HyperSutures (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 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. HyperSuture cables are available in USP 2-0, USP 2, and USP 5 and meet all surqical suture requirements established by the USP for class II non- absorbable surgical sutures.

HyperSuture tapes are non-absorbable, sterile, braid for surgery composed of multiple multifilament strands of ultra-high molecular weight polvethylene (UHMWPE) braided together to form the implant. HyperSuture tape sizes do not conform to USP diameter requirements; however, HyperSuture tapes meet USP tensile strength and needle attachment strength requirements for equivalent USP size sutures. HyperSuture tape sizes are available in Threadstone tape size 0.5 (USP 2-0 equivalent), tape 1.5 (USP 2 equivalent), and tape 2.5 (USP 5 equivalent).

Both HyperSuture cables and tapes are available in white/black, 40 inches in length, and with or without pre-attached needles.

AI/ML Overview

The provided text is a 510(k) summary for the device "HyperSuture." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include specific acceptance criteria for performance, nor does it detail a study that explicitly "proves the device meets the acceptance criteria" in terms of statistical comparisons or clinical outcomes for an AI/software device. The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device based on material, manufacturing, and general performance requirements for surgical sutures.

Therefore, many of the requested categories (such as sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document as it is for a physical medical device (surgical sutures), not a diagnostic AI/software device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from USP)	Reported Device Performance (HyperSuture)
HyperSuture Cables:
USP Diameter requirements	Meets USP diameter requirements
USP Needle attachment strength requirements	Meets USP needle attachment strength requirements
USP Tensile strength requirements	Meets USP tensile strength requirements
HyperSuture Tapes:
USP Tensile strength requirements (for equivalent USP size)	Meets USP tensile strength requirements for equivalent USP size sutures
USP Needle attachment strength requirements (for equivalent USP size)	Meets USP needle attachment strength requirements for equivalent USP size sutures
Threadstone specifications for tape width	Meets Threadstone specifications for tape width
Endotoxin quantities below recommended limits (following FDA Guidance "Pyrogens and Endotoxins Testing: Questions and Answers.")	Demonstrates endotoxin quantities below recommended limits

(Note: The document states "HyperSuture cables... meet all surgical suture requirements established by the USP for class II non-absorbable surgical sutures." and "HyperSuture tapes... meet USP tensile strength and needle attachment strength requirements for equivalent USP size sutures." The specific numerical or qualitative targets for these USP requirements are not detailed in this summary document, but the device states it meets them.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This document is for a physical medical device (suture) and the "test set" would refer to physical or mechanical bench testing, not a data-driven clinical study. The performance data section refers to "HyperSuture cables are tested per USP performance requirements..." but does not specify sample sizes or data provenance in the context of an AI/software device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. Ground truth in the context of expert consensus is not relevant for the performance testing of a surgical suture.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. This pertains to expert review of data, not physical device testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This device is a surgical suture, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Standards-based performance: The ground "truth" or reference standard for this device's performance is established by the United States Pharmacopeia (USP) requirements for surgical sutures, as well as Threadstone's internal specifications for tape width. Biological evaluations followed ISO 10993-1:2018 and endotoxin assessments followed FDA guidance for "Pyrogens and Endotoxins Testing."

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not Applicable. This is not an AI/machine learning device.

Summary

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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 24, 2023

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

Re: K230311

Trade/Device Name: HyperSuture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: October 25, 2023 Received: October 26, 2023

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"

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(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 OS 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: 2023.11.24 07:54:48
11.24 07:54:48 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

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230311

Device Name HyperSuture

Indications for Use (Describe)

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 of Threadstone HyperSuture (K230311)

1. Submitter Information

Submitter's Name:	Threadstone L.L.C.
Address:	1035 Benfield Blvd,Suite H, Millersville,MD 21163, USA
Phone Number:	(410) 544-2833
Fax Number:	N/A
Registration Number:	3017499940
Contact Person:	Jeremy Clark,Office@Threadstoneusa.com
Date of Preparation:	11/22/2023

2. Device Name

Trade Name:	HyperSuture™
Common or Usual Names:	Polyblend Suture, Non-absorbable Surgica l
Sutures Classification Name:	Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture

3. Device Classification

FDA Class:	II
Product Classification:	21CFR §878.5000: Suture, nonabsorbable, synthetic, polyethylene
Classification Code:	GAT
Review Panel:	General & Plastic Surgery

Classification Code:	GAT
Review Panel:	General & Plastic Surgery
Premarket Review:	Office of Device EvaluationDivision of Surgical Devices, Plastic andReconstructive General Surgery Devices Branch

4. Predicate Device

K181774 – Force Fiber Suture and Force Fiber OrthoTape Suture

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5. Device Description

Both HyperSuture cables and tapes are available in white/black, 40 inches in length, and with or without pre-attached needles.

6. Intended Use / Indication for Use

HyperSuture sutures (both cables and tapes) 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.

7. Substantial Equivalence and Comparison of Technical Characteristics

HyperSuture product family is substantially equivalent to the previously cleared Force Fiber Suture and Force Fiber OrthoTape. The HyperSuture product family has the same intended use and indications for use, the same principles of operation, and similar technical characteristics as the predicate device, Force Fiber Suture and Force Fiber OrthoTape cleared per K181774. Both the HyperSuture and the predicate device are sterilized using the same processes (EO Sterilization), are composed of the same material (UHMWPE), and are tested per USP performance requirements for length, tensile strength and needle attachment. The minor differences in technical characteristics are limited to the needle material, needle shapes and needle tips. The HyperSuture product family utilizes AISI 302 stainless steel needle with 1/2 circle curvature and taper cutting which is a subset of needle shape and tips provided by the predicate sutures. These differences do not raise new questions of safety or effectiveness as it will be discussed in the performance data; therefore, the HyperSuture suture product family is substantially equivalent to the currently marketed predicate device.

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8. Performance Data

HyperSuture sutures (both cables and tapes) meet requirements established by the United States Pharmacopeia. HyperSuture cables are tested per USP performance requirements for diameter, needle attachment and tensile strength. HyperSuture tapes are tested per USP performance requirements for tensile strength and needle attachment strength and Threadstone specifications for the tape width. FDA Guidance "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" was followed during the preparation of this submission. Materials used were evaluated per ISO 10993-1:2018 - Biological Evaluation of Medical Devices. Limulus Amebocyte Lysate (LAL) endotoxin quantification assessments, both process validation and routine testing, demonstrate endotoxin quantities below the recommended limits outlined in FDA Guidance "Pyrogens and Endotoxins Testing: Questions and Answers."

9. Conclusion

The information provided in this 510(k) demonstrates that HyperSuture™ (K230311) is substantially equivalent to the predicate sutures cleared under K181774.

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.