STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device

K221744 · ETHICON, Inc. · GAM · Nov 15, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K221744
• Device Name: STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device
• Applicant: ETHICON, Inc.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Nov 15, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

STRATAFIX™ Spiral MONOCRYL™ Plus Unidirectional Knotless Tissue Control Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

Device Story

Single-use, antibacterial, monofilament, synthetic absorbable surgical suture; composed of poliglecaprone 25 copolymer (glycolide and epsilon-caprolactone) with IRGACARE® MP (triclosan) and D&C Violet No.2 colorant. Features unidirectional barbs and an anchoring fixation loop; eliminates need for surgical knots. Used by physicians in clinical settings for soft tissue approximation. Barbs allow tissue holding; loop provides anchor. Benefits include secure tissue approximation without knot-related complications. Sterilized via ethylene oxide.

Clinical Evidence

Bench testing only. Evaluated suture loop tensile strength, straight tensile strength, diameter, needle attachment strength, and in-vivo breaking strength retention (BSR). Testing performed per FDA Guidance Document: "Class II Special Controls Guidance Document: Surgical Sutures" (2003). Stability evaluation supported equivalence to primary predicate.

Technological Characteristics

Material: Poliglecaprone 25 (glycolide/epsilon-caprolactone copolymer). Antibacterial agent: Triclosan (max 2360 ug/m). Colorant: D&C Violet No.2 (<0.050% w/w). Form: Monofilament, unidirectional barbed, welded loop, surgical needle. Sizes: USP 2-0, 3-0. Sterilization: Ethylene Oxide.

Indications for Use

Indicated for soft tissue approximation in patients requiring absorbable sutures.

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

• STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (K182873)

Reference Devices

• STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Knotless Tissue Control Device (K192580)

Submission Summary (Full Text)

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11/15/2022

Ethicon, Inc. Jenny Wang Regulatory Affairs Specialist 1000 Us-202 Raritan, New Jersey 08869-1425

#### Re: K221744

Trade/Device Name: STRATAFIX™ Spiral MONOCRYL™ Plus Unidirectional 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: June 15, 2022 Received: June 16, 2022

Dear Jenny Wang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Deborah A. Fellhauer -S

Deborah Fellhauer RN, BSN Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known)

K221744

Device Name

STRATAFIX™ Spiral MONOCRYL™ Plus Unidirectional Knotless Tissue Control Device

Indications for Use (Describe)

STRATAFIX™ Spiral MONOCRYL™ Plus Unidirectional Knotless Tissue Control Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary

| Submitter: | Ethicon Inc. a Johnson & Johnson company<br>1000 US-202 Raritan, New Jersey 08869 |
|----------------------|----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jenny Wang<br>Ethicon, Inc. a Johnson & Johnson company<br>Phone: [phone]<br>e-mail: [e-mail] |
| Date Prepared: | November 14, 2022 |
| Device Trade Name: | STRATAFIX™ Spiral MONOCRYL™ Plus Unidirectional<br>Knotless Tissue Control Device |
| Device Common Name: | Surgical Suture |
| Class: | II |
| Classification Name: | Suture, Absorbable, Synthetic, Polyglycolic Acid<br>(21 CFR 878.4493) |
| Product Code: | GAM |

| Predicate Devices | 510(k) Number | Purpose |
|-------------------------------------------------------------------------------------------------------------------------|---------------|-----------------------------------------------------------------------------------------------|
| <b>Primary Predicate Device:</b><br>STRATAFIX™ Spiral MONOCRYL™ Plus<br>Knotless Tissue Control Device | K182873 | Predicate for all<br>technological<br>characteristics, Indication<br>for Use, and Performance |
| <b>Reference Device for Dye:</b><br>STRATAFIX™ Spiral MONOCRYL™ Plus<br>Bidirectional Knotless Tissue Control<br>Device | K192580 | Reference device for Dye |

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#### Device Description:

The STRATAFIX™ Spiral MONOCRYL™ Plus Unidirectional Knotless Tissue Control Device is an antibacterial monofilament, synthetic absorbable single-use surgical suture device composed of a copolymer of glycolide and (epsilon) s-caprolactone. The device contains IRGACARE®: MP (triclosan), a broad-spectrum antibacterial agent, at no more than 2360 ug/m. The colorant employed is D&C Violet No.2, in <0.050% w/w concentration. Poliglecaprone 25 copolymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption. The subject device is intended for professional use only.

Same as the currently marketed undyed version, the subject device consists of a unidirectional barbed suture material, armed with a surgical needle on one end and an anchoring fixation loop at the opposite end. The barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.

While the formation of barbs in the subject STRATAFIX™ Spiral MONOCRYL™ Plus Unidirectional Device reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in non-barbed suture materials also reduces their effective strength. For this reason, the strength of the STRATAFIX™ Spiral MONOCRYL™ Plus Unidirectional Device can be compared to USP knot strength of non-barbed sutures. The actual diameter of the non-barbed section fiber is one size greater than the designated size with a maximum overage of 0.1 mm.

The subject device is sterilized by Ethylene Oxide, and is available in lengths of 6, 9, and 12 inches, with a USP diameter size 2-0 and 3-0 (metric sizes 3.0 and 2.0), and single armed with various needle sizes.

#### Indications for Use:

STRATAFIX™ Spiral MONOCRYL™ Plus Unidirectional Knotless Tissue Control Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

#### Performance Data:

Non-clinical laboratory performance testing on suture loop tensile strength and suture straight tensile strength was performed demonstrating that the subject device conforms to the current USP Monograph for absorbable surgical sutures, except for diameter. The testing was performed in accordance with FDA's Guidance Document: "Class II Special Controls Guidance Document: Surgical Sutures" issued on June 3, 2003. In addition, Suture diameter, Needle Attachment Strength, and In-vivo Breaking Strength Retention (BSR) were evaluated to show that the device performs as intended and as claimed. Stability evaluation was performed to support equivalence to the primary predicate device.

The added colorant in the subject device is the same as that used in the secondary predicate device for dye and does not raise new questions on safety or effectiveness. The subject device meets all testing criteria to demonstrate substantial equivalence to the primary predicate device.

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#### Summary of Similarities and Differences in Technological Characteristics, Performance, and Intended Use:

100979694| Rev. 1

The intended use, technological characteristics, and performance of the subject device are consistent with those of the primary predicate device. The subject and primary predicate (K182873) devices are identical except for the addition of the colorant and the subject device is supplied in a subset of sizes. The dye and its concentration used in the subject device is the same as that used in the reference device for dye (K192580), which is comprised of the identical base material but which does not include a welded loop.

The following table summarizes the similarities and differences between the subject device and the predicate and reference devices.

| Characteristic | Subject Device<br>STRATAFIXTM Spiral<br>MONOCRYLTM Plus<br>Unidirectional Device<br>(Dyed) | Primary Predicate<br>Device<br>STRATAFIXTM Spiral<br>MONOCRYLTM Plus<br>Knotless Tissue Control<br>Device (K182873) | Reference Device for<br>Dye<br>STRATAFIXTM Spiral<br>MONOCRYLTM Plus<br>Bidirectional Knotless<br>Tissue Control Device<br>(K192580) |
|-------------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Barb<br>Orientation | Unidirectional Barbed<br>suture with a welded loop | Same | Bidirectional Barb<br>suture without a welded<br>loop |
| Absorbable<br>Suture Material | Copolymer<br>poliglecaprone 25<br>composed of glycolide and<br>ε-caprolactone | Same | Same |
| Colorant | D&C Violet No.2 (21CFR<br>§74.3602) in <0.050% w/w<br>concentration | Undyed | Same |

#### Substantial Equivalence:

The subject device has the same intended use and indications for use as the primary predicate device. There is no polymer formulation, construction, specification, body/fluid contact. manufacturing, or sterilization process change to the currently marketed device.

The added colorant in the subject device is the same as that used in the reference device for dye and does not raise new questions on safety or effectiveness.

#### Conclusion:

Based on the intended use, technological characteristics, and safety and performance testing, and biocompatibility evaluation, the STRATAFIX™ Spiral MONOCRYL™Plus Unidirectional Knotless Tissue Control Device has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the primary predicate device.