(375 days)
No
The device description and performance studies focus on the physical properties and clinical outcomes of the sutures, with no mention of AI or ML.
Yes.
The device is used for soft tissue approximation and face suspension surgery, which are therapeutic interventions.
No
The device description indicates that the MINT Product Family Sutures are used for "soft tissue approximation" and "face suspension surgery to temporarily fixate the cheek sub dermis in an elevated position." These are treatment applications, not diagnostic ones. There is no mention of the device being used to detect, identify, or assess a medical condition.
No
The device description clearly states the device is comprised of physical sutures made of polydioxanone, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics 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 of the body to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the MINT Product Family sutures are surgical sutures comprised of polydioxanone. Their intended use is for soft tissue approximation and face suspension surgery. These are procedures performed within the body during surgery.
The device is a surgical implant used for physical manipulation of tissue, not for analyzing biological samples to diagnose or monitor a condition.
N/A
Intended Use / Indications for Use
MINT Product Family (Including MINT Lift, and MINT-I Sutures) are comprised of PDO and are indicated for use in soft tissue approximation where use of a barbed absorbable suture is appropriate.
These sutures are also indicated for use in face suspension surgery to temporarily fixate the cheek sub dermis in an elevated position.
Product codes (comma separated list FDA assigned to the subject device)
NEW
Device Description
MINT Product Family Sutures are synthetic, absorbable, sterile, surgical sutures comprised of polydioxanone. These sutures are available in a range of lengths and thicknesses and have bi-directional barbs which hold the suture in position and exert tension throughout the length of the suture. These sutures are provided sterile. They degrade and reabsorb over time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, face (cheek sub dermis)
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 Performance Data: Additional testing was conducted and relevant scientific data collated for this 510(k) in alignment with the FDA guidance "Class II Special Controls Guidance Document: Surgical Sutures," confirming that the design output meets the design inputs and specifications for the sutures. Testing conducted included biocompatibility evaluation and testing per ISO 10993-1, ISO 10993-5, and ISO 10993-10; tensile strength testing to confirm USP monograph strength; barb holding strength testing; suture-needle attachment strength testing to confirm USP monograph strength; needle corrosion resistance testing; needle flexural stress testing; cannula pull testing; and needle penetration testing. The results demonstrate substantial equivalency between the subject and predicate device.
Animal Performance Data: No animal testing was conducted for this submission.
Clinical Performance Data: Published clinical literature was reviewed and utilized to support his submission. A comprehensive literature search was conducted and 10 relevant articles were found and evaluated. This published literature includes the difference in indications for use, which expanded claims from the predicate and reference from use in mid-face suspension surgery to use in face suspension surgery. This consisted of published articles supporting the safety and effectiveness of the changes from the predicate, with an aggregate number of more than 500 patients with clinical follow-up of a minimum of 3 months, including some patients with follow-up of 22+ months. Patient demographics varied, and most patients were Asian and female. Most patients experienced significant improvements in appear and, when evaluated, were satisfied with the procedure. Complications were generally mild, self-resolving, and similar to those caused by similar devices and/or the procedure itself. Results of the clinical literature support that the subject sutures are substantially equivalent to the predicate device in performance, safety, and effectiveness.
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.
K172602, K190245, K082097, K130191, K163676
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.
0
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March 7, 2023
Hans Biomed Corporation % Sarah Fitzgerald Senior Consultant, Quality and Regulatory Affairs Emergo by UL 2500 Bee Caves Road, Building 1 Suite 300 Austin, Texas 78746
Re: K220549
Trade/Device Name: MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW Dated: February 8, 2023 Received: February 8, 2023
Dear Sarah Fitzgerald:
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
1
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) 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.
Deborah A. Fellhauer -S
Deborah Fellhauer RN, BSN Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220549
Device Name MINT Product Family
Indications for Use (Describe)
MINT Product Family (Including MINT Lift, and MINT-I Sutures) are comprised of PDO and are indicated for use in soft tissue approximation where use of a barbed absorbable suture is appropriate.
These sutures are also indicated for use in face suspension surgery to temporarily fixate the cheek sub dermis in an elevated position.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ✖ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K220549 510(k) Summary
MINT Product Family
1. Submission Sponsor
Hans Biomed Corporation 64, Yuseong-Daero 1628 Beon-Gil Yuseong-Gu, Daejeon 34054 Korea Contact: Lucy Choi Title: General Manager Telephone: 82-3-5436-2436 Email: lucy@hansbiomed.com
2. Submission Correspondent
Emergo by UL 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Contact: Sarah Marie Fitzgerald Title: Senior Consultant, Quality and Regulatory Affairs Office Phone: (512) 222-0250 x70250 Email: sarah.fitzgerald@ul.com
3. Date Prepared
February 23, 2023
4. Device Identification
| Trade/Proprietary Name: | MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures) |
|---|---|
| Common/Usual Name: | Polydioxanone absorbable surgical suture |
| Classification Name: | Polydioxanone absorbable surgical suture |
| Review Panel: | General & Plastic Surgery |
| Regulation Number: | 878.4840 |
| Class: | Class II |
| Product Code: | NEW |
5. Device Description
MINT Product Family Sutures are synthetic, absorbable, sterile, surgical sutures comprised of polydioxanone. These sutures are available in a range of lengths and thicknesses and have bi-directional
4
K220549 barbs which hold the suture in position and exert tension throughout the length of the suture. These sutures are provided sterile. They degrade and reabsorb over time.
Page 2 of 4
6. Indications for Use
MINT Product Family (including MINT, MINT Lift, and MINT-I Sutures) are comprised of PDO and are indicated for use in soft tissue approximation where use of a barbed absorbable suture is appropriate.
These sutures are also indicated for use in face suspension surgery to temporarily fixate the cheek sub dermis in an elevated position.
7. Equivalence Claimed to Predicate Device
The MINT Product Family (including MINT, MINT Lift, and MINT-I Sutures) is equivalent to the MINT Product Family (cleared in K192423), manufactured by Hans Biomed Corporation. Miracu (K172602), PDS Barbed Suture, PDO MAXX Threads (K190245), Demetech PDO Absorbable Suture (K082097), MINT (K130191), and Silhouette InstaLift (K163676) are provided as reference devices.
| | Subject MINT Product
Family Sutures | Predicate MINT Product
Family Sutures K192423 | Reference Devices
(As noted below) | Comparison |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code
/ Regulation | NEW / 21 CFR 878.4840 | NEW / 21 CFR 878.4840 | NEW / 21 CFR
878.4840 (K082097,
K130191, K172602,
K190245) or GAM /
21 CFR 879.4493
(K163676) | Same or Equivalent
Both product codes
are for absorbable,
sterile, flexible
surgical sutures for
soft tissue
approximation. GAM
is simply for a
different material. |
| Intended Use | Absorbable surgical
sutures for use in soft
tissue | Absorbable surgical
sutures for use in soft
tissue | Absorbable surgical
sutures for use in
soft tissue (All) | Same |
| Indications for
Use | MINT Product Family
(including MINT, MINT
Lift, and MINT-I Sutures)
are comprised of PDO
and are indicated for use
in soft tissue
approximation where use
of a barbed absorbable
suture is appropriate.
These sutures are also
indicated for use in face
suspension surgery to
temporarily fixate the
cheek sub dermis in an
elevated position. | MINT is indicated for use
in mid-face suspension
surgery to temporarily
fixate the cheek
subcutaneous fat layer
and SMAS layer in an
elevated position for the | The Silhouette
Instalift device is
indicated for use in
mid-face suspension
surgery to
temporarily fixate
the cheek sub dermis | Equivalent
Slight rewording for
clarity. No difference
in meaning.
Equivalent
Published clinical
data demonstrates
no difference in
safety or
effectiveness. |
Comparison of Characteristics
5
| K220549 | ||||
|---|---|---|---|---|
| Subject MINT Product | ||||
| Family Sutures | Predicate MINT Product | |||
| Family Sutures K192423 | Reference Devices | |||
| (As noted below) | Comparison | |||
| treatment of moderate to | ||||
| severe nasolabial folds. | in an elevated | |||
| position. (K163676) | ||||
| Suture | ||||
| Material | Polydioxanone | Polydioxanone | N/A (Subject same as | |
| predicate) | Same | |||
| Suture | ||||
| Characteristics | Synthetic absorbable | |||
| monofilament with bi- | ||||
| directional barbs along | ||||
| the long axis | Synthetic absorbable | |||
| monofilament with bi- | ||||
| directional barbs along | ||||
| the long axis | N/A (Subject same as | |||
| predicate) | Same | |||
| Sterilization | Ethylene oxide | Ethylene oxide | N/A (Subject same as | |
| predicate) | Same | |||
| Size (USP) | Compliant with USP | |||
| Standard Suture Sizes | Compliant with USP | |||
| Standard Suture Sizes | N/A (Subject same as | |||
| predicate) | Same | |||
| Contact Type | Implant, Absorbable | Implant, Absorbable | N/A (Subject same as | |
| predicate) | Same | |||
| Contact | ||||
| Duration | >30 Days | >30 Days | N/A (Subject same as | |
| predicate) | Same | |||
| Suture | ||||
| Diameter | Compliant with USP | |||
| requirements | Compliant with USP | |||
| requirements | N/A (Subject same as | |||
| predicate) | Same | |||
| Suture Tensile | ||||
| Strength | Compliant with USP | |||
| requirements | Compliant with USP | |||
| requirements | N/A (Subject same as | |||
| predicate) | Same | |||
| Suture-Needle | ||||
| Attachment | Compliant with USP | |||
| requirements | Compliant with USP | |||
| requirements | N/A (Subject same as | |||
| predicate) | Same | |||
| Accessories | Optional tapered / Blunt | |||
| needle or cannula | Optional tapered / blunt | |||
| needle | Optional sharp or | |||
| blunt needle / | ||||
| cannula (K172602 | ||||
| and K190245) | Equivalent | |||
| Accessory | ||||
| Material | ||||
| (Patient | ||||
| Contacting) | Stainless Steel (SUS 304) | Stainless Steel (SUS 304) | N/A (Subject same as | |
| predicate) | Same |
This submission is to add the following to the products cleared under K192423 and K130191:
- Expanded indications for use
- Additional MINT Suture types / models
- . Additional accessory to facilitate suture implantation
Non-Clinical Performance Data 8.
Additional testing was conducted and relevant scientific data collated for this 510(k) in alignment with the FDA guidance "Class II Special Controls Guidance Document: Surgical Sutures," confirming that the design output meets the design inputs and specifications for the sutures.
All differences form the previous cleared 510(k)s for MINT sutures are equivalent or the same as for reference devices. Testing and evaluation was conducted in alignment with "Class II Special Controls Guidance Document: Surgical Sutures." Testing conducted included biocompatibility evaluation and testing per ISO 10993-1, ISO 10993-5, and ISO 10993-10; tensile strength testing to confirm USP monograph strength; barb holding strength testing; suture-needle attachment strength testing to confirm USP
6
monograph strength; needle corrosion resistance testing; needle flexural stress testing; cannula pull testing; and needle penetration testing.
Additionally, the change in terminology to cheek sub dermis is supported as the language is the same as that used for the reference device.
The results of the non-clinical performance testing demonstrate substantial equivalency between the subject and predicate device.
9. Animal Performance Data
No animal testing was conducted for this submission.
10. Clinical Performance Data
Published clinical literature was reviewed and utilized to support his submission. A comprehensive literature search was conducted and 10 relevant articles were found and evaluated.
Published literature regarding clinical experience from regions where the additional suture types and accessories are legally available was provided to substantiate the differences from the subject and predicate device. This published literature includes the difference in indications for use, which expanded claims from the predicate and reference from use in mid-face suspension surgery to use in face suspension surgery. This consisted of published articles supporting the safety and effectiveness of the changes from the predicate, with an aggregate number of more than 500 patients with clinical follow-up of a minimum of 3 months, including some patients with follow-up of 22+ months. Patient demographics varied, and most patients were Asian and female. Most patients experienced significant improvements in appear and, when evaluated, were satisfied with the procedure. Complications were generally mild, self-resolving, and similar to those caused by similar devices and/or the procedure itself. Complications included skin dimpling, pain, edema, ecchymosis, pustule formation, swelling, tightness / discomfort, alopecia, thread exposure / extrusion, depression at entry point, irregularities of the skin, facial asymmetry, and infection.
Results of the clinical literature support that the subject sutures are substantially equivalent to the predicate device in performance, safety, and effectiveness.
11. Statement of Substantial Equivalence
All testing and evidence confirms that the subject device does not raise any new questions related to the safety or effectiveness and that the device is at least as effective as the predicate device for the intended use and indications for use. Therefore, the device can be considered substantially equivalent to the predicate device.