(138 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical function of a barbed suture, with no mention of AI or ML.
No.
The device is a surgical suture used for tissue approximation, which is a restorative rather than therapeutic function.
No
The device is described as a synthetic absorbable PDO suture used for soft tissue approximation. Its function is to approximate tissues, which is a therapeutic rather than a diagnostic action.
No
The device description clearly describes a physical, absorbable suture made of polydioxanone with barbs, which is a hardware medical 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 "soft tissue approximation where use of absorbable sutures is appropriate." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical suture made of polydioxanone with barbs. It is used to approximate tissues without tying knots. This is a physical device used in surgery.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The description of the MINT™ does not involve any of these activities.
The MINT™ is a surgical device used in vivo (within the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The MINT™ comprised of PDO is indicated for use in soft tissue approximation where use of an absorbable suture is appropriate.
Product codes
NEW
Device Description
The MINT™ synthetic absorbable PDO suture is made of polydioxanone has been found to be nonantigenic and to elicit only a slight tissue reaction during absorption. The pigment for the violet dye is D&C Violet No.2. The MINT™ is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue.
Each dyed (violet) suture has bi-directional barbs along the long axis of the suture monofilament without needle attachment. The MINTM Synthetic Absorbable PDO suture approximate tissues, without the need to tie surgical knots, by using the opposing barbs on the suture surface to embed in the tissues after the surgeon precisely places the suture within the tissues.
While the formation of barbs in the MINT™ reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in non-barbed suture materials also reduce their effective strength. For this reason, the strength of the MINT™ can be compared with USP knot strength of non-barbed sutures and the USP size of MINT™ is 1 while its tensile strength is equivalent to that of USP 2-0.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
Testing was performed per FDA's Class II Special Controls Guidance Document: Surgical Sutures, including testing in accordance with the USP monograph for absorbable sutures, in vitro and in vivo resorption testing, biocompatibility testing in accordance with ISO 10993, and a barb holding strength evaluation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
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K130191 Page 1/2
510(k) Submission
Mint™
510(K) SUMMARY
JUN 1 2 2013
This 510(k) Summary is being submitted in accordance with requirements of 21 CFR 807.92.
Submitter:
Ho Chan Hwang HansBiomed Corporation. 461-37, Jeonmin-dong, Yuseong-gu, Daejeon, 305-811, Korea Phone: 82-2-466-2266 Fax: 82-2-463-1554
Contact /US agent: April Lee KoDent, Inc. 325 N. Puente St. Unit B Brea, CA 92821 Phone: 714-525-0114 Fax: 714-525-0116
Date Prepared: 4/19/2013
Device Name: MINTTM
Trade Name: MINT™ Classification Name: Suture, Surgical, Absorbable, Polydioxanone Common Name: Absorbable polydioxanone surgical suture Classification: Class II Product Code: NEW Regulation number: 21 CFR 878.4840
General description
The MINT™ synthetic absorbable PDO suture is made of polydioxanone has been found to be nonantigenic and to elicit only a slight tissue reaction during absorption. The pigment for the violet dye is D&C Violet No.2. The MINT™ is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue.
Each dyed (violet) suture has bi-directional barbs along the long axis of the suture monofilament without needle attachment. The MINTM Synthetic Absorbable PDO suture approximate tissues, without the need to tie surgical knots, by using the opposing barbs on the suture surface to embed in the tissues after the surgeon precisely places the suture within the tissues.
While the formation of barbs in the MINT™ reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in non-barbed suture materials also reduce their effective strength. For this reason, the strength of the MINT™ can be compared with USP knot strength of non-barbed sutures and the USP size of MINT™ is 1 while its tensile strength is equivalent to that of USP 2-0.
1
510(k) Submission
Intended uses
The MINT™ comprised of PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.
Predicate device
- Quill™ Self-Retaining System (SRS) comprised of PDO(Polydioxanone), Angiotech . (Quill Medical, Inc) (K080985)
- . Quill™ Synthetic Absorbable Barbed Suture, Angiotech (Quill Medical, Inc) (K042075)
Safety and performance
Testing was performed per FDA's Class II Special Controls Guidance Document: Surgical Sutures, including testing in accordance with the USP monograph for absorbable sutures, in vitro and in vivo resorption testing, biocompatibility testing in accordance with ISO 10993, and a barb holding strength evaluation.
Substantial equivalence summary
The MINT™ has a substantially equivalent intended use as the identified predicate, Quill™ Self-Retaining System (SRS) comprised of PDO (Polydioxanone) manufactured by Angiotech and is made of polydioxanone intended for soft tissue approximation. The subject and predicate devices are composed of the same material (PDO), have bi-directional barbs, and have the same indications for use. The subject device differs from the predicate with respect to barb size and spacing.
Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Quill™ Self-Retaining System (SRS) comprised of PDO(Polydioxanone) (K080985) concludes that the MINT™ is substantially equivalent to predicate device as described herein.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing a bird or eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
June 12, 2013
HansBiomed Corporation % KoDent, Inc. Ms. April Lee 325 N. Puente Street, Unit B Brea, California 92821
Re: K130191
Trade/Device Name: MINT™ Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: Class II Product Code: NEW Dated: May 08, 2013 Received: May 10, 2013
Dear Ms. Lee:
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
3
Page 2 - Ms. April Lee
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
for
Sincerely yours.
David Kraiuse -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and "Radiological Health"
Enclosure
4
5. INDICATIONS FOR USE
510(k) Number (if known): K130191 Device Name: MINT™
Indications for Use:
The MINT™ comprised of PDO is indicated for use in soft tissue approximation where use of an absorbable suture is appropriate.
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)
David Krause -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130191