Calcium Hydroxylapatite Implant is a sterile, non-pyrogenic, flexible, semi-solid, cohesive paste containing calcium hydroxylapatite particles. Calcium Hydroxylapatite Implant is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects. Calcium Hydroxylapatite Implant contains calcium hydroxylapatite particles in a pasty gel of glycerin, water and sodium carboxymethylcellulose that acts as a binder for the particles. The calcium hydroxylapatite meets ASTM F1185. The gel ingredients are pharmacoutical grade excipients and are listed as GRAS materials.

AI/ML Overview

Here's an analysis of the provided text regarding the Calcium Hydroxylapatite Implant, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) Premarket Notification Summary from 2003. This type of submission primarily focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing de novo acceptance criteria through rigorous performance studies against predefined metrics. Therefore, the information provided below will reflect this regulatory context. Direct "acceptance criteria" as you might find in a performance study with specific quantitative targets and "reported device performance" against those targets are not explicitly presented in this type of submission. Instead, the "performance" is demonstrated through equivalence to predicates.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, there are no explicit quantitative acceptance criteria defined for the Calcium Hydroxylapatite Implant. Instead, the "acceptance criteria" are implicitly met by demonstrating that the device is substantially equivalent to legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.

Category	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (as demonstrated by argument of equivalence)
Intended Use	Same intended use as predicate devices.	"Calcium Hydroxylapatite Implant is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including: Periodontal Defects, Ridge Augmentation, Extraction Sites, Craniofacial Augmentation, Cystic Defects." This is stated to be the "same intended use" as the cited predicate devices.
Technological Characteristics	Similar composition, mechanism of action, and material properties to predicate devices (e.g., osteoconductivity, biocompatibility, form).	"Calcium Hydroxylapatite Implant is a sterile, non-pyrogenic, flexible, semi-solid, cohesive paste containing calcium hydroxylapatite particles... The CaHA Implant functions as an osteoconductive scaffold for bone infiltration, the same mechanism of action as the predicate devices." "The principal component of the Calcium Hydroxylapatite Implant, calcium hydroxylapatite is identical to the calcium hydroxylapatite used in most of the predicates and is very similar to the calcium phosphate glasses used in the rest of the predicate devices. All of these meet the same biocompatibility requirements." The device's "premixed and ready to use characteristic" is presented as an advantage/convenience feature compared to predicates that require mixing. The binder formulation is described as a technological characteristic providing controlled porosity for bone ingrowth and reducing migration, while still being a composite of resorbable/non-resorbable components like predicates. The gel ingredients are pharmaceutical grade excipients and GRAS materials.
Safety and Effectiveness	As safe and effective as the predicate devices. BioForm also asserts advantages in convenience and reduced contamination risk.	"The Calcium Hydroxylapatite Implant is substantially equivalent in intended use, technical characteristics and are as safe as the predicate devices cited." "In terms of risk versus benefit, BioForm believes that the CaHA Implant has obvious advantages compared to the predicate devices. The CAHA implant is provided as a sterile and ready to use paste that is more convenient for the physician, minimizes the potential for contamination during the mixing processes required by other devices, eliminates the risk and pain associated with drawing blood and is more convenient to place." "The components used in the Calcium Hydroxylapatite Implant and the predicate devices are biocompatible, based on the history use in many medical devices as well as from preclinical testing and clinical experience."

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a clinical performance study with a "test set" in the traditional sense (i.e., a group of patients receiving the device for evaluation against specific clinical endpoints). The submission is based on substantial equivalence to predicate devices, which are already legally marketed.

Sample Size: Not applicable for a traditional test set in this 510(k) submission.
Data Provenance: The 'data' supporting equivalence comes from:
- Descriptions and regulatory filings of the cited predicate devices (e.g., K882682, K852742, K852765, etc.).
- General understanding of the biocompatibility and mechanism of action of calcium hydroxylapatite and similar bone graft materials, often based on "history of use in many medical devices as well as from preclinical testing and clinical experience" of the material itself.
- Assertions about the device's characteristics and how they compare to predicates.
- The document does not refer to prospective or retrospective clinical data collected specifically for this device's performance demonstration.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. There was no "test set" in a clinical study sense where expert adjudication of ground truth was required for the Calcium Hydroxylapatite Implant.

4. Adjudication Method for the Test Set

Not applicable. No "test set" and no adjudication of ground truth for performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not performed or described in this document. This submission is for a material implant, not an imaging AI diagnostic device. The concept of "human readers" and "AI assistance" improving performance is not relevant to this type of medical device submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a bone graft material, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in the context of this 510(k) is the established safety and effectiveness profile of the predicate devices and the general scientific understanding of calcium hydroxylapatite as a bone graft material. The submission argues that the Calcium Hydroxylapatite Implant shares fundamental characteristics with these predicates, making it equally safe and effective.

Ground Truth Sources (Implied):
- Regulatory history and approvals of predicate devices.
- Preclinical and clinical experience with similar materials (calcium hydroxylapatite, calcium phosphate glasses) cited indirectly.
- ASTM standard F1185 for the calcium hydroxylapatite.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set for an AI/ML device.

Summary

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JUN 2 7 2003

Calcium Hydroxylapatite Implant 510(k) Premarket Notification Submission

KOZOLOSA

June 25, 2003

SECTION 4

510(k) Summary of Safety and Effectiveness

Manufacturer and Submitter Information: 4.1

BioForm Inc. 4133 Courtney Road, #10 Franksville, WI 53126 Telephone: (262) 835-9800 Contact: William G. Hubbard Summary Preparation Date: June 25, 2003

4.2	Device Trade Name:	Calcium Hydroxylapatite Implant
	Common Name:	Synthetic Bone Graft Material
	Classification Name:	Bone Filling and Augmentation Material
	Device Class:	Unclassified
	Product Code:	LYC
	Medical Specialty:	Dental (DE)
	Performance Standards:	No applicable mandatory performance standards orspecial controls exist for this device.

Substantial Equivalent Predicate Device: 4.3

The following are the predicate devices that are substantially equivalent to the Calcium Hydroxylapatite Implant:

K882682	CalcititeCalcitek, Inc., 4125-B Sorrento Valley Boulevard, SanDiego, CA 92121
K852742	Osteograf AR Alveolar Ridge Hydroxylapatite 18-40Coors Biomedical Company, 12860 West Cedar Drive,Lakewood, CO 80228
K852765	HA-2000Orthomatrix, Inc., 6968 Sierra Court, Dublin CA 94568
K992416	Perioglas-BioGlass Bone Graft ParticulateU.S. Biomaterials Corp., One Progress Boulevard, Alachua,FL 32615
K000149	Novabone-Bioglass Bone Graft ParticulateU.S. Biomaterials Corp., One Progress Boulevard, Alachua,FL 32615
K952922	Biogran Bioactive Glass Synthetic Bone Graft Material

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June 25, 2003

	Orthovita Co., 212 Carnegie Center Drive, Suite 206,
	Princeton, NJ 08540
K921468	PermaMesh Hydroxylapatite Matrix
	CeraMed Corp., 12860 West Cedar Drive, Lakewood,
	CO 80228
K862061	Osteograf/AR+ Permaridge Hydroxylapatite, 18-40
	Coors Biomedical Co., 12860 West Cedar Drive, Suite 210,
	Lakewood, CO 80228
K910432	HAPSET Hydroxylapatite Bone Graft Plaster
	Lifecore Biomedical, Inc., 1050 Connecticut Avenue, N.W.
	Washington Square, Suite 1100, Washington, D.C. 20036

Calcium Hydroxylapatite Craniofacial Implants are identical to Coaptite® Laryngeal Augmentation System (K013243) and Coaptite® Tissue Marker (K012955) manufactured by BioForm Inc. The Calcium Hydroxylapatite Implant is substantially equivalent to the predicate devices sited above.

Device Description: 4.4

4.5 Intended Use:

Calcium Hydroxylapatite Implant is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including:

Periodontal Defects 0
Ridge Augmentation
Extraction Sites ●
Craniofacial Augmentation .
Cystic Defects .

4.6 Technological Characteristics:

Calcium Hydroxylapatite Implant (CaHA Implant) is a paste of calcium hydroxylapatite (calcium phosphate) particles and a binder. The binder is resorbable and acts to hold the particles together. The resorption of the binder provides the controlled porosity for bono ingrowth. These 'porcs' are the interconnected pathways around and between the calcium hydroxylapatite particles that are non-absorbable. The calcium hydroxylapatite particles provide

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June 25, 2003

an osteoconductive scaffold for bone infiltration. The CaHA Implant functions as an osteoconductive scaffold for bone infiltration, the same mechanism of action as the predicate devices. The premixed and ready to use characteristic facilitates the delivery of CaHA Implant by allowing direct and controlled deposition using the syringe. This may be enhanced for implantation in difficult to access locations by the placing of a needle on the syringe. In addition, the binder serves to reduce or prevent migration during the application and in the post-operative healing period prior to incorporation of the particles by tissue ingrowth.

The Calcium Hydroxylapatite Implant (CaHA Implant) is substantially equivalent in composition and intended use to the predicate devices. The CaHA Implant and the predicate devices are all intended to fill and/or augment dental intraosseous and oral/maxillofacial defects. All of the predicate devices and the CaHA Implant are composites of resorbable (binder) and non-resorbable (calcium phosphate particles) components. The predicate devices use sterile water, saline, the patient's own blood or absorbable sutures to bind the particles together to facilitate delivery of the particles and minimize migration of the particles from the implant site. These other binding agents are resorbed within weeks or months depending upon the used and how it is prepared. All of these are also substantially equivalent in their mechanism of action as they provide a calcium phosphate particle that provides an osteoconductive scaffold for bone infiltration. The bone infiltration provides the final form of the implant.

The principal component of the Calcium Hydroxylapatite Implant, calcium hydroxylapatite is identical to the calcium hydroxylapatite used in most of the predicates and is very similar to the calcium phosphate glasses used in the rest of the predicate devices. All of these meet the same biocompatibility requirements. It is substantially equivalent in terms of biocompatibility and biological mechanism of action in that all of these products utilize tissue ingrowth to support and sustain augmentation.

In terms of risk versus benefit, BioForm believes that the CaHA Implant has obvious advantages compared to the predicate devices. The CAHA implant is provided as a sterile and ready to use paste that is more convenient for the physician, minimizes the potential for contamination during the mixing processes required by other devices, eliminates the risk and pain associated with drawing blood and is more convenient to place. The CaHA Implant also is convenient to use because the amount of filling or augmentation can be easily controlled through direct application.

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June 25, 2003

4.7 Conclusion:

In summary, Calcium Hydroxylapatite Implant is substantially equivalent to the cited predicate devices and, in some instances, identical to certain predicate devices. All have the same intended use designed to fill and/or augment dental intraosseous and oral/maxillofacial defects. The components used in the Calcium Hydroxylapatite Implant and the predicate devices are biocompatible, based on the history use in many medical devices as well as from preclinical testing and clinical experience. All function as composites that utilize a resorbable binder and a non-resorbable calcium phosphate particulate. The binder facilitates placement and the particles function as an osteoconductive matrix. All reach their final form after tissue infiltration. The Calcium Hydroxylapatite Implant is substantially equivalent in intended use, technical characteristics and are as safe as the predicate devices cited.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 7 2003

Mr. William G. Hubbard BioForm Incorporated 4133 Courtney Road, #10 Franksville, Wisconsin 53126

Re: K030682

Trade/Device Name: Calcium Hydroxylapatite Implant Regulation Number: None Regulation Name: Bone Filling and Augmentation Material Regulatory Class: Unclassified Product Code: LYC Dated: June 9, 2003 Received: June 10, 2003

Dear Mr. Hubbard:

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 your 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.

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Page 2 -- Mr. Hubbard

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 (OS) regulation (21 CFR Part 820); and if 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) 594-4613. 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.

Susan Quinn

Susan Runner, DDS, MA Interim 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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March 4, 2003 Revised June 9, 2003

SECTION 2

Indications for Use/Intended Use Statement

510(k) Number (if known): K030682

Device Name: Calcium Hydroxylapatite Implant

Indications for Use:

BioForm's Calcium Hydroxylapatite Implant is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including:

· Periodontal Defects
· Ridge Augmentation
· Extraction Sites
· Craniofacial Augmentation
· Cystic Defects

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) - - - - - - - - - - - - -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Over-the-Counter Use or (Per 21 CFR 801.109)

Optional Format 1-2-96

Ka Muluy for RSR

General Hospital,

Number K030682

510(k) Number

Regulation Number and Section

§ 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.