(240 days)
No
The description focuses on the mechanical and material properties of a steerable introducer and its reprocessing. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is an introducer for catheters, not a therapeutic agent itself.
No
The device is described as an introducer for various cardiovascular catheters, facilitating access to the heart. Its purpose is to guide other instruments, not to collect diagnostic information itself. While it is visualized using fluoroscopy, this is for placement guidance, not for diagnosing a condition.
No
The device description clearly details physical components such as a steerable sheath, plastic dilator, handle, knob, hemostasis valve, side port, and mentions radiopaque material for visualization under fluoroscopy. This indicates a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The description clearly states that this device is a steerable introducer used to introduce catheters into the heart. It is a tool used within the body for a medical procedure.
- Intended Use: The intended use is for introducing catheters into the heart, not for analyzing biological specimens.
Therefore, this device falls under the category of a medical device used for interventional procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The reprocessed steerable introducer devices are indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Product codes
PNE, DYB
Device Description
The reprocessed steerable introducer consists of a steerable sheath and plastic dilator, which is indicated for introducing various cardiovascular catheters including the left side of the heart through the interatrial septum. The device is always delivered over a guidewire. The steerable introducer device enters through the right femoral vein and is guided into the right atrium of the heart. A knob on the introducer handle dictates the amount and direction of curl at the distal tip of the sheath. The shaft of the introducer is filled with radiopaque material so the device can be seen using fluoroscopy. A guidewire pokes through the septum into the left atrium and a tapered dilator enlarges the hole. The dilator is then removed allowing the introduction of a catheter.
Note: The guidewire is not included in the scope of this submission as it is purchased off-the-shelf (K935170) and packaged with the reprocessed devices. Only the steerable sheath and plastic dilator are subject in this submission. In this submission references to the "device(s)" refers to both the sheath and dilator.
The device is an 8.5F asymmetrical bi-directional steerable introducer with a varying amount of curl (small, medium or large) at the distal tip and a useable length of 61 or 71 cm. The proximal end of the device sheath is fitted with a hemostasis valve to minimize blood loss during catheter insertion and/or exchange over a guidewire. A side port with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. A handle is equipped with a rotating collar to deflect the large curl 90 ° in the counterclockwise direction and 180° in the clockwise direction. The sheath is filled with radiopaque material for visualization under fluoroscopy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
heart, left side of the heart through the interatrial septum, right femoral vein, right atrium of the heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
No animal or clinical testing was conducted for this premarket notification submission. Physical and performance testing included:
- Cap Retention
- Shaft Deflection and Flexation
- Joint Strength
- Leak
- Shaft Torque
- Stiffness
- Distribution
- Torque Response
- Dimensional Verification
- Systems Use
In addition, the device was tested for biocompatibility per ISO 10993-1 for short duration contact with blood (
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 23, 2016
Sterilmed, Inc. % Ming Chew Regulatory Consultant Libra Medical Inc. 8401 63rd Avenue North, Suite 63 Brooklyn Park, Minnesota 55428
Re: K152090
Trade/Device Name: Reprocessed Steerable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: PNE Dated: February 25, 2016 Received: February 26, 2016
Dear Ming Chew:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
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Page 3 - Ming Chew
Attachment
The following models are included in the clearance of K152090:
G408318 G408319 408309 408310 G408324
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Image /page/3/Picture/0 description: The image shows the text "K152090" at the top, followed by a logo with the text "STERILMED.". Below the logo, the text "24 JULY 2015" is displayed. The logo features a circular design with green and gray colors, suggesting a medical or sterilization-related theme. The text is clear and legible, indicating a label or informational graphic.
| 5. INDICATIONS FOR USE STATEMENT | |
|---|---|
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
| Food and Drug Administration | Form Approved: OMB No. 0910-0120 |
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. | |
| Indications for Use | |
| 510(k) Number ( if known ) | K152090 |
| Device Name | Reprocessed Steerable Introducers |
| Indications for Use ( describe ) | |
| The reprocessed steerable introducer devices are indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. | |
| Type of Use ( select one or both, as applicable ) | |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (Part 21 CFR 801 Subpart C ) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995 | |
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAL ADDRESS BELOW. | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden to: | |
| Department of Health and Human Services | |
| Food and Drug Administration | |
| Office of Chief Information Officer | |
| Paperwork Reduction Act (PRA) Staff | |
| PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." |
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Image /page/4/Picture/0 description: The image shows the Sterilmed logo, which includes a green and silver circular design with the word "STERILMED" in gray text. Below the logo, the text "23 MARCH 2016" is displayed in a simple, sans-serif font. The text is likely a date associated with the logo or the image itself. The overall design is clean and professional.
1. 510(K) SUMMARY
1.1 ADMINISTRATIVE INFORMATION
1.1.1 Sponsor
Patricia Kaufman Sterilmed, Inc. 5010 Cheshire Parkway N, Suite 2 Plymouth, MN 55446
Tel: (763) 488-3211 Fax: (763) 488-2050 Email: tschrater@sterilmed.com
1.1.2 Primary Contact
Ming Cheng Chew Regulatory Consultant Libra Medical, Inc. 8401 73rd Ave North, Suite 63 Minneapolis, MN 55428 Tel: 763-232-3701 Fax: 763-477-6357 Email: mcchew@libramed.com
1.1.3 Secondary Contact
Julie Bodmer Regulatory Consultant Libra Medical, Inc. 8401 73rd Ave North, Suite 63 Minneapolis, MN 55428 Tel: 612-910-3412 Fax: 763-477-6357 Email: jbodmer@libramed.com
1.2 DEVICE NAME
Reprocessed Steerable Introducer Trade Name Common Name Steerable Introducer Classification Name Reprocessed Catheter Introducer Classification II PNE Primary Product Code
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Image /page/5/Picture/0 description: The image shows the Sterilmed logo, which includes a stylized symbol with a green and silver color scheme. The text "STERILMED" is written in a simple, sans-serif font next to the symbol. Below the logo, the date "23 MARCH 2016" is printed in a larger, serif font.
Secondary Product Code DYB
1.3 DEVICE DESCRIPTION OVERVIEW
The reprocessed steerable introducer consists of a steerable sheath and plastic dilator, which is indicated for introducing various cardiovascular catheters including the left side of the heart through the interatrial septum. The device is always delivered over a guidewire. The steerable introducer device enters through the right femoral vein and is guided into the right atrium of the heart. A knob on the introducer handle dictates the amount and direction of curl at the distal tip of the sheath. The shaft of the introducer is filled with radiopaque material so the device can be seen using fluoroscopy. A guidewire pokes through the septum into the left atrium and a tapered dilator enlarges the hole. The dilator is then removed allowing the introduction of a catheter.
Note: The guidewire is not included in the scope of this submission as it is purchased off-theshelf (K935170) and packaged with the reprocessed devices. Only the steerable sheath and plastic dilator are subject in this submission. In this submission references to the "device(s)" refers to both the sheath and dilator.
1.4 INDICATIONS FOR USE
The Reprocessed Steerable Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
TECHNOLOGY OVERVIEW 1.5
The device is an 8.5F asymmetrical bi-directional steerable introducer with a varying amount of curl (small, medium or large) at the distal tip and a useable length of 61 or 71 cm. The proximal end of the device sheath is fitted with a hemostasis valve to minimize blood loss during catheter insertion and/or exchange over a guidewire. A side port with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. A handle is equipped with a rotating collar to deflect the large curl 90 ° in the counterclockwise direction and 180° in the clockwise direction. The sheath is filled with radiopaque material for visualization under fluoroscopy.
1.6 PERFORMANCE TESTING OVERVIEW
The reprocessed steerable introducer devices are substantially equivalent to the new unreprocessed predicate devices (K061363 and K081645) in that the reprocessed devices are the same as the new un-reprocessed predicate devices in terms of form, fit, function, and intended use. No animal or clinical testing was conducted for this premarket notification submission. Physical and performance testing included:
- Cap Retention
- Shaft Deflection and Flexation
- Joint Strength
- Leak ●
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Image /page/6/Picture/0 description: The image shows the Sterilmed logo, which includes a stylized green and silver arrow. The text "STERILMED" is written in a simple, sans-serif font to the right of the arrow. Below the logo, the date "23 MARCH 2016" is written in a larger, serif font.
- Shaft Torque ●
- Stiffness ●
- Distribution ●
- Torque Response ●
- Dimensional Verification ●
- Systems Use ●
In addition, the device was tested for biocompatibility per ISO 10993-1 for short duration contact with blood (