(97 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a surgical suture, with no mention of AI or ML.
No.
The device is a surgical suture used for short-term wound support, not for treating or rehabilitating a disease or injury.
No
Explanation: The device is a surgical suture used for approximation of soft tissue, primarily the skin and mucosa. Its function is to support wound healing, not to diagnose medical conditions.
No
The device description clearly states it is a "synthetic absorbable braided surgical suture" and details its physical composition and form factors, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This includes tests for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that Novosyn Quick is a "synthetic absorbable braided surgical suture" used for "general soft tissue approximation of the skin and mucosa." This is a device used directly on the body during a surgical procedure, not for testing samples outside the body.
- Lack of IVD Characteristics: The document does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes. The performance studies focus on the physical properties of the suture (tensile strength, diameter, resorption) and its biocompatibility, which are relevant to a surgical implant, not an IVD.
Therefore, Novosyn Quick Absorbable Suture is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Novosyn Quick Absorbable Suture is indicated for use in general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. Novosyn Quick suture is not intended for use in ligation in ophthalmic, cardiovascular or neurological procedures.
Product codes (comma separated list FDA assigned to the subject device)
GAM
Device Description
Novosyn Quick is a synthetic absorbable braided surgical suture which is supplied sterile. Novosyn Quick is composed of a copolymer made from 90% gylcolide and 10% L-lactide (PGLA). The Novosyn Quick suture is coated with 35/65 poly(glycolide-co-L-lactide) and calcium stearate. The Novosyn Quick suture is undyed and will be offered in diameters ranging from USP size 6-0 through 2. It will be available in a variety of cut lengths with or without 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 (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 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 Novosyn Quick Absorbable Suture meets current performance requirements for synthetic absorbable sutures unless otherwise labeled, and that Novosyn Quick is substantially equivalent to other predicate devices.
Tests were conducted for diameter, tensile strength, and needle attachment. All specifications were met apart from diameter. The Novosyn Quick suture is considered an implant device, tissue/bone contact device of permanent duration (>30 days). Biocompatibility testing within this submission includes the following: Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Hemolysis, Genotoxicity - Chromosomal Aberration and Mouse Peripheral Blood Micronucleus, Bacterial Reverse Mutation and Muscle Implantation (6-week).
Testing demonstrated that the device is as safe and as effective as the predicate device. The subject device is concluded to be substantially equivalent to the predicate device.
The Novosyn Quick Absorbable Suture is blister packed and sterilized by Gamma. Real-time aging data for the Novosyn Quick 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.
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.
Not Found
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
§ 878.4493 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 8, 2017
Aesculap, Incorporated Ms. Kathy A. Racosky Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K170661
Trade/Device Name: Novosyn Quick Absorbable Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: May 10, 2017 Received: May 11, 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 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 -S3
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
Indications for Use
510(k) Number (if known) K170661
Device Name Novosyn Quick Absorbable Suture
Indications for Use (Describe)
Novosyn Quick Absorbable Suture is indicated for use in general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. Novosyn Quick suture is not intended for use in ligation in ophthalmic, cardiovascular or neurological procedures.
| 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) |
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3
510(k) SUMMARY (as required by 21 CFR 807.92)
| Aesculap Novosyn Quick Absorbable Suture | ||
|---|---|---|
| March 2, 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: | Novosyn Quick Absorbable Suture |
| COMMON NAME: | Synthetic Polyglycolic Absorbable Suture |
| CLASSIFICATION: | Class II |
| CLASSIFICATION NAME: | Suture, Absorbable, synthetic, Polyglycolic Acid |
| REGULATION NUMBER: | 878.4493 |
| PRODUCT CODE: | GAM |
PURPOSE FOR PREMARKET NOTIFICATION
The purpose for this submission is to gain marketing clearance for the Novosyn Quick Absorbable Suture.
PREDICATE DEVICE
- Primary Predicate: Novosyn Absorbable Suture, Aesculap Inc. (K122734) ●
- Vicryl Rapid Suture, Ethicon Inc. (K962480/K944110)
DEVICE DESCRIPTION
Novosyn Quick is a synthetic absorbable braided surgical suture which is supplied sterile. Novosyn Quick is composed of a copolymer made from 90% gylcolide and 10% L-lactide (PGLA). The Novosyn Quick suture is coated with 35/65 poly(glycolide-co-L-lactide) and calcium stearate. The Novosyn Quick suture is undyed and will be offered in diameters ranging from USP size 6-0 through 2. It will be available in a variety of cut lengths with or without needles attached.
INDICATIONS FOR USE
Novosyn Ouick Absorbable Suture is indicated for use in general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. Novosyn Quick suture is not intended for use in ligation in ophthalmic, cardiovascular or neurological procedures.
4
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))
As established in this submission, the Novosyn Quick suture is a synthetic absorbable braided 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 Novosyn Quick Absorbable Suture to the predicate devices are summarized below.
| | Aesculap, Inc.
Novosyn Quick
Absorbable Suture | Primary Predicate
Aesculap, Inc.
Novosyn Absorbable
Suture | Ethicon, Inc.
Vicryl Rapide Suture | | Aesculap, Inc.
Novosyn Quick
Absorbable Suture | Primary Predicate
Aesculap, Inc.
Novosyn Absorbable
Suture | Ethicon, Inc.
Vicryl Rapide Suture |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| K# | Pending | K122734 | K962480/K944110 | K# | Pending | K122734 | K962480/K944110 |
| Indications | Novosyn Quick Absorbable
Suture is indicated for use
in general soft tissue
approximation of the skin
and mucosa, where only
short term wound support
(7-10 days) is required.
Novosyn Quick suture is
not intended for use in
ligation in ophthalmic,
cardiovascular or
neurological procedures. | Novosyn sutures are
indicated for use in general
soft tissue approximation
and/or ligation, including
use in ophthalmic
procedures, but not for use
in cardiovascular and
neurological tissues. | Vicryl Rapide suture is
indicated only for use in
superficial general soft
tissue approximation of the
skin and mucosa, where
only short term wound
support (7-10 days) is
required. Vicryl rapide
suture is not intended for
use in ligation, ophthalmic,
cardiovascular or
neurological procedures. | Thread length | -45 cm to 150 cm
-ligature reels of longer
length | -5 cm to 150 cm
-ligature reels of longer
length | -45cm to 135cm |
| Absorption Type | Short term absorbable | Mid term absorbable | Short term absorbable | 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. |
| Absorption | Essentially complete by 42
days | Essentially completed
between 8-10 weeks | Essentially complete by 42
days | Needle material | 300 stainless steel | 300 stainless steel | unknown |
| Remaining Tensile
Strength | 5 days 50%
14 days 0% | 2 weeks 75% (6-0 and
larger)
2 weeks 56% (7-0 and
smaller)
3 weeks 52% (6-0 and
larger)
3 weeks 35 % (7-0 and
smaller)
4 weeks 23 % (5-0 and
larger) | 5 days 50%
14 days 0% | Packaging | Foil packaging in a second
outer peel-pack with paper
and plastic film | Foil packaging in a second
outer peel-pack with paper
and plastic film | unknown |
| Material | Polyglycolide-co-L-lactid
90/10 (PGLA) | Polyglycolide-co-L-lactid
90/10 (PGLA) | Polyglactin 910 (glycolic
and lactic acid) | Sterilization | Gamma irradiation | Ethylene Oxide (EO) | Ethylene Oxide (EO) or
Gamma Irradiation |
| Dyed, Un-dyed | Un-dyed | Un-dyed and Dyed | Un-dyed | | | | |
| Structure | Braided | Braided | Braided | | | | |
| Coating | Polyglycolide-co-L-lactid
35/65 + Calcium Stearate | Polyglycolide-co-L-lactid
35/65 + Calcium Stearate | Caproloctone / Glycolide +
Polyglactin 370
(glycolide/lactide) w/
Calcium Stearate | | | | |
| Size | 6-0 through 2 (various
lengths)
with or w/out needles
attached | 8-0 through 2 (various
lengths)
with or w/out needles
attached | 6-0 through 0 (various
lengths)
with or w/out needles
attached | | | | |
5
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 Novosyn Quick Absorbable Suture meets current performance requirements for synthetic absorbable sutures unless otherwise labeled, and that Novosyn Quick is substantially equivalent to other predicate devices.
Tests were conducted for diameter, tensile strength, and needle attachment. All specifications were met apart from diameter. The Novosyn Quick suture is considered an implant device, tissue/bone contact device of permanent duration (>30 days). Biocompatibility testing within this submission includes the following: Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Hemolysis, Genotoxicity - Chromosomal Aberration and Mouse Peripheral Blood Micronucleus, Bacterial Reverse Mutation and Muscle Implantation (6-week).
Testing demonstrated that the device is as safe and as effective as the predicate device. The subject device is concluded to be substantially equivalent to the predicate device.
The Novosyn Quick Absorbable Suture is blister packed and sterilized by Gamma. Real-time aging data for the Novosyn Quick Suture has been generated to support this submission.