(24 days)
Not Found
No
The document describes a mechanical suction and irrigation device with no mention of AI or ML capabilities.
No.
The device is described as an injection and draining device for the removal of fluids, which is a supportive function and not directly therapeutic in itself, as it does not treat or cure a medical condition.
No.
The device is intended for the application of low flow suction for the removal of fluids and to deliver saline to dilute and drain secretions. It does not analyze patient data or provide information about a patient's medical condition or diagnosis.
No
The device description clearly states it is a "sterile injection and draining device" containing "two syringes" and a "MASS main body," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "application of low flow suction for the removal of fluids, including irrigation fluids, body fluids and infectious materials." This describes a physical process of removing substances from the body, not analyzing them in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a "sterile injection and draining device" used to "deliver Saline fluid... and drain out all fluids." This further reinforces its function as a fluid management tool within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on the composition or properties of the removed fluids.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The AG MASS™ Suction Pump System does not fit this description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JCX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 878.4780 Powered suction pump.
(a)
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.(b)
Classification. Class II.
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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: (972)3-919-1648, FAX: (972)3-919-1649
Yoram Levy, Qsite Contact Person: 31 Haavoda St. Binyamina, Israel 30500 Tel (972)4-638-8837; Fax (972)4-638-0510 Yoram@gsitemed.com
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 | |||
| Suction Pump System | Boehirnger | ||
| Laboratories | K060277 | March 03, 2006 | |
| Aardvark nasal irrigation | |||
| and aspiration device | Aardvark | ||
| Medical | K082762 | Nov. 12 2008 | |
| Single Cannula Extended | |||
| 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.
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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.
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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
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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 (800) 638-2041 or (301) 796-7100 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