MASTRO PLUS BALLOON IN-DEFLATION DEVICE

K140943 · Beijing Demax Medical Technology Co.,Ltd · MAV · Mar 5, 2015 · Cardiovascular

Device Facts

• Record ID: K140943
• Device Name: MASTRO PLUS BALLOON IN-DEFLATION DEVICE
• Applicant: Beijing Demax Medical Technology Co.,Ltd
• Product Code: MAV · Cardiovascular
• Decision Date: Mar 5, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Disposable 20ml or 30ml manual inflation device; features threaded plunger, flexible high-pressure extension tube, and three-way high-pressure stopcock. Physician rotates palm grip to control plunger; luminescent pressure gauge with adjustable angle monitors pressure during balloon dilatation or stent implantation. Used in clinical environments by physicians. Device provides mechanical pressure control; output is visual pressure reading on gauge. Benefits include ergonomic handling and secure pressure monitoring during interventional procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (pyrogen, endotoxin, systemic toxicity, irritation, cytotoxicity, sensitization, haemolysis, thrombosis), package integrity, and performance testing (pressure sealing, gauge accuracy, luer lock testing).

Technological Characteristics

Manual inflation syringe; 20ml/30ml capacity; max pressure 30atm. Materials: Polycarbonate barrel, PA66+30% Fiberglass plunger, Polyurethane tubing, Brass/PC gauge. Threaded plunger mechanism. Sterilization: ETO (ISO 11135-1). Packaging: PETG and Tyvek (ISO 11607-1).

Indications for Use

Indicated for inflation and deflation of balloon dilatation catheters to dilate vessels or implant stents in patients undergoing interventional procedures.

Regulatory Classification

Special Controls

*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.

Predicate Devices

• basixTOUCH (K130566)
• IntelliSystem II Angioplasty Inflation Device (K993341)
• QL Inflation Device (K032840)

Submission Summary (Full Text)

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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 [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

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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.<br>Add: A13-7, Jingshengnansi Street,Tongzhou District, Beijing<br>101102, P.R.China |
| Primary Contact Person: | Mike Gu<br>Regulatory Affairs Manager<br>OSMUNDA Medical Device Consulting Co., Ltd.<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Secondary Contact Person: | Ellen Bian<br>Regulation Affairs Dept. Manager<br>BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD.<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Device: | Trade Name: Mastro™ Plus Balloon In-Deflation Device<br>Common/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 II<br>Angioplasty Inflation<br>Device | QL® Inflation<br>Device | Balloon in-deflation<br>device |
| Manufacturer | Merit Medical<br>Systems, Inc. | Merit Medical<br>Systems, Inc. | Atrion Medical<br>Products, Inc. | Beijing Demax<br>Medical<br>Technology Co., Ltd |
| Classification | II | II | II | II |
| Product Code | MAV | MAV | KOE and MAV | MAV |
| Regulation<br>Number | 870.1650 | 870.1650 | 876.5520 and<br>870.1650 | 870.1650 |
| Intended Use | The basixTOUCH<br>inflation syringe is<br>used to inflate and<br>deflate an<br>angioplasty balloon<br>or other<br>interventional<br>device, and to<br>measure the | The Merit Medical<br>Intellisystem II<br>Monitor is for use only<br>with the disposable In<br>Intellisystem25<br>syringe. It may be used<br>to monitor the<br>pressure of<br>interventional devices<br>as well as measure | The Inflation<br>Device is<br>recommended for<br>use with balloon<br>dilatation catheters<br>to create and<br>monitor the<br>pressure in the<br>balloon and to<br>deflate the balloon. | The Balloon In-<br>deflation device is<br>used for the<br>inflation and<br>deflation of a<br>balloon dilatation<br>catheter, to dilate<br>the vessel or |
| | pressure within the<br>balloon. | injectate pressure in<br>various areas of the<br>body. | | implant a stent. |
| | | | | |
| Volume | 30ml | 20ml | 10, 14, 20, 25, 40,<br>60 ml | 20ml, 30ml |
| Range of<br>positive<br>pressure | Zero to +35ATM | Zero to +35ATM | 15, 30, 40 ATM | Zero to +30ATM |
| Lock mechanism | Thread lock<br>mechanism | Thread lock<br>mechanism | Thread lock<br>mechanism | Thread lock<br>mechanism |
| Plunger | Unknown | Unknown | Screw-type plunger | Screw-type plunger |
| Volume<br>dispensed | Unknown | 0.45ml ±0.07ml per<br>360° handle rotation | Unknown | Syringe with<br>capacity 20ml:<br>0.43ml per 360°<br>handle rotation<br>Syringe with<br>capacity<br>30ml:0.76ml per<br>360° handle<br>rotation |
| Accuracy | ±2.5% full scale<br>typical (±0.9<br>ATM/Bar) | ±2.5% full scale typical<br>(±0.5 ATM/Bar) | Between ±0.5<br>ATM/Bar and ±0.6<br>ATM/Bar | ±4.0% full scale<br>typical (between<br>±0.8 and ±1<br>ATM/Bar) |
| Barrel material | Polycarbonate | Polycarbonate | Polycarbonate | Polycarbonate |
| Handle/plunger<br>material | ABS | ABS | Glass filled nylon<br>6/6 / Teflon | PA66+30%<br>Fiberglass |
| Extension tubing | Unknown | Unknown | Polyurethane | Polyurethane |
| Gauge | Unknown | Unknown | EPDM; brass and<br>stainless steel | Brass and PC |
| Connector | Male, rotating | Male, rotating | Male, rotating | Male, rotating |
| Mechanism of<br>quick release<br>handle | Yes | No | No | No |
| Display function | No | Yes | No | No |
| | No Cytoxicity | No Cytoxicity | Unknown | No Cytoxicity |
| Biocompatibility | No Evidence of<br>Dermal<br>No-Evidence of<br>Intracutaneous<br>Reactivity | No Evidence of Dermal<br>No-Evidence of<br>Intracutaneous<br>Reactivity | | No Evidence of<br>Dermal<br>No-Evidence of<br>Intracutaneous<br>Reactivity |
| Sterilization | ETO | ETO | ETO | ETO |
| SAL | $10^{-6}$ | $10^{-6}$ | $10^{-6}$ | $10^{-6}$ |
| Sterilization<br>Validation | Per ISO 11135-<br>1:2006 | Per ISO 11135-1 | ISO 11135-1 | Per ISO 11135-<br>1:2006 |
| Labeling | Complies with FDA Requirements | | | |
| Sterilization<br>Package<br>Performance | Complies with ISO 11607-1:2006 | | | |
| Package's<br>material | Unknown | Unknown | Unknown | PETG and Tyvek |

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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.

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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.