(140 days)
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.
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.
The provided text describes a 510(k) premarket notification for a medical device called "HyperSuture Extension Line". This process is for claiming substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria based on a clinical study of its performance in a clinical setting (such as for an AI/ML device where performance metrics like sensitivity/specificity are evaluated).
The documentation does cover acceptance criteria for physical and material characteristics of the suture, and outlines how the device meets these in comparison to a predicate device. So, while it doesn't involve an AI/ML style study, I can extract information related to acceptance criteria for the suture itself and the testing performed.
Here's a breakdown of the requested information based on the provided text, focusing on the available information regarding the device's characteristics and acceptance, rather than an AI/ML performance study:
Acceptance Criteria and Study for the HyperSuture Extension Line (K234079)
This submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device, not necessarily to prove clinical efficacy through a multi-reader, multi-case study, or standalone algorithm performance. The "acceptance criteria" here refer to the physical and material performance specifications of the suture itself, as well as biocompatibility, to ensure it is as safe and effective as the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Met by adherence to recognized standards) | Reported Device Performance (Demonstrated through testing) |
|---|---|---|
| Material Composition | UHMWPE (raw/white) and UHMWPE (Blue Dye: [Phthalocyaninato(2-)] copper for the subject device. Predicate used UHMWPE and/or Nylon). | Subject device uses White/Blue (Total 18 yarns) with sixteen (16) UHMWPE yarns and two (2) 20 denier UHMWPE yarns. Tapes are seventeen (17) UHMWPE yarns. This was compared to predicate's All White configuration (identical yarn counts) |
| Sterility | Sterile | Yes (EO Sterilization) |
| Single Use | Single Use | Yes |
| Coating Material | Uncoated | Uncoated |
| Absorbability | Nonabsorbable | Nonabsorbable |
| Construction | Braided (for cables) | Braided |
| Tape Construction | Suture Tapes are made of three distinct segments: cable section, tape section, followed by another cable section. Cable sections conform to USP diameter requirements. Tape sections have a rectangular cross-section that does not comply with USP diameter requirements. | Suture Tapes are made of three distinct segments: cable section, tape section, followed by another cable section; sections are one-third the length. Cable sections conform to USP diameter requirements, tape sections do not. |
| Sizes | Suture Cable Configuration: USP #2, USP #5. Suture Tape Configuration: Tape 1.5 (Cable sections – USP #2, Tape section width – 1.3mm ~ 1.6mm), Tape 2.5 (Cable sections – USP #5, Tape sections – 1.9mm ~ 2.3 mm) | Demonstrated to be identical to predicate's equivalent sizes, with the exception that this submission will not include the USP 2-0 size. |
| Length of Suture | 40-inch | 40-inch |
| Finish | Heat-stiffened | Heat-stiffened |
| Needle Material | AISI 302 Medical Grade Stainless Steel per ASTM F899 | AISI 302 Medical Grade Stainless Steel per ASTM F899 |
| Needle Type | 1/2 Circle, Trocar Point | 1/2 Circle, Trocar Point |
| Diameter of Suture Cables and Suture Cable Sections | Comply with diameter requirements listed in USP 43 <861> Sutures – Diameter (with the exception of the tape section of the suture tape). | Complied with USP 43 <861> Sutures – Diameter (with stated exception for tape sections). |
| Tensile Strength | Comply with tensile strength requirements listed in USP 43 <881> Tensile Strength. | Complied with USP 43 <881> Tensile Strength. |
| Needle Attachment Strength | Comply with needle attachment strength requirements listed in USP 43 <871> Sutures - Needle Attachment. | Complied with USP 43 <871> Sutures - Needle Attachment. |
| Biocompatibility | Materials evaluated per ISO 10993-1:2009 -Biological Evaluation of Medical Devices. | Demonstrated through testing. Blue dye ([Phthalocyaninato (2-)] copper) evaluated for biocompatibility. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each physical test (e.g., how many sutures were measured for diameter or tensile strength). However, it states that "The HyperSuture Extension Line sutures were tested per USP performance requirements for diameter, length, needle attachment and tensile strength." This implies adherence to the sample size and testing methodology defined by the USP standards for those specific tests.
- Data Provenance: The document does not explicitly state the country of origin of the data. The testing appears to be non-clinical (mechanical and biocompatibility testing) and not based on prospective or retrospective patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of information (number and qualifications of experts for ground truth) is typically relevant for studies validating AI/ML algorithms, especially in diagnostic imaging, where human expert consensus is used to establish "true" disease presence. For this device, the "ground truth" for the physical characteristics and biocompatibility is established by adherence to recognized international and national standards (USP, ISO, ASTM).
The biocompatibility evaluation of the blue dye was conducted "by trained, board certified veterinary pathologists." The number of such pathologists is not specified.
4. Adjudication Method for the Test Set
Not applicable in the context of physical property testing or substantial equivalence claims for a medical device like a suture. Adjudication methods (e.g., 2+1, 3+1) are primarily used in clinical studies where human readers provide interpretations (e.g., radiology reads) and their disagreements need to be resolved to establish ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is relevant for evaluating the performance of AI-assisted systems in diagnostic scenarios (e.g., whether AI improves a radiologist's accuracy). This submission is for a surgical suture, which is a physical medical device, not an AI/ML algorithm.
6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study
No. This concept is applicable to AI/ML algorithms. The HyperSuture Extension Line is a physical surgical suture. The "performance" assessment refers to its physical and material properties, not an algorithmic output.
7. The Type of Ground Truth Used
The "ground truth" for the device's characteristics (diameter, tensile strength, biocompatibility, etc.) is established by:
- Established Standards: Compliance with United States Pharmacopeia (USP) standards (USP 43 <861> for Diameter, <881> for Tensile Strength, <871> for Needle Attachment).
- International Standards: Compliance with ISO 10993-1:2009 for Biological Evaluation of Medical Devices.
- Material Specifications: Adherence to material specifications (e.g., AISI 302 Medical Grade Stainless Steel per ASTM F899 for needles).
- Expert Evaluation: Biocompatibility evaluation of the blue dye was assessed by trained, board-certified veterinary pathologists.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of medical device submission.
§ 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.