(216 days)
The Soft Tissue Augmentation Resorbable (STAR) Matrix is intended to support localized gingival augmentation to increase keratinized tissue.
STAR Matrix is indicated for:
- Covering of implants placed in immediate or delayed extraction sockets;
- Localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants.
The Soft Tissue Augmentation Resorbable Matrix (STAR Matrix) is a cross – linked, resorbable membrane engineered from highly purified Type I collagen fibers derived from Porcine Achilles Tendon for use in periodontal, oral, and maxillofacial surgery. STAR Matrix is composed of two structures: a smooth outer layer that acts as a barrier membrane and a porous matrix layer to allow cell invasion and tissue ingrowth. The product is oriented so that the porous layer is in contact with the host tissue bone/bone graft or periosteum to facilitate tissue integration. The product is provided sterile, non-pyrogenic, and for single use only. Product is provided in various sizes where it can be easily trimmed for appropriate fit and sutured into place during surgery.
The provided document is a 510(k) summary for a medical device (Soft Tissue Augmentation Resorbable Matrix - STAR Matrix) and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical study report for software as a medical device (SaMD) or AI/ML-driven devices.
The document primarily covers:
- Description of the device: A resorbable membrane for gingival augmentation.
- Comparison to predicate devices: Highlighting similarities and differences in technical characteristics.
- Performance data: Primarily non-clinical (in vitro, animal, biocompatibility, sterilization, shelf life).
- No clinical studies were required to determine substantial equivalence for this device.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets those criteria because the document does not describe such a study. The information requested (acceptance criteria table, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set details) is typically found in documentation for the validation of AI/ML-based medical devices or devices demonstrating clinical efficacy/safety through trials, which is not the nature of this 510(k) submission.
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Image /page/0/Picture/0 description: The image contains 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.
May 01, 2024
Collagen Matrix, Inc. Daniel Fernandez Regulatory Affairs Specialist 15 Thornton Rd. Oakland. New Jersey 07436
Re: K233203
Trade/Device Name: Soft Tissue Augmentation Resorbable Matrix Regulation Number: 21 CFR 872.3930 Regulation Name: Bone grafting material Regulatory Class: Class II Product Code: NPL Dated: April 03, 2024 Received: April 04, 2024
Dear Daniel Fernandez:
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.
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).
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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 OS 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.
For comprehensive regulatory information about medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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Enclosure
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Indications for Use
510(k) Number (if known) K233203
Device Name
Soft Tissue Augmentation Resorbable (STAR) Matrix
Indications for Use (Describe)
The Soft Tissue Augmentation Resorbable (STAR) Matrix is intended to support localized gingival augmentation to increase keratinized tissue.
STAR Matrix is indicated for:
- · Covering of implants placed in immediate or delayed extraction sockets;
· Localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Collagen Matrix, Inc. 510(k) Summary 510(k) Submission No.:K233203 Soft Tissue Augmentation Resorbable (STAR) Matrix Page 1 of 4
510(k) SUMMARY
| 1. Applicant Information | |
|---|---|
| Applicant Name: | Collagen Matrix, Inc. |
| Address: | 15 Thornton RoadOakland, New Jersey 07436 |
| Telephone: | (201) 405-1477 |
| Fax: | (201) 405-1355 |
| Contact Person: | Daniel FernandezRegulatory Affairs, Specialistdfernandez@collagenmatrix.com |
| Date Prepared: | May 01, 2024 |
| 2. Name of the Device | |
| Device Trade Name: | Soft Tissue Augmentation Resorbable (STAR) Matrix |
| Device Common Name(s): | Collagen Dental Membrane |
| Device Classification Name: | Barrier, animal source, intraoral872.3930NPLClass II |
| 3. Legally Marketed Devices to Which Substantial Equivalence is Claimed | |
| Predicate Device: | Geistlich Mucograft®, Geistlich Mucograft Seal®Geistlich Pharma AGK210280 |
| Reference Device(s): | Collagen Dental Membrane - Porcine Type ICollagenCollagen Matrix, Inc.K110600Porcine Mineral Collagen CompositeCollagen Matrix, Inc.K202183 |
| 4. Description of the Device |
The Soft Tissue Augmentation Resorbable Matrix (STAR Matrix) is a cross – linked, resorbable membrane engineered from highly purified Type I collagen fibers derived from Porcine Achilles Tendon for use in periodontal, oral, and maxillofacial surgery. STAR Matrix is composed of two structures: a smooth outer layer that acts as a barrier membrane and a porous matrix layer to allow cell invasion and tissue ingrowth. The product is oriented so that the porous layer is in contact with the host tissue bone/bone graft or periosteum to facilitate tissue integration. The
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product is provided sterile, non-pyrogenic, and for single use only. Product is provided in various sizes where it can be easily trimmed for appropriate fit and sutured into place during surgery.
5. Indications for Use
STAR Matrix is intended to support localized gingival augmentation to increase keratinized tissue.
STAR Matrix is indicated for:
- Covering of implants placed in immediate or delayed extraction sockets; -
- -Localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants.
6. Summary/Comparison of Technical Characteristics
The subject device has equivalent technological characteristics as the predicate Geistlich Mucograft® and Geistlich Mucograft Seal® (510(k) K210280) device.
| Feature | Soft TissueAugmentationResorbable (STAR)Matrix(Subject Device) | Geistlich Mucograft®,Geistlich MucograftSeal®(K210280)(Predicate Device) | Collagen DentalMembrane - PorcineTendon Type I Collagen(K110600)(Reference Device) | DeviceComparison |
|---|---|---|---|---|
| Indications forUse | STAR Matrix is intendedto support localizedgingival augmentation toincrease keratinizedtissue.STAR Matrix is indicatedfor:• Covering ofimplants placedin immediate ordelayedextractionsockets;Localizedgingivalaugmentation toincreasekeratinized tissue(KT) aroundteeth andimplants. | Geistlich Mucograft andMucograft seal areindicated forcovering of implantsplaced in immediate ordelayed extraction sockets,localized gingivalaugmentation to increasekeratinized tissue (KT)around teeth and implants,alveolar ridgereconstruction forprosthetic treatment,and recession defects forroot coverage. | Collagen DentalMembrane - PorcineTendon Type I Collagen isintended for use in oralsurgical procedures as aresorbable material forplacement in the area ofdental implants, bonedefect or ridgereconstruction to aid inwound healing. | Similar |
| Product Code& Regulation | NPL872.3930Bone Grafting Material | NPL872.3930Bone Grafting Material | NPL872.3930Bone Grafting Material | Identical |
| Material Origin | Porcine | Porcine | Porcine | Similar |
| MaterialComposition | Primarily Type I Porcinecollagen | Primarily Type I Porcinecollagen | Primarily Type I Porcinecollagen | Similar |
| Product Form | Smooth outer layerPorous matrix layer | Smooth "outer" surfacePorous "inner" structure | Membrane | Identical |
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| Feature | Soft TissueAugmentationResorbable (STAR)Matrix(Subject Device) | Geistlich Mucograft®,Geistlich MucograftSeal®(K210280)(Predicate Device) | Collagen DentalMembrane - PorcineTendon Type I Collagen(K110600)(Reference Device) | DeviceComparison |
|---|---|---|---|---|
| Product Sizes | 1.5 x 2.0 cm2.0 x 3.0 cm3.0 x 4.0 cm10 x 20 mm15 x 15 mm15 x 25 mm10 x 40 mm20 x 40 mm15 x 45 mm15 x 40 mm25 x 45 mmDiameter: 8 - 12 mm | Mucograft: 15 x 20 mm,20 x30 mm, and 30 x 40mmMucograft Seal: 8mm and12 mm diameter | 1.5 x 2.0 cm2.0 x 3.0 cm3.0 x 4.0 cm | Similar; Theadditionalpotentialsizes of thesubjectdevice fallwithin thesurfacearea of thelargestdevice. |
| DeviceThickness | Approx. 1.5 to 5 mm | Approx. 2.5 to 5 mm | 0.2 - 0.6 mm | Similar |
| ThermalStability | $53 \pm 8$ | $31.4 \pm 0.20$ | $57 \pm 7$ | Different |
| Suturability(kg) | ≥ 0.065 | 0.166 ± 0.0816 | ≥ 0.065 | Similar |
| Density | 0.047 ± 0.018 | 0.054 ± 0.003 | N/A | Similar |
| Cross-linking | Crosslinked withformaldehyde | N/A | Crosslinked withformaldehyde | Different |
| Biocompatibility | BiocompatibleMeets ISO 10993biocompatibility series oftesting | BiocompatibleMeets ISO 10993biocompatibility series oftesting | BiocompatibleMeets ISO 10993biocompatibility series oftesting | Identical |
| Sterility | Sterile using GammaIrradiation; SAL 10-6 | Sterile using GammaIrradiation | Sterile using GammaIrradiation; SAL 10-6 | Identical |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Non-pyrogenic | Identical |
| Single Use/Reuse | Single use only | Single use only | Single use only | Identical |
7. Performance Data
In vivo and in vitro testing of the subject device was conducted to demonstrate substantial equivalence of the subject device to its predicate device. The following performance data are provided in support of the substantial equivalence determination.
Viral inactivation to ensure product safety was performed in accordance with ISO 22442-3.
Biocompatibility Testing
Biocompatibility testing was conducted in accordance with the testing matrix of ISO 10993-1: Cytotoxicity, ISO 10993-5 Genotoxicity, ISO 10993-3 and ISO 10993-12 Muscle Implantation, ISO 10993-6 Implantation Assessment in Canine Study, ISO 10993-6 Intracutaneous Reactivity, ISO 10993-10 Acute System Toxicity, ISO 10993-11 Genotoxicity ISO 10993-12 Pyrogenicity ISO 10993-11
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A Toxicology Risk Assessment was performed to evaluate formaldehyde residuals. The assessment included an evaluation of information presented in scientific literature and biocompatibility testing conducted on the subject device as well as similar devices. The results of the assessment concluded that the amount of formaldehyde residual for single product use has been addressed. The level of formaldehyde residual present in the subject device is within the acceptable limit as found in previous FDA approved Collagen Matrix, Inc devices.
Bench Testing
- Purified Collagen Characterization Testing -
Product Characterization Testing -
- Suture Pull-out Strength -
- Thermal Transition Temperature -
- Density -
Animal Testing
The performance of the device was compared to that of the predicate device. Geistlich Mucograft® in a canine model, and evaluated by gross pathology and histological assessments. Critical soft tissue periodontal defects were made at the alveolar ridge, where devices were then implanted. Measurements of the defects were taken at baseline, 4 weeks, and 12 weeks, which included anterior, central, and posterior measurements of the keratinized and soft tissue thickness. Measurement and assessment of the keratinized tissue length in the defect site was made at each termination time point. Conclusion of the study indicates the positive healing performance of the device as compared to the predicate, with noticeable return to native structures and complete resorption of the device with no unresolved adverse effects. The results demonstrate performance substantially equivalent to the predicate device with regards to the indications for use.
Clinical Studies
Clinical performance data was not required to determine substantial equivalence.
Sterilization / Shelf Life
The device is provided sterile in following with ISO 11737. Sterilization for the subject device is based off of and leveraged from reference device K110600.
The subject device shelf-life program was developed taking into consideration ISO 11607, ASTM D4169, ASTM F-1886-09, ASTM F-88/F88-M15, and ISTA 3A. The shelf life of the subject device is 26 months.
8. Conclusions Drawn from Non-clinical Studies
The conclusions drawn from the nonclinical tests demonstrate that the device is substantially equivalent to its predicate devices.
§ 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.