(242 days)
Not Found
No
The device description and performance studies focus on the physical and biological properties of the suture material, with no mention of AI or ML.
No.
This device is a surgical suture, which is used for approximation and/or ligation of tissue. While medical, it does not directly prevent, diagnose, or treat a disease or condition in the way a therapeutic device would.
No
Explanation: The device, CRYLREX®, is described as a surgical suture used for soft tissue approximation and/or ligation. Its function is to hold tissues together, not to diagnose a condition or disease.
No
The device description explicitly states it is a physical medical device composed of suture material and a needle, not 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," which are surgical procedures performed directly on the body. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Description: The device is a surgical suture with a needle, designed for physical use in surgery. This is not consistent with the nature of an IVD, which typically involves reagents, instruments, or software for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
Therefore, CRYLREX® is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
CRYLREX® 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
CRYLREX® is a sterilized medical device composed with multifilament absorbable, braided, coated suture, 90% glycolide and 10% L-lactide, with needle, stainless steel SUS 304.
CRYLREX® Suture is a synthetic absorbable, braided, coated suture composed of a copolymer made from 90% glycolide and 10% L-lactide and is available both dyed and undyed. CRYLREX® Suture is coated with poly(glycolideco-lactide)(30/70) and calcium stearate. The suture is available undyed (natural) or dyed (D&C Violet No.2). Approximately 75% of tensile strength remain after 2 weeks, 50% of tensile strength remain after 3 weeks. Complete absorption in tissues takes around 56 to 70 days.
CRYLREX® Sutures are U.S.P. except for diameters in the following sizes:
SUTURE SIZE DESIGNATION: 8-0, MAXIMUM OVERSIZE (mm): 0.007
SUTURE SIZE DESIGNATION: 7-0, MAXIMUM OVERSIZE (mm): 0.010
SUTURE SIZE DESIGNATION: 6-0, MAXIMUM OVERSIZE (mm): 0.021
SUTURE SIZE DESIGNATION: 5-0, MAXIMUM OVERSIZE (mm): 0.036
SUTURE SIZE DESIGNATION: 4-0, MAXIMUM OVERSIZE (mm): 0.031
SUTURE SIZE DESIGNATION: 3-0, MAXIMUM OVERSIZE (mm): 0.036
SUTURE SIZE DESIGNATION: 2-0, MAXIMUM OVERSIZE (mm): 0.021
SUTURE SIZE DESIGNATION: 0, MAXIMUM OVERSIZE (mm): 0.056
SUTURE SIZE DESIGNATION: 1, MAXIMUM OVERSIZE (mm): 0.046
SUTURE SIZE DESIGNATION: 2, MAXIMUM OVERSIZE (mm): 0.031
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
General soft tissue, ophthalmic procedures (not cardiovascular or neural 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)
Bench tests were conducted to verify that the proposed device met all design specifications and 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 Absorbable Surgical Suture
Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA
ASTM F88-09. Standard Test Method for Seal Strength of Flexible Barrier Materials;
ASTM F1929-98(2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
USP, STERILITY TEST
USP 36, ; Pyrogen Test
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:
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
Real-time and accelerated aging stability testing was performed to support shelf life of CRYLREX®. 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, connected by flowing lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 10, 2017
SM ENG CO., Ltd % Mr. Sanglok Lee Wise Company, Inc. #306, 3 Daerim-ro 27ga-gil Yeongdeungpo-gu, 07413 KR
Re: K161629
Trade/Device Name: CRYLREX® Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: December 28, 2016 Received: January 5, 2017
Dear Mr. Lee:
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 devicerelated 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.
1
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/ResourcesforYou/Industry/default.htm. 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.
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,
Jennifer R. Stevenson -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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K161629
Device Name CRYLREX®
Indications for Use (Describe)
CRYLREX® 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)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
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510(k) Summary
The assigned 510(k) Number: K161629
01. Date of Submission: 2016.12.28
02. Applicant
Company name: SM ENG CO., LTD Address: 46, Nakdong-daero 1302beon-gil, Sasang-gu, Busan, Korea TEL: +82 51 3058016 FAX: +82 513058021 Email: leesg@sm-eng.net
03. Submission Correspondent
Sanglok, Lee Wise COMPANY Inc. #306, 3 Daerim-ro 27ga-gil,Yeongdeungpo-gu, Seoul, Korea TEL: +82 7088123619 / +82 28313615 FAX: +82 50 4031 3619 Email: info@wisecompany.org
04. Proposed Device Identification
Proprietary Name: CRYLREX® Common Name: Synthetic Absorbable Polyglactin Suture With or Without Needle Device Class: Class II Regulation Number:21 C.F.R. 878.4493 Product Code: GAM Device Classification Name: Suture, Absorbable, Synthetic, Polyglycolic Acid
05. Indication for use
CRYLREX® is indicated for use in general soft tissue approximationand/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
06. Predicate devices
Predicate device 01 510(k) Number:K130735 DeviceName: WEGO-PGLA Absorbable Surgical Suture Classification Name: Suture, Absorbable, Synthetic, Polyglycolic Acid Manufacturer: FOOSIN MEDICAL SUPPLIES INC.LTD
07. Device Description
CRYLREX® is a sterilized medical device composed with multifilament absorbable, braided, coated suture, 90% glycolide and 10% L-lactide, with needle, stainless steel SUS 304.
CRYLREX® Suture is a synthetic absorbable, braided, coated suture composed of a copolymer made from 90% glycolide and 10% L-lactide and is available both dyed and
5
undyed. CRYLREX® Suture is coated with poly(glycolideco-lactide)(30/70) and calcium stearate. The suture is available undyed (natural) or dyed (D&C Violet No.2). Approximately 75% of tensile strength remain after 2 weeks, 50% of tensile strength remain after 3 weeks. Complete absorption in tissues takes around 56 to 70 days.
CRYLREX® Sutures are U.S.P. except for diameters in the following sizes:
| U.S.P.
SUTURE SIZE
DESIGNATION | MAXIMUM
OVERSIZE
(mm) |
|--------------------------------------|-----------------------------|
| 8-0 | 0.007 |
| 7-0 | 0.010 |
| 6-0 | 0.021 |
| 5-0 | 0.036 |
| 4-0 | 0.031 |
| 3-0 | 0.036 |
| 2-0 | 0.021 |
| 0 | 0.056 |
| 1 | 0.046 |
| 2 | 0.031 |
MAXIMUM SUTURE OVERSIZE IN DIAMETER (mm) FROM U.S.P.
08. 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 proposeddevice complies with the following standards:
USP 35 SUTURES - DIAMETER
USP 35 SUTURES - NEEDLE ATTACHMENT
USP 35 TENSILE STRENGTH
USP Absorbable Surgical Suture
Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA
ASTM F88-09. Standard Test Method for Seal Strength of Flexible Barrier Materials;
ASTM F1929-98(2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
USP, STERILITY TEST
USP 36, ; Pyrogen Test
ISO 11135-1:2007 Sterilization of health care products- Ethylene oxide- Part 1: Requirements fordevelopment, validation and routing control of a sterilization process for medical devices;
USP Bacterial Endotoxin Limit;
ISO 10993, Biological Evaluation of Medical Devices:
Including:
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
Biological evaluation of medical devices - Part 3:Tests for genotoxicity, carcinogenicity and reproductivetoxicity (ISO 10993-3:2014)
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)
6
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
Real-time and accelerated aging stability testing was performed to support shelf life of CRYLREX®. 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.
09. Substantially Equivalent Conclusion
| Property | Proposed device
CRYLREX® | Predicate device 01
WEGO-PGLA Absorbable
Surgical Suture |
|----------------|-----------------------------|----------------------------------------------------------------|
| 510(k) Number | K161629 | K130735 |
| Product Code | GAM | Same |
| Regulation No, | 2 1 CFR 878.4493 | Same |
| Class | II | Same |
| Sterile | Yes | Same |
| Single Use | Yes | Same |
| Configuration | PGLA Suture and Needle | Same |
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| Suture | |||
|---|---|---|---|
| Raw Suture Material | Neosorb | Same | |
| Manufacturer of Raw Suture | |||
| Material | Samyang Biopharmaceuticals | ||
| Corporation | Same | ||
| Final Material Composition | 90% glycolide and 10% L- | ||
| lactide (PGLA) | Same | ||
| Coating material | Poly(glycolide-co-lactide) | ||
| (30/70)+ Calcium Stearate | Same | ||
| Color (Colorant) | Undyed (natural) or Dyed (D&C | ||
| Violet No.2) | Same | ||
| Absorbable/Nonabsorbable | Absorbable | Same | |
| Braided/Monofilament | Braided | Same | |
| Suture Size | The proposed device is | ||
| available in 8-0, 7-0, 6-0,5-0, 4- | |||
| 0,3-0,2-0, 0, 1 and 2, which are | |||
| the sizes identified in the | |||
| currently recognized United | |||
| States Pharmacopoeia except | |||
| for diameter | 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 except for | |||
| diameter | |||
| Length of Suture | 20cm, 30cm, 45cm, 60cm, | ||
| 70cm, 75cm, 90cm, 100cm, | |||
| 125cm, 140cm, 150cm, 250cm, | 30cm, 45cm, 60cm, 75cm, | ||
| 90cm, 100cm, 120cm, | |||
| 150cm,180cm, 200cm, 250cm, | |||
| 280cm, 300cm, 320cm, | |||
| 360cmand 390cm | |||
| Diameter of Suture | Oversize | Oversize | |
| Tensile strength | The tensile strengths of | ||
| proposed device comply with | |||
| thetensile requirement listed in | |||
| USP 35 TensileStrength | The tensile strengths of | ||
| proposed device comply with | |||
| thetensile requirement listed in | |||
| USP 35 TensileStrength | |||
| Needle Attachment | The bond between suture and | ||
| needle ofthe applicantdevice | |||
| meet the requirements defined | |||
| in USP 35 . | The bond between suture and | ||
| needle ofthe applicantdevice | |||
| meet the requirements defined | |||
| in USP 35 . | |||
| Needle | |||
| Material | Stainless Steel | Stainless Steel | |
| Needle type | Taper point, Reverse | ||
| Cutting, Conventional cutting, | |||
| Taper cutting, Spatula, Blunt | |||
| point | Taper, Spatula, Cutting, Blunt |
8
The proposed device, CRYLREX® Suture, is determined to be SubstantiallyEquivalent (SE) to the predicate device, SYNTHETIC ABSORBABLE SUTURE (K130735) in respect of safety and effectiveness.