(207 days)
No
The document describes a surgical suture and its physical properties and testing, with no mention of AI or ML.
No.
The device is a surgical suture used for tissue approximation and ligation, which is a supportive device rather than a therapeutic one designed to treat a disease or medical condition.
No
The device is a surgical suture used for approximation and/or ligation of soft tissue, not for diagnosing conditions.
No
The device description clearly states it is a physical surgical suture made of polypropylene and polyethylene, and includes physical components like needles and pledgets.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the sutures are for "general soft tissue approximation and/or ligation" in various parts of the body. This is a direct surgical application within the body.
- Device Description: The description details a physical surgical suture made of polypropylene and polyethylene, designed to be used to hold tissue together.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device does not perform any such function. It is a physical tool used during surgery.
The information provided describes a surgical implant/device, not an in vitro diagnostic.
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 (comma separated list FDA assigned to the subject device)
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 will be offered dyed with the FDA approved colorant [Phthalacyaninato(2-)] copper in accordance with Title 21 CFR, §74.3045. The Optilene suture will be offered in diameters ranging from USP size 10-0 through 0 and with be available in a variety of cut lengths with or without needles attached. The Optilene sutures will also be offered with or without pledgets composed of 100% polytetrafluorothylene (PTFE). The pledgets are also available separately packaged six per pouch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue, cardiovascular, ophthalmic, 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)
As recommended by the FDA's Class II Special Control Guidance Document for Surgical Sutures, including mechanical testing in accordance to USP 35 and biocompatibility testing in accordance to ISO 10993-1 has been performed to demonstrate that the Optilene Nonabsorbable Suture is substantially equivalent to other predicate devices. Tests were conducted for diameter, tensile strength, and needle attachment. All specifications were met. Biocompatibility testing within this submission includes the following: Cytotoxicity, Sensitization, Intracutaneous Irritation, Hemolysis, Genotoxicity - Mouse Lymphoma, Mouse Peripheral Blood Micronucleus, Bacterial Reverse Mutation and Muscle Implantation (12-week). Testing demonstrated that the device is as safe, as effective, and performs as well as the predicate devices. Additional chemical characterization testing and a biological risk assessment were conducted in order to evaluate the chemical equivalency of the polypropylene/polyethylene raw material. The results of this testing demonstrate that the Optilene Nonabsorbable Suture is substantially equivalent to the predicate devices. The Optilene Nonabsorbable Suture is blister packed and sterilized by ethylene oxide. Accelerated aging data for the Optilene Nonabsorbable Suture has been generated to support this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K980703, N16374, K050947/K010909/K954808
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Premarket Notification
Optilene Nonabsorbable Surgical Suture
JUL 15 2014
Page 1 of 4
B. 510(k) SUMMARY (as required by 21 CFR 807.92)
Aesculap Optilene Nonabsorbable Surgical Suture July 3. 2014
| 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.racosky@aesculap.com |
| TRADE NAME: | Aesculap Optilene Nonabsorbable Suture |
| COMMON NAME: | Nonabsorbable polypropylene/polyethylene surgical suture |
| CLASSIFICATION: | Class II |
| CLASSIFICATION NAME: | Suture, Nonabsorbable, Synthetic, Polypropylene |
| REGULATION NUMBER: | 878.5010 |
| PRODUCT CODE: | GAW |
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the Optilene Nonabsorbable Polypropylene/Polyethylene Surgical Suture is substantially equivalent to:
- . Premilene Nonabsorbable Polypropylene Surgical Suture, Aesculap Inc. (K980703)
- · Prolene Polypropylene Nonabsorbable Surgical Suture, Ethicon Inc. (N16374)
- · USS Polypropylene Suture, United States Surgical (K050947/K010909/K954808)
The Optilene Nonabsorbable Polypropylene/Polyethylene Surgical Suture pledget is substantially equivalent to:
- · PremiCron Nonabsorable PET Surgical Suture, Aesculap Inc. (K012201)
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 will be offered dyed with the FDA approved colorant [Phthalacyaninato(2-)] copper in accordance with Title 21 CFR, $74.3045. The Optilene suture will be offered in diameters ranging from USP size 10-0 through 0 and with be available in a variety of cut lengths with or without needles attached. The Optilene sutures will also be offered with or without pledgets composed of 100% polytetrafluorothylene (PTFE). The pledgets are also available separately packaged six per pouch.
1
Page 2 of 4
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.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s)}
As established in this submission, the Aesculap Optilene suture is a synthetic nonabsorbable monofilament surgical suture offered dyed in the same range of diameters and cut lengths that are substantially equivalent to other predicate devices cleared by FDA. The subject device is shown to be substantially equivalent and has the same technological characteristics to its predicate devices through comparison in design, intended use, material composition, function and range of sizes.
Please see attached Substantial Equivalence table comparing the Optilene Nonabsorbable Polypropylene/Polyethylene Suture to the predicate devices.
PERFORMANCE DATA
As recommended by the FDA's Class II Special Control Guidance Document for Surgical Sutures, including mechanical testing in accordance to USP 35 and biocompatibility testing in accordance to ISO 10993-1 has been performed to demonstrate that the Optilene Nonabsorbable Suture is substantially equivalent to other predicate devices.
Tests were conducted for diameter, tensile strength, and needle attachment. All specifications were met. Biocompatibility testing within this submission includes the following: Cytotoxicity, Sensitization, Intracutaneous Irritation, Hemolysis, Genotoxicity - Mouse Lymphoma, Mouse Peripheral Blood Micronucleus, Bacterial Reverse Mutation and Muscle Implantation (12-week).
Testing demonstrated that the device is as safe, as effective, and performs as well as the predicate devices.
Additional chemical characterization testing and a biological risk assessment were conducted in order to evaluate the chemical equivalency of the polypropylene/polyethylene raw material. The results of this testing demonstrate that the Optilene Nonabsorbable Suture is substantially equivalent to the predicate devices.
The Optilene Nonabsorbable Suture is blister packed and sterilized by ethylene oxide. Accelerated aging data for the Optilene Nonabsorbable Suture has been generated to support this submission.
2
10(k) Premarket Notification
Optilene Nonabsorbable Surgical Suture
Page 3 of 4
| K# | Indications | Material | Dyed, Un-dyed
Colorant | Structure | Size | Physical:
- Diameter
- Length
- Needle
Attachment - Tensile Strength
Needles | Pledgets | Packaging | Sterilization |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|--------------------------------------------------------|--------------|-------------------------------------|------------------------------------------------------------------------------------------------|-------------------------|-------------------------------------------------------------------------------------------------------------------------------|---------------------|
| | Aesculap, Inc.
Optilene Nonabsorbable
Suture | | | | | | | | |
| Pending | Indicated for use in all types of
general soft tissue
approximation and/or ligation,
including use in cardiovascular,
ophthalmic, microsurgery and
neural tissue. | 95% polypropylene and 5%
Polyethylene | Dyed, Un-dyed
Dyed
[Phthalacyaninato(2-)] copper | Monofilament | 10-0 through 0 (various
lengths) | with or w/out needles attached
with or w/out pledgets attached | | Oval HDPE support with an
oval card fold card lid in a
tyvek peel pouch and polyester-
polyethylenerephatalate film. | Ethylene Oxide (EO) |
| K980703 | Aesculap, Inc.
Premilene Nonabsorbable
Suture
Indicated for use in all types of
general soft tissue
approximation and ligation,
including use in cardiovascular,
ophthalmic, microsurgery and
neural tissue. | Polypropylene | Un-dyed and Dyed
[Phthalacyaninato(2-)] copper | Monofilament | 11-0 through 2 (various
lengths) | with or w/out needles attached | N/A | Oval HDPE support with an
oval card fold card lid in a
tyvek peel pouch and polyester-
polyethylenerephatalate film. | Ethylene Oxide (EO) |
| K050947/K010909/K954808 | USS Polypropylene
Nonabsorbable Suture
Indicated for use in general soft
tissue approximation and/or
ligation, including use in
cardiovascular, ophthalmic,
and neurological surgery. | Polypropylene and
Polyethylene | Un-dyed and Dyed
Copper phthalocyanine, CI
74160 | Monofilament | 10-0 through 2 (various
lengths) | with or w/out needles attached
with or w/out pledgets attached | polytetrafluoroethylene | Foil packaging in a second
outer peel-pack with paper and
plastic film | Ethylene Oxide (EO) |
| N16374 | Prolene Polypropylene
Nonabsorbable
Indicated for use in general soft
tissue approximation and/or
ligation, including use in
cardiovascular, ophthalmic,
and neurological surgery. | Polypropylene | Un-dyed and Dyed
Copper phthalocyanine, Cl
74160 | Monofilament | 10-0 through 1 (various
lengths) | with or w/out needles attached
with or w/out pledgets attached | polytetrafluoroethylene | Oval HDPE support with an
oval card fold card lid in a
tyvek peel pouch and polyester-
polyethylenerephatalate film. | Ethylene Oxide (EO) |
| | | | | | | All characteristics meet USP
Requirements. | | | |
| | | | | | | All characteristics meet USP
Requirements | | | |
| | | | | | | All characteristics meet USP
Requirements, except for
diameter. | | | |
| | | | | | | All characteristics meet USP
Requirements | | | |
| | | | | | | 300-series stainless steel | | | |
| | | | | | | 300 or 455 series stainless steel | | | |
| | | | | | | 300-series stainless steel and
tungsten-rhenium | | | |
·
.
.
3
510(k) Premarket Notificatio
・
......
Page 3 of 4
| K# | ||
|---|---|---|
| Aesculap, Inc. | ||
| Optilene Nonabsorbable Suture | Aesculap, Inc. | |
| PremiCron Nonabsorbable Suture | ||
| Indications | Pending | |
| Indicated for use in all types of general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, microsurgery and neural tissue. | K980703 | |
| Indicated for use in all types of general soft tissue approximation and ligation, including use in cardiovascular, ophthalmic, microsurgery and neural tissue. | ||
| Material | 95% polypropylene and 5% Polyethylene | poly(ethylene terephthalate) |
| Dyed, Un-dyed | Dyed | Un-dyed and Dyed |
| Colorant | [Phthalacyaninato(2-)] copper | D&C Green no. 6 |
| Structure | Monofilament | Multifilament |
| Size | 10-0 through 0 (various lengths) | |
| with or w/out needles attached | ||
| with or w/out pledgets attached | 8-0 through 5 (various lengths) | |
| with or w/out needles attached | ||
| with or w/out pledgets attached | ||
| Physical: |
- Diameter
- Length
- Needle Attachment
- Tensile Strength | All characteristics meet USP Requirements. | All characteristics meet USP Requirements |
| Needles | 300-series stainless steel | 300 or 400 series stainless steel |
| | polytetrafluoroethylene | polytetrafluoroethylene |
| Pledgets | | |
| Packaging | Oval HDPE support with an oval card fold card lid in a tyvek peel pouch and polyester-polyethylenerephatalate film. | Oval HDPE support with an oval card fold card lid in a tyvek peel pouch and polyester-polyethylenerephatalate film. |
| Sterilization | Ethylene Oxide (EO) | Ethylene Oxide (EO) |
1000
:
.
.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 15, 2014
Aesculap® Incorporated Ms. Kathy A. Racovsky Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K133890
Trade/Device Name: Aesculap Optilene Nonabsorbable Surgical Suture Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: Class II Product Code: GAW Dated: June 11, 2014 Received: June 12, 2014
Dear Mr. Racovsky:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Ms. Kathy A. Racovsky
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.
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" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fdagov/MedicalDevices/Safety/ReportalProblem/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 yours,
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
6
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 below.
510(k) Number (if known) K133890
Device Name
Aesculup Optilene Nonahsorbable Surgical Suture
Indications for Use (Describe)
Optilene Nonabsorbable Polypropylene 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)
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)
Peter L. Hudson -S
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