STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device

K151200 · ETHICON, Inc. · GAM · Aug 13, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K151200
• Device Name: STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
• Applicant: ETHICON, Inc.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Aug 13, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

STRATAFIX™ Spiral MONOCRYL™ and Plus Knotless Tissue Control Devices are monofilament, synthetic absorbable surgical devices; composed of glycolide and ε-caprolactone copolymer. Devices feature unidirectional barbs cut into the suture core to anchor tissue without surgical knots; include a surgical needle on one end and a fixation loop at the other. Plus version incorporates antibacterial agent IRGACARE® MP (triclosan). Used by surgeons in clinical settings for soft tissue approximation. Barbed design allows tissue approximation without knot-tying; provides mechanical anchoring. Benefits include simplified closure and reduced need for manual knotting. Devices are single-use and sterile.

Clinical Evidence

No clinical data. Evidence consists of non-clinical laboratory performance testing, including suture diameter, tensile strength, needle attachment, biocompatibility (intramuscular/subcutaneous implantation, irritation, pyrogenicity), and in-vitro/in-vivo performance (breaking strength retention, wound holding strength, wound healing, bacterial colonization). Testing confirms conformance to USP Monograph for absorbable surgical sutures and FDA Class II Special Controls Guidance.

Technological Characteristics

Materials: Copolymer of glycolide and ε-caprolactone (poliglecaprone 25). Plus version includes triclosan (max 2360 µg/m). Design: Monofilament, unidirectional barbs, variable loop. Sizes: 2-0 to 4-0. Sterilization: Ethylene Oxide. Single-use. Mechanical anchoring principle.

Indications for Use

Indicated for general soft tissue approximation in patients where use of an absorbable suture is appropriate.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture (K050845)
• Quill™ MONODERM™ Knotless Tissue Closure Device, Variable Loop Design (K141778)
• Quill™ MONODERM™ Knotless Tissue Closure Device, Variable Loop Design (K123836)
• Quill™ MONODERM™ Knotless Tissue Closure Device, Variable Loop Design (K123409)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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) |
|-----------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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<br>P.O. Box 151<br>Route 22 West<br>Somerville, NJ 08876-0151<br>USA |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Donna Marshall<br>Manager, Regulatory Affairs<br>Ethicon, Inc. a Johnson & Johnson company<br>Ph: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Date Prepared: | August 12, 2015 |
| Device Trade Name: | STRATAFIX™ Spiral MONOCRYL™<br>Knotless Tissue Control Device<br>and<br>STRATAFIX™ Spiral MONOCRYL™ Plus<br>Knotless Tissue Control Device |
| Device Common Name: | Suture, Surgical, Absorbable, Polyglcolic Acid |
| Class: | II |
| Classification Name: | Suture, Absorbable, Synthetic, Polyglcolic Acid<br>(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 |

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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.

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### 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.

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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:<br>STRATAFIXTM Spiral<br>MONOCRYLTM Knotless<br>Tissue Control Device | Subject Device: STRATAFIXTM<br>Spiral MONOCRYLTM Plus Knotless<br>Tissue Control Device | Predicate Device:<br>MONOCRYL Plus<br>Antibacterial Sutures<br>(K050845) | Predicate Device:<br>QuillTM Knotless Tissue<br>Closure Device<br>(Variable Loop Design)<br>Comprised of<br>MONODERMTM<br>(PGA-PCL)<br>(K141778, K123836, K123409) |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | STRATAFIXTM Spiral<br>MONOCRYLTM Knotless<br>Tissue Control Device is<br>indicated for use in soft tissue<br>approximation where the use<br>of absorbable sutures is<br>appropriate. | STRATAFIXTM Spiral<br>MONOCRYLTM Plus Knotless Tissue<br>Control Device is indicated for use in<br>soft tissue approximation where the use<br>of absorbable sutures is appropriate. | MONOCRYL Plus<br>Antibacterial sutures are<br>indicated for use in general<br>soft tissue approximation<br>and/or ligation, but not for use<br>in cardiovascular or<br>neurological tissues,<br>microsurgery or ophthalmic<br>surgery. | QuillTM MONODERM device is<br>indicated for use in soft tissue<br>approximation where use of<br>absorbable sutures is<br>appropriate. |
| Technological means for<br>achieving intended use | Monofilament strand to<br>approximate tissue anchored<br>without the need to tie surgical<br>knots. | Monofilament strand to approximate<br>tissue anchored without the need to tie<br>surgical knots. | Monofilament strand to<br>approximate tissue anchored<br>with surgical knots. | Monofilament strand to<br>approximate tissue anchored<br>without the need to tie surgical<br>knots. |
| Absorbable/<br>Suture Material | MONOCRYL is composed of<br>a copolymer of glycolide and<br>ε-caprolactone | MONOCRYL is composed of a<br>copolymer of glycolide and ε-<br>caprolactone | MONOCRYL is composed of<br>a copolymer of glycolide and<br>ε-caprolactone | MonodermTM (PGA-PCL) –<br>composed of a copolymer of<br>glycolide and e-caprolactone |
| Suture Design | Monofilament strand. Single<br>armed, unidirectional barbs<br>made by cutting into the core<br>of the suture strand. Contains<br>adjustable loop. | Monofilament strand. Single armed,<br>unidirectional barbs made by cutting<br>into the core of the suture strand.<br>Contains adjustable loop. | Monofilament strand | Uni-directional barbs along the<br>long axis of the monofilament |
| Colorant (if dyed) | Undyed | Undyed | Undyed or Dyed (D&C Violet<br>No.2) | Undyed or Violet (D&C Violet<br>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<br>Synthetic Absorbable Sutures<br>of the same size equivalent | Tensile requirements for Synthetic<br>Absorbable Sutures of the same size<br>equivalent | Synthetic Absorbable Sutures | Tensile requirements for<br>Synthetic Absorbable Sutures of<br>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<br>Antibacterial Agent | Not Applicable | < 2360 µg/m | < 2360 µg/m | Not Applicable |
| Approximate % Breaking<br>Strength Retention (BSR) | 62% @ 7 days<br>27% @ 14 days | 62% @ 7 days<br>27% @ 14 days | 50 – 60% @ 7 days<br>20 – 30% @ 14 days<br>(undyed) | 62% @ 7 days<br>27% @ 14 days |
| Absorption Profile | Essentially absorbed by<br>91days post-implantation | Essentially absorbed by 91days post-<br>implantation | Essentially complete between<br>91 and 119 days | Essentially complete between 90<br>and 120 days |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Single Use? | Yes | Yes | Yes | Yes |
| Packaging Configuration | Plastic tray with paper lid<br>(contains the suture) placed<br>within foil pouch (sterile<br>barrier). Sterile foil pouches<br>are packaged in a sales carton. | Plastic tray with paper lid or paper<br>folder (contains the suture) placed<br>within foil pouch (sterile barrier).<br>Sterile foil pouches are packaged in a<br>sales carton. | Paper folder or plastic tray<br>within a foil pouch. Pouches<br>placed within sales carton | Device wound onto inner<br>support card, within a Single<br>Barrier Foil Pouch |

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Traditional 510(k) STRATAFIX™ Spiral MONOCRYL™ and STRATAFIX™ Spiral MONOCRYL™ PLUS
Knotless Tissue Control Device Ethicon, Inc.

### Conclusion:

Based on the intended use, technological characteristics, safety and performance testing STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device have been shown to be appropriate for its intended use and are considered to be substantially equivalent to the predicate devices.

* Trademark

IRGACARE®* MP (triclosan) "Registered Trademark of BASF Group"