(136 days)
Not Found
No
The summary describes a physical bone graft barrier material and its intended use, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes
The device is described as a "Bone Graft Barrier" used for "bony defects" and mentions "animal testing" for "performance characteristics and safety," indicating it's intended to treat or manage a medical condition.
No
The device is a bone graft barrier used to cover bony defects and prevent graft material migration. It does not perform any diagnostic function such as detecting, identifying, or characterizing a disease or condition.
No
The device description clearly indicates it is a physical material (calcium sulfate and hydrating solution) used as a bone graft barrier, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being formed over bony defects and used as a barrier over bone grafts. This is a direct application within the body for a structural or barrier function.
- Device Description: The description details the composition of the material (calcium sulfate and HPMC) and a hydrating solution. This is a material intended for physical application.
- 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 in vitro (outside the body) to analyze biological samples. This device is clearly intended for in vivo (within the body) use.
N/A
Intended Use / Indications for Use
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.
Product codes
LYC
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bony defects
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)
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.
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
§ 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.
0
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 / Usual
Name | Surgical Grade Calcium Sulfate Hemihydrate (SGCSH)
(Plaster of Paris)/ HPMC |
| Classification
Name | None (unclassified)
No formal classification of Calcium Sulfate or Plaster of
Paris 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.
1
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.
2
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.
3
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
4
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
.
Angota SUANI : water Stan-Off)
... Je on or Anesthesinlogy, General Hospital, Intection Control, Dental Devices
30(k) Number. K046730