CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G

K042730 · Lifecorebiomedical · LYC · Feb 14, 2005 · Dental

Device Facts

• Record ID: K042730
• Device Name: CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G
• Applicant: Lifecorebiomedical
• Product Code: LYC · Dental
• Decision Date: Feb 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

CalForma is a surgical-grade calcium sulfate hemihydrate (SGCSH) bone graft barrier; includes hydroxypropyl methylcellulose (HPMC) excipient to improve handling; supplied as a pre-measured powder with a sterile water hydrating solution. Clinician mixes components to form a moldable barrier; applied over bone grafts in dental applications to prevent graft migration. Device acts as a physical barrier; biocompatible; provides stable containment of graft material. No software or electronic components.

Clinical Evidence

No clinical data. Evidence consists of in vitro and in vivo animal testing demonstrating biocompatibility and improved handling characteristics compared to the predicate device.

Technological Characteristics

Composition: Surgical grade calcium sulfate alpha-hemihydrate and hydroxypropyl methylcellulose (HPMC). Form: Pre-measured powder mixed with sterile water. Principle: Physical barrier for bone graft containment. Sterilization: Not specified. No software, electronics, or connectivity.

Indications for Use

Indicated for use as a stable barrier to prevent graft material migration when applied over bone grafts in bony defects.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• CAPSET® Calcium Sulfate Bone Graft Barrier (K943186)

Submission Summary (Full Text)

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K042730

## 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<br>• 0.5 g CalForma™<br>• 1.0 g CalForma™ |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Common / Usual<br>Name | Surgical Grade Calcium Sulfate Hemihydrate (SGCSH)<br>(Plaster of Paris)/ HPMC |
| Classification<br>Name | None (unclassified)<br>No formal classification of Calcium Sulfate or Plaster of<br>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.

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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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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 [phone]. 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 [phone] or [phone] 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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K042730

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