(90 days)
Not Found
No
The device description and performance studies focus on the material properties and physical performance of a surgical suture, with no mention of AI or ML.
Yes.
The device is a surgical suture used for soft tissue approximation, which indicates it's used in medical procedures to treat or mitigate a condition.
No
Explanation: The device is a surgical suture used for approximation of tissue, not for diagnosing a condition or disease.
No
The device description clearly states it is a physical surgical suture made of a copolymer, available with and without stainless steel needles. It is a tangible, physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "superficial soft tissue approximation of skin and mucosa". This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "synthetic, absorbable, braided, sterile surgical suture". This is a physical material used to close wounds.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. IVDs are typically used to test blood, urine, tissue samples, etc.
- Performance Studies: The performance studies focus on physical properties of the suture (diameter, tensile strength, needle attachment) and biological compatibility, not on diagnostic accuracy or analytical performance related to biological samples.
Therefore, the WEGO-PGLA RAPID suture is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
WEGO-PGLA RAPID sutures are intended for use in superficial soft tissue approximation of skin and mucosa where only short-term wound support is required. WEGO-PGLA RAPID is not in ligation, ophthalmic, cardiovascular or neurological procedures.
Product codes
GAM
Device Description
WEGO-PGLA RAPID sutures are synthetic, absorbable, braided, sterile surgical sutures composed of a copolymer made from 90% glycolide and 10% L-lactide. The empirical formula of the copolymer is (C2H2O2)m(C3H4O2)n. The characteristic rapid loss of strength is achieved by use of a polymer material with a lower molecular weight than regular WEGO-PGLA (Polyglactin 910) suture. WEGO-PGLA RAPID sutures are available undyed and dyed violet with D&C Violet No.2 (Colour Index number 60725).
WEGO-PGLA RAPID sutures are available in a range of gauge sizes and lengths, with and without stainless steel needles of varying types and sizes.
WEGO-PGLA RAPID sutures are uniformly coated with poly (glycolide-co-lactide) (30/70) and calcium stearate.
WEGO-PGLA RAPID sutures comply with the requirements of the European Pharmacopoeia for "Sutures, Sterile Synthetic Absorbable Braided" and the requirements of United States Pharmacopoeia for "Absorbable Surgical Suture" (except for an occasional slight oversize in diameter).
The Synthetic Absorbable Suture is provided EO sterilized as a single use device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
superficial soft tissue of skin and mucosa
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 40-NF 35:2017 Sutures – Diameter;
USP 40-NF 35:2017 Sutures - Needle Attachment;
USP 40-NF 35:2017 Tensile Strength;
A ISO 10993-3:2014 Biological Evaluation of Medical Devices, Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity;
A ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity;
ISO 10993-6:2007 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 10993-11:2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity;
USP 40-NF 35:2017 Bacterial Endotoxins Test;
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 Package by Dye Penetration;
ISO 10993-7:2008 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals;
USP 40-NF35:2017 Pyrogen Test
ASTM F756-13 Standard Practice For Assessment Of Hemolytic Properties Of Materials
The physical performance and stability of proposed device have been demonstrated by testing on samples before and after real-time-aging, to support the substantial equivalence between proposed device and the predicate, details are shown as follow:
Performance: Physical Performance
Test Sample: Device before aging
Test Item: Diameter, Result: Complies with USP
Test Item: Tensile Strength, Result: Complies with USP
Test Item: Needle Attachment, Result: Complies with USP
Performance: Stability
Test Sample: Device after real-time-aging
Test Item: Tensile Strength, Result: Complies with USP
Test Item: Needle Attachment, Result: Complies with USP
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
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.
January 28, 2019
Foosin Medical Supplies Inc., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 CN
Re: K183001
Trade/Device Name: WEGO-PGLA Rapid Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: September 28, 2018 Received: October 30, 2018
Dear Ms. Hong:
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 mav, 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 avare 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Cynthia Chang -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183001
Device Name WEGO-PGLA RAPID
Indications for Use (Describe)
WEGO-PGLA RAPID sutures are intended for use in superficial soft tissue approximation of skin and mucosa where only short-term wound support is required. WEGO-PGLA RAPID is not in ligation, ophthalmic, cardiovascular or neurological procedures.
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 of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K183001
-
- Date of Preparation: 01/24/2019
- Sponsor Identification 2.
Foosin Medical Supplies Inc., Ltd No.20, Xingshan Road, Weihai Torch Hi-tech Science Park, Weihai, Shandong, 264210, China
Establishment Registration Number: 3006562124
Contact Person: Lei Tang Position: Quality Manager Tel: +86-631-5661968 Fax: +86-631-5621680 Email: tang-lei@live.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Chengyu Wang (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: WEGO-PGLA RAPID
Common Name: Absorbable Synthetic Suture with or without Needle Size: USP 6-0, USP 5-0, USP 4-0, USP 3-0, USP 2-0, USP 0, USP 1 and USP 2
Regulatory Information
Classification Name: Suture, Absorbable, Synthetic, Polyglycolic Acid Classification: II Product Code: GAM Regulation Number: 21 CFR 878.4493 Review Panel: General & Plastic Surgery
Indications for Use:
WEGO-PGLA RAPID sutures are intended for use in superficial soft tissue approximation of skin and mucosa where only short-term wound support is required. WEGO-PGLA RAPID is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Device Description
WEGO-PGLA RAPID sutures are synthetic, absorbable, braided, sterile surgical sutures composed of a copolymer made from 90% glycolide and 10% L-lactide. The empirical formula of the copolymer is (C2H2O2)m(C3H4O2)n. The characteristic rapid loss of strength is achieved by use of a polymer material with a lower molecular weight than regular WEGO-PGLA (Polyglactin 910) suture. WEGO-PGLA RAPID sutures are available undyed and dyed violet with D&C Violet No.2 (Colour Index number 60725).
WEGO-PGLA RAPID sutures are available in a range of gauge sizes and lengths, with and without stainless steel needles of varying types and sizes.
WEGO-PGLA RAPID sutures are uniformly coated with poly (glycolide-co-lactide) (30/70) and calcium stearate.
WEGO-PGLA RAPID sutures comply with the requirements of the European Pharmacopoeia for "Sutures, Sterile Synthetic Absorbable Braided" and the requirements of United States Pharmacopoeia for "Absorbable Surgical Suture" (except for an occasional slight oversize in diameter).
The Synthetic Absorbable Suture is provided EO sterilized as a single use device.
5
-
- Identification of Predicate Device
510(k) Number: K944110 Product Name: VICRYL Rapide Suture Manufacturer: ETHICON, INC
- Identification of Predicate Device
-
- 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:
- Non-Clinical Test Conclusion
-
USP 40-NF 35:2017 Sutures – Diameter;
-
USP 40-NF 35:2017 Sutures - Needle Attachment;
-
USP 40-NF 35:2017 Tensile Strength;
-
A ISO 10993-3:2014 Biological Evaluation of Medical Devices, Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity;
-
A ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity;
-
ISO 10993-6:2007 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 10993-11:2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity;
-
USP 40-NF 35:2017 Bacterial Endotoxins Test;
-
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 Package by Dye Penetration;
-
ISO 10993-7:2008 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals;
-
USP 40-NF35:2017 Pyrogen Test
-
ASTM F756-13 Standard Practice For Assessment Of Hemolytic Properties Of Materials
The physical performance and stability of proposed device have been demonstrated by testing on samples before and after real-time-aging, to support the substantial equivalence between proposed device and the predicate, details are shown as follow:
6
Performance | Test Sample | Test Item | Result |
---|---|---|---|
Physical | |||
Performance | Device before | ||
aging | Diameter | Complies with USP | |
Tensile Strength | Complies with USP | ||
Needle Attachment | Complies with USP | ||
Stability | Device after | ||
real-time-aging | Tensile Strength | Complies with USP | |
Needle Attachment | Complies with USP |
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
-
Substantially Equivalent (SE) Comparison 8.
| Item | Proposed Device | Predicate Device
K944110 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | GAM | GAM |
| Regulation
Number | 21 CFR 878.4493 | 21 CFR 878.4493 |
| Class | II | II |
| Intended Use | WEGO-PGLA RAPID sutures are
intended for use in superficial soft
tissue approximation of skin and
mucosa where only short-term
wound support is required.
WEGO-PGLA RAPID is not
intended for use in ligation,
ophthalmic, cardiovascular or
neurological procedures. | The Vicryl Rapide Suture is indicated only
for use in superficial soft tissue
approximation of skin and mucosa where
only short-term wound support (7-10 days)
is required. Vicryl Rapide Suture is not
intended for use in ligation, ophthalmic,
cardiovascular or neurological procedures. |
| Configuration | Suture and Needle | Suture and Needle |
| Sterility | EO Sterilized | EO Sterilized |
| Single Use | Yes | Yes |
| Based Material | 90% glycolide and 10%
L-lactide.(PGLA) | 90% glycolide and 10% L-lactide (PGLA) |
| Coating
Material | poly(glycolide-co-lactide) (30/70)
and calcium stearate . | Polycaprolactone and calcium stearate |
| Color | Dyed and undyed | Dyed and undyed |
| Color Additive
Material | D&C Violet No.2 | D&C violet No. 2 |
Table 1 Comparison of Proposed Device and Predicated Device
7
| Absorbable /
Non-absorbable | Absorbable | Absorbable |
---|---|---|
Braided / | ||
Monofilament | Braided | Braided |
Suture Size | USP 6-0, USP 5-0, USP 4-0, USP | |
3-0, USP 2-0, USP 0, USP 1 and USP | ||
2 | Unknown | |
Length of | ||
Suture | 25cm, 30cm, 45cm, 50cm, 60cm, | |
70cm, 75cm and 90cm | Unknown | |
Absorption | ||
Time | 42~56days | 42 days |
The based material of proposed device is PGLA, which is similar with that of predicate device. And the performance and biocompatibility of proposed device has been demonstrated by various tests. The specifications of predicate devices are not known, however, the proposed device has been demonstrated to comply the requirements listed in USP Monograph of Absorbable Surgical Suture. The absorption time of proposed device is similar with predicate devices. The comparison and absorption tests have been conducted to confirm the absorption time of the proposed device.
Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate devices.