The Micro Medical Solutions PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including anterior tibial, posterior tibial, and pedal. Not for use in coronary arteries.

Device Description

The Micro Medical Solutions PTA Balloon Catheter is a single lumen catheter with a balloon located at the distal tip. As the MMS PTA Balloon Catheter is not an Over-The-Wire device. The catheter consists of a single lumen for balloon inflation and deflation.. Inscribed on the proximal strain relief of the catheter is the balloon diameter (mm) and balloon length (mm). Platinum/Iridium marker bands are positioned on the shaft within the balloon to enable visualization of the catheter/balloon under fluoroscopy.

AI/ML Overview

The provided text describes a 510(k) summary for the MMS PTA Balloon Catheter, focusing on its substantial equivalence to a predicate device. This document primarily details non-clinical performance testing for a medical device and does not include information about AI/ML algorithm performance studies or clinical studies with human readers. Therefore, I cannot provide details on questions related to AI-specific criteria, human reader performance, or multi-reader multi-case studies.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "Product testing was completed and met all of the acceptance criteria." However, it does not explicitly list the acceptance criteria for each test or detail the specific results. It only lists the tests performed.

Test Performed	Reported Device Performance
Dimensional verification	Met all of the acceptance criteria. Performed on sterile final product.
Surface Review	Met all of the acceptance criteria. Performed on sterile final product.
Leak	Met all of the acceptance criteria. Performed on sterile final product.
Tracking	Met all of the acceptance criteria. Performed on sterile final product.
Flex/Kink	Met all of the acceptance criteria. Performed on sterile final product.
Torque	Met all of the acceptance criteria. Performed on sterile final product.
Tensile	Met all of the acceptance criteria. Performed on sterile final product.
Balloon fatigue	Met all of the acceptance criteria. Performed on sterile final product.
Balloon burst	Met all of the acceptance criteria. Performed on sterile final product.
Packaging	Met all of the acceptance criteria. Performed on sterile final product.
Aging	Met all of the acceptance criteria. Performed on baseline (non-aged) products.
Biocompatibility (ISO 10993)	Found to be biocompatible (Cytotoxicity, Sensitization, Acute Systemic Toxicity, Hemolysis Extract, Hemolysis Direct Contact, Pyrogen, Complement Activation, Canine Thrombogenicity).
Animal Testing	Performed to specification.
Cadaver Experience	Performed to specification.

2. Sample Size Used for the Test Set and Data Provenance

Non-Clinical Testing: The document does not specify the sample size for the mechanical, physical, or chemical non-clinical tests (e.g., how many catheters were tested for burst pressure). It mentions testing was done on "sterile final product" and "baseline (non-aged) and aged products," but no specific numbers are given.
Animal Testing: The document mentions "Animal testing was conducted to assess the simulated clinical performance" but does not specify the number of animals or the type of animal used.
Cadaver Experience: "Cadaver testing was conducted using the vasculature below the knee" but does not specify the number of cadavers.
Data Provenance: The studies are non-clinical (bench testing, animal, cadaver). The country of origin for this data is not specified but is presumed to be internal testing by Micro Medical Solutions, Inc., a US-based company. These are retrospective tests performed to support premarket notification.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable. The device is a physical medical device (balloon catheter), and the "ground truth" for its performance is established through objective, non-clinical tests (mechanical, physical, chemical, biocompatibility, animal studies, cadaver studies), not through expert interpretation of data like images or clinical outcomes that would require human experts to establish ground truth.

4. Adjudication Method for the Test Set

This is not applicable as the studies described are non-clinical performance evaluations of a physical device, not an AI/ML diagnostic algorithm that requires expert adjudication of results.

5. 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

No such study was conducted or reported in this 510(k) summary. This document pertains to a physical medical device (balloon catheter), not an AI/ML diagnostic or assistive device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No standalone algorithm performance study was done. This document is for a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established through:

Objective Material and Mechanical Standards: Such as those defined by ISO 10993 for biocompatibility, and internal specifications for physical properties like burst pressure, dimensions, flexibility, etc.
Animal Models: For simulated clinical performance.
Cadaver Models: For simulated clinical use in specific anatomical contexts (below the knee vasculature).

8. The Sample Size for the Training Set

This is not applicable to a physical medical device. There is no AI/ML algorithm involved that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable to a physical medical device. There is no AI/ML algorithm involved that requires a training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 25, 2016

Micro Medical Solutions, Inc. Mr. Gregory Mathison Vice President, Regulatory, Clinical & Quality 790 Willard Street #209 Ouincy, MA 02169

Re: K152934

Trade/Device Name: MMS PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: February 29, 2016 Received: March 17, 2016

Dear Mr. Mathison:

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.

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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,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K152934

Device Name

MMS PTA Balloon Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☒Prescription Use (Part 21 CFR 801 Subpart D)	☐Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

General Information

Applicant:	Micro Medical Solutions240 Andover StreetWilmington, MA 01887Tel: 978.909.3045
Trade Name:	MMS PTA Balloon Catheter
Common Name:	Balloon Catheter
Classification Name:	Catheter, continuous flush
21CFR Number:	870.1250
Device Classification:	Class II
Product Code:	LIT
Predicate Devices:	Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter(K122940)
Contact	Greg MathisonVP Regulatory, Clinical & Quality
Date:	March 1, 2016

Substantially Equivalent to:

The MMS PTA Balloon Catheter is equivalent in intended use, principal of operation and technological characteristics to the Advance Micro 14 catheter (K122940).

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Description of the device subject to premarket notification

Indications for Use

The Micro Medical Solutions PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including anterior tibial, and pedal. Not for use in coronary arteries.

Materials

All materials used in the manufacture of the MMS PTA Balloon Catheter are suitable for this use and have been used in numerous previously cleared products. The MMS PTA Balloon Catheter materials were tested per ISO10993 and found to be biocompatible. Testing included the following:

Cytotoxicity ●
Sensitization ●
Acute Systemic Toxicity ●
Hemolysis Extract
Hemolysis Direct Contact ●
Pyrogen
Complement Activation ●
Canine Thrombogenicity ●

Animal Testing

Animal testing was conducted to assess the simulated clinical performance of the Guide Catheter. The product performed to specification.

Cadaver Experience

Cadaver testing was conducted using the vasculature below the knee to assess the simulated clinical use of the product. The product performed to specification.

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Non-Clinical Testing

Product testing was completed and met all of the acceptance criteria. Testing was conducted on sterile final product. Testing was performed on baseline (non-aged) and aged products. Testing included:

Dimensional verification ●
Surface Review ●
Leak ●
Tracking ●
Flex/Kink ●
Torque ●
Tensile ●
Balloon fatigue ●
Balloon burst ●
Packaging ●
Aging ●

Performance Data

All necessary verification and validation testing has been performed for the MMS PTA Balloon Catheter to assure substantial equivalence to the predicate devices.

Basis for Determination of Substantial Equivalence

Upon reviewing the performance testing provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the MMS PTA Balloon Catheter is determined to be substantially equivalent to existing legally marketed devices.

Comparison of Product Features

Trade name	MMS PTA Balloon Catheter	Advance Micro 14 Ultra Low-Profile PTA Balloon	SE Discussion
Product code	LIT	DQY	Equivalent
510(k) number	K152934	K122940
21CFR	870.1250	870.1250	Same CFR number
DeviceClassification	II	II	Same - Class II
Devicedescription	The Micro Medical SolutionsPTA Balloon Catheter is asingle lumen catheter with aballoon located at the distaltip. As the MMS PTABalloon Catheter is not anOver-The-Wire device. Thecatheter consists of a singlelumen for balloon inflationand deflation.. Inscribed onthe proximal strain relief of	The Advance Micro 14 Ultra Lo The device description is theProfile PTA Balloon Catheter is same.over-the-wire catheter availablewith an inflated balloon diameterof 1.5 mm with balloon lengths2 and 4 cm and balloon diameterof 2, 2.5, and 3 mm with balloonlengths of 2, 3, 4, 6,8, 10, and 12cm. The catheter is 2.5 French inouter diameter with a length of 590, or 150 cm. The catheter is	The device description is thesame.
	the catheter is the balloondiameter (mm) and balloonlength (mm).Platinum/Iridium markerbands are positioned on theshaft within the balloon toenable visualization of thecatheter/balloon underfluoroscopy.	compatible with a 0.014 inch (0.mm) diameter wire guide. It willsupplied sterile, intended for onetime use.
Intended Use	The Micro Medical SolutionsPTA Balloon Catheter isintended for percutaneoustransluminal angioplasty(PTA) of lesions in peripheralarteries including anteriortibial, posterior tibial, andpedal. Not for use in coronaryarteries.	The Advance Micro 14 UltraLow-Profile PTA BalloonCatheter is intended forpercutaneoustransluminal angioplasty(PTA) of lesions in peripheralarteries including internalpudendal,iliac, renal; popliteal, femoral,iliofemoral, anterior tibia],posterior tibial, peroneal,pedal, radial, brachial, andulnar, as well as obstructivelesions of native or syntheticarteriovenous dialysis fistulae.Not for use in the coronaryarteries.	Same Indications for Use
Catheter Length	65 cm working length	50cm, 90cm, and 150cm
CatheterDiameter	3.2 Fr	3.2 Fr maximum	Equivalent
BalloonDiameters	2.0, 2.5, 4.0 F	2, 2.5, and 3 mm	Equivalent
Balloon length	20, 40 and 80mm	2, 3, 4, 6, 8, 10, and 12 cm	Equivalent
Guidewire	Not over-the-wireRemovable stylet	.014 compatible	Equivalent
Method ofvisualization	Fluoro / Ultrasound	Fluoro	Equivalent
Sterilization	Yes - ETO	Yes - ETO	Both devices are suppliedsterile.
Single use	Yes	Yes	Same
Shelf life	12 months after production	Not indicated on submission	This will be on the productlabel

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Packaging	Hoop sealed in a Tyvek / Polypouch	Hoop sealed in a Tyvek / Polypouch	Equivalent
Materials	Biocompatible	Biocompatible	Biocompatible

Conclusion

The products are substantially equivalent as the indications for use are the same, the clinical application is the same, the materials are equivalent, the dimensions are equivalent and the tested product performance attributes are equivalent.

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).