(59 days)
Easy Whip™ is indicated for use in approximation and/or ligation of soft tissues, including the use of allograft tissue for orthopedic surgeries.
EasyWhip™ is a non-absorbable suture with specialized needle that simplifies and standardizes existing manual suturing methods as a convenience to surgeons. It is designed to facilitate easy, fast, and accurate stitch placement with less variation. EasyWhip™ is versatile and enables several stitch techniques or patterns, including a whip stitch, a WhipLock™ stitch (which combines a whip stitch with a locking stitch similar to a Krakow stitch), and custom patterns according to individual user needs and preferences.
EasyWhip™ consists of a single USP size 2, braided 40" strand of suture (20" loop) with portions of a two-part needle attached to each end. The needle portions consist of a tip with a sharp point and a dull insert that slides within the needle tip during stitching. The suture is non-absorbable Ultra-High Molecular Weight Polyethylene (UHMWPE) dyed black (D&C Black #4 not to exceed 1.0% by weight). The device is provided sterile for single use only. EasyWhip™ meets all surgical suture requirements established by USP for non-absorbable surgical sutures, except for oversize diameter.
This document is a 510(k) Premarket Notification from the FDA for a medical device called EasyWhip™. It is not a document describing an AI/ML device that requires acceptance criteria for AI performance. Therefore, I cannot extract the information requested as it pertains to AI/ML device performance.
The document discusses a surgical suture and its needle, focusing on its physical properties, biocompatibility, and substantial equivalence to a predicate device. The testing described is primarily mechanical, biological, and stability testing for this type of medical device, not AI/ML performance evaluation.
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May 3, 2021
Winter Innovations, Inc. Ms. Lia Winter CEO 2450 EJ Chapman Drive, Suite 114 Knoxville, Tennessee 37996
Re: K210675
Trade/Device Name: EasyWhip™ Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: March 1, 2021 Received: March 5, 2021
Dear Ms. Winter:
We have reviewed vour 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
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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) 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 (QS) 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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210675
Device Name EasyWhip™
Indications for Use (Describe)
Easy Whip™ is indicated for use in approximation and/or ligation of soft tissues, including the use of allograft tissue for orthopedic surgeries.
**Type of Use (Select one or both, as applicable)**X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY – EasyWhip™, K210675
| Sponsor/Applicant: | Winter Innovations Inc.2450 EJ Chapman Drive, Suite 114Knoxville, TN 37996 |
|---|---|
| Date Prepared: | March 01, 2021 |
| 510(k) Contact: | Lia Winter, MS-MBAChief Executive Officer |
| Trade Name: | EasyWhip™ |
| Common Name: | Polyethylene non-absorbable surgical suture with two-partneedle |
| Product Code,Classification Name, andRegulation Number | GAT; Suture, Non-Absorbable, Synthetic, Polyethylene; 21 CFR§ 878.5000 |
| Device Class: | II |
| Classification Panel: | General and Plastic Surgery |
| Device Description | EasyWhip™ is a non-absorbable suture with specialized needlethat simplifies and standardizes existing manual suturingmethods as a convenience to surgeons. It is designed tofacilitate easy, fast, and accurate stitch placement with lessvariation. EasyWhip™ is versatile and enables several stitchtechniques or patterns, including a whip stitch, a WhipLock™stitch (which combines a whip stitch with a locking stitch similarto a Krakow stitch), and custom patterns according to individualuser needs and preferences.EasyWhip™ consists of a single USP size 2, braided 40" strandof suture (20" loop) with portions of a two-part needle attached toeach end. The needle portions consist of a tip with a sharp pointand a dull insert that slides within the needle tip during stitching.The suture is non-absorbable Ultra-High Molecular WeightPolyethylene (UHMWPE) dyed black (D&C Black #4 not toexceed 1.0% by weight). The device is provided sterile for singleuse only. EasyWhip™ meets all surgical suture requirementsestablished by USP for non-absorbable surgical sutures, exceptfor oversize diameter. |
| Indications for Use | EasyWhip™ is indicated for use in approximation and/or ligationof soft tissues, including the use of allograft tissue for orthopedicsurgeries. |
| Substantial Equivalence | EasyWhip™ claims substantial equivalence to the currentlymarketed primary predicate Teleflex Force Fiber Suture clearedunder 510(k) K191268 on 6/11/2019. Any differences betweenEasyWhip™ and the predicate are considered minor and do notraise new or different questions of safety and effectiveness. |
| TechnologicalCharacteristics | EasyWhip™ is a non-absorbable suture with specialized needlethat simplifies and standardizes suturing techniques. The suturecomponent of the device is identical to the primary predicateTeleflex Force Fiber UHMWPE Suture K191268. The needlecomponents of the device are fabricated from stainless steel,which is identical or substantially equivalent to materials used inthe predicate device.The needle component of EasyWhip™ differs from conventionalneedles and the predicate device in that it has a unique two-partdesign with a needle tip and connectable rod/insert. The twoneedle components are fixed to ends of a length of suture. Theycan be connected to create a continuous loop of suture anddisconnect to create a straight length of suture, which facilitateseasier stitching and creation of patterns that cannot be madewith conventional needles. Conventional suture needles aretypically only one part.The attachment of a needle and rod/insert to the predicatedevice 510(k) cleared suture does not raise new or differentquestions of safety or efficacy. Testing supports that EasyWhip™is as safe and effective as the currently marketed predicatedevice. |
| Summary of Testing | EasyWhip™ was evaluated in accordance with therecommendations in the Class II Special Controls Guidance:Surgical Sutures; Guidance for Industry and FDA; June 2003.EasyWhip™ was tested in accordance with the USP for non-absorbable surgical sutures for suture diameter, tensile strength,and needle attachment. EasyWhip meets all USP requirements,with the exception of an oversize in diameter, which is identifiedin the labeling.The device has been evaluated through biological safety tests asoutlined in Use of International Standard ISO 10993-1, "BiologicalEvaluation of Medical Devices -Part 1: Evaluation and testingwithin a risk management process"; September 2020. Resultssupport that the device is biocompatible.Packaging and device stability evaluations were performed tosupport that device packaging will maintain a sterile barrier andthat device performance is maintained for the entirety of theproposed shelf life.Ex vivo testing was performed to confirm functionality of thespecialized needle and to evaluate biomechanical performanceof grafts stitched with EasyWhip™. Results support that thedevice functions as intended.The suture component has been tested to demonstrate it is "MRSafe" and poses no known hazards in MR environments. |
| Conclusion | Conclusions drawn from the comparative non-clinical testsdemonstrate that EasyWhip™ is as safe, as effective, andperforms as well as or better than the identified legally marketeddevice. |
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§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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.