(338 days)
Smartcord is knitted retraction cord made from 100% cotton for the temporary gingival retraction.
Smartcord X is knitted retraction cord made from 100% cotton, impregnated with Aluminum Chloride for the temporary gingival retraction and hemostasis of the gingival margin.
Smartcord is non-impregnated knitted retraction cord made from 100% cotton. Smartcord X is knitted retraction cord made from 100% cotton, impregnated with Aluminum Chloride Hexahydrate.
The provided document is a 510(k) summary for the medical devices Smartcord and Smartcord X. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study proving the device meets those criteria.
Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance results are not available in this type of document.
Here's an analysis based on the information available in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly define specific performance acceptance criteria (e.g., minimum tensile strength, specific retraction efficacy metrics) or report quantitative results for the device against such criteria. Instead, it relies on demonstrating equivalence in material composition, intended use, and general properties to the predicate device.
The "performance" described is in the context of biocompatibility testing, which confirmed the device is biocompatible as directed.
| Acceptance Criteria (Not Explicitly Stated, Inferred from Equivalence) | Reported Device Performance (Summary from Biocompatibility) |
|---|---|
| Biocompatible for gingival sulcus contact (< 24 hours, external communicating device) | Meets ISO 10993-5 (Cytotoxicity) |
| Meets ISO 10993-10 (Oral mucous Irritation) | |
| Meets ISO 10993-10 (Sensitization) | |
| Functional equivalence to predicate in terms of gingival retraction and hemostasis (for Smartcord X) | Considered substantially equivalent due to similar materials, intended use, and performance characteristics to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified. The biocompatibility tests would have involved samples of the Smartcord X device, but the number of samples is not stated.
- Data Provenance: Not specified, but generally, non-clinical performance testing for 510(k) submissions is conducted as part of the device development and validation process by the manufacturer or accredited labs on behalf of the manufacturer. It's prospective in the sense that the tests are planned and executed to evaluate the device. The country of origin of the data is not specified beyond "EASTDENT CO., LTD." being from Korea.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not applicable. For biocompatibility testing, the "ground truth" is established by the standardized methods outlined in ISO 10993, and the results are interpreted by trained laboratory personnel. There isn't a concept of "expert ground truth" in the way it would be applied to diagnostic imaging interpretation.
- Qualifications of Experts: Not specified, but implied to be qualified laboratory personnel experienced in conducting and interpreting biocompatibility tests according to ISO standards.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. Biocompatibility testing involves objective laboratory measurements and observations against pre-defined criteria in the ISO standards, rather than subjective judgments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess performance improvement. Smartcord and Smartcord X are physical dental retraction cords, not diagnostic algorithms.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Standalone Performance Study: No, this is not applicable. There is no algorithm involved in the Smartcord or Smartcord X product. The assessment is of the physical device's properties and biological safety.
7. The Type of Ground Truth Used:
- Ground Truth: For biocompatibility, the "ground truth" is defined by the established biological responses and thresholds outlined in the ISO 10993 series of standards. This involves measuring cytotoxicity, irritation, and sensitization responses in laboratory models (e.g., cell cultures, animal models) and comparing them to acceptable limits defined by the standards.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. There is no AI or machine learning algorithm in these devices, so there is no training set.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" written below in a smaller font.
EASTDENT Co., Ltd Hyonsu Kim CEO 601-1 Sogong B/D. 64 Gugal-ro. Giheung-gu Yongin-si, 16972 Korea
Re: K171577
Trade/Device Name: Smartcord, Smartcord X Regulatory Class: Unclassified Product Code: MVL Dated: March 26, 2018 Received: April 3, 2018
Dear Hyonsu 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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
May 3, 2018
{1}------------------------------------------------
Page 2 - Hyonsu Kim
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -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}------------------------------------------------
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Smartcord, Smartcord X
Indications for Use (Describe)
Smartcord is knitted retraction cord made from 100% cotton for the temporary gingival retraction.
Smartcord X is knitted retraction cord made from 100% cotton, impregnated with Aluminum Chloride for the temporary gingival retraction and hemostasis of the gingival margin.
| ☑ 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
"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."
Type of Use (Select one or both, as applicable)
{3}------------------------------------------------
K171577
510(K) SUMMARY
Smartcord, Smartcord X
Date: ___ March 26, 2018
I. SUBMITTER
EASTDENT CO., LTD. 601-1, 64, Gugalro, Giheung-gu, Yongin-si, Gyeonggi-do, 16972, Korea
Tel: +82-31-693-5767 Fax: +82-31-693-5768
Contact Name: Hyonsu, Kim Email: eastdent@east-dent.com
II. DEVICE
| Name of Device: | Smartcord, Smartcord X |
|---|---|
| Regulation Name: | Retraction Cord |
| Classification Name: | Cord, Retraction |
| Regulatory Class: | Unclassified |
| Product Code: | MVL |
III. PREDICATE DEVICE
K132526, Knit Pak plus / Knit Pak ™, Premier dental company products, Inc.
IV. DEVICE DESCRIPTION
Smartcord is non-impregnated knitted retraction cord made from 100% cotton. Smartcord X is knitted retraction cord made from 100% cotton, impregnated with Aluminum Chloride Hexahydrate.
V. INDICATIONS FOR USE
{4}------------------------------------------------
Smartcord is knitted retraction cord made from 100% cotton for the temporary gingival retraction.
Smartcord X is knitted retraction cord made from 100% cotton, impregnated with Aluminum Chloride Hexahydrate for the temporary gingival retraction and hemostasis of the gingival margin.
VI. COMPARISON OF TECHNILOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE Smartcord
| Subject Device | Predicate Device | Summary | |
|---|---|---|---|
| Device Name | Smartcord | Knit-Pak™ | - |
| Manufacturer | EASTDENT CO., LTD. | Premier Dental CompanyProducts | - |
| 510(k) Number | New | K132526 | - |
| ClassificationName | Retraction Cord | Retraction Cord | Same |
| Product Code | MVL | MVL | Same |
| Device Class | Unclassified | Unclassified | Same |
| Intended user | Dental professional | Dental professional | Same |
| Description | Smartcord is non-impregnated knittedretraction cord made from100% cotton. | Knit-Pak™ Gingivalretraction cord is non-impregnated knitted cordmade from 100% cotton. | Same |
| Indications forUse | Smartcord is knittedretraction cord made from100% cotton for thetemporary gingivalretraction. | Not Listed | - |
| Raw material | Yarn : cottonColoring agent | Yarn : cottonColoring agent | Same |
| Gingivalretraction cordType | Non-Impregnated | Non-Impregnated | Same |
| Recommendedcontact time | 3 minutes | Not Listed | - |
| Color | · 03 : black/gray· 02 : brown/yellow· 0 : purple/light purple· 1 : blue/light blue· 2 : green/light green | · 000 : Green· 00 : Brown· 0 : Purple· 1 : Blue· 2 : Orange | Different. But theretraction cords areavailable in various colorsto be a dark to maximize |
| 3 : Yellow | contrast with the tissues, tooth, and cord. | ||
| Thickness | · 03· 02· 0· 1· 2 | · 000· 00· 0· 1· 2· 3 | Different. But the retraction cords are available in various diameters(thickness) to accommodate variations in gingival anatomy. |
| Length | 305 cm / 120 inches | 254 cm / 100 inches | Different |
| Biocompatibility | Device is biocompatible when used as directed by dental professionals per ISO 10993-1. | Device is biocompatible when used as directed by dental professionals per ISO 10993-1. | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
| Storage condition | Store in a dry, dark place between 1 and 35°C | Not Listed | - |
| Shelf Life | N/A | N/A | Same |
{5}------------------------------------------------
Smartcord X
| Subject Device | Predicate Device | Summary | |
|---|---|---|---|
| Device Name | Smartcord X | Knit-Pak+ | - |
| Manufacturer | EASTDENT CO., LTD. | Premier Dental CompanyProducts | - |
| 510(k) Number | New | K132526 | - |
| ClassificationName | Retraction Cord | Retraction Cord | Same |
| Product Code | MVL | MVL | Same |
| Device Class | Unclassified | Unclassified | Same |
| Intended user | Dental professional | Dental professional | Same |
| Description | Smartcord X is knittedretraction cord made from100% cotton, impregnatedwith Aluminum ChlorideHexahydrate. | Not Listed | - |
| Indications forUse | Smartcord X is knittedretraction cord made from100% cotton, impregnatedwith Aluminum Chloride | Knit-Pak+ impregnatedconsists of a specializeddesign of knittedpolyamide/polyester | Same |
| Hexahydrate for thetemporary gingivalretraction and hemostasisof the gingival margin. | conjugated cord. Thisretraction cord isimpregnated withAluminumChlorideHexahydrate andis intended for accurateand enhanced resultswhen acquiring dentalimpressions, for cavitypreparation or whereverhemostasis and retractionis required. | ||
| Contents | Aluminum chloridehexahydrate(1.2mg±0.8mg/inch) | AlCl36H2O(0.5mg±0.1mg/inch) | Different. But the productsconsisting up to 15%Aluminum Chloride(Aluminum ChlorideHexahydrate) fall underthe OTC monographaccepted by the FDA. |
| Raw material | Yarn : cottonHemostatic agent :Aluminum chloridehexahydrateColoring agent | Yarn : polyamide/polyesterHemostatic agent :Aluminum chloridehexahydrateColoring agent | Different. Yarns aredifferent, but hemostaticagent (Aluminum chloridehexahydrate) is the same. |
| Gingivalretraction cordType | Impregnated | Impregnated | Same |
| Body contact | Gingival sulcus | Gingival sulcus | Same |
| Recommendedcontact time | 3 minutes | Not Listed | - |
| Color | · 03 : black/gray· 02 : brown/yellow· 0 : purple/light purple· 1 : blue/light blue· 2 : green/light green | · 000.0 : Dark Green· 000 : Green· 00 : Brown· 0 : Purple· 1 : Blue· 2 : Orange | Different. But theretraction cords areavailable in various colorsto be a dark to maximizecontrast with the tissues,tooth, and cord. |
| Thickness | · 03· 02· 0· 1· 2 | · 000.0· 000· 00· 0· 1· 2 | Different. Retraction cordsare available in variousdiameters (thickness) toaccommodate variationsin gingival anatomy. |
| Length | 254cm / 100 inches | 254 cm / 100 inches | Same |
| Biocompatibility | Device is biocompatiblewhen used as directed bydental professionals perISO 10993-1. | Device is biocompatiblewhen used as directed bydental professionals perISO 10993-1. | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
| Storagecondition | Store in a dry, dark placebetween 1 and 35°C | Not Listed | |
| Shelf Life | 3 years | 3 years | Same |
{6}------------------------------------------------
{7}------------------------------------------------
VII. NON-CLINICAL PERFORMANCE TESTING
The biocompatibility evaluation for the Smartcord X device was conducted in accordance with the Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff, issued on: June 16, 2016, and international Standard ISO 10993-1 "Biological evaluation of medical devices - part 1: evaluation and testing within a risk management process" as recognized by FDA. The tests carried out for the devices and standards applied for each test are:
- . Cytotoxicity, ISO 10993-5[2009]
- . Oral mucous Irritation, ISO 10993-10[2010]
- ・ Sensitization, ISO 10993-10[2010]
Smartcord X is considered to be in contact with gingival sulcus for duration of less than 24 hours, while being the external communicating device.
VIII.SUBSTANTIAL EQUIVALENCE DISCUSSION
The subject device consists of gingival retraction non-impregnated or impregnated cord, as is the predicate device. The subject device is same to predicate device in terms of classification name, product code, device class, indication for use, intended user, contents, raw materials, gingival retraction cord type, body contact, biocompatibility, sterilization, storage condition and shelf life.
There are no new ingredients or technology used on subject device. Their physical properties and performance of subject device are not significantly different from the predicate device, as indicated by non-clinical performance testing. The colors and thickness are different between subject device and predicate device. Differences of thickness and colors exist between the subject device and the predicate device.
{8}------------------------------------------------
However, these differences of colors and thickness do not influence(affect) its intended use for performance. Dentist select the thickness of retraction cord by the type and form of gingiva. The purpose of color use is only to distinguish the retraction cords from the gingiva, and the various colors is used for identification of the thickness to accommodate variations in gingival types and forms.
IX. CONCLUSIONS
The indications and technological characteristics of Smartcord X are very similar to predicate device. Therefore, Subject devices are substantially equivalent to the identified predicate device.
N/A