(121 days)
No
The document describes a surgical suture and does not mention any AI or ML components or functionalities.
No.
The device is a surgical suture used for tissue approximation and ligation, which is a medical device but not a therapeutic device in the context of treating or curing a disease.
No
The device, a surgical suture, is used for approximating and ligating soft tissue, which are treatment/surgical actions, not diagnostic ones.
No
The device description clearly indicates it is a physical surgical suture made of polyethylene terephthalate, coated with beeswax and dyed green. It is a tangible medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that this is a "Non-absorbable Surgical Polyester Suture" used for "general soft tissue approximation and/or ligation." This is a device used within the body during a surgical procedure to hold tissues together.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
Therefore, this device falls under the category of a surgical implant or device used directly on the patient's body, not an IVD.
N/A
Intended Use / Indications for Use
Non-absorbable Surgical Polyester Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular, and neurological procedures. The device is limited to use where short term wound support (7-10 days) is required and can be left in place for a maximum of 10 days.
Product codes
GAT
Device Description
The subject device is a coated, braided, non-absorbable synthetic surgical suture composed of polyethylene terephthalate which is supplied sterile. The suture is coated with bees wax and dyed green. The color additive is D&C Green 6.
The subject device will be offered in diameters ranging from USP size 6-0 through 2 and available in length varying from 45cm to 150cm with or without needles attached.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the subject device. The test results demonstrated that the subject device complies with the following standards:
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- USPBacterial Endotoxins Test
- USPSutures - Diameter
- USPSutures - Needle Attachment
- USPTensile Strength
The biocompatibility evaluation for the subject device was conducted in accordance with the ISO 10993-1:2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process".
The tests were conducted following these standards:
- ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro Cytotoxicity
- ISO 10993-6:2016 Biological evaluation of medical devices -- Part 6: Tests for local effects A after implantation
- ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin Sensitization
- ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic Toxicity
- USP Pyrogen Test (USP Rabbit Test)
- ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
No animal study is included in this submission.
No clinical study is included in this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
August 25, 2023
Shandong Haidike Medical Products Co.,Ltd. Yan Wang Registration Manager Tianfu Road, Dongcheng District, Shan County Heze. Shandong 274300 China
Re: K231183
Trade/Device Name: Non absorbable Surgical Polyester Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: July 25, 2023 Received: July 25, 2023
Dear Yan Wang:
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 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
1
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,
Tek N. Digitally signed by Lamichhane Tek N. Lamichhane -S.
Lamichhane Date: 2023.08.25 -5 10:53:57 -04'00' Tek N. Lamichhane, Ph.D. Acting 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
2
Indications for Use
510(k) Number (if known) K231183
Device Name Non-absorbable Surgical Polyester Suture
Indications for Use (Describe)
Non-absorbable Surgical Polyester Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular, and neurological procedures. The device is limited to use where short term wound support (7-10 days) is required and can be left in place for a maximum of 10 days.
| 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
510(k) Summary-K231183
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
1. Administrative Information
Date of preparation: 07/24/2023
Shandong Haidike Medical Product Co., Ltd.
Tianfu Road, Dongcheng District, Shan County, 274300 Heze City, Shandong Province, China.
Establishment Registration Number: 3016426842
Contact Person: Yan Wang Position: Registration Manager Tel: +86-530-4660062 Fax: +86-530-4660055 Email: registration01(@suturescn.com
Identification of Subject Device 2.
Trade Name: Non-absorbable Surgical Polyester Suture Common Name: Nonabsorbable Poly (Ethylene Terephthalate) Suture
Regulatory Information Classification Name: Suture, Nonabsorbable, Synthetic, Polyester Classification: II Product Code: GAT Regulation Number: 21CFR 878.5000 Review Panel: General & Plastic Surgery
3. Identification of Predicate Device
510(k) Number: K172149 Regulation Number: 21CFR 878.5000 Classification: II Product Code: GAT Review Panel: General & Plastic Surgery Product name: MERICRON XL - Non-Absorbable Polyester Surgical Suture
4. Device Description
The subject device is a coated, braided, non-absorbable synthetic surgical suture composed of polyethylene terephthalate which is supplied sterile. The suture is coated with bees wax and dyed green. The color additive is D&C Green 6.
The subject device will be offered in diameters ranging from USP size 6-0 through 2 and available in length varying from 45cm to 150cm with or without needles attached.
4
5. Indications for Use:
Non-absorbable Surgical Polyester Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular, and neurological procedures. The device is limited to use where short term wound support (7-10 days) is required and can be left in place for a maximum of 10 days.
6. Summary of Technological Characteristics
| ITEM | Subject Device
(K231183) | Predicate Device
K172149 | Remark |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Product Code | GAT | |
| Regulation Number | 21CFR 878.5000 | 21CFR 878.5000 | Same |
| Class | II | II | Same |
| Sterile | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Same |
| Indication for Use | Non absorbable Surgical
Polyester Suture is indicated for
use in general soft tissue
approximation and/or ligation, but
not for use in ophthalmic,
cardiovascular, and neurological
procedures. The device is limited
to use where short term wound
support (7-10 days) is required
and can be left in place for a
maximum of 10 days. | MERICRON XL suture is
intended for use in general soft
tissue approximation and/or
ligation including
cardiovascular surgery,
neurosurgery, and ophthalmic
procedures. | Analysis 1 |
| | Configuration | Polyester Suture with or without
needle | 1、MERICRON XLTM Suture
with or without needle.
2、MERICRON XLTM Suture is
available with or without
PTFE
(Polytetrafluoroethylene)
Pledget |
| Suture | | | |
| Material | polyethylene terephthalate | poly (ethylene terephthalate) | Same |
| Structure | braided | braided | Same |
| Coating | Bees wax | Bees wax | Same |
| Dyed. Un-dyed | Dyed | Undyed/Dyed | Same |
| Colorant | D&C Green 6 | D & C Green No.6 | same |
| Length | 45cm to 150cm | Unknown | |
| Diameter | 6-0 through 2 | 6-0 through 5 | Analysis 3 |
| Needle | | | |
| Material | Stainless Steel | Stainless Steel | Same |
| Performance Test | | | |
| Diameter of suture | Comply with USP | | |
| Needle Attachment | Comply with USP | All characteristics meet USP
Requirement | |
| Tensile Strength | Comply with USP | | Same |
| Length | Not less than 95.0% of the length
stated on the label | Unknown | Analysis 3 |
| Biocompatibility | | | |
| Cytotoxicity (ISO
10993-5) | Pass | The Surgical Suture has been
Evaluated:
a.In Vitro Cytotoxicity Study
b. Skin Sensitization Study
c.Intracutaneous Reactivity Test
d.Acute Systemic Toxicity
Study
e.Sub Chronic Toxicity Study
f. Intramuscular Implantation
Test
g. Bacterial Reverse Mutation
Test
h. Mammalian Erythrocyte
Micronucleus Test
i. In Vitro Hemolysis Test
j. Pyrogen Test | |
| Sensitization (ISO
10993- 10) | Pass | | |
| Intracutaneous
Reactivity (ISO
10993- 10) | Pass | | |
| Acute systemic
toxicity (ISO
10993- 11) | Pass | | |
| Pyrogen (USP 43
NF38 ) | Pass | | |
| Subacute
Systemic Toxicity
(ISO 10993- 11) | Pass | | Analysis 4 |
| Bacterial Reverse
Mutation (ISO
10993-3) | Pass | | |
| Chromosome
Aberration (ISO
10993-3) | Pass | | |
| Gene Mutation (ISO
10993-3) | Pass | | |
| Implantation (ISO
10993-6) | Pass | | |
| Hemolysis ( ASTM
F756-17) | Pass | | |
Table 1: Comparison of Technological Characteristics
5
Analysis 1-Indications for Use
The indications for use for the subject device is not exactly the same as the predicate device. The subject device is indicated for general tissue approximation but not for use in ophthalmic, cardiovascular, and neurological procedures. In addition, the longest duration of use for the subject device is up to 10 days,
6
while the predicate device is a permanent contact device per the contact duration. However, the biocompatibility tests have been conducted on the subject device, and the test results showed that the material and colorant of the subject device will not have any adverse effects when used for up to 10 days.
Analysis 2-Configuration
The configuration of the subject device is different from the predicate device. However, the configuration of Polyester Suture with or without a needle is the same as the predicate device.
Analysis 3-Length & Diameter
The length and diameter of the subject device is different from the predicate device. However, the length and diameter of the proposed device is within the range of that of the predicate device. In addition, the performance test about the length and diameter has been conducted on the subject device and the test result shows that the length and diameter of the subject device met the acceptance criteria. Therefore, the difference will not affect the safety and effectiveness of the subject device.
Analysis 4-Biocompatibility
The subject device is a prolonged contact device, while the predicate device is a permanent contact device. Based on the identified contact duration and indication for use of subject device, the biocompatibility tests were performed in accordance with ISO 10993- 1: 2018 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, and FDA guidance document entitled Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" dated September 4, 2020.
Although the Biocompatibility contact duration is not the biocompatibility test has been conducted on the subject device and the test result showed that the material of the subject device will not have adverse effects.
7. Performance Data
Non-clinical Testing a.
The biocompatibility evaluation for the subject device was conducted in accordance with the ISO 10993-1:2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process".
The tests were conducted following these standards:
-
ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
-
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro Cytotoxicity
-
ISO 10993-6:2016 Biological evaluation of medical devices -- Part 6: Tests for local effects
- A after implantation
-
ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
-
ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin Sensitization
-
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic
7
Toxicity
-
USP Pyrogen Test (USP Rabbit Test)
-
ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
Non-clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the subject device. The test results demonstrated that the subject device complies with the following standards:
-
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
- ハ ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
-
USPBacterial Endotoxins Test
-
USPSutures - Diameter
-
USPSutures - Needle Attachment
-
USPTensile Strength
c. Animal Study
No animal study is included in this submission.
d. Clinical Test Conclusion
No clinical study is included in this submission.
7. Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the subject device, Non-absorbable Surgical Polyester Suture (K231183), is as safe, as effective, and performs as well as the legally marketed predicate device, K172149.