Gazelle Polypropylene Suture and Delivery Device

K173644 · Dura Tap, LLC · GAW · Feb 15, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K173644
• Device Name: Gazelle Polypropylene Suture and Delivery Device
• Applicant: Dura Tap, LLC
• Product Code: GAW · General, Plastic Surgery
• Decision Date: Feb 15, 2018
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Gazelle™ Polypropylene Suture and Delivery Device is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures. Gazelle™ Polypropylene Suture and Delivery Device is provided sterile as a single use device.

Device Story

Device consists of monofilament polypropylene suture pre-loaded into manual surgical delivery device; includes optional knot pusher. Suture composed of isotactic crystalline stereoisomer of polypropylene; blue pigment [Phthalocyaninato(2-)] copper added for visibility. Used by surgeons in clinical settings for soft tissue approximation/ligation. Suture delivered to target site via device tip. Device assists with suture placement; facilitates surgical workflow. Benefits include standardized delivery and handling of nonabsorbable suture material.

Clinical Evidence

Bench testing only. Includes mechanical testing per USP for nonabsorbable sutures, biocompatibility testing per ISO 10993-1, and performance testing of the delivery device (button push force, shaft pull forces). Surgeon evaluation performed.

Technological Characteristics

Monofilament polypropylene (synthetic linear polyolefin); blue pigment [Phthalocyaninato(2-)] copper (Color Index 74160). Sterile, single-use. Meets USP requirements for nonabsorbable surgical sutures. Manual surgical delivery device (Class I).

Indications for Use

Indicated for general soft tissue approximation and/or ligation in cardiovascular, ophthalmic, and neurosurgical procedures. For single use only.

Regulatory Classification

Identification

Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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

• Riverpoint Medical RIVERPRO Suture (K100006)

Submission Summary (Full Text)

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February 15, 2018

Dura Tap, LLC % Ms. Vikki M. O'Connor Regulatory Affairs Consulting Ambriel Associates, Inc. 411 Walnut St. Unit 9236 Green Cove Springs, Florida 32043

Re: K173644

Trade/Device Name: Gazelle Polypropylene Suture and Delivery Device Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable Polypropylene Surgical Suture Regulatory Class: Class II Product Code: GAW Dated: November 22, 2017 Received: November 27, 2017

Dear Ms. O'Connor:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# David Krause -S

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

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Dura Tap LLC Polypropylene Suture 510K

Abbreviated 510(k) Premarket Notification

Section 2A - Indications for Use

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

## 510(k) Number (if known)

K173644

Device Name

Gazelle™ Polypropylene Suture and Delivery Device

#### Indications for Use (Describe)

Gazelle™ Polypropylene Suture and Delivery Device is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures. Gazelle™ Polypropylene Suture and Delivery Device is provided sterile as a single use device.

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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (7/17)

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PSC Publishing Services [phone] E

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510(k) Summary: Gazelle Polypropylene and Suture Delivery Device

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular, 21 CFR Part 807.92, the following summary of information is provided:

| Submitter: | Dura Tap LLC<br>Wayne, PA<br>USA |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ms. Vikki M. O'Connor<br>Regulatory Affairs Consultant<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared | January 17, 2018 |
| Trade Name | Gazelle Polypropylene Suture and Delivery Device |
| Proposed Class | Class II (special controls); General and Plastic Surgery |
| Classification Name<br>and Number | Suture, Nonabsorbable, Synthetic, Polypropylene<br>878.5010 |
| Common Name | Polypropylene Nonabsorbable Surgical Sutures |
| Product Code | GAW |
| Predicate Device | Riverpoint Medical RIVERPRO Suture – K100006 |
| Special Controls | FDA Guidance, “Class II Special Controls Guidance<br>Document: Surgical Sutures, Guidance for Industry and<br>FDA” was followed during the preparation of this<br>submission. |
| Device Description | The Gazelle Polypropylene surgical sutures are sterile, nonabsorbable suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The pigmented suture is pigmented blue (with [Phthalocyaninato(2-)] copper, Color Index Number 74160) to enhance visibility. The sutures are attached to a |
| | The Gazelle Suture Delivery Device is a Class I Manual<br>Surgical Instrument that assists with suture placement.<br>The Polypropylene suture is loaded into the Gazelle<br>Delivery Device and is delivered to the desired location<br>through the tip of the Gazelle Delivery Device. A standard<br>knot pusher may be included with the Gazelle<br>Polypropylene Suture and Delivery Device. |
| Intended Use | The Gazelle™ Polypropylene Suture and Delivery Device<br>is indicated for use in general soft tissue approximation<br>and / or ligation, including cardiovascular, ophthalmic and<br>neurosurgical procedures. Gazelle™ Polypropylene Suture<br>and Delivery Device is provided sterile as a single use<br>device. |
| Summary of the<br>Technological<br>Characteristics | Gazelle polypropylene Sutures are monofilament sutures<br>composed of an isotactic crystalline stereoisomer of<br>spropylene, a synthetic linear olefin. The pigmented suture<br>is pigmented blue with [Phthalocyaninato(2-)] copper,<br>Color Index Number 74160. The Gazelle Polypropylene<br>Suture and Delivery Device is provided sterile for single<br>use and meet all applicable USP requirements. |
| Performance Data | Gazelle Polypropylene Sutures meet the requirements<br>specified in FDA's Class II Special Controls Guidance<br>Document: Surgical Sutures, Guidance for Industry and<br>FDA". In addition, the Gazelle Polypropylene Suture has<br>passed performance testing, including mechanical testing<br>in accordance to USP for nonabsorbable suture and<br>biocompatibility testing of the suture material in<br>accordance with ISO 10993-1. Packaging and sterilization<br>validation and shelf life testing have been successfully<br>performed. The Gazelle Delivery Device was tested for |
| | Button Push Force, Distal Tip / Shaft Pull Force, Handle / |
| | Shaft Pull Force, Stylet / Button Pull Force and underwent |
| | surgeon evaluation. All testing has confirmed that the |
| | Gazelle Polypropylene Suture and Delivery Device is |
| | substantially equivalent and will meet customer / user |
| | performance requirements. |
| Summary of | Both the subject and predicate are monofilament |
| Similarities and | Polypropylene Nonabsorbable Surqical Sutures. Both are |
| Differences | available in USP size 5-0 and 6-0 and are attached to |
| | stainless steel surgical needles. Both are undyed or dyed |
| | with pigmented blue with [Phthalocyaninato(2-)] copper, |
| | Color Index Number 74160. Both are provided sterilized for |
| | single use. Both meet USP requirements for Nonabsorbale |
| | Surgical Sutures, Tensile Strength and Needle |
| | Attachment. The only other difference is that the Gazelle |
| | suture is pre-loaded into the delivery device. |
| Conclusion | Based on the indications for use, technological |
| | characteristics, required performance testing and |
| | comparison to the predicate device, Gazelle Polypropylene |
| | Suture and Delivery Device has been shown to be |
| | substantially equivalent to legally marketed predicate |
| | devices for its intended use. |

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