Hang&Go PAC
Device Facts
| Record ID | K161613 |
|---|---|
| Device Name | Hang&Go PAC |
| Applicant | Rand S.R.L. |
| Product Code | LGZ · General Hospital |
| Decision Date | Dec 28, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Disposable device intended to recirculate, filtrate and perfuse physiologically compatible sterile solution (i.e. saline solution) in the thoracic or abdominal cavity. The device is intended for use in a single procedure.
Device Story
Hang&Go PAC is a disposable, single-use kit for recirculating, filtrating, and perfusing sterile saline solution in thoracic or abdominal cavities; used exclusively with the PERFORMER HT system. Kit includes circulation tubing, heater bag, reservoir, and table pack with integrated temperature probes and pre-assembled catheters. Includes a 'Flow Reverse' accessory featuring manual clamps to exchange patient inlet/outlet flows. Operated by clinicians in a clinical setting. Device maintains fluid circulation and temperature control to support therapeutic procedures. Benefits include integrated monitoring and simplified setup via pre-assembled components.
Clinical Evidence
Bench testing only. No clinical data provided. Testing included packaging qualification (ASTM D4169), accelerated aging (ASTM F1980), catheter force at break (EN 1617), static priming volume, pressure drop determination, temperature probe qualification, and physical integrity/hydraulic testing of the Flow Reverse component.
Technological Characteristics
Disposable kit; materials include tubing, connectors, and reservoir. Features integrated temperature probes and manual flow-reversal clamps. Sterilized via ethylene oxide (ISO 11135). Compliant with ISO 14971 (risk management), ISO 10993 series (biocompatibility), and ISO 11607 (packaging). Connectivity: Designed for use with PERFORMER HT system. No software/algorithm.
Indications for Use
Indicated for patients requiring recirculation, filtration, and perfusion of physiologically compatible sterile solutions (e.g., saline) within the thoracic or abdominal cavity during a single procedure.
Regulatory Classification
Identification
An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.
Predicate Devices
- Hang&Go HT Basic (K120026)
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
December 28, 2016
RanD S.r.1. Simone Ceretti Regulatory Affairs Manager via Statale 12, 62 Medolla 41036 ITALY
Re: K161613
Trade/Device Name: Hang&Go PAC Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LGZ Dated: November 25, 2016 Received: December 1, 2016
Dear Simone Ceretti:
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.
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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 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 (OS) 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,
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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
510(k) Number (if known) K161613
Device Name
Hang&Go PAC
Indications for Use (Describe)
Disposable device intended to recirculate, filtrate and perfuse physiologically compatible sterile solution (i.e. saline solution) in the thoracic or abdominal cavity. The device is intended for use in a single procedure.
| <span> <span style="font-size: 12px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
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INNOVATION IN MEDICAL TECHNOLOGY
### 510(k) Summary
21 CFR 807.92(a)(1): Submitter and Manufacturing site information RanD S.r.1. via Statale 12, 62 41036 Medolla (MO) – ITAL Y Telephone: +39 0535 49283 Fax: +39 0535 660636 Contact person: Simone Ceretti
Establishment registration number: 3003793891
Date of the present summary preparation: 28th December, 2016
| 21 CFR 807.92(a)(2): Device information | | | | |
|-----------------------------------------|---------------------------------------|--|--|--|
| Trade name: | Hang&Go PAC | | | |
| Device: | Infusion pump | | | |
| Classification Panel: | General Hospital | | | |
| Product Code: | LGZ (Warmer, Thermal, Infusion Fluid) | | | |
| Regulation name: | Infusion pump | | | |
| Regulation number: | 21 CFR § 880.5725 | | | |
| Regulatory Class: | 2 | | | |
#### 21 CFR 807.92(a)(3): Predicate device
Hang&Go HT Basic (cleared under K120026, dtd. May 8 2012).
#### 21 CFR 807.92(a)(4): Description of the device
The Hang&Go PAC is intended to be used like the Hang&Go HT Basic R9900090, cleared under K120026. The Hang&Go PAC, just like the Hang&Go HT Basic, is a disposable, single use kit intended to circulate and filtrate physiologically compatible sterile solution (i.e. saline solution) in the thoracic or abdominal cavity. The Hang&Go PAC is supplied sterile and packaged in a proprietary-design container and it is intended to be used only with the PERFORMER HT.
The Hang&Go PAC, just like the Hang&Go HT Basic, includes all necessary tubing and components for the treatment execution:
- · circulation tubing
- · heater bag
- · reservoir
- · table pack (Patient inlet and outlet tubing) with thermal protections
#### 21 CFR 807.92(a)(4): Description of the device (Flow Reverse)
The Flow Reverse is a disposable, sterile component of the Hang&Go PAC. It is supplied sterile, individually packaged and included in the Hang&Go PAC carton box. The crossed layout of the 4 tubing segments allow to exchange the Patient's inlet and outlet flows by selectively opening / closing two segments at a time with the provided manual clamps.
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INNOVATION IN MEDICAL TECHNOLOGY
# 21 CFR 807.92(a)(5): Indications for use
The Hang&Go PAC is a disposable device intended to recirculate, filtrate and perfuse physiologically compatible sterile solution (i.e. saline solution) in the thoracic or abdominal cavity.
The device is intended for use in a single procedure.
## Predicate device intended use
The Hang&Go HT Basic is a disposable device intended to recirculate, filtrate and perfuse clear solutions in the thoracic or abdominal cavity.
The device is intended for use in a single procedure.
## 21 CFR 807.92(a)(6): Comparison of technological characteristics
The Hang&Go PAC has the same intended, materials and principle of use of the Hang&Go HT Basic.
The design of the Hang&Go PAC differs from the Hang&Go HT Basic in the following aspects:
- . The inlet and outlet tubing to/from the Patient of the Hang&Go PAC have two access points, instead of three:
- . The inlet and outlet tubing of the Hang&Go PAC have two additional integrated temperature probes;
- . The inlet and outlet tubing of the Hang&Go PAC have pre-assembled catheters, instead the Hang&Go HT Basic inlet and outlet tubing have proper connectors at one end ant the user must connect catheters at the moment of use;
- . the Hang&Go PAC includes in the packaging an accessory, the Flow Reverse. Comparison with this component is detailed in the following section.
Manufacturing process for the assembly of the components and the sterilization process are the same conducted on the Hang&Go HT Basic. Moreover, main technical features and mode of use are the same. Thus, all the validation activities made on the Hang&Go HT Basic (mechanical tests, efficacy tests, shelf life, compatibility, validation of sterilization process and microbiological controls) apply to the Hang&Go PAC too.
## 21 CFR 807.92(a)(6): Comparison of technological characteristics (Flow Reverse)
As said above, the Flow Reverse is a component included into the Hang&Go PAC packaging. The Flow Reverse is made of elements (i.e. tubing, quick connectors, Y connectors, manual clamps) already used for the Hang&Go HT Basic manufacture. Manufacturing process for the assembly of the components and the sterilization process are the same conducted on the Hang&Go HT Basic.
## 21 CFR 807.92(b)(1): Discussion of the non-clinical tests
The table below lists all standards to which the Hang&Go PAC is compliant. Biocompatibility and sterilization are covered by the testing and validation done on the Hang&Go HT Basic.
Packaging qualification acc. to ASTM D4169 and accelerated aging test acc. to ASTM F1980 were instead repeated using the same protocols of the Hang&Go HT Basic, and force at break of the pre-assembled catheters acc. to EN 1617 (not applicable to the Hang&Go HT
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TO M Fr STE
Basic) was also conducted. The biocompatibility and sterilization verification testing associated with the standards listed below were applied to the predicate device and cross referenced to support the substantial equivalence of the Hang&Go PAC and Reverse Flow components.
| Area | US Recognized standard # | Title |
|------------------------|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | ISO 14971:2007 | Medical devices - Application of risk management to medical devices |
| Packaging and labeling | ASTM D4169-14 | Standard Practice for Performance Testing of Shipping Containers and Systems |
| Biocompatibility | AAMI ANSI ISO 10993-1:2009/(R)2013 | Biological evaluation of medical devices - Part 1: Evaluation and testing |
| | AAMI ANSI ISO 10993-5:2009/(R)2014 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood |
| | AAMI ANSI ISO 10993-7:2008/(R)2012 | Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity |
| | ISO 10993-10:2010 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals |
| | AAMI ANSI ISO 10993-11:2006/(R)2010) | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
| | ISO 11135:2014 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity |
| Sterility | ISO 11607-1:2006 | Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices. |
| | ISO 11607-2:2006 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| | ASTM F1980-07(2011) | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes |
| | ISO 11737-1:2006 | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. |
| | | Sterilization of medical devices-Microbiological methods-Part 1: Determination of the population of microorganisms on product |
#### Table 1: Applicable Reference Standards list
In addition, the following tests (they do not follow any reference standard method) were conducted using saline solution to demonstrate continued conformance of new design outputs with the defined requirements:
- Static priming volume of the Hang&Go table pack inlet/outlet lines; ●
- . Qualification of the two additional temperature probes assembled on the table pack lines;
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CALLE
- Pressure drops determination of the Hang&Go table pack inlet/outlet lines; ●
- Verification of the fitting interfaces and effectiveness of the Flow Reverse. ●
- Physical integrity verification through hydraulic test in pressure of the Flow Reverse ●
- Static and Dynamic Priming Volume of the Flow Reverse. .
### 21 CFR 807.92(b)(1): Discussion of the non-clinical tests (Flow Reverse)
As said, the Flow Reverse uses the same components already in use in the Hang&Go HT Basic. Manufacturing process, sterilization, and packaging are also the same. All above listed reference standards apply also to the Flow Reverse (except EN 1617 being specifically related for the catheters, preassembled to the Hang&Go PAC table pack lines). All testing and validations for packaging, sterilization and biocompatibility conducted on the Hang&Go HT Basic apply to the Hang&Go PAC and the Flow Reverse too.
The tests listed in the last 3 bullet points of the previous paragraph were conducted on the Flow Reverse for qualification of the related features. The protocols used in these tests were similar to those used for qualifying the same features of the Hang&Go HT Basic. Saline was used as the test liquid to represent the physiologically compatible sterile solution.
## 21 CFR 807.92(b) (3): Conclusions
Based upon performance testing and compliance with voluntary standards, RanD believes that the Hang&Go PAC is substantially equivalent to the predicate device, and does not raise new concerns of safety or effectiveness.
