(30 days)
Not Found
No
The 510(k) summary describes a surgical suture and a line extension. There is no mention of AI or ML technology in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
This device is a surgical suture used for approximation and ligation, which are mechanical functions rather than therapeutic (treating or curing a disease).
No
Explanation: The device is a surgical suture used for tissue approximation and ligation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a surgical suture made of physical materials (polypropylene and polyethylene) and is supplied with or without needles and pledgets. It is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
The provided text describes a surgical suture, which is a medical device used for closing wounds and approximating tissues within the body. IVD devices, on the other hand, are used to examine specimens taken from the body (like blood, urine, or tissue) to provide information about a person's health.
The description of the Optilene suture clearly indicates its use in surgical procedures on living tissue, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
Optilene Nonabsorbable Polypropylene Polyethylene Surgical sutures are indicated for use in all types of general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, microsurgery and neural tissue.
Product codes
GAW
Device Description
Optilene is a nonabsorbable monofilament surgical suture which is supplied sterile. Optilene is composed of 95% polypropylene and 5% polyethylene. The Optilene suture is offered dyed with the FDA approved colorant [Phthalacyaninato(2-)] copper in accordance with Title 21 CFR, §74.3045. The Optilene suture previously ranged in diameters from USP size 10-0 through 0 in lengths ranging from 8 cm to 150 cm. The Optilene suture is offered with or without needles attached. The Optilene sutures are also offered with or without pledgets composed of 100% polytetrafluorothylene (PTFE). The pledgets are available separately packaged six per pouch.
The purpose of this submission is to seek clearance for a line extension to the Optilene Nonabsorbable Surgical Suture (K133890). This submission proposes two additional USP sizes, size 1 and 2 and to extend the length range to 240 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
all types of general soft tissue, cardiovascular, ophthalmic, microsurgery and 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
Performance tests: Non-clinical laboratory performance testing was conducted to verify that the Optilene Nonabsorbable Surgical Suture, USP sizes I and 2 conforms to the USP monograph for nonabsorbable sutures (as applicable). This testing was performed in accordance with FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003. Materials used were evaluated per ISO 10993-1.
The test results demonstrate that proposed device complies with the following standards:
USP 40 Monograph for Nonabsorbable Surgical Sutures
USP40Sutures-Diameter
USP 40 Tensile Strength
USP 40 Sutures -Needle Attachment
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 7, 2018
Aesculap, Inc. Kathy Racosky Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K180321
Trade/Device Name: Aesculap Optilene Nonabsorbable Suture Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable Polypropylene Surgical Suture Regulatory Class: Class II Product Code: GAW Dated: February 5, 2018 Received: February 5, 2018
Dear Ms. Racosky:
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 (OS) 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
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 medical devices and radiation-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
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K180321
Device Name
Aesculap Optilene Nonabsorbable Surgical Suture
Indications for Use (Describe)
Optilene Nonabsorbable Polypropylene Polyethylene Surgical sutures are indicated for use in all types of general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, microsurgery and 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
Special 510(k) Premarket Notification
Page 1 of 3
B. 510(k) SUMMARY (as required by 21 CFR 807.92)
Aesculap Monosyn Synthetic Absorbable Surgical Suture February 5, 2018
| COMPANY: | Aesculap®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 2916714 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Kathy A. Racosky
610-984-9291 (phone)
610-791-6882 (fax)
kathy.racoskv@acscula p.com |
| TRADE NAME: | Aesculap Optilene Nonabsorbable Suture |
| COMMON NAME: | Nonabsorbable polypropylene/polyethylene surgical suture |
| CLASSIFICATION: | Class II |
| CLASSIFICATION NAME: | Nonabsorbable polypropylene surgical suture |
| REGULATION NUMBER: | 878.5010 |
| PRODUCT CODE: | GAW |
PREDICATE DEVICE
- Optilene Nonabsorbable Surgical Suture (K133890) ●
DEVICE DESCRIPTION
Optilene is a nonabsorbable monofilament surgical suture which is supplied sterile. Optilene is composed of 95% polypropylene and 5% polyethylene. The Optilene suture is offered dyed with the FDA approved colorant [Phthalacyaninato(2-)] copper in accordance with Title 21 CFR, §74.3045. The Optilene suture previously ranged in diameters from USP size 10-0 through 0 in lengths ranging from 8 cm to 150 cm. The Optilene suture is offered with or without needles attached. The Optilene sutures are also offered with or without pledgets composed of 100% polytetrafluorothylene (PTFE). The pledgets are available separately packaged six per pouch.
The purpose of this submission is to seek clearance for a line extension to the Optilene Nonabsorbable Surgical Suture (K133890). This submission proposes two additional USP sizes, size 1 and 2 and to extend the length range to 240 cm.
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Page 2 of 3
INDICATIONS FOR USE
Optilene Nonabsorbable Polypropylene/Polyethylene Surgical sutures are indicated for use in all types of general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, microsurgery and neural tissue.
SUBSTANTIAL EOUIV ALENCE and COMPARISON OF TECHNOLICAL
CHARACTERISTICS
The Optilene Nonabsorbable Surgical Suture line extension is as safe an effective as the previously cleared Optilene Nonabsorbable Surgical Suture. The proposed additional USP sizes, size 1 and 2, and suture lengths up to 240 cm to the Optilene Nonabsorbable Surgical Suture (K133890) product line have the same material, design, intended use and technological characteristics as the predicate device. The only difference between the proposed and predicate device is the suture diameter and length. The device characteristics comparing the Optilene Nonabsorbable Surgical Suture to the predicate device are summarized below.
| | Aesculap Inc.
Optilene Nonabsorbable Surgical
Suture | Aesculap, Inc.
Optilene Nonabsorbable Surgical
Suture |
|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| K# | Predicate device (K133890) | Proposed device |
| Indications | Indicated for use in all types of general
soft tissue approximation and/or ligation,
including use in cardiovascular,
ophthalmic, microsurgery and neural
tissue. | Same |
| Material | 95% oolypropylene and 5% Polyethylene | Same |
| Colorant | Phthalacyaninato(2-)l conner | Same |
| Dyed | Yes | Same |
| Structure | Monofilament | Same |
| Size | USP 10-0 through 0 | USP 1 & 2 |
| | with or w/out needles attached
with or w/out oledgets attached | same
same |
| Thread length | -8 cm to 150 cm
-ligature reels oflon•er len""h | -8 cm to 240 cm
-li!!ature reels of lon.2'.er len£Jth |
| Physical:
- Diameter
- Length
- Needle Attachment
- Tensile Strength | All characteristics meet USP | Same |
| Needle material | 300 series stainless steel | Same |
| Pled!!ets | oolvtetrafluoroethylene | Same |
| Packaging | Oval HDPE support with an oval card
fold card lid in a tyvek peel pouch and
oolvester-oolvethylene tereohatalate film. | Same |
| Sterilization | Ethylene Oxide (EO) | Same |
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Special 510(k) Premarket Notification
Page 3 of 3
PERFORMANCE DATA
Performance tests: Non-clinical laboratory performance testing was conducted to verify that the Optilene Nonabsorbable Surgical Suture, USP sizes I and 2 conforms to the USP monograph for nonabsorbable sutures (as applicable). This testing was performed in accordance with FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003. Materials used were evaluated per ISO 10993-1.
The test results demonstrate that proposed device complies with the following standards:
USP 40 Monograph for Nonabsorbable Surgical Sutures USP40Sutures-Diameter USP 40 Tensile Strength USP 40 Sutures -Needle Attachment
CONCLUSION:
The information provided in this submission demonstrates that the Optilene Nonabsorbable Surgical Suture line extension is substantially equivalent to the marketed predicate device.