(199 days)
Not Found
No
The device description and performance studies focus on the physical properties and equivalence to a predicate device, with no mention of AI or ML.
Yes
The device is used in the treatment of periodontal defects, which makes it a therapeutic device.
No
Explanation: The device is described as a temporarily implantable material used as a space-making barrier in the treatment of periodontal defects. Its purpose is therapeutic (treatment), not diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly states it is a physical membrane made of PTFE material, which is a hardware component.
No, 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 device used in vivo (within the body) for a therapeutic purpose (treating defects).
- Device Description: The description details a "temporarily implantable material" made of PTFE. This further confirms its use within the body.
- Lack of IVD Characteristics: An IVD is a device used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The information provided clearly indicates this is a medical device used for surgical intervention, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Salvin CytoSurg™ Non-Resorbable PTFE Membrane is a temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.
Product codes
NPK
Device Description
The Salvin CytoSurg™ Non-Resorbable PTFE Membrane is composed of microporous PTFE material. It has a nominal thickness of 250 microns and is supplied in two sizes (25mm x 30mm and 12mm x 24mm). The membranes are single use and are supplied in sterile sealed pouches.
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
Bench testing including tensile strength and tear resistance, as well as geometric comparisons of the Salvin Cytosurg™ device to the Unicare Biomedical Cytoflex® device demonstrated substantial equivalence.
The results for Biocompatibility Testing, Packaging Validations and Sterile Validation met their acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 8, 2016
Salvin Dental Specialties c/o John Kapitan President Kapstone Medical 100 E. South Main St., PO Box 1458 Waxhaw, North Carolina 28173
Re: K160493
Trade/Device Name: Salvin CytoSurg110 Non-Resorbable PTFE Membrane Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPK Dated: August 8, 2016 Received: August 11, 2016
Dear John Kapitan:
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. 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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely Yours,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510(k) Number (if known): K160493
Device Name: Salvin CytoSurg™ Non-Resorbable PTFE Membrane
Indications for Use:
The Salvin CytoSurg™ Non-Resorbable PTFE Membrane is a temporarily implantable material (nonresorbable) for use as a space-making barrier in the treatment of periodontal defects.
Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)
3
510(k) Summary
K160493
1. Applicant
Salvin Dental Specialties, Inc. 3450 Latrobe Drive Charlotte, NC 28211
Date Prepared: September 7, 2016 Contact Person: John Kapitan Tel: (704) 516-5120 Email: jkapitan@kapstonemedical.com
2. Device Name
| Proprietary Trade Name: | Salvin CytoSurg™ Non-Resorbable PTFE Membrane |
|---|---|
| Common/Usual Name: | PTFE Barrier Membrane |
| Classification Name: | Bone grafting material |
| Regulation Number: | 21CFR872.3930 |
| Product Code: | NPK |
| Classification: | II |
| Panel: | Dental |
3. Predicate Devices
The Salvin CytoSurg™ Non-Resorbable PTFE Membrane is substantially equivalent to the Cytoflex® Non-Resorbable Barrier Membrane, produced by Unicare Biomedical.
| Applicant | Salvin Dental | Unicare Biomedical |
|---|---|---|
| Product Name | CytoSurg™ Non-Resorbable | |
| PTFE Membrane | Cytoflex® Non-Resorbable | |
| Barrier Membrane | ||
| 510(k) Number | K160493 | K012144 |
| Product Code | NPK | NPK |
| Regulation # | 21CFR872.3930 | 21CFR872.3930 |
| Class | II | II |
| Prescription or O-T-C? | Prescription | Prescription |
| Provided Sterile or Non- | ||
| sterile? | Sterile | Sterile |
| Indications for Use | The Salvin CytoSurg™ Non- | |
| Resorbable PTFE Membrane is | ||
| a temporarily implantable | ||
| material (non-resorbable) for | ||
| use as a space-making barrier | ||
| in the treatment of | ||
| periodontal defects. | Cytoflex® is a temporarily | |
| implantable material (non- | ||
| resorbable) for use as a space- | ||
| making barrier in the | ||
| treatment of periodontal | ||
| defects. | ||
| Components and Size(s) | 250 micron thickness | 250 micron thickness |
Comparison Table
4
| Applicant | Salvin Dental | Unicare Biomedical |
|---|---|---|
| Product Name | CytoSurg™ Non-Resorbable | |
| PTFE Membrane | Cytoflex® Non-Resorbable | |
| Barrier Membrane | ||
| 25mm x 30mm | ||
| 12mm x 24mm | 25mm x 30mm | |
| Device/Implant Materials | ePTFE | ePTFE |
| Sterilization Methodology | ETO | ETO |
4. Description of the Device
The Salvin CytoSurg™ Non-Resorbable PTFE Membrane is composed of microporous PTFE material. It has a nominal thickness of 250 microns and is supplied in two sizes (25mm x 30mm and 12mm x 24mm). The membranes are single use and are supplied in sterile sealed pouches.
5. Indications for Use
The Salvin CytoSurg™ Non-Resorbable PTFE Membrane is a temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.
6. Technology Characteristics
The technological characteristics of the Salvin CytoSurg™ Non-Resorbable PTFE Membrane are equivalent to the predicate device. The subject and predicate devices have the same design including the same material, fiber size, and membrane thickness.
7. Summary of Performance Data
| Specific Tests Performed: | Tensile Strength |
|---|---|
| Tear Resistance | |
| ISO 10993-5 / Tests Cytotoxicity | |
| ISO 10993-6 / Tests Local Effects After Implantation | |
| ISO 10993-10 / Tests for irritation and skin sensitization | |
| ISO 10993-11 / Tests for Systemic Toxicity | |
| Packaging Validation | |
| Sterilization Validation |
Bench testing including tensile strength and tear resistance, as well as geometric comparisons of the Salvin Cytosurg™ device to the Unicare Biomedical Cytoflex® device demonstrated substantial equivalence. The results for Biocompatibility Testing, Packaging Validations and Sterile Validation met their acceptance criteria.
7. Conclusion
The Salvin CytoSurg™ Membrane is substantially equivalent to the Unicare Biomedical Cytoflex predicate device (K012144). In addition to conclusions from performance testing and geometric comparisons, the devices have "Indications for Use," are available by prescription only, utilize ePTFE material, and are provided sterile for single-use only. It can be concluded that the Salvin CytoSurg™ Membrane is substantially equivalent to the predicate device.