(302 days)
No
The device description and performance studies focus on the physical properties and material composition of a surgical suture, with no mention of AI or ML technology.
No.
Explanation: A therapeutic device is one that treats or alleviates a disease, injury, or condition. This device is a surgical suture, which is used for soft tissue approximation and/or ligation (holding tissues together), rather than directly treating a condition or curing a disease.
No
Explanation: The device is an absorbable surgical suture used for approximation and/or ligation of soft tissues. It performs a medical intervention, not a diagnostic function.
No
The device description clearly states it is a physical surgical suture composed of PGLA suture and needle, and describes its physical properties and testing. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general soft tissue approximation and/or ligation" during surgical procedures. This is a direct surgical intervention on the body.
- Device Description: The device is a surgical suture, a physical material used to close wounds or tie off blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on analysis of these specimens.
Therefore, the WEGO-PGLA Absorbable Surgical Suture is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The WEGO-PGLA Absorbable Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
Product codes
GAM
Device Description
The WEGO-PGLA Absorbable Surgical Suture is a multifilament (braided), synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue
It is composed of PGLA suture and needle.
The PGLA Suture is composed of a copolymer made from 90% glycolide and 10% L-lactide (PGLA); it is coated with the copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate. The PGLA suture 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, 3-0, 2-0, 0 and 1, which are the sizes identified in the currently recognized United States Pharmacopoeia.
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
general soft tissue, ophthalmic
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)
Bench 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
ASTM F88-09, Standard Test Method for Seal Strength of Flexible Barrier Materials;
ASTM F 1140-07 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Package for Medical Applications;
ASTM F1929-98(2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
ISO 11135-1:2007 Sterilization of health care products- Ethylene oxide- Part 1: Requirements for development, validation and routing control of a sterilization process for medical devices;
USP Bacterial Endotoxin Limit;
ISO 10993, Biological Evaluation of Medical Devices:
Including:
ISO 10993-3:2003 Biological Evaluation of Medical Devices, Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity;
ISO 10993-5:1999, Biological Evaluation of Medical Devices - Part 5: Test for in vitro cytotoxicity;
ISO 10993-6:1994 Biological Evaluation of Medical Devices, Part6: Test for Local Effects after Implantation:
ISO 10993-10:2002, Biological Evaluation of Medical Devices - Part 10: Tests for irritation and delayed-type hypersensitivity;
ISO 10993-11:1993, Biological Evaluation of Medical Devices - Part 11: Tests for systemic toxicity International Organization for Standardization.
Additionally, the residual strength and absorption rate studies were performed and the sutures were evaluated in accordance with the requirements outlined in FDA's Class II Special Controls Guidance Document: Surgical Sutures.
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
§ 878.4493 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
JAN 1 4 2014
Exhibit# 8 Revised 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number: K130735
-
- Date of Submission: Jan 07, 2014
- Sponsor
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
3. Submission Correspondent
.. ...
Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
E8-1
1
4. Proposed Device Identification
Proposed Device Name: WEGO-PGLA Absorbable Surgical Suture Common Device Name: PGLA Synthetic Absorbable Suture
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-PGLA Absorbable Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
-
- Predicate Device Identification
510(k) Number: K122734 Product Name: Aesculap® Novosyn Absorbable Suture Manufacturer: Aesculap® Inc.
- Predicate Device Identification
-
- Device Description
The WEGO-PGLA Absorbable Surgical Suture is a multifilament (braided), synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue
- Device Description
It is composed of PGLA suture and needle.
The PGLA Suture is composed of a copolymer made from 90% glycolide and 10% L-lactide (PGLA); it is coated with the copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate. The PGLA suture 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, 3-0, 2-0, 0 and 1, which are the sizes identified in the currently recognized United States Pharmacopoeia.
2
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 use device.
7. Non-Clinical Test Conclusion
Bench 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
ASTM F88-09, Standard Test Method for Seal Strength of Flexible Barrier Materials;
ASTM F 1140-07 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Package for Medical Applications;
ASTM F1929-98(2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
ISO 11135-1:2007 Sterilization of health care products- Ethylene oxide- Part 1: Requirements for development, validation and routing control of a sterilization process for medical devices;
USP Bacterial Endotoxin Limit;
ISO 10993, Biological Evaluation of Medical Devices:
Including:
ISO 10993-3:2003 Biological Evaluation of Medical Devices, Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity;
ISO 10993-5:1999, Biological Evaluation of Medical Devices - Part 5: Test for in vitro cytotoxicity;
ISO 10993-6:1994 Biological Evaluation of Medical Devices, Part6: Test for Local Effects after Implantation:
ISO 10993-10:2002, Biological Evaluation of Medical Devices - Part 10: Tests for irritation and delayed-type hypersensitivity;
ISO 10993-11:1993, Biological Evaluation of Medical Devices - Part 11: Tests for systemic toxicity International Organization for Standardization.
Additionally, the residual strength and absorption rate studies were performed and the sutures were evaluated in accordance with the requirements outlined in FDA's Class II Special Controls Guidance Document: Surgical Sutures.
3
: · · ·
:
8. Substantially Equivalent Conclusion
| ITEM | Proposed Device | Predicate Device |
|---|---|---|
| WEGO-PGLA Absorbable Surgical Suture | K122734 | |
| Aesculap® Novosyn Absorbable Suture | ||
| Product Code | GAM | Same |
| Regulation No. | 21 CFR 878.4493 | Same |
| Class | II | Same |
| Sterile | Yes | Yes |
| Single Use | Yes | Yes |
| Configuration | PGLA Suture and Needle | Same |
| Suture | ||
| Material | 90% glycolide and 10% L-lactide (PGLA) | Same |
| Color | Dyed suture (Violet) and Undyed suture | Same |
| Absorbable/Nonabsorbable | Absorbable | Same |
| Braided/Monofilament | Braided | Same |
| Suture Size | The proposed device is available in 6-0, 5-0, 4-0, 3-0, 2-0, 0 and 1, which are the sizes identified in the currently recognized United States Pharmacopoeia. | Available suture sizes are standard according to USP requirements. |
| Length of Suture | 30cm, 45cm, 60cm, 75cm, 90cm, 100cm, 120cm, 150cm, 180cm, 200cm, 250cm, 280cm, 300cm, 320cm, 360cm and 390cm | Unknown |
| Diameter of Suture | The suture diameters of proposed device comply with the diameter requirement listed in USP 35 Diameter. | Meet the requirements defined in the USP |
| Tensile strength | The tensile strengths of proposed device comply with the tensile requirement listed in USP 35 Tensile Strength | Meet the requirements defined in the USP |
| Needle Attachment | The bond between suture and needle of the applicant device meet the requirements defined in USP 35 . | Meet the requirements defined in the USP |
| Needle | ||
| Material | Stainless Steel | Same |
| Needle type | Taper, Spatula, Cutting, Blunt | Similar |
Tab. 1 SE Comparison
The proposed device, WEGO-PGLA Absorbable Surgical Suture, is determined to be Substantially Equivalent (SE) to the predicate device, Aesculap® Novosyn Absorbable Suture (K122734), in respect of safety and effectiveness.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Foosin Medical Supplies Incorporated, Ltd % Ms. Diana Hong PO Box 120-119 Shanghai, 200120 CHINA
January 14, 2014
Re: K130735
Trade/Device Name: WEGO-PGLA Absorbable Surgical Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/l-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: December 2, 2013 Received: December 4, 2013
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 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
5
Page 2 - Ms. Diana Hong
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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.
For
Sincerely yours,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Exhibit #10 Indications for Use
510(k) Number: K130735 Device Name: WEGO-PGLA Absorbable Surgical Suture
Indications for Use:
The WEGO-PGLA Absorbable Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
OPRESCRIPTION USE (Part 21 CFR 801 Subpart D) []OVER-THE-COUNTER USE (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
David Krause -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130735