AG MASS

K131099 · Hospitech Respiration , Ltd. · JCX · May 13, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K131099
• Device Name: AG MASS
• Applicant: Hospitech Respiration , Ltd.
• Product Code: JCX · General, Plastic Surgery
• Decision Date: May 13, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2

Intended Use

The AG MASSTM Suction Pump System is intended for the application of lowflow suction for the removal of fluids, including irrigation fluids, body fluids and infectious materials.

Device Story

AG MASS is a sterile, single-use injection and draining device designed for use with Hospitech's AnapnoGuard Endotracheal Tube (ETT). It integrates two syringes (35 CC and 10 CC) within a main body to deliver saline for diluting secretions accumulated above the ETT cuff and subsequently draining the fluids. The device operates via manual injection and vacuum application, mimicking the common clinical practice of manual secretion evacuation. It is intended for use in clinical settings to manage respiratory secretions. By automating the delivery and suction process, it aims to safely and efficiently remove infectious materials from the patient's respiratory support system.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included draining validation, chemical and toxicological assessment of the prefilled saline syringe, and evaluation of leachables and extractables post-sterilization. The device complies with ISO 11137-1 (sterilization) and ISO 10993-1 (biological evaluation).

Technological Characteristics

Sterile, single-use injection and draining device. Contains 35 CC and 10 CC syringes within a main body. Manual operation. Complies with ANSI/AAMI/ISO 11137-1 for radiation sterilization and ISO 10993-1 for biological evaluation.

Indications for Use

Indicated for patients requiring removal of fluids, including irrigation fluids, body fluids, and infectious materials, via low-flow suction, specifically for use with Hospitech's AnapnoGuard Endotracheal Tube.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

• Boehirnger Laboratories Suction Pump System (K060277)
• Aardvark nasal irrigation and aspiration device (K082762)
• Single Cannula Extended Applicator (K102563)

Submission Summary (Full Text)

{0}------------------------------------------------

page 1/3

MAY 1 3 2013

### 510(K) SUMMARY

## AG MASSTM

### 510(k) Number K131099

Applicant's Name:

#### Hospitech Respiration Ltd.

20 Hamagshimim St. Kiryat Matalon, POB 7970 · Petach-Tikva, 49250 Israel TEL: [phone], FAX: [phone]

Yoram Levy, Qsite Contact Person: 31 Haavoda St. Binyamina, Israel 30500 Tel [phone]; Fax [phone] [e-mail]

Summary 510(k) Preparation Date: April 14, 2013

AG MASSTM Trade Name:

Irrigation Syringe Device Type

Regulatory Name: Powered suction pump Classification:

Product Code: JCX

Regulation No: 21 CFR 878.4780

Class: II

Classification Panel: General Hospital

### Device Description:

The AG MASS™ is a sterile injection and draining device.

The device is intended to deliver Saline fluid in order to dilute secretions accumulated above the cuff of an Endotracheal Tube and drain out all fluids. The AG MASS™ contains two syringes of 35 CC and 10 CC that are enclosed within MASS main body and is designed for use with Hospitech's AnapnoGuard ETT.

The AG MASSTM is provided sterile for single use.

### Intended Use Statement:

{1}------------------------------------------------

The AG MASSTM Suction Pump System is intended for the application of lowflow suction for the removal of fluids, including irrigation fluids, body fluids and infectious materials.

Substantial equivalence to the following predicate devices is Predicate Devices: claimed:

| Device Name | Manufacturer | 510k No | Date of approval |
|----------------------------------------------------|----------------------------|---------|------------------|
| Boehirnger Laboratories<br>Suction Pump System | Boehirnger<br>Laboratories | K060277 | March 03, 2006 |
| Aardvark nasal irrigation<br>and aspiration device | Aardvark<br>Medical | K082762 | Nov. 12 2008 |
| Single Cannula Extended<br>Applicator | Micromedics, Inc. | K102563 | March 15, 2011 |

#### Performance Standards

- AG MASSTM was tested and complies with the following standards:
- ANSI/AAMI/ISO 11137-1: 2006 Sterilization of health care � products - Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
- ISO 10993-1:2003(E), Biological evaluation of medical . devices -- Part 1: Evaluation and testing.

Refer to Section 5 for the complete list of standards.

### Performance Bench Tests

Bench testing demonstrated that the AG MASS™ is as safe and effective as the cleared predicate devices. The following bench tests were conducted:

- Draining Validation .
- AG MASS prefilled saline syringechemical and . toxicological assessment
- The device was also tested for Chemical and toxicological . assessment (possible leachable and extractable) following the sterilization process and found safe.

{2}------------------------------------------------

K131099 page 3/3

#### Summary of Pre-Clinical and clinical study

The common practice for evacuating secretions that accumulates while using endotracheal tubes is by manually injecting saline with a standard syringe connected to the proximal port of the suction lumen and then applying vacuum to remove the diluted secretions.

The AG MASS™ removes secretions in a similar way to the commonly used syringe, implementing the same technology. The AG MASSTM was tested in bench performance tests and in preclinical testing to perform its intended use safely and efficiently. Thus, Hospitech believes that clinical studies are not required to determine the safety and efficacy of the device.

#### Comparison with the Predicate Device

The AG MASSIM, like its primary predicate device - the Boehirnger Laboratories Suction Pump System is intended for the removal of infectious materials from the patient's respiratory support system.

The AG MASSIM and its predicate devices, the Aardvark nasal irrigation and aspiration device and the Single Cannula Extended Applicator, have the same technological characteristics. Furthermore, the AG MASSTM and the predicate devices have identical or similar technological features as discussed in the substantial equivalence section (section 8). Performance testing show compliance of the device with its intended use, and that any minor differences in the design do not raise any new safety and effectiveness issues. Therefore the AG MASSTM is substantially equivalent to its predicate devices.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is also black.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

May 13, 2013

Hospitech Respiration, Ltd. % Qsite Mr. Yoram Levy 31 Haavoda Street Binyamina, Israel 30500

Re: K131099

Trade/Device Namė: AG MASS™ Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: JCX Dated: April 17, 2013 Received: April 19, 2013

Dear Mr. Levy:

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

{4}------------------------------------------------

Page 2 - Mr. Yoram Levy

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please, note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/MedicalDeyices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, FOR

# Peter Dikumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K131099

Device Name:

AG MASSTM

Indications for Use:

The AG MASSTM Suction Pump System is intended for the application of low flow suction for the removal of fluids, including irrigation fluids, body fluids and infectious materials.

Prescription Use X (Part 21 CFR 801 Subpart D)

.

. . . . . . . . . . . . . . .

AND/OR

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

.

- - - - - - - -- -- -- -------------------------------------------------------------------------------------------------------------------------------------------------------

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

## David Krause - S

(Division Sign-Off) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number: K131099

- --- ---