(202 days)
No
The device description and performance studies focus on the physical and biological properties of a surgical suture, with no mention of AI or ML.
No
The device is a surgical suture used for approximation of soft tissue, which is a supportive function rather than a therapeutic one aimed at treating a disease or condition.
No
The device, Monosyn Quick Suture, is described as an absorbable surgical suture used for tissue approximation, not for diagnosing conditions.
No
The device is a surgical suture, which is a physical, absorbable material used for tissue approximation. The description focuses on its material composition, physical properties, and performance testing related to mechanical strength, biocompatibility, and absorption, all of which are characteristic of a hardware medical device. There is no mention of software functionality.
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 of the skin and mucosa," which is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "flexible monofilament suture," a physical material used to close wounds.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. This description does not mention any such use or interaction with biological specimens for diagnostic purposes.
The information clearly describes a surgical suture, which is a medical device used for wound closure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Monosyn Quick Synthetic Absorbable Surgical Suture is intended for general soft tissue approximation of the skin and mucosa, where only short term wound support (6-7 days) is required. Monosyn Quick suture is not indicated for use in cardiovascular or neurosurgery.
Product codes
GAM
Device Description
Monosyn Quick is an absorbable flexible monofilament suture which is supplied sterile. It is composed of a synthetic polyglycolic acid-based copolymer. The Monosyn Quick suture is undyed and will be offered in diameters ranging from USP size 6-0 through 1. It is uncoated and will be available in a variety of cut lengths with or with out needles attached.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin and mucosa
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
Non clinical testing demonstrated that the device is as safe, as effective, and performs as well as the predicate devices.
In addition, residual strength and absorption rate studies were performed. The results of this testing demonstrates that the Monosyn Quick is substantially equivalent to the predicate devices.
Studies performed:
- mechanical testing in accordance to USP 39 for synthetic absorbable suture
- biocompatibility testing in accordance to ISO 10993-1
- in vitro as well as in vivo resorption testing
- Accelerated aging data
The test results demonstrate that the Monosyn Quick complies with the following standards:
- USP 39 Monograph for Absorbable Surgical Sutures
- USP 39 861 Sutures - Diameter (where diameter deviates minimally from USP requirements, it will be labeled as such)
- USP 39 881 Tensile Strength
- USP 39 871 Sutures - Needle Attachment
- ISO 10993-1:2009, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process. (Biocompatibility)
- ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-6 2007, Biological Evaluation Of Medical Devices - Part 6: Tests For Local Effects After Implantation
- ISO 10993-7, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- ISO 10993-10 2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- ISO 10993-11 2006, Biological Evaluation Of Medical Devices - Part 11: Tests For Systemic Toxicity
- 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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines connecting them.
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
October 23, 2017
Aesculap®, Inc. Ms. Kathy Racosky Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K171001
Trade/Device Name: Monosyn Quick Synthetic Absorbable Surgical Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: September 12, 2017 Received: September 13, 2017
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
1
801); medical device reporting of medical device-related 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.
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 (DICE) 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 (DICE) 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.
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
apple Synggerics Aps 25 25 27 2017 11 20
Expiration Date: January 31, 2017
See PRA Statement below.
Monosyn
510(k) Prematic Metifisetion OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K171001
Device Name
Aesculap Monosyn Quick Synthetic Absorbable Surgical Suture
Indications for Use (Describe)
Monosyn Quick Synthetic Absorbable Surgical Suture is intended for general soft tissue approximation of the skin and mucosa, where only short term wound support (6-7 days) is required. Monosyn Quick suture is not indicated for use in cardiovascular or neurosurgery.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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B. 510(k) SUMMARY (as required by 21 CFR 807.92)
Aesculap Monosyn Quick Synthetic Absorbable Surgical Suture September 12, 2017
| 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: | Monosyn Quick Synthetic Absorbable Surgical Suture |
| COMMON NAME: | Synthetic Absorbable Surgical Suture |
| CLASSIFICATION: | Class II |
| CLASSIFICATION NAME: | Absorbable poly(glycolide/l-lactide) surgical suture |
| REGULATION NUMBER: | 878.4493 |
| PRODUCT CODE: | GAM |
PURPOSE FOR PREMARKET NOTIFICATION
The purpose for this submission is to gain marketing clearance for the Monosyn Quick Synthetic Absorbable Surgical Suture.
PREDICATE DEVICE
- Primary predicate: Monosyn Synthetic Absorbable Surgical Suture (K011375) .
- . Reference predicate: Caprosyn Absorbable Surgical Suture (K032586)
DEVICE DESCRIPTION
Monosyn Quick is an absorbable flexible monofilament suture which is supplied sterile. It is composed of a synthetic polyglycolic acid-based copolymer. The Monosyn Quick suture is undyed and will be offered in diameters ranging from USP size 6-0 through 1. It is uncoated and will be available in a variety of cut lengths with or with out needles attached.
INDICATIONS FOR USE
Monosyn Quick Synthetic Absorbable Surgical Suture is intended for general soft tissue approximation of the skin and mucosa, where only short term wound support (6-7 days) is required. Monosyn Quick suture is not indicated for use in cardiovascular or neurosurgery.
4
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s)}
As established in this submission, the Monosyn Quick suture is a synthetic absorbable monofilament surgical suture offered undyed 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. The device characteristics comparing the Monosyn Quick Synthetic Absorbable Surgical Suture to the predicate devices are summarized below.
| | Aesculap Inc.
Monosyn Quick Synthetic
Absorbable Surgical
Suture | Aesculap, Inc.
Monosyn Synthetic
Absorbable Surgical
Suture | United States Surgical
Caprosyn Absorbable
Surgical Suture |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K# | Proposed device | K011375 | K032586 |
| Indications | Monosyn Quick Synthetic
Absorbable Surgical Suture
is intended for general soft
tissue approximation of the
skin and mucosa, where
only short term wound
support (6-7 days) is
required. Monosyn Quick
suture is not indicated for
use in cardiovascular or
neurosurgery. | Monosyn Synthetic
Absorbable Surgical Suture
is indicated for use in
general soft tissue
approximation and/or
ligation, but not for use in
cardiovascular or
neurological surgery. | Caprosyn synthetic
absorbable sutures are
indicated for use in general
soft tissue approximation
and/or ligation, including
use in ophthalmic
procedures, but not for use
in cardiovascular or
neurological surgery, or
microsurgery. |
| Absorption Type | Short term absorbable | Mid term absorbable | Short term absorbable |
| Absorption | Essentially complete by 56
days | Essentially completed
between 60-90 days | Essentially complete by 56
days |
| Remaining Tensile
Strength | 5 days 60-70%
10 days 25-35% | 14 days 50% | 5 days 60%
10 days 20-30% |
| Material | 72% glycolide
14% ε-caprolactone
14% trimethylene carbonate | 72% glycolide
14% ε-caprolactone
14% trimethylene carbonate | Glycolide, Caprolactone,
Trimethylene Carbonate
and Lactide |
| Dyed, Un-dyed | Undyed | Un-dyed and Dyed | Un-dyed and Dyed |
| Structure | Monofilament | Monofilament | Monofilament |
| Size | 6-0 through 1 (various
lengths) with or w/out
needles attached | 5-0 through 1 (various
lengths) with or w/out
needles attached | 6-0 through 1 (various
lengths) with or w/out
needles attached |
| Thread length | -45 cm to 120 cm | -35 cm to 150 cm
-ligature reels of longer
length | -18 in to 60 in
-ligature reels of longer
length |
| Physical:
- Diameter
- Length
- Needle Attachment
- Tensile Strength | All characteristics meet
USP Requirements, except
for diameter. | All characteristics meet
USP Requirements, except
for diameter. | All characteristics meet
USP Requirements, except
for diameter. |
| Needle material | 300 or 400 series stainless
steel | 300 or 400 series stainless
steel | unknown |
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| | Aesculap Inc.
Monosyn Quick Synthetic
Absorbable Surgical
Suture | Aesculap, Inc.
Monosyn Synthetic
Absorbable Surgical
Suture | United States Surgical
Caprosyn Absorbable
Surgical Suture |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| K# | Pending | K011375 | K032589 |
| Packaging | Coated cardboard support
in double peel pouch. Inner
pouch composed of PET,
aluminum foil and LDPE
layers. Medical grade
paper and PET/LDPE
laminate outer pouch.
or
Oval HDPE support with a
coated cardboard lid in a
single pouch composed of
polyethylene terephthalate
polyester (PETP).
or
cardboard support fold card
in a single pouch composed
of polyethylene
terephthalate polyester
(PETP). | Coated cardboard support
in double peel pouch. Inner
pouch composed of PET.
aluminum foil and LDPE
layers. Medical grade
paper and PET/LDPE
laminate outer pouch. | unknown |
| Sterilization | Ethylene Oxide (EO) | Ethylene Oxide (EO) | unknown |
PERFORMANCE DATA
As recommended by the FDA's Class II Special Control Guidance Document for Surgical Sutures, including mechanical testing in accordance to USP 39 for synthetic absorbable suture, biocompatibility testing in accordance to ISO 10993-1, and in vitro as well as in vivo resorption testing has been performed to demonstrate that the Monosyn Quick Synthetic Absorbable Surgical Suture meets current performance requirements for synthetic absorbable sutures unless otherwise labeled, and that Monosyn Quick is substantially equivalent to other predicate devices. The test results demonstrate that the Monosyn Quick complies with the following standards:
USP 39 Monograph for Absorbable Surgical Sutures
USP 39 Sutures - Diameter (where diameter deviates minimally from USP requirements, it will be labeled as such)
USP 39 Tensile Strength
USP 39 Sutures - Needle Attachment
ISO 10993-1:2009, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process. (Biocompatibility)
ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity ISO 10993-6 2007, Biological Evaluation Of Medical Devices - Part 6: Tests For Local Effects After Implantation
ISO 10993-7, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-10 2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
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ISO 10993-11 2006, Biological Evaluation Of Medical Devices - Part 11: Tests For Systemic Toxicity
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
The Monosyn Quick Synthetic Absorbable Surgical Suture is blister packed and sterilized by Ethylene Oxide. Accelerated aging data for the Monosyn Quick has been generated to support this submission.
CONCLUSION:
Non clinical testing demonstrated that the device is as safe, as effective, and performs as well as the predicate devices.
In addition, residual strength and absorption rate studies were performed. The results of this testing demonstrates that the Monosyn Quick is substantially equivalent to the predicate devices.