(74 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical function of a peelable introducer kit, with no mention of AI or ML technologies.
No
The device is an introducer kit used for percutaneous insertion of leads or catheters, which are typically therapeutic, but the introducer itself is an accessory device, not a therapeutic one.
No
The device is an introducer for percutaneous insertion of pacing leads or catheters, not for diagnosing conditions. It facilitates a medical procedure rather than identifying a disease or condition.
No
The device description clearly outlines multiple physical components (needle, syringe, guidewire, dilator, sheath) and describes their physical properties and function, indicating it is a hardware medical device.
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 percutaneous insertion of pacing leads or catheters in the venous system. This is a procedure performed on the patient's body, not on a sample taken from the patient.
- Device Description: The device components (needle, syringe, guidewire, introducer set) are all designed for direct interaction with the patient's vascular system.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical/interventional tool used for accessing the venous system.
N/A
Intended Use / Indications for Use
The PTFE Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.
Product codes
DYB
Device Description
The Greatbatch Medical PTFE Peelable Introducer Kit consists of a disposable needle, a disposable syringe, a guidewire, and a peelable introducer set consisting of a dilator and sheath with integrated proximal handles. The introducer is available in various lengths in 3.5F through 16.5F. The dilator is designed to be delivered over a guidewire.
The PTFE Peelable Introducer sheath has a "peel-away" feature which allows the user to remove the sheath without removing the inserted catheter or pacing lead. The PTFE Peelable Introducer is provided sterile and is intended for single use. The device is not intended for sterilization by the user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Testing for this device was performed to verify that the device continues to function in a safe and effective manner. The performance testing included the device specifications, functional and dimensional testing of the PTFE Peelable Introducer and other testing as applicable to the device. Test results verify that the device performs per specification requirements and is equivalent to the predicate device without creating additional risk to the patient or user.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Greatbatch Medical Special Premarket Notification 510(k)
PTFE Peelable Introducer
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NOV 1 6 2010
1102540
510(k) Summary
5.1 Applicant Information
| Submitter's Name: | |
|---|---|
| Address: |
Greatbatch Medical 2300 Berkshire Lane North Minneapolis, MN 55441
Establishment Registration No. 2183787
Kristi Fox Contact Person: Regulator Affairs Specialist kfox@greatbatchmedical.com 763-951-8205 (phone) (763) 559-0148 (fax) Steris, Inc. Sterilization Facility: 380 90th Avenue Northwest Minneapolis, MN 55433 (763) 786-2929 (phone) (763) 786-8199 (fax) Establishment Registration No. 2183744
5.2 Device Information
Trade Name: PTFE Peelable Introducer Classification Name: Introducer, Catheter Product Code: DYB Regulation: Class II 21 CFR 870.1340 Panel: Cardiovascular
Device Description 5.3
The Greatbatch Medical PTFE Peelable Introducer Kit consists of a disposable needle, a disposable syringe, a guidewire, and a peelable introducer set consisting of a dilator and sheath with integrated proximal handles. The introducer is available in various lengths in 3.5F through 16.5F. The dilator is designed to be delivered over a guidewire.
The PTFE Peelable Introducer sheath has a "peel-away" feature which allows the user to remove the sheath without removing the inserted catheter or pacing lead. The PTFE Peelable Introducer is provided sterile and is intended for single use. The device is not intended for sterilization by the user.
5.4 Indications for Use
The PTFE Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.
1
Predicate Device Comparison / Technological Characteristics 5.5
The PTFE Peelable Introducer Kit has the same indication for use, technological characteristics and principles of operation as the market cleared Greatbatch Medical PTFE Peelable Introducer Kit (K093023). In addition, functional characteristics of the PTFE Peelable Introducer are substantially equivalent to the currently marketed device (K093023) including materials and method of construction. Where dimensional differences exist between the proposed device and the predicate device, performance testing was performed to demonstrate that these differences do not raise questions of safety or efficacy.
5.6 Summary of Testing
Testing for this device was performed to verify that the device continues to function in a safe and effective manner. The performance testing included the device specifications, functional and dimensional testing of the PTFE Peelable Introducer and other testing as applicable to the device. Test results verify that the device performs per specification requirements and is equivalent to the predicate device without creating additional risk to the patient or user. The following tests were performed on the PTFE Peelable Introducer:
| Test | Result |
|---|---|
| Sheath Compatibility with | |
| Dilator | Pass |
| Initial Handle Break Force, | |
| Sheath | Pass |
| Peel Force | Pass |
| Peelability | Pass |
| Sheath/Tube Handle Integrity | Pass |
| Dilator Hub/Tube Tensile Force | Pass |
| Handle ID (min) | Pass |
| Dilator Hub ID | Pass |
| Tip ID | Pass |
| Flat on Tip | Pass |
| Tip Angle | Pass |
| Length | Pass |
5.7 Statement of Equivalence
The PTFE Peelable Introducer has the same indication for use, principles of operation, and technological and functional characteristics as the market cleared Greatbatch Medical PTFE Peelable Introducer (K093023). The testing performed confirms that the PTFE Peelable Introducer will perform as intended. Therefore the PTFE Peelable Introducer is substantially equivalent to the previously cleared Greatbatch Medical PTFE Peelable Introducer (K093023).
2
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 depiction of a bird or abstract human figure, with three curved lines representing wings or arms. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figure.
ど
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Kristi Fox Regulatory Affairs Specialist Greatbatch Medical 2300 Berkshire Lane North Minneapolis, MN 55441
Re: K102540
Trade/Device Name: PTFE Peelable Introducer Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: October 15, 2010 Received: November 3, 2010
NOV 1 6 2010
Dear Ms. Fox:
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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
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
3
Page 2 - Ms. Kristi Fox
addition, FDA may publish further announcements concerning your device in the Eederal 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 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,
bana R. lahmer
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Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Greatbatch Medical Special Premarket Notification 510(k)
PTFE Peelable Introducer
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: PTFE Peelable Introducer
NOV 16 2010
Indications for Use:
The PTFE Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
ノ
uma R. Vachner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_k102540