(100 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and biocompatibility of a catheter, with no mention of AI or ML.
No
The device, a Long Sheath, is described as a catheter used to introduce other interventional devices and provide access to target sites. It does not exert a therapeutic effect itself, but rather facilitates the delivery of therapeutic devices or agents.
No
The device description clearly states its purpose is for "the introduction of interventional devices" and to "provide access to the target site and once in place, provide a reinforcing conduit for other intravascular devices." This indicates a tool for delivering other devices, not for diagnosing conditions.
No
The device description clearly details a physical catheter with specific material properties, dimensions, and accessories, indicating it is a hardware medical device, not software-only.
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, coronary, and neuro vasculature. This describes a device used within the body for a therapeutic or interventional procedure, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description details a catheter designed for insertion into blood vessels to facilitate other procedures. This aligns with an interventional device, not a diagnostic test performed on samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely procedural and interventional.
N/A
Intended Use / Indications for Use
The Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasulature.
Product codes
DQY
Device Description
The Long Sheath or LS is a variable stiffness catheter and has a catheter shaft reinforced with a stainless steel braid and has a radiopaque Platinum/Iridium marker band on the distal end. The catheter has a nominal outer diameter of 0.109 inches. It is available with a nominal inner diameter of 0.088 inches. They are available in three working lengths: 70 cm, 80 cm, and 90 cm. The Long Sheath has a PTFE-lined lumen, which is braid-reinforced, flexible, and has a hydrophilic coating. The LS are inserted through a guide catheter or vascular sheath, provide access to the target site and once in place, provide a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve with an extension luer and a dilator. The LS 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, coronary, 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
Biocompatibility tests conducted with the Long Sheath 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 text "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
January 8, 2016
TNI Manufacturing, Inc. Ms. Marianne Grunwaldt Director, Quality Assurance & Regulatory Affairs 4635 NW 103td Avenue Sunrise. Florida 33351
Re: K152876
Trade/Device Name: Long Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 3, 2015 Received: December 7, 2015
Dear Ms. Grunwaldt:
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 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.
1
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,
Carlos L. Pena AS
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) K152876
Device Name Long Sheath
Indications for Use (Describe)
The Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasulature.
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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3
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
Marianne Grunwaldt Director, Quality Assurance & Regulatory Affairs InNeuroCo, Inc 4635 NW 103rd Avenue Sunrise, Florida 33351 Telephone: 1-305-495-3883 Facsimile: 1-954-742-5989 E-Mail: Marianne@InNeuroCo.com
Date Prepared
September 25, 2015
Device Trade or Proprietary Name
Long Sheath or LS
Device Common or Classification Name:
Catheter, Percutaneous, 21CFR870.1250, Class II
Product Code:
DQY
4
Identification of the Legally Marketed Devices to which Equivalence is Being Claimed
| Name of Predicate Device | Name of Manufacturer | 510(k) Number |
|---|---|---|
| NEURON MAX SYSTEM | Penumbra, Inc. | |
| Alameda, California | K111380 |
Device Description
The Long Sheath or LS is a variable stiffness catheter and has a catheter shaft reinforced with a stainless steel braid and has a radiopaque Platinum/Iridium marker band on the distal end. The catheter has a nominal outer diameter of 0.109 inches. It is available with a nominal inner diameter of 0.088 inches. They are available in three working lengths: 70 cm, 80 cm, and 90 cm. The Long Sheath has a PTFE-lined lumen, which is braidreinforced, flexible, and has a hydrophilic coating. The LS are inserted through a guide catheter or vascular sheath, provide access to the target site and once in place, provide a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve with an extension luer and a dilator. The LS is supplied sterile, non-pyrogenic, and intended for single use only.
Indications for Use
The Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
| | Predicate Device
Penumbra NEURON
MAX SYSTEM | TNI Manufacturing, Inc.
Long Sheath |
|----------------|---------------------------------------------------|----------------------------------------|
| 510(k) Number | K111380 | K152876 |
| Classification | 21CFR870.1250, Class II | 21CFR870.1250, Class II |
| Product Code | DQY | DQY |
Comparison to Predicate Device
5
| Review Panel | Cardiovascular | Cardiovascular |
|---|---|---|
| Indication For Use | The Neuron™ MAX | |
| System is indicated for the | ||
| introduction of | ||
| interventional devices into | ||
| the peripheral, coronary, | ||
| and neuro vasculature. | The Long Sheath is | |
| indicated for the | ||
| introduction of | ||
| interventional devices into | ||
| the peripheral, coronary, | ||
| and neuro vasculature. | ||
| Components Supplied | Sheath, Vessel Dilator, | |
| Hemostasis Valve, | Sheath, Vessel Dilator, | |
| Hemostasis Valve | ||
| Catheter Shaft | ||
| Material | Nylon, Polyurethane | Polyether Block Amide, |
| (PEBAX) | ||
| Inner Liner | PTFE | PTFE |
| Hub Material | Polycarbonate | Polycarbonate |
| Strain Relief | Polyolefin | Polyolefin |
| Catheter Shaft | ||
| Reinforcement | Stainless Steel Braid | Stainless Steel Braid |
| Lubricious Coating | Hydrophilic Coating | Hydrophilic Coating |
| Radiopaque Marker | ||
| Band | Platinum/ Iridium | Platinum/ Iridium |
| Packaging | Tyvek Pouch, | |
| polyethylene support tube, | ||
| packaging card, SBS | ||
| carton | Tyvek/Nylon Pouch, | |
| polyethylene support tube, | ||
| packaging card, SBS carton | ||
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Pyrogenicity | Nonpyrogenic | Nonpyrogenic |
| Working Lengths | 70, 80, 90, and 100 cm | 70, 80, 90 cm |
| Internal Diameter | 0.088 inches | 0.088 inches |
| Outer Diameter | 0.108 inches | 0.109 inches |
| Shelf Life | 3 years | 3 years |
| Vessel Dilator | Aid in sheath introduction | |
| during procedure | Aid in sheath introduction | |
| during procedure | ||
| Hemostasis Valve | Minimizes blood loss | Minimizes blood loss |
| Luer Tapered Hub | Yes | Yes |
6
Summary of Non Clinical Data
Biocompatibility tests conducted with the Long Sheath and accessories were selected in accordance with ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) for limited duration (