(48 days)
No
The device description and performance studies focus on the physical properties and biological compatibility of a barbed suture, with no mention of AI or ML.
No
This device, Secret Line up and i-Thread, is an absorbable polydioxanone suture used for soft tissue approximation, primarily for dermatological use. Its function is to hold tissues together and prevent movement, which is a structural or supportive function rather than a direct therapeutic effect on a disease or condition.
No
Explanation: The device is a polydioxanone suture, which is used for soft tissue approximation. Its function is to hold tissues together; it does not diagnose any condition.
No
The device description clearly details a physical medical device consisting of a suture, needle, cannula, and other hardware components. The performance studies also focus on physical properties and biological evaluation, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in soft tissue approximation where use of absorbable suture is appropriate." This describes a surgical or procedural use, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a "Sterile single use absorbable polydioxanone suture with needle." This is a physical implantable material used to close wounds or approximate tissue.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on the physical properties of the suture (diameter, tensile strength, needle attachment, bending, barb holding strength, biodegradability) and biocompatibility, which are relevant to a surgical device, not a diagnostic one.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture) comprised of dyed polydioxanone suture with a sterile needle. It is indicated for use in soft tissue approximation where use of absorbable suture is appropriate. This device is not intended for body cavity applications or lifting and is intended for dermatological use only.
Product codes
NEW
Device Description
Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture with needle) consist of a cannula type needle which is straight and hollow (pre-loaded on the suture), a needle cap, a hub, a sponge and polydioxanone (PDO) suture which is sterilized by ethylene oxide (EO) gas. The pigment for the violet dye is D&C Violet No.2.
Secret Line up/i-Thread Sutures are characterized by their bidirectional barbs along the long axis of the monofilament. The bi-directional barbs of barbed suture are precisely lodged in tissue, making it feasible to anchor in the tissue and prevent movement in both directions without the need for a surgical knot.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue (Skin, Dermal or Sub- dermal tissue)
Indicated Patient Age Range
Adults, but inappropriate for elderly population
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)
Performance testing was conducted on the subject device to prove that all the design specifications are substantially equivalent to the predicate device. The test results of the subject device are demonstrated in accordance with the following FDA and international standards:
-
- FDA Guidance on Surgical Sutures Performance Criteria for Safety and Performance Based Pathway"
-
- Surgical Sutures Class II Special Controls Guidance Document for Industry and FDA Staff
-
- USP 43-NF38 Sutures Diameter
-
- USP 43-NF38 Sutures Needle Attachment
-
- USP 43-NF38 Sutures Tensile Strength
-
- USP 37-NF 32: 2014 Dimension test
-
- ASTM F1874-98 9 bending test
- ISO 10993-1:2020, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process
-
- ISO 10993-7:2008, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterlization Results
-
- ISO 11135:2014, Sterilization of Healthcare Products Ethylene oxide Part 1: Requirements for
- development, validation and routine control of a sterilization process for medical devices
-
- ISO 10993:2009, Biological Evaluation of medical devices Part 5: Test for in vitro cytotoxicity
-
- ISO 10993:2017, Biological Evaluation of medical devices Part 4: Selection of Test for Interaction with Blood, Annex D.5 Hemolysis Testing
-
- ISO 10993:2017, Biological Evaluation of medical devices Part 11: Test for systemic Toxicity, Annex G -Information on material mediated pyrogens
-
- ISO 10993:2021, Biological Evaluation of medical devices Part 23: Tests for Irritation, 7.3 Animal Irritation test by Intracutaneous (Intradermal) administration
-
- ISO 10993:2010, Biological Evaluation of medical devices Part 10: Test for Irritation and Skin Sensitization, 7.5 Guinea Pig Maximization Test
-
- ISO 10993:2021, Biological Evaluation of medical devices Part 12: Sample preparation and reference materials
-
- ISO 10993:2016, Biological Evaluation of medical devices Part 6: Test for local effects after implantation
-
- ISO 10993:2014, Biological Evaluation of medical devices Part 3: Test for Genotoxicity, Carcinogenicity and Reproductive toxicity, 5. Genotoxicity test
-
- ISO 14971:2019, Medical Devices Risk Management for Medical Devices.
Furthermore, the following non-clinical bench tests were performed on the subject device:
-
- Measurement (Outside diameter, Length, hub)
-
- Bending test
-
- Barb Holding strength
-
- Flexural test
-
- Pulling out (or) Extraction Test
Animal Studies: The purpose of the in vivo study is to evaluate the biodegradability of the Sterile Single Use Absorbable Polydioxanone Suture by comparing the two models in "absorption", "Tensile strength test" and "Barb holding strength test" by the time.
Clinical studies: As per the Guidance document "Surgical Sutures - Class II Special Controls Guidance Document for Industry and FDA Staff', no Clinical Studies were performed nor required.
Key Results: Performance testing result: Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 27, 2024
HyunDae MediTech Co., Ltd. Ju-In Oh Senior QA staff 80, Cheongjeong-ro, Jijeong-myeon, Wonju-si, Gangwon-do 26347 Korea, South
Re: K240389
Trade/Device Name: Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150) Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW Dated: January 30, 2024 Received: February 8, 2024
Dear Ju-In Oh:
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 (the 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 available 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Nils Potter Nils Potter -S 2024.03.27 - S 11:59:01 -04'00'
for Tek Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240389
Device Name Secret Line up / i-Thread
Indications for Use (Describe)
Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture) comprised of dyed polydioxanone suture with a sterile needle. It is indicated for use in soft tissue approximation where use of absorbable suture is appropriate. This device is not intended for body cavity applications or lifting and is intended for dermatological use only.
| 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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4
Traditional 510(k) Summary
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
| Date 510k summary prepared: | February 19, 2024 |
|---|---|
| ----------------------------- | ------------------- |
I. SUBMITTER
| Submitter's Name | Hyundae MediTech Co.,Ltd. |
|---|---|
| Submitter's Address | 80, Cheongjeong-ro, Jijeong-myeon, |
| Wonju-si, Gangwon-do, Republic of Korea | |
| Submitter's Telephone | +82 (070) 4490-2602 |
| Contact person | Gwang-jun, Park / Quality management dept General Manager |
| qa@hyundaemed.co.kr | |
| Telephone | +82-70-4490-2602 |
| Fax: | +82-33-734-3065 |
II. DEVICE
| Trade/proprietary Name | Secret Line up / i-Thread |
|---|---|
| Common or Usual Name | Absorbable polydioxanone suture with needle |
| Regulation Name | Absorbable Polydioxanone Suture with Needle |
| Regulation Number | 21 CFR 878.4840 (Product Code: NEW) |
| Regulatory Class | Class II |
III. PREDICATE DEVICE
| Primary Manufacturer | Feeltech Co., Ltd. |
|---|---|
| Device Name | MiracuTM (MiracuTM barbed surgical suture) |
| 510(k) Number | K172602 |
| Regulation Name | Absorbable Polydioxanone Suture with Needle |
| Regulation Number | 21 CFR 878.4840 (Product Code: NEW) |
| Regulatory Class | Class II |
5
Absorbable polydioxanone suture with needle
This predicate has not been subject to a design-related recall.
Exceptionally, the Reference Device for the largest needle size is K220549.
| Manufacturer | Hans Biomed Corporation |
|---|---|
| Device Name | MINT TM FINE+ (MINT Product Family) |
| 510(k) Number | K220549 |
| Regulation Name | Polydioxanone absorbable surgical suture |
| Regulation Number | 21 CFR 878.4840 (Product Code: NEW) |
| Regulatory Class | Class II |
IV. DEVICE DESCRIPTION
Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture with needle) consist of a cannula type needle which is straight and hollow (pre-loaded on the suture), a needle cap, a hub, a sponge and polydioxanone (PDO) suture which is sterilized by ethylene oxide (EO) gas. The pigment for the violet dye is D&C Violet No.2.
Secret Line up/i-Thread Sutures are characterized by their bidirectional barbs along the long axis of the monofilament. The bi-directional barbs of barbed suture are precisely lodged in tissue, making it feasible to anchor in the tissue and prevent movement in both directions without the need for a surgical knot.
V. INDICATIONS FOR USE
Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture) comprised of dyed polydioxanone suture with a sterile needle. It is indicated for use in soft tissue approximation where use of absorbable suture is appropriate. This device is not intended for body cavity applications or lifting and supporting tissues and is intended for dermatological use only.
6
VI. SUBTANTIALLY EQUIVALENT (SE) COMPARISON CHART:
Subject device is substantially equivalent to Miracu™ (K172602) and MINT (K220549). The following comparison table is presented to demonstrate substantial equivalence.
| Category | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| 510(k) Number | K240389 | K172602 | Not applicable |
| Product Code | NEW | NEW | SE |
| Regulation Number | 21 CFR 878.4840 | 21 CFR 878.4840 | SE |
| Class | II | II | SE |
| Device Trade | |||
| (Brand) Name | Secret Line and i-Thread | ||
| (Absorbable polydioxanone suture | |||
| with needle) | MiracuTM | ||
| (MiracuTM barbed surgical suture) | Not applicable | ||
| Common Name | Absorbable polydioxanone suture | ||
| with needle | Absorbable Polydioxanone Suture | ||
| with Needle | SE | ||
| Manufacturer | Hyundae MediTech Co.,Ltd. | Feeltech Co., Ltd. | Not applicable |
| Device description | Secret line up, i-Thread (Sterile single | ||
| use absorbable polydioxanone suture | |||
| with needle) consist of a cannula type | |||
| needle which is straight and hollow | |||
| (pre-loaded on the suture), a needle cap, | |||
| a hub, a sponge and polydioxanone | |||
| (PDO) suture which is sterilized by | |||
| ethylene oxide (EO) gas. The pigment | |||
| for the violet dye is D&C Violet No.2 | MiracuTM synthetic barded surgical | ||
| absorbable polydioxanone (PDO) | |||
| suture with needle. The needle is | |||
| straight, hollow, cannula and is pre- | |||
| loaded onto the suture. The pigment | |||
| for the violet dye is D&C Violet No.2 | |||
| The MiracuTM is available sterile after | |||
| ethylene oxide (EO) gas sterilization | |||
| and degrades or dissolves over time in | |||
| tissue. | Similar - As the | ||
| subject device | |||
| and predicate | |||
| device consist of | |||
| the same suture | |||
| material along | |||
| with the needle | |||
| Indication for Use | Secret Line and i-Thread (Sterile single | ||
| use absorbable polydioxanone suture) | |||
| comprised of dyed polydioxanone | |||
| suture with a sterile needle. It is | |||
| indicated for use in soft tissue | |||
| approximation where use of absorbable | |||
| suture is appropriate. This device is not | |||
| intended for body cavity applications or | |||
| lifting and supporting tissues and is | |||
| intended for dermatological use only. | The MiracuTM barbed surgical suture | ||
| is comprised of dyed polydioxanone, | |||
| is indicated for soft tissue | |||
| approximation where use of an | |||
| absorbable suture is appropriate. | |||
| The anatomical location(s) of use are | |||
| on the skin for dermatological | |||
| applications only. The suture is not | |||
| intended for interior body cavity | |||
| applications and the suture is not | |||
| intended for lifting and supporting | |||
| tissues. | Similar - As the | ||
| subject device | |||
| and predicate | |||
| device have same | |||
| indication of use | |||
| for soft tissue | |||
| approximation | |||
| and not intended | |||
| to be used for | |||
| interior body | |||
| cavity | |||
| Sterilization method | E.O. sterilization (SAL: 1.0×10-6) | E.O. sterilization (SAL: 1.0×10-6) | SE |
| Stability time | 2 years | 2 years | SE |
| Suture material | Polydioxanone | Polydioxanone | SE |
| Configuration | PDO Suture and Needle. The subject | ||
| device is pre-loaded with a hollow | |||
| needle and is not swaged. | PDO Suture and Needle. The subject | ||
| device is pre-loaded with a hollow | |||
| needle and is not swaged. | SE | ||
| Suture Color | Dyed suture (violet) | Dyed suture (violet) | SE |
| Suture Size (USP) | 2-0, 2, 0 | 4-0, 3-0, 2-0, 0 | Similar - As the |
| range of suture | |||
| size for predicate | |||
| device is more | |||
| compared to | |||
| subject device | |||
| Suture Length | 150, 160 mm | 90, 110, and 150 mm | Similar - As the |
| predicate device | |||
| has various | |||
| ranges of suture | |||
| lengths compared | |||
| to subject device | |||
| Suture type | Cog (barb) type | Cog (barb) type | SE |
| Barb angle | 50 - 80 degrees | 2 - 45 degrees | This is justified by |
| the barb holding | |||
| performance test | |||
| Suture composition | Polydioxanone, | ||
| Dyed with D&C Violet No.2 | Polydioxanone, | ||
| Dyed with D&C Violet No.2 | SE | ||
| Needle Material | Stainless steel | Stainless steel | SE |
| Absorbable / | |||
| Non- Absorbable | Absorbable | Absorbable | SE |
| Braided / | |||
| Monofilament | Monofilament | Monofilament | SE |
| Barb Type | Bi-directional | Bi-directional | SE |
| Biocompatible | Yes | Yes | SE |
| Material of components | |||
| that come into patient | |||
| contact | Needle: Stainless steel | ||
| Suture: Polydioxanone | Needle: Stainless steel | ||
| Suture: Polydioxanone | SE | ||
| Anatomical Location | Soft tissue | ||
| (Skin, Dermal or Sub- dermal tissue) | Soft tissue | ||
| (Skin, Dermal or Sub- dermal tissue) | SE | ||
| Intended population | Adults, but inappropriate | ||
| for elderly population | Adults population | SE | |
| Performance Test | |||
| conducted | Suture : Length, Diameter, Tensile | ||
| strength, Barb-Holding, Needle | |||
| attachment strength | |||
| Needle : Length, Outer diameter, | |||
| Bending(elasticity), Flexural strength, | |||
| Pulling out | |||
| REFER: IX Bench Test Summary for | |||
| test results | Suture : Length, Diameter, Tensile | ||
| strength, Barb-Holding, Needle | |||
| attachment strength | |||
| Needle : Length, Outer diameter, | |||
| Bending(elasticity), Flexural strength, | |||
| Pulling out | |||
| REFER: IX Bench Test Summary for | |||
| test results | SE | ||
| Performance | |||
| (Animal Testing) | In Vivo testing in Sprague-Dawley Rat |
- Absorption, Barb Holding force and
Tensile Strength over time | In Vivo Biodegradation in Sprague-
Dawley Rat - Barb Holding forces,
Absorption and Residual Tensile
Strength over time | SE |
| Performance testing
result | Pass | Pass | SE |
| Single use | Yes | Yes | SE |
| Reusable component | N/A | N/A | SE |
| Nano technology | N/A | N/A | SE |
| Clinical test | Not required | Not required | SE |
510(k) Summary page 3 / 6
7
Absorbable polydioxanone suture with needle
Despite the differences, the test results submitted in this 510k show that the subject device is substantally equivalent to In almost all aspects, the subject device is substantially equivalent in its capacity and function to the predicate device.
8
VII. DESCRIPTION FOR DIFFERENCE
The Subject device has the same intended use as that of the predicate device. There are minor differences between the two devices where it is indicated "similar", in all other cases it is seen that the subject stays as "Substantial Equivalent" to that of the predicate device characteristics.
Few main differences observed from the above table are with respect to suture length and the performance test results. Despite these difference, it is witnessed from the test results submitted as part of 510(K) that the subject device is substantially equivalent to the predicate device in terms of safety and effectiveness and there is no difference in terms of intended clinical application. Additionally, the subject device is substantially equivalent to the capacity and function of the predicate device.
VIII. Performance Testing
Performance testing was conducted on the subject device to prove that all the design specifications are substantially equivalent to the predicate device. The test results of the subject device are demonstrated in accordance with the following FDA and international standards:
-
- FDA Guidance on Surgical Sutures Performance Criteria for Safety and Performance Based Pathway"
-
- Surgical Sutures Class II Special Controls Guidance Document for Industry and FDA Staff
-
- USP 43-NF38 Sutures Diameter
-
- USP 43-NF38 Sutures Needle Attachment
-
- USP 43-NF38 Sutures Tensile Strength
-
- USP 37-NF 32: 2014 Dimension test
-
- ASTM F1874-98 9 bending test
- ISO 10993-1:2020, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process
-
- ISO 10993-7:2008, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterlization Results
-
- ISO 11135:2014, Sterilization of Healthcare Products Ethylene oxide Part 1: Requirements for
- development, validation and routine control of a sterilization process for medical devices
-
- ISO 10993:2009, Biological Evaluation of medical devices Part 5: Test for in vitro cytotoxicity
-
- ISO 10993:2017, Biological Evaluation of medical devices Part 4: Selection of Test for Interaction with Blood, Annex D.5 Hemolysis Testing
-
- ISO 10993:2017, Biological Evaluation of medical devices Part 11: Test for systemic Toxicity, Annex G -Information on material mediated pyrogens
-
- ISO 10993:2021, Biological Evaluation of medical devices Part 23: Tests for Irritation, 7.3 Animal Irritation test by Intracutaneous (Intradermal) administration
-
- ISO 10993:2010, Biological Evaluation of medical devices Part 10: Test for Irritation and Skin Sensitization, 7.5 Guinea Pig Maximization Test
-
- ISO 10993:2021, Biological Evaluation of medical devices Part 12: Sample preparation and reference materials
-
- ISO 10993:2016, Biological Evaluation of medical devices Part 6: Test for local effects after implantation
-
- ISO 10993:2014, Biological Evaluation of medical devices Part 3: Test for Genotoxicity, Carcinogenicity and Reproductive toxicity, 5. Genotoxicity test
-
- ISO 14971:2019, Medical Devices Risk Management for Medical Devices.
Furthermore, the following non-clinical bench tests were performed on the subject device:
-
- Measurement (Outside diameter, Length, hub)
-
- Bending test
-
- Barb Holding strength
-
- Flexural test
-
- Pulling out (or) Extraction Test
9
IX. Animal Studies
The purpose of the in vivo study is to evaluate the biodegradability of the Sterile Single Use Absorbable Polydioxanone Suture by comparing the two models in "absorption", "Tensile strength test" and "Barb holding strength test" by the time.
Clinical studies X.
As per the Guidance document "Surgical Sutures - Class II Special Controls Guidance Document for Industry and FDA Staff', no Clinical Studies were performed nor required.
XI. Summary
Based on the indications for use and safety and performance testing, the subject device meets the requirements that are considered for its intended use and is substantially equivalent in design materials, sterilization, and indications for use. The conclusions drawn from the non-clinical and biocompatibility test reports to demonstrate that the device is as safe, as effective, and performs at least as safely and effectively as the legally marketed device.