(409 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterilization of surgical sutures, with no mention of AI or ML capabilities.
Yes
The device, a non-absorbable suture, is used for "general soft tissue approximation and/or ligation," which directly treats a medical condition (suturing wounds) and thus has a therapeutic effect.
No
The device, surgical sutures, is used for soft tissue approximation and/or ligation, which are therapeutic actions, not diagnostic ones. It does not provide information about a patient's medical condition.
No
The device description clearly states the device consists of physical components: polypropylene, polyester, or polyamide surgical suture and a stainless steel needle. It also describes physical characteristics like monofilament/braided, coated, dyed, and available sizes and needle types. This is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "general soft tissue approximation and/or ligation." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a surgical suture with or without a needle, made of materials like polypropylene, polyester, or polyamide. These are materials used for physically joining tissues.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The description of this device and its intended use do not involve the examination of specimens outside the body.
Therefore, this device is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Non-absorbable Polypropylene Suture is indicated for use in general soft tissue approximation and/or ligation. The device can be left in place for a maximum of 30 days.
- Non-absorbable Polyester Suture is indicated for use in general soft tissue approximation and/or ligation. The device can be left in place for a maximum of 30 days.
- Non-absorbable Polyamide suture is indicated for use in general soft tissue approximation and/or ligation. The device can be left in place for a maximum of 30 days.
Product codes (comma separated list FDA assigned to the subject device)
GAR, GAW, GAT
Device Description
a. The applicant devices of Non-absorbable Polypropylene Suture consist of polypropylene surgical suture made of polypropylene and a stainless steel needle. It is monofilament. It is EO sterilized, and prygon-free. It is dyed by §74.3045 [Phthalocyaninato(2-)] copper.(CI Number 74160) which is less than 0.1 % by weight.
The applicant devices of Non-absorbable Polypropylene Suture are available in 11-0, 10-0, 8 -0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-0, 0, 1, 2 and 3, which are the sizes identified in the currently recognized United States Pharmacopoeia.
b. The applicant devices of Non-absorbable Polyester Suture consist of a polyester surgical suture made of polyester and a stainless steel needle. It is braided and coated with silicone. It is EO sterilized, and prygon-free.It is undyed (natural white) or dyed green with § 74.3206 D&C Green No. 6. (CI Number 61565), which is less than 0.1 % by weight. The applicant devices of Non-absorbable Polyester Suture are available in 9-0, 8-0, -0, 6-0, 5-0, 4-0, 3-0, 2-0, 0, 1, 2 and 3, which are the sizes identified in the currently recognized United States Pharmacopoeia.
c. The applicant devices of Non-absorbable Polyamide suture consist of a polyamide surgical suture made of long-chain, aliphatic polymers nylon and a stainless steel needle. It is monofilament. It is EO sterilized, and prygon-free. It is dyed by § 74.3102 FD&C Blue No. 2. ( CI Number 73015) or § 73.1410 Logwood Black (CI Number 75290), which is less than 0.1 % by weight.
The applicant devices of Non-absorbable Polyamide suture are available in 11-0, 10-0, 8-0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-0, 0, 1, 2 and 3, which are the sizes identified in the currently recognized United States Pharmacopoeia.
The proposed devices are provided sterile and single use.
The proposed device is composed of suture with or without the needle.
The needle is made of stainless steel. The needles are available in six types: Taper, Cutting, Taper Cutting, Reverse Cutting, Diamond, Premium Cutting and Spatula. The Arc (Circle) of needle has 1/4 circle, 3/8circle,1/2circle,5/8circle,compound curve, straight.
The proposed devices are provided in various combinations of suture length, diameter, color (dyed or undyed), quantity of needle and needle types.
The proposed devices are sterilized by EO to achieve a SAL 106 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- USP 43-NF 38:2020 Non-absorbable Surgical Suture
- USP 43-NF 38:2020 Bacterial Endotoxins Limit;
- USP 43-NF 38:2020 Sterility Test
- USP 43-NF 38:2020 Sutures - Diameter
- USP 43-NF 38:2020 Sutures Needle Attachment
- USP 43-NF 38:2020 Tensile Strength
- ISO 10993-3:2014 Biological Evaluation of Medical Devices, Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity;
- ISO 10993-4:2017 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
- 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 10993-10: 2010 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;
- ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
- 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 Package by Dye Penetration;
- ASTM F1140-13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
The following stability testing was performed to support the proposed shelf life: Performance and Package Integrity Test Report after Accelerated Aging (five years)
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.5030 Natural nonabsorbable silk surgical suture.
(a)
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.(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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
July 31, 2023
Huaian Seamen Medical Technology Co., LTD % Liu Hui General manager Tianjin Zongxin Weiye Consulting Co. LTD. Building 3, Jinfeng Building, Nankai District Tianjin, Tianjin 300110 China
Re: K221767
Trade/Device Name: Surgical Sutures with or without Needle Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable Polyamide Surgical Suture Regulatory Class: Class II Product Code: GAR, GAW, GAT Dated: June 14, 2023 Received: June 14, 2023
Dear Liu Hui:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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,
David Krause -S
David Krause, Ph.D. Deputy Director OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K221767
Device Name
Surgical Sutures with or without Needle, Polypropylene
Indications for Use (Describe)
Non-absorbable Polypropylene Suture is indicated for use in general soft tissue approximation and/or ligation. The device can be left in place for a maximum of 30 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) |
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
"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."
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K221767
Device Name
Surgical Sutures with or without Needle, Polyester
Indications for Use (Describe)
Non-absorbable Polyester Suture is indicated for use in general soft tissue approximation and/or ligation. The device can be left in place for a maximum of 30 days.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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
"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."
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K221767
Device Name
Surgical Sutures with or without Needle, Polyamide
Indications for Use (Describe)
Non-absorbable Polyamide Suture is indicated for use in general soft tissue approximation and/or ligation. The device can be left in place for a maximum of 30 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) |
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
"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."
Form Approved: OMB No. 0910-0120
5
Tab # 6 510(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: _
-
- Date of Preparation: 2023.07.19
-
- Sponsor Identification
Huaian Seamen Medical Technology Co.LTD
No. 6, Wang Yuan Pioneering Park (Qunli Road), Yanhe Sub-district Office, Qingjiangpu District, Huai 'an City, Jiangsu Province, China Establishment Registration Number: 3021275641
Contact Person: Zhang Xinjie Position: Technical manager Tel: 13163746779
Email: lifeseasea123@163.com
-
- Designated Submission Correspondent
(Primary Contact Person) Hui Liu (Alternative Contact Person) Anna Sun
- Designated Submission Correspondent
Tianjin Zongxin Weiye Consulting Co., Ltd.
Building 3, Jinfeng Building, northeast of the intersection of Nanma Road and Chengxiang West Road, Nankai District, Tianjin City, China
Tel:15922145259 Email: registration anna@hotmail.com
-
- Identification of Proposed Device
Device Trade/Proprietary Name: Surgical Sutures with or without Needle
- Identification of Proposed Device
Classification Information
Non-absorbable Polypropylene Suture a.
- Classification Name: Suture, Non-absorbable, Synthetic, Polypropylene (1)
- (2) Product Code: GAW
- (3) Regulation Number: 878.5010
- (4) Class: II
- Review Panel: General & Plastic Surgery (5)
6
Non-absorbable Polyester Suture b.
- (1) Classification Name: Suture, Non-absorbable, Synthetic, Polyester
- (2) Product Code: GAT
- (3) Regulation Number: 878.5000
- (4) Class: II
- Review Panel: General & Plastic Surgery (5)
Non-absorbable Polyamide Suture C.
- (1) Classification Name: Suture, Non-absorbable, Synthetic, Polyamide
- (2) Product Code: GAR
- (3) Regulation Number: 878.5020
- (4) Class: II
- (ર) Review Panel: General & Plastic Surgery
Indications for Use
a. Non-absorbable Polypropylene Suture is indicated for use in general soft tissue approximation and/or ligation. The device can be left in place for a maximum of 30 days.
- b. Non-absorbable Polyester Suture is indicated for use in general soft tissue approximation and/or ligation. The device can be left in place for a maximum of 30 days.
c. Non-absorbable Polyamide suture is indicated for use in general soft tissue approximation and/or ligation. The device can be left in place for a maximum of 30 days.
Device Description
-
a. The applicant devices of Non-absorbable Polypropylene Suture consist of polypropylene surgical suture made of polypropylene and a stainless steel needle. It is monofilament. It is EO sterilized, and prygon-free. It is dyed by $74.3045 [Phthalocyaninato(2-)] copper.(CI Number 74160) which is less than 0.1 % by weight.
The applicant devices of Non-absorbable Polypropylene Suture are available in 11-0, 10-0, 8 -0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-0, 0, 1, 2 and 3, which are the sizes identified in the currently recognized United States Pharmacopoeia. -
The applicant devices of Non-absorbable Polyester Suture consist of a polyester surgical suture b. made of polyester and a stainless steel needle. It is braided and coated with silicone. It is EO sterilized, and prygon-free.It is undyed (natural white) or dyed green with § 74.3206 D&C Green No. 6. (CI Number 61565), which is less than 0.1 % by weight. The applicant devices of Non-absorbable Polyester Suture are available in 9-0, 8-0, -0, 6-0, 5-0, 4-0, 3-0, 2-0, 0, 1, 2 and 3, which are the sizes identified in the currently recognized United States Pharmacopoeia.
-
The applicant devices of Non-absorbable Polyamide suture consist of a polyamide surgical c. suture made of long-chain, aliphatic polymers nylon and a stainless steel needle. It is monofilament. It is EO sterilized, and prygon-free. It is dyed by § 74.3102 FD&C Blue No. 2. ( CI Number 73015) or § 73.1410 Logwood Black (CI Number 75290), which is less than 0.1 % by weight.
The applicant devices of Non-absorbable Polyamide suture are available in 11-0, 10-0, 8-0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-0, 0, 1, 2 and 3, which are the sizes identified in the currently recognized United States Pharmacopoeia.
The proposed devices are provided sterile and single use.
7
The proposed device is composed of suture with or without the needle.
The needle is made of stainless steel. The needles are available in six types: Taper, Cutting, Taper Cutting, Reverse Cutting, Diamond, Premium Cutting and Spatula. The Arc (Circle) of needle has 1/4 circle, 3/8circle,1/2circle,5/8circle,compound curve, straight.
The proposed devices are provided in various combinations of suture length, diameter, color (dyed or undyed), quantity of needle and needle types.
The proposed devices are sterilized by EO to achieve a SAL 106 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.
-
- Identification of Predicate
Devices Predicate Device 510(k) Number: K080684 Product Name: WG-SURGICAL SUTURES WITH NEEDLE Manufacturer: Foosin Medical Supplies Inc., Ltd.
- Identification of Predicate
6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
8
-
USP 43-NF 38:2020 Non-absorbable Surgical Suture
-
USP 43-NF 38:2020 Bacterial Endotoxins Limit;
- USP 43-NF 38:2020 Sterility Test >
-
USP 43-NF 38:2020 Sutures - Diameter
- USP 43-NF 38:2020 Sutures Needle Attachment >
-
USP 43-NF 38:2020 Tensile Strength
-
ISO 10993-3:2014 Biological Evaluation of Medical Devices, Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity;
-
ISO 10993-4:2017 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
-
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 10993-10: 2010 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;
-
ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
-
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 Package by Dye Penetration;
-
ASTM F1140-13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
The following stability testing was performed to support the proposed shelf life: Performance and Package Integrity Test Report after Accelerated Aging (five years)
- Clinical Test Conclusion 7.
No clinical study is included in this submission.
9
8. Substantially Equivalent (SE) Comparison
| Item | Proposed Device
Non-absorbable Polypropylene Suture
Non-absorbable Polyester Suture Non-
absorbable Polyamide suture | Predicate Device K080684
Non-absorbable Polypropylene Suture with Needle
Non-absorbable Polyester Suture with Needle
Non-absorbable Polyamide Suture with Needle | Remark |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Product Code | GAW
GAT
GAR | GAW
GAT
GAR | SE |
| Regulation
Number | CFR 878. 5010
CFR878.5000
CFR878.5020 | CFR 878. 5010
CFR878.5000
CFR878.5020 | SE |
| Class | II | II | SE |
| Indications for Use | Non-absorbable Polypropylene Suture is indicated for use in
general soft tissue approximation and/or ligation. The device can
be left in place for a maximum of 30 days.
Non-absorbable Polyester Suture is indicated for use in general
soft tissue approximation and/or ligation. The device can be left
in place for a maximum of 30 days.
Non-absorbable Polyamide suture is indicated for use in general
soft tissue approximation and/or ligation. The device can be left
in place for a maximum of 30 days. | Non-absorbable Polypropylene Suture with Needle is
indicated for use in general soft tissue approximation
and/or ligation including use in cardiovascular,
ophthalmic and neurological procedures.
Non-absorbable Polyester Suture with Needle is
indicated for use in general soft tissue approximation
and/or ligation including use in cardiovascular,
ophthalmic and neurological procedures.
Non-absorbable Polyamide suture with needle is
indicated for use in general soft tissue approximation
and/or ligation, including use in ophthalmic
procedures. | Different
Analysis 1 |
| Configuration | Suture with or without Needle | Suture with or without Needle | SE |
| Sterility | EQ Sterilized | EQ Sterilized | SE |
| SAL | $1.0×10-6$ | $1.0×10-6$ | SE |
| Single Use | Yes | Yes | SE |
| Duration of use | Prolonged exposure(24h-30d) | long-term exposure(≥30days) | Different
Analysis 2 |
| Material | Polypropylene/ Polyester/Polyamide | Polypropylene/ Polyester/Polyamide | SE |
| Color | Polypropylene:
§ 74.3045 [Phthalocyaninato(2-)] copper.
(CI Number 74160)
Polyester: undyed (natural white) and dyed green with
§ 74.3206 D&C Green No. 6. (CI Number 61565).
Polyamide:
§ 74.3102 FD&C Blue No. 2.(CI Number 73015)
§ 73.1410 Logwood Black (CI Number 75290)
Weight percentage of color additive is less than 0.1%. | / | Different
Analysis 3 |
| Absorbable /
Non-absorbable | Non-absorbable | Non-absorbable | SE |
| Braided /
Monofilament | Polyester: braided.
Polypropylene/Polyamide: monofilament | Polyester: braided.
Polypropylene/Polyamide: monofilament | SE |
| Suture Size | Polypropylene: 11-0, 10-0, 9-0, 8-0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-
0, 0, 1, 2 and 3
Polyester: 9-0, 8-0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-0, 0, 1, 2 and 3
Polyamide: 11-0, 10-0, 9-0, 8-0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-0, 0, 1,
2 and 3 | 11-0, 10-0, 9-0, 8-0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-
0, 0, 1, 2 and 3 | Different
Analysis 4 |
| 510(k) Summary | K221767 | | 7/9 |
| Suture Length | Polypropylene: 5cm, 10cm, 13cm, 15cm, 20cm, 23cm, 25cm,
30cm, 45cm, 50cm, 60cm, 70cm, 75cm, 80cm, 85cm, 90cm,
100cm, 120cm, 150cm, 180cm, 200cm, 203cm, 220cm, 240cm,
250cm, 280cm, 300cm, 320cm, 350cm, 390cm | ≤3.9m | Different
Analysis 5 |
| | Polyester: 5cm, 15cm, 23cm, 25cm, 30cm, 45cm, 50cm,
60cm,70cm, 75cm, 90cm, 95cm, 100cm, 107cm, 120cm, 150cm,
180cm, 200cm, 220cm, 250cm, 280cm, 300cm, 320cm, 350cm,
360cm | | |
| | Polyamide: 5cm, 10cm, 13cm, 15cm, 18cm, 20cm, 23cm, 25cm,
30cm, 35cm, 38cm, 40cm, 45cm, 50cm, 60cm, 70cm, 75cm,
90cm, 100cm, 120cm, 150cm, 180cm, 200cm, 203cm, 220cm,
240cm, 250cm, 280cm, 350cm | | |
| Diameter of Suture | The suture diameters of proposed device comply with the
diameter requirement listed
in USP Diameter. | The suture diameters of proposed device comply with
the diameter requirement listed
in USP Diameter. | SE |
| Tensile Strength | The tensile strengths of proposed device comply with the
tensile requirement listed in
USP Tensile Strength | The tensile strengths of proposed device complies with
the tensile requirement listed in USP Tensile
Strength Tensile Strength | SE |
| Needle Attachment | The bond between suture and needle of the applicant device meet
the requirements defined
in USP . | The bond between suture and needle of the
applicant device meet the requirements defined
in USP . | SE |
| Biocompatibility of Needles | | | |
| Cytotoxicity | No cytotoxicity. | The specific test items are unknown. However,
the product should meet the requirements of
ISO10993 series
standards. | Different
Analysis 6 |
| Max Sensitization | No skin sensitization. | | |
| Intracutaneous
Reactivity Test | No intracutaneous reactivity. | | |
| Acute systemic toxicity | No systemic toxicity. | | |
| Pyrogenicity test | No potential febrile reaction. | | |
| Hemolysis test (Direct contact) | No Hemolysis | | |
| Hemolysis test (Indirect contact) | No Hemolysis | | |
| Biocompatibility of Sutures | | | |
| Cytotoxicity | No cytotoxicity. | The specific test items are unknown. However,
the product should meet the requirements of
ISO10993 series standards. | Different
Analysis 7 |
| Max Sensitization | No skin sensitization. | | |
| Intracutaneous
Reactivity Test | No intracutaneous reactivity. | | |
| Acute Systemic
Toxicity Test | No systemic toxicity. | | |
| Genotoxicity | No genotoxicity. | | |
| Pyrogenicity | No potential febrile reaction. | | |
| Muscle Implantation
Study | No reaction to the tissue. | | |
| Subacute/Subchronic
Toxicity Study | No systemic toxicity. | | |
| Hemolysis Test
(Direct Contact) | No Hemolysis | | |
| Hemolysis Test
(Indirect Contact) | No Hemolysis | | |
Table 1 Comparison of Technology Characteristics
10
11
12
13
Different Analysis 1- Indications for Use
The Indications for Use of proposed device is different from the predicate device. However, the Indications for Use of the proposed device is included in the range of the Indications for Use of the predicate device.
Therefore, this difference does not affect safety and effectiveness of the proposed device.
Different Analysis 2- Duration of use
The Duration of use of proposed device is different from the predicate device. However, the Duration of use of the proposed device is included in the range of the Duration of use of the predicate device. Therefore, this difference does not affect safety and effectiveness of the proposed device.
Different Analysis 3- Color
The color of predicate devices are not known. The color additive is usually used for Non-Absorbable Surgical Suture. The proposed device has been demonstrated to comply the requirements listed in USP Monograph of Non-Absorbable Surgical Suture. The color additive used conform to requirement of § 70.5 General restrictions on use of color additives- (c) Color additives for use in surgical sutures. Therefore, this item does not impact the safety and effectiveness.
Different Analysis 4- Suture Size
The Suture Size of the proposed device is within the scope of the Suture Size of predicate devices. The proposed device has been demonstrated to comply the requirements listed in USP Monograph of Non-Absorbable Surgical Suture. Therefore, this item does not impact the safety and effectiveness.
Different Analysis 5- Suture Length
The Suture Length of the proposed device is within the scope of the Suture length of predicate devices. The proposed device has been demonstrated to comply the requirements listed in USP Monograph of Non-Absorbable Surgical Suture. Therefore, this item does not impact the safety and effectiveness.
Different Analysis 6- Needle Biocompatibility
The needle biocompatibility of Proposed Device and Predicate Device should meet the requirements of ISO10993 series standards; although we do not know the specific test items of Predicate Device, but the needle biocompatibility tests of Proposed Device have been performed in Cytotoxicity Test Report, Max Sensitization Test Report, Intracutaneous Reactivity Test Report, Acute Systemic Toxicity Test Report, Pyrogenicity Test Report, Hemolysis Test Report (Direct contact), Hemolysis Test Report (Indirect contact). These studies can demonstrate the needle biocompatibility of Proposed Device. Therefore, this item is considered to be substantially equivalent.
Different Analysis 7- Suture Biocompatibility
The biocompatibility of Proposed Device and Predicate Device should meet the requirements of ISO10993 series standards; although we do not know the specific test items of Predicate Device, but the biocompatibility tests of of Proposed Device have been performed in Cytotoxicity, Max Sensitization, Intracutaneous Reactivity Test. Acute Systemic Toxicity Test. Genotoxicity, Pyrogenicity, Muscle Implantation Subacute/Subchronic Toxicity Study, Hemolysis Test (Direct Contact) and Hemolysis Test (Indirect Contact). These studies can demonstrate the biocompatibility of Proposed Device. Therefore, this item is considered to be substantially equivalent.
9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.