(103 days)
Not Found
No
The description focuses on mechanical and fluid delivery mechanisms. There is no mention of AI, ML, image processing, or data analysis for decision-making.
No
The device is described as a wound retraction and protection system, intended to provide access, retract the incision, and irrigate the wound edge. While it may aid in preventing contamination, its primary functions are mechanical (retraction, access) and hygiene-related (irrigation, fluid removal), not directly therapeutic in terms of treating a disease or condition.
No
The device is described as a surgical tool designed to retract incisions, provide access to the abdominal cavity, and irrigate surgical wounds. Its function is to aid in surgical procedures and wound management, not to diagnose medical conditions or diseases.
No
The device description clearly details a physical, sterile, single-use irrigating wound retractor device with mechanical components (sheath, rings, connections for fluid and vacuum). It undergoes performance testing related to material properties, sterilization, and physical function, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during surgery to retract, provide access, and irrigate the surgical wound edge. This is a direct surgical intervention, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details a physical system for surgical retraction, wound barrier protection, and fluid management within the surgical site. It does not involve analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, tissue, or other biological fluids for diagnostic purposes. The fluid delivery and removal are for irrigation and wound management during the procedure.
- Performance Studies: The performance studies focus on the physical and biological compatibility of the device materials and its functional performance during surgery (e.g., forces required to deploy, fluid rates). They do not involve diagnostic accuracy metrics like sensitivity, specificity, or AUC, which are typical for IVDs.
Therefore, the CleanCision™ Wound Retraction System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
PQI
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 fixed-diameter ring at the bottom, designed to be inserted into the abdominal cavity, and a radially-adjustable 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon during abdominal surgery / hospital
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)
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 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 :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 and determined to be non-pyrogenic per the ● requirements of USP .
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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)
3
510(K) SUMMARY - K172132
GENERAL INFORMATION
| Submitted By: | Prescient Surgical
1585 Industrial Road
San Carlos, CA 94070
Tel: 650-489-5025 |
|-----------------------|-----------------------------------------------------------------------------------------|
| Contact Person: | Lisa Claude
lclaude@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 Protection
System |
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
4
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 Trade | ||
Name | CleanCision Wound Retraction and | |
Protection System | Same | |
Incision Range | 7-16 cm | 3-9 cm |
Common or | ||
Usual Name | Irrigating Wound Retractor Device | Same |
Classification | Class II | Same |
Indications for | ||
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 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. | Same | |
Technological | ||
Characteristics | ||
Comparison of CleanCision System to Predicate Device | ||
Predicate Device (DEN150038) | This Submission (K172132) | |
Principle of | ||
Operation | A wound retractor device that integrates | |
surgical retraction, wound barrier | ||
protection, and fluid delivery and removal. | Same | |
Design Features | ||
Device | ||
Dimensions | Upper Ring Diameter (fully expanded): 23cm | |
Sheath Length: 13cm | ||
Bottom Ring Diameter: 16cm | Upper Ring Diameter (fully expanded): 21cm | |
Sheath Length: 10cm | ||
Bottom Ring Diameter: 9cm | ||
Retraction | Sheath connected to bottom ring and | |
expanding top ring | Same | |
Barrier | ||
Protection | Flexible, double-walled sheath with an | |
impermeable inner layer | Same | |
Fluid Irrigation | Fluid delivered via gravitational field from | |
an external sterile irrigation solution bag | ||
into the devices and delivered to the wound | ||
edges through the permeable outer layer of | ||
the sheath | Fluid delivered via gravitational field from | |
an external sterile irrigation solution bag | ||
into the devices and delivered to the wound | ||
edges through the permeable outer layer of | ||
the sheath via a modified fluid delivery | ||
pathway. | ||
Fluid Removal | Excess fluid removed through a separate | |
chamber within the sheath via a | ||
connection with the hospital's standard | ||
vacuum suction mechanism. | Excess fluid is removed through a separate | |
chamber within the bottom ring via a | ||
connection with the hospital's standard | ||
vacuum suction mechanism. | ||
Key Component | ||
Materials | ||
Semi-Rigid | ||
Polymer Top | ||
Ring | Polycarbonate | Polycarbonate and ABS |
Semi-Rigid | ||
Polymer Bottom | ||
Ring | Urethane | Same |
Flexible Polymer | ||
Sheath | Polyurethane | Same |
Sterilization | ||
Single Use | Yes | Same |
Provided Sterile | Yes | Same |
Sterilization | ||
Method | Ethylene Oxide | Same |
Sterilization | ||
Assurance Level | 10-6 | Same |
EO Residuals | Meets requirements of ISO 10993-7 | Same |
Biocompatibility | Meets requirements of ISO 10993-1 and | |
Use of International Standard ISO 10993- | Meets requirements of ISO 10993-1 and | |
Use of International Standard ISO 10993- | ||
Comparison of CleanCision System to Predicate Device | ||
Predicate Device (DEN150038) | This Submission (K172132) | |
1, Guidance for Industry and Food and | ||
Drug Administration Staff including: | 1, Guidance for Industry and Food and | |
Drug 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 |
Other | ||
Technological | ||
Features | ||
Sheath Material | ||
Properties | ||
(Tensile Strength, | ||
Elongation, Tear | ||
Strength) | Tested in accordance with ASTM D1004 | |
and ASTM D882 | Same | |
Barrier Material | ||
Resistant to | ||
Penetration by | ||
Blood | Tested in accordance with ASTM 1670 | Same |
Flammability | Normal Flammability | Same |
Surgical Drape | ||
Properties | Meets requirements of Barrier Performance | |
Class Level 4 | Same | |
Energy Source | No energy source used | Same |
5
6
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
7
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 :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 and determined to be non-pyrogenic per the ● requirements of USP .
- 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.