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.

AI/ML Overview

Based on the provided text, here's a description of the acceptance criteria and the study that proves the device meets them:

The document does not detail specific acceptance criteria for each performance characteristic of the Mastro Plus Balloon In-deflation Device. Instead, it asserts substantial equivalence to predicate devices through a comparison of design specifications and non-clinical performance testing. The overarching "acceptance criteria" appear to be that the proposed device must meet all design specifications and perform as safely and effectively as the predicate devices.

1. A table of acceptance criteria and the reported device performance

While explicit acceptance criteria are not presented as numerical targets to be met, the table below infers the performance characteristics evaluated and the proposed device's performance as compared to its predicates. The "Acceptance Criteria" column reflects the general expectation for substantial equivalence (i.e., being comparable to or within acceptable ranges of the predicate's performance).

Performance Characteristic	Inferred Acceptance Criteria (Comparable to Predicates)	Reported Device Performance (Mastro Plus Balloon In-deflation Device)
Volume	Comparable to predicate devices (20ml, 30ml)	20ml, 30ml
Range of Positive Pressure	Zero to +35ATM (or similar)	Zero to +30ATM
Lock Mechanism	Thread lock mechanism	Thread lock mechanism
Plunger	Screw-type plunger	Screw-type plunger
Volume Dispensed	Comparable to predicate volume dispensed/rotation	Syringe with 20ml capacity: 0.43ml per 360° handle rotation; Syringe with 30ml capacity: 0.76ml per 360° handle rotation
Accuracy	±2.5% full scale typical (or similar)	±4.0% full scale typical (between ±0.8 and ±1 ATM/Bar)
Barrel Material	Polycarbonate	Polycarbonate
Handle/Plunger Material	ABS, Glass filled nylon 6/6 / Teflon (or similar)	PA66+30% Fiberglass
Extension Tubing	Polyurethane	Polyurethane
Gauge Material	EPDM; brass and stainless steel (or similar)	Brass and PC
Connector	Male, rotating	Male, rotating
Mechanism of quick release handle	Yes/No (depending on specific predicate feature)	No
Display Function	Yes/No (depending on specific predicate feature)	No
Biocompatibility	No Cytotoxicity; No Evidence of Dermal/Intracutaneous Reactivity	No Cytotoxicity; No Evidence of Dermal/Intracutaneous Reactivity
Sterilization	ETO	ETO
SAL	10^-6	10^-6
Sterilization Validation	Per ISO 11135-1:2006	Per ISO 11135-1:2006
Labeling	Complies with FDA Requirements	Implied compliance
Sterilization Package Performance	Complies with ISO 11607-1:2006	Implied compliance
Package Material	Unknown (predicate)	PETG and Tyvek

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for any of the non-clinical tests (biocompatibility or bench testing). It also does not provide details on the data provenance such as country of origin or whether the data was retrospective or prospective. The tests are described as general performance testing and biocompatibility testing.

3. 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)

This section is not applicable. The device is a "Balloon In-deflation Device," which is a physical medical instrument used for inflation/deflation of balloons and stents. The "ground truth" here is established through engineering and biological testing against specifications and standards, not through expert clinical consensus on interpretations of medical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable. As above, the "test set" refers to physical device testing, not clinical data requiring adjudication by experts.

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

This section is not applicable. The device is a physical medical instrument for catheter inflation/deflation, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.

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

This section is not applicable. The device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is established through:

Design specifications: The device is designed to perform according to a set of pre-defined engineering and functional specifications (e.g., pressure range, volume dispensed per rotation, material composition).
Recognized industry standards: Compliance with standards like ISO 11135-1:2006 for sterilization validation and ISO 11607-1:2006 for sterilization package performance.
Biocompatibility testing results: Tests like pyrogen, endotoxin, acute systemic toxicity, irritation, cytotoxicity, skin sensitization, haemolysis, complement activity, and thrombosis tests provide "ground truth" regarding the device's biological safety.
Bench testing results: Tests for appearance, positive/negative pressure sealing, male luer lock, capacity scale, and gauge accuracy provide "ground truth" for the device's physical and functional performance.

8. The sample size for the training set

This section is not applicable. This device is a physical medical instrument, not a machine learning model. Therefore, there is no "training set."

9. How the ground truth for the training set was established

This section is not applicable. As stated above, there is no "training set" for this device.

Summary

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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

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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 (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.

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

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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)

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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, Beijing101102, P.R.China
Primary Contact Person:	Mike GuRegulatory Affairs ManagerOSMUNDA Medical Device Consulting Co., Ltd.Tel: (+86) 20-6232 1333Fax: (+86) 20-8633 0253Email: mike.gu@osmundacn.com
Secondary Contact Person:	Ellen BianRegulation Affairs Dept. ManagerBEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD.Tel: (+86) 10-5977 1799-816Fax: +86-10-5977 1883Email: bianyuejing@demax.cn
Device:	Trade Name: Mastro™ Plus Balloon In-Deflation DeviceCommon/Usual Name: Inflation Syringe
Classification Names:	Angiographic injector and syringe
Product Code:	MAV

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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

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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 IIAngioplasty InflationDevice	QL® InflationDevice	Balloon in-deflationdevice
Manufacturer	Merit MedicalSystems, Inc.	Merit MedicalSystems, Inc.	Atrion MedicalProducts, Inc.	Beijing DemaxMedicalTechnology Co., Ltd
Classification	II	II	II	II
Product Code	MAV	MAV	KOE and MAV	MAV
RegulationNumber	870.1650	870.1650	876.5520 and870.1650	870.1650
Intended Use	The basixTOUCHinflation syringe isused to inflate anddeflate anangioplasty balloonor otherinterventionaldevice, and tomeasure the	The Merit MedicalIntellisystem IIMonitor is for use onlywith the disposable InIntellisystem25syringe. It may be usedto monitor thepressure ofinterventional devicesas well as measure	The InflationDevice isrecommended foruse with balloondilatation cathetersto create andmonitor thepressure in theballoon and todeflate the balloon.	The Balloon In-deflation device isused for theinflation anddeflation of aballoon dilatationcatheter, to dilatethe vessel or
	pressure within theballoon.	injectate pressure invarious areas of thebody.		implant a stent.

Volume	30ml	20ml	10, 14, 20, 25, 40,60 ml	20ml, 30ml
Range ofpositivepressure	Zero to +35ATM	Zero to +35ATM	15, 30, 40 ATM	Zero to +30ATM
Lock mechanism	Thread lockmechanism	Thread lockmechanism	Thread lockmechanism	Thread lockmechanism
Plunger	Unknown	Unknown	Screw-type plunger	Screw-type plunger
Volumedispensed	Unknown	0.45ml ±0.07ml per360° handle rotation	Unknown	Syringe withcapacity 20ml:0.43ml per 360°handle rotationSyringe withcapacity30ml:0.76ml per360° handlerotation
Accuracy	±2.5% full scaletypical (±0.9ATM/Bar)	±2.5% full scale typical(±0.5 ATM/Bar)	Between ±0.5ATM/Bar and ±0.6ATM/Bar	±4.0% full scaletypical (between±0.8 and ±1ATM/Bar)
Barrel material	Polycarbonate	Polycarbonate	Polycarbonate	Polycarbonate
Handle/plungermaterial	ABS	ABS	Glass filled nylon6/6 / Teflon	PA66+30%Fiberglass
Extension tubing	Unknown	Unknown	Polyurethane	Polyurethane
Gauge	Unknown	Unknown	EPDM; brass andstainless steel	Brass and PC
Connector	Male, rotating	Male, rotating	Male, rotating	Male, rotating
Mechanism ofquick releasehandle	Yes	No	No	No
Display function	No	Yes	No	No
	No Cytoxicity	No Cytoxicity	Unknown	No Cytoxicity
Biocompatibility	No Evidence ofDermalNo-Evidence ofIntracutaneousReactivity	No Evidence of DermalNo-Evidence ofIntracutaneousReactivity		No Evidence ofDermalNo-Evidence ofIntracutaneousReactivity
Sterilization	ETO	ETO	ETO	ETO
SAL	$10^{-6}$	$10^{-6}$	$10^{-6}$	$10^{-6}$
SterilizationValidation	Per ISO 11135-1:2006	Per ISO 11135-1	ISO 11135-1	Per ISO 11135-1:2006
Labeling	Complies with FDA Requirements
SterilizationPackagePerformance	Complies with ISO 11607-1:2006
Package'smaterial	Unknown	Unknown	Unknown	PETG and Tyvek

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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.

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.