EXPANDED BODY SUTURE

• K Number: K961025
• Device Name: EXPANDED BODY SUTURE
• Manufacturer: MEDICINE LODGE, INC.
• Date Cleared: 1996-04-15 ( 32 days)
• Product Code: GAT
• Regulation Number: 878.5000
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The EXPANDED BODY suture is indicated for use in soft-tissue approximation and/or ligation in rotator cuff repair procedures.

Device Description

The EXPANDED BODY suture is a braided, nonabsorbable, sterile, surgical suture composed of Poly(ethylene terapthalate) intended for use in rotator cuff soft-tissue repair procedures. This device is prepared from fibers of high molecular weight, fong-chain, linear polyesters having recurrent aromatic rings as an integral component.

The EXPANDED BODY suture is identical to currently marketed polyester sutures within this device class with the exception of the following:

1. a new labeled indication for use stating specific use in rotator cuff soft tissue repair procedures, and
2. a new design which incorporates an expanded midsection equidistant from both ends of the suture possessing a larger outer diameter (two to four times) than the standard USP size.

The outer diameter of the expanded midsection thus has a cross-sectional area equal to or greater than the cross-sectional area of the needle or drill used to create the hole in the tissue. This ensures that the expanded midsection firmly engages the hole created by the drill or needle in the tissue.

AI/ML Overview

Acceptance Criteria and Device Performance Study for EXPANDED BODY Suture

This document describes the acceptance criteria and the study conducted to demonstrate that the EXPANDED BODY Suture meets these criteria, as detailed in the provided 510(k) Premarket Notification.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Meets USP Monograph for Nonabsorbable Surgical Suture requirements (except diameter)	USP Compliance Testing:
	1) Suture Needle Attachment Testing (USP #871): Results confirm the USP #5 EXPANDED BODY suture exceeds applicable requirements.
	2) Suture Tensile (Knot Pull) Test (USP #881): Results confirm the USP #5 EXPANDED BODY suture exceeds applicable requirements.
Equivalent to predicate device in simulated pull-out strength	Comparative Testing with TI•CRON: The EXPANDED BODY suture performs equivalent to the TI•CRON suture in simulated pull-out strength using Last-a-Foam Polyurethane Foam as a bone material surrogate.
Materials are biocompatible/established	Materials: Constructed of Poly(ethylene terephthalate), D&C Blue #6, D&C Green #6 (colors), and 420C Stainless Steel (needles). These materials are similarly used in predicate devices and are well-established. FDA has also approved the color additives for polyester sutures.
Sterilization method is appropriate	Sterilization: Gamma sterilization is used, which is identical to predicate devices.
Packaging is appropriate	Packaging: Method of manufacture and device packaging are identical to predicate devices.
Indication for use is supported by literature/device design	Indication for Use (Soft-tissue approximation and/or ligation in rotator cuff repair procedures): Although a new labeled indication, medical literature documents the widespread use of nonabsorbable polyester suture devices for soft-tissue repair of the shoulder, including rotator cuff repair. The expanded midsection design improves engagement and distributes force more evenly, which supports the rationale for this specific application.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size:
  • For USP Compliance Testing (USP #871 and #881): A representative USP #5 EXPANDED BODY suture was used.
  • For Comparative Testing (pull-out strength): A representative USP #5 EXPANDED BODY design configuration was used, compared against a USP #5 TI•CRON nonabsorbable, polyester suture.
• Data Provenance: The studies were conducted by MedicineLodge, Inc. and are described as internal testing to verify conformance and comparative performance. This indicates a prospective nature, with data generated specifically for this submission. The country of origin of the data is not explicitly stated but can be inferred as the United States, given the manufacturer's location and FDA submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This submission does not rely on expert consensus or human interpretation for its performance evaluation. The "ground truth" for the test set is based on established, quantitative engineering and material standards, specifically the United States Pharmacopeia (USP) Monograph for Nonabsorbable Surgical Suture and direct comparative physical testing against a predicate device. Therefore, no human experts were explicitly used to establish a subjective "ground truth" for the performance tests described.

4. Adjudication Method

Not applicable. The tests performed are objective, quantitative physical tests comparing against specified standards (USP) or direct comparison in a simulated environment, not clinical studies requiring adjudication of outcomes or interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. A MRMC comparative effectiveness study was not performed. This device is a surgical suture, and its performance is evaluated through biomechanical and material property testing, not through human interpretation of images or clinical data where MRMC studies would be relevant.

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

This question is not applicable to the device under review. The EXPANDED BODY Suture is a physical medical device, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept here. All performance testing described is for the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" used for testing the EXPANDED BODY Suture is based on:

• Established Industry Standards: Specifically, the United States Pharmacopeia (USP) Monograph for Nonabsorbable Surgical Suture for tests like suture needle attachment and tensile strength.
• Comparative Performance to a Predicate Device: For pull-out strength, the "ground truth" for comparison was the performance of a legally marketed predicate device (TI•CRON) under identical simulated conditions.
• Material Science and Biocompatibility Data: The material composition (poly(ethylene terephthalate), color additives, stainless steel) is accepted as "ground truth" based on prior FDA approvals and established biocompatibility for predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device. The concepts of "training set" and "validation set" are relevant to machine learning or AI algorithm development, which is not applicable here. The device's design and manufacturing processes are based on established engineering principles and material science, not statistical training from a data set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" for a physical medical device of this nature.

Summary

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തി ശക്ക

K961025

--- CDRH ODE

APR 1 5 1996

Premarket Notification

510(k) Summary of Safety and Effectiveness Information

DATE OF SUMMARY PREPARATION

March 5, 1996

MANUFACTURER

MedicineLodge, Incorporated 152 South 600 West Logan, Utah 84321 Telephone: [phone] [phone] Fax:

MANUFACTURER CONTACT PERSON

Alan Chervitz, President MedicineLodge, Inc. 152 South 600 West Logan, Utah 84321 Telephone: [phone] Fax: [phone]

REGULAIQRY CORRESPONDENCE

Correspondence related to this submission may be addressed to:

Brian T. Cleary Director of RA/QA Hayes Medical, Inc. 819 Striker Avenue, Suite 10 Sacramento, CA 95834-5432

[phone] Telephone: Fax: [phone]

PROPRIETARY DEVICE NAME

EXPANDED BODY Suture

COMMON NAME

Braided Nonabsorbable Polyester Surgical Suture

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CLASSIEICATION NAME

Nonabsorbable Poly(ethylene terephthalate) Surgical Suture

CLASSIEICATION BEEEBENCE

21 CFR § 878.5000

DEVICE PRODUCT CODE

79 GAT

BEGULATORY CLASS

In accordance with FDA classification of nonabsorbable synthetic poly(ethylene terepthalate) sutures as Class II medical devices, this device is proposed for placement in Class II.

SPECIAL CONTROLS

At this time, Food and Drug Administration generated Performance Standards applicable to the EXPANDED BODY suture are not in force. In accordance with 21 CFR § 878.5000, testing has been performed confirming that the EXPANDED BODY suture meets applicable United States Pharmacopiea (USP) requirements as described in the USP Monograph for Nonabsorbable Surgical Suture, with the exception of suture diameter.

USP COMPLIANCE TESTING

As required by 21 CFR § 878.5000, device testing has been conducted to verify that the EXPANDED BODY suture meets all applicable USP standards for nonabsorbable surgical sutures, with the exception of suture diameter. MedicineLodge, Inc. has conducted the following tests on a representative USP #5 EXPANDED BODY suture to verify conformance with the USP standards listed below.

• 1. Suture Needle Attachment Testing (USP # 871)
• 2. Suture Tensile (Knot Pull) Test (USP # 881)

Results from these tests confirm that the USP #5 EXPANDED BODY suture exceeds applicable requirements for USP tests #871 and #881 for nonabsorbable surgical sutures. MedicineLodge, Inc. believes that the results of this testing are representative of the performance of all USP sizes of this device and demonstrate that all USP size EXPANDED BODY sutures will exceed these requirements.

MATERIALS

The following materials are used in the manufacture of the EXPANDED BODY suture.

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Polylethylene terepthalate); in accordance with 21 CFR § 878.5000, the EXPANDED BODY suture is constructed of poly(ethylene terepthalate). This material is similarly used in the manufacture of the all predicate devices and its clinical use is therefore well established. The expanded midsection of the device is similarly comprised of this material.

Color Additives: the EXPANDED BODY suture will be colored using the following coloring additives:

• . D&C Blue #6
• D&C Green #6 .
• White (Standard/Undyed) .

D&C Blue #6 and D&C Green #6 are similarly used to dye all predicate devices. FDA has indicated that these colors are approved for the dying of polyester sutures.

Stainless Steel; the needle portion of the EXPANDED BODY suture is manufactured from 420C Stainless Steel (ASTM F-899).

INDICATIONS FOR USE

The EXPANDED BODY suture is indicated for use in soft-tissue approximation and/or ligation in rotator cuff repair procedures.

DEVICE DESCRIPTION

The EXPANDED BODY suture is a braided, nonabsorbable, sterile, surgical suture composed of Poly(ethylene terapthalate) intended for use in rotator cuff soft-tissue repair procedures. This device is prepared from fibers of high molecular weight, fong-chain, linear polyesters having recurrent aromatic rings as an integral component.

The EXPANDED BODY suture is identical to currently marketed polyester sutures within this device class with the exception of the following:

• 1. a new labeled indication for use stating specific use in rotator cuff soft tissue repair procedures, and
• 2. a new design which incorporates an expanded midsection equidistant from both ends of the suture possessing a larger outer diameter (two to four times) than the standard USP size.

The outer diameter of the expanded midsection thus has a cross-sectional area equal to or greater than the cross-sectional area of the needle or drill used to create the hole in the tissue. This ensures that the expanded midsection firmly engages the hole created by the drill or needle in the tissue. The rationale behind this new design is discussed in detail on the following page.

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MedicineLodge, Inc. plans to provide the EXPANDED BODY suture in USP sizes #0 through #5 (metric sizes 3.5 through 7). All sutures will be 30 inches in length, available in 5 different colors lundyed white, dyed green, dyed blue, and white/blue and white/green combinations], and provided with and without attached needles.

For all EXPANDED BODY sutures, the length of the expanded midsection of the device will range from 15 mm to 25 mm and the diameter of the expanded midsection will range from two to four times the diameter of the corresponding USP size of the suture. All device labeling will specify exact expanded midsection dimensions for each USP size.

SUBSTANTIALLY EQUIVALENT PREDICATE DEVICES

MedicineLodge, Inc. believes that several commercially available devices are substantially equivalent to the EXPANDED BODY suture. Within the proposed class, the following devices were used as predicate devices for comparison in establishing the substantial equivalence of the EXPANDED BODY suture:

• TI•CRON Nonabsorbable Polyester Surgical Suture 1) Davis + Geck, Manati, PR; Danbury, CT
• POLYVIOLENE Nonabsorbable Polyester Surgical Suture 2) Look, Inc., Norwell, MA

SUBSTANTIAL EQUIVALENCE COMPARISON

To begin, the materials, method of manufacture, method of sterilization, and device packaging are identical to predicate devices. Additionally, as with all predicate devices, the EXPANDED BODY suture meets all USP requirements applicable to nonabsorbable sutures, with the exception of suture diameter.

As indicated previously, the only differences that distinguish the EXPANDED BODY suture from the selected predicate devices are:

• 1. a new labeled indication for use stating specific use in rotator cuff soft tissue repair procedures, and
• 2. a new design which incorporates an expanded midsection possessing a larger outer diameter (two to four times) than the standard USP size.

Devices that have previously received 510(k) clearance within 21 CFR § 878.5000 are specifically indicated for use in all types of soft tissue repair, including specific stated use in cardiovascular, opthalmic and neurological procedures. Unlike the proposed labeling for the EXPANDED BODY suture, the predicate devices do not specify a labeled indication for use in orthopedic soft-tissue repair.

However, it should be mentioned that all predicate device labeling states no known contraindications. It is our understanding that suture devices are used regularly in orthopedic soft tissue approximation and/or ligation.

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Medical literature documents the widespread use of nonabsorbable polyester suture devices for soft-tissue repair of the shoulder, including rotator cuff repair. Hence, although the labeled indication for use of the EXPANDED BODY suture is new, the practice of using nonabsorbable, polyester suture devices for the same indication is well documented in medical literature.

Design Difference - Expanded Midsection

The rationale behind the expanded midsection design is to increase the outer diameter of the suture to more firmly engage and fit the hole created by the needle or drill in the bone tissue during suture insertion. This increased outer diameter also results in an increased suture surface area contained in the formed hole.

This larger surface area potentially reduces the chances of suture or bone failure by more evenly distributing any applied force to the surrounding bone tissue. The expanded midsection feature more evenly distributes the applied force over the bone surface, the EXPANDED BODY suture potentially increases the maximum pulli-out strength of the suture relative to standard, similarly sized polyester sutures.

A representative USP #5 EXPANDED BODY design configuration was used for all comparative testing. This design combines dimensions for the expanded midsection that fall at the lower end of the design limits for a USP #5 EXPANDED BODY suture - lower-end design limit length (16.5 mm) and less than minimum outer diameter (1.27 mm < 2x = 1.499 mm). The predicate device used for comparison was a USP #5 Tt•CRON (Davis + Geck) nonabsorbable, polyester suture.

Comparative testing was performed using Last-a-Foam Polyurethane Foam as a simulated bone material. Use of this material for comparative device testing assures that the EXPANDED BODY and TI•CRON suture samples are tested in a uniform material so that variation of material properties is controlled. In this way, the results of the test measure only the difference in performance of the two suture types.

The test results confirm that the EXPANDED BODY suture performs equivalent to the TI.CRON suture in this simulated application.

Conclusion

Based on the design concept, use of standard materials, feature comparisons to the selected predicate devices, and device testing, MedicineLodge, Inc. believes that sufficient evidence exists to conclude that the EXPANDED BODY suture is substantially equivalent to existing legally marketed nonabsorbable polyester suture devices.

Additionally, the information presented herein should support our request for labeled "indications for use" in soft-tissue approximation and/or ligation in rotator cuff repair procedures.

Table 1 on the following page summarizes the relevant feature comparisons between the EXPANDED BODY suture and the selected predicate devices.

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TABLE 1

Feature comparisons between the EXPANDED BODY suture and Ti•Cron (Davis + Geck) and Polyviolene {Look, Inc.) predicate devices (differences are indicated in bold print)

	EXPANDED BODY	TI•CRON	POLYVIOLENE
	Polyester Nonabsorbable	Polyester Nonabsorbable	Polyester Nonabsorbable
	Surgical Suture, USP	Surgical Suture, USP	Surgical Suture, USP
Indications	Soft-tissue approximationand/or ligation in rotatorcuff repair procedures.	General soft tissueapproximation and/orligation, including use incardiovascular, ophthalmicand neurological procedures.	General soft tissueapproximation and/orligation, including use incardiovascular, ophthalmicand neurological procedures.
Contraindications	None known	None known	None known
Materials	Poly(ethylene terephthalate)	Poly(ethylene terephthalate)	Poly(ethylene terephthalate)
ExpandedMidsection	Length: 15 mm to 25 mmOuter Diameter: 2 to 4times the correspondingUSP size	No	No
Sterilization	Gamma	Gamma	Gamma
Pledgets	No	Yes (PTFE)	Yes (PTFE)
Needles	With and without	With and without	With and without
Sizes	USP 0 through 5	USP #7-0 through #5	USP #11-0 through #5
Colors	Blue, Green, White;Blue/White and Green/Whitecombinations	Blue and White	Green and White
Manufacturer	Medicine Lodge, Inc.	Davis + Geck	Look, Inc.
510(k) Approved	N/A	Yes	Yes

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.