The Percutaneous Surgical Set with 5 mm or 10 mm Attachments is indicated for the means to penetrate soft tissue to access certain areas of the human abdomen and used to grasp, hold and manipulate tissue.

Device Description

The Percutaneous Surgical Set with 5mm or 10mm Attachments is a family of minimally invasive devices that can penetrate soft tissue, be assembled in situ, and allow access to certain areas of the abdomen. The Set is designed for assembly within the abdomen to grasp, hold or manipulate soft tissue. There attachments (or end effectors): a 5 mm grasper, 5 mm Maryland dissector and a 10 mm Babcock grasper. The attachments can be mounted individually to the 3 mm percutaneous metal shaft. The device is for single use only and is disposable.

AI/ML Overview

The provided text describes a medical device, the "Percutaneous Surgical Set with 5 mm or 10 mm Attachments," and the studies conducted to support its de novo classification. This device is not an AI/ML powered device, therefore many of the requested fields are not applicable.

Here's an analysis based on the information provided:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance/Study Findings
Biocompatibility	Patient-contacting components must be demonstrated to be biocompatible (ISO 10993-1).	"All patient-contacting devices were shown to be biocompatible per ISO 10993-1:2003 with respect to their intended uses." Testing included cytotoxicity (ISO 10993-5), irritation and sensitization (ISO 10993-10), and systemic toxicity (ISO 10993-11).
Sterility	Performance data must demonstrate the sterility of patient-contacting components.	"The Percutaneous Surgical Set is sterilized by cobalt irradiation. The sterilization process validation and routine monitoring comply with ISO 11137:2006 and ISO 11137:2007, using the method VDmax25."
Shelf Life	Performance data must support the shelf life by demonstrating continued sterility, package integrity, and device functionality over the requested shelf life.	"The shelf life of one year has been established through testing of devices and packaging exposed to a combination of accelerated and real-time aging in accordance with ASTM F 1980-07: Standard Guide for Accelerated Aging of Sterile Medical Device Packages. All test devices and packages underwent environmental testing in a climate controlled area for the full shelf-life duration."
Non-clinical Performance	The device performs as intended under anticipated conditions of use.	Comprehensive bench testing was successfully completed. "All devices were shown to meet pre-determined acceptance criteria." Tests were conducted using six devices. Includes: - Functional Verification: Device could be assembled/disassembled in the abdomen and could grasp, hold, and manipulate soft tissue. - Dimensional Verification: Dimensions were adequate for use in the abdomen (e.g., working length, overall length, trocar fit). - Force Verification: Measured pressure applied to grips during use.
Simulated Use Testing	In an anatomically relevant animal model, demonstrate the device's ability to penetrate soft tissue, be assembled in situ, and to grasp, hold and manipulate soft tissues in the intended treatment area.	Conducted in a porcine model (1 pig, 3 Percutaneous Surgical Sets). 25 surgeons performed the test procedure in the insufflated porcine abdomen, resulting in 75 attempts. Comparison testing with alternative surgical instruments (control group of three devices not requiring in-situ assembly) was also performed. Results: "2 attempts resulting in an unsuccessful attachment (the unsuccessful attachment occurred during the users' first attempt with the device)." "Total assembly/disassembly times averaged slightly over 80 seconds for the first test procedure, decreasing to 60 seconds by the third test procedure." No inadvertent device disassembly was observed.
Labeling	Instructions for use (assembly, disassembly, removal) and shelf life must be included. Must comply with 21 CFR 807.87(e) and 21 CFR § 801.109.	"The Percutaneous Surgical Set complies with the labeling requirements under 21 CFR 807.87(e) and prescription device requirements under 21 CFR § 801.109." Labeling includes: "Caution: Federal law restricts this device to sale by or on the order of a physician." "The labeling includes a shelf life and instructions for instrument assembly, disassembly, and removal."

Study Details (As applicable to a non-AI/ML device)

Sample size used for the test set and the data provenance:
- Biocompatibility: Not explicitly stated as a test set in the sense of patient data. Testing was performed on "finished, sterilized devices." This implies multiple samples of the physical device.
- Shelf Life: "All test devices and packages underwent environmental testing" - implies multiple samples of the device and its packaging.
- Performance Testing - Bench: "six devices" were used for functional, dimensional, and force verification.
- Simulated Use Testing: "1 pig was used" with "3 Percutaneous Surgical Sets." Comparision testing: "three devices not requiring in situ assembly already cleared for a similar indication were used as the control."
- Data Provenance: Not applicable in the context of data used for algorithm training/testing. The studies are laboratory and animal-based. No patient data is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to the non-AI/ML device described. The "truth" for this device is based on physical performance, material properties, and functionality, not expert interpretation of data.
- For the simulated use testing, "25 surgeons" performed the procedures, but their role was as users/operators of the device, not "experts establishing ground truth" for an algorithmic outcome. Their feedback on performance and time to completion served as qualitative and quantitative performance metrics.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not an AI/ML diagnostic device requiring adjudication of interpretations. The tests described are engineering and simulated-use performance evaluations.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI/ML device, and no MRMC study, particularly one involving human readers with or without AI assistance, was conducted or described.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This device is a manual surgical instrument, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Biocompatibility: Laboratory test standards (ISO 10993 series).
- Sterility: Laboratory test standards (ISO 11137 series).
- Shelf Life: Laboratory test standards (ASTM F 1980-07).
- Performance Testing - Bench: Pre-determined engineering acceptance criteria based on functional, dimensional, and force requirements. The "ground truth" is adherence to these specifications.
- Simulated Use Testing: Direct observation of physical performance and functionality in an animal model (e.g., successful assembly/disassembly, grasping, holding, manipulation, comparison to control devices, time metrics, absence of inadvertent disassembly). The "ground truth" is the observed physical outcome in the simulated environment.
The sample size for the training set:
- Not applicable. This is not an AI/ML device requiring a training set.
How the ground truth for the training set was established:
- Not applicable as there is no training set for an AI/ML algorithm.

Summary

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DE NOVO CLASSIFICATION REQUEST FOR PERCUTANEOUS SURGICAL SET WITH 5 MM OR 10 MM ATTACHMENTS

REGULATORY INFORMATION

FDA identifies this generic type of device as:

Manual percutaneous surgical set assembled in the abdomen. A manual percutaneous surgical set assembled in the abdomen is a prescription device consisting of a percutaneous surgical set and accessories used as a means to penetrate soft tissue to access certain areas of the abdomen. The device's effectors or attachments are provided separately from the percutaneous shaft and are introduced to the site via a traditional conduit such as a trocar. The attachment or effectors are connected to the shaft once the tip of the shaft is inside the abdomen. Once inside the abdomen, the surgical set is used to grasp, hold, and manipulate soft tissues. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

NEW REGULATION NUMBER: 21 CFR 878.4805

CLASSIFICATION: II

PRODUCT CODE: OXT

BACKGROUND

DEVICE NAME: Percutaneous Surgical Set with 5 mm or 10 mm Attachments

SUBMISSION NUMBER: DEN110016 (K110431)

DATE OF DE NOVO: September 20, 2011

CONTACT: Ethicon Endo-Surgery, Incorporated 4545 Creek Road M/L 131 Cincinnati, Ohio 20993

INDICATIONS FOR USE

LIMITATIONS

Do not use excessive force.

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Once partial entry has been accomplished, very little pressure may be required to complete entry. Excessive pressure could cause injury to intra-abdominal or intrathoracic structures.

To prevent damage to trocar seals, do not insert the exposed obturator through the seals of the trocar.

Do not attempt to bend the percutaneous shaft. Forcefully bending the shaft could lead to device damage and the inability to disconnect the attachment from the shaft.

Do not attempt to remove the percutaneous shaft from the body with attachment still connected. This could lead to enlargement of initial percutaneous defect.

After removing the percutaneous shaft from the cavity, always inspect the site for hemostasis. If hemostasis is not present, appropriate techniques should be used to achieve hemostasis.

Do not introduce or withdraw the loader in the articulated position through a trocar.

Do not use the device to crush or crimp other surgical instruments or foreign bodies.

Minimally invasive procedures should be performed only by persons having adequate training and familiarity with minimally invasive techniques. Consult medical literature relative to techniques, complications, and hazards prior to performance of any minimally invasive procedure.

Minimally invasive instruments may vary in diameter from manufacturer to manufacturer. When minimally invasive instruments and accessories from different manufacturers are employed together in a procedure, verify compatibility prior to initiation of the procedure.

Please refer to the labeling for a more complete list of warnings, precautions and contraindications.

DEVICE DESCRIPTION

The device is for single use only and is disposable.

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SUMMARY OF NONCLINICAL/BENCH STUDIES

BIOCOMPATIBILITY/MATERIALS

All components of the Percutaneous Surgical Set are made of surgical grade stainless steel, with exception of the loader end, which is comprised of a polycarbonate. These are commonly used materials for surgical instruments.

The patient-contacting components of the Percutaneous Surgical Set were evaluated with respect to their intended use per ISO 10993-1:2003. Testing was performed on finished, sterilized devices. The Percutaneous Surgical Set was evaluated for cytotoxicity (ISO 10993-5), irritation and sensitization (ISO 10993-10), and systemic toxicity (ISO 10993-11). All patient-contacting devices were shown to be biocompatible per ISO 10993-1:2003 with respect to their intended uses.

SHELF LIFE/STERILITY

The Percutaneous Surgical Set is packaged as one unit. Each surgical set is placed in a polyethylene terephthalate glycol-modified (PETG) tray with lid, then heat sealed with a Tyvek® lid to form the sterile barrier. Each sealed tray is placed inside a carton. Each carton contains only one tray. The single pouch is placed in an outer carton along with the instructions for use (IFU). The Percutaneous Surgical Set attachment with attachment cartridge is placed in a plastic insert, packaged in a Tyvek® pouch and heat sealed to form the sterile barrier.

The Percutaneous Surgical Set is sterilized by cobalt irradiation. The sterilization process validation and routine monitoring comply with ISO 11137:2006 and ISO 11137:2007, using the method VDmax25.

The shelf life of one year has been established through testing of devices and packaging exposed to a combination of accelerated and real-time aging in accordance with ASTM F 1980-07: Standard Guide for Accelerated Aging of Sterile Medical Device Packages. All test devices and packages underwent environmental testing in a climate controlled area for the full shelf-life duration.

PERFORMANCE TESTING - BENCH

Comprehensive bench testing has been successfully completed on the Percutaneous Surgical Set. Testing included functional, dimensional and force verification, as summarized below. Testing was performed on finished, sterile devices. All devices were shown to meet pre-determined acceptance criteria. These tests were conducted using six devices to show that the mechanical design is able to be used in the abdomen.

A summary of each test is provided below:

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. Functional Verification – Test developed to determine whether the device could be assembled or disassembled in the abdomen. Additionally, this test was used to demonstrate that the device could grasp, hold and manipulate soft tissue.
. Dimensional Verification - Test developed to determine whether the dimensions of the device are adequate for use in the abdomen, including items such as working length, overall length, and ability to fit through a trocar.
. Force Verification - Test developed to measure the pressure applied to the grips each time the device is in use.

SIMULATED USE TESTING

To demonstrate the device's ability to penetrate soft tissue, to be assembled in situ, and to grasp, hold, and manipulate soft tissues, the sponsor conducted testing in a porcine model (1 pig was used), with 3 Percutaneous Surgical Sets. Comparison testing with alternative surgical instruments that are not designed for assembly/disassembly in situ was also conducted to ensure that the Percutaneous Surgical Set could penetrate, grasp, hold and manipulate soft tissue without inadvertent device disassembly. Multiple insertion sites were conducted on the animal. Also, testing on three devices not requiring in situ assembly already cleared for a similar indication were used as the control.

The sponsor provided descriptions about how the device functions as well as videos, including 25 surgeons performing the test procedure in the insufflated porcine abdomen. There were a total of 75 attempts with 2 attempts resulting in an unsuccessful attachment (the unsuccessful attachment occurred during the users' first attempt with the device). Total assembly/disassembly times averaged slightly over 80 seconds for the first test procedure, decreasing to 60 seconds by the third test procedure.

Based on the findings of the simulated use testing, no clinical testing was determined to be necessary.

LABELING

The Percutaneous Surgical Set complies with the labeling requirements under 21 CFR 807.87(e) and prescription device requirements under 21 CFR § 801.109. The device labeling bears the following: "Caution: Federal law restricts this device to sale by or on the order of a physician."

The labeling includes a shelf life and instructions for instrument assembly, disassembly, and removal.

RISKS TO HEALTH

Table 1 below identifies the risks that may be associated with the use of a manual percutaneous surgical set assembled in the abdomen and the measures recommended to mitigate these risks.

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Identified Risk	Mitigation Measures
Adverse tissue reaction	Biocompatibility evaluation
Device failure	Non-clinical performance testing,Sterilization validation, andShelf life testing
User error	Non-clinical performance testing,Simulated use testing, andLabeling
Abdominal cavity damage	Non-clinical performance testing,Simulated use testing, andLabeling
Infection	Sterilization validation, andShelf life testing

Table 1 - Identified Risks to Health and Mitigation Measures

SPECIAL CONTROLS

In combination with the general controls of the Food, Drug & Cosmetic Act, the manual percutaneous surgical set assembled in the abdomen is subject to the following special controls:

1. The patient-contacting components of the device must be demonstrated to be biocompatible.
1. Performance data must demonstrate the sterility of patient-contacting components of the device.
1. Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the requested shelf life.
1. Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
- a. Dimensional verification testing must be conducted.
- b. Force verification testing must be conducted. The force testing must demonstrate the forces necessary to insert and operate each component of the device during use as intended.
- c. Functional verification testing of the device components must be conducted.
1. Simulated use testing in an anatomically relevant animal model must demonstrate the device's ability to penetrate soft tissue, be assembled in situ, and to grasp, hold and manipulate soft tissues in the intended treatment area.
1. The labeling must include the following:
- Instructions for use, including detailed instructions for instrument assembly, a. disassembly, and removal.
- b. A shelf life.

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CONCLUSION

The De Novo request for the Percutaneous Surgical Set with 5 mm or 10mm Attachments is granted and the device is classified under the following:

Product Code: OXT Device Type: Manual percutaneous surgical set assembled in the abdomen Class: II Regulation: 21 CFR 878.4805

Regulation Number and Section

§ 878.4805 Manual percutaneous surgical set assembled in the abdomen.

(a)
Identification. A manual percutaneous surgical set assembled in the abdomen is a prescription device consisting of a percutaneous surgical set used as a means to penetrate soft tissue to access certain areas of the abdomen. The device's effectors or attachments are provided separately from the percutaneous shaft and are introduced to the site via a traditional conduit such as a trocar. The attachment or effectors are connected to the shaft once the tip of the shaft is inside the abdomen. Once inside the abdomen, the surgical set is used to grasp, hold, and manipulate soft tissues. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(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.
(2) Performance data must demonstrate the sterility of patient-contacting components of the device.
(3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the requested shelf life.
(4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Dimensional verification testing must be conducted.
(ii) Force verification testing must be conducted. The force testing must demonstrate the forces necessary to insert and operate each component of the device during use as intended.
(iii) Functional verification testing of the device components must be conducted.
(5) Simulated use testing in an anatomically relevant animal model must demonstrate the device's ability to penetrate soft tissue, be assembled in situ, and to grasp, hold and manipulate soft tissues in the intended treatment area.
(6) The labeling must include the following:
(i) Instructions for use, including detailed instructions for instrument assembly, disassembly, and removal; and
(ii) A shelf life.