(59 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical function of a surgical suture and needle, with no mention of AI or ML.
No
The device is a non-absorbable suture used for approximation and/or ligation of soft tissues in orthopedic surgeries, which are not considered therapeutic actions.
No
The Easy Whip™ is described as a non-absorbable suture with a specialized needle used for approximation and/or ligation of soft tissues. Its intended use is to facilitate suturing, which is a therapeutic action, not a diagnostic one.
No
The device description clearly states that EasyWhip™ is a non-absorbable suture with a specialized needle, which are physical hardware components. The summary focuses on the physical properties and performance of these components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "approximation and/or ligation of soft tissues, including the use of allograft tissue for orthopedic surgeries." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "non-absorbable suture with specialized needle." This is a physical tool used in surgery.
- Lack of IVD characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GAT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
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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 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. |
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