The Symmetry Surgical Single Use Cuffed Catheter Removal Device is a catheter accessory device intended for the minimally invasive removal of tunneled long term catheters. The Cuffed Catheter Removal Device is indicated for use with tunneled, double lumen Permcath catheters with sizes ranging from 6.0 French to 16.0 French

Device Description

Symmetry Surgical Single Use Cuffed Catheter Removal devices are sold as sterile, single use devices, unless otherwise noted. The Symmetry Surgical Single Use Cuffed Catheter Removal Device is a tool for minimizing surgical trauma associated with catheter removal. The device jaws are normally in the closed position. The device is equipped with a trigger, a button located on the handle, actuated feature that opens the jaws. Upon release of the trigger, the jaws return to the normally closed position with a spring assist mechanism. The Single Use Cuffed Catheter Removal Device has no locking mechanism. During use the jaws are opened outside the patient and allowed to close around the catheter. The catheter then serves as a guide for moving the closed tip down into the catheter tunnel. When cutting the catheter cuff, the jaws may be activated to allow for tissue dissection and release which will then ease the catheter removal. The opening of the jaws in vivo are limited by the constraint of the surrounding tissue tunnel as well as the design limit of no more than a maximum angle of 57°.

AI/ML Overview

The provided text describes a 510(k) submission for the Symmetry Surgical Single Use Cuffed Catheter Removal Device. This submission primarily focuses on establishing substantial equivalence to a predicate device based on technological characteristics and performance testing. Crucially, clinical data was not required for this device, and therefore, the information typically associated with studies proving device performance against acceptance criteria for AI/ML devices is not present.

The document outlines an animal study and biocompatibility testing as the basis for substantial equivalence, but it does not detail specific acceptance criteria or performance metrics in a way that aligns with the request for AI/ML device evaluations.

Therefore, many of the requested sections regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not applicable or cannot be extracted from this document, as it pertains to a physical medical device that did not require clinical trials for its 510(k) clearance due to its classification and the nature of its equivalence claim.

However, I can extract the available information that relates to performance assessment, even if it doesn't fit the typical "acceptance criteria" and "device performance" format for AI/ML.

1. Table of Acceptance Criteria and Reported Device Performance

As clinical data was not required and this is not an AI/ML device, the concept of "acceptance criteria" and "reported device performance" in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC) is not applicable. Instead, the performance assessment focused on demonstrating safety and functional equivalence through non-clinical testing.

Acceptance Criteria (Proxy)	Reported Device Performance (Proxy)
Biocompatibility with recognized standards (ISO 10993, CFR Title 21 Part 58, etc.)	Device passed biocompatibility testing as per listed standards (implied by "biocompatibility testing includes performance assessment").
Functional equivalence to predicate device	Design does not alter the fundamental technology or intended use of the predicate. Device shown to be substantially equivalent in terms of function, operating principles, surgical application, indications for use, material, classification, device description, performance, and sterility.
Minimizing surgical trauma	Device described as a "tool for minimizing surgical trauma associated with catheter removal."
Jaws operation within design limits	Jaws open and close as designed, constrained by tissue tunnel, with a maximum angle of 57° (design limit, implied acceptance criteria).
Compatibility with specified catheter sizes	Indicated for use with tunneled, double lumen Permcath catheters with sizes ranging from 6.0 French to 16.0 French (design specification, implied acceptance criteria).

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: Not specified for any specific performance test in the document. The document mentions "animal study and biocompatibility testing," but doesn't provide the number of animals or samples used.
Data Provenance: The studies were non-clinical (animal study and biocompatibility testing). No country of origin for data is stated, but the submission is to the US FDA. The studies were likely prospective experimental tests, not retrospective analyses.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. Ground truth as typically understood for AI/ML models (e.g., expert consensus on image interpretation, pathology reports) was not established for this device. Performance was assessed through engineering and biocompatibility testing, not human expert evaluations of diagnostic output.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication process is described as clinical data or human interpretive tasks were not required.

5. 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

Not applicable. This is a physical surgical instrument, not an AI/ML diagnostic aid. No MRMC study was conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. This is a physical surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device would be based on physical and biological standards and measurements as opposed to clinical outcomes or expert labels. This includes:

Physical measurements against design specifications (e.g., jaw opening angle, compatibility with catheter sizes).
Biocompatibility test results against established safety thresholds (e.g., cytotoxicity, sensitization, irritation as per ISO 10993).
Animal physiological responses during the animal study, likely assessing tissue response, ease of removal, or absence of adverse events, compared to a control or predicate device (though specific outcomes are not detailed).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no concept of a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set.

Summary

{0}------------------------------------------------

SEP 2 8 2012

K122263

5.0 510(k) Summary
1. Sponsor Symmetry Surgical 3034 Owen Drive Antioch, TN 37013

Primary Contact:	Hannah Foley
Telephone:	1- 615-964-5509

Date Prepared: July 24, 2012

1. Device Name and Classification: Proprietary Name: Symmetry Surgical Single Use Cuffed Catheter Removal Device Common/Usual Name: Percutaneous, Implanted Long-Term Intravascular Catheter Percutaneous, Implanted Long-Term Classification Name: Intravascular Catheter (880.5970), Class II Product Code: ODY
  (NOTE: The Symmetry Surgical Single Use Cuffed Catheter Removal Device is an Instrument and Not an Implant of any kind)

3. Predicate Devices

This 510(k) submission provides pre-market notification of the Single Use Cuffed Catheter Removal Device. The cuffed catheter removal device's design does not alter the fundamental technology of the predicate device or the devices' intended use.

K063048 - Trans Catheter Extractor

4. Device Description

{1}------------------------------------------------

closed tip down into the catheter tunnel. When cutting the catheter cuff, the jaws may be activated to allow for tissue dissection and release which will then ease the catheter removal. The opening of the jaws in vivo are limited by the constraint of the surrounding tissue tunnel as well as the design limit of no more than a maximum angle of 57°.

5. Intended Use

6. Technological Characteristics

The Symmetry Surgical Single Use Cuffed Catheter Removal Device was shown to be substantially equivalent to predicate devices through comparison of indications for use, function, operating principles, clinical literature study, animal testing and materials.

7. Basis for Substantial Equivalence

The Symmetry Surgical Single Use Cuffed Catheter Removal Device was evaluated and has been found to be substantial equivalent to the predicate device in terms of the similarity in surgical application, intended use, Indications for use, material, classification, device description, performance and sterility. Clinical data was not required for this device. The animal study and biocompatibility testing includes performance assessment per the following recognized test methods:

-Code of Federal Requlation (CFR), Title 21. Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies(2008)

-International Organization (ISO) 10993-2, Biological Evaluation of Medical Devices - Part 2: Animal Welfare Requirements (2006)

-National research Council. Guide for the Care and Use of Laboratory Animals, Washington, D.C: National Academy Press, 2011

-Office of Laboratory Animal Welfare (OLAW), Public Health Service Policy on Humane Care and Use of Laboratory Animals

-International Organization for Standardization (ISO) 13485, Medical Device -Quality Management Systems- Requirements for Requlatory Purpose (2003) -AAMI / ANSI HE75:2009 Human Factors Engineering - Design of Medical Devices.

ANSI/AAMI/ISO 10993:2010 -- Biological evaluation of medical devices. Parts 1, 5,11, 12

-Code of Federal Requlation (CFR), Title 21, Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies(2008)

-U.S. Pharmacopeia, Section 88 & 87, Current revision

-ASTM F756-08 Standard Practice for Assessment of Hemolytic Properties of Material.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Symmetry Surgical Ms. Hannah Foley Quality Assurance & Regulatory Affairs Engineer 3034 Owen Drive Antioch, Tennessee 37013

SEP
28
2012

Re: K122263

Trade/Device Name: Symmetry Surgical Single Use Cuffed Catheter Removal Device Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: ODY Dated: July 24, 2012 Received: July 27, 2012

Dear Ms. Foley:

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 Eederal Register.

{3}------------------------------------------------

Page 2- Ms. Foley

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Number (if Known):

Symmetry Surgical Single Use Cuffed Catheter Removal Device Device Name:

Indications For Use:

iii

Prescription Use: _X

Over-The-Counter Use: (Part 21 CFR 807.109)

ﺎﻧﺎ

PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rhod Chung 9/24/2

(Division Sign-Off) (Division Sign-Òff)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anesthestology, 2008

fection Committee
K122263
510(k) Number:

510(k) Number:

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”