(248 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the material properties and biological performance of a collagen barrier membrane, with no mention of AI or ML technology.
Yes
The device, Striate+TM, is indicated for therapeutic uses such as augmentation around implants, filling bone defects, and guided bone and tissue regeneration procedures, which directly address and aim to treat medical conditions.
No
Striate+TM is a resorbable collagen barrier membrane used for guided bone and tissue regeneration in dental procedures. It is a therapeutic device that aids in physical restoration, not a diagnostic device that identifies diseases or conditions.
No
The device description clearly states it is an "implantable biocompatible, sterile, resorbable collagen barrier membrane," which is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Striate+TM Function: Striate+TM is an implantable barrier membrane used in dental procedures to aid in bone and tissue regeneration. It is placed inside the body to physically guide the growth of bone and tissue.
- Intended Use: The intended use clearly describes a surgical implant for augmentation and regeneration, not a diagnostic test performed on a sample.
- Device Description: The description details a physical barrier made of collagen, not a reagent or instrument used for analyzing biological samples.
Therefore, based on the provided information, Striate+TM is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Striate+TM is indicated for use in:
- augmentation around implants placed in immediate extraction sockets
- augmentation around implants placed in delayed extraction sockets
- filling of bone defects after root resection or removal of retained teeth
- guided bone regeneration in dehiscence defects; and
- guided tissue regeneration procedures in intrabony periodontal defects
Product codes (comma separated list FDA assigned to the subject device)
NPL
Device Description
Striate+TM is an implantable biocompatible, sterile, resorbable collagen barrier membrane intended for use in dental guided bone and guided tissue regeneration procedures.
Striate+TM has a bilayer structure (rough and smooth sides). The rough side, placed facing the bone defect, is composed of a loose distribution of collagen bundles allowing ingrowth of bone forming cells. The smooth side, facing the soft tissue, is composed of densely packed collagen bundles forming a barrier to soft tissue ingrowth into the defect. Striate+TM is supplied dry and can be easily trimmed to the required size. The collagen material becomes soft and pliable when hydrated allowing conformation to the repair site. Striate+TM has sufficient mechanical strength to be sutured in place, if required, and is gradually resorbed into the surrounding tissue. Striate+TM is sterilized with gamma radiation. Striate+TM is provided in the following sizes: 15 mm x 20 mm, 20 mm x 30 mm x 40 mm, 40 mm x 50 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data was provided in support of the substantial equivalence discussion.
- Biocompatibility (ISO 10993-1)
- Viral Inactivation (ISO 22442)
- Sterilization Validation (ISO 11737-1, ISO 1137-2, ISO 11737-3)
- Shelf Life Validation (real-time) (ASTM F2212, ASTM F2150)
- Endotoxin Level (USP , USP )
- Tensile strength
- Suture pull-out strength
- Absorbency/Wettability
- Thickness
- Composition (amino acid analysis, total protein, GAG, lipid and DNA content, SDS-PAGE, Western Blot Analysis )
- SEM imaging
The bench testing demonstrated that the subject and predicate device displayed equivalent characteristics with respect to structure, composition, tensile strength, suturability, thickness and absorbency.
Biocompatibility
The biocompatibility evaluation for Striate+TM was conducted according to International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" as recognized by the FDA. The battery of tests included the following:
- Cytotoxicity
- Irritation
- Sensitization
- Local and systemic toxicity
- Genotoxicity
- Pyrogenicity
Animal Study
Pre-clinical animal studies conducted in a large animal intra oral model comparing Striate+TM and the predicate device at 4, 8 and 12 weeks demonstrate that both are cellocclusive, preventing ingrowth of epithelial cells into the bone defect, and that the subject and predicate device are fully resorbable and biocompatible. Bone formation, inflammatory response and membrane degradation rate of Striate+TM was no different to the predicate when evaluated by micro-computed tomography, histomorphometric analysis and histological analysis, providing in vivo evidence for substantial equivalence of the two devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below it.
Orthocell Ltd Alison Carleton Regulatory Affairs Associate Building 191 Murdoch University, South St. MURDOCH Perth, West Australia 6150 AUSTRALIA
Re: K201241
Trade/Device Name: Striate+ TM Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL Dated: December 11, 2020 Received: December 14, 2020
Dear Alison Carleton:
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. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located 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
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 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 (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
Andrew Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201241
Device Name Striate+TM
| Indications for Use (Describe) | ||
|---|---|---|
| 1 10 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - |
Striate+TM is indicated for use in:
- augmentation around implants placed in immediate extraction sockets
- augmentation around implants placed in delayed extraction sockets
- filling of bone defects after root resection or removal of retained teeth
- guided bone regeneration in dehiscence defects; and
- guided tissue regeneration procedures in intrabony periodontal defects
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)
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."
3
510(k) Summary
Striate+TM
I. SUBMITTER
Orthocell Ltd Building 191, Murdoch University South Street, Murdoch WA 6150 AUSTRALIA Phone + 61 8 9360 6268
| Contact Person: | Dr. Alison Carleton |
|---|---|
| Date prepared: | 11 January 2021 |
II. DEVICE
| Device Name: | Striate+TM |
|---|---|
| Common Name: | Implantable Collagen Membrane |
| Regulation: | 21 CFR 872.3930 Bone grafting material |
| Regulatory Class: | Class II |
| Product Code: | NPL (Barrier, animal source, intraoral) |
| Panel: | Dental |
III. PREDICATE DEVICE
Substantial equivalence is claimed to:
Geistlich Bio-Gide® K042197
This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
DEVICE DESCRIPTION IV.
Striate+TM is an implantable biocompatible, sterile, resorbable collagen barrier membrane intended for use in dental guided bone and guided tissue regeneration procedures.
Striate+1M has a bilayer structure (rough and smooth sides). The rough side, placed facing the bone defect, is composed of a loose distribution of collagen bundles allowing ingrowth of bone forming cells. The smooth side, facing the soft tissue, is composed of densely packed collagen bundles forming a barrier to soft tissue ingrowth into the defect. Striate+TM is supplied dry and can be easily trimmed to the required size. The collagen material becomes soft and pliable when hydrated allowing conformation to the repair site. Striate+TM has sufficient mechanical strength to be sutured in place, if required, and is gradually resorbed into the surrounding tissue. Striate+TM is sterilized with gamma radiation. Striate+TM is provided in the following sizes: 15 mm x 20 mm, 20 mm x 30 mm x 40 mm, 40 mm x 50 mm.
4
V. INDICATIONS FOR USE
Striate+TM is indicated for use in:
- Augmentation around implants placed in immediate extraction sockets ●
- . Augmentation around implants placed in delayed extraction sockets
- . Filling of bone defects after root resection or removal of retained teeth
- Guided bone regeneration in dehiscence defects; and ●
- . Guided tissue regeneration procedures in intrabony periodontal defects
The indications for use statement of Striate+1M is not identical to the predicate device (Table 1); however, the differences do not alter the intended therapeutic use of the subject device, nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use as a barrier membrane in guided bone and guided tissue regeneration procedures.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
Striate+™ and the predicate device have the same intended use as barrier membranes in guided tissue and guided bone regeneration procedures. Both the subject and predicate devices are derived from porcine tissue and have the same technological and biochemical characteristics, associated with their intended use (Table 1).
Differences in technology, including raw material tissue sources or manufacturing processes, that exist between the subject and predicate devices have been demonstrated not to affect the substantial equivalence through comparative performance data. The difference in the size variants between the subject and predicate devices are not considered to be different enough to have any effect on function, useability or substantial equivalence as they are all clinically relevant sizes for intra-oral surgical procedures.
5
| Table 1 Device Comparison - Striate+TM and Bio-Gide® barrier membranes | ||
|---|---|---|
| Device name | Striate+ | Bio-Gide® (K042197) |
| Intended | ||
| purpose | Striate+ is a biocompatible, sterile, | |
| resorbable collagen barrier membrane | ||
| intended for use in guided bone and | ||
| tissue regeneration. | Bio-Gide® is a biocompatible, sterile, | |
| resorbable bilayer collagen membrane | ||
| for guided tissue and bone | ||
| regeneration. | ||
| Indications for | ||
| use | Striate+TM is indicated for use in: | |
| augmentation around implants placed in immediate extraction sockets augmentation around implants placed in delayed extraction sockets filling of bone defects after root resection or removal of retained teeth guided bone regeneration in dehiscence defects; and guided tissue regeneration procedures in intrabony periodontal defects. | Bio-Gide® is indicated for: | |
| augmentation around implants placed in immediate extraction sockets; augmentation around implants placed in delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects after root resection, cystectomy, removal of retained teeth; guided bone regeneration in dehiscence defects; and guided tissue regeneration procedures in periodontal defects. | ||
| Technological | ||
| characteristics | Bilayer structure Suturable Absorbent Retains tensile strength when wet Cell-occlusive Resorbed in 3-6 months | Bilayer structure Suturable Absorbent Retains tensile strength when wet Cell-occlusive Resorbed in 3-6 months |
| Form | Flexible, dry, white sheet of material | |
| with distinct smooth and rough sides | Flexible, dry, white sheet of material | |
| with distinct smooth and rough sides | ||
| Size variants | 15 mm x 20 mm 20 mm x 30 mm 30 mm x 40 mm 40 mm x 50 mm | 13 mm x 25 mm 25 mm x 25 mm 40 mm x 50 mm |
| Composition | Type I collagen | Type I collagen |
| Biocompatibility | Biocompatible (ISO 10993) Biocompatible (animal model of GBR) | Biocompatible (ISO 10993) Biocompatible (animal model of GBR) |
| Source material | Porcine collagen | Porcine collagen |
| Packaging | Double PETG trays with Tyvek® seals | Double PETG trays with Tyvek® seals |
| Sterilization | Gamma irradiation (SAL 10-6) | Gamma irradiation (SAL 10-6) |
| Shelf life | 36 months | 36 months |
6
VII. PERFORMANCE DATA
The following performance data was provided in support of the substantial equivalence discussion.
- . Biocompatibility (ISO 10993-1)
- Viral Inactivation (ISO 22442) ●
- . Sterilization Validation (ISO 11737-1, ISO 1137-2, ISO 11737-3)
- Shelf Life Validation (real-time) (ASTM F2212, ASTM F2150) .
- Endotoxin Level (USP , USP ) ●
- Tensile strength ●
- Suture pull-out strength .
- Absorbency/Wettability .
- Thickness ●
- Composition (amino acid analysis, total protein, GAG, lipid and DNA content, . SDS-PAGE, Western Blot Analysis )
- . SEM imaging
The bench testing demonstrated that the subject and predicate device displayed equivalent characteristics with respect to structure, composition, tensile strength, suturability, thickness and absorbency.
Biocompatibility
The biocompatibility evaluation for Striate+™ was conducted according to International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" as recognized by the FDA. The battery of tests included the following:
- Cytotoxicity .
- Irritation .
- Sensitization .
- Local and systemic toxicity ●
- Genotoxicity ●
- Pyrogenicity .
Animal Study
Pre-clinical animal studies conducted in a large animal intra oral model comparing Striate+TM and the predicate device at 4, 8 and 12 weeks demonstrate that both are cellocclusive, preventing ingrowth of epithelial cells into the bone defect, and that the subject and predicate device are fully resorbable and biocompatible. Bone formation, inflammatory response and membrane degradation rate of Striate+™ was no different to the predicate when evaluated by micro-computed tomography, histomorphometric analysis and histological analysis, providing in vivo evidence for substantial equivalence of the two devices.
CONCLUSION IX.
The intended use, principles of operation, and technological characteristics of Striate+TM are substantially equivalent to the predicate device Bio-Gide (K042197). Any differences observed between the subject and predicate device were minor and would not be expected to impact the safety and performance of the device. Therefore, it can be concluded that Striate+TM is substantially equivalent to the predicate Bio-Gide®.