FOCUS™-PV Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty of the large vessels of the renal, femoral, popliteal, tibial, peroneal, iliac and profunda arteries and for treatment of obstructive lesions of native or synthetic arterovenous dialysis fistulae.

Device Description

Not Found

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the FOCUS™-PV Balloon Dilatation Catheter. A 510(k) submission is primarily for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a formal study with detailed performance metrics as one might find in a de novo application or a clinical trial for a novel device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets them in the way clinical trials or performance studies for novel devices typically would.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: This document focuses on comparing the new device's specifications and intended use to predicate devices, not on setting and meeting specific performance acceptance criteria from a study.
Sample size used for the test set and the data provenance: No test set is described. The 510(k) primarily relies on substantial equivalence to existing devices rather than new performance data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such test set or ground truth establishment is mentioned.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device (balloon catheter), not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Explanation based on the provided text:

The document is a 510(k) summary for the FOCUS™-PV Balloon Dilatation Catheter. The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a predicate device already legally marketed. This means the device has:

The same intended use as a predicate device.
The same technological characteristics as a predicate device; OR
Different technological characteristics from a predicate device but does not raise different questions of safety and effectiveness, and the new device is as safe and effective as the predicate device.

The provided text details:

Intended Use: The FOCUS™-PV Balloon Dilatation Catheter is intended for percutaneous transluminal angioplasty of large vessels in various arteries and for treatment of obstructive lesions in arteriovenous dialysis fistulae. This is compared to the intended uses of several predicate devices, demonstrating similarity.
Comparison of Characteristics: A detailed table (TABLE 1) compares the physical and material characteristics of the FOCUS™-PV catheter with several predicate PTA catheters (Schneider Match 35™, Schneider Total Cross™, Medi-tech MS Classique™, Medi-tech Ultra-Thin™, and previous versions of CardioVascular Dynamics' FOCUS™). This comparison highlights similarities in balloon size ranges, lengths, shaft sizes, materials, and guidewire compatibility.

The FDA's letter states that they "determined the device is substantially equivalent... to 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..." This "substantial equivalence" determination is the "acceptance criteria" met in the context of a 510(k) process, rather than specific performance metrics from a dedicated clinical study.

Summary

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FOCUS™-PV Balloon Dilatation Catheter April 18, 1997

K971577

SECTION 3 - 510(k) SUMMARY

Submitted By:

CardioVascular Dynamics Incorporated (CVD) 13700 Alton Parkway Irvine, CA 92618 714-457-9546 Contact: Pamela Misajon

JUN 18 1997

Summary Preparation:

Classification Name:

Predicate Device: PTA Catheters: April 18, 1997

Device:

FOCUS™-PV Balloon Dilatation Catheter

Catheter, Peripheral, Balloon Type

Match 35TM PTA Balloon Catheters Schneider

Total Cross™ Balloon Dilatation Catheter Schneider

MS Classique™ Balloon Dilatation Catheter Medi-tech

Ultra-Thin™ Balloon Dilatation Catheter Medi-tech

FOCUSTM Balloon Dilatation Catheter CardioVascular Dynamics, Inc. 510(k) K944016 SE Date: December 20,1994

FOCUSTM Balloon Dilatation Catheter CardioVascular Dynamics, Inc. 510(k) K952064 SE Date: June 21, 1995

FOCUSTM Balloon Dilatation Catheter CardioVascular Dynamics, Inc. 510(k) K954313 SE Date: December 1, 1995

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INTENDED USE

COMPARISON TO PREDICATE DEVICES:

The intended use of the CVD FOCUSTM-PV catheter as it appears in the labeling is as . follows:
"FOCUSTM-PV Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty of the large vessels of the renal, femoral, popliteal, tibial, peroneal, iliac and profunda arteries and for treatment of obstructive lesions of native or synthetic arterovenous dialysis fistulae."
The intended use of the predicate Schneider Match 35™ catheter as it appears in the . labeling is as follows:
"Schenider MATCH 35™ Percutaneous Transluminal Angioplasty (PTA) Catheters are recommended for use in percutaneous transluminal angioplasty of narrowed segments of peripheral vessels. This catheter is not designed for use in the coronary arteries. Any use other than those indicated is not recommended."
The intended use of the predicate Schneider Total Cross™ .021 catheter as it appears in . the labeling is as follows:
"Schenider TOTAL CROSS™ .021 Percutaneous Transluminal Angioplasty (PTA) Catheters are recommended for use in percutaneous transluminal angioplasty of narrowed segments of peripheral vessels. This catheter is not designed for use in the coronary arteries. Any use other than those indicated is not recommended."
The intended use of the predicate Medi-tech MS Classique™ catheter as it appears in the . labeling is as follows:
"The MS Classique Balloon Catheter is recommended for: percutaneous transluminal angioplasty of the aorta, superior mesenteric, subclavian, brachial, iliac, femoral, popliteal and renal arteries; percutaneous transhepatic biliary tract stenosis and/or sphincter stenosis, use in conjunction with choledochojejunostomy performed with a Roux-en Y; transureteral and transurethral dilatation of strictures in the urinary tract."

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The intended use of the predicate Medi-tech Ultra-Thin™ catheter as it appears in the . labeling is as follows:
"Ultra-thin Balloon Dilatation Catheters are recommended for Percutaneous Transluminal Angioplasty of the iliac, Femoral and Renal Arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Ultra-thin Catheters are not indicated for use in coronary arteries."
The intended use of the CVD FOCUS catheter as it appears in the labeling is as follows: .
"FOCUS Balloon Dilatation Catheters are recommended for perculaneous transluminal angioplasty of the small vessels of the femoral, popliteal, tibial, peroneal, and profunda arteries."

DISCUSSION

All of the above catheters are recommended for balloon angioplasty of the peripheral vessels. All predicate devices listed have been through the 510(k) process.

The FOCUS™-PV Balloon Dilatation Catheter is intended to be used in the same anatomical sites as the predicate devices.

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TABLE 1

-COMPARISON OF FOCUS WITH CURRENTLY MARKETED PTA CATHETERS

MANUFACTURERProduct Name	CardioVascularDynamicsFOCUS BalloonDilatationCatheter	CardioVascularDynamicsFOCUS -PVBalloon DilatationCatheter	SchneiderMatch 35 PTABalloon DilatationCatheter	SchneiderTotal Cross PTABalloondilatationCatheter	Medi-techMS ClassiqueBalloonDilatationCatheter	Medi-techMS Ultra-ThinBalloon DilatationCatheter
Balloon size	2.5 - 4. mm(0.5 incr.)	4.0/5.0-7.0/8.0mm (1.0 incr)	3.0 -- 10.0 mm	2.0 - 8.0 mm	4.0 - 10.0 mm	4.0 - 10.0 mm
Balloon Length	20, 25 mm	25, 30, 40 mm	20, 40, 80, 100 mm	20, 40, 80 mm	25, 40, 80,100 mm	20, 40, 80,100 mm
Shaft Size	3.5F proximal3.0F distal	4.3F/5.0F	4.3F/5.0F	4.3F	4.8F and 5.2F	5.0F
Shaft Length	135 cm	75 - 150 cm	75 - 150 cm	95 - 150 cm	75 - 120 cm	75 - 150 cm
BalloonMaterials	Polyethylene/PET	PolyethyleneTerephalate (PET)	PolyethyleneTerephalate (PET)	Polyethylene/PET	PolyethyleneTerephalate(PET)	PolyethyleneTerephalate (PET)
Shaft	Polyethylene	Nylon	Polyester	Polyester	Polyester	Polyester
Guidewire size (Max)	0.014 in.	0.018/0.035 in.	0.035 in.	0.021 in.	0.035 in.	0.035 in.

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Reason for Premarket Notification:

This 510(k) is for a modification to an existing device, 510(k) number K963688 SE Date March 28, 1997.

Predicate Devices:

Schneider Match 35TM PTA Balloon catheter

Schneider Total Cross™ Balloon dilatation Catheter

Medi-tech MS Classique™ Balloon Dilatation Catheter

Medi-tech Ultra-Thin™ Balloon Dilatation Catheter

CardioVascular dynamics, Inc. FOCUSTM Balloon Dilatation Catheter 510(k) number K944016 SE Date: December 20, 1994

510(k) number K952064 SE Date: June 21, 1995

510(k) number K954313 SE Date: December 1, 1995

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). 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 a human figure, represented by three curved lines that suggest a profile view of a person's head and shoulders.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 18 1997

Ms. Kimberly Sailer Product Requlation Manager CardioVascular Dynamics, Inc. 13700 Alton Parkway Irvine, California 92618

Re : K971577 FOCUS™ - PV Balloon Dilatation Catheter Requlatory Class: II (two) Product Code: LIT Dated: April 18, 1997 Received: April 21, 1997

Dear Ms. Sailer:

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 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, qood 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 Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this 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.

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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) 594-4648. 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

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

Enclosure

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1 Page of

K971577 510(k) Number (if known):

FOCUS PV BALLOON DILATATION CATHETER Device Name:

Indications For Use:

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FOCUS™-PV Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty of the large vessels of the renal, femoral, popliteal, tibial, peroneal, iliac and arratophasty of as and for treatment of obstructive lesions of native or synthetic arterovenous dialysis fistulae.

Tut. R

(On-Off)
Cardiovascular, Respiratory.
Devices
510(k) Number: K971572

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
✓

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).