Oral Matrix

K231513 · Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · NPL · Feb 16, 2024 · Dental

Device Facts

• Record ID: K231513
• Device Name: Oral Matrix
• Applicant: Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
• Product Code: NPL · Dental
• Decision Date: Feb 16, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Oral Matrix is intended for use in extraction sockets only to contain or prevent migration of graft material. The device is supplied sterile and intended for one time use.

Device Story

Oral Matrix is a bioabsorbable extracellular collagen membrane matrix derived from porcine Small Intestinal Submucosa (SIS). Device is supplied as freeze-dried, layered sheets in various sizes (1x1 cm to 8x8 cm) and thicknesses (0.05-0.13 mm). Used by oral surgeons in extraction sockets to contain or prevent migration of graft material. Device acts as a physical barrier; it is absorbed by the body over time. Sterilized via ethylene oxide. Benefits include preservation of extraction socket integrity during bone grafting procedures. Clinical application occurs in oral surgery settings.

Clinical Evidence

No clinical study included. Evidence consists of bench testing (burst strength, suture retention, tensile strength, physical performance), composition analysis (protein, sugar, lipid, DNA/peroxyacetic acid residues), biocompatibility (ISO 10993 series), and a canine animal study demonstrating efficacy in preserving teeth extraction sockets.

Technological Characteristics

Material: Porcine Small Intestinal Submucosa (SIS). Form: Freeze-dried, layered collagen membrane sheets. Dimensions: 1x1 cm to 8x8 cm; 0.05-0.13 mm thickness. Sterilization: Ethylene oxide (SAL 10^-6). Packaging: Tyvek pouch. Standards: ISO 22442-3 (virus inactivation), ISO 10993 (biocompatibility), ASTM F88/F1886/F1929 (package integrity).

Indications for Use

Indicated for use in human oral extraction sockets to contain or prevent migration of graft material. Intended for prescription use in settings appropriate for oral surgery.

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

• Dynamatrix/dynamatrix Plus (K161762)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 16, 2024

Beijing Biosis Healing Biological Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co, Ltd. P.O. Box 120-119 Shanghai. 200120 CHINA

Re: K231513

Trade/Device Name: Oral Matrix Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL Dated: January 23, 2024 Received: January 23, 2024

Dear Diana Hong:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

{1}------------------------------------------------

2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

{2}------------------------------------------------

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Sherrill Lathrop Blitzer

for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

# Indications for Use

510(k) Number (if known) K231513

Device Name Oral Matrix

Indications for Use (Describe)

The Oral Matrix is intended for use in extraction sockets only to contain or graft material. The device is supplied sterile and intended for one time use.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

# 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K231513

- 1. Date of Preparation: 2/16/2024
- 2. Sponsor Identification

# Beijing Biosis Healing Biological Technology Co., Ltd.

No.6 plant west, Valley No.1 Bio-medicine Industry Park, Daxing District, Beijing, 102600, China.

Establishment Registration Number: 3016668451

Contact Person: Ting Jiang Position: Regulatory Affair Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone] Fax: [phone] Email: [e-mail]

{5}------------------------------------------------

#### 4. Identification of Subject Device

Trade Name: Oral Matrix

Regulatory Information

Regulation Number: 872.3930 Classification Name: Barrier, Animal Source, Intraoral Classification: II Product Code: NPL; Review Panel: Dental;

Indication for use:

The Oral Matrix is intended for use in extraction sockets only to contain or prevent migration of graft material. The device is supplied sterile and intended for one time use.

Device Description:

The Oral Matrix consists of layered sheets of bioabsorbable extracellular collagen membrane matrix derived from porcine Small Intestinal Submucosa (SIS). These sheets are freeze-dried, packaged in a Tyvek pouch, and sterilized using ethylene oxide to achieve a SAL of 10-6.

The Oral Matrix is available in eighteen different models, the differences between the models are shown in the table below.

| Model | Size (cm) | Tolerance | Thickness |
|--------------------|-----------|-----------|-------------|
| SIS-ORP-4L-1×1 | 1×1 | | |
| SIS-ORP-4L-2×2 | 2×2 | | |
| SIS-ORP-4L-2×3 | 2×3 | | |
| SIS-ORP-4L-3×3 | 3×3 | | |
| SIS-ORP-4L-4×3 | 4×3 | | |
| SIS-ORP-4L-6×6 | 6×6 | | |
| SIS-ORP-4L-1.5×1.5 | 1.5×1.5 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-3×5 | 3×5 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-2.5×1.5 | 2.5×1.5 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-5×4 | 5×4 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-4×6 | 4×6 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-7×7 | 7×7 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-3×3.5 | 3×3.5 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-3×7 | 3×7 | ±0.2cm | 0.05~0.13mm |

{6}------------------------------------------------

| SIS-ORP-4L-4×4 | 4×4 |
|----------------|-----|
| SIS-ORP-4L-5×5 | 5×5 |
| SIS-ORP-4L-6×8 | 6×8 |
| SIS-ORP-4L-8×8 | 8×8 |

#### 5. Identification of Predicate Device

510(k) Number: K161762 Product Name: Dynamatrix/dynamatrix Plus

#### 6. Non-Clinical Test Conclusion

Following non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.

### Product performance comparison testing

Comparison test has been conducted on the subject device and predicate device, including Burst Strength, Suture Retention Strength, Tensile Strength, Physical Performance, The test results demonstrate the subject device has the similar product performance as those of the predicate device.

### Product composition comparison testing

The total protein content, total sugar content, lipid content testing, DNA Residue and peroxyacetic Acid Residue were conducted on the subject device and predicate device. The test results demonstrate the subject device has the similar product composition as those of the predicate device.

#### Virus Inactivation

In order to demonstrate that the sum of the log clearance of DNA and RNA virus from the virus inactivation processes is at least 6 logs greater than the concentration of virus anticipated in the unprocessed source animal, the sponsor conducted virus inactivation according to o ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents. The test results demonstrate that the virus inactivation processes of the subject device reduce more than 6 logs virus.

#### Package integrity testing

The package integrity test of the sterility maintenance package was conducted according to ASTM F88/F88M-15, ASTM F1886 and ASTM F1929-15. It include: Flexible Packaging by Visual Inspection: seal strength, which shall no less than 1.5N/15mm, and dye penetration, which shall no dye penetration cross the package. The test results demonstrate the sterility maintenance package of the subject device meets the requirements of standards and thus provides sterility maintenance for the finished device.

{7}------------------------------------------------

### Shelf life testing

In order to ensure the safety and effectiveness of the subject device in the shelf life, package integrity and product performance testing was conducted on the real-time aged device. The test results demonstrate the subject device can claim 24 month as shelf life.

#### Biocompatibility testing_

The following biocompatibility testing was conducted and the test results demonstrate there are no negative impacts from the materials that are used in the subject device.

Cytotoxicity (ISO 10993-5),

Sensitization (ISO 10993-10),

Intracutaneous reactivity (ISO 10993-23),

Acute systemic toxicity (ISO 10993-11),

Pyrogen (ISO 10993-11),

Implantation (ISO 10993-6),

Subchronic systemic toxicity (ISO 10993-11),

Bacterial reverse mutation test (ISO 10993-3),

Mouse lymphoma TK assay (ISO 10993-3),

Hemolysis study (ASTM F756),

Complement activation (ISO 10993-4),

Partial thromboplastin time (ISO 10993-4).

Chronic system toxicity (ISO 10993-11)

Chemical Characterization (ISO 10993-18, ISO 10993-17).

## Animal study

The animal study was performed on a canine model to evaluate the performance and safety by comparing with the predicate device. The results demonstrated that the subject device has ability to preserve the teeth extraction socket compared with predicate device.

- 7. Clinical Test Conclusion
No clinical study is included in this submission.

- 8. Summary of Technological characteristics

| ITEM | Subject Device | Predicate Device<br>K161762 | Remark |
|--------------|----------------|-----------------------------|--------|
| Product code | NPL | NPL | Same |
| Class | Class II | Class II | Same |

## Table 1 Comparison of Technology Characteristics

{8}------------------------------------------------

| Indication for Use | The Oral Matrix is intended<br>for use in extraction sockets<br>only to contain or prevent<br>migration of graft material.<br>The device is supplied<br>sterile and intended for one<br>time use. | DynaMatrix is intended for<br>use in guided tissue<br>regeneration and bone<br>regeneration procedures. It<br>may be used for bone<br>regeneration and healing of<br>periodontal defects, for<br>gingival augmentation, to<br>maintain or enhance<br>alveolar ridges, or to<br>contain or prevent migration<br>of graft material. The device<br>is supplied sterile and<br>intended for one-time use. | Different |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Sterile | Yes | Yes | Same |
| Sterilization method | EO | EO | Same |
| Single use | Yes | Yes | Same |
| Material | Porcine small intestinal<br>submucosa | Porcine small intestinal<br>submucosa; primarily<br>collagen types I and III | Same |
| Drying method | Freeze-dried extracellular<br>matrix | Freeze-dried extracellular<br>matrix | Same |
| Absorbable | Yes | Yes | Same |
| Intended for Prescription<br>use only? | Yes | Yes | Same |
| Target population | Human, oral, periodontal | Human, oral, periodontal | Same |
| Location of intended<br>application | Setting appropriate for oral<br>surgery | Setting appropriate for oral<br>surgery | Same |
| Packaging<br>configuration | Tyvek Pouch | Tyvek Pouch | Same |
| Sizes | 1 cm² to 64 cm²<br>(From 1cm×1cm to<br>8cm×8cm) | 2 cm² to 12 cm² | Different |
| Thickness (mm) | 0.05mm~0.13mm | 0.05mm~0.13mm | Same |
| Biocompatibility | No Cytotoxicity<br>No Sensitization<br>No Intracutaneous<br>Reactivity<br>No Acute Systemic Toxicity<br>Non irritant after | Comply with ISO 10993<br>series standards | |

{9}------------------------------------------------

| Implantation |
|--------------------------------------------------------------------------------------------------------------|
| No Subchronic Systemic<br>Toxicity |
| No Bacterial Reverse<br>Mutation |
| No mutagenic to mouse<br>lymphoma cell |
| No Hemolysis |
| Pyrogen meet the<br>acceptable USP limits. |
| No Complement Activation |
| No Partial Thromboplastin |
| No Chronic System Toxicity |
| No unacceptable risks<br>associated with the extract<br>based on the chemical<br>characterization evaluation |

### Different-Indications for Use

The indications for use of subject device is covered by the indications for use of the predicate device. Based on the animal study, the results demonstrated that the subject device has ability to preserve the teeth extraction socket compared with the blank control group and it was similar compared with the predicate device. Therefore, this item is considered substantial equivalent.

#### Different- Sizes

The size of the subject device is different from the predicate device. However, the test results of product performance comparison testing (burst strength, suture retention strength, tensile strength and physical performance) and product composition comparison testing(total protein content, total sugar content and lipid content, DNA residue and peroxyacetic acid residue) show the performance and composition of the subject device and predicate device have no statistical difference. The difference will not affect the safety and effectiveness of the subject device.

#### 9. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is substantially equivalent to the legally marketed predicate device K161762.