(95 days)
Not Found
No
The summary describes a simple material change to a catheter introducer and makes no mention of AI or ML.
No
Explanation: The device is described as an introducer to facilitate catheter or pacing lead insertion, not as a device that delivers therapy itself. Its function is to create access, not to treat.
No
Explanation: The device is described as an introducer facilitating catheter insertion for central venous access, not for diagnosing conditions. Its primary function is to aid in a medical procedure, not to collect diagnostic information.
No
The device description clearly states it is a catheter introducer, which is a physical medical 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 to "obtain central venous access to facilitate catheter insertion or placing pacing leads into the central venous system." This describes a device used in vivo (within the body) for a medical procedure, not a device used in vitro (outside the body) to examine specimens like blood, urine, or tissue for diagnostic purposes.
- Device Description: The description details a "catheter introducer" and its components (sheath and dilator). This aligns with a surgical or interventional device, not a diagnostic test kit or instrument used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a medical device used for a procedural purpose, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PTFE Super Sheath Introducers are intended to obtain central venous access to facilitate catheter insertion or placing pacing leads into the central venous system.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The PTFE Super Sheath Introducer 2.1. The sole difference between the predicate device (K130855; Super Sheath 2.0) and the proposed device is the material change to dilatory. The dilator material that was approved in the predicate 510K submission was nylon, the proposed has a dilator composed of a nylon/Pebax blend.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system
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 following in-vitro testing was performed PTFE Super Sheath Introducer v2.1 to assure reliable design and performance in accordance with ISO standards and/or internal procedures. (See Section 10: Bench/Performance Data)
Liquid Leakage
Air Leakage
Force at Break
Simulated Use
Equipment Interaction
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
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, overlapping each other to create a sense of depth and unity. The faces are simple and abstract, with no distinct features other than the outline of the head and neck.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2016
Courtney Nix Regulatory Associate MedComp (Medical Components, Inc.) 1499 Delp Dr. Harleysville, PA 19438
Re: K153246
Trade/Device Name: PTFE Super Sheath Introducer 2.1 Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: January 11, 2016 Received: January 15, 2016
Dear Ms. Nix:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 yours,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K153246
Device Name PTFE Super Sheath 2.1
Indications for Use (Describe)
The PTFE Super Sheath Introducers are intended to obtain central venous access to facilitate catheter insertion or placing pacing leads into the central venous system.
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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Image /page/3/Picture/0 description: The image features the logo for medCOMP. The logo consists of a stylized geometric shape in red, resembling a house or an abstract letter. Below the shape, the word "med" is written in red, followed by "COMP" in gray. The overall design is clean and modern.
1499 Delp Drive
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
| Section 9 | 510(k) SUMMARY | Special 510K | |
|---|---|---|---|
| A. | Submitter Information: | ||
| Submitter: | Medcomp (Medical Components, Inc.) | ||
| 1499 Delp Drive | |||
| Harleysville, PA 19438 | |||
| (215) 256-8833 Telephone | |||
| (215) 256-9191 Fax | |||
| Contact: | Courtney Nix | ||
| Cnix@medcompnet.com | |||
| Date Prepared: | 11/3/2015 | ||
| B. | Device Name: | PTFE Super Sheath Introducer 2.1 | |
| Common Name: | Super Sheath 2.1 | ||
| Classification Name: | Catheter Introducer (74 DYB) | ||
| C.F.R. Section: | 870.1340 | ||
| Product Code | DYB | ||
| Class: | II | ||
| Sizes: | 3F - 5.5F | ||
| C. | Predicate Devices: | K130855 | |
| PTFE Super Sheath Introducer 2.0 | |||
| Original Applicant: Martech Medical | |||
| Products | |||
| Current: Medcomp (Medical Components, Inc) | |||
| Transferred: February 12, 2015 | |||
| D. | Intended Use: | The Super Sheath Introducer is intended to obtain central | |
| venous access to facilitate catheter insertion or placing | |||
| pacing leads into the central venous system. The Super | |||
| Sheath is compatible with a 0.018" or smaller guidewire. | |||
| This is the identical intended use as previously cleared in PTFE | |||
| Super Sheath 2.0, K130855. | |||
| E. | Indications for Use: | ||
| 9-1 |
是
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Image /page/4/Picture/0 description: The image shows the logo for medCOMP. The logo consists of a red geometric shape that resembles a stylized house or building. Below the shape, the word "med" is written in red, while "COMP" is written in gray. The logo has a clean and modern design.
1499 Delp Drive
Harleysville, PA 19438
F.
Tel: 215-256-4201
Fax. 215-256-1787
The PTFE Super Sheath Introducers are intended to obtain central venous access to facilitate catheter insertion of placing pacing leads into the central venous system.
This is the identical indications for use as previously cleared in PTFE Super Sheath 2.0, K130855.
Comparison to Predicate Devices:
The PTFE Super Sheath Introducer 2.1 is substantially equivalent to the predicate devices in terms of intended use, indications for use. anatomical location, and general design. The sole difference between the predicate device (K130855; Super Sheath 2.0) and the proposed device is the material change to dilatory. The dilator material that was approved in the predicate 510K submission was nylon, the proposed has a dilator composed of a nylon/Pebax blend.
G. Substantial Equivalence:
The modified Super Sheath 2.1 has the following similarities to the predicate device (Super Sheath 2.0, K130855):
- Identical indicated use .
- . Identical indications for use
- Identical operating procedure ●
- Identical manufacturing processing and sterilization method .
- o Identical packaging
- Identical design and operation o
In summary the Super Sheath 2.1, as described with modifications in this submission is, in our opinion, substantially equivalent to the predicate device.
H. Summary of Design Control Activities:
A risk analysis was conducted per ISO 14971 Second Edition 2007-03-01, Medical Devices - Application of Risk Management To Medical Devices (General I (QS/RM)). The design verification tests that were performed as a result of this risk analysis are listed in Section 10: Bench/Performance Data of this submission (Tables 1-6).
The test methods used are the same as those submitted in the original submission.
A declaration of conformity with design controls is included in this submission
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Image /page/5/Picture/0 description: The image shows the MedComp logo. The logo consists of a stylized letter "M" in pink, with the word "med" in pink and "COMP" in gray below it. The "M" is made up of geometric shapes, including a triangle at the top and a diamond shape in the middle.
1499 Delp Drive
Harlevsville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Labeling:
J.
There are no changes in the labeling or IFU from the predicate device.
Bench / Performance Data:
The following in-vitro testing was performed PTFE Super Sheath Introducer v2.1 to assure reliable design and performance in accordance with ISO standards and/or internal procedures. (See Section 10: Bench/Performance Data)
- Liquid Leakage g
- の Air Leakage
- Force at Break ●
- Simulated Use 0
- Equipment Interaction @
H. Biocompatibility:
Results for all biocompatibility testing demonstrate the materials used meet the requirements of ISO 10993. (See Section 11: Biocompatibility)
ا. Software:
This section in not applicable as the Super Sheath 2.0 does not utilize software.
J. Sterility Information:
There are no changes to the sterilization method, or parameters for the proposed device. Sterilization is identical to what was approved for the predicate device, Super Sheath 2.0. K130855.
K. Conclusion:
The proposed devices meet the performance criteria of design verification as specified by ISO standards and test protocols. The proposed device has the same intended use, operation and function as the predicates. There are no differences that raise new issues of safety and effectiveness. The proposed devices are substantially equivalent to the legally marketed predicate devices.