OSTA MAXIGRO AND REGIGRO

K091424 · Osta Technologies · NPM · Aug 18, 2010 · Dental

Device Facts

• Record ID: K091424
• Device Name: OSTA MAXIGRO AND REGIGRO
• Applicant: Osta Technologies
• Product Code: NPM · Dental
• Decision Date: Aug 18, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Osta Maxigro™ in both forms (powder & blocks) and Osta Regigro™ in both forms (powder & blocks) are Recommended for: Filling of large oral and maxillofacial intra-osseous cavities .

Device Story

Osta Maxigro and Osta Regigro are natural bovine-derived bone mineral grafting materials. Manufacturing involves fat extraction, collagen removal, and sintering to create a porous, hydroxyapatite-based scaffold. Available as powder or blocks, the material provides a high-surface-area structure that supports host bone ingrowth and remodeling; it is resorbed over time and replaced by natural bone. Used by dental/oral surgeons in clinical settings for maxillofacial bone defects. The device is not intended for load-bearing applications. Clinicians pack the material into the surgical site to facilitate bone regeneration. Benefits include providing a stable scaffold for bone formation in oral/maxillofacial procedures.

Clinical Evidence

Bench testing only. Evidence includes chemical and physical characterization (XRD, FTIR, crystallinity), in vitro dissolution rate comparisons, and in vivo muscle pouch implantation studies (ISO 10993-6). Biocompatibility testing included cytotoxicity (ISO 10993-5), intracutaneous injection (ISO 10993-5), sensitization (ISO 10993-10), and genotoxicity (ISO 10993-3). Results demonstrated no significant difference (99% confidence) between subject devices and predicate in dissolution, inflammation, encapsulation, or angiogenesis.

Technological Characteristics

Bovine-derived hydroxyapatite bone mineral; microporous scaffold structure. Osta Maxigro surface area >100m²/g; Osta Regigro surface area >80m²/g. Sterilized via gamma radiation (ISO 11137, SAL 10^-6). Prion reduction via hydrogen peroxide gas treatment. Non-load bearing. Complies with ISO 10993 standards for biocompatibility.

Indications for Use

Indicated for augmentation or reconstructive treatment of alveolar ridge; filling of periodontal defects; filling of defects after root resection, apicectomy, and cystectomy; filling of extraction sockets for alveolar ridge preservation; elevation of maxillary sinus floor; and filling of periodontal defects in conjunction with GTR/GBR products. Contraindicated for patients with hyperthyroidism, osteoporosis, osteomalacia, liver disease, renal dysfunction, diabetes, and acute or chronic infections.

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

• Bio Oss (K033815)

Submission Summary (Full Text)

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1091424

# As Required by 21 section 807.92 ( c )

1-Submitter Name: Osta Technologies 19 Virgo Road. Farrarmere. Benoni 1518. South Africa 2-Address: 3-Phone: [phone]-Fax: [phone]-Contact Person: Mr Dimitri Markoulides (Managing director) 6-Date summary prepared: 29 July, 2010

7 - Official Correspondent: Mansour Consulting LLC

8- Address: 845 Aronson Lake Court. Roswell, GA 30075 USA

9- Phone: [phone]

10- Fax: [phone]

11- Contact Person: Jay Mansour, President

12-Device Trade or Proprietary Name: Osta Maxigro™ and Osta Regigro™

13-Device Common or usual name: Anorganic Bovine Bone grafting material

14-Device Classification Name: Bone Filling Material

15-Substantial Equivalency is claimed against Bio Oss, cleared under K033815

#### 16-Description of the Device:

Osta Maxigro™ and Osta Regigro™ are natural bone minerals which have been derived from a bovine extract. The material is essentially free from collagen and comprises of a highly purified mineral structure with micropores and trabecules which is comparable to that of human bone. The materials are prepared by extracting the fat and removal of the collagen, thereby resulting in a pure bone mineral that is sintered in block form and then crushed to form powder granules. This natural sponge like geometry comprising of Hydroxyapatite nano-crystalls results in a high internal surface area scaffold that typically exceeds 100m /g for Osta Maxigro™ and 80m /g for Osta Regigro™. The high surface area properties of these materials make them ideal for allowing blood flow to the wound site where bony contact is established during the bone remodeling process. Osta Maxigro™ and Osta Regigro™ have low crystallinities comparable to that of human bone which is completely resorbed and replaced by host bone during bone regeneration process. The materials support bone formation but do not induce bone formation. Osta Maxigro™ are available in powder or block form and both undergo final sterilization by y- radiation of Osta Maxigro™ blocks and granules can be utilized for the indications shown below depending on the defect size. Osta Maxigro™ Blocks is ideally recommended for filling of large bone cavities with limited bone height and or wall thickness.

### 17-Intended Use:

Osta Maxigro™ in both forms (powder & blocks) and Osta Regigro™ in both forms (powder & blocks) are Recommended for:

> Filling of large oral and maxillofacial intra-osseous cavities .

AUG 1 8 2010

ﻟﻠﺘﻨﺘ

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2074

# 18-Indications for Use: (refer to FDA form attached)

- 1. Augmentation or reconstructive treatment of alveolar ridge
- 2. Filling of periodontal defects
- 3. Filling of defects after root resection, apicectomy, and cystectomy
- 4. Filling of extraction sockets to enhance preservation of the alveolar ridge
- 5. Elevation of maxillary sinus floor
- 6. Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)

# 19-Technological Characteristics

| TECHNOLOGICAL<br>CHARACTERISTICS | Comparison between K091424 and K033815 | Location of justification<br>within K091424<br>submission |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Identical-See above | 510k Summary |
| Target population | Identical- Not for patients who exhibit<br>Hyperthyroidism, Osteoporosis, Osteomalacia,<br>Liver disease and renal dysfunction, diabetes and<br>acute or chronic infections. | Device Labeling |
| Design | Similar, the only slight difference being is that<br>Osta Maxigro has higher surface area than the<br>predicate due to a higher volume of micropores<br>which is closer to mimicking that of natural bone.<br>The higher surface area of the device is not<br>detrimental to the performance characteristics of<br>the device relative to the predicate as verified by<br>dissolution and implantation tests. Osta Regigro<br>has an identical surface area to the predicate and<br>has the same volume of micropores. | Original Submission<br>Tab15 pp4-11 |
| Materials | Similar, both devices are sourced from bovine<br>femurs and are treated with similar thermal<br>treatments. | S2-Tab 3 |
| Performance | Similar, there is no statistical difference between<br>the dissolution characteristics or immunogenic<br>responses from implantation testing. | S2-Tab G<br>Original Submission Tab F |
| Sterility | Similar both conform to ISO11137 in using a<br>sterilization cycle validated sterility assurance<br>level (SAL) of 1x10-6 | Original Submission Tab P |
| Biocompatibility | Similar both conform to the requirements of the<br>bluebook memorandum G95-1 which<br>encompasses the following:<br>Cytotoxicity testing ISO 10993-5<br>Intracutaneous Injection ISO 10993-5<br>Sensitization testing ISO 10993-10<br>Genotoxicity Testing ISO 10993-3 | Original Submission Tab 18<br>Original Submission Tab 18<br>Original Submission Tab 18<br>S2 Tab A<br>Original Submission Tab B-F |
| | K091424 | 3074 |
| | | |
| Mechanical safety | Similar in Compressive Strength and Young's<br>Modulus, however Osta Maxigro & Osta Regigro<br>Are not intended for loading. | Original Submission Tab 15 |
| Chemical composition | Similar, based on Chemical Analysis, XRD, FTIR<br>and Crystallinity analysis. The similar dissolution<br>performance characteristics are evidence that the<br>chemical composition is very similar. | Original Submission Tab 15 |
| Chemical safety | Not applicable | |
| Anatomical sites | Identical- Periodontal and Maxillo Facial | |
| Human factors | Not applicable | |
| Energy used and/or<br>delivered | Not Applicable | |
| Compatibility with<br>environment and other<br>devices | Not Applicable. | |
| Where used | Identical, both devices have the same intended<br>uses except for implant loading | 510k Summary |
| Standards met | Similar, they comply with<br>Cytotoxicity testing ISO 10993-5<br>Intracutaneous Injection ISO 10993-10<br>Sensitization testing ISO 10993-10<br>Genotoxicity Testing ISO 10993-3<br>Implantation Testing ISO 10933-6 | |
| Electrical safety | Not applicable | |
| Thermal safety | Not applicable | |
| Radiation safety | Not applicable | |

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19- Brief discussion of the non clinical tests submitted, referenced or relied on in this 510k submission.

## Effectiveness discussion

Assessment of the performance characteristics of the Osta Maxigro™ and Osta Regigro™ was carried out by a full chemical and physical characterization of the test devices relative to the predicate. The physical and chemical characteristics of the devices were comparable to the predicate; however, the key performance output that has a direct link to the chemical and physical characteristics was the dissolution performance of the devices relative to the predicate. It is well accepted that the in vitro dissolution rate comparisons of the devices relative to the predicate would be indicative of the in vivo resorption rates which would demonstrate substantially equivalence to the predicate. Given that at 99% confidence there was no significant difference in the dissolution rates of the devices (in either form powder or block) to the predicate, it follows that from a performance characteristic point of view, the devices would be as effective as that of the predicate.

# Safety discussion

From a biological tolerance point of view the Osta Maxigro™ and Osta Regigro™ devices were tested individually regarding cytotixicity according to ISO 10993-5 and intracutaneous injection (ISO 10993-5) and in combination testing for cytotoxicity, sensitization testing ISO10993-10 and genotoxic screening (ISO 10993-3). It should be borne in mind that both Osta Maxigro™ and Osta Regigro™ devices are exposed to the same chemical treatments for the same times during processing. The Osta Maxigro™ and Osta Regigro™ devices conformed to all the standards mentioned above regarding safety. An in vivo impiantation muscle pouch study also concluded that at 99% confidence there was no significant difference, regarding inflammation, encapsulation and angiogenesis with respect to the predicate as per ISO10993-6. From a sterility point of view the devices also conformed to ISO 11137 in terms of achieving a sterility level SAL 1x10 °. In terms of mitigating the potential

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K 091424

presence of prions, a hydrogen peroxide gas treatment was incorporated in to the process to reduce the potential presence of prions on the devices as per published data. Based on the biological screening, sterility tests and prion reduction initiatives as described above, the fact that the Osta Maxigro™ devices complies to all safety standards for biological tolerance means that the devices are as safe as that of the predicate.

## 20-Safety and Effectiveness of the devices:

Based on the summaries in (18 &19) above it is demonstrated that Osta Maxigro™ and Osta Regigro™ devices are substantially equivalent to the predicate Bio Oss™ and effective regarding the indications for use.

**Page.**

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Osta Technologies C/O Mr. Jay Mansour Mansour Consulting, LLC 845 Aronson Lake Court . Roswell, Georgia 30075

AUG 1 8 2010

Re: K091424

Trade/Device Name: Osta Maxigro ™ and Osta Regigro Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPM Dated: July 30, 2010 Received: August, 02, 2010

Dear Mr. Mansour:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Mansour

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital,

Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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K09/424

Indications for Use

171

510(k) Number (if known): K091424

Device Name: Osta Maxigro™ and Osta Regigro™

Indications For Use:

1. Augmentation or reconstructive treatment of alveolar ridge

2. Filling of periodontal defects

3. Filling of defects after root resection apicocectomy, and cystectorny

4. Filling of extraction sockets to enhance preservation of the alveolar ridge

5. Elevation of maxillary sinus floor

6. Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rai Mreby for MSN

(Division Sign-Off)

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anesthoolors .
Infection Control, Dental Devices

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510(k) Number: _ KO91 424