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510(k) Data Aggregation
(24 days)
HYSTERX, INC.
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(163 days)
HYSTERX, INC.
The LIGA-LOOP Suture Applicator is intended for use in the suturing of soft tissue and ligation of blood vessels during open and guidance-assisted surgical procedures. The LIGA-LOOP Suture Applicator with polyglycolic acid (PGA) suture and the LIGA-LOOP Suture Applicator with gut suture (plain and chromic) are intended for the same use, excluding cardiovascular and neurological procedures.
The LIGA-LOOP™ Suture Applicator is an instrument designed for ligation of soft tissue and blood vessels during surgical procedures. The device also incorporates a central lumen for use in irrigation and/or imaging to increase patient safety during suturing. The LIGA-LOOP™ Suture Applicator contains similar materials, is of similar design, and has the same operating principle as the predicate devices.
The provided document describes the LIGA-LOOP™ Suture Applicator, a surgical instrument designed for ligation of soft tissue and blood vessels. The summary of safety and effectiveness mainly focuses on demonstrating substantial equivalence to predicate devices rather than reporting on specific acceptance criteria and performance data from a standalone study.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria for the LIGA-LOOP™ Suture Applicator or specific performance metrics against those criteria. Instead, it focuses on qualitative comparisons to predicate devices and general statements about "reliable performance."
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly stated in quantitative terms. The primary acceptance criterion was likely demonstrating substantial equivalence to predicate devices in terms of intended use, operating principle, and material characteristics, and ensuring no new safety or performance issues. | "Test results indicate reliable performance when the device is used in accordance with the Instructions for Use. Manipulation of the suture material does not affect suture diameter or knot pull-strength. The LIGA-LOOP™ Suture Applicator does not raise any new safety, effectiveness, or performance issues." (This is a general statement, not quantitative performance against a specific criterion). |
| Knot pull strength of suture material | "Manipulation of the suture material does not affect... knot pull-strength." (Implies meeting an unstated threshold relative to the predicate or industry standards). |
| Suture diameter | "Manipulation of the suture material does not affect suture diameter..." (Implies meeting an unstated threshold relative to the predicate or industry standards). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the tests performed on the LIGA-LOOP™ Suture Applicator.
The data provenance is not mentioned, but given the nature of the device (surgical instrument), the tests would have been conducted in a laboratory or simulated environment, likely in the US, as the applicant is a US company. The tests are non-clinical.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The tests described are "Knot pull strength testing and diameter measurements of suture materials," which are objective physical measurements rather than assessments requiring expert judgment for ground truth establishment.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, the tests involved objective physical measurements, not subjective evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. The device is a surgical instrument, not an AI or imaging diagnostic tool that would typically involve such a study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done:
Not applicable. The device is a physical surgical instrument, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth for the tests (knot pull strength and suture diameter) would be the objective measurements obtained from standardized testing methods.
8. The Sample Size for the Training Set:
Not applicable. The LIGA-LOOP™ Suture Applicator is a physical medical device, not an AI/machine learning model, so there is no training set in this context.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, for the same reason as point 8.
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(54 days)
HYSTERX, INC.
The MicroGRASP Monopolar Coagulator is indicated for use in the grasping and coagulation of soft tissue and blood vessels up to 3 mm during open and guidance-assisted surgical procedures.
The MicroGRASP Monopolar Coagulator is an instrument designed for grasping and coagulation of soft tissue and blood vessels during surgical procedures. The MicroGRASP Monopolar Coagulator contains materials similar to those used in the predicate device, is of similar design and has the same operating principle as the predicate device.
The provided document describes a premarket notification for the "MicroGRASP Monopolar Coagulator," a device designed for grasping and coagulation of soft tissue and blood vessels during surgical procedures. The document aims to demonstrate substantial equivalence to a predicate device, the "Microsurge Front-End Grasping Devices."
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative sense with corresponding performance metrics for the new device. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The primary "acceptance criteria" appear to be meeting applicable standards and not raising new safety/effectiveness issues compared to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with applicable standards (e.g., for electrical safety, performance) | "The MicroGRASP Monopolar Coagulator has been designed and tested to applicable standards (ANSI/AAMI HF-18/1993)." |
| No new issues of safety, effectiveness, or performance compared to predicate. | "The MicroGRASP Monopolar Coagulator does not raise any new issues of safety, effectiveness, or performance of the product." |
| Similar intended use to predicate. | Intended Use for MicroGRASP is "For grasping and coagulation of soft tissue and blood vessels up to 3 mm during open and guidance-assisted surgical procedures," which is analogous to the predicate's "To remove tissue or control bleeding during general surgical endoscopic or laparoscopic procedures." |
| Similar operating principle to predicate (Monopolar Electrosurgical handpiece). | MicroGRASP: "Electrosurgical handpiece for coagulation." Predicate: "Electrosurgical handpiece for coagulation; electro-cautery." Both are Monopolar. |
| Similar materials and design to predicate. | "The MicroGRASP Monopolar Coagulator contains materials similar to those used in the predicate device, is of similar design and has the same operating principle as the predicate device." Specific material comparisons are provided in the table. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention a "test set" in the context of clinical or performance data from a sample of cases or patients. The evaluation appears to be based on bench testing and comparison of technical characteristics. Therefore, information on sample size for a test set, country of origin, or retrospective/prospective nature is not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided as the submission relies on bench testing and comparison to standards, not human expert evaluation of a test set in the traditional medical device study sense.
4. Adjudication Method for the Test Set
This information is not provided as there is no described test set that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a mon-AI surgical instrument (Monopolar Coagulator), not an AI diagnostic or assistance tool. Therefore, an MRMC study related to AI assistance for human readers was not performed or mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical surgical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's acceptable performance appears to be:
- Compliance with published standards: Specifically, ANSI/AAMI HF-18/1993 for electrosurgical devices.
- Demonstration of substantial equivalence to a legally marketed predicate device (Microsurge Front-End Grasping Devices) in terms of intended use, operating principle, and technical characteristics.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical surgical instrument, and there is no mention of a "training set" in the context of machine learning or AI development.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above.
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