(130 days)
Not Found
No
The device description focuses on the physical characteristics and materials of a catheter, and there is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as an Intermediate Catheter for introducing interventional devices, providing access and a conduit, but it does not perform any therapeutic action itself. Its function is to facilitate other devices which would then perform the therapy.
No
The device is described as an "Intermediate Catheter" for introducing interventional devices and providing access to a target site. Its function is to facilitate interventions, not to diagnose conditions.
No
The device description clearly outlines a physical catheter with various material components (stainless steel, Nitinol, Platinum/Iridium) and physical dimensions. It also mentions accessories like a hemostasis valve and introducer sheath, all of which are hardware components. The performance studies focus on physical and material properties, not software validation.
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 "introduction of interventional devices into the peripheral and neuro vasculature." This describes a device used within the body for a procedural purpose, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a catheter designed for insertion into blood vessels to facilitate other procedures. This is consistent with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
- Performance Studies: The performance studies focus on biocompatibility, physical properties, and mechanical performance, which are relevant for an implantable or interventional device, not an IVD.
In summary, the device's function and description clearly align with an interventional medical device used for accessing and navigating within the vascular system, not a device used for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The Intermediate Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY, DTL, DYB
Device Description
The Intermediate Catheter is a variable stiffness catheter and has a catheter shaft reinforced with a stainless steel braid, a stainless steel coil, a Nitinol coil, and has a radiopaque Platinum/Iridium marker band on the distal end. The catheter has a nominal distal outer diameter of 0.072" and a nominal proximal outer diameter of 0.078". It is available with a nominal inner diameter of 0.060". They are available in three working lengths, 105 cm, 115 cm. and 125 cm. The Intermediate Catheters have a PTFE-lined lumen, which is braid and coil reinforced, flexible, and has a hydrophilic coating. The Intermediate Catheters are inserted through a guide catheter or vascular sheath, provide access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve and a split introducer sheath. The Intermediate Catheter is supplied sterile, non-pyrogenic, and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neuro vasculature
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)
Biocompatibility tests conducted with the Intermediate Catheters and accessories were selected in accordance with ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) for limited duration (
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(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 & 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 human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 14, 2015
TNI Manufacturing, Inc. % Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, Minnesota 55313
Re: K152202
Trade/Device Name: Intermediate Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, DYB, DTL Dated: November 19, 2015 Received: November 23, 2015
Dear Mr. Job:
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,
Carlos L. Pena -S/^
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152202
Device Name Intermediate Catheter
Indications for Use (Describe)
The Intermediate Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Submitter's Name and Address
TNI Manufacturing, Inc. 4635 NW 103rd Avenue Sunrise, Florida 33351 Telephone: 1-954-742-5988 Facsimile: 1-954-742-5989
Contact Information
Daniel Sablyak President 4635 NW 103rd Avenue Sunrise, Florida 33351 Telephone: 1-954-742-5988 Facsimile: 1-954-742-5989 E-Mail: Dan@tnimfg.com
Date Prepared
November 16, 2015
Device Trade or Proprietary Name
Intermediate Catheter Hemostasis Valve Split Sheath Introducer
Device Common or Classification Name:
Catheter, Percutaneous, 21CFR870.1250, Class II Hemostasis Valve, 21CFR870.4290, Class II Catheter Introducer, 21CFR870.1340, Class II
Product Code:
4
DQY (Catheter)
DTL (Hemostasis Valve)
DYB (Catheter Dilator)
Identification of the Legally Marketed Devices to which Equivalence is Being Claimed
| Name of Predicate Device | Name of Manufacturer | 510(k) Number |
|---|---|---|
| 5MAXTM DDC | ||
| Distal Delivery Catheters | Penumbra, Inc. | |
| Alameda, California | K122772 | |
| Predicate Device | ||
| Penumbra 5MAXTM | ||
| DDC | Intermediate Catheter | |
| 510(k) Number | K122772 | K152202 |
| Classification | 21CFR870.1250, Class II | Same |
| Product Code | DQY | Same |
| Indication For Use | The DDC Catheters are | |
| indicated for the | ||
| introduction of | ||
| interventional devices into | ||
| the peripheral and neuro | ||
| vasculature. | The Intermediate Catheter is | |
| indicated for the | ||
| introduction of | ||
| interventional devices into | ||
| the peripheral and neuro | ||
| vasculature. | ||
| Inner Lumen | PTFE | PTFE |
| Catheter Shaft | ||
| Material | Nylon, PTFE, | |
| polyurethane, | ||
| hydrophilic coating | Nylon, PTFE, polyimide, | |
| polyether block amide, PET, | ||
| polycarbonate/urethane | ||
| hydrophilic coating | ||
| Hub Material | Polycarbonate | Same |
| Catheter Shaft | ||
| Reinforcement | Stainless Steel/Nitinol | Same |
| Marker Band | Platinum/Iridium | Same |
| Packaging | Tyvek Pouch, | |
| polyethylene support | ||
| hoop, packaging card, | ||
| SBS Carton | Same | |
| Sterilization | Ethylene Oxide | Same |
| Pyrogenicity | Nonpyrogenic | Same |
| Inside Diameter (ID) | 0.062" | Same |
| Outside Diameter | ||
| (OD) | 6 Fr | Same |
| Working Lengths (cm) | 115 and 125 cm | 105, 115, and 125 cm |
| Predicate Device | ||
| Penumbra 5MAX™ | ||
| DDC | Intermediate Catheter | |
| Compatible Guidewire | 0.038" | Same |
Device Description
The Intermediate Catheter is a variable stiffness catheter and has a catheter shaft reinforced with a stainless steel braid, a stainless steel coil, a Nitinol coil, and has a radiopaque Platinum/Iridium marker band on the distal end. The catheter has a nominal distal outer diameter of 0.072" and a nominal proximal outer diameter of 0.078". It is available with a nominal inner diameter of 0.060". They are available in three working lengths, 105 cm, 115 cm. and 125 cm. The Intermediate Catheters have a PTFE-lined lumen, which is braid and coil reinforced, flexible, and has a hydrophilic coating. The Intermediate Catheters are inserted through a guide catheter or vascular sheath, provide access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve and a split introducer sheath. The Intermediate Catheter is supplied sterile, non-pyrogenic, and intended for single use only.
Indications For Use
The Intermediate Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Comparison to Predicate Device
5
6
Summary of Non Clinical Data
Biocompatibility tests conducted with the Intermediate Catheters and accessories were selected in accordance with ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) for limited duration (