K Number

Device Name

HyperSuture Extension Line

Manufacturer

Threadstone L.L.C.

Date Cleared

2024-05-10

(140 days)

Product Code

GAT

Regulation Number

878.5000

Intended Use

HyperSuture Extension Line (both tape and cable) are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.

Device Description

HyperSuture Extension Line cables are non-absorbable, sterile, surgical sutures composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. The sutures are intended to be used for general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and allograft tissues for orthopedic procedures. HyperSuture Extension Line cables are available in USP 2 and USP 5 and tapes are available in 1.5 (USP 2 equivalent) and 2.5 (USP 5 equivalent). Both HyperSuture Extension Line cables and tapes are available in white/blue, 40 inches in length, and with or without pre-attached AISI 302 stainless steel needles.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K230311

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus solely on the physical properties and performance of surgical sutures, with no mention of AI or ML capabilities.

Therapeutic

No
Explanation: This device is a surgical suture used for tissue approximation and ligation, which is a structural and supportive function, not a therapeutic one that directly treats a disease or condition.

Diagnostic

The device is a surgical suture used for approximation and ligation of tissues, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description explicitly states it is composed of physical materials (UHMWPE, stainless steel needles) and is a surgical suture, which is a hardware component.

IVD (In Vitro Diagnostic)

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 are surgical procedures performed directly on the patient's body. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
Device Description: The device is described as a "surgical suture" composed of materials like UHMWPE. This is a physical implant used during surgery, not a reagent, instrument, or system used for testing biological samples.
Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.

Therefore, the HyperSuture Extension Line is a surgical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

GAT

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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

The Threadstone HyperSuture™ Extension Line sutures (both cables and tapes) meet requirements established by the United States Pharmacopeia (USP). The HyperSuture Extension Line sutures were tested per USP performance requirements for diameter, length, needle attachment and tensile strength. Materials were evaluated per ISO 10993-1:2009 -Biological Evaluation of Medical Devices. The Threadstone HyperSuture™ Extension Line products demonstrated substantial equivalence to the Threadstone HyperSuture™ products.

Key Metrics

Not Found

Predicate Device(s)

K230311

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 10, 2024

Threadstone L.L.C. Jeremy Clark President 1035 Benfield Blvd, Suite H Millersville, Maryland 21108

Re: K234079

Trade/Device Name: HyperSuture Extension Line Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: April 9, 2024 Received: April 9, 2024

Dear Jeremy Clark:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,

Digitally signed by Tek N. Tek N. Lamichhane -S Lamichhane -S Date: 2024.05.10 12:17:20
12:17:20 Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

Submission Number (if known)

K234079

Device Name

HyperSuture Extension Line

Indications for Use (Describe)

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)

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510(k) Summary of Threadstone HyperSuture™ Extension Line (K234079)

Submitter Information

Applicant:	Threadstone L.L.C.
Address:	1035 Benfield Blvd, Suite H,
Millersville, MD 21163, USA
Phone Number:	443-790-6536
Fax Number:	N/A
Registration Number:	3017499940
Contact Person:	Jeremy Clark
Office@Threadstoneusa.com
Date of Preparation:	08MAY2024
Device Name
Trade Name:	HyperSuture™ Extension Line
Common or Usual Names:	Polyblend Suture, Non-absorbable Surgical Sutures
Classification Name:	Nonabsorbable poly(ethylene terephthalate) Surgical
Suture
Device Classification
FDA Class:	II
Product Classification:	21 CFR 878.5000
Suture, nonabsorbable, synthetic, polyethylene
Classification Code:	GAT
Review Panel:	General & Plastic Surgery
Premarket Review:	Office of Device Evaluation
Division of Surgical Devices, Plastic and Reconstructive
General Surgery Devices Branch

K230311 – HyperSuture™ (GAT – 21 CFR 878.5000 Suture, nonabsorbable, synthetic, polyethylene)

Predicate Device

Device Description Summary:

Intended Use / Indication for Use:

HyperSuture Extension Line sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic procedures.

Substantial Equivalence Summary:

The Threadstone HyperSuture Extension Line devices are substantially equivalent to the predicate devices as the features and intended uses are the same. The HyperSuture Extension Line devices have the same principles of operation and similar technical characteristics as the predicate device. Biocompatibility testing and mechanical testing have been conducted, including implantation studies, chemical characterization, toxicology assessments, length, diameter, tensile strength, and needle attachment strength, to demonstrate that the proposed product has met the acceptance criteria for the proposed indications.

Technical Characteristic Comparison Chart:

Characteristics	Subject Device	Predicate Device	Substantial Equivalence
	HyperSuture™ Extension Line	HyperSuture™
510(k) Number	K234079	K230311	N/A
Product Code	GAT	GAT	Identical

Regulation No.	21 CFR 878.5000
Suture, nonabsorbable, synthetic,
polyethylene	21 CFR 878.5000
Suture, nonabsorbable, synthetic,
polyethylene	Identical
Class	II	II	Identical
Sterile	Yes (EO Sterilization)	Yes (EO Sterilization)	Identical
Single Use	Yes	Yes	Identical
Indication for Use	For use in general soft tissue
approximation and/or ligation,
including use in cardiovascular,
and the use of allograft tissue for
orthopedic procedures.	For use in general soft tissue
approximation and/or ligation,
including use in cardiovascular,
and the use of allograft tissue for
orthopedic procedures.	Identical
Configurations	Cable and Tape with or without
needle attached	Cable and Tape with or without
needle attached	Identical
Cable Material	White/Blue (Total 18 yarns)
Cables are made from sixteen
(16) UHMWPE yarns with two (2)
20 denier UHMWPE yarns	White/Black (Total 18 yarns)
Cables are made from fourteen
(14) UHMWPE yarns and two (2)
Nylon yarns with two (2) 20
denier UHMWPE yarns
All White (Total 18 yarns)
Cables are made from sixteen
(16) UHMWPE yarns with two (2)
20 denier UHMWPE yarns	Yes, the number of UHMWPE
yarns is identical to that of the All
White configuration. Eighteen (18)
Total.
Tape Material	White/Blue (Total 17 yarns)
Tapes are made from seventeen
(17) UHMWPE	White/Black (Total 17 yarns)
Tapes are made fifteen (15)
UHMWPE yarns and two (2)
Nylon yarns
All White (Total 17 yarns)
Tapes are made from seventeen
(17) UHMWPE	Yes, the number of UHMWPE
yarns is identical to that of the All
White configuration. Seventeen
(17) Total.
Cable Denier
Selection	Denier used in the suture is
determined by the USP size of the
suture.	Denier used in the suture is
determined by the USP size of the
suture.	Identical
Tape Denier
Selection	Denier used in the suture is
determined by the USP size
equivalent of the suture tape.
Ex. USP #2 (1.5 tape) and
USP #5 (2.5 tape)	Denier used in the suture is
determined by the USP size
equivalent of the suture tape.
Ex. USP #2-0 (0.5 tape), USP #2
(1.5 tape) and USP #5 (2.5 tape)	Identical, this submission will not
include the USP 2-0 size
Dye Information	Blue is [Phthalocyaninato (2-)]
copper Sutures –
Diameter with the exception of the
tape section of the suture tape.	The suture diameters of the
proposed devices comply with the
diameter requirements listed in
USP 43 Sutures –
Diameter with the exception of
the tape section of the suture
tape.	Identical
Tensile Strength	Both cables and tapes comply
with the tensile strength
requirements listed in USP 43
Tensile Strength.	Both cables and tapes comply
with the tensile strength
requirements listed in USP 43
Tensile Strength.	Identical
Needle Attachment	The needle attachment strengths
between suture and needle of the
applicable devices (suture and
tape) comply with the needle
attachment strength requirements
listed in USP 43 Sutures -
Needle Attachment.	The needle attachment strengths
between suture and needle of the
applicable devices (suture and
tape) comply with the needle
attachment strength requirements
listed in USP 43 Sutures -
Needle Attachment.	Identical

Device Comparison Discussion:

Substantial equivalence between the Threadstone HyperSuture Extension Line and the Threadstone HyperSuture (K230311) can be demonstrated according to the FDA's guidelines for substantial equivalence decision making process for at least the following reasons:

1. The Threadstone HyperSuture Extension Line has equivalent intended use and indications as the Threadstone HyperSuture (K230311)
1. Major technological characteristics are substantially equivalent between the Threadstone HyperSuture Extension Line and the Threadstone including, but not limited to:
- a. Substantially equivalent materials
- b. Substantially equivalent size range
- c. Substantially equivalent method of use
- d. Substantially equivalent mechanical strength

The Threadstone HyperSuture (K230311) are also made from UHMWPE material (raw/white) and/or a combination of UHMWPE material (raw/white) and Nylon (black). The Threadstone HyperSuture extension line is made from a combination of UHMWPE material (raw/white) and UHMWPE (Blue Dye: [Phthalocyaninato(2-)] copper) which has been evaluated for biocompatibility by trained, board certified veterinary pathologists.

Non-Clinical Testing Summary:

Conclusion:

Based on the results of completed performance testing inclusive of physical testing, biocompatibility testing, it can be concluded that the Threadstone HyperSuture™ Extension Line is substantially equivalent in terms of safety and effectiveness to HyperSuture™