(181 days)
Not Found
No
The device description and performance studies focus on the physical properties and material standards of a surgical suture, with no mention of AI or ML technology.
No.
The device is a surgical suture used for tissue approximation and ligation, which is a structural component of a medical procedure, not a therapeutic agent itself.
No
Explanation: The device is a non-absorbable surgical suture, indicated for general soft tissue approximation and ligation. Its function is to hold tissues together, not to diagnose a condition or disease.
No
The device description clearly states it is a physical, nonabsorbable monofilament surgical suture made of polypropylene, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "general soft tissue approximation and/or ligation." This describes a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a "nonabsorbable monofilament surgical suture." This is a physical material used to close wounds or tie off vessels during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests outside of the body on samples taken from the body. This device is used inside the body during a surgical procedure.
N/A
Intended Use / Indications for Use
Non absorbable Surgical Polypropylene Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic procedures, 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
GAW
Device Description
The subject device is a nonabsorbable monofilament surgical suture which is supplied sterile. The proposed device is dyed blue. The color additive is [phtalocyaninato(2-)] copper(Color Index Number 74160), and the weight percentage for the color additive is less than 0.1%. The device will be offered in diameters ranging from USP size 6-0 through 2 and is available in length 75cm or 150cm with or without needles attached. Polypropylene suture meets all the requirements of USP for Non-absorbable surgical suture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate 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
- A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- A ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
- 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 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) A
- USPBacterial Endotoxins Test
- USPSutures - Diameter
- USPSutures - Needle Attachment
- USPTensile Strength
- ASTM F3014-14 Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures
- ASTM F1874-98 Standard Test Method for Bend Testing of Needles Used in Surgical Sutures
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."
September 14, 2023
Shandong Haidike Medical Products Co.,Ltd. Yan Wang Registration Manager Tianfu Road, Dongcheng District, Shan County, Heze, Shandong 274300 China
Re: K230746
Trade/Device Name: Non absorbable Surgical Polypropylene Suture Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable Polypropylene Surgical Suture Regulatory Class: Class II Product Code: GAW Dated: March 15, 2023 Received: March 17, 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.
1
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.
| Tek N.
Lamichhane -
S | Digitally signed by
Tek N. Lamichhane -S
Date: 2023.09.14
09:51:31 -04'00' |
| ----------------------------- | ------------------------------------------------------------------------------------- |
|---|
Tek N. Lamichhane, Ph. D. 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) K230746
Device Name
Non Absorbable Surgical Polypropylene Suture
Indications for Use (Describe)
Non absorbable Surgical Polypropylene Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic procedures, 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
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K230746
-
- Date of Preparation: 08/12/2023
-
- Sponsor Identification
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: registration(01(@suturescn.com
-
- Identification of Subject Device:
Trade Name: Non Absorbable Surgical Polypropylene Suture Common Name: Nonabsorbable Polypropylene Surgical Suture
- Identification of Subject Device:
Regulatory Information
Classification Name: Suture, Nonabsorbable, Synthetic, Polypropylene Classification: II Product Code: GAW Regulation Number: 21CFR 878.5010 Review Panel: General & Plastic Surgery
-
- Identification of Predicate Device 510(k) Number: K080684 Regulation Number: 21CFR 878.5010 Classification: II Product Code: GAW Review Panel: General & Plastic Surgery Product name: WG-Surgical Sutures with Needle
4
-
- Device description
The subject device is a nonabsorbable monofilament surgical suture which is supplied sterile. The proposed device is dyed blue. The color additive is [phtalocyaninato(2-)] copper(Color Index Number 74160), and the weight percentage for the color additive is less than 0.1%. The device will be offered in diameters ranging from USP size 6-0 through 2 and is available in length 75cm or 150cm with or without needles attached. Polypropylene suture meets all the requirements of USP for Non-absorbable surgical suture.
- Device description
-
- Indications for Use
Non absorbable Surgical Polypropylene Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic procedures, 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.
- Indications for Use
-
- Technological characteristic comparison
| ITEM | Subject Device
(K230746) | Predicate Device
(K080684) | Remark |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | GAW | GAW | Same |
| Regulation Number | 21CFR 878.5010 | 21CFR 878.5010 | Same |
| Class | II | II | Same |
| Sterile | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Same |
| Indication for Use | Non absorbable Surgical
Polypropylene Suture is indicated
for use in general soft tissue
approximation and/or ligation, but
not for use in ophthalmic
procedures, 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. | Nonabsorbable Polypropylene
Suture with Needle is indicated
for use in general soft tissue
approximation and/or ligation
including use in cardiovascular,
ophthalmic and neurological
procedures. | Analysis 1 |
| Configuration | Polypropylene Suture with or
without needle | Polypropylene Suture with needle | Similar |
| Suture | | | |
| Material | Polypropylene | Polypropylene | Same |
Table 1: Comparison of Technological Characteristics
5
| Structure | Monofilament | Monofilament | Same |
|---|---|---|---|
| Dyed, Un-dyed | Dyed | Dyed | Same |
| Colorant | [phtalocyaninato(2-)] copper | Blue | Analysis 2 |
| Length | 75cm, 150cm | Unknown | Analysis |
| Diameter | 6-0 through 2 | 10-0 through 2 | 3 |
| Needle | |||
| Material | Stainless Steel | Stainless Steel | Same |
| Performance Test | |||
| Diameter of suture | Comply with USP | All characteristics meet USP | |
| Requirement | |||
| Needle Attachment | Comply with USP | Same | |
| Tensile Strength | Comply with USP | ||
| Length | Not less than 95.0% of the | ||
| length stated on the label | Unknown | Analysis3 | |
| Suture Biocompatibility | |||
| Cytotoxicity | The viability is not reduced to less | ||
| than 70% | |||
| Sensitization | The Magnusson and Kligman | ||
| grades is less than 1. | |||
| Intracutaneous | |||
| Reactivity | The erythema and edema grades is | ||
| less than 1.0. | The specific test items are | ||
| unknown. However, the product | |||
| should meet the requirements of | |||
| ISO10993 series standards. | |||
| Acute systemic | |||
| toxicity | No animal died or abnormal | ||
| behavior occurred. | |||
| Pyrogen | Temperature raise is less than 0.5℃ | ||
| No behavioral change or sign of | |||
| toxicity was observed. | |||
| Clinical pathology parameter | |||
| within the reference range. | |||
| Subacute | |||
| Systemic Toxicity | No macroscopic changes in the | ||
| viscera at necropsy. | |||
| Histopathology within normal | |||
| histomorphological limits | |||
| Bacterial | |||
| Reverse | |||
| Mutation | No obviously increase in the mean | ||
| number of revertant of colonies | |||
| between the test group and control | |||
| group. | |||
| Chromosome | |||
| Aberration | No significant difference in the | ||
| percentage of cells with | |||
| chromosome aberrations | |||
| between the test group and | |||
| control group. | |||
| Gene Mutation | There was no significant difference | ||
| in the TFT-resistant mutant | |||
| frequency between the test article |
6
| Implantation | No lesion at the implantation site.
The irritation score is less than 1.0. |
|--------------|-------------------------------------------------------------------------------|
| Hemolysis | Hemolytic index is less than 2% |
Analysis 1-Indication for Use
The indication for use for the subject device is not exactly the same as the predicate device. The proposed device is just indicated for general tissue approximation but not for use in ophthalmic procedures, cardiovascular and neurological procedures and this indication can be covered by the predicate device. In addition, the longest duration of use for the proposed device is up to 10 days, while the predicate device is a permanent contact device per the contact duration. However, the biocompatibility test has been conducted on the proposed device and the test result showed that the material and colorant of the proposed device will not have an adverse effect when used for up to 10 days.
Analysis 2- Colorant
The material and colorant of the proposed device is different from the predicate device. However, the biocompatibility test has been conducted on the proposed device and the test result showed that the material and colorant of the proposed device will not have adverse effects. Therefore, the difference will not affect the safety and effectiveness of the proposed device.
Analysis 3- Length & Diameter
The length and diameter of the proposed device is different from the predicate device. However, the length and diameter of the proposed device are 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 proposed device met the acceptance criteria. Therefore, the difference will not affect the safety and effectiveness of the proposed device.
8. Non-Clinical Performance Data
Non clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate 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 >
- A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- A ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
-
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
7
Sensitization
-
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic Toxicity
- USP Pyrogen Test (USP Rabbit Test) A
-
USPBacterial Endotoxins Test
-
USPSutures - Diameter
-
USPSutures - Needle Attachment
-
USPTensile Strength
-
ASTM F3014-14 Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures
-
ASTM F1874-98 Standard Test Method for Bend Testing of Needles Used in Surgical Sutures
-
- Clinical Test Conclusion
No clinical study is included in this submission.
10. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device is as safe, effective, and performs as well as the legally marketed predicate device, K080684.