(261 days)
OpenTex is a temporarily implantable material (non-resorbable) for as a space-making barrier in the treatment of periodontal defects.
OpenTex is a non-resorbable PTFE membrane composed of proprietary 100% polytetrafluoroethylene (PTFE) sheet with inert biological features and predictable barrier effect. OpenTex is designed to function as a physical barrier to avoid gingival cell invasion, thus providing a favorable environment for neovascularization and bone derived cells to repopulate and repair the defect. Since space-making is critical to this procedure, the membrane is sufficiently stiff to prevent spontaneous collapse but supple enough to conform easily to tissue contours. OpenTex is supplied sterile and intended for single use only. It is available in various sizes.
This is a 510(k) summary for a medical device called OpenTex, a non-resorbable PTFE membrane for guided tissue regeneration in periodontal defects. The information provided is for regulatory clearance and does not involve AI or algorithms with human-in-the-loop performance. Therefore, many of the requested fields are not applicable.
Here's an analysis of the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Method | Acceptance Criteria | Reported Device Performance (OpenTex) | Predicate Device Performance (Salvin CytoSurg™) | Remarks |
|---|---|---|---|---|---|
| pH | pH measurement test | Difference between blank and extracts < 1.5 | 6.23 (pH) | 6.21 (pH) | Results met criteria and were comparable. |
| Dissolution / Solubility | Evaporation residue test | Evaporation residue of extraction liquid $\leq$ 1.0 mg | 0 mg | 0 mg | Results met criteria and were comparable. |
| Tensile Strength | ASTM D882 | $\geq$ 34 MPa (Internal) | 72.1524 MPa | 33.8444 MPa | Met criteria and was higher than predicate. |
| Tear Resistance | ISO 6383-1 | $\geq$ 1.5 kgf/mm (Internal) | 5.9254 kgf/mm | 1.288 kgf/mm | Met criteria and was higher than predicate. |
| Suture Retention Strength | ANSI/AAMI/ISO 7198 | Equivalent to result of predicate device. (There isn't a numerical criterion, but rather a comparative one.) | 1.083 MPa | 0.842 MPa | Higher than predicate device. |
| Biocompatibility | ISO 10993 series | Compliance with ISO 10993-1, -3, -5, -6, -10, -11 | Evaluated and presumably met | Not explicitly stated; assumed compliant as predicate. | Evaluated for Cytotoxicity, Irritation, Sensitization, Genotoxicity, Acute Toxicity, Subacute Toxicity, Implantation, Material mediated pyrogenicity. |
| Sterilization | ISO 11135 | Sterility Assurance Level (SAL) of 10^-6 | SAL of 10^-6 | SAL of 10^-6 | Demonstrated compliance with standard. |
2. Sample size used for the test set and the data provenance
The document describes non-clinical bench testing comparing the physical and chemical properties of OpenTex to its predicate device. This type of testing typically uses a small number of samples (often 3-5 per test) to evaluate material properties under controlled laboratory conditions, rather than a "test set" in the context of AI or clinical trials. The specific sample sizes for each test are not explicitly provided in the document.
The data provenance is from laboratory testing performed by the manufacturer, Purgo Biologics Inc. The country of origin for the data is implicitly South Korea, where the company is located. The data is non-clinical performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the document describes bench testing of physical and chemical properties, not a clinical study involving human reads or expert ground truth establishment for diagnostic purposes. The "ground truth" here is the adherence to established international standards and internal criteria for material performance.
4. Adjudication method for the test set
This question is not applicable as there is no clinical test set requiring adjudication by experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. The device is a physical bone grafting material (membrane), not an AI-assisted diagnostic or therapeutic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the performance tests is based on established international standards (e.g., ASTM D882, ISO 6383-1, ANSI/AAMI/ISO 7198, ISO 10993 series, ISO 11135) and internal criteria set by the manufacturer to demonstrate substantial equivalence to the predicate device.
8. The sample size for the training set
This question is not applicable. There is no "training set" as this is a physical medical device for which performance is evaluated through non-clinical testing, not a machine learning model.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as #8.
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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.
Purgo Biologics Inc. Byungsun Kim RA Team Manager #812, 27 Dunchon-daero 457beon-gil, Jungwon-gu Seongnam-si, Gyeonggi-do 13219 Korea. South
5/11/23
Re: K222549
Trade/Device Name: OpenTex Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPK Dated: April 10, 2023 Received: April 11, 2023
Dear Byungsun Kim:
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 aware 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.
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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 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 Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image contains a logo for "Purgo Dental Biologics Solution". The logo features a gray circular icon with a smaller circle inside and a line extending upwards, resembling a stylized atom or molecule. To the right of the icon, the word "Purgo" is written in a bold, purple font. Further to the right, the words "Dental Biologics Solution" are stacked vertically, also in purple, but in a smaller font size.
Indication for use
510(k) Number: K222549
Device Name: OpenTex
Indication for use:
OpenTex is a temporarily implantable material (non-resorbable) for as a space-making barrier in the treatment of periodontal defects.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _____________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Indication for use
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Image /page/3/Picture/0 description: The image shows the logo for Purgo Dental Biologics Solution. The logo features a gray atom-like symbol on the left, followed by the word "Purgo" in a bold, purple font. To the right of "Purgo" are the words "Dental Biologics Solution" stacked on top of each other, also in purple.
510(k) Summary
05/10/2023
1. Company
| Submitter | |
|---|---|
| Name | Purgo Biologics Inc. |
| Address | #812, 27 Dunchon-daero 457beon-gil, Jungwon-gu, Seongnam-si,Gyeonggi-do, Korea 13219 |
| Phone/Fax | Tel. +82-70-4827-0451, Fax. +82-70-8673-0660 |
| Contact person | Byungsun Kim / RAkimbs@purgobio.com |
| Summary Date | 05/10/2023 |
2. Device Name
| Proprietary name | : | OpenTex |
|---|---|---|
| Regulation number | : | 21 CFR 872.3930 |
| Regulation Description | : | Bone Grafting Material |
| Product code | : | NPK |
| Classification name | : | Barrier, Synthetic, Intraora |
| Device class | : | Class II |
| Classification Panel | : | Dental |
3. Predicate Device
| Primary predicate device | |
|---|---|
| K160493 | Salvin CytoSurg™ Non-Resorbable PTFE Membrane |
Reference device K964342 Cytoplast GBR
510(k) Summary
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4. Indication for use
OpenTex is a temporarily implantable material (non-resorbable) for as a space-making barrier in the treatment of periodontal defects.
5. Description
OpenTex is a non-resorbable PTFE membrane composed of proprietary 100% polytetrafluoroethylene (PTFE) sheet with inert biological features and predictable barrier effect.
OpenTex is designed to function as a physical barrier to avoid gingival cell invasion, thus providing a favorable environment for neovascularization and bone derived cells to repopulate and repair the defect. Since space-making is critical to this procedure, the membrane is sufficiently stiff to prevent spontaneous collapse but supple enough to conform easily to tissue contours.
OpenTex is supplied sterile and intended for single use only. It is available in various sizes as shown below.
| Size | Thickness | Packaging |
|---|---|---|
| 12 x 20 mm | 0.16 mm | |
| 14 x 24 mm | ||
| 17 x 25 mm | 1ea / box | |
| 20 x 25 mm | 5ea / box | |
| 24 x 30 mm | 10ea / box | |
| 30 x 40 mm |
6. Performance Data
Non-clinical testing was performed in accordance with FDA recognized consensus standards and FDA guidance as applicable.
· Performance testing was performed to demonstrate substantial equivalence of the subject device to its primary predicate device as table below. The test results of the subject device met the criteria and was equal or higher than that of the predicate device.
510(k) Summary
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Image /page/5/Picture/0 description: The image shows the logo for Purgo Dental Biologics Solution. The logo features a gray circular icon with a smaller circle inside, followed by the word "Purgo" in a purple, bold font. To the right of "Purgo" are the words "Dental Biologics Solution" stacked on top of each other in a smaller, purple font.
| Test item | Test method | Criteria | Results |
|---|---|---|---|
| pH | pH measurement test | Difference between the blankand the extracts< 1.5 (Internal)* pH measured- Blank: 6.23- Subject device: 6.23- Predicate device: 6.21 | The results of both devices metthe criteria. |
| Dissolution/ Solubility | Evaporation residue test | Evaporation residue of theextraction liquid$\leq$ 1.0mg | The results of both devices metthe criteria. |
| Tensile strength | ASTM D882 | ≥ 34 MPa (Internal) | The result of the subject devicemet the criteria and was higherthan that of predicate device. |
| Tear resistance | ISO 6383-1 | ≥ 1.5 kgf/mm (Internal) | The result of the subject devicemet the criteria and was higherthan that of predicate device. |
| Suture retentionstrength | ANSI/AAMI/ISO 7198 | Criteria for the subject devicewas established as equivalentto result of predicate device. | The result of the subject devicewas higher than that of predicatedevice. |
· Biocompatibility was evaluated in accordance with ISO 10993 series as followings.
- Biocompatibility risk assessment per ISO 10993-1
- Cytotoxicity per ISO 10993-5
- Irritation per ISO 10093-10
- Sensitization per ISO 10993-10
- Genotoxicity per ISO 10993-3
- Acute toxicity per ISO 10993-11
- Subacute toxicity per ISO 10993-11
- Implantation per ISO 10993-6
- Material mediated pyrogenicity per ISO 10993-11
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Image /page/6/Picture/0 description: The image shows the logo for Purgo Dental Biologics Solution. The logo features a gray atom-like symbol on the left, followed by the word "Purgo" in a purple sans-serif font. To the right of "Purgo" are the words "Dental Biologics Solution" stacked vertically, also in purple.
· EO(Ethylene Oxide) gas sterilization process validation was performed accordance with ISO 11135 demonstrating a sterility assurance level (SAL) of 10-6.
No clinical data were included in this submission.
7. Technological Characteristics
The following comparison table of the technological characteristics of the subject device and the predicate device outlines and provides the substantial equivalency of the subject device and the predicate.
| Subject device | Predicate device | |||
|---|---|---|---|---|
| Primary predicatedevice | Reference device | Discussion | ||
| Device name | OpenTex | Salvin CytoSurg™Non-Resorbable PTFEMembrane | Cytoplast GBR | - |
| Manufacturer | Purgo Biologics Inc. | Salvin DentalSpecialties | OsteogenicsBiomedical, Inc. | - |
| 510(k) Number | New Device | K160493 | K964342 | - |
| Indication foruse | OpenTex is a temporarilyimplantable material (non-resorbable) for as a space-making barrier in thetreatment of periodontaldefects. | The Salvin CytoSurg™Non-Resorbable PTFEMembrane istemporarily implantablematerial(non-resorbable) for asa space-making barrierin the treatment ofperiodontal defects. | A temporarilyimplantable material(non-resorbable) for useas a space-makingbarrier in the treatmentof periodontal defects. | Substantially equivalent |
| Materials | PTFE | PTFE | PTFE | EquivalentThe subject and predicatedevices are composed ofPTFE. |
| Form | Membrane(Plain, Textured type) | Membrane(Textured type) | Membrane(Textured type) | EquivalentThe subject device isprovided in plain andtextured type while thepredicate devices areprovided in textured type.Textured type ismanufactured by giving |
| PTFE sheet a texturedsurface through the 'patteninput' process. Because thisprocess does not affect theproperties of PTFE sheet,the property of plain andtextured type is same. Theequivalence of performanceto the predicate device wasverified trough the benchtesting.Equivalent | ||||
| Size | 12 x 20 mm, 14 x 24 mm17 x 25 mm, 20 x 25 mm24 x 30 mm, 30 x 40 mm | 12 x 24 mm, 25 x 30mm | 12 x 24 mm, 25 x 30mm | EquivalentThe subject and predicatedevices are provided invarious sizes for intra-oralsurgical procedures. |
| Thickness | 0.16 mm | 0.25 mm | 0.25 mm | EquivalentThe subject is thinner thanthe predicate, but theequivalence of performancewas verified trough thebench testing. |
| Sterilization | Sterile(ETO, SAL 10-6) | Sterile(ETO, SAL 10-6) | Sterile(ETO, SAL 10-6) | Identical |
| Shelf-life | 5 years | Unknown | 5 years | EquivalentThe shelf-life of the subjectdevice is equivalent to thereferemce device. |
| pH | 6.23 | 6.21 | Unknown | Equivalent |
| Dissolution/ Solubility | 0 mg | 0 mg | Unknown | EquivalentThe performance test resultsof the subject device met thecriteria and was equal orhigher than that of thepredicate device. |
| Tensile strength | 72.1524 MPa | 33.8444 MPa | Unknown | |
| Tear resistance | 5.9254 kgf/mm | 1.288 kgf/mm | Unknown | |
| Suture retentionstrength | 1.083 MPa | 0.842 MPa | Unknown | |
| Use | Prescription | Prescription | Prescription | |
| Single Use Only | Yes | Yes | Yes | Identical |
| Duration ofimplantation | Less than 30 days | Less than 30 days | Less than 30 days | EquivalentThe subject and predicatedevices are temporarilyimplantable materials andintended to be removedwithin 30 days. |
Comparison of Characteristics
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Image /page/7/Picture/0 description: The image contains a logo for a dental biologics solution. The logo features a gray atom-like symbol on the left, followed by the word "Purgo" in a purple, bold font. To the right of "Purgo", the words "Dental Biologics Solution" are stacked vertically, also in purple.
The subject device is substantially equivalent to the primary predicate device K160493 in indication for use, material, design(form), sterilization and duration of implantation. Both devices are provided
510(k) Summary
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Image /page/8/Picture/0 description: The image is a logo for Purgo Dental Biologics Solution. The logo features a gray atom-like symbol on the left, followed by the word "Purgo" in a purple sans-serif font. To the right of "Purgo" are the words "Dental Biologics Solution" stacked vertically, also in purple.
in various sizes for intra-oral surgical procedures. The subject device is thinner than the predicate devices, but the equivalence of performance was verified through tensile strength and tear resistance tests.
8. Conclusion
Based on the information provided, the subject device is substantially equivalent to the primary predicate device.
§ 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.