Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard PTA balloon catheter and does not mention any AI or ML components or functionalities.

Therapeutic

Yes
The device is described as a "PTA Balloon Catheter" intended for "percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries," which is a therapeutic medical procedure.

Diagnostic

No

The device is a PTA (percutaneous transluminal angioplasty) balloon catheter, which is used for treatment (dilating lesions) in peripheral arteries, not for diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical catheter with a balloon, lumen, marker bands, and strain relief. The performance studies also focus on physical characteristics and performance in animal and cadaver models, not software validation.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
Device Function: The Micro Medical Solutions PTA Balloon Catheter is a medical device used inside the body (in vivo) to perform a therapeutic procedure (angioplasty) on peripheral arteries. It is a physical tool used to treat a condition, not to analyze a sample for diagnostic purposes.
Intended Use: The intended use clearly states "percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries," which is a treatment procedure.
Device Description: The description details the physical components of a catheter designed for insertion into blood vessels and balloon inflation, not for analyzing biological samples.

Therefore, based on the provided information, the Micro Medical Solutions PTA Balloon Catheter is a therapeutic medical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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, posterior tibial, and pedal. Not for use in coronary arteries.

Product codes

LIT

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Fluoro / Ultrasound

Anatomical Site

peripheral arteries including anterior tibial, posterior tibial, and pedal. Not for use in coronary arteries.

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

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

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

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

Key Metrics

Not Found

Predicate Device(s)

K122940

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and well-being. The eagle is positioned above the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA," which are arranged in a circular fashion around the eagle.

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.

1

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)

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
*"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."*PSC Publishing Services (301) 443-6740

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Image /page/3/Picture/0 description: The image shows the logo for Micro Medical Solutions. The logo features a stylized red DNA strand above the words "micro medical" in gray, with "solutions" in a smaller font below. The logo is clean and modern, with a focus on the company's name and its connection to medical solutions.

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 Solutions
240 Andover Street
Wilmington, MA 01887
Tel: 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 Mathison
VP 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

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.

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
Device
Classification	II	II	Same - Class II
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 Advance Micro 14 Ultra Lo The device description is the
Profile PTA Balloon Catheter is same.
over-the-wire catheter available
with an inflated balloon diameter
of 1.5 mm with balloon lengths
2 and 4 cm and balloon diameter
of 2, 2.5, and 3 mm with balloon
lengths of 2, 3, 4, 6,8, 10, and 12
cm. The catheter is 2.5 French in
outer diameter with a length of 5
90, or 150 cm. The catheter is	The device description is the
same.
	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.	compatible with a 0.014 inch (0.
mm) diameter wire guide. It will
supplied sterile, intended for one
time use.
Intended Use	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.	The Advance Micro 14 Ultra
Low-Profile PTA Balloon
Catheter is intended for
percutaneous
transluminal angioplasty
(PTA) of lesions in peripheral
arteries including internal
pudendal,
iliac, renal; popliteal, femoral,
iliofemoral, anterior tibia],
posterior tibial, peroneal,
pedal, radial, brachial, and
ulnar, as well as obstructive
lesions of native or synthetic
arteriovenous dialysis fistulae.
Not for use in the coronary
arteries.	Same Indications for Use
Catheter Length	65 cm working length	50cm, 90cm, and 150cm
Catheter
Diameter	3.2 Fr	3.2 Fr maximum	Equivalent
Balloon
Diameters	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-wire
Removable stylet	.014 compatible	Equivalent
Method of
visualization	Fluoro / Ultrasound	Fluoro	Equivalent
Sterilization	Yes - ETO	Yes - ETO	Both devices are supplied
sterile.
Single use	Yes	Yes	Same
Shelf life	12 months after production	Not indicated on submission	This will be on the product
label

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| Packaging | Hoop sealed in a Tyvek / Poly
pouch | Hoop sealed in a Tyvek / Poly
pouch | 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.