(103 days)
The CleanCision™ Wound Retraction System is intended for use by a surgeon during abdominal surgery to: retract the surgical incision, provide access to the abdominal cavity, and irrigate the surgical wound edge. The device may aid in the prevention of wound edge contamination. This device is intended to deliver a sterile irrigant solution and serve as a conduit for fluid removal from the surgical wound edge.
The CleanCision™ Wound Retraction and Protection System is a sterile, single-use irrigating wound retractor device that integrates surgical retraction, wound barrier protection, and fluid delivery and removal. The wound barrier protection component is comprised of a flexible, double-walled sheath with an impermeable inner layer that protects the wound edges from contamination. The wound retraction component is formed by attaching the sheath to a fixeddiameter ring at the bottom, designed to be inserted into the abdominal cavity, and a radiallyadjustable upper retraction ring at the top, designed to remain outside of the body and be actuated to achieve wound retraction. The double-walled sheath also includes integrated fluid delivery. Fluid is delivered via gravitational feed from an external fluid bag into the device and delivered to the wound edges through the permeable outer layer of the sheath. Excess fluid is removed through the bottom ring via a connection with the hospital's standard vacuum suction mechanism.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CleanCision Wound Retraction and Protection System:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA submission for the CleanCision Wound Retraction and Protection System (K172132) primarily focuses on demonstrating substantial equivalence to a predicate device (DEN150038) rather than presenting a performance study against predefined numerical clinical acceptance criteria. The acceptance criteria are implicit in meeting established standards and regulations for medical devices of this type, and the "reported device performance" is that the device meets these standards.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets requirements of ISO 10993-1 and guidance for externally communicating, tissue contacting, limited exposure devices, including: Chemical Characterization (ISO 10993-18), Cytotoxicity (ISO 10993-5), Irritation (ISO 10993-10), Sensitization (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Material-Mediated Pyrogenicity (ISO 10993-11), Hemocompatibility – Hemolysis (ISO 10993-4 and ASTM F756) | The device meets the requirements for externally communicating, tissue contacting, limited exposure devices, including: Chemical Characterization, Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, and Hemocompatibility Hemolysis (Indirect Method). |
| Particulate Matter | Meets requirements of :2012 | The device meets the requirements for particulate matter per :2012. |
| Sterilization | Sterility Assurance Level (SAL) of 10^-6 for Ethylene Oxide sterilization. | The CleanCision System provides a sterility assurance level of 10-6. |
| Non-Pyrogenicity | Meets requirements of USP and . | The device is determined to be non-pyrogenic per the requirements of USP and USP . |
| Material Properties | Meets tensile strength, elongation, and tear resistance requirements in accordance with ASTM D1004-13 and ASTM D882-12 for sheath materials. | The materials used meet tensile strength, elongation, and tear resistance requirements. |
| Liquid Barrier Resistance | Resistant to penetration by blood per ASTM F1670-08. | Liquid barrier material is resistant to penetration by blood per ASTM F1670-08. |
| Flammability | Meets requirements for normal flammability per NFPA 702-1980. | The device meets the requirements for normal flammability. |
| Surgical Drape Properties | Meets requirements of Barrier Performance Class Level 4. | Meets requirements of Barrier Performance Class Level 4. |
| Functional Performance (New Design) | Device can be deployed with required forces; fluid delivery and removal rates are adequate. These functions are maintained post-aging for shelf life. | The CleanCision System passed the required testing including: forces required to deploy the device, fluid delivery, and fluid removal rates. Functional testing was repeated post aging to demonstrate continued functionality and sterility of the device over the identified shelf life. |
| EO Residuals | Meets requirements of ISO 10993-7. | Meets requirements of ISO 10993-7. |
| Compatibility (Predicate Equivalence) | Performs as intended and conforms to all requirements listed in the special controls for Irrigating Wound Retractor Devices (21 CFR 878.4371); substantially equivalent to the predicate device in design, clinical use, principle of operation, materials, and physical/functional characteristics. | Performance testing demonstrated that the subject device performs as intended and conforms to all the requirements listed in the special controls. The device is substantially equivalent in design, clinical use, principle of operation, materials and physical / functional characteristics to the legally marketed predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of clinical trial data or a distinct dataset with specific sample sizes for evaluating diagnostic accuracy or patient outcomes. Instead, it refers to non-clinical performance testing that was "repeated to ensure that the new design met the same essential performance specifications."
- Sample Size: Not specified in terms of patient numbers or clinical cases. The "sample size" would refer to the number of devices or material specimens tested for each non-clinical performance test (e.g., number of devices subjected to deployment force testing, number of material samples for tensile strength). These specific quantities are not provided in the summary.
- Data Provenance: The data comes from non-clinical laboratory and engineering testing, applying recognized international standards (ISO, ASTM, USP) and addressing specific performance aspects relevant to the device's function and safety. It is not patient or human-derived data, so retrospective/prospective distinctions are not applicable, nor is country of origin for clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable to this submission. The "ground truth" for the non-clinical tests described is established by the specifications and pass/fail criteria defined within the referenced international standards (ISO, ASTM, USP). There's no mention of experts establishing ground truth for performance testing results; rather, the tests themselves dictate the "truth" of whether a product characteristic meets the standard.
4. Adjudication Method for the Test Set
This is not applicable to this submission. Adjudication methods like "2+1" or "3+1" are used in clinical studies or expert reviews to resolve discrepancies in diagnoses or assessments. Since the tests are non-clinical and rely on quantitative measurements against defined standards, there is no need for expert adjudication in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The document does not describe an MRMC comparative effectiveness study, nor does it refer to human readers or AI assistance. This submission is for a physical surgical device, not an AI-powered diagnostic tool. Therefore, there is no information on the effect size of human readers improving with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This question is also not applicable as the device is a physical surgical tool and not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Compliance with established international and national standards: ISO 10993, ASTM F1670, ASTM D1004, ASTM D882, USP , USP , USP , NFPA 702.
- Engineering design specifications and functional requirements: Defining adequate forces for deployment, fluid delivery rates, and fluid removal rates.
- Substantial equivalence to a predicate device (DEN150038) for the stated intended use and indications.
Essentially, the ground truth is regulatory compliance and engineering performance specifications, validated through laboratory testing.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" described, as this is a physical medical device and not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this device submission.
§ 878.4371 Irrigating wound retractor device.
(a)
Identification. An irrigating wound retractor device is a prescription device intended to be used by a surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible and evaluated for particulate matter.
(2) Performance data must demonstrate the sterility and pyrogenicity of the patient-contacting components of the device.
(3) Performance data must support shelf life by demonstrating continued functionality and sterility of the device over the identified shelf life.
(4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must:
(i) Characterize the tear resistance, tensile strength, and elongation properties of the barrier material;
(ii) Demonstrate that the liquid barrier material is resistant to penetration by blood, and is non-flammable;
(iii) Characterize the forces required to deploy the device;
(iv) Characterize the device's ranges of operation, including flow rates and maximum suction pressures;
(v) Demonstrate the ability of the device irrigation apparatus to maintain a user defined or preset flow rate to the surgical wound; and
(vi) Demonstrate the ability of the device to maintain user defined or preset removal rates of fluid from the surgical wound.
(5) The labeling must include or state the following information:
(i) Device size or incision length range;
(ii) Method of sterilization;
(iii) Flammability classification;
(iv) Non-pyrogenic;
(v) Shelf life; and
(vi) Maximum flow rate and suction pressure.