(375 days)
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.
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.
The provided text is a 510(k) summary for the MINT Product Family of absorbable polydioxanone surgical sutures. It describes the device, its intended use, and argues for substantial equivalence to a predicate device. However, it does not contain the type of AI/ML device performance data, acceptance criteria, or study details (sample sizes, expert consensus, MRMC studies, etc.) that would typically be found for an AI/ML powered medical device.
The document is for surgical sutures, a physical medical device, not an AI/ML software device. Therefore, the requested information about acceptance criteria for an AI/ML device, details of diagnostic performance studies, expert involvement in ground truth, etc., are not present in this document.
The document discusses "non-clinical performance data" and "clinical performance data" related to the physical sutures, but these are for the material properties and safety/effectiveness of the suture itself, not for an AI/ML algorithm's diagnostic performance.
Therefore, I cannot provide the requested information because the provided text is about a physical surgical suture device, not an AI/ML software device.
The document does not describe:
- Acceptance criteria related to AI/ML performance (e.g., sensitivity, specificity, AUC)
- A test set size for an AI/ML model
- Data provenance for AI/ML training/testing
- Number/qualifications of experts for AI/ML ground truth
- Adjudication methods for AI/ML ground truth
- MRMC studies for AI/ML assistance
- Standalone AI algorithm performance
- Type of ground truth for an AI/ML model
- Training set size for an AI/ML model
- How ground truth for a training set was established for an AI/ML model.
What the document does discuss (related to the physical suture device):
- Non-Clinical Performance Data: Bench testing confirming compliance with USP standards for tensile strength, barb holding strength, suture-needle attachment strength, needle corrosion resistance, needle flexural stress, cannula pull testing, and needle penetration testing. Biocompatibility testing per ISO 10993.
- Clinical Performance Data: A review of published clinical literature (10 relevant articles) from regions where the product is available. This literature involved over 500 patients with a minimum of 3 months follow-up (some 22+ months) supporting the safety and effectiveness of the sutures for face suspension surgery. The literature addressed complications associated with the sutures and procedure, not an AI algorithm.
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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
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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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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
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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 ProductFamily Sutures | Predicate MINT ProductFamily Sutures K192423 | Reference Devices(As noted below) | Comparison | |
|---|---|---|---|---|
| Product Code/ Regulation | NEW / 21 CFR 878.4840 | NEW / 21 CFR 878.4840 | NEW / 21 CFR878.4840 (K082097,K130191, K172602,K190245) or GAM /21 CFR 879.4493(K163676) | Same or EquivalentBoth product codesare for absorbable,sterile, flexiblesurgical sutures forsoft tissueapproximation. GAMis simply for adifferent material. |
| Intended Use | Absorbable surgicalsutures for use in softtissue | Absorbable surgicalsutures for use in softtissue | Absorbable surgicalsutures for use insoft tissue (All) | Same |
| Indications forUse | MINT Product Family(including MINT, MINTLift, and MINT-I Sutures)are comprised of PDOand are indicated for usein soft tissueapproximation where useof a barbed absorbablesuture is appropriate.These sutures are alsoindicated for use in facesuspension surgery totemporarily fixate thecheek sub dermis in anelevated position. | MINT is indicated for usein mid-face suspensionsurgery to temporarilyfixate the cheeksubcutaneous fat layerand SMAS layer in anelevated position for the | The SilhouetteInstalift device isindicated for use inmid-face suspensionsurgery totemporarily fixatethe cheek sub dermis | EquivalentSlight rewording forclarity. No differencein meaning.EquivalentPublished clinicaldata demonstratesno difference insafety oreffectiveness. |
Comparison of Characteristics
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| K220549 | ||||
|---|---|---|---|---|
| Subject MINT ProductFamily Sutures | Predicate MINT ProductFamily Sutures K192423 | Reference Devices(As noted below) | Comparison | |
| treatment of moderate tosevere nasolabial folds. | in an elevatedposition. (K163676) | |||
| SutureMaterial | Polydioxanone | Polydioxanone | N/A (Subject same aspredicate) | Same |
| SutureCharacteristics | Synthetic absorbablemonofilament with bi-directional barbs alongthe long axis | Synthetic absorbablemonofilament with bi-directional barbs alongthe long axis | N/A (Subject same aspredicate) | Same |
| Sterilization | Ethylene oxide | Ethylene oxide | N/A (Subject same aspredicate) | Same |
| Size (USP) | Compliant with USPStandard Suture Sizes | Compliant with USPStandard Suture Sizes | N/A (Subject same aspredicate) | Same |
| Contact Type | Implant, Absorbable | Implant, Absorbable | N/A (Subject same aspredicate) | Same |
| ContactDuration | >30 Days | >30 Days | N/A (Subject same aspredicate) | Same |
| SutureDiameter | Compliant with USP<861> requirements | Compliant with USP<861> requirements | N/A (Subject same aspredicate) | Same |
| Suture TensileStrength | Compliant with USP<881> requirements | Compliant with USP<881> requirements | N/A (Subject same aspredicate) | Same |
| Suture-NeedleAttachment | Compliant with USP<871> requirements | Compliant with USP<871> requirements | N/A (Subject same aspredicate) | Same |
| Accessories | Optional tapered / Bluntneedle or cannula | Optional tapered / bluntneedle | Optional sharp orblunt needle /cannula (K172602and K190245) | Equivalent |
| AccessoryMaterial(PatientContacting) | Stainless Steel (SUS 304) | Stainless Steel (SUS 304) | N/A (Subject same aspredicate) | 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 <881> monograph strength; barb holding strength testing; suture-needle attachment strength testing to confirm USP <871>
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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.
§ 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.