← Product Code [GAT](/productcode/GAT) · K210675 # EasyWhip (K210675) _Winter Innovations, Inc. · GAT · May 3, 2021 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K210675 ## Device Facts - **Applicant:** Winter Innovations, Inc. - **Product Code:** [GAT](/productcode/GAT.md) - **Decision Date:** May 3, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.5000 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use EasyWhip™ is indicated for use in approximation and/or ligation of soft tissues, including the use of allograft tissue for orthopedic surgeries. ## Device Story EasyWhip™ is a non-absorbable surgical suture system designed to simplify and standardize manual suturing techniques. The device consists of a USP size 2, braided 40-inch strand of Ultra-High Molecular Weight Polyethylene (UHMWPE) suture with a specialized two-part needle attached to each end. The needle features a sharp tip and a dull insert that slides within the tip, allowing the needle to be connected into a continuous loop or disconnected into a straight length. This mechanism facilitates specific stitch patterns, such as whip stitches and WhipLock™ stitches, which are difficult to achieve with conventional single-part needles. Used by surgeons in clinical settings, the device enables faster, more accurate stitch placement. The suture is provided sterile for single use. By standardizing stitch placement and reducing variation, the device aims to improve the efficiency and consistency of soft tissue approximation and ligation during orthopedic procedures. ## Clinical Evidence No clinical data. Evidence is based on bench testing, including USP requirements for non-absorbable sutures (diameter, tensile strength, needle attachment), biocompatibility testing per ISO 10993-1, packaging/shelf-life stability, and ex vivo biomechanical performance testing of stitched grafts. The suture is confirmed MR Safe. ## Technological Characteristics Non-absorbable braided UHMWPE suture; two-part needle system (stainless steel) with sliding tip/insert mechanism; USP size 2; 40-inch strand length; sterile, single-use; MR Safe. ## Regulatory 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. ## 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 - Teleflex Force Fiber Suture ([K191268](/device/K191268.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) ## 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 "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(K) SUMMARY – EasyWhip™, K210675 | Sponsor/Applicant: | Winter Innovations Inc.
2450 EJ Chapman Drive, Suite 114
Knoxville, TN 37996 | |----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared: | March 01, 2021 | | 510(k) Contact: | Lia Winter, MS-MBA
Chief Executive Officer | | Trade Name: | EasyWhip™ | | Common Name: | Polyethylene non-absorbable surgical suture with two-part
needle | | Product Code,
Classification Name, and
Regulation 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 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. | | Indications for Use | EasyWhip™ is indicated for use in approximation and/or ligation
of soft tissues, including the use of allograft tissue for orthopedic
surgeries. | | Substantial Equivalence | EasyWhip™ claims substantial equivalence to the currently
marketed primary predicate Teleflex Force Fiber Suture cleared
under 510(k) K191268 on 6/11/2019. Any differences between
EasyWhip™ and the predicate are considered minor and do not
raise new or different questions of safety and effectiveness. | | Technological
Characteristics | EasyWhip™ is a non-absorbable suture with specialized needle
that simplifies and standardizes suturing techniques. The suture
component of the device is identical to the primary predicate
Teleflex Force Fiber UHMWPE Suture K191268. The needle
components of the device are fabricated from stainless steel,
which is identical or substantially equivalent to materials used in
the predicate device.
The needle component of EasyWhip™ differs from conventional
needles and the predicate device in that it has a unique two-part
design with a needle tip and connectable rod/insert. The two
needle components are fixed to ends of a length of suture. They
can be connected to create a continuous loop of suture and
disconnect to create a straight length of suture, which facilitates
easier stitching and creation of patterns that cannot be made
with conventional needles. Conventional suture needles are
typically only one part.
The attachment of a needle and rod/insert to the predicate
device 510(k) cleared suture does not raise new or different
questions of safety or efficacy. Testing supports that EasyWhip™
is as safe and effective as the currently marketed predicate
device. | | Summary of Testing | EasyWhip™ was evaluated in accordance with the
recommendations 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 identified
in the labeling.
The device has been evaluated through biological safety tests as
outlined in Use of International Standard ISO 10993-1, "Biological
Evaluation of Medical Devices -Part 1: Evaluation and testing
within a risk management process"; September 2020. Results
support that the device is biocompatible.
Packaging and device stability evaluations were performed to
support that device packaging will maintain a sterile barrier and
that device performance is maintained for the entirety of the
proposed shelf life.
Ex vivo testing was performed to confirm functionality of the
specialized needle and to evaluate biomechanical performance
of grafts stitched with EasyWhip™. Results support that the
device functions as intended.
The suture component has been tested to demonstrate it is "MR
Safe" and poses no known hazards in MR environments. | | Conclusion | Conclusions drawn from the comparative non-clinical tests
demonstrate that EasyWhip™ is as safe, as effective, and
performs as well as or better than the identified legally marketed
device. | {4}------------------------------------------------ --- **Source:** [https://fda-staging.innolitics.com/device/K210675](https://fda-staging.innolitics.com/device/K210675) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com