MASTRO PLUS BALLOON IN-DEFLATION DEVICE

• K Number: K140943
• Device Name: MASTRO PLUS BALLOON IN-DEFLATION DEVICE
• Manufacturer: BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD.
• Date Cleared: 2015-03-05 ( 325 days)
• Product Code: MAV
• Regulation Number: 870.1650

Intended Use

The Balloon In-deflation device is used for the inflation of a balloon dilatation catheter, to dilate the vessel or implant a stent.

Device Description

The Balloon In-deflation Device is a 20ml or 30ml disposable device capable of producing a maximum pressure of 30atm/bars. It is fitted with a threaded plunger, a flexible high pressure extension tube, and a three-way high pressure stopcock. The luminescent pressure gauge with adjustable angle allows physician to read and monitor more easily in clinical environment. The product is designed under ergonomic principle that could be handled comfortably, easily and securely. The balloon in-deflation device mainly composes of four parts, injecting system (syringe), pressure gauge and extension tube, 3way stopcock, respectively. The syringe consists of a screw type plunger and a locking lever, by rotating palm grip to control the plunger; the pressure gauge is to measure pressure and the extension tube is to connect catheters. The angle of the pressure gauge can be re-adjusted during the procedure.

Predicate Devices

K130566, K993341, K032840

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical components and pressure measurement, with no mention of AI/ML terms or functions.

Therapeutic

No.
The device acts as an accessory for a balloon dilatation catheter, which is used for treatment. The device itself does not directly treat the patient; instead, it inflates the balloon of another device that performs the therapeutic action.

Diagnostic

No
The device is used for inflation of a balloon dilatation catheter to dilate vessels or implant stents, which are therapeutic actions, not diagnostic ones. It measures pressure during inflation, but this is for control of the therapeutic action rather than diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as a syringe, plunger, extension tube, pressure gauge, and stopcock, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to inflate a balloon dilatation catheter to dilate a vessel or implant a stent. This is a therapeutic or interventional procedure performed directly on the patient's body.
• Device Description: The description details a mechanical device used for applying pressure and monitoring it during a medical procedure. It does not involve the examination of specimens derived from the human body.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.

IVD devices are used to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely mechanical and procedural, not diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Balloon In-deflation device is used for the inflation of a balloon dilatation catheter, to dilate the vessel or implant a stent.

Product codes (comma separated list FDA assigned to the subject device)

MAV

Device Description

The Balloon In-deflation Device is a 20ml or 30ml disposable device capable of producing a maximum pressure of 30atm/bars. It is fitted with a threaded plunger, a flexible high pressure extension tube, and a three-way high pressure stopcock. The luminescent pressure gauge with adjustable angle allows physician to read and monitor more easily in clinical environment. The product is designed under ergonomic principle that could be handled comfortably, easily and securely.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

vessel

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)

Performance testing was conducted to validate and verify that the proposed device met all design specifications and was found to be substantially equivalent to the predicate device:

• Biocompatibility Testing: Pyrogen Test Endotoxin Test Acute Systemic Toxicity Test Irritation Test Cytotoxicity Test Skin sensitization Test Haemolysis Study Complement Activity Test Thrombosis test

Package Penetrate Testing
Asepsis Testing
Aging Testing
EtO and ECH Residue Testing

Bench Testing
Appearance test
Positive pressure sealing
Negative pressure sealing
Male luer lock testing
Capacity scale
Gauge accuracy

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K130566, K993341, K032840

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Summary

0

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right.

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

March 5, 2015

Beijing Demax Medical Technology Co., Ltd. % Mike Gu Regulatory Affairs Manager Osmunda Medical Device Consulting Co., LTD. 7th Floor, Jingui Business Building, No 982, Congyun Road Baiyun District Guangzhou, 510420 CN

Re: K140943

Trade/Device Name: Mastro Plus Balloon In-deflation Device Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: MAV Dated: February 2, 2015 Received: February 4, 2015

Dear Mike Gu.

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

1

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.

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Melissa A. Torres -S

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

Enclosure

2

Indications for Use

510(k) Number (if known) K140943

Device Name Mastro Plus Balloon in-deflation device

Indications for Use (Describe)

The Balloon In-deflation device is used for the inflation of a balloon dilatation catheter, to dilate the vessel or implant a stent.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

3

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."

4

Image /page/4/Picture/0 description: The image shows the logo for Demax Medical, which is a blue text logo with a plus sign in the middle. Below the logo is the text "510(k) Summary" in black. The text is centered below the logo.

In accordance with the requirements of SMDA 1990 and 21 CFR 807.92, the following summary of information is provided:

Date:	March 13, 2014
Submitter:	BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD.
Add: A13-7, Jingshengnansi Street,Tongzhou District, Beijing
101102, P.R.China
Primary Contact Person:	Mike Gu
Regulatory Affairs Manager
OSMUNDA Medical Device Consulting Co., Ltd.
Tel: [phone]
Fax: [phone]
Email: [e-mail]
Secondary Contact Person:	Ellen Bian
Regulation Affairs Dept. Manager
BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD.
Tel: [phone]
Fax: [phone]
Email: [e-mail]
Device:	Trade Name: Mastro™ Plus Balloon In-Deflation Device
Common/Usual Name: Inflation Syringe
Classification Names:	Angiographic injector and syringe
Product Code:	MAV

5

870.1650 Regulation number K130566, K032840 and K993341 Predicate Device(s): Device Description: The Balloon In-deflation Device is a 20ml or 30ml disposable device capable of producing a maximum pressure of 30atm/bars. It is fitted with a threaded plunger, a flexible high pressure extension tube, and a three-way high pressure stopcock. The luminescent pressure gauge with adjustable angle allows physician to read and monitor more easily in clinical environment. The product is designed under ergonomic principle that could be handled comfortably, easily and securely. Intended Use: The Balloon In-deflation device is used for the inflation and deflation of a balloon dilatation catheter, to dilate the vessel or implant a stent. The balloon in-deflation device mainly composes of four parts, Technology: injecting system (syringe), pressure gauge and extension tube, 3way stopcock, respectively. The syringe consists of a screw type plunger and a locking lever, by rotating palm grip to control the plunger; the pressure gauge is to measure pressure and the extension tube is to connect catheters. The angle of the pressure gauge can be re-adjusted during the procedure. Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

Performance testing was conducted to validate and verify that the proposed device met all design specifications and was found to be substantially equivalent to the predicate device:

• Biocompatibility Testing: Pyrogen Test Endotoxin Test Acute Systemic Toxicity Test Irritation Test Cytotoxicity Test Skin sensitization Test Haemolysis Study Complement Activity Test Thrombosis test

6

Package Penetrate Testing Asepsis Testing Aging Testing EtO and ECH Residue Testing

Bench Testing

Appearance test

Positive pressure sealing

Negative pressure sealing

Male luer lock testing

Capacity scale

Gauge accuracy

Comparison to predicates:

ITEM	Predicate Device	Predicate Device	Predicate Device	Proposed Device
K Number	K130566	K993341	K032840	---
Device name	basixTOUCH™	IntelliSystem II
Angioplasty Inflation
Device	QL® Inflation
Device	Balloon in-deflation
device
Manufacturer	Merit Medical
Systems, Inc.	Merit Medical
Systems, Inc.	Atrion Medical
Products, Inc.	Beijing Demax
Medical
Technology Co., Ltd
Classification	II	II	II	II
Product Code	MAV	MAV	KOE and MAV	MAV
Regulation
Number	870.1650	870.1650	876.5520 and
870.1650	870.1650
Intended Use	The basixTOUCH
inflation syringe is
used to inflate and
deflate an
angioplasty balloon
or other
interventional
device, and to
measure the	The Merit Medical
Intellisystem II
Monitor is for use only
with the disposable In
Intellisystem25
syringe. It may be used
to monitor the
pressure of
interventional devices
as well as measure	The Inflation
Device is
recommended for
use with balloon
dilatation catheters
to create and
monitor the
pressure in the
balloon and to
deflate the balloon.	The Balloon In-
deflation device is
used for the
inflation and
deflation of a
balloon dilatation
catheter, to dilate
the vessel or
	pressure within the
balloon.	injectate pressure in
various areas of the
body.		implant a stent.
Volume	30ml	20ml	10, 14, 20, 25, 40,
60 ml	20ml, 30ml
Range of
positive
pressure	Zero to +35ATM	Zero to +35ATM	15, 30, 40 ATM	Zero to +30ATM
Lock mechanism	Thread lock
mechanism	Thread lock
mechanism	Thread lock
mechanism	Thread lock
mechanism
Plunger	Unknown	Unknown	Screw-type plunger	Screw-type plunger
Volume
dispensed	Unknown	0.45ml ±0.07ml per
360° handle rotation	Unknown	Syringe with
capacity 20ml:
0.43ml per 360°
handle rotation
Syringe with
capacity
30ml:0.76ml per
360° handle
rotation
Accuracy	±2.5% full scale
typical (±0.9
ATM/Bar)	±2.5% full scale typical
(±0.5 ATM/Bar)	Between ±0.5
ATM/Bar and ±0.6
ATM/Bar	±4.0% full scale
typical (between
±0.8 and ±1
ATM/Bar)
Barrel material	Polycarbonate	Polycarbonate	Polycarbonate	Polycarbonate
Handle/plunger
material	ABS	ABS	Glass filled nylon
6/6 / Teflon	PA66+30%
Fiberglass
Extension tubing	Unknown	Unknown	Polyurethane	Polyurethane
Gauge	Unknown	Unknown	EPDM; brass and
stainless steel	Brass and PC
Connector	Male, rotating	Male, rotating	Male, rotating	Male, rotating
Mechanism of
quick release
handle	Yes	No	No	No
Display function	No	Yes	No	No
	No Cytoxicity	No Cytoxicity	Unknown	No Cytoxicity
Biocompatibility	No Evidence of
Dermal
No-Evidence of
Intracutaneous
Reactivity	No Evidence of Dermal
No-Evidence of
Intracutaneous
Reactivity		No Evidence of
Dermal
No-Evidence of
Intracutaneous
Reactivity
Sterilization	ETO	ETO	ETO	ETO
SAL	$10^{-6}$	$10^{-6}$	$10^{-6}$	$10^{-6}$
Sterilization
Validation	Per ISO 11135-
1:2006	Per ISO 11135-1	ISO 11135-1	Per ISO 11135-
1:2006
Labeling	Complies with FDA Requirements
Sterilization
Package
Performance	Complies with ISO 11607-1:2006
Package's
material	Unknown	Unknown	Unknown	PETG and Tyvek

7

Image /page/7/Picture/0 description: The image shows the logo for Demax Medical. The logo consists of the word "Demax" in a bold, sans-serif font, followed by a stylized plus sign that is also shaped like the letter "D". The word "Medical" is written in a similar font to the right of the plus sign. The entire logo is in a light blue color.

4 / 5

8

Image /page/8/Picture/0 description: The image shows the logo for Demax Medical. The logo is in blue and features the word "Demax" on the left, followed by a stylized plus sign in the center, and the word "Medical" on the right. The plus sign is formed by overlapping squares.

Summary of Clinical Tests:

The proposed device of this premarket submission, Balloon In-deflation Device, does not require clinical studies to support substantial equivalence.

Conclusion: The comparison between the predicate devices and the proposed devices demonstrates that the proposed devices are as safe and as effective and performs as well as the predicate device. Balloon In-deflation Device can be claimed to be Substantially Equivalent (SE) to the predicate device, namely, the basixTouch inflation device cleared in K130566, IntelliSystem II Angioplasty Inflation Device cleared in K993341and the QL® inflation device cleared in K032840.