(77 days)
Not Found
No
The device description and performance studies focus on the physical and biological properties of a surgical suture, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a surgical suture used for approximation and ligation of tissues, which are mechanical functions, not therapeutic ones that treat disease or disorder.
No
Explanation: The device is a synthetic absorbable suture used for general soft tissue approximation and/or ligation. It is a surgical tool, not a diagnostic device.
No
The device description clearly states it is a physical suture made of PGLA and stainless steel needles, and describes physical testing and sterilization methods.
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," which are surgical procedures performed directly on the body.
- Device Description: The device is a "Synthetic Absorbable Suture," which 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 in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The Holycon Synthetic Absorbable Sutures 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 Holycon Synthetic Absorbable Sutures are 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.
The Holycon Synthetic Absorbable Sutures are composed of PGLA suture and needle.
The Holycon Synthetic Absorbable Sutures are composed of a copolymer made from 90% glycolide and 10% L-lactide (PGLA); they are coated with copolymer of 30% glycolide and 70% lactide and calcium stearate. The PGLA suture is dyed suture.
The needles are available in four types: Taper, Cutting, Spatula and Blunt. The material of needles is stainless steel.
The performance of this absorbable suture complies with United States Pharmacopeia (U.S.P.) monograph requirements for Absorbable Surgical Suture, USP 40, USP 40 and USP 40 .
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)
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;
- 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 10993-6:2007 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-09 Standard Test Method for Seal Strength of Flexible Barrier Materials:
- ASTM F1929-12 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;
- A USP Pyrogen Test
The in vivo tensile strength testing, which is to determine the in vivo breaking strength retention study, was conducted in subcutaneous implantation study, and the testing was conducted with the predicate device as a control.
The 3-year real-time aging tests were conducted to support that the proposed device to mitigate the risk of time-dependent degradation of the suture material. The real-aging testing includes package integrity, stability and physical test.
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
§ 878.4493 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.
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Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 14, 2017
Nantong Holycon Medical Devices Co., Ltd. % Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 China
Re: K173043
Trade/Device Name: Holycon Synthetic Absorbable Sutures Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: September 26, 2017 Received: September 28, 2017
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 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);
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
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
Indications for Use
510(k) Number (if known)
Device Name Holycon Synthetic Absorbable Sutures
Indications for Use (Describe)
The Holycon Synthetic Absorbable Sutures 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.
| 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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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: K173043
-
- Date of Preparation: 12/12/2017
-
- Sponsor Identification
Nantong Holycon Medical Devices Co., Ltd. No.66, Zhongyang Road, Economic Technology Development Area, Nantong, Jiangsu, 226009, China
Establishment Registration Number: Not yet registered
Contact Person: Feng Lu Position: Quality Manager Tel: +86-513-80979102 Fax: +86-513-83599100 Email: fengl@holycom.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (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
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Identification of Proposed Device 4.
Trade Name: Holycon Synthetic Absorbable Sutures Common Name: PGLA Synthetic Absorbable Suture Size: USP 6-0, USP 5-0, USP 4-0, USP 3-0, USP 2-0, USP 0 and USP 1
Regulatory Information Regulation Description: Absorbable poly (glycolide/l-lactide) surgical suture Classification: II Product Code: GAM Regulation Number: 21 CFR 878.4493 Review Panel: General & Plastic Surgery
Indications for Use:
The Holycon Synthetic Absorbable Sutures 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.
Device Description
The Holycon Synthetic Absorbable Sutures are 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.
The Holycon Synthetic Absorbable Sutures are composed of PGLA suture and needle.
The Holycon Synthetic Absorbable Sutures are composed of a copolymer made from 90% glycolide and 10% L-lactide (PGLA); they are coated with copolymer of 30% glycolide and 70% lactide and calcium stearate. The PGLA suture is dyed suture.
The needles are available in four types: Taper, Cutting, Spatula and Blunt. The material of needles is stainless steel.
The performance of this absorbable suture complies with United States Pharmacopeia (U.S.P.) monograph requirements for Absorbable Surgical Suture, USP 40, USP 40 and USP 40 .
The Synthetic Absorbable Suture is provided EO sterilized as a single use device.
5
-
- Identification of Predicate Device
510(k) Number: K130735 Product Name: WEGO-PGLA Absorbable Surgical Suture Manufacturer: Foosin Medical Supplies Inc., Ltd
- Identification of Predicate Device
-
- Non-Clinical Testing
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 Testing
-
USP 40-NF 35:2017 Sutures - Diameter;
-
USP 40-NF 35:2017 Sutures - Needle Attachment;
-
USP 40-NF 35:2017 Tensile Strength;
-
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 10993-6:2007 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-09 Standard Test Method for Seal Strength of Flexible Barrier Materials:
-
ASTM F1929-12 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;
-
A USP Pyrogen Test
The in vivo tensile strength testing, which is to determine the in vivo breaking strength retention study, was conducted in subcutaneous implantation study, and the testing was conducted with the predicate device as a control.
The 3-year real-time aging tests were conducted to support that the proposed device to mitigate the risk
6
of time-dependent degradation of the suture material. The real-aging testing includes package integrity, stability and physical test.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
7
8. Substantially Equivalent (SE) Comparison
| Proposed Device | Predicate Device | |
|---|---|---|
| Item | Holycon Synthetic Absorbable | WEGO-PGLA Absorbable |
| Sutures | Surgical Suture, K130735 | |
| Product Code | GAM | GAM |
| Regulation Number | 21 CFR 878.4493 | 21 CFR 878.4493 |
| Class | II | II |
| Intended Use | The Holycon Synthetic | |
| Absorbable Sutures 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. | 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. | ||
| Material | 90% glycolide and 10% L-lactide | |
| (PGLA) | 90% glycolide and 10% L-lactide | |
| (PGLA) | ||
| Color | Dyed | Dyed and Undyed |
| Absorbable / | ||
| Non-absorbable | Absorbable | Absorbable |
| Braided / | ||
| Monofilament | Braided | Braided |
| Sterility | EO Sterilized | EO Sterilized |
| Suture Size | USP 6-0, USP 5-0, USP 4-0, USP | |
| 3-0, USP 2-0, USP 0 and USP 1 | USP 6-0, USP 5-0, USP 4-0, USP | |
| 3-0, USP 2-0, USP 0 and USP 1 | ||
| Length of Suture | 45cm, 75cm, 90cm and 150cm | 30cm, 45cm, 60cm, 75cm, |
| 90cm,100cm, 120cm, 150cm, 180cm, | ||
| 200cm, 250cm, 280cm, 300cm, | ||
| 320cm, 360cm and 390cm | ||
| Single Use | Yes | Yes |
| Performance | Comply with: | |
| USP | ||
| USP | ||
| USP | Comply with: | |
| USP | ||
| USP | ||
| USP | ||
| Biocompatibility | Conforms to the requirements of | |
| ISO 10993 series Standards | Conforms to the requirements of ISO | |
| 10993 series Standards |
Table 1 Comparison of Proposed Device and Predicated Device (K072076)
The main differences between proposed device and predicate device are color and length of suture. There is only dyed suture available for proposed device, and the suture length range of proposed
8
device is smaller than that of the predicate device, the dyed suture length range of proposed device are included in predicate 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.