(29 days)
Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture with needle) 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. The suture is not intended for body cavity applications, nor is it intended for lifting and supporting tissues; it is intended for dermatological use only.
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. PDO Sutures are characterized by their bidirectional barbs along axis of the monofilament. The bidirectional 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. As a result, the barbed suture improves the effectiveness of treatment.
The provided document is a 510(k) premarket notification for a medical device called "Secret Line up" and "i-Thread," which are absorbable polydioxanone sutures with needles. The document asserts that the subject device is substantially equivalent to a previously cleared predicate device (K240389).
However, the document does not contain any acceptance criteria or study results that prove the device meets specific performance criteria related to AI or algorithm-only performance. This is because the device described is a physical surgical suture, not an AI/algorithm-driven device.
Therefore, I cannot fulfill the request for information regarding AI/algorithm acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as these types of studies are not applicable to the non-AI medical device described in the input.
The document primarily focuses on demonstrating substantial equivalence of the subject suture to a predicate suture based on material, manufacturing, sterilization, and physical performance tests, not on any AI or software-related functional performance.
Therefore, many parts of your request for information related to AI/algorithm performance studies cannot be answered based on the provided document.
Here’s what can be extracted and inferred from the document regarding the physical medical device:
Acceptance Criteria and Device Performance (Not for AI, but for the physical suture)
The document does not present a formal table of "acceptance criteria" for the device's main performance as a suture with corresponding "reported device performance" in a quantitative manner as one might expect for an AI algorithm. Instead, it lists the types of performance tests conducted and states that they "Pass." The acceptance criteria are implicitly the successful completion of these tests as per relevant standards.
Table of Acceptance Criteria (Inferred from standards and tests listed) and Reported Device Performance (Summary)
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Suture Physical Properties: | |
| - Length conformance (USP 43-NF38 <861>) | Pass |
| - Diameter conformance (USP 43-NF38 <861>) | Pass |
| - Tensile strength (USP 43-NF38 <881>) | Pass |
| - Barb-Holding strength | Pass |
| - Needle attachment strength (USP 43-NF38 <871>) | Pass |
| Needle Physical Properties: | |
| - Length conformance | Pass |
| - Outer diameter conformance | Pass |
| - Bending (elasticity) (ASTM F1874-98) | Pass |
| - Flexural strength | Pass |
| - Pulling out (Extraction Test) | Pass |
| Biocompatibility: | |
| - Cytotoxicity (ISO 10993-5) | Pass |
| - Hemolysis (ISO 10993-4) | Pass |
| - Systemic Toxicity (ISO 10993-11) | Pass |
| - Irritation (ISO 10993-23) | Pass |
| - Skin Sensitization (ISO 10993-10) | Pass |
| - Local effects after implantation (ISO 10993-6) | Pass |
| - Genotoxicity (ISO 10993-3) | Pass |
| Sterilization: | |
| - Ethylene Oxide (EO) Sterilization (SAL: 1.0x10^-6) (ISO 11135) | Pass (Maintained SAL of 1.0x10^-6) |
| In Vivo Performance (Animal Study): | |
| - Absorption profile in vivo | Evaluated, implied to be comparable to predicate ("Pass") |
| - Barb Holding force over time in vivo | Evaluated, implied to be comparable to predicate ("Pass") |
| - Tensile Strength over time in vivo | Evaluated, implied to be comparable to predicate ("Pass") |
Information Not Applicable or Not Found (Relevant to AI/Algorithm Studies):
- Sample sizes used for the test set and data provenance (e.g., country of origin of the data, retrospective or prospective): This information is not provided as the tests are for a physical device, not an AI algorithm. The document mentions "in vivo testing in Sprague-Dawley Rat" for animal studies, but doesn't specify sample sizes for these, nor does it detail human subject data for an AI test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical suture's performance (e.g., tensile strength) is established by direct measurement and compliance with engineering standards, not by expert consensus on interpretations of data.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This pertains to expert review for AI ground truth.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical suture, not an AI assistance tool for human readers. The document explicitly states "no Clinical Studies were performed nor required."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this physical device is established by bench testing against ISO, USP, and ASTM standards, and animal studies for in-vivo performance (absorption, barb holding, tensile strength over time).
- The sample size for the training set: Not applicable, as this is not an AI device with a training set.
- How the ground truth for the training set was established: Not applicable, as this is not an AI device.
In summary, the provided document is a 510(k) submission for a traditional physical medical device (a surgical suture) and, therefore, does not contain any of the specific information requested regarding acceptance criteria and study designs pertinent to AI/algorithm performance. The 'acceptance criteria' for this device are implicitly derived from the successful execution of a range of standard physical, chemical, biological, and sterilization tests.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 27, 2024
Hyundae Meditech Co., Ltd. Oh Ju-In Senior QA Staff 80. Cheongjeong-ro. Jijeong-myeon Wonju-si, Gangwon 26347 Korea, South
Re: K242571
Trade/Device Name: Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938E80 FCW1950E90 FCW1960E100 FCW1970E120 FCW1990E150 FCW19100E160 FCW2138G80 FCW2150G90 FCW2160G100 FCW2170G120 FCW2190G150 FCW21100G160); i-Thread (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150
Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW Dated: August 21, 2024 Received: August 29, 2024
Dear Oh Ju-In:
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
{1}------------------------------------------------
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" (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 QS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Re"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these
{2}------------------------------------------------
requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
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,
Tek N. -Digitally signed by Lamichhane Tek N.Lamichhane -S
Date: 2024.09.27 -5 12:06:14 -04'00' Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices 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
Submission Number (if known)
Device Name
Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162
FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938E80 FCW1950E90 FCW1960E100 FCW1970E120
{4}------------------------------------------------
FCW1990E150 FCW19100E160 FCW2138G80 FCW2150G90 FCW2160G100 FCW2170G120 FCW2190G150 FCW21100G160); i-Thread (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938E80 FCW1950E90 FCW1960E100 FCW1970E120
{5}------------------------------------------------
| FCW1990E150 |
|---|
| FCW19100E160 |
| FCW2138G80 |
| FCW2150G90 |
| FCW2160G100 |
| FCW2170G120 |
| FCW2190G150 |
| FCW21100G160) |
| Indications for Use (Describe) |
Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture with needle) 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. The suture is not intended for body cavity applications, nor is it intended for lifting and supporting tissues; it 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)
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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."
{6}------------------------------------------------
510(k) Summary (Special 510k-K242571)
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date prepared: August 21, 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 | +82-70-4490-2604 |
| Contact person | Ju-in Oh / Quality management dept / Assistant managerqa@hyundaemed.co.kr |
| Telephone | +82-70-4490-2604 |
| 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 Surgical Suture |
| Regulation Number | 21 CFR 878.4840 |
| Product Code | NEW |
| Regulatory Class | Class II |
III. PREDICATE DEVICE
| Primary Manufacturer | Hyundae MediTech Co.,Ltd. |
|---|---|
| Device Name | Secret Line up / i-Thread |
| 510(k) Number | K240389 |
| Regulation Name | Absorbable Polydioxanone Suture with Needle |
| Regulation Number | 21 CFR 878.4840 |
| Product Code | NEW |
| Regulatory Class | Class II |
{7}------------------------------------------------
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.
PDO Sutures are characterized by their bidirectional barbs along axis of the monofilament. The bidirectional 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. As a result, the barbed suture improves the effectiveness of treatment.
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. The suture is not intended for body cavity applications, nor is it intended for lifting and supporting tissues; it is intended for dermatological use only.
VI. SUBTANTIALLY EQUIVALENT (SE) COMPARISON CHART
Subject device is substantially equivalent to Secret Line up / i-Thread (K240389). The following comparison table is presented to demonstrate substantial equivalence.
| Category | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| 510(k) number | K242571 (special 510k) | K240389 | Not applicable |
| Product code | NEW | NEW | SE |
| Regulation number | 21 CFR 878.4840 | 21 CFR 878.4840 | SE |
| Class | II | II | SE |
| Device trade name(Brand name) | Secret Line up and i-Thread(Absorbable PolydioxanoneSurgical Suture) | Secret Line up and i-Thread(Absorbable PolydioxanoneSurgical Suture) | SE |
| Common name | Absorbable polydioxanone suturewith needle | Absorbable Polydioxanone Suturewith Needle | SE |
| Manufacturer | Hyundae MediTech Co.,Ltd. | Hyundae MediTech Co.,Ltd. | SE |
| Device description | Secret line up, i-Thread (Sterilesingle use absorbablepolydioxanone suture withneedle) consist of a cannulatype needle which is straightand hollow (pre-loaded on thesuture), a needle cap, a hub, asponge and polydioxanone(PDO) suture which is sterilizedby ethylene oxide (EO) gas.The pigment for the violet dyeis D&C Violet No.2. | Secret line up, i-Thread (Sterilesingle use absorbablepolydioxanone suture withneedle) consist of a cannulatype needle which is straightand hollow (pre-loaded on thesuture), a needle cap, a hub, asponge and polydioxanone(PDO) suture which is sterilizedby ethylene oxide (EO) gas.The pigment for the violet dyeis D&C Violet No.2. | SE |
| Indication for use | Secret Line and i-Thread(Sterile single use absorbablepolydioxanone suture)comprised of dyedpolydioxanone suture with asterile needle. It is indicated foruse in soft tissue approximationwhere use of absorbable sutureis appropriate. The suture is notintended for body cavityapplications, nor is it intendedfor lifting and supportingtissues; it is intended fordermatological use only. | Secret Line and i-Thread(Sterile single use absorbablepolydioxanone suture)comprised of dyedpolydioxanone suture with asterile needle. It is indicatedfor use in soft tissueapproximation where use ofabsorbable suture isappropriate. This device is notintended for body cavityapplications or lifting andsupporting tissues and isintended for dermatologicaluse only. | SE |
| 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.(Pre-loaded with a hollow needleand is not swaged.) | PDO Suture and Needle.(Pre-loaded with a hollow needleand is not swaged.) | SE |
| Suture color | Dyed suture (violet) | Dyed suture (violet) | SE |
| Suture size (USP) | 2-0, 0, 2 | 2-0, 0, 2 | SE |
| Suture length | 80, 90, 100, 120, 150, 160,162, 185, 170, 280, 420 mm | 150, 160 mm | Similar - As thepredicate device hasvarious ranges of suturelengths compared tosubject device. |
| Suture type | Cog (barb) type | Cog (barb) type | SE |
| Barb angle | 50 - 80 degrees | 50 - 80 degrees | SE |
| 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 thatcome into patient contact | 1) Needle: Stainless steel2) Suture: Polydioxanone | 1) Needle: Stainless steel2) Suture: Polydioxanone | SE |
| Anatomical location | Soft tissue(Skin, Dermal or Sub-dermaltissue) | Soft tissue(Skin, Dermal or Sub-dermaltissue) | SE |
| Intended population | Adults, but inappropriate forelderly population | Adults, but inappropriate forelderly population | SE |
| Performance testconducted | 1) Suture : Length, Diameter,Tensile strength, Barb-Holding,Needle attachment strength2) Needle : Length, Outer diameter,Bending(elasticity), Flexuralstrength, Pulling out | 1) Suture : Length, Diameter,Tensile strength, Barb-Holding,Needle attachment strength2) Needle : Length, Outer diameter,Bending(elasticity), Flexuralstrength, Pulling out | SE |
| Performance test(Animal testing) | In Vivo testing in Sprague-DawleyRat - Absorption, Barb Holdingforce and Tensile Strength overtime | In Vivo testing in Sprague-DawleyRat - Absorption, Barb Holdingforce and Tensile Strength overtime | SE |
| Performance testingresult | 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 |
| Despite the differences, the test results submitted in this 510(k) show that the subject device is substantially equivalent to thepredicate devices in safety and effectiveness. |
{8}------------------------------------------------
{9}------------------------------------------------
In almost all aspects, the subject device is substantially equivalent in its capacity and function to the predicate device.
DESCRIPTION FOR DIFFERENCE VII.
The Subject device has the same intended use as that of the predicate device. There is minor difference 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.
Differences observed from the above table are with respect to suture length. Despite this difference, it is
{10}------------------------------------------------
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 <861> Sutures Diameter
-
- USP 43-NF38 <871> Sutures Needle Attachment
- USP 43-NF38 <881> 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 Sterilization 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.
{11}------------------------------------------------
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
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.
X. 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.
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.
§ 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.