(32 days)
Not Found
Not Found
No
The device description and performance studies focus solely on the physical properties and mechanical performance of a surgical suture, with no mention of AI or ML.
Yes
The device is a surgical suture used for approximation and ligation of soft tissue (rotator cuff repair), which directly treats a medical condition.
No
The device is a surgical suture used for tissue approximation and ligation, not for diagnosing medical conditions.
No
The device description clearly describes a physical surgical suture made of polyester, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "soft-tissue approximation and/or ligation in rotator cuff repair procedures." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a surgical suture, a physical object used to hold tissue together during surgery. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on laboratory testing.
The device is clearly a surgical implant/device used directly in a surgical procedure.
N/A
Intended Use / Indications for Use
The EXPANDED BODY suture is indicated for use in soft-tissue approximation and/or ligation in rotator cuff repair procedures.
Product codes (comma separated list FDA assigned to the subject device)
79 GAT
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:
-
- a new labeled indication for use stating specific use in rotator cuff soft tissue repair procedures, and
-
- 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rotator cuff
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)
Comparative testing was performed using Last-a-Foam Polyurethane Foam as a simulated bone material. 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
§ 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.
0
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--- 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: (801) 753-7675 (801) 753-7698 Fax:
MANUFACTURER CONTACT PERSON
Alan Chervitz, President MedicineLodge, Inc. 152 South 600 West Logan, Utah 84321 Telephone: (801) 753-7675 Fax: (801) 753-7698
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
(916) 646-5441 Telephone: Fax: (916) 646-5432
PROPRIETARY DEVICE NAME
EXPANDED BODY Suture
COMMON NAME
Braided Nonabsorbable Polyester Surgical Suture
1
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.
-
- Suture Needle Attachment Testing (USP # 871)
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- 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.
2
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:
-
- a new labeled indication for use stating specific use in rotator cuff soft tissue repair procedures, and
-
- 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.
3
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:
-
- a new labeled indication for use stating specific use in rotator cuff soft tissue repair procedures, and
-
- 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.
4
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