(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 <USP 788>:2012 | The device meets the requirements for particulate matter per <USP 788>: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 <85> and <161>. | The device is determined to be non-pyrogenic per the requirements of USP <85> and USP <161>. |
| 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 <788>, USP <85>, USP <161>, 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 25, 2017
Prescient Surgical, Inc. Lisa Claude Sr. Director of Clinical and Regulatory Affairs 1585 Industrial Rd. San Carlos, California 94070
Re: K172132
Trade/Device Name: CleanCision Wound Retraction and Protection System Regulation Number: 21 CFR 878.4371 Regulation Name: Irrigating Wound Retractor Device Regulatory Class: Class II Product Code: PQI Dated: September 20, 2017 Received: September 22, 2017
Dear Lisa Claude:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -S
for Tina Kiang, PhD Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172132
Device Name
CleanCision™ Wound Retraction and Protection System
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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CONFIDENTIAL
Prescient Surgical Traditional 510(k)
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510(K) SUMMARY - K172132
GENERAL INFORMATION
| Submitted By: | Prescient Surgical1585 Industrial RoadSan Carlos, CA 94070Tel: 650-489-5025 |
|---|---|
| Contact Person: | Lisa Claudelclaude@prescientsurgical.com |
| Date Prepared: | October 25, 2017 |
| Device Trade Name: | CleanCision™ Wound Retraction and Protection System |
| Common Name: | Irrigating Wound Retractor Device |
| Classification: | Class II |
| Regulation Number: | 21 CFR 878.4371 |
| Regulation Title: | Irrigating Wound Retractor Device |
| Product Code: | PQI |
| Classification Panel: | General and Plastic Surgery |
| Predicate Device: | DEN150038 - CleanCision™ Wound Retraction and ProtectionSystem |
DEVICE DESCRIPTION
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.
INTENDED USE
The CleanCision™ Wound Retraction and Protection 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
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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 subject device has identical intended use and indications for use as the predicate device.
SUMMARY COMPARING THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject device has the same principle of operation as the predicate device. An additional device size was developed to accommodate smaller incision lengths. There were also some minor design modifications made to the subject device. This submission includes the following changes in technological characteristics.
- Dimensional changes to accommodate new incision range (new device size) ●
- . Updated upper retraction ring to improve user experience
- Adjusted the fluid delivery pathway
- Adjusted the fluid removal pathway
- Updated materials
- . Updated packaging configuration
| Comparison of CleanCision System to Predicate Device | ||
|---|---|---|
| Predicate Device (DEN150038) | This Submission (K172132) | |
| Manufacturer | Prescient Surgical | Same |
| Device TradeName | CleanCision Wound Retraction andProtection System | Same |
| Incision Range | 7-16 cm | 3-9 cm |
| Common orUsual Name | Irrigating Wound Retractor Device | Same |
| Classification | Class II | Same |
| Indications forUse | The CleanCision™ Wound Retraction andProtection System is intended for use by asurgeon during abdominal surgery to:retract the surgical incision, provide accessto the abdominal cavity, and irrigate thesurgical wound edge. The device may aid inthe prevention of wound edgecontamination. This device is intended todeliver a sterile irrigant solution and serveas a conduit for fluid removal from thesurgical wound edge. | Same |
| TechnologicalCharacteristics | ||
| Comparison of CleanCision System to Predicate Device | ||
| Predicate Device (DEN150038) | This Submission (K172132) | |
| Principle ofOperation | A wound retractor device that integratessurgical retraction, wound barrierprotection, and fluid delivery and removal. | Same |
| Design Features | ||
| DeviceDimensions | Upper Ring Diameter (fully expanded): 23cmSheath Length: 13cmBottom Ring Diameter: 16cm | Upper Ring Diameter (fully expanded): 21cmSheath Length: 10cmBottom Ring Diameter: 9cm |
| Retraction | Sheath connected to bottom ring andexpanding top ring | Same |
| BarrierProtection | Flexible, double-walled sheath with animpermeable inner layer | Same |
| Fluid Irrigation | Fluid delivered via gravitational field froman external sterile irrigation solution baginto the devices and delivered to the woundedges through the permeable outer layer ofthe sheath | Fluid delivered via gravitational field froman external sterile irrigation solution baginto the devices and delivered to the woundedges through the permeable outer layer ofthe sheath via a modified fluid deliverypathway. |
| Fluid Removal | Excess fluid removed through a separatechamber within the sheath via aconnection with the hospital's standardvacuum suction mechanism. | Excess fluid is removed through a separatechamber within the bottom ring via aconnection with the hospital's standardvacuum suction mechanism. |
| Key ComponentMaterials | ||
| Semi-RigidPolymer TopRing | Polycarbonate | Polycarbonate and ABS |
| Semi-RigidPolymer BottomRing | Urethane | Same |
| Flexible PolymerSheath | Polyurethane | Same |
| Sterilization | ||
| Single Use | Yes | Same |
| Provided Sterile | Yes | Same |
| SterilizationMethod | Ethylene Oxide | Same |
| SterilizationAssurance Level | 10-6 | Same |
| EO Residuals | Meets requirements of ISO 10993-7 | Same |
| Biocompatibility | Meets requirements of ISO 10993-1 andUse of International Standard ISO 10993- | Meets requirements of ISO 10993-1 andUse of International Standard ISO 10993- |
| Comparison of CleanCision System to Predicate Device | ||
| Predicate Device (DEN150038) | This Submission (K172132) | |
| 1, Guidance for Industry and Food andDrug Administration Staff including: | 1, Guidance for Industry and Food andDrug Administration Staff 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) Limulus Abebocyte Lysate (LAL) Bacterial Endotoxin Test (USP 85) Hemocompatibility – Hemolysis (ISO 10993-4 and ASTM F756) Particulate Testing (USP 788) | 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) Limulus Abebocyte Lysate (LAL) Bacterial Endotoxin Test (USP 85) Hemocompatibility – Hemolysis, Indirect Method (ISO 10993-4 and ASTM F756) Particulate Testing (USP 788) | |
| Packaging | Tyvek/ Polyethylene-Nylon Pouch | Tyvek / PET-G Tray |
| OtherTechnologicalFeatures | ||
| Sheath MaterialProperties(Tensile Strength,Elongation, TearStrength) | Tested in accordance with ASTM D1004and ASTM D882 | Same |
| Barrier MaterialResistant toPenetration byBlood | Tested in accordance with ASTM 1670 | Same |
| Flammability | Normal Flammability | Same |
| Surgical DrapeProperties | Meets requirements of Barrier PerformanceClass Level 4 | Same |
| Energy Source | No energy source used | Same |
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NON-CLINICAL PERFORMANCE DATA
Performance testing was repeated to ensure that the new design met the same essential performance specifications and conforms to all the requirements listed in the special controls for Irrigating Wound Retractor Devices (21 CFR 878.4371). The following performance testing
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confirmed the CleanCision Wound Retraction and Protection System in this submission to be substantially equivalent to the predicate device.
- The device was tested in accordance with ISO 10993-1:2009 and "Use of International . Standard ISO 10993-1, Biological Evaluation of medical devices – Part 1: Evaluation of testing within a risk management process – Guidance for Industry and Food and Drug Administration Staff" and meets the requirements for externally communicating, tissue contacting, limited exposure devices including:
- Chemical Characterization (ISO 10993-18) O
- Cytotoxicity (ISO 10993-5) O
- Irritation (ISO 10993-10) O
- Sensitization (ISO 10993-10) O
- Acute Systemic Toxicity (ISO 10993-11) O
- Material-Mediated Pyrogenicity (ISO 10993-11) O
- Hemocompatibility Hemolysis, Indirect Method (ISO 10993-4 and ASTM o F756)
- The device has been evaluated for particulate matter per <USP 788>:2012 and meets the requirements.
- The CleanCision System is sterilized using Ethylene Oxide and provides a sterility assurance level of 10-6.
- The device has been evaluated per USP <85> and determined to be non-pyrogenic per the ● requirements of USP <161>.
- The materials used in the manufacture of the CleanCision System have been tested in ● accordance with ASTM D1004-13 and ASTM D882-12 and meet tensile strength, elongation, and tear resistance requirements.
- . Liquid barrier material is resistant to penetration by blood per ASTM F1670-08.
- The device meets the requirements for normal flammability per NFPA 702-1980. ●
- Physical, functional and performance design verification was conducted and 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.
CONCLUSION
The CleanCision Wound Retraction and Protection System has the same principle of operation and intended use as the predicate device (DEN150038). Performance testing demonstrated that the subject device performs as intended and conforms to all the requirements listed in the special controls. In conclusion, the CleanCision Wound Retraction and Protection System is substantially equivalent in design, clinical use, principle of operation, materials and physical / functional characteristics to the legally marketed predicate device.
§ 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.