K Number
K981407
Device Name
OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER
Manufacturer
Date Cleared
1998-05-20

(30 days)

Product Code
Regulation Number
870.1250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Opta LP and Powerflex Plus PTA Balloon Catheters are intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and, for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Device Description
The Opta LP and Powerflex Plus PTA Balloon Catheters have a dual lumen design with distal inflatable balloon. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. The balloon inflation lumen is used to inflate and deflate the balloon. The nominal balloon size is printed on the hub. The guidewire lumen is used to track the catheter over a prepositioned guidewire or to inject contrast medium and/or saline. The maximum injection pressure is 150 psi. The compatible guidewire size, catheter shaft French size and catheter length are printed on the hub. The radiopaque marker bands indicate the stated nominal length of the balloon
More Information

Cordis Opta LP PTA Balloon Catheter, Cordis Powerflex Plus PTA Balloon Catheter, Cordis Opta5 PTA Balloon Catheter, Cordis Powerflex PTA Balloon Catheter

Not Found

No
The device description focuses on the mechanical components and function of a balloon catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".

Yes
The device is intended to "dilate stenoses," which is a treatment for a medical condition.

No
The device is a balloon catheter intended to dilate stenoses, which is a therapeutic rather than a diagnostic function.

No

The device description clearly details a physical medical device (balloon catheter) with hardware components like lumens, balloons, and marker bands. It is not solely software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
  • Device Description and Intended Use: The provided information describes a PTA (Percutaneous Transluminal Angioplasty) Balloon Catheter. This is a medical device used within the body (in vivo) to physically dilate narrowed blood vessels. It is a therapeutic device, not a diagnostic test performed on samples outside the body.

The description clearly outlines its use in procedures to open up arteries and fistulae, which is a treatment, not a diagnostic process.

N/A

Intended Use / Indications for Use

The Opta LP and Powerflex Plus PTA Balloon Catheters are intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and, for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Product codes

LIT

Device Description

The Opta LP and Powerflex Plus PTA Balloon Catheters have a dual lumen design with distal inflatable balloon. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. The balloon inflation lumen is used to inflate and deflate the balloon. The nominal balloon size is printed on the hub. The guidewire lumen is used to track the catheter over a prepositioned guidewire or to inject contrast medium and/or saline. The maximum injection pressure is 150 psi. The compatible guidewire size, catheter shaft French size and catheter length are printed on the hub. The radiopaque marker bands indicate the stated nominal length of the balloon

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 and renal arteries; native or synthetic 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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Cordis Opta LP PTA Balloon Catheter, Cordis Powerflex Plus PTA Balloon Catheter, Cordis Opta5 PTA Balloon Catheter, Cordis Powerflex PTA Balloon Catheter

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

K981407

Attachment 4

_ ------ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ

1.2.

MAY 20 1998Summary of Safety and Effectiveness
General
ProvisionsTrade Name: Opta LP PTA Balloon Catheter
Powerflex Plus PTA Balloon Catheter
Common/Classification Name: Peripheral Transluminal Angioplasty Balloon
Catheter
Name of
Predicate
DevicesCordis Opta LP PTA Balloon Catheter
Cordis Powerflex Plus PTA Balloon Catheter
Cordis Opta5 PTA Balloon Catheter
Cordis Powerflex PTA Balloon Catheter
ClassificationClass II.
Performance
StandardsPerformance standards have not been established by the FDA under section
514 of the Food, Drug and Cosmetic Act.
Intended Use
and Device
DescriptionThe Opta LP and Powerflex Plus PTA Balloon Catheters are intended to
dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and
renal arteries and, for the treatment of obstructive lesions of native or
synthetic arteriovenous dialysis fistulae.
The Opta LP and Powerflex Plus PTA Balloon Catheters have a dual lumen
design with distal inflatable balloon. Two radiopaque marker bands indicate
the dilating section of the balloon and aid in balloon placement.
All balloons distend to sizes above the nominal size at pressures greater than
the nominal pressure.
The balloon inflation lumen is used to inflate and deflate the balloon. The
nominal balloon size is printed on the hub.
The guidewire lumen is used to track the catheter over a prepositioned
guidewire or to inject contrast medium and/or saline. The maximum injection
pressure is 150 psi. The compatible guidewire size, catheter shaft French size
and catheter length are printed on the hub. The radiopaque marker bands
indicate the stated nominal length of the balloon

ar and o

1

Summary of Substantial Equivalence

The Opta LP and Powerflex Plus PTA Balloon Catheters described in this submission are similar in their basic design, construction, indications for use and performance characteristics to Opta LP, Powerflex Plus, Opta5 and Powerflex PTA catheters which previously received 510(k) concurrence.

000000

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 20 1998

Mirjam Barboza, M.D. Manager, Regulatory Affairs Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014

Re: K981407 Trade Name: Cordis Opta LP PTA Balloon Catheter and Cordis Powerflex Plus PTA Balloon Catheter Regulatory Class: II Product Code: LIT Dated: April 17, 1998 Received: April 20, 1998

Dear Dr. Barboza:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this

3

Page 2 - Dr. Barboza

response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Thomas J. Callahan

Thomas J. Callaha Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

in and the same

4

Indications for Use Statement

| 510(k) Number

(if known)
Device NameCordis Powerflex Plus PTA Balloon Catheter
Indications for
UseThe Powerflex Plus PTA Balloon Catheter is indicated to dilate stenoses in
iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries, and for
treatment of obstructive lesions of native or synthetic arteriovenous dialysis
fistulae.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Turt. A. Q

(Division Sign-Off) Division of Cardiovascular, P and Neurological Devices 18/45/ 510(k) Number

Prescription Use _ (Per 21 CFR 801.109)

. --

OR

Over-The-Counter Use_