(30 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a balloon catheter, with no mention of AI or ML technologies.
Yes
The device is intended to dilate stenoses and treat obstructive lesions, which are therapeutic actions.
No
This device is a therapeutic device (dilatation catheter) used to treat stenoses, not to diagnose them. The description explicitly states it does not have a lumen for distal dye injections or pressure measurements, which would be typical for diagnostic purposes.
No
The device description clearly details a physical catheter with a balloon, lumens, and a guidewire, 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 clearly states that the device is used to dilate stenoses in various arteries and for the treatment of obstructive lesions in dialysis fistulae. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a catheter with a balloon for mechanical dilation. This is a physical intervention, not a test performed on a sample taken from the body.
- 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 therapeutic tool used for physical intervention within the body.
N/A
Intended Use / Indications for Use
The Cordis AVIATOR Peripheral Dilatation catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes (comma separated list FDA assigned to the subject device)
DQY, LIT
Device Description
The AVIATOR Peripheral Dilatation Catheter has an integrated shaft system and a balloon near the distal tip. The shaft has a combination of single lumen and dual lumen tubing. One lumen is used for inflation of the balloon with contrast medium. The second lumen, located only in the distal shaft, permits the use of a .014" diameter guidewire to facilitate the advancement of the catheter to and through the stenosis to be dilated. The catheter shaft has a distal port (hole) near the distal end that accesses the guidewire lumen. The guidewire lumen begins at the distal port and ends at the distal tip. This "rapid exchange" design allows insertion and removal of the catheter without extension of the guidewire.
The balloon has radiopaque marker(s) to aid in positioning the balloon. The balloon is further designed to provide an expandable segment of known diameter and length at a specific pressure.
The design of this catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.
A flushing needle accessory is also provided with the device to facilitate flushing/lubricating the catheter's inner guidewire lumen prior to use.
The AVIATOR Peripheral Dilatation Catheter is provided sterile and is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries, arteriovenous dialysis fistulae
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)
The safety and effectiveness of the Cordis AVIATOR Peripheral Dilatation Catheter have been demonstrated via data collected from non-clinical tests and analyses, which addressed the following, among other considerations, as determined necessary per applicable risk analyses:
- Biocompatibility
- Balloon minimum burst strength
- Balloon compliance (distensibility)
- Balloon inflation/deflation performance
- Balloon fatigue (repeated balloon inflation) endurance
- Bond strengths
- Catheter diameter and balloon profile
- Catheter body minimum burst strength
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K971448, K981407, K003159, K003920, K010831
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 870.1250 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
| NOV 2 8 2001 | 510(k) | |||
|---|---|---|---|---|
| Summary of Safety and Effectiveness | ||||
| Submitter: | Cordis Corporation, a Johnson & Johnson Company | |||
| 7 Powderhorn Drive | ||||
| Warren, New Jersey 07059 | ||||
| Contact Person: | Chuck Ryan | |||
| Manager, Regulatory Affairs | ||||
| Cordis Corporation, a Johnson & Johnson Company | ||||
| 7 Powderhorn Drive | ||||
| Warren, New Jersey 07059 | ||||
| Telephone: (908) 412-7446 | ||||
| Fax: (908) 412-3915 | ||||
| E-mail: cryan@crdus.jnj.com | ||||
| Date Prepared: | October 26, 2001 | |||
| Trade Name: | Cordis AVIATOR™ Peripheral Dilatation Catheter | |||
| Common Name: | Percutaneous Transluminal Angioplasty (PTA) Balloon | |||
| Catheter | ||||
| Classification Name: | (unclassified; FDA product code LIT) | |||
| Device Classification: | Class II |
Summary of Substantial Equivalence:
0 0 0004
The design, materials, specifications, performance, packaging and intended use featured with the Cordis AVIATOR Peripheral Dilatation Catheter are substantially equivalent to those featured among the following predicate devices:
- Cordis OPTA® LP PTA Catheter (ref. K971448 and K981407); .
- Cordis SLALOM™ .018 PTA Balloon Catheter (ref. K003159); ●
- Cordis M3 PTA Dilatation Catheter (ref. K003920); and, .
- Guidant AVIATOR Peripheral Dilatation Catheter (ref. K010831). .
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In short, the subject AVIATOR Peripheral Dilatation Catheter represents a line extension to the predicate Cordis devices that introduces substitute catheter materials.
Device Description:
The AVIATOR Peripheral Dilatation Catheter has an integrated shaft system and a balloon near the distal tip. The shaft has a combination of single lumen and dual lumen tubing. One lumen is used for inflation of the balloon with contrast medium. The second lumen, located only in the distal shaft, permits the use of a .014" diameter guidewire to facilitate the advancement of the catheter to and through the stenosis to be dilated. The catheter shaft has a distal port (hole) near the distal end that accesses the guidewire lumen. The guidewire lumen begins at the distal port and ends at the distal tip. This "rapid exchange" design allows insertion and removal of the catheter without extension of the guidewire.
The balloon has radiopaque marker(s) to aid in positioning the balloon. The balloon is further designed to provide an expandable segment of known diameter and length at a specific pressure.
The design of this catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.
A flushing needle accessory is also provided with the device to facilitate flushing/lubricating the catheter's inner guidewire lumen prior to use.
The AVIATOR Peripheral Dilatation Catheter is provided sterile and is intended for single use only.
Intended Use:
The AVIATOR Peripheral Dilatation catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Technological Characteristics:
The subject AVIATOR Peripheral Dilatation Catheter incorporates substantially equivalent indications for use, design, and dimensional and performance specifications as those found with the aforementioned predicate devices. The AVIATOR Peripheral Dilatation Catheter is provided in a range of expanded diameters from 4 to 7 mm and in lengths of 15 to 40 mm. The device features a useable catheter length of 75 to 135 cm.
Performance Data:
The safety and effectiveness of the Cordis A VIATOR Peripheral Dilatation Catheter have been demonstrated via data collected from non-clinical tests and analyses, which addressed the following, among other considerations, as determined necessary per applicable risk analyses:
. Biocompatibility
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- Balloon minimum burst strength .
- Balloon compliance (distensibility) .
- Balloon inflation/deflation performance .
- Balloon fatigue (repeated balloon inflation) endurance .
- Bond strengths ●
- Catheter diameter and balloon profile .
- Catheter body minimum burst strength .
A statement of substantial equivalence to another product is required by 21 CFR 807.87 and relates A statement of substantial can be marketed without prior reclassification or clinical only to whicher the present submission not related to the coverage of any patent and is not to apply of a present valsion or used as evidence in a patent infringement lawsuit. As the be interpreted as an administion of substantial equivalence under the Federal Food, commissioner of the stated, "I decembact that the product can be lawfully marketed without pre-Drug and Cosment received ton. This determination is not intended to have any bearing marker approval of reclassified in "This ingement suits." 42 Federal Register 42, 50 et seq. (1977).
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 8 2001
Mr. Chuck Ryan Manager, Regulatory Affairs Cordis Corporation, a Johnson & Johnson Company 7 Powder Horn Drive Warren, NY 07059
Re: K013581
Trade Name: Cordis AVIATOR™ Peripheral Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY and LIT Dated: October 26, 2001 Received: October 29, 2001
Dear Mr. Ryan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosule) to regars) at tegally and the Medical Device Amendments, or to conninered print to thay 20, 1978, are cassified in accordance with the provisions of the Federal Food, DINAA de necs that have been recidential in quire approval of a premarket approval application (PMA). and Cosmetic Act (110c) that ao not requent of the general controls provisions of the Act. The 1 ou may, dicrorolo, market are act include requirements for annual registration, listing of general voltared provision practice, 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 If your device is olassified (600 a00 voyals. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of t may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Chuck Ryan
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4645. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
James E. Dillard III
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Cordis Franchise Form - CFF 20-014 Rev.01 Intended Use Statement
Page 1 of 1 Effective Date: 1 1/15/00
Image /page/5/Picture/2 description: The image shows the word "Cordis" in a bold, sans-serif font. A thick line underlines the word. Below the line, the name "Cordis-Johnson" is written in a smaller, cursive font. The text appears to be a logo or brand name.
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Cordis AVIATOR Peripheral Dilatation Catheter
Indications for Use Statement
The Cordis AVIATOR Peripheral Dilatation catheter is intended to dilate senoses in the illio, femoral, ilio-I IIC Cordis A VIA I OK Feripies and for the treatment of obstructive lesions of naive or synthetic arteriovenous dialysis fistulae.
Division of Cardiovascular & Respiratory Devices
510(k) Number K01 3581
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Usc _________________
..............................................................................................................................................................................
OR
Over-The-Counter Use
..............................................................................................................................................................................
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