(338 days)
Not Found
No
The device description and intended use clearly state it is a physical retraction cord made of cotton, with or without aluminum chloride. There is no mention of software, algorithms, or any computational processing that would suggest AI/ML.
No
The device is used for temporary gingival retraction and hemostasis, which are procedures that facilitate other dental work rather than directly treating a disease or condition. While it aids in a medical procedure, its primary function is not therapeutic in nature.
No
Explanation: The device, Smartcord, is described as a "knitted retraction cord" for "temporary gingival retraction and hemostasis." Its function is to physically retract gingival tissue and control bleeding, which are therapeutic actions, not diagnostic. There is no mention of it being used to detect, diagnose, or monitor a medical condition.
No
The device description clearly states it is a knitted retraction cord made from cotton, which is a physical material, not software. The performance studies also focus on biocompatibility testing of the material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "temporary gingival retraction" and "hemostasis of the gingival margin." These are procedures performed directly on a patient's tissues (in vivo), not on samples taken from the body (in vitro).
- Device Description: The device is a physical retraction cord made of cotton, with or without aluminum chloride. This is a physical device used in a dental procedure, not a reagent or instrument used to analyze biological samples.
- Anatomical Site: The device is used on the "gingival margin" and "gingival sulcus," which are parts of the patient's mouth.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MVL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gingival margin, Gingival sulcus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental professional
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 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]
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.
Not Found
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
N/A
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:
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"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 Company | |
| Products | - | ||
| 510(k) Number | New | K132526 | - |
| Classification | |||
| Name | 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 knitted | ||
| retraction cord made from | |||
| 100% cotton. | Knit-Pak™ Gingival | ||
| retraction cord is non-impregnated knitted cord | |||
| made from 100% cotton. | Same | ||
| Indications for | |||
| Use | Smartcord is knitted | ||
| retraction cord made from | |||
| 100% cotton for the | |||
| temporary gingival | |||
| retraction. | Not Listed | - | |
| Raw material | Yarn : cotton | ||
| Coloring agent | Yarn : cotton | ||
| Coloring agent | Same | ||
| Gingival | |||
| retraction cord | |||
| Type | Non-Impregnated | Non-Impregnated | Same |
| Recommended | |||
| contact 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 the | ||
| retraction cords are | |||
| available in various colors | |||
| to 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 Company | |
| Products | - | ||
| 510(k) Number | New | K132526 | - |
| Classification | |||
| Name | 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 knitted | ||
| retraction cord made from | |||
| 100% cotton, impregnated | |||
| with Aluminum Chloride | |||
| Hexahydrate. | Not Listed | - | |
| Indications for | |||
| Use | Smartcord X is knitted | ||
| retraction cord made from | |||
| 100% cotton, impregnated | |||
| with Aluminum Chloride | Knit-Pak+ impregnated | ||
| consists of a specialized | |||
| design of knitted | |||
| polyamide/polyester | Same | ||
| Hexahydrate for the | |||
| temporary gingival | |||
| retraction and hemostasis | |||
| of the gingival margin. | conjugated cord. This | ||
| retraction cord is | |||
| impregnated with | |||
| Aluminum | |||
| ChlorideHexahydrate and | |||
| is intended for accurate | |||
| and enhanced results | |||
| when acquiring dental | |||
| impressions, for cavity | |||
| preparation or wherever | |||
| hemostasis and retraction | |||
| is required. | |||
| Contents | Aluminum chloride | ||
| hexahydrate(1.2mg±0.8m | |||
| g/inch) | AlCl36H2O(0.5mg±0.1mg/ | ||
| inch) | Different. But the products | ||
| consisting up to 15% | |||
| Aluminum Chloride | |||
| (Aluminum Chloride | |||
| Hexahydrate) fall under | |||
| the OTC monograph | |||
| accepted by the FDA. | |||
| Raw material | Yarn : cotton | ||
| Hemostatic agent : | |||
| Aluminum chloride | |||
| hexahydrate | |||
| Coloring agent | Yarn : polyamide/polyester | ||
| Hemostatic agent : | |||
| Aluminum chloride | |||
| hexahydrate | |||
| Coloring agent | Different. Yarns are | ||
| different, but hemostatic | |||
| agent (Aluminum chloride | |||
| hexahydrate) is the same. | |||
| Gingival | |||
| retraction cord | |||
| Type | Impregnated | Impregnated | Same |
| Body contact | Gingival sulcus | Gingival sulcus | Same |
| Recommended | |||
| contact 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 the | ||
| retraction cords are | |||
| available in various colors | |||
| to be a dark to maximize | |||
| contrast with the tissues, | |||
| tooth, and cord. | |||
| Thickness | · 03 | ||
| · 02 | |||
| · 0 | |||
| · 1 | |||
| · 2 | · 000.0 | ||
| · 000 | |||
| · 00 | |||
| · 0 | |||
| · 1 | |||
| · 2 | Different. Retraction cords | ||
| are available in various | |||
| diameters (thickness) to | |||
| accommodate variations | |||
| in gingival anatomy. | |||
| Length | 254cm / 100 inches | 254 cm / 100 inches | Same |
| 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 | 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.