The Smash™ Percutaneous Transluminal Angioplasty (PTA) Catheter is recommended for use in percutaneous dilatation of the iliac, femoral, popliteal, tibial, renal, and tibioperoneal vessels in whose lumens are obstructed by atherosclerotic plaque. This catheter is not intended for use in the coronary arteries. Any other use than those indicated is not recommended.

Device Description

The Smash™ Percutaneous Transluminal Angioplasty (PTA) Catheter consists of a bilumen catheter with a controlled-compliance balloon mounted at the distal tip. The balloon is designed to inflate to a known diameter and length at a specific pressure and is inflated and deflated via the side port. The second lumen allows access to the distal tip of the catheter for guidewire insertion, pressure monitoring and infusion of contrast media. Two marker bands are positioned under the balloon at the proximal and distal tapers to aid in accurate placement.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Smash™ PTA Catheter, which primarily relies on demonstrating substantial equivalence to a predicate device (Match-35™ PTA Catheter) rather than novel acceptance criteria and a standalone clinical study. Therefore, several of the requested sections about AI/algorithm performance, expert-established ground truth, and training sets are not applicable to this device submission.

Here's a breakdown based on the provided information:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by the technical characteristics of the predicate device, the Match-35™ Percutaneous Transluminal Angioplasty (PTA) Catheter, and compliance with general performance testing guidelines. The "reported device performance" for the Smash™ PTA Catheter is that it performed acceptably in "non-clinical performance testing" similar to the predicate device and generally followed the "PTCA Balloon Catheters section in Part II of the 'Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices', May 1994."

Table of Acceptance Criteria (based on predicate device characteristics) and Reported Device Performance (Smash™ PTA Catheter):

Feature	Acceptance Criteria (Match-35™ PTA Catheter)	Reported Device Performance (Smash™ PTA Catheter)
Configuration	Bilumen	Bilumen
Shaft Length (cm)	40-200	60-120 (within predicate range)
Shaft French Size	5	5
Balloon Length (mm)	20-100	20-80 (within predicate range)
Balloon Diameter (mm)	3-12	3-12
Rated Burst Pressure (atm)	7-12	7-15 (equal or higher than predicate range)
Guidewire Size (inches)	0.035	0.035
Balloon Markers	2 (Gold / Tantalum)	2 (Gold)
Balloon Material	Polyethylene Terephthalate	Nylon (Different material, but considered acceptable via testing)
Manifold Material	Polycarbonate	ABS (Different material, but considered acceptable via testing)
Shaft Material	Polyester	Nylon (Different material, but considered acceptable via testing)

Study Information:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The submission refers to "non-clinical performance testing" which typically involves a defined number of units for each test (e.g., a certain number of balloons for burst pressure, fatigue).
- Data Provenance: Not specified, but given it's non-clinical testing performed by Schneider (USA) Inc., it would be internal lab data, likely from the United States. It is prospective testing designed to evaluate the physical properties of the device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This is a medical device submission based on physical and mechanical performance testing, not diagnostic accuracy requiring expert interpretation of images or clinical data. The "ground truth" is established by measured physical properties and engineering specifications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This pertains to clinical or diagnostic studies with human interpretation of data. The performance testing of this catheter would follow standard engineering and quality control protocols.
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 device is a medical catheter, not an AI-powered diagnostic or assistive technology.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a medical catheter, not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this submission is based on engineering specifications, measured physical and mechanical properties, and compliance with recognized industry standards and guidance documents (e.g., PTCA Balloon Catheters section in Part II of the "Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices", May 1994).
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device requiring a training set.
How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device requiring a training set.

Summary

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Premarket Notification for - Smash™ PTA Catheter

FEB 1 2 1998

16. 510(k) Summary

Date Prepared	June 30, 1997
Submitter
Address:	Schneider (USA) Inc5905 Nathan LaneMinneapolis, MN 55442
Phone :	(612) 550-5500
Fax :	(612) 550-5771
Contact Person
	Ronald W. BennettSenior Regulatory Affairs Specialist
Device Name and Classification
Trade Name	Smash™ Percutaneous Transluminal Angioplasty(PTA) Catheter
Common Name	Percutaneous Transluminal Angioplasty (PTA)Catheter
Classification	Class II
Predicate Device	Match-35TM Percutaneous TransluminalAngioplasty (PTA) Catheter - K913297, K926271

Device Description

and K942154

Intended Use

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Technical Characteristic Comparison to Predicate

The Smash™ Percutaneous Transluminal Angioplasty (PTA) Catheter has the same intended use and basic construction as the predicate device, the Match-35™ Percutaneous Transluminal Angioplasty (PTA) Catheter. The following table compares the technical characteristics of the two devices:

Feature	Match-35™ PercutaneousTransluminal Angioplasty(PTA) Catheter	Smash™ PercutaneousTransluminal Angioplasty(PTA) Catheter
Configuration	Bilumen	Bilumen
Shaft Length (cm)	40-200	60-120
Shaft French Size	5	5
Balloon Length (mm)	20-100	20-80
Balloon Diameter (mm)	3-12	3-12
Rated Burst Pressure (atm)	7-12	7-15
Guidewire Size (inches)	0.035	0.035
Balloon Markers	2 (Gold / Tantalum)	2 (Gold)
Balloon Material	Polyethylene Terephthalate	Nylon
Manifold Material	Polycarbonate	ABS
Shaft Material	Polyester	Nylon

Performance Data

The Smash™ Percutaneous Transluminal Angioplasty (PTA) Catheter had non-clinical performance testing as did the predicate device, the Match-35TM Percutaneous Transluminal Angioplasty (PTA) Catheter.

Testing of the Smash™ Percutaneous Transluminal Angioplasty (PTA) Catheter generally followed the PTCA Balloon Catheters section in Part II of the "Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices", May 1994. The following types of tests were performed similar to those in the guidance:

Balloon Minimum Burst Strength Balloon Compliance (Distensibility) Balloon Inflation/Deflation Performance Balloon Fatigue (Repeated Balloon Inflation) Bond Strength Catheter Diameter and Balloon Profile Catheter Body Burst Pressure

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The following additional evaluations were also performed by Schneider (USA):

Resistance through Stenosis Pull Back Resistance into Introducer Trackability Catheter Prep Time

The biocompatibility of the catheter was also tested and found acceptable.

Summary

In summary, Schneider (USA) Inc has demonstrated the Smash™ Percutaneous Transluminal Angioplasty (PTA) Catheter is substantially equivalent to the Match-35TM Percutaneous Transluminal Angioplasty (PTA) Catheter based on design, test results, and indications for use and is therefore acceptable for commercialization.

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Image /page/3/Picture/2 description: The image is a black and white seal for the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

FEB 1 2 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ronald W. Bennett Senior Regulatory Affairs Specialist Schneider (USA) Inc. Pfizer Hospital Products Group 5905 Nathan Lane Minneapolis, MN 55442

K972512 Re: Smash™ Percutaneous Transluminal Angioplasty (PTA) Regulatory Class: II (two) Product Code: 74 LIT Dated: January 16, 1998 Received: January 20, 1998

Dear Mr. Bennett:

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, 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 requlations 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 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 requlation 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-Also, please note the regulation entitled, "Misbranding by 4639. 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. Callahon

Thomas J. Cállahan, 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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Premarket Notification for Smash™ PTA Catheter

Page of

510(k) Number (if known):

Device Name:

Smash™ Percutaneous Transluminal Angioplasty (PTA) Catheter

Indications for Use:

The Smash™ Percutaneous Transluminal Angioplasty (PTA) Catheter is recommended for use in percutaneous dilation of the iliac, femoral, popliteal, tibial, renal, and tibioperoneal vessels in whose lumens are obstructed by atherosclerotic plaque. This catheter is not intended for use in the coronary arteries. Any other use than those indicated is not recommended.

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

		Concurrence of CDRH, Office of Device Evaluation (ODE)
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		(Division Sign-Off)Division of Cardiovascular, Respiratory,and Neurological Devices	(Division Sign-Off)	Division of Cardiovascular, Respiratory,	and Neurological Devices
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices

510(k) Number	K972512
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Prescription Use (Per 21 CFR 801.109)	OR	Over-The-Counter Use
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(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).