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 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.

AI/ML Overview

The provided document describes the predicate comparison for the TWBM Pump and its substantial equivalence determination to the Penumbra Pump MAX™. It outlines acceptance criteria and test results for non-clinical performance and regulatory compliance.

Here's an analysis based on your request:

Acceptance Criteria and Reported Device Performance

Attributes	Acceptance Criteria	Reported Device Performance (Result)	Study that Proves Acceptance Criteria Met
TWBM Pump
Compliance with ANSI/AAMI ES60601-1 and CAN/CSA C22.2 NO. 60601-1	100% Pass	YES (Passed)	Performance bench testing
Compliance with IEC 60601-1-2	100% Pass	YES (Passed)	Electromagnetic Compatibility testing
Compliance with ISO 10079-1	100% Pass	YES (Passed)	Performance bench testing
Compliance with IEC 60529 for IP Code	The requirement for the IP 21 marking should be met.	YES (Met)	Performance bench testing
TWBM Canister (Compliance with ISO 10079-1)
Design and Operational Requirements for TWBM Canister and its Components	100% Pass	YES (Passed)	Performance bench testing

Key takeaway: The document states that "All the test results from the performance testing passed the acceptance criteria set forth by the respective standards."

Further Information (Based on the provided document)

Sample size used for the test set and the data provenance: The document does not specify the number of units (sample size) for the TWBM Pump and TWBM Canister that were subjected to the performance and EMC testing. The provenance of the data is from laboratory testing conducted by Taiwan Biomaterial Co., Ltd. (TWBM) and implied third-party testing for compliance standards. The document doesn't mention country of origin for data in terms of patient data, as this is a non-clinical submission. It is a non-clinical (bench) study rather than a study involving patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is a non-clinical (bench) study for device performance and regulatory compliance, not an AI/imaging device. Therefore, the concept of "ground truth" as established by medical experts (e.g., radiologists) for diagnostic accuracy is not applicable here. The "ground truth" in this context is defined by the technical specifications and performance requirements of the relevant industry standards (e.g., ISO 10079-1, IEC 60601-1-2). Testers/engineers conducted the tests against these pre-defined standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus among medical experts for image interpretation or diagnosis. For bench testing, results are objective (pass/fail against a standard).
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This study focuses on the safety and performance of a physical medical device (suction pump) and its substantial equivalence to a predicate device through non-clinical testing, not an AI or imaging diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this non-clinical study is the technical specifications and performance requirements outlined in the cited international and national standards (e.g., ISO 10079-1, ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60529). The device's performance was measured against these engineering and safety benchmarks.
The sample size for the training set: Not applicable. This is a non-clinical submission for a physical device, not an AI model that requires a training set.
How the ground truth for the training set was established: Not applicable, as no training set was used.

Summary

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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.

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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

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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)

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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,Hsinchu County 30261, Taiwan.
Telephone	+886-3-6683088
Fax	+886-3-6683099
Contact Person	Monoj Mon Kalita, PhDRegulatory Affairs SpecialistPhone: +886-3-6683088 ext. 309Email: 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, ACPowered
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

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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(Predicate Device)	TWBM Pump(Subject Device)
510(k) Number	K122756	K180115
ClassificationName	Apparatus, Suction, Ward Use,Portable, AC-Powered	Same as predicate
Class	II	Same as predicate
Product Code	JCX	Same as predicate
Intended Use	General suction use in hospitals orclinics	Same as predicate
Product Type	AC-Powered suction pump	Same as predicate
Manufacturer	Penumbra Inc.	TWBM
Electricalrequirement	100-115Vac50Hz, 60Hz	110-120Vac60Hz
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(39.37cm×28.45cm×33.53 cm)	12.2in×6.2in×11.3in(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
Overflowprotection	Yes	Same as predicate
Filter	Microbial, hydrophobic	Same as predicate
OperatingEnvironment	Temp: 65°F~~75°F (18°C~~ 24°C)Humidity: <75% RHPressure: Sea Level – 6000 ft (1829m)	Same as predicate
StorageEnvironment	Temp: - 20°F~~120°F (-29°C~~ 49°C)Humidity: <95% RH	Same as predicate

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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(YES/NO)
TWBM Pump
Compliance with ANSI/AAMI ES60601-1 andCAN/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 theIP 21 marking should bemet.	YES
TWBM Canister (Compliance with ISO 10079-1)
Design and Operational Requirements for TWBMCanister 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.

Regulation Number and Section

§ 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.