(80 days)
Not Found
No
The device description and performance studies focus on the physical properties of the suture and the manual delivery device, with no mention of AI or ML.
No
A therapeutic device is one that treats or manages a disease or condition. This device is a surgical suture and delivery device used for tissue approximation and ligation, which are procedures that assist in surgery but do not directly treat a disease or condition.
No
The device is a surgical suture and delivery system used for tissue approximation and ligation, not for diagnosing medical conditions.
No
The device description clearly outlines physical components: polypropylene sutures, a suture delivery device (a Class I Manual Surgical Instrument), and potentially a standard knot pusher. These are all hardware components, 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 for "general soft tissue approximation and/or ligation," which is a surgical procedure performed directly on the patient's body. IVDs are used to examine specimens taken from the body (like blood, urine, tissue samples) to provide information about a person's health.
- Device Description: The device is a surgical suture and a delivery device for placing the suture. This is a tool used in surgery, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
The device is clearly described as a surgical tool used in vivo (within the living body) during surgical procedures.
N/A
Intended Use / Indications for Use
The 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.
Product codes
GAW
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 Surgical Instrument that assists with suture placement. The Polypropylene suture is loaded into the Gazelle Delivery Device and is delivered to the desired location through the tip of the Gazelle Delivery Device. A standard knot pusher may be included with the Gazelle Polypropylene Suture and Delivery Device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general 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
Gazelle Polypropylene Sutures meet the requirements specified in FDA's Class II Special Controls Guidance Document: Surgical Sutures, Guidance for Industry and FDA". In addition, the Gazelle Polypropylene Suture has passed performance testing, including mechanical testing in accordance to USP for nonabsorbable suture and biocompatibility testing of the suture material in accordance with ISO 10993-1. Packaging and sterilization validation and shelf life testing have been successfully 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.
Key Metrics
Not Found
Predicate Device(s)
Riverpoint Medical RIVERPRO Suture – K100006
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
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.(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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 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
Wayne, PA
USA |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ms. Vikki M. O'Connor
Regulatory Affairs Consultant
Phone: 1-207-214-8535
Email: vikki0730@yahoo.com |
| 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
and Number | Suture, Nonabsorbable, Synthetic, Polypropylene
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
Document: Surgical Sutures, Guidance for Industry and
FDA” was followed during the preparation of this
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
Surgical Instrument that assists with suture placement.
The Polypropylene suture is loaded into the Gazelle
Delivery Device and is delivered to the desired location
through the tip of the Gazelle Delivery Device. A standard
knot pusher may be included with the Gazelle
Polypropylene Suture and Delivery Device. |
| Intended Use | The Gazelle™ Polypropylene Suture and Delivery Device
is indicated for use in general soft tissue approximation
and / or ligation, including cardiovascular, ophthalmic and
neurosurgical procedures. Gazelle™ Polypropylene Suture
and Delivery Device is provided sterile as a single use
device. |
| Summary of the
Technological
Characteristics | Gazelle polypropylene Sutures are monofilament sutures
composed of an isotactic crystalline stereoisomer of
spropylene, a synthetic linear olefin. The pigmented suture
is pigmented blue with [Phthalocyaninato(2-)] copper,
Color Index Number 74160. The Gazelle Polypropylene
Suture and Delivery Device is provided sterile for single
use and meet all applicable USP requirements. |
| Performance Data | Gazelle Polypropylene Sutures meet the requirements
specified in FDA's Class II Special Controls Guidance
Document: Surgical Sutures, Guidance for Industry and
FDA". In addition, the Gazelle Polypropylene Suture has
passed performance testing, including mechanical testing
in accordance to USP for nonabsorbable suture and
biocompatibility testing of the suture material in
accordance with ISO 10993-1. Packaging and sterilization
validation and shelf life testing have been successfully
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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