TWBM Pump
Device Facts
| Record ID | K180115 |
|---|---|
| Device Name | TWBM Pump |
| Applicant | Taiwan Biomaterial Co., Ltd. |
| Product Code | JCX · General, Plastic Surgery |
| Decision Date | Jul 24, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4780 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
TWBM Pump is intended for general suction use in hospitals or clinics.
Device Story
TWBM Pump is an AC-powered, oil-less positive displacement suction pump used in hospitals or clinics to remove secretions, blood, and body fluids. The device features a plastic casing with an ON/OFF button, vacuum regulator, and analog pressure gauge. It utilizes a 1000 mL collection canister with tubing, a microbial filter, and an overflow protection device. The operator connects the canister to the pump via tubing; the pump generates up to 29 inHg (737 mmHg) of vacuum to draw fluids into the canister. The device assists healthcare providers in fluid management, facilitating cleaner surgical or clinical sites and patient care environments.
Clinical Evidence
No clinical data. Substantial equivalence is supported by non-clinical bench testing, including electromagnetic compatibility (IEC 60601-1-2), electrical safety (ANSI/AAMI ES60601-1, CAN/CSA C22.2 NO. 60601-1), and performance testing (ISO 10079-1, IEC 60529). All tests met established acceptance criteria.
Technological Characteristics
AC-powered oil-less positive displacement pump. Vacuum range: 0-29 inHg (0-737 mmHg). Flow rate: 0-0.8 SCFM (0-23 LPM). Includes 1000 mL canister with microbial filter and overflow protection. IP21 rated. Complies with ISO 10079-1, ANSI/AAMI ES60601-1, CAN/CSA C22.2 NO. 60601-1, and IEC 60601-1-2.
Indications for Use
Indicated for general suction use in hospitals or clinics for the removal of secretions, blood, and other body fluids via continuous negative pressure.
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
- Penumbra Pump MAX™ (K122756)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
July 24, 2018
Taiwan Biomaterial Co., Ltd. Monoj Kalita Regulatory Affairs Specialist 6F, No. 26-1, Sec.2, Shengyi Rd. Zhubei City, Hsinchu County, Taiwan 30261
Re: K180115
Trade/Device Name: TWBM Pump Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: JCX Dated: January 12, 2018 Received: January 16, 2018
Dear Monoj Kalita:
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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related 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.
{1}------------------------------------------------
K180115
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
## Indications for Use
510(k) Number (if known) K180115
Device Name TWBM Pump
Indications for Use (Describe)
TWBM Pump is intended for general suction use in hospitals or clinics.
| 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)
## CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
## SECTION 2: 510(K) SUMMARY
#### 2.1. APPLICANT INFORMATION
| Applicant Name | Taiwan Biomaterial Co., Ltd. (TWBM) |
|----------------|--------------------------------------------------------------------------------------------------------------------|
| Address | 6F, No. 26-1, Sec.2, Shengyi Rd., Zhubei City,<br>Hsinchu County 30261, Taiwan. |
| Telephone | +886-3-6683088 |
| Fax | +886-3-6683099 |
| Contact Person | Monoj Mon Kalita, PhD<br>Regulatory Affairs Specialist<br>Phone: +886-3-6683088 ext. 309<br>Email: mon@twbm.com.tw |
Date Prepared
June 21, 2018
#### SUBJECT DEVICE 2.2.
| Trade Name | TWBM Pump |
|---------------------|-------------------------------------------------------|
| Common/Usual Name | Powered Suction Pump |
| Device Class | Class II |
| Regulation Number | 21 CFR 878.4780 |
| Classification Name | Apparatus, Suction, Ward Use, Portable, AC<br>Powered |
| Product Code | JCX |
#### 2.3. PREDICATE DEVICE NAME
Penumbra Pump MAX™ (K122756)
#### INTENDED USE 2.4.
TWBM Pump is intended for general suction use in hospitals or clinics.
#### 2.5. DEVICE DESCRIPTION
The TWBM Pump is intended for general suction use in hospitals or clinics where secretions, blood and other body fluids must be removed through the application of continuous negative pressure. The TWBM Canister is an accessory to the TWBM Pump and the removed body fluids are collected in it. The TWBM Pump is an AC powered oil-less positive displacement pump capable of delivering up to 29 inHg (737 mmHg) of vacuum to draw fluid and small particles. The TWBM Pump has a plastic casing fitted with a power (ON/OFF) button, one vacuum regulator, an analog pressure gauge and one sliding canister holder. The TWBM Canister is a preassembled 1000 mL canister including canister tubing fitted with a microbial filter at the distal end. The canister is fitted with a removable lid for fluid containment and an overflow protection device. The TWBM Canister should be placed in the in-built sliding canister holder, and connect
{4}------------------------------------------------
the TWBM Canister with the TWBM Pump via the connectors of the canister tubing prior to use. Both, the TWBM Pump and the TWBM Canister, are provided non-sterile and are packaged separately.
### TECHNOLOGICAL AND REGULATORY ATTRIBUTES 2.6. COMPARISON
The technological and regulatory attributes of the subject device are compared with the predicate device as illustrated in the table below:
| Attributes | Penumbra Pump MAXTM<br>(Predicate Device) | TWBM Pump<br>(Subject Device) |
|---------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------|
| 510(k) Number | K122756 | K180115 |
| Classification<br>Name | Apparatus, Suction, Ward Use,<br>Portable, AC-Powered | Same as predicate |
| Class | II | Same as predicate |
| Product Code | JCX | Same as predicate |
| Intended Use | General suction use in hospitals or<br>clinics | Same as predicate |
| Product Type | AC-Powered suction pump | Same as predicate |
| Manufacturer | Penumbra Inc. | TWBM |
| Electrical<br>requirement | 100-115Vac<br>50Hz, 60Hz | 110-120Vac<br>60Hz |
| Flow Rate | 0-0.8 SCFM (0-23 LPM) | Same as predicate |
| Vacuum Range | 0-29 inHg (0-737mmHg) | Same as predicate |
| Noise level | <60dB | Same as predicate |
| Dimensions | 15.5in×11.2in×13.2in<br>(39.37cm×28.45cm×33.53 cm) | 12.2in×6.2in×11.3in<br>(30.9cm×15.7cm×28.7cm) |
| Weight | 22.3 lb (10.1 kg) | 14.8 lb (6.7 kg) |
| Accessories | 1 L canister with canister tubing | Same as predicate |
| Overflow<br>protection | Yes | Same as predicate |
| Filter | Microbial, hydrophobic | Same as predicate |
| Operating<br>Environment | Temp: 65°F~75°F (18°C~ 24°C)<br>Humidity: <75% RH<br>Pressure: Sea Level – 6000 ft (1829m) | Same as predicate |
| Storage<br>Environment | Temp: - 20°F~120°F (-29°C~ 49°C)<br>Humidity: <95% RH | Same as predicate |
{5}------------------------------------------------
#### SUMMARY OF DEVICE TESTING 2.7.
TWBM Pump was subjected to Electromagnetic Compatibility testing in accordance with IEC 60601-1-2 and performance bench testing in accordance with ISO 10079-1, ANSI/AAMI ES60601-1 and CAN/CSA C22.2 NO. 60601-1 as well as IEC 60529. Testing for TWBM Pump were conducted by following the FDA's "Guidance Document for Powered Suction Pump 510(k)s'' (Sept. 30, 1998). All the test results from the performance testing passed the acceptance criteria set forth by the respective standards.
#### SUMMARY OF NON-CLINICAL PERFORMANCE TESTING 2.8.
The table below highlights the non-clinical performance testing of the TWBM Pump and its accessory, TWBM Canister conducted for the determination of substantial equivalence with the predicate Penumbra Pump MAX™.
| Attributes | Acceptance Criteria | Result<br>(YES/NO) |
|-----------------------------------------------------------------------------|------------------------------------------------------------|--------------------|
| TWBM Pump | | |
| Compliance with ANSI/AAMI ES60601-1 and<br>CAN/CSA C22.2 NO. 60601-1 | 100% Pass | YES |
| Compliance with IEC 60601-1-2 | 100% Pass | YES |
| Compliance with ISO 10079-1 | 100% Pass | YES |
| Compliance with IEC 60529 for IP Code | The requirement for the<br>IP 21 marking should be<br>met. | YES |
| TWBM Canister (Compliance with ISO 10079-1) | | |
| Design and Operational Requirements for TWBM<br>Canister and its Components | 100% Pass | YES |
#### CONCLUSION 2.9.
Both the TWBM Pump as well as the predicate Penumbra Pump MAX™ are AC-Powered Suction Pumps with similar accessories for fluid containment. Additionally, the non-clinical bench testing results and the comparison of technological characteristics, intended use, the principle of operation and operating environment support the determination of TWBM Pump to be substantially equivalent to the predicate Penumbra Pump MAX™. It can be concluded that the subject device performs as safe and effective as the predicate device.
