(63 days)
Not Found
No
The device description details a purely mechanical tool with a trigger and spring mechanism. There is no mention of any computational or data-driven components, nor are there sections describing AI/ML training or testing data.
No.
The device is described as a "catheter accessory device" intended for the "minimally invasive removal of tunneled long term catheters," which is a surgical tool, not a device that provides therapy.
No
The device is described as a tool for the minimally invasive removal of tunneled long-term catheters, specifically for minimizing surgical trauma and facilitating catheter removal. It is an interventional device, not one that gathers information about a patient's health status to diagnose or monitor a condition.
No
The device description clearly details a physical, mechanical tool with jaws, a trigger, and a spring assist mechanism, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal of tunneled long term catheters from a patient's body. This is a surgical/procedural device used in vivo (within the living body).
- Device Description: The description details a mechanical tool with jaws and a trigger for manipulating a catheter within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) outside the body to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed to perform tests on biological samples in vitro (in glass, or outside the living organism). This device is clearly designed for a physical procedure in vivo.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
ODY
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°.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
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
§ 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.”
0
SEP 2 8 2012
-
5.0 510(k) Summary
-
- Sponsor Symmetry Surgical 3034 Owen Drive Antioch, TN 37013
| Primary Contact: | Hannah Foley |
|---|---|
| Telephone: | 1- 615-964-5509 |
Date Prepared: July 24, 2012
-
- 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)
- 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
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
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
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
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
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
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
Prescription Use: _X
Over-The-Counter Use: (Part 21 CFR 807.109)
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PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
OR
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: