(46 days)
No
The 510(k) summary describes a standard surgical suture and does not mention any AI or ML components or functionalities. The testing described focuses on material properties and performance standards for sutures.
Yes
The device, a surgical suture, is used for soft tissue approximation and/or ligation, which are therapeutic interventions.
No
Explanation: This device is an absorbable surgical suture, used for tissue approximation and ligation, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is a physical surgical suture made of poly (glycolide-co-caprolactone) (PGCL), which is a hardware component. The testing described also focuses on physical properties of the suture.
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 "monofilament, synthetic absorbable suture." This is a physical material used to close wounds or tie off blood vessels during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body during a surgical procedure.
N/A
Intended Use / Indications for Use
The WEGO-PGCL Absorbable Surgical Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological procedures
Product codes
GAM
Device Description
The WEGO-PGCL Absorbable Surgical Monofilament Suture is a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery.
The Synthetic Absorbable Suture is composed of poly (glycolide-co-caprolactone) (PGCL); and it is available dyed and undyed (natural). The D&C violet No. 2 (Colour Index Number 60725) is the used colorant for dyed suture.
The proposed suture is available in 6-0, 5-0, 4-0, 2-0, 0 and 1, which are the sizes identified in the currently recognized United States Pharmacopoeia.
The performance of this absorbable sutures complies with United States Pharmacopeia (U.S.P.) monograph requirements for Absorbable Surgical Suture, USP 35, USP 35 and USP35 .
The Synthetic Absorbable Suture is provided EO sterilized as a single used device.
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
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 35 SUTURES - DIAMETER
USP 35 SUTURES – NEEDLE ATTACHMENT
USP 35 TENSILE STRENGTH
USP MONOGRAPH OF ABSORBABLE SURGICAL SUTURE
Additionally, the residual strength and absorption rate studies were demonstrated and the sutures were evaluated in accordance with the requirements outlined in FDA's Class II Special Controls Guidance Document: Surgical Sutures
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 14, 2014
Foosin Medical Supplies Incorporated, LTD Ms. Diana Hong MID-LINK Consulting Company, LTD P.O. Box 120-119 200120 Shanghai China
Re: K142810
Trade/Device Name: WEGO-PGCL Absorbable Surgical Monofilament Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly (glycolide/1-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: October 27, 2014 Received: October 30, 2014
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 may, therefore, market the device, subject to the general controls provisions of the Act. 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 requirements, including, but not limited to: registration and listing (21
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -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
DEPARIMENT OF HEALIH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
WEGO-PGCL Absorbable Surgical Monofilament Suture
Proposed Models: 6-0, 5-0, 4-0, 2-0, 0 and 1
Indications for Use (Describe)
The WEGO-PGCL Absorbable Surgical Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological procedures
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CER 801 Subpart D)
- Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IE NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED EORM IO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect: of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Section 3 510(k) Summary
This 510(k) Summary of 510(k) information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: __________________________________________________________________________________________________________________________________________________
-
- Date the summary was prepared: 09/01/2014
- 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: Suxia Zhao Position: Deputy Chief Engineer Tel: +86-631-5621632 Fax: +86-631-5620555 Email: zsx9001@sina.com
-
- Submission Correspondent
Ms. Diana Hong& Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
- Submission Correspondent
4
-
- Proposed Device Identification
Proposed Device Name: WEGO-PGCL Absorbable Surgical Monofilament Suture Common Device Name: PGCL Synthetic Absorbable Suture Proposed Models: 6-0, 5-0, 4-0, 2-0, 0 and 1
- Proposed Device Identification
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
Intended Use Statement:
The WEGO-PGCL Absorbable Surgical Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological procedures.
-
న్. Predicate Device Identification
510(k) Number: K130737 Product Name: WEGO-PGCL Absorbable Surgical Monofilament Suture Manufacturer: Foosin Medical Supplies Inc., Ltd -
- Device Description
The WEGO-PGCL Absorbable Surgical Monofilament Suture is a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery.
- Device Description
The Synthetic Absorbable Suture is composed of poly (glycolide-co-caprolactone) (PGCL); and it is available dyed and undyed (natural). The D&C violet No. 2 (Colour Index Number 60725) is the used colorant for dyed suture.
The proposed suture is available in 6-0, 5-0, 4-0, 2-0, 0 and 1, which are the sizes identified in the currently recognized United States Pharmacopoeia.
The performance of this absorbable sutures complies with United States Pharmacopeia (U.S.P.) monograph requirements for Absorbable Surgical Suture, USP 35, USP 35 and USP35 .
5
The Synthetic Absorbable Suture is provided EO sterilized as a single used 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 35 SUTURES - DIAMETER USP 35 SUTURES – NEEDLE ATTACHMENT USP 35 TENSILE STRENGTH USP MONOGRAPH OF ABSORBABLE SURGICAL SUTURE
Additionally, the residual strength and absorption rate studies were demonstrated and the sutures were evaluated in accordance with the requirements outlined in FDA's Class II Special Controls Guidance Document: Surgical Sutures
-
- Substantially Equivalent (SE) Conclusion
The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.
- Substantially Equivalent (SE) Conclusion
| Item | Proposed Device(s) | Predicate Device |
|---|---|---|
| K130737 | ||
| Product Code | GAM | GAM |
| Regulation Number | 21 CFR 878.4493 | 21 CFR 878.4493 |
| Class | II | II |
| Intended Use | The WEGO-PGCL Absorbable Surgical | |
| Monofilament Sutureis indicated for use in | ||
| general soft tissue approximation and/or ligation, | ||
| but not for use in cardiovascular or neurological | ||
| procedures. | The WEGO-PGCL Absorbable Surgical | |
| Monofilament Sutureis indicated for use in | ||
| general soft tissue approximation and/or | ||
| ligation, but not for use in cardiovascular | ||
| or neurological procedures. | ||
| Configuration | PGCL Suture and Needle | PGCL Suture and Needle |
| Sterile | Yes | Yes |
| Single Use | Yes | Yes |
| Suture | ||
| Material | glycolide-co-caprolactone (PGCL) | SAME |
| Color | Dyed suture (Violet), Undyed Suture | SAME |
Table 3-1 Comparison of Technology Characteristics
6
Project #: M0092014
| Absorbable/Nonabsorbable | Absorbable | SAME |
|---|---|---|
| Multifilament/Monofilament | Monofilament | SAME |
| Suture Size | The proposed device is available in6-0, 5-0, 4-0, | |
| 2-0, 0 and 1, which are the sizes identified in the | ||
| currently recognized United States | ||
| Pharmacopoeia. | The proposed device only has 3-0 model, | |
| which is the size identified in the currently | ||
| recognized United States Pharmacopoeia. | ||
| Length of Suture | 30cm, 45cm, 60cm, 75cm, 90cm, 100cm, 120cm, | |
| 150cm, 180cm, 200cm, 250cm, 280cm, 300cm, | ||
| 320cm, 360cm and 390cm | SAME | |
| Diameter of Suture | The suture diameters of proposed device comply | |
| with the diameter requirement listed in USP 35 | ||
| Diameter. | SAME | |
| Tensile strength | The tensile strengths of proposed device comply | |
| with the tensile requirement listed in USP 35 | ||
| Tensile Strength | SAME | |
| Needle Attachment | The bond between suture and needle of the | |
| applicant device meet the requirements defined | ||
| in USP 35 . | SAME | |
| Needle | ||
| Material | Stainless Steel | SAME |
| Needle type | Taper, Cutting, Blunt | SAME |
| Biocompatibility | Comply with ISO 10993-3, ISO 10093-5, ISO | |
| 10993-6, ISO 10993-10, ISO 10993-11 Standard | SAME |
The proposed device, WEGO-PGCL Absorbable Surgical Monofilament Suture, is determined to be Substantially Equivalent (SE) to the predicate device, WEGO-PGCL Absorbable Surgical Monofilament Suture (K130737), in respect of safety and effectiveness.