(261 days)
No
The device description and performance studies focus on the physical properties and biocompatibility of a PTFE membrane, with no mention of AI or ML capabilities.
Yes
The device is described as a "temporarily implantable material... for as a space-making barrier in the treatment of periodontal defects," which clearly indicates its use in the treatment of a medical condition.
No
Explanation: The device is described as a material for space-making barrier in the treatment of periodontal defects, functioning purely as a physical barrier for tissue regeneration. It does not mention any function related to identifying, analyzing, or monitoring medical conditions or diseases.
No
The device description clearly states it is a "temporarily implantable material" and a "non-resorbable PTFE membrane," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a space-making barrier in the treatment of periodontal defects." This describes a physical barrier used in vivo (within the body) during a surgical procedure.
- Device Description: The description details a temporarily implantable material (PTFE membrane) designed to function as a physical barrier to aid in tissue regeneration. This is a medical device used directly on or within the patient.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside the body.
This device is clearly a medical device used for a surgical procedure within the body, not a test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
OpenTex is a temporarily implantable material (non-resorbable) for as a space-making barrier in the treatment of periodontal defects.
Product codes
NPK
Device 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 |
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)
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.
Test item: pH
Test method: pH measurement test
Criteria: Difference between the blank and the extracts = 34 MPa (Internal)
Results: The result of the subject device met the criteria and was higher than that of predicate device.
Test item: Tear resistance
Test method: ISO 6383-1
Criteria: >= 1.5 kgf/mm (Internal)
Results: The result of the subject device met the criteria and was higher than that of predicate device.
Test item: Suture retention strength
Test method: ANSI/AAMI/ISO 7198
Criteria: Criteria for the subject device was established as equivalent to result of predicate device.
Results: The result of the subject device was higher than that of predicate device.
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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.
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 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
3
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 / RA |
| kimbs@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
4
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
5
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 blank | |
| and the extracts |