(378 days)
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
The device is a surgical suture used for approximation and ligation, which are mechanical support functions, not therapeutic actions.
No
Explanation: The device is a surgical suture used for tissue approximation and ligation, not for diagnosing medical conditions.
No
The device description clearly states it is a physical surgical suture made of polypropylene, which is a hardware component. The performance studies also focus on physical properties like diameter, tensile strength, and biocompatibility.
Based on the provided information, this device, REXLENE, 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 is a surgical procedure performed on the body. IVDs are used to examine specimens from the body (like blood, urine, or tissue samples) outside the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states it's a "surgical suture," a physical material used to close wounds or tie off blood vessels during surgery. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
In summary, REXLENE is a surgical suture, which is a medical device used in surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
REXLENE 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
GAW
Device Description
REXLENE is a sterilized nonabsorbable monofilament surgical suture made out of polypropylene used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.
REXLENE suture is a nonabsorbable, sterile surgical monofilament suture composed of polypropylene. REXLENE sutures are not coated. The sutures are dyed blue to enhance visibility in tissue.
REXLENE suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surgical suture. Available suture size is as below. - Dyed suture blue ([Phthalocyaninato (2-)] Copper): USP 8-0 ~ USP 1
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue, ophthalmic procedures (excluding 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)
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 SUTURES - DIAMETER
USP SUTURES - NEEDLE ATTACHMENT
USP TENSILE STRENGTH
USP Nonabsorbable Surgical Suture
Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.
Real-time and accelerated aging stability testing was performed to support shelf life of REXLENE. Testing confirmed that the sutures conform to USP requirements for nonabsorbable sutures and are stable over the proposed shelf life.
Raw suture of REXLON were evaluated in accordance with ISO 10993 standards below, they are biocompatible and suitable to use as medical device.
ISO 10993, Biological Evaluation of Medical Devices Including:
- ISO 10993-5: Test for Cytotoxicity
- ISO 10993-10: Test for Irritation and Sensitization
- ISO 10993-11: Test for Systemic Toxicity
- ISO 10993-3: Tests for Genotoxicity
- ISO 10993-6: Test for Local Effects after Implantation
- ISO 10993-4: Selection of Tests for Interaction with Blood
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene 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 undyed or dyed with an FDA approved color additive; and 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/0 description: The image contains 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 21, 2018
Sm Eng Co., Ltd % Sanglok Lee Manager Wise Company Inc. #1005, 11-19, Gamasan-ro 27a-gil Guro-gu, 08301 Kr
Re: K173747
Trade/Device Name: Rexlene Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable Polypropylene Surgical Suture Regulatory Class: Class II Product Code: GAW Dated: September 1, 2018 Received: September 19, 2018
Dear Sanglok 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. 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 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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,
Digitally signed by David David Krause -S Date: 2018.12.21 12:36:59
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name REXLENE
Indications for Use (Describe)
REXLENE 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)
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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"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."
4
Image /page/4/Picture/1 description: The image shows the text "WISE COMPANY Inc." in a serif font. The text is a light tan color. The words are all capitalized, except for the "c" in "Inc."
#1005, 11-19, Gamasan-ro 27-gil, Guro-gu, Seoul, Republic of Korea Tel: +82 2 831 3615
Image /page/4/Picture/4 description: The image shows the logo for WISE COMPANY Inc. The logo features a stylized "W" shape above the company name. Below the company name, there is text in Korean that says "와이즈컴퍼니(주)".
510(k) Summary
The assigned 510(k) Number: K173747
01. Date of Submission: December 14, 2017
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. #1005, 11-19, Gamasan-ro 27-gil, Guro-gu, Seoul, Korea TEL: +82 70 8812 3619 / +82 2 831 3615 FAX: +82 50 4031 3619 Email: info@wisecompany.org
04. Proposed Device Identification
Proprietary Name: REXLENE Common Name: Synthetic Nonabsorbable Polypropylene Suture With or Without Needle Device Class: Class II Regulation Number: 21 C.F.R. 878.5010 Product Code: GAW Regulation Description: Nonabsorbable polypropylene surgical suture
05. Indication for use
REXLENE is indicated for use in general soft tissue approximation and/or ligation, including use in tophthalmic procedures, but not for use in cardiovascular or neural tissue.
06. Predicate devices
-Primary Predicate Device 510(k) Number: K080684 Device Name: , WG-Surgical Sutures with Needle Manufacturer: FOOSIN MEDICAL SUPPLIES INC.LTD
-Reference Predicate Device
5
Image /page/5/Picture/1 description: The image shows the logo for WISE COMPANY Inc. The logo features a stylized "W" that is formed by a line that resembles a heartbeat. Below the symbol is the text "WISE COMPANY Inc." and below that is the text "와이즈컴퍼니(주)".
#1005, 11-19, Gamasan-ro 27-gil, Guro-gu, Seoul, Republic of Korea Tel: +82 2 831 3615
510(k) Number: K133356
Device Name: PROLENETM Polypropylene Nonabsorbable Suture Manufacturer: ETHICON, Inc
07. Device Description
REXLENE is a sterilized nonabsorbable monofilament surgical suture made out of polypropylene used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.
REXLENE suture is a nonabsorbable, sterile surgical monofilament suture composed of polypropylene. REXLENE sutures are not coated. The sutures are dyed blue to enhance visibility in tissue.
REXLENE suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surgical suture. Available suture size is as below. - Dyed suture blue ([Phthalocyaninato (2-)] Copper): USP 8-0 ~ USP 1
08. 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:
USP SUTURES - DIAMETER
USP SUTURES - NEEDLE ATTACHMENT
USP TENSILE STRENGTH
USP Nonabsorbable Surgical Suture
Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.
Real-time and accelerated aging stability testing was performed to support shelf life of REXLENE. Testing confirmed that the sutures conform to USP requirements for nonabsorbable sutures and are stable over the proposed shelf life.
Raw suture of REXLON were evaluated in accordance with ISO 10993 standards below, they are biocompatible and suitable to use as medical device.
ISO 10993, Biological Evaluation of Medical Devices Including:
- ISO 10993-5: Test for Cytotoxicity
- ISO 10993-10: Test for Irritation and Sensitization
- ISO 10993-11: Test for Systemic Toxicity
- ISO 10993-3: Tests for Genotoxicity
- ISO 10993-6: Test for Local Effects after Implantation
- ISO 10993-4: Selection of Tests for Interaction with Blood
6
Image /page/6/Picture/1 description: The image shows the logo for WISE COMPANY Inc. The logo features a stylized "W" that resembles a heartbeat line. Below the company name, the Korean translation "와이즈컴퍼니(주)" is written.
#1005, 11–19, Gamasan-ro 27-gil, Guro-gu, Seoul, Republic of Korea Tel: +82 2 831 3615
09. Summary of Technological characteristic of subject and predicate devices.
| Property | Subject device
REXLENE | Primary Predicate
Device
WG-Surgical Sutures
with Needle | Reference Predicate
Device
PROLENETM
Polypropylene
Nonabsorbable Suture | Suture | | | | | |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--|--|
| 510(k) Number | K173747 | K080684 | K133356 | Material | Polypropylene | Polypropylene | Polypropylene | | |
| Product Code | GAW | Same | Same | Coating | uncoated | same | same | | |
| Regulation No, | 21 C.F.R. 878.5010 | Same | Same | Color | Blue dyed | same | same | | |
| Class | II | Same | Same | Absorbable/Nonabsor
bable | Nonabsorbable | same | same | | |
| Sterile | Yes | Same | Same | Braided/Monofilament | Monofilament | same | same | | |
| Single Use | Yes | Same | Same | Suture Size | The proposed device is
available in 8-0 through
1, which are the sizes
identified in the
currently recognized
United States
Pharmacopoeia. | Available suture sizes
(USP 10-0 ~ USP 2) are
standard according to
USP requirements | Available suture (USP
10-0 ~ USP 2) sizes are
standard according to
USP requirements
except for USP size 7-0 | | |
| Indications for use
statements | REXLENE 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 | Nonabsorbable
Polypropylene Suture
with Needle is indicated
for use in general soft
tissue approximation
and/or ligation including
use in cardiovascular,
ophthalmic and
neurological
procedures. | PROLENETM suture is
indicated for use in
general soft tissue
approximation and/or
ligation, including use in
cardiovascular,
ophthalmic and
neurological
procedures. | Length of Suture | 13, 15, 45, 50, 60, 70,
75, 90, 100, 120, 180
cm | Unknown | Unknown | | |
| Configuration | Polypropylene Suture
and Needle | Same | Same | Diameter of Suture | The suture diameters of
proposed device comply
with the diameter
requirement listed in
USP Diameter. | same | Meet the requirements
defined in the USP
except for USP size 7-0 | | |
| Tensile strength | The tensile strengths of
proposed device comply
with the tensile
requirement listed in
USP Tensile
Strength | same | Meet the requirements
defined in the USP
except for USP size 7-0 | | | | | | |
7
Image /page/7/Picture/1 description: The image shows the logo for WISE COMPANY Inc. The logo consists of a stylized line that resembles a heartbeat or a mountain range. Below the line is the text "WISE COMPANY Inc." in a simple sans-serif font. Underneath the English text is the Korean translation, "와이즈컴퍼니(주)".
#1005, 11–19, Gamasan-ro 27-gil, Guro-gu, Seoul, Republic of Korea Tel: +82 2 831 3615
8
Image /page/8/Picture/1 description: The image shows the logo for WISE COMPANY Inc. The logo consists of a stylized "W" shape above the company name. Below the English name is the Korean translation of the company name, "와이즈컴퍼니(주)".
#1005, 11-19, Gamasan-ro 27-gil, Guro-gu, Seoul, Republic of Korea Tel: +82 2 831 3615
| Needle Attachment | The bond between
suture and needle of
the applicant device
meet the requirements
defined in USP . | same | Meet the requirements
defined in the USP
except for USP size 7-0 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization method | Ethylene oxide gas
sterilization | same | same |
| Needle | | | |
| Material | Stainless Steel | Same | same |
| Indication for use | Disposable suturing
needle | Same | Same |
| Needle Tip Geometry
(Needle type) | Taper point, Tapper cut
Spatula, Reverse
cutting, | Same.
Taper point
Tapper cut
Conventional cutting
Reverse Cutting
Extra-Sharp cutting
Blunt
Spatula | Same.
Based on Ethicon's
catalog, they provide
ATRALOC needles to
surgeons. Surgeon
select type of needle
that, in their experience,
is appropriate for the
specific procedure and
Needle shapes are
generally classified
according to the degree
of curvature of the body
and needle type
- 1/2, 3/8, 1/4, 5/8,
straight - Tapper point, Blunt
point, Conventional
cutting, Reverse
Cutting, Spatula, Micro
point |
| Circle (Shape) | 1/2, 3/8, straight | Same.
1/2, 3/8, 1/4, 5/8,
Straight, Ski Needle,
Compound curve | - 1/2, 3/8, 1/4, 5/8,
straight - Tapper point, Blunt
point, Conventional
cutting, Reverse
Cutting, Spatula, Micro
point |
10. Substantially Equivalent Conclusion
The proposed device, REXLENE is determined to be Substantially Equivalent (SE) to the predicate devices in respect of safety and effectiveness.