The data submitted in this 510(k) supports substantial equivalence of the modified device, CalForma™ Calcium Sulfate Bone Graft Barrier, to Lifecore Biomedical's CAPSET® Calcium Sulfate Bone Graft Barrier (K943186).
Substantial equivalence is based on the indications for use, primary ingredient, sterilization methods, instructions for use, and performance in vivo.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and has a simple, clean design. The caduceus symbol is a common symbol associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2005
Mr. Jeremy Huotari Project Manager LifeCore Biomedical, Incorporated 3515 Lyman Boulevard Chaska, Minnesota 55318-3051
Re: K042730
Trade/Device Name: CalForma™ Calcium Sulfate Bone Graft Barrier Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LYC Dated: December 2, 2004 Received: December 16, 2004
Dear Mr. Huotari:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo have reveal above and have determined the device is substantially equivalent (for the referenced above and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of / Innendinently, of to are and Cosmetic Act (Act) that do not require approval of a premarket the rederal I vou, Drag, and Countmay, therefore, market the device, subject to the general approvin application (1 the Act. The general controls provisions of the Act include controls provided by 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 If your device is classified (souch additional controls. Existing major regulations affecting (1 Mrx), it may of subject to back and of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the announcements concerning your device in the Federal Register.
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Page 2 – Mr. Huotari
Please be advised that FDA's issuance of a substantial equivalence determination does not r lease be act roca that 22 a determination that your device complies with other requirements modi that 127 may made statutes and regulations administered by other Federal agencies. or the recor any I outh all the Act's requirements, including, but not limited to: registration r ou inust compry with as 07); labeling (21 CFR Part 801); good manufacturing practice aller listing (21 OF RT art 007), as times (QS) regulation (21 CFR Part 820); and if requirements as sectoritis in the quadistion 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) I mis letter will anow you to began finding of substantial equivalence of your device to a premilared 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), If you desire specific advice for Joinnee at (240) 276-0115. 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 may overn 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/industry/support/index.html.
Sincerely vours,
Susan Runnes
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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LIFECORE BIOMEDICAL, INC. CalForma™ Calcium Sulfate Bone Graft Barrier
Confidential
Indications for Use Statement Attachment C:
INDICATIONS FOR USE STATEMENT
Page 1 of 1 Page 1 of 1
510(k) Number (if known): __ KO 42736
Device Name: CalForma™ Calcium Sulfate Bone Graft Barrier
Indications For Use:
When mixed to the proper consistency using the pre-measured mixing solution when mixed to the proper CollForma Calcium Sulfate Bone Graft Barrier can be formed over bony defects. When used over a bone graft, CalForma provides a stable barrier to graft material migration.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The-Counter Use
.
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... Je on or Anesthesinlogy, General Hospital, Intection Control, Dental Devices
30(k) Number. K046730
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.