(137 days)
Not Found
No
The device description and performance testing sections focus on the physical and mechanical properties of a catheter, with no mention of AI or ML capabilities.
No
The device is described as a catheter for introducing interventional devices, providing access to a target site, and reinforcing a conduit, which indicates it is an accessory for other medical procedures, not a device that directly treats a condition.
No
The device, a catheter, is indicated for the introduction of interventional devices, acting as a conduit rather than providing diagnostic information. Its description and performance testing focus on physical and mechanical properties, not on identifying or quantifying physiological or anatomical conditions.
No
The device description clearly details a physical catheter with specific material properties, dimensions, and accessories, indicating it is a hardware device, not software only.
No, 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.
- Device Description: The description details a catheter designed for insertion into blood vessels to facilitate other procedures. This is consistent with an interventional device, not a diagnostic test performed on a sample.
- 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 the physical, mechanical, and biological compatibility of the catheter itself for its intended use within the body. They do not involve evaluating the accuracy or performance of a diagnostic test.
In summary, the Super Distal Access (SDA) is a medical device used for interventional procedures within the body's vasculature, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The Super Distal Access (SDA) 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
Device Description
The Super Distal Access (SDA) is a single lumen, variable stiffness catheter and has a shaft reinforced with a Stainless Steel/Nitinol coil. The SDA has a radiopaque Platinum/Iridium marker band on the distal end. The catheter has a maximum outer diameter of 0.084 inches. It has a tapered design that includes a nominal inner diameter of 0.062 inches in the distal end and 0.068 inches in the proximal end. There are three working lengths available: 115 cm, 125 cm, and 135 cm. The Super Distal Access has a PTFE-lined lumen in the distal end a Polyimide/PTFE-lined lumen in the proximal end. The catheter is flexible and has a hydrophilic coating. The SDA is inserted through a guide catheter or vascular sheath, provides 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 with an extension luer and a split sheath introducer. The SDA 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 were conducted in accordance with ISO 10993-1 guidelines 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" around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird, formed by three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 19, 2016
InNeuroCo, Inc. Ms. Marianne Grunwaldt Director, Quality Assurance & Regulatory Affairs 4635 NW 103td Avenue Sunrise. Florida 33351
Re: K161262
Trade/Device Name: Super Distal Access (SDA) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, DTL Dated: August 15, 2016 Received: August 17, 2016
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,
Michael J.Hoffmann -A
- for Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161262
Device Name Super Distal Access (SDA)
Indications for Use (Describe)
The Super Distal Access (SDA) 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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3
510(k) SUMMARY
Submitter's Name and Address
InNeuroCo 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 16, 2016
Device Trade or Proprietary Name
Super Distal Access (SDA)
Device Common or Classification Name:
Catheter, Percutaneous, 21CFR870.1250, Class II Hemostasis Valve, 21CFR870.4290, Class II
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Product Code:
DQY(Catheter) DTL (Hemostasis Valve)
Identification of the Legally Marketed Devices to which Equivalence is Being Claimed
| Name of Predicate Device | Name of Manufacturer | 510(k) Number |
|---|---|---|
| INTERMEDIATE CATHETER | InNeuroCo | K152202 |
Device Description
The Super Distal Access (SDA) is a single lumen, variable stiffness catheter and has a shaft reinforced with a Stainless Steel/Nitinol coil. The SDA has a radiopaque Platinum/Iridium marker band on the distal end. The catheter has a maximum outer diameter of 0.084 inches. It has a tapered design that includes a nominal inner diameter of 0.062 inches in the distal end and 0.068 inches in the proximal end. There are three working lengths available: 115 cm, 125 cm, and 135 cm. The Super Distal Access has a PTFE-lined lumen in the distal end a Polyimide/PTFE-lined lumen in the proximal end. The catheter is flexible and has a hydrophilic coating. The SDA is inserted through a guide catheter or vascular sheath, provides 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 with an extension luer and a split sheath introducer. The SDA is supplied sterile, non-pyrogenic, and intended for single use only.
Indications for Use
The Super Distal Access (SDA) is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
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Comparison to Predicate Device
| | Predicate Device
InNeuroCo, Inc.
Intermediate Catheter | InNeuroCo, Inc.
Super Distal Access |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K152202 | K161262 |
| Classification | 21CFR870.1250, Class II | 21CFR870.1250, Class II |
| Product Code | DQY | DQY |
| Review Panel | Cardiovascular | Cardiovascular |
| Indication For Use | The Intermediate Catheter is
indicated for the introduction
of interventional devices into
the peripheral and neuro
vasculature. | The Super Distal Access (SDA)
is indicated for the introduction
of interventional devices into the
peripheral and neuro
vasculature. |
| Components Supplied | Catheter, Peel Away
Introducer, Hemostasis Valve | Catheter, Peel Away
Introducer, Hemostasis Valve |
| Catheter Shaft Material | Polyimide, Polyether Block
Amide (PEBAX), PET,
Polycarbonate/Urethane,
Nylon | Polyimide, Polyether Block
Amide (PEBAX), PET,
Polycarbonate/Urethane |
| Inner Liner | PTFE | Distal: PTFE
Proximal: PTFE/Polyimide |
| Hub Material | Polycarbonate | Polycarbonate |
| Strain Relief | Polyolefin | Polyolefin |
| Catheter Shaft
Reinforcement | Stainless Steel/Nitinol | Stainless Steel/Nitinol |
| Lubricious Coating | Hydrophilic Coating | Hydrophilic Coating |
| Radiopaque Marker
Band | Platinum/ Iridium | Platinum/ Iridium |
| Packaging | Tyvek/Nylon Pouch,
polyethylene support hoop,
packaging card, SBS Carton | Tyvek/Nylon Pouch,
polyethylene support hoop,
packaging card, SBS Carton |
| | Predicate Device
InNeuroCo, Inc.
Intermediate Catheter | InNeuroCo, Inc.
Super Distal Access |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Pyrogenicity | Nonpyrogenic | Nonpyrogenic |
| Working Lengths | 105, 115, 125 cm | 115, 125, 135 cm |
| Compatible Guidewire | 0.038 inches | 0.038 inches |
| Internal Diameter | 0.060 inches distal
0.062 inches proximal | 0.062 inches distal
0.068 inches proximal |
| Proximal Outer Diameter | 0.079 inches | 0.084 inches |
| Distal Outer Diameter | 0.072 inches | 0.078 inches |
| Shelf Life | 3 years | 3 years |
| Split Sheath Introducer | Aid in catheter introduction
during procedure | Aid in catheter introduction
during procedure |
| Hemostasis Valve | Minimizes blood loss | Minimizes blood loss |
| Luer Tapered Hub | Yes | Yes |
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Summary of Non Clinical Data
Biocompatibility tests conducted with the Super Distal Access (SDA) and its accessories were selected in accordance with ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) for limited duration (