(100 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical function of a barbed suture, with no mention of AI or ML.
No
The device is a surgical suture used for soft tissue approximation. While it aids in the healing process, its primary function is mechanical closure, not the active treatment or prevention of a disease/condition in a therapeutic sense.
No
The device is a tissue control device (suture) used for soft tissue approximation. Its indications for use and device description confirm it is a therapeutic device, not a diagnostic one that identifies illnesses or conditions.
No
The device description clearly describes a physical, absorbable suture with barbs and a needle, which is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "soft tissue approximation where use of an absorbable suture is appropriate." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "monofilament, synthetic absorbable device" (suture) with barbs and a needle, designed for physically joining tissue.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on samples. It is a surgical tool used in the body.
The description clearly indicates a surgical suture used for closing wounds and approximating tissue, which is a direct treatment/procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device are indicated for soft tissue approximation where use of an absorbable suture is appropriate.
Product codes (comma separated list FDA assigned to the subject device)
GAM
Device Description
The STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device is a monofilament, synthetic absorbable device prepared from a copolymer of glycolide and s-caprolactone. Poliglecaprone 25 copolymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption.
The STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device, Variable Loop Design consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The STRATAFIX™ Spiral MONOCRYL™ Device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. The STRATAFIX™ Spiral MONOCRYL™ Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.
While the formation of barbs in the STRATAFIX™ Spiral MONOCRYL™ Device reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in nonbarbed suture materials also reduces their effective strengths. For this reason, the strength of the STRATAFIX™ Spiral MONOCRYL™ Device can be compared to USP knot strength of nonbarbed sutures. USP designations for diameter are used to describe the STRATAFIX™ Spiral MONOCRYL™ Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1 mm.
The STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device is an antibacterial monofilament, synthetic absorbable device prepared from a copolymer of glycolide and s-caprolactone. The device contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m. Poliglecaprone 25 copolymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption.
The STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device. Variable Loop Design consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The STRATAFIX™ Spiral MONOCRYL™ Plus Device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. The STRATAFIX™ Spiral MONOCRYL™ Plus Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.
While the formation of barbs in the STRATAFIX™ Spiral MONOCRYL™ Plus Device reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in nonbarbed suture materials also reduces their effective strengths. For this reason, the strength of the STRATAFIX™ Spiral MONOCRYL™ Plus Device can be compared to USP knot strength of non-barbed sutures. USP designations for diameter are used to describe the STRATAFIX™ Spiral MONOCRYL™ Plus Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft 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 laboratory performance testing was performed demonstrating that STRATAFIX™ Spiral MONOCRYLTM Knotless Tissue Control Devices and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Devices conforms to the current USP Monograph for absorbable surgical sutures, except for diameter. This testing was performed in accordance with FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3. 2003. In addition, bench and animal testing was provided showing that the device performed as intended and as claimed.
Bench Testing: Suture Diameter, Tensile Strength, Needle Attachment
Biocompatiblity: Intramuscular Implantation, Subcutaneous Implantation, Irritation (Intracutaneous Reactivity), Pyrogenicity
In-vitro/In-vivo: Breaking Strength Retention, Wound Holding Strength, Wound Healing, Bacterial Colonization
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.
K050845, K141778, K123836, K123409
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 features a stylized eagle with three heads in profile, facing right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 13, 2015
Ethicon Incorporated a Johnson & Johnson company Ms. Donna Marshall Manager, Regulatory Affairs Route 22 West, P.O. Box 151 Somerville, New Jersey 08876
Re: K151200
Trade/Device Name: STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device and STRATAFIX™ Spiral MONOCRYLTM Plus Knotless Tissue Control Device Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/l-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: July 9, 2015 Received: July 10, 2015
Dear Ms. Marshall:
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
1
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 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/Resourcesfor You/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.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.
for
Sincerely yours.
David Krause -S
- 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) K151200
Device Name
STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device
Indications for Use (Describe)
STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device are indicated for soft tissue approximation where use of an absorbable suture is appropriate.
| 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
Traditional 510(k)
STRATAFIX™ Spiral MONOCRYL™ and
STRATAFIX™ Spiral MONOCRYL™ PLUS
Knotless Tissue Control Device Ethicon, Inc.
Image /page/3/Picture/1 description: The image features the logo for ETHICON, INC. The text "ETHICON, INC." is displayed in a bold, red font. Below the company name, there is a smaller tagline that reads "a Johnson & Johnson company" in a cursive font.
510(k) Summary
| Submitter: | Ethicon Inc. a Johnson & Johnson company
P.O. Box 151
Route 22 West
Somerville, NJ 08876-0151
USA |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Donna Marshall
Manager, Regulatory Affairs
Ethicon, Inc. a Johnson & Johnson company
Ph: (908) 541-3990
Fax: (908) 218-2595
e-mail: dmarsha2@its.jnj.com |
| Date Prepared: | August 12, 2015 |
| Device Trade Name: | STRATAFIX™ Spiral MONOCRYL™
Knotless Tissue Control Device
and
STRATAFIX™ Spiral MONOCRYL™ Plus
Knotless Tissue Control Device |
| Device Common Name: | Suture, Surgical, Absorbable, Polyglcolic Acid |
| Class: | II |
| Classification Name: | Suture, Absorbable, Synthetic, Polyglcolic Acid
(21 CFR 878.4493) |
| Product Code: | GAM |
| Predicate Device | 510(k) Number |
|---|---|
| MONOCRYLTM Plus Antibacterial (poliglecaprone 25) Suture | K050845 |
| QuillTM MONODERMTM Knotless Tissue Closure Device, Variable Loop Design | K141778 |
| K123836 | |
| K123409 |
4
Traditional 510(k) STRATAFIX™ Spiral MONOCRYL™ and STRATAFIX™ Spiral MONOCRYL™ PLUS Knotless Tissue Control Device Ethicon. Inc.
Device Description:
The STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device is a monofilament, synthetic absorbable device prepared from a copolymer of glycolide and s-caprolactone. Poliglecaprone 25 copolymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption.
The STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device, Variable Loop Design consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The STRATAFIX™ Spiral MONOCRYL™ Device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. The STRATAFIX™ Spiral MONOCRYL™ Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.
While the formation of barbs in the STRATAFIX™ Spiral MONOCRYL™ Device reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in nonbarbed suture materials also reduces their effective strengths. For this reason, the strength of the STRATAFIX™ Spiral MONOCRYL™ Device can be compared to USP knot strength of nonbarbed sutures. USP designations for diameter are used to describe the STRATAFIX™ Spiral MONOCRYL™ Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1 mm.
The STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device is an antibacterial monofilament, synthetic absorbable device prepared from a copolymer of glycolide and s-caprolactone. The device contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m. Poliglecaprone 25 copolymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption.
The STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device. Variable Loop Design consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The STRATAFIX™ Spiral MONOCRYL™ Plus Device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. The STRATAFIX™ Spiral MONOCRYL™ Plus Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.
While the formation of barbs in the STRATAFIX™ Spiral MONOCRYL™ Plus Device reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in nonbarbed suture materials also reduces their effective strengths. For this reason, the strength of the STRATAFIX™ Spiral MONOCRYL™ Plus Device can be compared to USP knot strength of non-barbed sutures. USP designations for diameter are used to describe the STRATAFIX™ Spiral MONOCRYL™ Plus Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1 mm.
5
Indications for Use:
STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Devices and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Devices are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.
Performance Data:
Non-clinical laboratory performance testing was performed demonstrating that STRATAFIX™ Spiral MONOCRYLTM Knotless Tissue Control Devices and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Devices conforms to the current USP Monograph for absorbable surgical sutures, except for diameter. This testing was performed in accordance with FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3. 2003. In addition, bench and animal testing was provided showing that the device performed as intended and as claimed.
Below you will find a list of non-clinical performance data completed for the STRATAFIX™ Spiral MONOCRYLTM Knotless Tissue Control Devices and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Devices:
| Bench Testing | Biocompatiblity | In-vitro/In-vivo |
|---|---|---|
| Suture Diameter | Intramuscular Implantation | Breaking Strength Retention |
| Tensile Strength | Subcutaneous Implantation | Wound Holding Strength |
| Needle Attachment | Irritation (Intracutaneous Reactivity) | Wound Healing |
| Pyrogenicity | Bacterial Colonization |
Substantial Equivalence:
STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Devices and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Devices have the same intended use and similar indications for use as the predicate devices. The technological differences between the subject devices, STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device and the predicate devices raise no new questions of safety or effectiveness. STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Devices and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Devices met all testing criteria to demonstrate substantial equivalence to the predicates devices. The following table compares the subject devices to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.
6
Traditional 510(k) STRATAFIX™ Spiral MONOCRYL™ and STRATAFIX™ Spiral MONOCRYL™ PLUS Knotless Tissue Control Device Ethicon, Inc.
Comparison Table:
Comparison of Subject Device Characteristics to Predicate Devices
| Characteristic | Subject Device:
STRATAFIXTM Spiral
MONOCRYLTM Knotless
Tissue Control Device | Subject Device: STRATAFIXTM
Spiral MONOCRYLTM Plus Knotless
Tissue Control Device | Predicate Device:
MONOCRYL Plus
Antibacterial Sutures
(K050845) | Predicate Device:
QuillTM Knotless Tissue
Closure Device
(Variable Loop Design)
Comprised of
MONODERMTM
(PGA-PCL)
(K141778, K123836, K123409) |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | STRATAFIXTM Spiral
MONOCRYLTM Knotless
Tissue Control Device is
indicated for use in soft tissue
approximation where the use
of absorbable sutures is
appropriate. | STRATAFIXTM Spiral
MONOCRYLTM Plus Knotless Tissue
Control Device is indicated for use in
soft tissue approximation where the use
of absorbable sutures is appropriate. | MONOCRYL Plus
Antibacterial sutures are
indicated for use in general
soft tissue approximation
and/or ligation, but not for use
in cardiovascular or
neurological tissues,
microsurgery or ophthalmic
surgery. | QuillTM MONODERM device is
indicated for use in soft tissue
approximation where use of
absorbable sutures is
appropriate. |
| Technological means for
achieving intended use | Monofilament strand to
approximate tissue anchored
without the need to tie surgical
knots. | Monofilament strand to approximate
tissue anchored without the need to tie
surgical knots. | Monofilament strand to
approximate tissue anchored
with surgical knots. | Monofilament strand to
approximate tissue anchored
without the need to tie surgical
knots. |
| Absorbable/
Suture Material | MONOCRYL is composed of
a copolymer of glycolide and
ε-caprolactone | MONOCRYL is composed of a
copolymer of glycolide and ε-
caprolactone | MONOCRYL is composed of
a copolymer of glycolide and
ε-caprolactone | MonodermTM (PGA-PCL) –
composed of a copolymer of
glycolide and e-caprolactone |
| Suture Design | Monofilament strand. Single
armed, unidirectional barbs
made by cutting into the core
of the suture strand. Contains
adjustable loop. | Monofilament strand. Single armed,
unidirectional barbs made by cutting
into the core of the suture strand.
Contains adjustable loop. | Monofilament strand | Uni-directional barbs along the
long axis of the monofilament |
| Colorant (if dyed) | Undyed | Undyed | Undyed or Dyed (D&C Violet
No.2) | Undyed or Violet (D&C Violet
No.2) |
| USP Suture Size | 2-0 through 4-0 | 2-0 through 4-0 | 0, 1, 2-0 through 6-0 | 0, 2-0 through 5-0 |
| Tensile Strength | Straight Tensile meets USP | Straight Tensile meets USP Knot | Meets USP requirement for | Straight Tensile meets USP Knot |
| | Knot Tensile requirements for
Synthetic Absorbable Sutures
of the same size equivalent | Tensile requirements for Synthetic
Absorbable Sutures of the same size
equivalent | Synthetic Absorbable Sutures | Tensile requirements for
Synthetic Absorbable Sutures of
one size smaller equivalent |
| Needle Pull-Off | Meets USP requirements | Meets USP requirements | Meets USP requirements | Meets USP requirements |
| Antibacterial Agent | Not Applicable | Irgacare MP (Triclosan) | Irgacare MP (Triclosan) | Not Applicable |
| Maximum Level of
Antibacterial Agent | Not Applicable |