(268 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a surgical suture, with no mention of AI or ML.
No.
A therapeutic device is one that treats or cures a disease or condition. This device is a surgical suture used to join tissue edges or ligate tissues, which is a supportive surgical tool, not a therapeutic agent itself.
No
Explanation: The device is a surgical suture, which is used for joining tissues. Its intended use and description do not mention any diagnostic functions, such as detecting, diagnosing, or monitoring diseases or conditions.
No
The device description clearly states it is a physical surgical suture made of nylon and stainless steel needles, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "join the edges of soft-tissue wound or incision to ligate soft tissues." This is a direct surgical intervention on the body.
- Device Description: The device is a surgical suture, a physical material used to close wounds.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such examination of specimens.
The information provided clearly describes a surgical device used in vivo (within the body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
CROWNJUN Nylon Suture is intended to join the edges of soft-tissue wound or incision to ligate soft tissues.
Product codes
GAR
Device Description
The CROWNJUN Nylon Suture is a sterile nonabsorbable polyamide surgical suture. The CROWNJUN Nylon Suture is composed of long-chain aliphatic polymers polyamide 6,6 which is available undyed or dyed black using logwood extract (Hematein) per 21 CFR 73.1410. The CROWNJUN Nylon Suture is offered in diameters ranging from USP size 12-0 through USP 0 and available in various lengths from 2.5 cm to 90 cm with pre-attached needles. The needle is composed of 300 series stainless steel of various types of tip shapes, curvatures, and sizes. The product meets all requirements established by the United States Pharmacopeia (USP) for nonabsorbable surgical sutures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 testing was conducted on The CROWNJUN Nylon Suture per FDA's Special Control Guidance Document: Surgical Sutures, to prove conformance to the requirements of USP for synthetic nonabsorbable suture, and biocompatibility testing in accordance to ISO 10993-1 to further demonstrate substantial equivalence to the predicate device. Biocompatibility testing within this submission includes the following: Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic and Muscle Implantation (12-week), Genotoxicity, Subchronic System Toxicity, Hemolysis, and Pyrogenicity. Physical properties and functionality testing assured that the device conformed with suture diameter and suture length, extractable color and sterility to methods outlined in USP.
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
§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 29, 2020
Kono Seisakusho Co., Ltd. % Akiko Dohi Regulatory / Research Specialist Ken Block Consulting 800 East Campbell Drive, Suite 202 Richardson, Texas 75081
Re: K192420
Trade/Device Name: Crownjun Nylon Suture Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable Polyamide Surgical Suture Regulatory Class: Class II Product Code: GAR Dated: September 2, 2019 Received: September 4, 2019
Dear Akiko Dohi:
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 Actinclude 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 (QS) 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-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,
For Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192420
Device Name CROWNJUN Nylon Suture
Indications for Use (Describe)
CROWNJUN Nylon Suture is intended to join the edges of soft-tissue wound or incision to ligate soft tissues.
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)
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510(K) Summary
| Submission Date: | 09/04/2019 | |||
|---|---|---|---|---|
| K192420 | ||||
| SUBMITTER INFORMATION: | ||||
| Company Name: | Kono Seisakusho Co., Ltd. | |||
| Company Address: | 3-43-16 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan | |||
| Contact Person: | Hiroyuki Arai | |||
| Phone: +81-(0)3-3813-7411 | ||||
| harai@crownjun.co.jp | ||||
| Device Trade Name: | CROWNJUN Nylon Suture | |||
| Device Common Name: | Suture, Nonabsorbable, Synthetic, Polyamide | |||
| Class: | Class II | |||
| Classification: | 21 CFR 878.5020 | |||
| Nonabsorbable Polyamide Surgical Suture | ||||
| Product Code: | GAR | |||
| Predicate Devices: | K151165, AESCULAP, INC. Dafilon Nonabsorbable Polyamide Surgical Suture. |
Device Description:
The CROWNJUN Nylon Suture is a sterile nonabsorbable polyamide surgical suture. The CROWNJUN Nylon Suture is composed of long-chain aliphatic polymers polyamide 6,6 which is available undyed or dyed black using logwood extract (Hematein) per 21 CFR 73.1410. The CROWNJUN Nylon Suture is offered in diameters ranging from USP size 12-0 through USP 0 and available in various lengths from 2.5 cm to 90 cm with pre-attached needles. The needle is composed of 300 series stainless steel of various types of tip shapes, curvatures, and sizes. The product meets all requirements established by the United States Pharmacopeia (USP) for nonabsorbable surgical sutures.
Intended Use:
CROWNJUN Nylon Suture is intended to join the edges of soft-tissue wound or incision to ligate soft tissues.
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Summary of Technological Characteristics:
The CROWNJUN Nylon Suture is a synthetic nonabsorbable monofilament sterile surgical suture as the predicate devices. It is available in black or undyed.
The proposed device has the same technological characteristics as its predicate device through comparison in product design, intended use, material composition, function, and range of sizes. The proposed device also has some differences in technological characteristics from those of the predicate device. These differences in the technological characteristics only reflect market strategy and/or perceived user preferences and do not impact substantial equivalence of the device.
Non-Clinical Tests Performed:
Non-clinical testing was conducted on The CROWNJUN Nylon Suture per FDA's Special Control Guidance Document: Surgical Sutures, to prove conformance to the requirements of USP for synthetic nonabsorbable suture, and biocompatibility testing in accordance to ISO 10993-1 to further demonstrate substantial equivalence to the predicate device. Biocompatibility testing within this submission includes the following: Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic and Muscle Implantation (12-week), Genotoxicity, Subchronic System Toxicity, Hemolysis, and Pyrogenicity. Physical properties and functionality testing assured that the device conformed with suture diameter and suture length, extractable color and sterility to methods outlined in USP.
| Comparison
| ltems | New Device | Predicate Device |
|---|---|---|
| 510 (k) | K192420 | K151165 |
| Product Code | GAR | GAR |
| Product Name | CROWNJUN Nylon Suture | Dafilon Nonabsorbable |
| Polyamide Surgical Suture | ||
| Labeling | Sterile, Single Use, | |
| Nonabsorbable Suture | Sterile, Single Use, | |
| Nonabsorbable Suture | ||
| Indication for | ||
| Use | CROWNJUN Nylon Suture is | |
| intended to join the edges of | ||
| soft-tissue wound or incision to | ||
| ligate soft tissues. | Dafilon Nonabsorbable Polyamide | |
| Surgical Sutures are indicated for | ||
| use in all types of general soft | ||
| tissue approximation and/or | ||
| ligation, including use in | ||
| cardiovascular, ophthalmic, | ||
| microsurgery and neurological | ||
| procedures. | ||
| Material | Polyamide 6,6 | Polyamide 6 and/or |
| polyamide 6,6 |
Substantial Equivalence:
5
| Dyed/Undyed | Un-dyed and Dyed | Un-dyed and Dyed |
|---|---|---|
| Structure | Monofilament | Monofilament |
| Size | USP 12-0, 11-0, 10-0, 9-0, 8-0, 7-0, | |
| 6-0, 5-0, 4-0, 3-0, 2-0, 0 | ||
| (various lengths) | USP 11/0 (0.1), 10/0 (0.2), 9/0 | |
| (0.3), 8/0 (0.4), 7/0 (0,5), 6/0 (0,7), | ||
| 5/0 (1), 4/0 (1.5), 3/0 (2), 2/0 (3), 0 | ||
| (3,5), 1 (4), 2 (5) , 3 (6), 5 (7) | ||
| (various lengths) | ||
| Thread | ||
| Length | 2.5 cm – 90 cm | 30 mm- 2500 mm |
| Needle | 300 series stainless steel | 300 or 400 series stainless steel |
| Sterilization | Ethylene Oxide (EO) | Gamma Irradiation or Ethylene |
| Oxide (EO) | ||
| Standards | Suture Material meets or exceeds | |
| the performance requirements | ||
| defined in: | ||
| USP 41 | ||
| USP 41 | ||
| USP 41 | ||
| ISO 10993-1 | Suture Material meets or exceeds | |
| the performance requirements | ||
| defined in: | ||
| USP 35 | ||
| USP 35 | ||
| USP 35 | ||
| ISO 10993-1 |
Clinical Tests Performed:
No clinical trials were conducted.
Conclusion:
The CROWNJUN Nylon Suture is substantially equivalent to the predicate device, Dafilon Nonabsorbable Polyamide Surgical Suture in indications for use, fundamental scientific technology, and technological characteristics. It has the same design being a sterile, flexible, monofilament nonabsorbable thread meeting all the requirements of the United States Pharmacopeia (USP). The selected nylon suture material also has established history of use in the surgical suture industry.
The biocompatibility data and the results of performance testing presented, demonstrate the substantial equivalence of the CROWNJUN Nylon Suture to that of the predicate device. It further demonstrates conformance with the USP, ISO 10993, and FDA Guidance for Surgical Suture 510(k).